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full study rank 61406 study protocol section identification module n c t id NCT04836884 org study id info org study id 20-011265 organization org full name Mayo Clinic org class OTHER brief title Vascular Anomaly Pathology and Genomics Biopsy Study official title Validation of Core Biopsy of Vascular Anomalies for Clinical Pathology and Genomics status module status verified date April 2022 overall status Completed expanded access info has expanded access No start date struct start date April 6, 2021 start date type Actual primary completion date struct primary completion date January 31, 2022 primary completion date type Actual completion date struct completion date January 31, 2022 completion date type Actual study first submit date March 25, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 20, 2022 last update post date struct last update post date April 21, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Emily C. Bendel, M.D. responsible party investigator title Principal Investigator responsible party investigator affiliation Mayo Clinic lead sponsor lead sponsor name Mayo Clinic lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this research is to gather information on the safety and effectiveness of core biopsy of vascular anomalies for clinical pathology and clinical genomics studies. detailed description Vascular anomalies or vascular malformations often are treated with minimally invasive sclerotherapy, embolization or ablation based on clinical and imaging features without acquisition of tissue. Over the last two decades there have been significant advancements in the understanding of the genetic basis for various vascular anomalies/malformations, which may guide use of therapies for individualized treatment. As such, given the emergence of novel medications for treatment of vascular anomalies/malformations based on genetic information, acquisition of tissue for pathology and genomic characterization will be increasingly important as treatment of vascular anomalies/vascular malformations moves toward individualized medicine approach. conditions module condition list condition Vascular Malformations Vascular Anomaly Hemangioma Arteriovenous Malformations Venous Malformation Klippel Trenaunay Syndrome Lymphatic Malformation design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Basic Science design masking info design masking None (Open Label) enrollment info enrollment count 3 enrollment type Actual arms interventions module arm group list arm group arm group label Vascular anomaly/malformation biopsy arm group type Experimental arm group description Subjects with a vascular anomaly will have a research percutaneous vascular anomaly/malformation biopsy completed at the time of the clinically indicated percutaneous sclerotherapy, embolization and/or ablation. arm group intervention list arm group intervention name Procedure: Percutaneous Vascular Anomaly/Malformation Biopsy intervention list intervention intervention type Procedure intervention name Percutaneous Vascular Anomaly/Malformation Biopsy intervention description US-guided percutaneous vascular anomaly core needle biopsy of up to 10 cores using an 18-gauge co-axial core needle biopsy device at the time of clinically indicated sclerotherapy, embolization or ablation treatment. intervention arm group label list intervention arm group label Vascular anomaly/malformation biopsy outcomes module primary outcome list primary outcome primary outcome measure Adequacy of core biopsy of vascular anomalies for clinical genomics studies primary outcome description DNA and RNA will be extracted from the biopsy specimens, undergo qualitative/quantitative quality control assessment and be analyzed by whole genome sequencing (DNA) and RNA sequence analysis (RNA-seq) to determine the adequacy of vascular anomaly biopsy for vascular anomaly genomics characterization. primary outcome time frame 18 months primary outcome measure Adequacy of core biopsy of vascular anomalies for clinical pathology evaluation primary outcome description Tissue from the vascular anomaly biopsies will undergo histopathology and immunohistochemical staining to determine the adequacy of vascular anomaly core biopsy for clinical pathology characterization. primary outcome time frame 18 months secondary outcome list secondary outcome secondary outcome measure Safety of vascular anomaly core biopsy secondary outcome description Number of participants with biopsy-related adverse events as assessed by CTCAE v4.0 secondary outcome time frame 30 days eligibility module eligibility criteria Inclusion Criteria: Patients with a clinical and imaging diagnosis of a vascular anomaly. No prior treatment for the vascular anomaly. Subjects undergoing clinically indicated sclerotherapy, embolization and/or ablation. Male or female with age greater than or equal to 18 years. Capacity and willingness to provide a written informed consent.. Exclusion Criteria: Subjects with prior treatment for their vascular anomaly. Uncorrectable coagulopathy. Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the procedure. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Emily Bendel, MD overall official affiliation Mayo Clinic overall official role Principal Investigator overall official name David A Woodrum, MD, PhD overall official affiliation Mayo Clinic overall official role Principal Investigator location list location location facility Mayo Clinic in Rochester location city Rochester location state Minnesota location zip 55905 location country United States references module see also link list see also link see also link label Mayo Clinic Clinical Trials see also link u r l https://www.mayo.edu/research/clinical-trials derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006391 condition mesh term Hemangioma condition mesh id D000008202 condition mesh term Lymphangioma condition mesh id D000001165 condition mesh term Arteriovenous Malformations condition mesh id D000054079 condition mesh term Vascular Malformations condition mesh id D000007715 condition mesh term Klippel-Trenaunay-Weber Syndrome condition mesh id D000044148 condition mesh term Lymphatic Abnormalities condition mesh id D000000013 condition mesh term Congenital Abnormalities condition ancestor list condition ancestor condition ancestor id D000009383 condition ancestor term Neoplasms, Vascular Tissue condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000018376 condition ancestor term Cardiovascular Abnormalities condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000018190 condition ancestor term Lymphatic Vessel Tumors condition ancestor id D000008206 condition ancestor term Lymphatic Diseases condition ancestor id D000000798 condition ancestor term Angiomatosis condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M12 condition browse leaf name Congenital Abnormalities condition browse leaf as found Malformations condition browse leaf relevance high condition browse leaf id M3625 condition browse leaf name Arteriovenous Malformations condition browse leaf as found Arteriovenous Malformations condition browse leaf relevance high condition browse leaf id M26711 condition browse leaf name Vascular Malformations condition browse leaf as found Vascular Anomalies condition browse leaf relevance high condition browse leaf id M10351 condition browse leaf name Lymphangioma condition browse leaf as found Lymphatic Malformations condition browse leaf relevance high condition browse leaf id M9887 condition browse leaf name Klippel-Trenaunay-Weber Syndrome condition browse leaf as found Klippel Trenaunay Syndrome condition browse leaf relevance high condition browse leaf id M24430 condition browse leaf name Lymphatic Abnormalities condition browse leaf as found Lymphatic Malformations condition browse leaf relevance high condition browse leaf id M8631 condition browse leaf name Hemangioma condition browse leaf as found Hemangioma condition browse leaf relevance high condition browse leaf id M15283 condition browse leaf name Sturge-Weber Syndrome condition browse leaf relevance low condition browse leaf id M11480 condition browse leaf name Neoplasms, Vascular Tissue condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M19656 condition browse leaf name Cardiovascular Abnormalities condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M10355 condition browse leaf name Lymphatic Diseases condition browse leaf relevance low condition browse leaf id M3278 condition browse leaf name Angiomatosis condition browse leaf relevance low condition browse leaf id T3529 condition browse leaf name Lymphatic Malformations condition browse leaf as found Lymphatic Malformations condition browse leaf relevance high condition browse leaf id T3248 condition browse leaf name Klippel-Trenaunay Syndrome condition browse leaf as found Klippel Trenaunay Syndrome condition browse leaf relevance high condition browse leaf id T4428 condition browse leaf name Parkes Weber Syndrome condition browse leaf as found Klippel Trenaunay Syndrome condition browse leaf relevance high condition browse leaf id T5905 condition browse leaf name Weber Syndrome condition browse leaf as found Klippel Trenaunay Syndrome condition browse leaf relevance high condition browse leaf id T5493 condition browse leaf name Sturge-Weber Syndrome condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04836884
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full study rank 61640 study protocol section identification module n c t id NCT04833842 org study id info org study id SİVAS CUMHURİYET ÜNİVERSİTESİ organization org full name Cumhuriyet University org class OTHER brief title Childbirth Preparation Program Developed Based on Health Belief Model official title The Effect of Pre-Birth Program Developed Based on Health Belief Model on Fear of Birth, Birth Self-Efficacy, Birth Process and Perception in Primigravida Pregnant Women status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 15, 2021 start date type Anticipated primary completion date struct primary completion date June 15, 2021 primary completion date type Anticipated completion date struct completion date July 30, 2021 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 2, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Bi̇rnur Yeşi̇ldağ Çeli̇k responsible party investigator title lecturer responsible party investigator affiliation Cumhuriyet University lead sponsor lead sponsor name Cumhuriyet University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Pregnants who underwent a web-based preparation for labor program, which was developed based on the health belief model and supported by motivational interviews, had a higher perception of birth self-efficacy than those who did not pass. Pregnant women who underwent a web-based preparation for labor program, which was developed based on a health belief model and supported by motivational interviews, had a more positive perception of birth than those who did not pass. The level of fear experienced at birth is lower in pregnant women who underwent a web-based preparation for labor program, which was developed based on the health belief model and supported by motivational interviews. The frequency of voluntary cesarean delivery is lower in pregnant women who undergo a web-based preparation for labor program, which is developed based on the health belief model and supported by motivational interviews. The frequency of episiotomy is lower in pregnant women who undergo a web-based preparation for labor program, which is developed based on a health belief model and supported by motivational interviews. Induction frequency is lower in pregnant women who underwent a web-based preparation for labor program, which was developed based on the health belief model and supported by motivational interviews, than those who did not pass. Pregnants who underwent a web-based preparation program for labor, which was developed based on the health belief model and supported by motivational interviews, had a shorter delivery period than those who did not pass. detailed description In the three-month study, a web-based childbirth preparation program will be applied to primigravida women in the initiative group, based on the Health Belief Model and supported by motivational interviews. Training will take five weeks. Beginning from the 30th week of pregnancy, pregnant women will be asked to read the first part of the website and a suitable time will be determined for a motivational interview by calling the phone within that week. All applications of pregnant women related to the website will be evaluated. At the specified time, pregnant women will be taken to motivational interview training based on the Health Belief Model and the trainings will be carried out individually and online. A web-based birth preparation program based on the Health Belief Model will be applied to primigravida women in the control group. Training will take five weeks. Beginning from the 30th week of pregnancy, pregnant women will be asked to read the first part of the website. All applications of pregnant women related to the website will be evaluated. conditions module condition list condition Fear of Childbirth Self-efficacy keyword list keyword motivational interviewing childbirth training fear of childbirth, self-efficacy primigravida women design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description This study is a randomized controlled trial. design primary purpose Supportive Care design masking info design masking Double design masking description In the study, the single blinding method, in which the participants are blinded, will be used. A placebo-controlled approach will be used in the control group (website training group) so that the participants in the groups do not know which group they are in. In the research, the statistician who also evaluates the outputs and performs data analysis will be blinded. design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 74 enrollment type Anticipated arms interventions module arm group list arm group arm group label Web-based birth preparation program supported by motivational interview arm group type Experimental arm group description A web-based childbirth preparation program prepared based on the Health Belief Model and supported by motivational interviews will be applied to primigravida women in the initiative group. arm group intervention list arm group intervention name Other: Web-based childbirth preparation program developed based on health belief model and supported by motivational interview arm group label web-based birth preparation program arm group type Experimental arm group description A web-based birth preparation program based on the Health Belief Model will be applied to primigravida women in the control group. arm group intervention list arm group intervention name Other: Web-based childbirth preparation program based on health belief model intervention list intervention intervention type Other intervention name Web-based childbirth preparation program developed based on health belief model and supported by motivational interview intervention description In the three-month study, primigravida women in the initiative group will be given a web-based childbirth preparation program, which is prepared based on the Health Belief Model and supported by motivational interviews. Before starting the training program, pre-test will be applied to pregnant women and a five-week program will be implemented. A final test will be applied at the end of the program. The birth process will be evaluated immediately after the pregnant women give birth. intervention arm group label list intervention arm group label Web-based birth preparation program supported by motivational interview intervention type Other intervention name Web-based childbirth preparation program based on health belief model intervention description In the three-month study, a web-based childbirth preparation program based on the Health Belief Model will be applied to primigravida women in the control group. Before starting the training program, pre-test will be applied to pregnant women and a five-week program will be implemented. A final test will be applied at the end of the program. The birth process will be evaluated immediately after the pregnant women give birth. intervention arm group label list intervention arm group label web-based birth preparation program outcomes module primary outcome list primary outcome primary outcome measure has an effect on the fear of childbirth fear of birth birth self-efficacy primary outcome description Wijma Birth Expectation / Experience Scale Version A: It is a scale consisting of 33 items. The answers in the scale are numbered from 0 to 5, and are in six-point Likert type. Zero is expressed as "completely" and 5 as "nothing". While the minimum score on the scale is 0, the maximum score is 165. A high item total score indicates a high level of fear. Eighty-five and above points indicate clinical level fear. primary outcome time frame 3 months primary outcome measure has an impact on birth self-efficacy primary outcome description Short Version of the Self-Efficacy Scale in Labor: Each sub-dimension of the scale consists of two sub-dimensions, and consists of 16 questions. The lowest score to be obtained from the scale sub-dimensions is 16 and the highest score is 160. The lowest total score that can be obtained from the scale is 32, and the total highest score is 320. High scores to be obtained from the scale indicate that pregnant women have high levels of self-efficacy in labor. primary outcome time frame 3 months primary outcome measure has an effect on birth health belief primary outcome description Birth Health Belief Scale: The scale consists of 34 items and has five sub-dimensions. According to the subscales of the scale, the average "self-efficacy and motivation perception" is high 3.810 ± 1.409 (Min = 1; Max = 5), the average "benefit and motivation perception" is very high 4.368 ± 0.909 (Min = 1.75; Max = 5), "sensitivity perception of perception high 3,500 ± 1,502 (Min = 1; Max = 5), "caring / seriousness perception" average high 3,441 ± 1,600 (Min = 1; Max = 5), average "obstacle perception" 3,071 ± 1,508 (Min = 1; Max = 5). primary outcome time frame 3 months eligibility module eligibility criteria Inclusion Criteria: Between the ages of 18-35, At least a primary school graduate, According to the last menstrual period or the results of ultrasonography of pregnant women who do not know the last menstrual period, who are in the 28-30 weeks of pregnancy, Primigravida, Live single pregnancy, Without any obstacle to give birth through normal vaginal way, No specified cesarean indication or risk factors that would adversely affect normal delivery (Heart disease, placenta previa, oligohydramnios, preeclampsia, anhydramnios, diabetes, epilepsy), Not pregnant as a result of infertility treatment, The state anxiety scale average score is below 60, Edinburgh Postpartum Depression Scale average score of 12 or below, Residing within the provincial borders of Sivas, Internet at home, Able to use a computer or mobile phone, They are pregnant women who agree to participate in the research. Exclusion Criteria: Participants in the birth preparation class healthy volunteers Accepts Healthy Volunteers gender Female gender based Yes gender description primigravida pregnant women minimum age 18 Years maximum age 35 Years std age list std age Adult contacts locations module central contact list central contact central contact name BİRNUR YEŞİLDAĞ ÇELİK, Lecturer central contact role Contact central contact phone 05336815923 central contact e mail nurumbirnur@gmail.com overall official list overall official overall official name BİRNUR YEŞİLDAĞ ÇELİK, Lecturer overall official affiliation SİVAS CUMHURİYET UNIVERSITY overall official role Principal Investigator overall official name ZEHRA GÖLBAŞI, Prof. Dr overall official affiliation LOKMAN HEKİM UNIVERSITY overall official role Study Director location list location location facility Sivas Cumhuriyet Üniversitesi location city Sivas location zip 58100 location country Turkey references module reference list reference reference p m i d 20421842 reference type background reference citation Artieta-Pinedo I, Paz-Pascual C, Grandes G, Remiro-Fernandezdegamboa G, Odriozola-Hermosilla I, Bacigalupe A, Payo J. The benefits of antenatal education for the childbirth process in Spain. Nurs Res. 2010 May-Jun;59(3):194-202. doi: 10.1097/NNR.0b013e3181dbbb4e. reference p m i d 31964346 reference type background reference citation Munkhondya BMJ, Munkhondya TE, Chirwa E, Wang H. Efficacy of companion-integrated childbirth preparation for childbirth fear, self-efficacy, and maternal support in primigravid women in Malawi. BMC Pregnancy Childbirth. 2020 Jan 21;20(1):48. doi: 10.1186/s12884-019-2717-5. reference p m i d 24325752 reference type background reference citation Byrne J, Hauck Y, Fisher C, Bayes S, Schutze R. Effectiveness of a Mindfulness-Based Childbirth Education pilot study on maternal self-efficacy and fear of childbirth. J Midwifery Womens Health. 2014 Mar-Apr;59(2):192-7. doi: 10.1111/jmwh.12075. Epub 2013 Dec 10. reference p m i d 25303111 reference type background reference citation Toohill J, Fenwick J, Gamble J, Creedy DK, Buist A, Turkstra E, Ryding EL. A randomized controlled trial of a psycho-education intervention by midwives in reducing childbirth fear in pregnant women. Birth. 2014 Dec;41(4):384-94. doi: 10.1111/birt.12136. Epub 2014 Oct 9. i p d sharing statement module i p d sharing Yes i p d sharing description All IPD collected will share i p d sharing info type list i p d sharing info type Study Protocol i p d sharing time frame starts 1 month after broadcast i p d sharing access criteria all people have access. derived section misc info module version holder December 02, 2022
NCT04833842
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full study rank 61786 study protocol section identification module n c t id NCT04831944 org study id info org study id INCB 50465-108 organization org full name Incyte Corporation org class INDUSTRY brief title To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Hepatic Function and Hepatic Impairment. official title A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Parsaclisib in Participants With Normal Hepatic Function and Participants With Hepatic Impairment status module status verified date August 2022 overall status Completed expanded access info has expanded access No start date struct start date March 29, 2021 start date type Actual primary completion date struct primary completion date March 10, 2022 primary completion date type Actual completion date struct completion date March 11, 2022 completion date type Actual study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date August 25, 2022 last update post date struct last update post date August 26, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Incyte Corporation lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No description module brief summary The purpose of the study is to evaluate the pharmacokinetics and safety of parsaclisib in participants With normal hepatic function and participants with hepatic impairment. conditions module condition list condition Advanced Malignancies keyword list keyword Hepatic Impairment parsaclisib design module study type Interventional phase list phase Phase 1 design info design allocation Non-Randomized design intervention model Parallel Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 21 enrollment type Actual arms interventions module arm group list arm group arm group label Treatment Group 1 : Severe hepatic impairment arm group type Experimental arm group description Child Pugh (CP) assessment score of 10-14 points arm group intervention list arm group intervention name Drug: parsaclisib arm group label Treatment Group 2 : Moderate hepatic impairment arm group type Experimental arm group description Child Pugh (CP) assessment score of 7-9 points arm group intervention list arm group intervention name Drug: parsaclisib arm group label Treatment Group 3 : Mild hepatic impairment arm group type Experimental arm group description Child Pugh (CP) assessment score of 5-6 points arm group intervention list arm group intervention name Drug: parsaclisib arm group label Treatment Group 4 : Normal hepatic impairment arm group type Experimental arm group description Normal hepatic function arm group intervention list arm group intervention name Drug: parsaclisib intervention list intervention intervention type Drug intervention name parsaclisib intervention description parsaclisib will be administered orally after 8 hours of fasting. intervention arm group label list intervention arm group label Treatment Group 1 : Severe hepatic impairment Treatment Group 2 : Moderate hepatic impairment Treatment Group 3 : Mild hepatic impairment Treatment Group 4 : Normal hepatic impairment intervention other name list intervention other name INCB050465 outcomes module primary outcome list primary outcome primary outcome measure Pharmacokinetics Parameter : Cmax of parsaclisib primary outcome description Maximum Observed Plasma Concentration of parsaclisib primary outcome time frame 5 Days primary outcome measure Pharmacokinetics Parameter : AUC 0-∞ of parsaclisib primary outcome description Area Under the Concentration-time Curve From 0 to Infinity of parsaclisib primary outcome time frame 5 Days primary outcome measure Pharmacokinetics Parameter : AUC(0-t) of parsaclisib primary outcome description Area Under the concentration- time curve up to the last measurable concentration of parsaclisib primary outcome time frame 5 Days secondary outcome list secondary outcome secondary outcome measure Number of Treatment Emergent Adverse Events (TEAE) secondary outcome description Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment. secondary outcome time frame Up to10 Days secondary outcome measure Pharmacokinetics Parameter : tmax of parsaclisib secondary outcome description Time to reach maximum plasma concentration of parsaclisib secondary outcome time frame 5 Days secondary outcome measure Pharmacokinetics Parameter : t1/2 of parsaclisib secondary outcome description Apparent terminal phase disposition half-life of parsaclisib secondary outcome time frame 5 Days secondary outcome measure Pharmacokinetics Parameter : CL/F of parsaclisib secondary outcome description Oral dose clearance of parsaclisib secondary outcome time frame 5 Days secondary outcome measure Pharmacokinetics Parameter : Vz/F of parsaclisib secondary outcome description Apparent oral dose volume of distribution of parsaclisib secondary outcome time frame 5 Days eligibility module eligibility criteria Inclusion Criteria: Participants with hepatic impairment. Participants eligible for Group 4 should be in good health. Participants eligible for Groups 1 through 3 may have medical findings consistent with their degree of hepatic dysfunction. Participants with abnormal findings considered not clinically significant by the investigator are eligible. Body mass index within the range of 18.0 to 40.0 kg/m2 (inclusive) at screening. Willingness to avoid pregnancy or fathering children. Exclusion Criteria: Evidence of rapidly deteriorating hepatic function. Participants with serum calcium and phosphorus levels over the upper limits of the institutional normal ranges. History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study, including any of the following: Participants who have a current, functioning organ transplant or have a scheduled organ transplant in the next 6 weeks from check-in. History of malignancy within 5 years of screening, with the exception of cured basal cell carcinoma, squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer. History of clinically significant gastrointestinal disease or surgery (cholecystectomy and appendectomy are allowed) that could impact the absorption of study drug. Participants with severe ascites or an encephalopathy ≥ Grade 2. Any major surgery within 4 weeks of screening. Donation of blood to a blood bank within 4 weeks of screening (within 2 weeks for plasma only). Blood transfusion within 4 weeks of check-in. Current or recent history (within 30 days before screening) of a clinically significant bacterial, fungal, parasitic, or mycobacterial infection, or currently receiving systemic antibiotics. Current clinically significant viral infection at screening or check-in. Positive serology for hepatitis B virus (eg, hepatitis B surface antigen) or human immunodeficiency virus. Participants whose results are compatible with immunity due to infection or prior immunization for hepatitis B may be included at the discretion of the investigator. History of alcoholism within 3 months of screening. Positive breath test for ethanol or positive urine screen for drugs of abuse that is not otherwise explained by permitted concomitant medications. Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) of study drug administration with another investigational medication or current enrollment in another investigational drug protocol. Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) of study drug administration with strong or moderate inducer or potent inhibitor of CYP3A4. Receipt of live (including attenuated) vaccines or anticipation of need for such a vaccine during the study. (Note: Non-live or inactivated vaccines allowed up to 2 weeks before first dose administration.) Known hypersensitivity or severe reaction to parsaclisib or excipients of parsaclisib. History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator. Inability to be venipunctured or tolerate venous access. Participants eligible for Group 4 who have a history or presence of liver disease or liver injury as indicated by an abnormal clinically significant liver function profile at screening or check-in. Participants eligible for Group 4 who have a positive test for hepatitis C virus. Participants eligible for Group 4 who used tobacco- or nicotine-containing products within 6 months of screening. Women who are pregnant or breastfeeding healthy volunteers Accepts Healthy Volunteers gender All gender based Yes minimum age 18 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module location list location location facility Inland Empire Liver Foundation location city Rialto location state California location zip 92377 location country United States location facility Orange County Research Center location city Tustin location state California location zip 92780 location country United States location facility Clinical Pharmacology of Miami location city Hialeah location state Florida location zip 33014 location country United States location facility Orlando Clinical Research Center location city Orlando location state Florida location zip 32809 location country United States location facility Texas Liver Institute Tli the Liver Institute of South Texas List Downtown Office location city San Antonio location state Texas location zip 78215 location country United States i p d sharing statement module i p d sharing Yes i p d sharing description Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) i p d sharing time frame Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications. i p d sharing access criteria Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement. i p d sharing u r l https://www.incyte.com/our-company/compliance-and-transparency derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009369 condition mesh term Neoplasms condition mesh id D000008107 condition mesh term Liver Diseases condition ancestor list condition ancestor condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition browse leaf list condition browse leaf condition browse leaf id M10259 condition browse leaf name Liver Diseases condition browse leaf as found Hepatic Impairment condition browse leaf relevance high condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04831944
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full study rank 61579 study protocol section identification module n c t id NCT04834635 org study id info org study id FundoRingOAGB organization org full name The Society of Bariatric and Metabolic Surgeons of Kazakhstan org class OTHER brief title The FundoRingOAGB Versus Non-wrapping (Non-banded) Standard Method of Laparoscopic One Anastomosis Gastric Bypass official title The Total Wrapping of the Fundus of the Gastric Excluded Part (FundoRing) Versus Non- Wrapping (Non-banded) Standard Method of Laparoscopic One Anastomosis Gastric Bypass/Mini - Gastric Bypass: A Randomized Controlled Trial acronym FundoRingMGB status module status verified date January 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date March 29, 2021 start date type Actual primary completion date struct primary completion date April 5, 2024 primary completion date type Anticipated completion date struct completion date May 10, 2024 completion date type Anticipated study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date January 1, 2022 last update post date struct last update post date January 4, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name The Society of Bariatric and Metabolic Surgeons of Kazakhstan lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Currently, one anastomosis gastric bypass (OAGB) or mini-gastric bypass (MGB) is a common bariatric procedure for treating obesity. Weight gain after surgery is a big problem in bariatric practice. Therefore, adjustable bands and rings are used, for example, "FobiRing". But foreign material can cause complications - the erosion of the stomach wall. For this reason, surgeons avoid the use of various mechanical devices on living tissues. The greatest criticism is of the OAGB for the likelihood of biliary reflux. In case of reflux of bile into the esophagus after surgery, as a rule, a second operation is required with conversion OAGB to the Roux-en-Y method. In addition, along with obesity, gastroesophageal reflux disease (GERD) are steadily increasing world weight and antireflux surgery must be performed simultaneously with bariatric surgery in obese patients. In these cases, most often in bariatric practice, hiatus cruroraphy is performed, and less often fundoplication using the fundus of the excluded part of the stomach. We hypothesize that total fundoplication can not only treat GERD but also significant prevent the return of weight like after a banded gastric bypass and prevent postoperative bile reflux in the esophagus. The aim study is to compare primary outcome as weight loss after total wrapping of the fundus of the gastric excluded part (FundoRing) and non - wrapping (non - banded) standard method of laparoscopic one anastomosis gastric bypass and measure secondary outcome: bile reflux in the esophagus and GERD symptoms. Methods: Adult participants (n=100) are randomly allocated to one of two groups: Experimental surgical bariatric procedure in the first (A) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and suture cruroplasty if present hiatal hernia (FundoRingOAGB group); Active comparator surgical bariatric procedure in the second (B) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass and with only suture cruroplasty if present hiatal hernia (OAGB group). detailed description One anastomosis Gastric Bypass/Mini Gastric Bypass (OAGB/MGB) is gaining popularity as a primary surgical treatment for morbid obesity. The aim study is to compare primary outcome as weight loss after total wrapping of the fundus of the gastric excluded part (FundoRing) and non - wrapping (non - banded) standard method of laparoscopic one anastomosis gastric bypass and measure secondary outcome: bile reflux in the esophagus and GERD symptoms. Methods: Adult participants (n=100) are randomly allocated to one of two groups: Experimental surgical bariatric procedure in the first (A) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and suture cruroplasty if present hiatal hernia (FundoRingOAGB group); Active comparator surgical bariatric procedure in the second (B) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass and with only suture cruroplasty if present hiatal hernia (OAGB group). All patients are then followed up 12, 24, 36 months after surgery where record the changing body mass index and and measure secondary outcome: bile reflux in the esophagus and GERD symptoms. conditions module condition list condition Obesity, Morbid keyword list keyword Obesity Bariatric surgery One anastomosis gastric bypass FundoRingOAGB Fundoplication design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 100 enrollment type Actual arms interventions module arm group list arm group arm group label FundoRingOAGB group arm group type Experimental arm group description laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part (and suture cruroplasty if present hiatal hernia). arm group intervention list arm group intervention name Procedure: FundoRingOAGB arm group label OAGB group arm group type Active Comparator arm group description laparoscopic one anastomosis gastric bypass (and suture cruroplasty if present hiatal hernia). arm group intervention list arm group intervention name Procedure: OAGB intervention list intervention intervention type Procedure intervention name FundoRingOAGB intervention description laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and with suture cruroplasty if present hiatal hernia intervention arm group label list intervention arm group label FundoRingOAGB group intervention type Procedure intervention name OAGB intervention description laparoscopic one anastomosis gastric bypass with suture cruroplasty if present hiatal hernia intervention arm group label list intervention arm group label OAGB group outcomes module primary outcome list primary outcome primary outcome measure Change of body mass index primary outcome description The measure is assessing a change of body mass index. Weight (kg) and height (cm) will be combined with the report of measurement by body mass index (BMI) kg/m2. primary outcome time frame Baseline, at 12, 24, 36 months after surgery secondary outcome list secondary outcome secondary outcome measure Postoperative bile reflux in esophagus secondary outcome description The endoscopic finding of postoperative bile reflux in the esophagus secondary outcome time frame at 12, 24, 36 months after surgery secondary outcome measure GERD symptoms secondary outcome description Change og GERD symptoms if present GERD or postoperative de Novo GERD symptoms (GERD-HRQL) secondary outcome time frame Baseline, 12, 24, 36 months after surgery eligibility module eligibility criteria Inclusion Criteria: BMI from 30 to 50 kg / m2. The person is generally fit for anesthesia (ASA grading 1-2) and surgery. The person commits to the need for long-term follow-up. Exclusion Criteria: BMI less than 30 kg / m2 and more than 50 kg / m2. Prosthetic (mesh) Hiatal herniorrhaphy or large hiatal hernia; Esophageal shortening Los Angeles Classification of Oesophagitis (LA grade) C or D reflux esophagitis History of surgery on the stomach or esophagus Less than 18 or more than 60 years of age Not fit for bariatric surgery Psychiatric illness Patients unwilling or unable to provide informed consent healthy volunteers No gender All minimum age 18 Years maximum age 60 Years std age list std age Adult contacts locations module overall official list overall official overall official name Oral Ospanov overall official affiliation President of Society of Bariatric and Metabolic Surgeons of Kazakhstan" (SBMSK) overall official role Principal Investigator location list location location facility Oral Ospanov location city Astana location zip 010000 location country Kazakhstan references module reference list reference reference p m i d 35392958 reference type derived reference citation Ospanov O, Yeleuov G, Fursov A, Yelembayev B, Fursov R, Sergazin Z, Mustafin A. A laparoscopic one anastomosis gastric bypass with wrapping versus nonwrapping fundus of the excluded part of the stomach to treat obese patients (FundoRingOAGB trial): study protocol for a randomized controlled trial. Trials. 2022 Apr 7;23(1):264. doi: 10.1186/s13063-022-06252-6. reference p m i d 34059995 reference type derived reference citation Ospanov OB. The Gastric Bypass and Fundoplication in Bariatric Surgery: the Comments on Published Papers and Our Classification of Combination Procedures. Obes Surg. 2021 Oct;31(10):4643-4644. doi: 10.1007/s11695-021-05505-8. Epub 2021 Jun 1. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009767 condition mesh term Obesity, Morbid condition ancestor list condition ancestor condition ancestor id D000009765 condition ancestor term Obesity condition ancestor id D000044343 condition ancestor term Overnutrition condition ancestor id D000009748 condition ancestor term Nutrition Disorders condition ancestor id D000050177 condition ancestor term Overweight condition ancestor id D000001835 condition ancestor term Body Weight condition browse leaf list condition browse leaf condition browse leaf id M11853 condition browse leaf name Obesity condition browse leaf relevance low condition browse leaf id M11854 condition browse leaf name Obesity, Morbid condition browse leaf as found Obesity, Morbid condition browse leaf relevance high condition browse leaf id M24460 condition browse leaf name Overnutrition condition browse leaf relevance low condition browse leaf id M11836 condition browse leaf name Nutrition Disorders condition browse leaf relevance low condition browse leaf id M25339 condition browse leaf name Overweight condition browse leaf relevance low condition browse leaf id M4266 condition browse leaf name Body Weight condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions
NCT04834635
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full study rank 61593 study protocol section identification module n c t id NCT04834453 org study id info org study id R 75/2021 organization org full name Ain Shams University org class OTHER brief title Correlation of Trans Cranial Doppler Ultrasound and CT Scan in Monitoring of Posttraumatic Brain Edema official title Correlation of Trans Cranial Doppler Ultrasound and CT Scan in Monitoring of Posttraumatic Brain Edema status module status verified date July 2022 overall status Completed expanded access info has expanded access No start date struct start date April 28, 2021 start date type Actual primary completion date struct primary completion date November 10, 2021 primary completion date type Actual completion date struct completion date December 28, 2021 completion date type Actual study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 20, 2022 last update post date struct last update post date July 21, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Mona Ammar responsible party investigator title Assistant professor responsible party investigator affiliation Ain Shams University lead sponsor lead sponsor name Ain Shams University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The most common tool for diagnosis and follow up of cerebral edema in ICU is brain CT scan that necessitate patient transportation with risk of hemodynamic instability, and exposure to radiation. Transcranial Doppler (TCD) sonography allows true and rapid imaging of blood flow velocities of intracranial vessels. Transcranial Doppler sonography provides noninvasive evaluation of intracranial pressure by its characteristic wave patterns conditions module condition list condition Brain Edema design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 32 enrollment type Actual arms interventions module intervention list intervention intervention type Diagnostic Test intervention name transcranial ultrasound intervention description - Transcranial Doppler sonography will be performed with the patients in the supine position., using low frequency probe of 2 MHz will be placed on temporal bone- will be performed daily outcomes module primary outcome list primary outcome primary outcome measure the correlation between CCT scans score and Pulsatility Index of each patient primary outcome time frame 7 days eligibility module eligibility criteria Inclusion Criteria: isolated blunt Traumatic Brain Injury age 18-60 years Exclusion Criteria: Pregnancy Intracerebral hemorrhage Patients whose blood flow velocities could not be obtained from Trans temporal acoustic bone windows. gender All minimum age 18 Years maximum age 60 Years std age list std age Adult study population Patients with isolated blunt TBI from (age 18-60 years) of both sex, will be included in the study and followed prospectively. Severity of trauma is evaluated by GCS, Rotterdam computed tomography score (CTS) care system with the help of our radiodiagnosis colleagues sampling method Probability Sample contacts locations module location list location location facility Ain Shams University location city Cairo location country Egypt derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001929 condition mesh term Brain Edema condition mesh id D000004487 condition mesh term Edema condition ancestor list condition ancestor condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M6809 condition browse leaf name Edema condition browse leaf as found Edema condition browse leaf relevance high condition browse leaf id M4358 condition browse leaf name Brain Edema condition browse leaf as found Brain Edema condition browse leaf relevance high condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases
NCT04834453
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full study rank 61912 study protocol section identification module n c t id NCT04830293 org study id info org study id 2119-40-14/02 organization org full name Zonguldak Bulent Ecevit University org class OTHER brief title Effect of Head Position During Thyroidectomy on Postoperative Cognitive Functions official title The Effect of Head Position During Thyroidectomy on Cerebral Oxygenation and Postoperative Cognitive Functions status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date March 1, 2019 start date type Actual primary completion date struct primary completion date October 30, 2020 primary completion date type Actual completion date struct completion date December 31, 2020 completion date type Actual study first submit date March 30, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 1, 2021 last update post date struct last update post date April 5, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Bengü Gülhan Aydin responsible party investigator title associate professor doctor responsible party investigator affiliation Zonguldak Bulent Ecevit University lead sponsor lead sponsor name Zonguldak Bulent Ecevit University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The aim of our study is to observe the effect of head-neck position of patients scheduled for thyroidectomy, on carotid artery blood flow, regional cerebral oxygen saturation measured using near-infrared spectroscopy technology, and postoperative cognitive dysfunction. conditions module condition list condition Thyroid Carotid Doppler Cerebral Perfusion keyword list keyword Head position Cerebral Oxygenation Postoperative Cognitive Dysfunction design module study type Observational patient registry Yes target duration 3 Months design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 1 enrollment type Actual arms interventions module intervention list intervention intervention type Procedure intervention name Carotis Doppler Ultrasound intervention description Neck was rotated about 30-45 ° to the opposite side of the image. The common carotid artery and internal jugular vein were viewed transversely on the B Mode USG image. Then, the probe was rotated approximately 90 ° and the carotid artery was visualized in the longitudinal plane. The probe and guide line were adjusted so that the Doppler angle was 60 °. The image was created with the guiding line parallel to the blood flow. After imaging of the carotid artery bifurcation, measurements were made 1 cm distal to this level. outcomes module primary outcome list primary outcome primary outcome measure Changes in cognitive functions primary outcome description determine cognitive dysfunction using mini mental state examination primary outcome time frame 3 months after surgery secondary outcome list secondary outcome secondary outcome measure Changes in Cerebral Perfusion secondary outcome description Changes in main carotid artery blood flow and cerebral oxygenation by using carotid doppler secondary outcome time frame during surgery eligibility module eligibility criteria Inclusion Criteria: undergo a total thyroidectomy operation ASA I-II euthyroid patients in the preoperative period Exclusion Criteria: Hemoglobin< 8 g / dl Hypertension Hyperlipidemia Pregnancy Patients diagnosed with diabetes mellitus Cerebrovascular insufficiency Known carotid artery lesion Metabolic diseases Any intracranial pathology present Surgeries exceeding 180 minutes healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 50 Years std age list std age Adult study population Patients between the ages of 18-50 who will undergo total thyroidectomy under general anesthesia due to elective thyroid cancer, Hashimoto's thyroiditis or thyrotoxicosis, in the American Society of Anesthesiologists (ASA) I-II risk group, who are euthyroid in the preoperative period sampling method Probability Sample contacts locations module location list location location facility Zonguldak Bülent Ecevit University Medicine Faculty location city Zonguldak location state Kozlu location zip 67600 location country Turkey i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M15870 condition browse leaf name Thyroid Diseases condition browse leaf relevance low condition browse leaf id M28858 condition browse leaf name Cognitive Dysfunction condition browse leaf relevance low condition browse leaf id M2076 condition browse leaf name Postoperative Cognitive Complications condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology
NCT04830293
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full study rank 61370 study protocol section identification module n c t id NCT04837352 org study id info org study id RC-P00105 organization org full name Lille Catholic University org class OTHER brief title Therapeutic Adherence of Multiple Sclerosis Patients official title Obstacles and Levers of the Therapeutic Adherence of Multiple Sclerosis Patients acronym FELSA-SEP status module status verified date January 2022 overall status Recruiting expanded access info has expanded access No start date struct start date November 30, 2021 start date type Actual primary completion date struct primary completion date November 30, 2024 primary completion date type Anticipated completion date struct completion date November 30, 2024 completion date type Anticipated study first submit date February 2, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date January 5, 2022 last update post date struct last update post date January 6, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Lille Catholic University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The goal of this study is to assess the role of sociocognitive and interpersonal factors in the therapeutic adherence of multiple sclerosis patients. This study will provide a better understanding of the socio-psychological issues associated with different types of non-adherence to treatment, and identify the risk factors and vulnerability of each patient. detailed description Multiple sclerosis is a chronic and progressive disease that affects young adults (between 20 and 40 years old), impacting significantly the patients quality of life. The adherence to therapy affects the long-term functional clinical course (lower risk of relapses, reduction in disability progression and quality of life). The non-adherence rate to therapy in multiple sclerosis is estimated at 40%. The main identified causes of non-adherence are: forgetting to take treatment and adverse effects of drugs. Sociocognitive models as the Theory of Planned Behaviour (TPB) have been developed to help to understand and predict health-related behaviours. This model postulates that the intention to adopt a behaviour is one of the major determinants in the context of health. This intention comes from three independent elements : Personal positive or negative attitudes towards the behaviour, Social expectations or entourage perception (subjective norms), Difficulty in accomplishing this behaviour (perceived control) Multiple sclerosis adherence to therapy studies have mainly focused on somatic variables (physical disability, illness duration, type of treatment) and some clinical variables (cognitive impairment, fatigue, depression). The few studies that have examined the multiple sclerosis therapeutic adherence determinants have mainly taken a one-dimensional perspective, such as perceived control. In the FELSA-SEP study, the role of sociocognitive factors (norms and beliefs, perceived threat to disease and health behaviours) and interpersonal factors (social support, patient-doctor relationship) will be explored. conditions module condition list condition Multiple Sclerosis keyword list keyword Theory of Planned Behaviour Therapeutic adherence Sociocognitive and interpersonal factors design module study type Observational patient registry No design info design observational model list design observational model Other design time perspective list design time perspective Prospective enrollment info enrollment count 153 enrollment type Anticipated arms interventions module arm group list arm group arm group label Multiple sclerosis patients arm group description Patients with multiple sclerosis over 18 years old who have already started a long-term treatment and consent to participate to the study arm group intervention list arm group intervention name Other: Study of the role of sociocognitive factors intervention list intervention intervention type Other intervention name Study of the role of sociocognitive factors intervention description Questionnaires intervention arm group label list intervention arm group label Multiple sclerosis patients outcomes module primary outcome list primary outcome primary outcome measure Therapeutic adherence evaluated by a Likert scale primary outcome description This 19-item self-questionnaire provides 5 sub-scores corresponding to each of the sub-dimensions (Attitudes, Subjective norms, Perception of control, Behavioural intention and Behaviour) and an overall score (sum of the 5 sub-scores). primary outcome time frame 6 months secondary outcome list secondary outcome secondary outcome measure Perceived threat measured with a self-assessment form secondary outcome description The perceived threat will be measured with a self-assessment form using a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). This 11-item self-questionnaire provides 2 sub-scores and an overall score (sum of the 2 sub-scores). secondary outcome time frame 3 weeks secondary outcome measure Perceived interpersonal relationships quality measure by the perceived social support questionnaire (QSSP) secondary outcome description The QSSP is a 6 items questionnaire which assess availability and satisfaction with respect to perceived social support. 4-Point ordinal Alliance Scale (11-items 4-PAS). This self-questionnaire concerns the patient's perception about the therapeutic alliance. secondary outcome time frame 6 months secondary outcome measure Perceived interpersonal relationships quality measure by the 4-Point ordinal Alliance Scale (11-items 4-PAS) secondary outcome description The 4-Point ordinal Alliance Scale (11-items 4-PAS). This self-questionnaire concerns the patient's feelings about the therapeutic alliance and includes eleven items, placing the patient on 5-point scale on : the patient's feeling about the doctor's ability to help him/her; his/her understanding of the symptoms of the illness; the psychological improvement felt; the adaptation to the doctor-patient relationship; the doctor's availability and competence; the clarity of the information given by the doctor and the understanding he/she shows; the doctor's desire of clinical improvement; the quality of the relationship and the understanding of psychological difficulties secondary outcome time frame 6 months secondary outcome measure Illness duration in days secondary outcome description In order to evaluate the vulnerability and protective factors related to somatic disease illness duration will be evaluated. secondary outcome time frame 3 weeks secondary outcome measure Handicap will be evaluated by the Expanded Disability Status Scale (EDSS) secondary outcome description In order to evaluate the vulnerability and protective factors related to somatic the handicap will be evaluated by the EDSS. The EDSS quantifies disability in eight Functional Systems (FS) by assigning a Functional System Score in each of these functional systems. The clinical meaning of each possible result goes from 0.0: Normal Neurological Exam to 10.0: Death secondary outcome time frame 3 weeks secondary outcome measure Relapses number secondary outcome description In order to evaluate the vulnerability and protective factors related to somatic disease number of relapses will be evaluated secondary outcome time frame 3 weeks secondary outcome measure Fatigue perceived through the FSS (Fatigue Severity Scale) secondary outcome description In order to evaluate the vulnerability and protective factors related to somatic disease fatigue will be evaluated. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity. secondary outcome time frame 3 weeks secondary outcome measure Cognitive disorders through the SDMT (Symbol Digit Modalities Test) secondary outcome description In order to evaluate the vulnerability and protective factors related to somatic disease cognitive disorders will be evaluated The SDMT is a sign coding test that assesses attentional abilities (sustained attention and speed of processing information). Participants are required to use a coded key to match nine abstract symbols paired with numerical digits. The final score is the correct number of substitutions in 90 seconds, and scores range between 0 and 110. secondary outcome time frame 3 weeks secondary outcome measure Anxiety-depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS) secondary outcome description The vulnerability and protective factors linked to psychological functioning- as Anxiety-depressive symptoms will be determined. - Personality traits: Big Five Inventory-FR questionnaire (BFI-FR) secondary outcome time frame 3 weeks secondary outcome measure Personality traits measured by the Big Five Inventory-FR questionnaire (BFI-FR) secondary outcome description The vulnerability and protective factors linked to psychological functioning as personality traits will be determined. The Big Five personality traits is a suggested grouping for personality traits. The theory identifies five factors: openness to experience (inventive/curious vs. consistent/cautious) conscientiousness (efficient/organized vs. extravagant/careless) extraversion (outgoing/energetic vs. solitary/reserved) agreeableness (friendly/compassionate vs. challenging/callous) neuroticism (sensitive/nervous vs. resilient/confident) secondary outcome time frame 3 weeks eligibility module eligibility criteria Inclusion Criteria: Multiple sclerosis defined according to McDonald criteria; Already undergone or beginning substantive treatment (self-managed, excluding treatment administered in hospital) Aged ≥ 18 years; Given the informed consent form. Exclusion Criteria: Severe cognitive impairment (score below the 5th percentile); Any associated neurological pathology or serious or chronic somatic disease (cancer); Being under a legal protection measure. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population Persons with multiple sclerosis who will be recruited during a routine neurological consultation and who present eligibility criterion. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Amélie Lausiaux, MD, PhD central contact role Contact central contact phone 03.20.22.52.69 central contact e mail lansiaux.amelie@ghicl.net central contact name Valentine Duriez central contact role Contact central contact phone 03.20.22.59.02 central contact e mail duriez.valentine@ghicl.net overall official list overall official overall official name Bruno Lenne overall official affiliation Hôpital Saint-Vincent de Paul - Lille overall official role Principal Investigator location list location location facility Hôpital Saint-Vincent de Paul location status Recruiting location city Lille location zip 59000 location country France location contact list location contact location contact name Bruno Lenne, PhD location contact role Contact location facility Hôpital Saint-Philibert location status Recruiting location city Lomme location zip 59462 location country France location contact list location contact location contact name Caroline Massot, MD location contact role Contact i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009103 condition mesh term Multiple Sclerosis condition mesh id D000012598 condition mesh term Sclerosis condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000020278 condition ancestor term Demyelinating Autoimmune Diseases, CNS condition ancestor id D000020274 condition ancestor term Autoimmune Diseases of the Nervous System condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000003711 condition ancestor term Demyelinating Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M11212 condition browse leaf name Multiple Sclerosis condition browse leaf as found Multiple Sclerosis condition browse leaf relevance high condition browse leaf id M14567 condition browse leaf name Sclerosis condition browse leaf as found Sclerosis condition browse leaf relevance high condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M21251 condition browse leaf name Demyelinating Autoimmune Diseases, CNS condition browse leaf relevance low condition browse leaf id M21247 condition browse leaf name Autoimmune Diseases of the Nervous System condition browse leaf relevance low condition browse leaf id M6061 condition browse leaf name Demyelinating Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology
NCT04837352
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full study rank 61864 study protocol section identification module n c t id NCT04830930 org study id info org study id A73_04FDI2102 organization org full name Chong Kun Dang Pharmaceutical org class INDUSTRY brief title A Study to Investigate the Effect of Food on the PK, PD of CKD-381 in Healthy Volunteers official title A Randomized, Open-label, Single-dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics and Pharmacodynamics of CKD-381 in Healthy Volunteers status module status verified date March 2021 overall status Completed expanded access info has expanded access No start date struct start date April 21, 2021 start date type Actual primary completion date struct primary completion date June 17, 2021 primary completion date type Actual completion date struct completion date July 26, 2021 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date August 17, 2021 last update post date struct last update post date August 18, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Chong Kun Dang Pharmaceutical lead sponsor class INDUSTRY oversight module is f d a regulated drug No is f d a regulated device No description module brief summary A study to investigate the effect of food on the Pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers detailed description A randomized, open-label, single-dose, crossover study to investigate the effect of food on the pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers conditions module condition list condition GERD keyword list keyword CKD-381 design module study type Interventional phase list phase Phase 1 design info design allocation Randomized design intervention model Crossover Assignment design intervention model description Crossover Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 28 enrollment type Actual arms interventions module arm group list arm group arm group label Sequence 1 arm group type Experimental arm group description Period 1: fasted condition/ Period 2: fed condition arm group intervention list arm group intervention name Drug: CKD-381 arm group label Sequence 2 arm group type Experimental arm group description Period 1: fed condition/ Period 2: fasted condition arm group intervention list arm group intervention name Drug: CKD-381 intervention list intervention intervention type Drug intervention name CKD-381 intervention description single-dose, oral administration of CKD-381 1 tablet intervention arm group label list intervention arm group label Sequence 1 Sequence 2 outcomes module primary outcome list primary outcome primary outcome measure Cmax primary outcome description maximum observed concentration after dose primary outcome time frame 0-24 hours primary outcome measure AUClast primary outcome description Area under the plasma concentration versus time curve over the dosing interval after dose primary outcome time frame 0-24 hours primary outcome measure Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose primary outcome time frame 0-24 hours eligibility module eligibility criteria Inclusion Criteria: Between 19 aged and 50 aged in healthy adult Body weight more than 55.0kg and body mass index over 18.0kg/m2 and under 30.0kg/m2 Have negative result on Helicobacter Pylori antibody test Exclusion Criteria: Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease. Have a gastrointestinal disease history(including surgery) that can effect evaluation of safety, pharmacokinetics and pharmacodynamics of investigational product. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of investigational product, additives or benzimidazole family. healthy volunteers Accepts Healthy Volunteers gender All minimum age 19 Years maximum age 50 Years std age list std age Adult contacts locations module overall official list overall official overall official name Kyungsang Yu, M.D., Ph.D. overall official affiliation ksyu@snu.ac.kr overall official role Principal Investigator location list location location facility Seoul National University Hospital location city Seoul location state Jongno-gu location zip 03080 location country Korea, Republic of i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022
NCT04830930
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full study rank 61255 study protocol section identification module n c t id NCT04838847 org study id info org study id CV-NCOV-012 secondary id info list secondary id info secondary id 2020-005064-54 secondary id type EudraCT Number organization org full name CureVac org class INDUSTRY brief title A Study to Evaluate the Immunogenicity and Safety of the SARS-CoV-2 mRNA Vaccine CVnCoV in Elderly Adults Compared to Younger Adults for COVID-19 official title COVID-19 (CoviCompareCV): A Phase 3, Non-randomized, Open Label Clinical Trial to Evaluate the Immunogenicity and Safety of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV Administered Intramuscularly in Adults Aged 65 Years or Above Compared to Younger Adults Aged 18-45 Years status module status verified date April 2021 overall status Withdrawn why stopped The study was withdrawn based on an assessment of immunogenicity in elderly adults. expanded access info has expanded access No start date struct start date October 1, 2021 start date type Anticipated primary completion date struct primary completion date January 2022 primary completion date type Anticipated completion date struct completion date September 2022 completion date type Anticipated study first submit date April 8, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date August 16, 2021 last update post date struct last update post date August 20, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name CureVac lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The primary objective of this study is to evaluate the humoral immune response to CVnCoV in elderly adults aged ≥65 years and younger adults aged 18-45 years, 14 days after the second dose administration. conditions module condition list condition Coronavirus Covid19 SARS-CoV-2 Severe Acute Respiratory Syndrome keyword list keyword Covid19 SARS-CoV-2 mRNA vaccine CVnCoV Vaccine SARS COVID Safety Immunogenicity design module study type Interventional phase list phase Phase 3 design info design allocation Non-Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 0 enrollment type Actual arms interventions module arm group list arm group arm group label Participants / Healthy Participants Aged ≥65 Years arm group type Experimental arm group description Participants will be vaccinated with CVnCoV 12 μg mRNA on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm. arm group intervention list arm group intervention name Biological: CVnCoV Vaccine arm group label Participants / Healthy Participants Aged 18-45 Years arm group type Experimental arm group description Participants will be vaccinated with CVnCoV 12 μg mRNA on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm. arm group intervention list arm group intervention name Biological: CVnCoV Vaccine intervention list intervention intervention type Biological intervention name CVnCoV Vaccine intervention description Intramuscular (IM) injection intervention arm group label list intervention arm group label Participants / Healthy Participants Aged 18-45 Years Participants / Healthy Participants Aged ≥65 Years intervention other name list intervention other name CV07050101 outcomes module primary outcome list primary outcome primary outcome measure Antibody Concentrations Against SARS-CoV-2 Spike Protein-specific Immunoglobulin G (IgG) in Serum primary outcome description Measured by enzyme-linked immunosorbent assay (ELISA). primary outcome time frame Day 43 secondary outcome list secondary outcome secondary outcome measure Antibody Concentrations Against SARS-CoV-2 Spike Protein-specific Immunoglobulin G (IgG) in Serum secondary outcome description Measured by enzyme-linked immunosorbent assay (ELISA). secondary outcome time frame Month 6, Month 12 and Month 26 secondary outcome measure Antibody Concentrations Against SARS-CoV-2 Spike Protein-specific Immunoglobulins in Serum secondary outcome description Antibody concentrations against SARS-CoV-2 spike protein-specific immunoglobulin A (IgA) and immunoglobulin M (IgM) in serum. Measured by enzyme-linked immunosorbent assay (ELISA). secondary outcome time frame Day 29, Day 43, Month 6, Month 12 and Month 26 secondary outcome measure Number of Participants With Neutralizing Antibody Titers Against SARS-CoV-2 Spike Protein in Serum secondary outcome description Measured by an in vitro neutralization assay. secondary outcome time frame Day 29, Day 43, Month 6, Month 12 and Month 26 secondary outcome measure Number of Participants Who Experience a Solicited Local Adverse Event (AE) secondary outcome time frame Up to 7 days after vaccination secondary outcome measure Intensity of Solicited Local Adverse Events (AEs) per the US Food and Drug Administration (FDA) Toxicity Grading Scale secondary outcome description Intensity of solicited local AEs will be graded per the FDA Toxicity Grading Scale at grades 0-3, where higher grades indicate a worse outcome. secondary outcome time frame Up to 7 days after vaccination secondary outcome measure Duration of Solicited Local Adverse Events (AEs) secondary outcome time frame Up to 7 days after vaccination secondary outcome measure Number of Participants Who Experience a Solicited Systemic Adverse Event (AE) secondary outcome time frame Up to 7 days after vaccination secondary outcome measure Intensity of Solicited Systemic Adverse Events (AEs) per the US Food and Drug Administration (FDA) Toxicity Grading Scale secondary outcome description Intensity of solicited systemic AEs will be graded per the FDA Toxicity Grading Scale at grades 0-3, where higher grades indicate a worse outcome. secondary outcome time frame Up to 7 days after vaccination secondary outcome measure Duration of Solicited Systemic Adverse Events (AEs) secondary outcome time frame Up to 7 days after vaccination secondary outcome measure Number of Participants Who Experience a Treatment-related Solicited Systemic Adverse Event (AE) secondary outcome time frame Up to 7 days after vaccination secondary outcome measure Number of Participants Who Experience an Unsolicited Adverse Event (AE) secondary outcome time frame Up to 28 days after vaccination secondary outcome measure Intensity of Unsolicited Adverse Events (AEs) per the Investigator's Assessment secondary outcome time frame Up to 28 days after vaccination secondary outcome measure Number of Participants Who Experience a Treatment-related Unsolicited Adverse Event (AE) secondary outcome time frame Up to 28 days after vaccination secondary outcome measure Number of Participants Who Experience a Medically Attended Adverse Event (AE) secondary outcome time frame Day 1 up to approximately 26 months secondary outcome measure Number of Participants Who Experience a Treatment-related Medically Attended Adverse Event (AE) secondary outcome time frame Day 1 up to approximately 26 months secondary outcome measure Number of Participants Who Experience a Medically Attended Serious Adverse Event (SAE) secondary outcome time frame Day 1 up to approximately 26 months secondary outcome measure Number of Participants Who Experience a Medically Attended Treatment-related Serious Adverse Event (SAE) secondary outcome time frame Day 1 up to approximately 26 months secondary outcome measure Number of Participants Who Experience a Medically Attended Adverse Event of Special Interest (AESI) secondary outcome time frame Day 1 up to approximately 26 months secondary outcome measure Number of Participants Who Experience a Treatment-related Medically Attended Adverse Event of Special Interest (AESI) secondary outcome time frame Day 1 up to approximately 26 months secondary outcome measure Number of Participants With Virologically-confirmed SARS-CoV-2 Infection secondary outcome description Measured by reverse transcription polymerase chain reaction (RT-PCR). secondary outcome time frame Screening up to approximately 26 months eligibility module eligibility criteria Inclusion Criteria: Male or female participants between the ages of 18 and 45 years or aged 65 years and older. Healthy adults or adults with pre-existing medical conditions who are in a stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment. Capable of giving personal signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this study protocol. Physical examination without clinically significant findings according to the Investigator's assessment. Affiliated to a social security system (except state medical aid). Females: At the time of enrollment, negative human chorionic gonadotropin (hCG) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrollment. On Day 1 (pre-vaccination): negative urine pregnancy test (hCG), (only required if serum pregnancy test was performed more than 3 days before). Note: Women that are postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to screening [Day 1]) or permanently sterilized will be considered as not having reproductive potential. Females of childbearing potential must use highly effective of birth control from 1 month before the first administration of the trial vaccine until 3 months following the last administration. The following methods of birth control are considered highly effective when used consistently and correctly: Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal); Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable); Intrauterine devices (IUDs); Intrauterine hormone-releasing systems (IUSs); Bilateral tubal occlusion; Vasectomized partner. Same sex relationships. Sexual abstinence (periodic abstinence [e.g., calendar, ovulation symptothermal and post-ovulation methods]) and withdrawal are not acceptable methods. Exclusion Criteria: Participant ill or febrile (body temperature ≥38.0°C) within 72 hours prior to screening and/or symptoms suggestive of coronavirus disease 2019 (COVID-19) within the past 14 days prior to screening (ill or febrile participants may be re-scheduled within the predefined interval when no longer presenting symptoms). Previous or currently active SARS-CoV-2 infection (currently as confirmed by reactive polymerase chain reaction [PCR] or positive serology test prior to the first trial vaccine administration). Use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the administration of the trial vaccine, or planned use during the trial period. Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration. Receipt of any investigational or licensed/authorized SARS-CoV-2 or other coronavirus vaccine, including non-specific vaccines such as Bacillus Calmette-Guérin, prior to the administration of the trial vaccine or planned administration during the trial. Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals and Methotrexate) for > 14 days total within 6 months preceding the administration of trial vaccine or planned use during the trial. For corticosteroid use, this means prednisone or equivalent, 0.5 mg/kg/day for 14 days or more. The use of inhaled, topical, or localized injections of corticosteroids (e.g., for joint pain/inflammation) is permitted. Receipt of any lipid nanoparticles (LNP)-formulated messenger ribonucleic acid vaccine prior to the administration of the trial vaccine. Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including known human immunodeficiency virus infection, hepatitis B virus infection and hepatitis C virus infection. History of potential immune-mediated disease. History of angioedema. Any known allergy to any component of investigational CVnCoV or aminoglycoside antibiotics. History of or current alcohol and/or drug abuse. History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (self-reported). Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine or planned administration during the trial. Participants with a significant acute or chronic medical or psychiatric illness that, in the opinion of the Investigator, precludes trial participation (e.g., may increase the risk of trial participation, render the participant unable to meet the requirements of the trial, or may interfere with the participant's trial evaluations). These include severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, respiratory disease, endocrine disorder, and neurological and psychiatric illnesses. However, those with controlled and stable cases can be included in the trial. Foreseeable non-compliance with protocol as judged by the Investigator. For females: pregnancy or lactation. History of any anaphylactic reactions. Participants with a significant bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder) or prior history of significant bleeding or bruising following intramuscular (IM) injections or venipuncture. Participants employed by the Sponsor, Investigator or trial site, or relatives of research staff working on this trial. Participant is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities). healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition mesh id D000045169 condition mesh term Severe Acute Respiratory Syndrome condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M24598 condition browse leaf name Severe Acute Respiratory Syndrome condition browse leaf as found Severe Acute Respiratory Syndrome condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id T5186 condition browse leaf name Severe Acute Respiratory Syndrome condition browse leaf as found Severe Acute Respiratory Syndrome condition browse leaf relevance high condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M16512 intervention browse leaf name Vaccines intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04838847
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full study rank 61497 study protocol section identification module n c t id NCT04835701 org study id info org study id IRB-20-03749 organization org full name Icahn School of Medicine at Mount Sinai org class OTHER brief title Music as a Nonpharmacologic Approach to Pain Control With Intrauterine Device Placement official title Music as a Nonpharmacologic Approach to Pain Control With Intrauterine Device Placement status module status verified date July 2022 overall status Terminated why stopped Limited staffing support to continue screening and enrollment process expanded access info has expanded access No start date struct start date December 14, 2020 start date type Actual primary completion date struct primary completion date November 16, 2021 primary completion date type Actual completion date struct completion date November 16, 2021 completion date type Actual study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 13, 2022 last update post date struct last update post date July 15, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Melissa Lozano responsible party investigator title Assistant Professor, Obstetrics, Gynecology and Reproductive Science responsible party investigator affiliation Icahn School of Medicine at Mount Sinai lead sponsor lead sponsor name Icahn School of Medicine at Mount Sinai lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The intervention of this study is the addition of patient-selected music during IUD insertion procedure. Subjects randomized to the music group will choose 10 songs, which will be played during the procedure, from the time of positioning through completion of IUD insertion and speculum removal. Music may be played through a portable speaker in close proximity to the patient or through the patient's own headphones, if preferred. Music will be played at a low enough volume for subjects to hear standard anticipatory guidance during the procedure. Both control and music groups will otherwise undergo the same standard protocol for IUD insertion in an outpatient clinic setting. Total participation is predicted to last approximately 30 minutes. Subjects in both control and intervention groups will undergo the same assessment of pain during IUD insertion using the 100-mm visual analog scale (VAS). This will be administered at 8 points during the procedure. All subjects will also answer the same 5-question satisfaction survey following IUD insertion. Pain scores will be measured and compared between music and control groups to assess the primary and secondary outcomes of this study. detailed description This is a prospective, two-center, randomized controlled trial evaluating whether music reduces pain and improves satisfaction during IUD insertion. Computer-generated randomization assignments will allocate subjects to either music or standard protocol groups. 40 music and 40 control designations will be allocated to both sites, and all designations will be block-stratified into 10 blocks, each containing 4 controls and 4 intervention (music) subjects. This will ensure there are close to equal numbers of subjects in both groups if recruitment is halted before the minimum of 80 patients are enrolled. Assignments are available in a read-only document accessible by all co-investigators at the time of enrollment and randomization. Subjects randomized to the music group will choose 10 songs, which will be played during the procedure, from the time of positioning through completion of IUD insertion and speculum removal. Music may be played through a portable speaker in close proximity to the patient or through the patient's own headphones, if preferred. Both control and music groups will otherwise undergo the same standard anticipatory guidance and protocol for IUD insertion in an outpatient clinic setting. Total participation is predicted to last approximately 30 minutes, as is standard for an appointment for IUD insertion. Study subjects will not interact with other participants. Patients in both control and intervention groups will undergo intrauterine device (IUD) insertion. Pain will be assessed using a 100-mm visual analog scale (VAS) at 8 points during the procedure, including: (1) anticipated pain, (2) baseline pain prior to IUD insertion, (3) after speculum placement, (4) on tenaculum application, (5) on uterine sounding, (6) at IUD insertion, (7) after speculum removal, and (8) 5 minutes following the procedure. Patients will also answer a brief 5-question satisfaction survey following IUD insertion. Pain scores will be measured and compared between music and control groups to assess the primary and secondary outcomes of this study. VAS scores will be recorded by the attending physician or co-investigator, as they will reliably note when each step of the procedure occurs and pain should be assessed. They will present the 100mm visual analog scale (VAS) to the patient at each of the 8 points of the procedure, and the patient will mark their pain score. Scores will be measured and documented by a single co-investigator to eliminate bias or differences in measurement. VAS scores will be analyzed separately for each of the 8 distinct points described during the IUD insertion procedure. Differences between the intervention (music) and control groups will be assessed using a 0.05 level Wilcoxon ranksum test. A significant difference in pain will be noted if at least a 20 mm difference in VAS pain score exists between the two groups at any point of the procedure when VAS score is collected. The aim of this study is to determine if music, chosen by the patient and played during IUD insertion, leads to lower pain scores and improved patient satisfaction with the procedure. conditions module condition list condition Contraception keyword list keyword Intrauterine device IUD Pain Music design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Diagnostic design masking info design masking None (Open Label) enrollment info enrollment count 8 enrollment type Actual arms interventions module arm group list arm group arm group label Music Intervention group arm group type Experimental arm group description Subjects randomized to the music group will choose 10 songs, which will be played during the procedure, from the time of positioning through completion of IUD insertion and speculum removal. Participants will otherwise undergo standard protocol for IUD insertion in an outpatient clinic setting. Total participation is predicted to last approximately 30 minutes. arm group intervention list arm group intervention name Behavioral: Music arm group label Control group arm group type No Intervention arm group description Participants to undergo same standard protocol for IUD insertion in an outpatient clinic setting. No music will be played during the procedure. intervention list intervention intervention type Behavioral intervention name Music intervention description Music may be played through a portable speaker in close proximity to the patient or through the patient's own headphones, if preferred. Music will be played at a low enough volume for subjects to hear standard anticipatory guidance during the procedure. intervention arm group label list intervention arm group label Music Intervention group outcomes module primary outcome list primary outcome primary outcome measure 100-mm visual analog scale (VAS) primary outcome description 100-mm VAS total scale from 1-100 with higher score indicating more pain primary outcome time frame Day 1, at time of IUD insertion secondary outcome list secondary outcome secondary outcome measure 100-mm visual analog scale (VAS) secondary outcome description 100-mm VAS total scale from 1-100 with higher score indicating more pain secondary outcome time frame Day 1, baseline prior to IUD insertion secondary outcome measure 100-mm visual analog scale (VAS) secondary outcome description 100-mm VAS total scale from 1-100 with higher score indicating more pain secondary outcome time frame Day 1, after speculum placement secondary outcome measure 100-mm visual analog scale (VAS) secondary outcome description 100-mm VAS total scale from 1-100 with higher score indicating more pain secondary outcome time frame Day 1, on tenaculum application secondary outcome measure 100-mm visual analog scale (VAS) secondary outcome description 100-mm VAS total scale from 1-100 with higher score indicating more pain secondary outcome time frame Day 1, on uterine sounding secondary outcome measure 100-mm visual analog scale (VAS) secondary outcome description 100-mm VAS total scale from 1-100 with higher score indicating more pain secondary outcome time frame Day 1, after speculum removal secondary outcome measure 100-mm visual analog scale (VAS) secondary outcome description 100-mm VAS total scale from 1-100 with higher score indicating more pain secondary outcome time frame Day 1, 5 minutes following the procedure secondary outcome measure Patient Satisfaction Survey secondary outcome description Patient Satisfaction Survey consists of 5-question administered post-procedure. Full scale from 1 to 5, with higher score indicating higher satisfaction. secondary outcome time frame Day 1, post procedure at 30 minutes eligibility module eligibility criteria Inclusion Criteria: Provision of signed and dated informed consent form Nulliparous adult females age 18 years or older (nulliparous is defined as no prior pregnancies greater than or equal to 20 weeks of gestation) English-speaking patients Undergoing insertion of a copper or levonorgestrel intrauterine device Willing to comply with all study procedures Exclusion Criteria: Non-English speaking patients Patients with a support person in the room during IUD insertion Patients desiring a paracervical block for analgesia healthy volunteers Accepts Healthy Volunteers gender All gender based Yes gender description 2. Nulliparous adult females age 18 years or older (nulliparous is defined as no prior pregnancies greater than or equal to 20 weeks of gestation) minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Neha R Bhardwaj, MD overall official affiliation Icahn School of Medicine at Mount Sinai overall official role Principal Investigator location list location location facility Mount Sinai Beth Israel location city New York location state New York location zip 10003 location country United States location facility Mount Sinai West location city New York location state New York location zip 10019 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions
NCT04835701
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full study rank 61474 study protocol section identification module n c t id NCT04836000 org study id info org study id 2021100 organization org full name Hacettepe University org class OTHER brief title EFFECTIVENESS OF LOW-LEVEL LASER THERAPY official title EFFECTIVENESS OF LOW-LEVEL LASER THERAPY FOR THE NONOPERATIVE TREATMENT OF SMALL AND MEDIUM-SIZED ROTATOR CUFF TEARS status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date December 1, 2021 primary completion date type Anticipated completion date struct completion date January 1, 2022 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Caner Karartı responsible party investigator title Caner Karartı, Hacettepe University responsible party investigator affiliation Hacettepe University lead sponsor lead sponsor name Hacettepe University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary During rotator cuff tear healing stages, there are complex interactions between a variety of tissue growth factors and cells, ultimately resulting in tissue that is markedly different from that of normal, uninjured tendon. Hence, there is a strong drive to investigate the role of potential therapies in the form of biological augments that may restore the pathologic tissue to a near normal physiological state. In this context, low-level laser therapy (LLLT) may be an effective choice in the treatment of nonoperative small and medium-sized rotator cuff tears (RCT). To the best of our knowledge, there is no randomized controlled study investigating the effects of the LLLT in patients with a RCT size not exceeding 3 cm. Therefore, the aim of the current study is to investigate all the possible effects of the LLLT in terms of functional status, pain-free mobility, and quality-of-life. detailed description Recently, there is a increasing evidence that the addition of low-level laser therapy (LLLT) to treatment program of shoulder problems plays an important role in stimulation of healing, augmenting tissue repair, relief of pain and inflammation, and restoration of function. LLLT, phototherapy or photobiomodulation refers to the use of photons at a non-thermal irradiance to alter biological activity. The basic biological mechanism behind the effects of LLLT is thought to be through absorption of red and near infrared light by mitochondrial chromophores, in particular cytochrome c oxidase (CCO) which is contained in the respiratory chain located within the mitochondria, and perhaps also by photoacceptors in the plasma membrane of cells. It is hypothesized that this absorption of light energy may cause photodissociation of inhibitory nitric oxide from CCO9 leading to enhancement of enzyme activity, electron transport, mitochondrial respiration and adenosine triphosphate (ATP) production. In turn, LLLT alters the cellular redox state which induces the activation of numerous intracellular signaling pathways, and alters the affinity of transcription factors concerned with cell proliferation, survival, tissue repair and regeneration. During rotator cuff tear healing stages, there are complex interactions between a variety of tissue growth factors and cells, ultimately resulting in tissue that is markedly different from that of normal, uninjured tendon. Hence, there is a strong drive to investigate the role of potential therapies in the form of biological augments that may restore the pathologic tissue to a near normal physiological state. In this context, LLLT may be an effective choice in the treatment of nonoperative small and medium-sized rotator cuff tears (RCT). To the best of our knowledge, there is no randomized controlled study investigating the effects of the LLLT in patients with a RCT size not exceeding 3 cm. Therefore, the aim of the current study is to investigate all the possible effects of the LLLT in terms of functional status, pain-free mobility, and quality-of-life. conditions module condition list condition Rotator Cuff Tears Rehabilitation Rotator Cuff Injuries keyword list keyword Laser Therapy Low-Level Biostimulation Phototherapy Rotator Cuff Injuries Rotator Cuff Tears design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Randomized design primary purpose Treatment design masking info design masking Double design masking description Double-blind design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 72 enrollment type Anticipated arms interventions module arm group list arm group arm group label Placebo Group arm group type Placebo Comparator arm group description In addition to the conservative treatment of the control group, low-level laser therapy (turned off) will be applied for 12 weeks. In the placebo group, laser instrument will be applied in the same way but the device will be turned off during treatment sessions. arm group intervention list arm group intervention name Other: In addition to the conservative treatment, Low-level laser therapy (turned off) arm group label Experimental Group arm group type Experimental arm group description In addition to the conservative treatment of the control group, low-level laser therapy will be applied for 12 weeks. arm group intervention list arm group intervention name Other: In addition to the conservative treatment, Low-level laser therapy arm group label Control Group arm group type Active Comparator arm group description For 12 weeks, all three groups will receive five sessions per week of a protocolised treatment based on therapeutic exercises, analgesic electrotherapy and cryotherapy. arm group intervention list arm group intervention name Other: Conservative treatment solely intervention list intervention intervention type Other intervention name In addition to the conservative treatment, Low-level laser therapy intervention description For Experimental Group A Gallium-aluminum-arsenide (Ga-Al-As) diode laser instrument (Roland Serie, Elettronica Pagani, Paderno, Italy, Mod IR 27/1) will be used (wavelength 904 nm, 5500 Hz frequency, 27 W maximum power output per pulse, 13.2 mW average power, 0.8-cm2 spot size, 1.6 J of total energy will be delivered per point at each session at a power density of 16.5 mW/cm2, and the cumulative energy per point for all sessions was 16 J). Ga-Al-As laser therapy will be applied to experimental group patients two times per week for 12 weeks in 10-min sessions. LLLT will be applied over the tuberculum majus and minus, the anterior and posterior faces of the capsule, and the subacromial regions. Each point will be treated for 120 sec. The head of the instrument will be held perpendicular to the body surface and in skin contact without pressure. intervention arm group label list intervention arm group label Experimental Group intervention type Other intervention name In addition to the conservative treatment, Low-level laser therapy (turned off) intervention description For Placebo Group In the placebo group, laser instrument will be applied in the same way but the device will be turned off during treatment sessions. Patients and physiotherapist will be asked to use protective eyeglasses during therapy for safety. intervention arm group label list intervention arm group label Placebo Group intervention type Other intervention name Conservative treatment solely intervention description For Control Group The rehabilitation program for the 3 groups will be equal and consist of 3 phases.Each phase contains several recommended exercises from which the physiotherapist can choose, with respect to restrictions. The physiotherapist decides when the patient is ready to move on to the next phase, considering aspects of quality of motion and pain. Phase 1 includes standardized information about the condition and exercises aimed at promoting good posture and stabilization of the scapula. Initially, range of motion exercises that unload the rotator cuff will be used, such as the wall slide and supported active flexion on a table using a ball and active assisted exercises in elevation, abduction, and external rotation. Phase 2 contains active unloaded exercises in elevation, external, and internal rotation as well as isometric strengthening exercises. Phase 3 includes dynamic strengthening exercises for the rotator cuff and scapula stabilizers. intervention arm group label list intervention arm group label Control Group outcomes module primary outcome list primary outcome primary outcome measure Constant-Murley score (Functional Outcome) primary outcome description It assesses four aspects related to shoulder pathology; two subjective: pain and activities of daily living (ADL) and two objective: range of motion (ROM) and strength. The subjective components can receive up to 35 points and the objective 65, resulting in a possible maximum total score of 100 points (best function). Pain and ADL are answered by the patient; ROM and strength require a physical evaluation and are answered by the orthopaedic surgeon or the physiotherapist primary outcome time frame 12 weeks secondary outcome list secondary outcome secondary outcome measure Western Ontario Rotator Cuff index (Functional Outcome) secondary outcome description It is a self-administering health questionnaire. It has 21 items, exploring 5 different domains: Physical symptoms, Sports and recreation, Work, Social function, Emotions. Each question uses a visual analogue scale (VAS) - which is a straight line, representing a 100-point scale, ranging from 0-100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. To make the final score more clinically friendly, some minor math is involved. The score can be reported as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This will give you an overall percentage. Total final WORC scores can, therefore, range from 0% ( lowest functional status level) to 100% (the highest functional status). secondary outcome time frame 12 weeks secondary outcome measure Pain-free mobility of the shoulder secondary outcome description Pain-free flexion and abduction will be assessed with universal goniometer. secondary outcome time frame 12 weeks secondary outcome measure EQ-5D-5L (quality-of-life) secondary outcome description The 5-level EQ-5D version (EQ-5D-5L) essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. secondary outcome time frame 12 weeks eligibility module eligibility criteria Inclusion Criteria: pain at rest or exercise laterally on the shoulder, a painful motion arc, a positive impingement sign, passive shoulder motion of at least 140° for abduction and flexion, demonstration of a full-thickness tear of the rotator cuff by both sonography and magnetic resonance imaging (MRI), a tear size not exceeding 3 cm, muscle atrophy not exceeding Thomazeau stage 2 on MRI. Exclusion Criteria: patient age of <18 years and older than 65 years, tears involving >25% of the width of the subscapularis tendon, presence of other local or systemic diseases affecting shoulder function, history of surgical treatment of the involved shoulder, medical contraindication for training, inability to understand written and spoken communication. healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Caner KARARTI, PT, PhD. central contact role Contact central contact phone +903862805362 central contact e mail fzt.caner.92@gmail.com central contact name Hakkı Çağdaş BASAT, Assoc.Prof. central contact role Contact central contact phone +905057721489 central contact e mail cagdasbasat@gmail.com location list location location facility Caner KARARTI location status Recruiting location city Kırşehir location zip 40100 location country Turkey location contact list location contact location contact name Caner KARARTI, PT, PhD. location contact role Contact location contact phone 03862805362 location contact e mail fzt.caner.92@gmail.com references module reference list reference reference p m i d 23540577 reference type background reference citation Kuhn JE, Dunn WR, Sanders R, An Q, Baumgarten KM, Bishop JY, Brophy RH, Carey JL, Holloway BG, Jones GL, Ma CB, Marx RG, McCarty EC, Poddar SK, Smith MV, Spencer EE, Vidal AF, Wolf BR, Wright RW; MOON Shoulder Group. Effectiveness of physical therapy in treating atraumatic full-thickness rotator cuff tears: a multicenter prospective cohort study. J Shoulder Elbow Surg. 2013 Oct;22(10):1371-9. doi: 10.1016/j.jse.2013.01.026. Epub 2013 Mar 27. reference p m i d 31924516 reference type background reference citation Ranebo MC, Bjornsson Hallgren HC, Holmgren T, Adolfsson LE. Surgery and physiotherapy were both successful in the treatment of small, acute, traumatic rotator cuff tears: a prospective randomized trial. J Shoulder Elbow Surg. 2020 Mar;29(3):459-470. doi: 10.1016/j.jse.2019.10.013. Epub 2020 Jan 7. reference p m i d 26537160 reference type background reference citation Kukkonen J, Joukainen A, Lehtinen J, Mattila KT, Tuominen EK, Kauko T, Aarimaa V. Treatment of Nontraumatic Rotator Cuff Tears: A Randomized Controlled Trial with Two Years of Clinical and Imaging Follow-up. J Bone Joint Surg Am. 2015 Nov 4;97(21):1729-37. doi: 10.2106/JBJS.N.01051. Erratum In: J Bone Joint Surg Am. 2016 Jan 6;98(1):e1. reference p m i d 25925768 reference type background reference citation Awotidebe AW, Inglis-Jassiem G, Young T. Low-level laser therapy and exercise for patients with shoulder disorders in physiotherapy practice (a systematic review protocol). Syst Rev. 2015 Apr 30;4:60. doi: 10.1186/s13643-015-0050-2. reference p m i d 25450903 reference type background reference citation Haslerud S, Magnussen LH, Joensen J, Lopes-Martins RA, Bjordal JM. The efficacy of low-level laser therapy for shoulder tendinopathy: a systematic review and meta-analysis of randomized controlled trials. Physiother Res Int. 2015 Jun;20(2):108-25. doi: 10.1002/pri.1606. Epub 2014 Dec 2. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000070636 condition mesh term Rotator Cuff Injuries condition ancestor list condition ancestor condition ancestor id D000012421 condition ancestor term Rupture condition ancestor id D000014947 condition ancestor term Wounds and Injuries condition ancestor id D000070599 condition ancestor term Shoulder Injuries condition ancestor id D000013708 condition ancestor term Tendon Injuries condition browse leaf list condition browse leaf condition browse leaf id M624 condition browse leaf name Rotator Cuff Injuries condition browse leaf as found Rotator Cuff Tear condition browse leaf relevance high condition browse leaf id M14393 condition browse leaf name Rupture condition browse leaf relevance low condition browse leaf id M21938 condition browse leaf name Lacerations condition browse leaf relevance low condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse leaf id M602 condition browse leaf name Shoulder Injuries condition browse leaf relevance low condition browse leaf id M15631 condition browse leaf name Tendon Injuries condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3184 intervention browse leaf name Analgesics intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04836000
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full study rank 61286 study protocol section identification module n c t id NCT04838444 org study id info org study id VLA1553-303 organization org full name Valneva Austria GmbH org class INDUSTRY brief title Antibody Persistence And Long Term Safety Of A Chikungunya Virus Vaccine Candidate (VLA1553) official title An Open-Label, Single Arm Study To Evaluate Antibody Persistence And Long Term Safety Of A Live-Attenuated Chikungunya Virus Vaccine Candidate (VLA1553) In Adults Aged 18 Years and Above status module status verified date October 2021 overall status Enrolling by invitation expanded access info has expanded access No start date struct start date April 2, 2021 start date type Actual primary completion date struct primary completion date December 2025 primary completion date type Anticipated completion date struct completion date December 2025 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date October 21, 2021 last update post date struct last update post date October 22, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Valneva Austria GmbH lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary In this open-label Phase 3b, single arm study, persistence of antibodies and long term safety will be evaluated in up to 375 subjects rolled over from study VLA1553-301 (NCT number: NCT04546724). detailed description In this open-label Phase 3b, single arm study, persistence of antibodies and long term safety in up to 375 subjects rolled over from study VLA1553-301 (NCT number: NCT04546724) These subjects will have annual follow-up visits at Months 12, 24, 36, 48 and 60 after immunization. The primary objective of this study will be to evaluate persistence of antibodies annually from 1 to 5 years after the single immunization with VLA1553. The secondary objective is to evaluate long-term safety 6 months to 2 years after the single immunization with VLA1553. conditions module condition list condition Chikungunya Virus Infection design module study type Interventional phase list phase Phase 3 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 375 enrollment type Anticipated arms interventions module arm group list arm group arm group label VLA1553 arm group type Experimental arm group intervention list arm group intervention name Biological: VLA1553 intervention list intervention intervention type Biological intervention name VLA1553 intervention description Study participants previously vaccinated with VLA1553 in study VLA1553-301 will be followed up for safety and immunogenicity. intervention arm group label list intervention arm group label VLA1553 outcomes module primary outcome list primary outcome primary outcome measure Proportion of subjects with a seroprotective CHIKV antibody level post-vaccination. primary outcome time frame until Year 5 secondary outcome list secondary outcome secondary outcome measure Frequency of any Serious Adverse Event (SAE) secondary outcome time frame until Year 2 secondary outcome measure Relatedness of any Serious Adverse Event (SAE) secondary outcome time frame until Year 2 secondary outcome measure Immune r esponse as measured by CHIKV-specific neutralizing antibody titers post-vaccination secondary outcome time frame until Year 5 secondary outcome measure Proportion of subjects with seroconversion secondary outcome time frame until Year 5 secondary outcome measure Fold increase of CHIKV-specific neutralizing antibody titers post-vaccination as compared to baseline (i.e. at start of study VLA1553-301) secondary outcome time frame until Year 5 secondary outcome measure Proportion of subjects reaching an at least 4-fold, 8-fold, 16-fold or 64-fold increase in CHIKV-specific neutralizing antibody titer compared to baseline secondary outcome time frame until 5 Year 5 eligibility module eligibility criteria Inclusion Criteria: Subject participated in the VLA1553-301 clinical study; Subject has an understanding of the study and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any study-related procedures; Subject had immunogenicity blood samples taken at baseline (Visit 1) and either Day 29 (Visit 3), Day 85 (Visit 4) or Day 180 (Visit 5) in Study VLA1553-301 and was negative for neutralizing antibodies at baseline Exclusion Criteria: Subject presents with clinical conditions representing a contraindication to blood draws; Subject has donated blood or use of blood products prior 30 days of immunogenicity sampling; Subject has received an active drug with potential immunosuppressive action or investigational drug or device within a period of 30 days prior a study visit; Subject has a known or suspected problem with alcohol or drug abuse as determined by the Investigator; Subject has any condition that, in the opinion of the Investigator, may compromise the subject's well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study; Subject is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities); Subject is a member of the team conducting the study or in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the Investigator or site personnel conducting the study. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Valneva Clinical Development overall official affiliation Valneva Austria GmbH overall official role Study Chair location list location location facility Accelerated Enrollment Solutions (AES) location city Phoenix location state Arizona location zip 85020 location country United States location facility Accelerated Enrollment Soutions (AES) location city San Diego location state California location zip 92108 location country United States location facility ELITE Research Network location city Hallandale Beach location state Florida location zip 33090 location country United States location facility Accelerated Enrollment Solutions (AES) location city Chicago location state Illinois location zip 60602 location country United States location facility Alliance for Multispecialty Research (AMR) location city Lexington location state Kentucky location zip 40509 location country United States location facility Meridian Clinical Research location city Grand Island location state Nebraska location zip 68803 location country United States location facility Platinum Research Network location city Omaha location state Nebraska location zip 68134 location country United States location facility Alliance for Multispecialty Research (AMR) location city Knoxville location state Tennessee location zip 37920 location country United States location facility ELITE Research Network location city Cedar Park location state Texas location zip 78613 location country United States location facility ELITE Research Network location city West Jordan location state Utah location zip 84088 location country United States location facility Allliance for Multispecialty Research (AMR) location city Norfolk location state Virginia location zip 23502 location country United States i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000065632 condition mesh term Chikungunya Fever condition ancestor list condition ancestor condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000018354 condition ancestor term Alphavirus Infections condition ancestor id D000001102 condition ancestor term Arbovirus Infections condition ancestor id D000079426 condition ancestor term Vector Borne Diseases condition ancestor id D000014036 condition ancestor term Togaviridae Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition browse leaf list condition browse leaf condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M29699 condition browse leaf name Chikungunya Fever condition browse leaf as found Chikungunya condition browse leaf relevance high condition browse leaf id M2455 condition browse leaf name Hyperthermia condition browse leaf relevance low condition browse leaf id M7616 condition browse leaf name Fever condition browse leaf relevance low condition browse leaf id M19645 condition browse leaf name Alphavirus Infections condition browse leaf relevance low condition browse leaf id M3564 condition browse leaf name Arbovirus Infections condition browse leaf relevance low condition browse leaf id M2054 condition browse leaf name Vector Borne Diseases condition browse leaf relevance low condition browse leaf id M15944 condition browse leaf name Togaviridae Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id T1131 condition browse leaf name Chikungunya condition browse leaf as found Chikungunya condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M9336 intervention browse leaf name Immunoglobulins intervention browse leaf relevance low intervention browse leaf id M3377 intervention browse leaf name Antibodies intervention browse leaf relevance low intervention browse leaf id M16512 intervention browse leaf name Vaccines intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04838444
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full study rank 61490 study protocol section identification module n c t id NCT04835792 org study id info org study id FP-LD-001 organization org full name FlightPath Biosciences, Inc. org class INDUSTRY brief title Biomarker Study of Previously Treated Lyme Disease Volunteers in Comparison to Healthy Volunteers official title Biomarker Study to Evaluate Participants With Previously Treated Lyme Disease in Comparison to Healthy Volunteers status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 21, 2021 start date type Actual primary completion date struct primary completion date September 30, 2021 primary completion date type Anticipated completion date struct completion date September 30, 2021 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name FlightPath Biosciences, Inc. lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Non-interventional study evaluating stool and blood samples collected from individuals previously treated with Lyme disease versus healthy volunteers conditions module condition list condition Lyme Disease design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 1000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Previously Treated for Lyme Disease arm group intervention list arm group intervention name Other: Stool and blood collection arm group label Healthy Volunteers arm group intervention list arm group intervention name Other: Stool and blood collection intervention list intervention intervention type Other intervention name Stool and blood collection intervention description One-time stool and blood collection intervention arm group label list intervention arm group label Healthy Volunteers Previously Treated for Lyme Disease outcomes module primary outcome list primary outcome primary outcome measure • To evaluate and compare the microbiome of normal participants and participants with previously treated Lyme Disease primary outcome time frame 30 days primary outcome measure • To evaluate and compare the transcriptome of normal participants and participants with previously treated Lyme Disease primary outcome time frame 30 days primary outcome measure • To evaluate and compare the metabolome of normal participants and participants with previously treated Lyme Disease primary outcome time frame 30 days primary outcome measure • Evaluation of symptoms and prior medications/treatments of normal participants and participants with previously treated Lyme Disease primary outcome time frame 30 days eligibility module eligibility criteria Inclusion Criteria: Males and females ≥18 years of age. Able to read, understand, and provide signed informed consent. Willing to provide blood and stool samples. Able to communicate adequately and to comply with the requirements for the entire study. Must be willing to discontinue antibiotics 2 weeks prior to sample collection. If participating in the previously treated Lyme Disease arm, the participants must meet the following criteria: 1) Diagnosis of prior Lyme Disease supported by either an erythema migrans rash (either classic "bull's eye" or irregular) OR a CDC-positive Western blot, 2) previously treated with antibiotics for Lyme Disease, 3) remains ill six months or more after receiving preliminary treatment with antibiotics for Lyme disease (e.g., fatigue, musculoskeletal pain, or neurocognitive symptoms). If participating in the healthy volunteer arm, the participants must meet the following criteria: 1) must not have had a Lyme Disease diagnosis, 2) in generally good health Exclusion Criteria: 1. Unwilling or unable to comply with the protocol (e.g., scheduled visits, laboratory tests, other study procedures, and study restrictions). healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult study population Previously treated Lyme disease volunteers and healthy volunteers sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Matt Tindall central contact role Contact central contact phone 415-530-1828 central contact e mail matt@flightpath.bio location list location location facility Dr. Curtis Scribner location status Recruiting location city Berkeley location state California location zip 94710 location country United States location contact list location contact location contact name Matt Tindall location contact role Contact location contact phone 415-530-1828 location contact e mail matt@flightpath.bio derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000008193 condition mesh term Lyme Disease condition ancestor list condition ancestor condition ancestor id D000016905 condition ancestor term Gram-Negative Bacterial Infections condition ancestor id D000001424 condition ancestor term Bacterial Infections condition ancestor id D000001423 condition ancestor term Bacterial Infections and Mycoses condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000001899 condition ancestor term Borrelia Infections condition ancestor id D000013145 condition ancestor term Spirochaetales Infections condition ancestor id D000017282 condition ancestor term Tick-Borne Diseases condition ancestor id D000079426 condition ancestor term Vector Borne Diseases condition browse leaf list condition browse leaf condition browse leaf id M10342 condition browse leaf name Lyme Disease condition browse leaf as found Lyme Disease condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M3874 condition browse leaf name Bacterial Infections condition browse leaf relevance low condition browse leaf id M18401 condition browse leaf name Gram-Negative Bacterial Infections condition browse leaf relevance low condition browse leaf id M11288 condition browse leaf name Mycoses condition browse leaf relevance low condition browse leaf id M3873 condition browse leaf name Bacterial Infections and Mycoses condition browse leaf relevance low condition browse leaf id M4329 condition browse leaf name Borrelia Infections condition browse leaf relevance low condition browse leaf id M18729 condition browse leaf name Tick-Borne Diseases condition browse leaf relevance low condition browse leaf id M2054 condition browse leaf name Vector Borne Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology
NCT04835792
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full study rank 61871 study protocol section identification module n c t id NCT04830839 org study id info org study id R24HD096350 org study id type U.S. NIH Grant/Contract org study id link https://reporter.nih.gov/quickSearch/R24HD096350 organization org full name Children's Hospital Medical Center, Cincinnati org class OTHER brief title Recovery After Stress Toolkit (ReSeT): Pilot Study official title Online Modules to Help Children Manage Medical Stress After an Injury: Recovery After Stress Toolkit (ReSeT) Pilot Study acronym ReSeT status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date November 1, 2020 start date type Actual primary completion date struct primary completion date June 30, 2021 primary completion date type Actual completion date struct completion date June 30, 2021 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date December 9, 2021 last update post date struct last update post date December 10, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Children's Hospital Medical Center, Cincinnati lead sponsor class OTHER collaborator list collaborator collaborator name University of Utah collaborator class OTHER collaborator name The University of Texas Health Science Center, Houston collaborator class OTHER collaborator name Tulane University collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Experiencing an accident and staying in the hospital can be scary and traumatic for children. The goal of this project is to develop an online resource to help children and their parents develop effective coping skills to manage their stress. Children ages 8-17 who exhibit signs of posttraumatic stress will view 8 online modules and attend weekly videoconferencing sessions with a therapist. Parents will have 4 modules to assist them in supporting their child after the injury. detailed description The overarching goal of this project is to provide a research and treatment resource for the management of psychological distress in children who have been hospitalized for a physical trauma. The investigators will pilot an innovative, brief e-health approach to treatment of PTSS designed to be delivered through the trauma system. The investigators will create interactive web-based psychoeducational modules that are developmentally tailored for school age children (8 to 17 years) for use with synchronous e-health therapy sessions with a trained therapist. Companion modules for parents will help parents to understand and respond to their child's PTSS. The investigators will perform a single-arm pilot trial of a brief e-health approach to treatment of PTSS (i.e., Recovery after Stress Toolkit; ReSeT). ( delete with usual care.) conditions module condition list condition Post-traumatic Stress Disorder keyword list keyword post-traumatic stress medical stress e-health design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design intervention model description This is a single group design as all eligible participants will be offered the 8 session Recovery after Stress Toolkit (ReSeT) program, including 8 self-guided child modules and 4 parent modules, as well as 8 parallel videoconferencing sessions with a therapist. design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 6 enrollment type Actual arms interventions module arm group list arm group arm group label Recovery after Stress Toolkit (ReSeT) arm group type Experimental arm group description ReSeT is comprised of interactive web-based psychoeducational modules that are developmentally tailored for school age children (8-17 years) for use with synchronous e-health therapy sessions with a trained therapist. Participants in the ReSeT treatment will complete 8 modules and therapy sessions. Parents will also have access to 4 modules During the study, children/youth will be asked to complete all eight sessions of the online treatment together with the therapist over an 8 -12 week time period (to allow for scheduling/cancellations). For younger children, parents will participate in the beginning and end of each session. Sessions will last approximately 30-60 minutes and will occur approximately every week for an anticipated 4-8 hour time commitment. Parents of older children will be permitted to review the content independently and participate in feedback sessions. arm group intervention list arm group intervention name Behavioral: Recovery after Stress Toolkit (ReSeT) intervention list intervention intervention type Behavioral intervention name Recovery after Stress Toolkit (ReSeT) intervention description ReSeT involves online modules with parallel videoconferencing sessions. ReSeT integrates two evidence-based treatment methods: cognitive behavioral therapy coping skills (coping CBT) and direct exposure to trauma reminders through a trauma narrative. intervention arm group label list intervention arm group label Recovery after Stress Toolkit (ReSeT) outcomes module primary outcome list primary outcome primary outcome measure Adherence primary outcome description Adherence to the ReSeT intervention will be assessed by calculating the number of sessions participants complete out of the 8 proposed sessions. primary outcome time frame Feasibility will be assessed at 12 weeks post-enrollment. primary outcome measure Acceptability primary outcome description The acceptability of the ReSeT intervention will be assessed with child and parent satisfaction surveys, and a qualitative interview with open-ended feedback about the program. The satisfaction surveys ask participants to rate their satisfaction with the program on a 4 point Likert scale (from "strongly disagree" to "strongly agree"), with higher scores indicative of greater satisfaction and acceptability. primary outcome time frame Acceptability will be assessed at 12 weeks post-enrollment. primary outcome measure Length of time to complete sessions primary outcome description The feasibility of the ReSeT intervention will be assessed with the number of weeks that it takes participants to complete the 8 sessions of the intervention. The intervention was designed to take place over a 12 week period, with sessions occurring weekly. primary outcome time frame This outcome will be assessed at the end of the 8 sessions of the intervention. secondary outcome list secondary outcome secondary outcome measure Child post-traumatic stress symptoms (PTSS) secondary outcome description The Child Post-Traumatic Stress Disorder Scale (CPSS; Foa et al, 2001) is a validated child report and parent proxy measure of PTSS. The measure is comprised of 24-items. The CPSS includes 17 questions mapping on to DSM-IV symptoms of PTSD rated on a 4-point scale that indicates how frequently each symptom occurs (0 = not at all, 1 = once a week or less/once in a while, 2 = 2 to 4 times a week/half the time, 3 = 5 or more times a week/almost always). In addition, the CPSS includes seven questions regarding functional impairment. These questions are scored dichotomously as absent (0) or present (1). Scores range from 0 - 7, with higher scores indicating greater functional impairment. secondary outcome time frame Child PTSS from pre-intervention (within 6 months of the injury discharge) will be compared to the child's PTSS post-intervention, at 12 weeks post-enrollment or until the child has finished treatment. secondary outcome measure Child anxiety symptoms secondary outcome description The Screen Child Anxiety and Related Emotional Disorders (SCARED; Birmaher et al., 1999) is a widely used questionnaire that screens for anxiety and emotional disorders in children. The child self-report version will be used in this study, which consists of 41 items rated on a 3-point Likert scale ( 0 = not true or hardly ever true, 1 = somewhat true or sometimes true, 2 = very true or often true). This measures yields raw scores for anxiety disorder, panic disorder, generalized anxiety disorder, separation anxiety, social anxiety disorder, and significant school avoidance. secondary outcome time frame Child anxiety from pre-intervention (within 6 months of the injury discharge) will be compared to child anxiety post-intervention, at 12 weeks post-enrollment or until the child has finished treatment. secondary outcome measure Child quality of life secondary outcome description The Pediatric Quality of Life Inventory (PedsQL 4.0; Varni et al., 2001) is a well-validated parent- report measure consisting of 15 items that takes less than 5 minutes to complete. The PedsQL evaluates health-related quality of life by assessing the dimensions of physical, emotional, social, and cognitive functioning in children from infancy to 18 years of life age. The total quality of life scale score will be utilized. secondary outcome time frame Child quality of life from pre-intervention (within 6 months of the injury discharge) will be compared to child quality of life post-intervention, at 12 weeks post-enrollment or until the child has finished treatment. secondary outcome measure Child depressive symptoms secondary outcome description The Patient Reported Outcomes Measurement Information System (PROMIS; Varni et al., 2014) is a National Institutes of Health (NIH) initiative created to advance assessment of patient-reported outcomes. The PROMIS Pediatric Cooperative Group has developed pediatric self-report item banks across five generic health domains that have been further delineated into eight latent structures. The current study will use both the pediatric self-report and parent proxy short forms for the anger, anxiety, depression, psychological stress, and physical stress scales which are each eight items and the global health scale which is seven items. Additionally, the eight item sleep disturbance questionnaire will be completed by parents. secondary outcome time frame Child depressive symptoms from pre-intervention (within 6 months of the injury discharge) will be compared to child depressive symptoms post-intervention, at 12 weeks post-enrollment or until the child has finished treatment. eligibility module eligibility criteria Inclusion Criteria: Ages of 8 to 17 years at time of enrollment Hospitalized for trauma at one of the following sites: PICU, ward or rapid treatment/observation unit (less than 23 hours stay) Both the parent and the child participating have the ability to read and speak English Have broadband internet availability at their home address Elevated post-traumatic stress symptoms (If the child exhibits clinically significant PTSS determined with the CPSS [Foa et al., 2001] with a score greater than or equal to 11 on the sum of the highest item by item score of parent/child report, they will be invited to participate in the pilot intervention. This methodology for using a joint score on the CPSS was informed by previous work indicating that both parents and children tend to underreport PTSS symptoms. Thus, implementing a multi-informant approach yields a more valid estimation of a child's psychopathology.) Exclusion Criteria: Has sustained a moderate or severe TBI, as defined by a Glasgow Coma Score of less than 13 Has been diagnosed with moderate or severe intellectual disability , low functioning autism spectrum disorder, or a developmental disability (This will be determined by medical chart review and confirmed with parent report: Has the child ever been diagnosed with an intellectual or developmental disability? i.e., child must be able to talk; the rationale for this is that they may have difficulty mastering the course content) Has a pre-existing severe psychiatric disorder that required prior psychiatric hospitalization (e.g., bipolar disorder, schizophrenia) The mechanism of the injury was abuse or interpersonal violence They are currently receiving psychotherapy Has been hospitalized for their injury for over 30 days No attempt will be made to recruit caregivers while their child is unstable, e.g. vitals are abnormal, there are major complications, or death may be imminent. Children with multiple injuries are eligible to participate but their caregivers will not be approached until any interventions (surgery, casting, etc.) are completed. healthy volunteers No gender All minimum age 8 Years maximum age 17 Years std age list std age Child contacts locations module overall official list overall official overall official name Shari Wade, PhD overall official affiliation Children's Hospital Medical Center, Cincinnati overall official role Principal Investigator location list location location facility Cincinnati Children's Hospital Medical Center location city Cincinnati location state Ohio location zip 45229 location country United States references module reference list reference reference p m i d 11501254 reference type background reference citation Foa EB, Johnson KM, Feeny NC, Treadwell KR. The child PTSD Symptom Scale: a preliminary examination of its psychometric properties. J Clin Child Psychol. 2001 Sep;30(3):376-84. doi: 10.1207/S15374424JCCP3003_9. reference p m i d 10517055 reference type background reference citation Birmaher B, Brent DA, Chiappetta L, Bridge J, Monga S, Baugher M. Psychometric properties of the Screen for Child Anxiety Related Emotional Disorders (SCARED): a replication study. J Am Acad Child Adolesc Psychiatry. 1999 Oct;38(10):1230-6. doi: 10.1097/00004583-199910000-00011. reference p m i d 24085345 reference type background reference citation Varni JW, Magnus B, Stucky BD, Liu Y, Quinn H, Thissen D, Gross HE, Huang IC, DeWalt DA. Psychometric properties of the PROMIS ® pediatric scales: precision, stability, and comparison of different scoring and administration options. Qual Life Res. 2014 May;23(4):1233-43. doi: 10.1007/s11136-013-0544-0. Epub 2013 Oct 2. reference p m i d 11468499 reference type background reference citation Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. i p d sharing statement module i p d sharing No i p d sharing description The pilot is only anticipated to have 12-16 participants and thus,data may be identifiable. The investigators have decided to withhold the sharing individual participant data. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000040921 condition mesh term Stress Disorders, Traumatic condition mesh id D000013313 condition mesh term Stress Disorders, Post-Traumatic condition ancestor list condition ancestor condition ancestor id D000068099 condition ancestor term Trauma and Stressor Related Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M15255 condition browse leaf name Stress Disorders, Post-Traumatic condition browse leaf as found Post Traumatic Stress Disorder condition browse leaf relevance high condition browse leaf id M24069 condition browse leaf name Stress Disorders, Traumatic condition browse leaf as found Traumatic Stress Disorder condition browse leaf relevance high condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse leaf id M222 condition browse leaf name Trauma and Stressor Related Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries
NCT04830839
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full study rank 61806 study protocol section identification module n c t id NCT04831684 org study id info org study id Pro00102334 organization org full name Medical University of South Carolina org class OTHER brief title Novel mGluR5 Modulator Effects on Alcohol Drinking and MRI Outcomes official title Effects of a Novel mGluR5 Negative Allosteric Modulator on Alcohol Drinking, Neurochemistry, and Brain Reactivity to Alcohol Cues in Alcohol Use Disorder status module status verified date January 2022 overall status Recruiting expanded access info has expanded access No start date struct start date September 15, 2021 start date type Actual primary completion date struct primary completion date April 15, 2026 primary completion date type Anticipated completion date struct completion date April 22, 2026 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date January 5, 2022 last update post date struct last update post date January 11, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name James J. Prisciandaro responsible party investigator title Associate Professor responsible party investigator affiliation Medical University of South Carolina lead sponsor lead sponsor name Medical University of South Carolina lead sponsor class OTHER collaborator list collaborator collaborator name National Institutes of Health (NIH) collaborator class NIH collaborator name National Institute on Alcohol Abuse and Alcoholism (NIAAA) collaborator class NIH oversight module is f d a regulated drug Yes is f d a regulated device No description module brief summary This study evaluates the effects of the medication GET73 among non-treatment-seeking individuals who regularly drink alcohol. Participants in the study will take GET73 or placebo for an 8-day study. There are 4 study visits including 2 MRI scans. conditions module condition list condition Alcohol Use Disorder design module study type Interventional phase list phase Phase 1 Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Basic Science design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 90 enrollment type Anticipated arms interventions module arm group list arm group arm group label Group A arm group type Placebo Comparator arm group intervention list arm group intervention name Drug: Placebo arm group label Group B arm group type Experimental arm group intervention list arm group intervention name Drug: GET73 intervention list intervention intervention type Drug intervention name Placebo intervention description Participants will be getting placebo for 8 days of dosing. intervention arm group label list intervention arm group label Group A intervention type Drug intervention name GET73 intervention description Participants will be getting GET73 for 8 days of dosing. intervention arm group label list intervention arm group label Group B outcomes module primary outcome list primary outcome primary outcome measure Number of drinks consumed during bar-lab paradigm (free drinking period) primary outcome time frame 165 minutes primary outcome measure Change in Gamma aminobutyric acid (GABA) and glutamate levels primary outcome description Acquired via spectroscopy sequence completed at baseline and day 7 scans primary outcome time frame baseline to day 7 primary outcome measure Levels of cortical activation to visual cues of alcohol primary outcome description Acquired via functional magnetic resonance imaging completed at baseline and day 7 scans primary outcome time frame baseline to day 7 eligibility module eligibility criteria Inclusion Criteria: Age 21-40 (to focus on an age group still on a trajectory of increasing alcohol consumption, consistent with our pilot data and past iterations of the ARC). Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for current Alcohol Use Disorder, with at least Moderate severity. Reports drinking, on average, at least 20 standard alcoholic drinks per week for at least the past 3 months. Currently not engaged in, and does not want treatment for, alcohol-related problems. Able to read and understand questionnaires and informed consent. Lives within 50 miles of the study site. Able to maintain abstinence from alcohol the evening prior to appointments (without the aid of detoxification medications), as determined by self-report and breathalyzer measurements. Amenable to drinking liquor in fruit juice. Exclusion Criteria: Current DSM-5 diagnosis of any other substance use disorder except Nicotine Use Disorder. Any psychoactive substance use (except marijuana and nicotine) within the last 30 days, as indicated by self-report and urine drug screen. For marijuana, no use within the last seven days by verbal report and negative (or decreasing) urine THC levels. Current DSM-5 Axis I diagnosis, including major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder. Current suicidal ideation or homicidal ideation. Using CYP2C19 and/or CYP3A4 inhibitors or inducers in the 14 days before dosing or during the study. Need for maintenance or acute treatment with any psychoactive medication, including antiepileptic medications. Currently taking medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, topiramate). History of severe alcohol withdrawal (e.g., tremor, sweating, anxiety, seizure, delirium tremens), as evidenced by self-report and assessment with Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar). Clinically significant medical problems such as cardiovascular, renal, gastrointestinal, or endocrine problems that would impair participation or limit medication ingestion. Past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, or peptic ulcer. Has hepatocellular disease indicated by elevations of SGPT (ALT) or SGOT (AST) greater than 2.5 times normal at screening. Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control. Current charges pending for a violent crime (not including DUI-related offenses). Lack of a stable living situation. Presence of ferrous metal in the body, as evidenced by metal screening and self-report. Severe claustrophobia or extreme obesity that preclude placement in the MRI scanner. Neurological disease or history of head injury with > 2 minutes of unconsciousness. healthy volunteers No gender All minimum age 21 Years maximum age 40 Years std age list std age Adult contacts locations module central contact list central contact central contact name Sara Hix central contact role Contact central contact phone 843-792-0572 central contact e mail hixs@musc.edu overall official list overall official overall official name James Prisciandaro overall official affiliation Medical University of South Carolina overall official role Principal Investigator location list location location facility Charleston Alcohol Research Center, Institute of Psychiatry, Medical University of South Carolina location status Recruiting location city Charleston location state South Carolina location zip 29425 location country United States location contact list location contact location contact name Sara Hix location contact role Contact location contact phone 843-792-0572 location contact e mail hixs@musc.edu i p d sharing statement module i p d sharing Yes i p d sharing description Per NOT-AA-19-020, this study will submit and share data with NIAAA Data Archive, a data repository housed within the NIMH Data Archive. This includes broad sharing of all research subjects' de-identified data. i p d sharing info type list i p d sharing info type Study Protocol i p d sharing time frame De-identified participant data will be uploaded to the NIMH Data Archive twice yearly (by April 1 and October 1) during the course of this study, and will remain available with no end date. i p d sharing access criteria Data and supporting documentation submitted to the NIMH Data Archive may be accessed and used broadly by approved users for research and other activities as authorized by and consistent with law. i p d sharing u r l https://nda.nih.gov/niaaa/award/data-sharing-expectations.html derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000000437 condition mesh term Alcoholism condition mesh id D000000428 condition mesh term Alcohol Drinking condition ancestor list condition ancestor condition ancestor id D000004327 condition ancestor term Drinking Behavior condition ancestor id D000019973 condition ancestor term Alcohol-Related Disorders condition ancestor id D000019966 condition ancestor term Substance-Related Disorders condition ancestor id D000064419 condition ancestor term Chemically-Induced Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M2926 condition browse leaf name Alcohol Drinking condition browse leaf as found Alcohol Drinking condition browse leaf relevance high condition browse leaf id M2935 condition browse leaf name Alcoholism condition browse leaf as found Alcohol Use Disorder condition browse leaf relevance high condition browse leaf id M6654 condition browse leaf name Drinking Behavior condition browse leaf relevance low condition browse leaf id M20995 condition browse leaf name Alcohol-Related Disorders condition browse leaf relevance low condition browse leaf id M20990 condition browse leaf name Substance-Related Disorders condition browse leaf relevance low condition browse leaf id M29455 condition browse leaf name Chemically-Induced Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC25 condition browse branch name Substance Related Disorders intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M2929 intervention browse leaf name Ethanol intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04831684
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full study rank 61290 study protocol section identification module n c t id NCT04838392 org study id info org study id US-312-01 organization org full name Bionime Corporation org class INDUSTRY brief title Effectiveness and Safety of the RIGHTEST Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus official title Effectiveness and Safety of the RIGHTEST Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date July 2021 start date type Anticipated primary completion date struct primary completion date February 2022 primary completion date type Anticipated completion date struct completion date February 2022 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Bionime Corporation lead sponsor class INDUSTRY oversight module is f d a regulated drug No is f d a regulated device Yes is unapproved device Yes description module brief summary The purpose of this study is to evaluate the effectiveness and safety of the RIGHTEST Continuous Monitoring (CGM) System in adult population with diabetes mellitus. detailed description This is a prospective, open-label, non-randomized, multicenter, single-arm pivotal study without a control group. In total, 150 subjects with type 1 or type 2 diabetes will be enrolled at 16 investigational sites in the United States. All subjects are required to wear 1 Sensor on the back of each upper arm for up to 14 days (up to 336 hours) and participate in both study visit and home use portion in this study. All subjects will have venous blood draws for evaluation of the blood glucose reference measurements in in-clinic visits, and to collect accuracy information against a laboratory reference method. conditions module condition list condition Diabetes Mellitus design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) design masking description All information as provided by CGM system will be masked from subjects and study team during the study. enrollment info enrollment count 150 enrollment type Anticipated arms interventions module arm group list arm group arm group label CGM System arm group type Experimental arm group description Blood draw and glucose challenge will be performed to evaluate performance of CGM system compared to reference measurement during in in-clinic visits. arm group intervention list arm group intervention name Device: RIGHTEST Continuous Glucose Monitoring System intervention list intervention intervention type Device intervention name RIGHTEST Continuous Glucose Monitoring System intervention description RIGHTEST Continuous Glucose Monitoring System intervention arm group label list intervention arm group label CGM System outcomes module primary outcome list primary outcome primary outcome measure RIGHTEST Continuous Glucose Monitoring System Performance primary outcome description The CGM System performance will be evaluated in terms of point and trend accuracy of CGM System readings comparted to the reference measurements. primary outcome time frame 14 days secondary outcome list secondary outcome secondary outcome measure RIGHTEST Glucose Monitoring System Related Adverse Device Effects secondary outcome description The CGM System will be characterized by Adverse Device Effects experienced by study participants. secondary outcome time frame 14 days eligibility module eligibility criteria Inclusion Criteria: Subjects must be at least 18 years of age. Subjects must have type 1 or type 2 diabetes mellitus. Subjects must be available to participate in all study visits. Willing to wear 1 Sensor on each upper arm simultaneously. Subjects must be willing and able to provide signed written consent. Subjects must be able to read and understand the device instructions. Subjects must be able to speak, read and write English. Exclusion Criteria: Known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin. Extensive skin changes or diseases at the proposed application sites. Subjects who have or are: Pregnant, A hematocrit level >37%, A condition requiring or likely requiring magnetic resonance imaging (MRI), computerized tomography (CT) or diathermy scheduled during the study, Participated in another clinical trial within 2 weeks prior to screening or are intending to participate in another clinical trial during the study. Unsuitable for participation due to any other cause as determined by the Investigator. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility Lakeview Clinical Research location city Guntersville location state Alabama location zip 35976 location country United States location facility Novak Clinical Research location city Tucson location state Arizona location zip 85741 location country United States location facility Hope Clinical Research, LLC location city Canoga Park location state California location zip 91303 location country United States location facility AMCR Institute location city Escondido location state California location zip 92029 location country United States location facility Diablo Clinical Research, Inc. location city Walnut Creek location state California location zip 94598 location country United States location facility Dr. De Armas Research Center, LLC location city Miami location state Florida location zip 11373 location country United States location facility Atlanta Diabetes Associates location city Atlanta location state Georgia location zip 30318 location country United States location facility RNA America,LLC location city Buford location state Georgia location zip 30518 location country United States location facility Infinite Clinical Trials location city Morrow location state Georgia location zip 30274 location country United States location facility L-MARC Research Center location city Louisville location state Kentucky location zip 40213 location country United States location facility Research Integrity, LLC. location city Owensboro location state Kentucky location zip 42303 location country United States location facility Scott Research,Inc location city Laurelton location state New York location zip 11413 location country United States location facility PMG Research of Wilmington, LLC location city Wilmington location state North Carolina location zip 28401 location country United States location facility Oregon Health location city Portland location state Oregon location zip 97239 location country United States location facility The Research Center of the Upstate location city Greenville location state South Carolina location zip 29607 location country United States location facility Research Trials WorldWide location city Humble location state Texas location zip 77338 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003920 condition mesh term Diabetes Mellitus condition ancestor list condition ancestor condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition browse leaf list condition browse leaf condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf as found Diabetes Mellitus condition browse leaf relevance high condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04838392
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full study rank 61717 study protocol section identification module n c t id NCT04832841 org study id info org study id G-21-07 organization org full name Institute for Clinical and Experimental Medicine org class OTHER_GOV brief title IgG Antibodies After SARS-CoV-2 mRNA Vaccine in Kidney Transplantation (TASMANIA) official title IgG Antibodies After SARS-CoV-2 mRNA Vaccine in Kidney Transplantation acronym TASMANIA status module status verified date December 2021 overall status Active, not recruiting expanded access info has expanded access No start date struct start date March 18, 2021 start date type Actual primary completion date struct primary completion date September 30, 2021 primary completion date type Actual completion date struct completion date December 30, 2021 completion date type Anticipated study first submit date April 3, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date December 16, 2021 last update post date struct last update post date January 6, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Prof. Ondřej Viklický, M.D., Ph.D. responsible party investigator title Head of Department of Nephrology and Transplant Center responsible party investigator affiliation Institute for Clinical and Experimental Medicine lead sponsor lead sponsor name Institute for Clinical and Experimental Medicine lead sponsor class OTHER_GOV oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The aim of this study is to assess humoral immune response in kidney transplant recipients after SARS-CoV-2 mRNA vaccine. detailed description TASMANIA is a single-center prospective observational study with 1000 kidney transplant recipients from Institute for Clinical and Experimental Medicine (IKEM), Prague. The primary objective of the study is to assess humoral immune response to SARS-CoV-2 mRNA vaccines in SARS-CoV-2-naive kidney transplant recipients using immunochemiluminescent assay. As comparator several cohorts will be evaluated: kidney transplant recipients with previous SARS-CoV-2 exposition verified by real-time reverse transcription polymerase chain reaction (RT-PCR) kidney transplant recipients vaccinated on waiting list (a) SARS-CoV-2 naive (b) SARS-CoV-2 previously exposed The secondary objective is to determine clinical variables affecting antibody levels. SARS-CoV-2 anti S1/2 antibodies will be tested ≥ 15 days after the second dose of mRNA vaccines and in 3 months after the first blood sampling. In subanalysis 50 kidney transplant recipients will be examined for a cell-mediated immune response after SARS-CoV-2 mRNA vaccine Enzyme Linked using Immuno Spot (ELISPOT) assay. conditions module condition list condition Kidney Transplantation keyword list keyword kidney transplantation SARS-CoV-2 humoral immunity design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective bio spec bio spec retention Samples Without DNA bio spec description blood enrollment info enrollment count 753 enrollment type Actual arms interventions module arm group list arm group arm group label SARS-CoV-2 naive arm group description Kidney transplant recipients without previous SARS-CoV-2 infection verified by absence of RT-PCR test in national database who receive SARS-CoV-2 mRNA vaccine after transplantation. arm group intervention list arm group intervention name Diagnostic Test: anti-spike SARS-CoV-2 IgG arm group label SARS-Cov-2 exposed arm group description Kidney transplant recipients with previous SARS-CoV-2 exposition verified by positivity of RT-PCR test in national database who receive SARS-CoV-2 mRNA vaccine after transplantation. arm group intervention list arm group intervention name Diagnostic Test: anti-spike SARS-CoV-2 IgG arm group label Waiting list arm group description Kidney transplant recipients who were vaccinated on waiting list (a) SARS-CoV-2 naive (b) SARS-Cov-2 exposed arm group intervention list arm group intervention name Diagnostic Test: anti-spike SARS-CoV-2 IgG intervention list intervention intervention type Diagnostic Test intervention name anti-spike SARS-CoV-2 IgG intervention description Immunochemiluminescent assay by DiaSorin S.p.A. Italy intervention arm group label list intervention arm group label SARS-CoV-2 naive SARS-Cov-2 exposed Waiting list outcomes module primary outcome list primary outcome primary outcome measure Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination. primary outcome description anti-spike SARS-CoV-2 IgG measured ≥15 days after vaccination primary outcome time frame 15 days-90 days secondary outcome list secondary outcome secondary outcome measure Humoral immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination. secondary outcome description anti-spike SARS-CoV-2 IgG measured 3 ≥ months after the first blood sampling secondary outcome time frame 3 months - 6 months secondary outcome measure Cellular immune response in kidney transplant recipients following anti-SARS-CoV2 mRNA vaccination. secondary outcome description Cellular immunity measured by ELISPOT assay in subgroup of 50 patients secondary outcome time frame 15 - 90 days secondary outcome measure Graft function after vaccination secondary outcome description Estimated glomerular filtration rate (eGFR) secondary outcome time frame 15 days-90 days secondary outcome measure Clinical variables affecting antibody levels secondary outcome description Sex, previous SARS-CoV-2 infection, Age, Retransplantation, BMI, time from transplant, eGFR, diabetes mellitus, use of imunosuppression (tacrolimus, cyclosporine A, CNI-free regimen, mycophenolate mofetil, depleting therapy). secondary outcome time frame 15 days-90 days secondary outcome measure The impact of frailty syndrom on humoral response in older kidney recipients (70+ years of age) following anti-SARS-CoV-2 mRNA vaccination secondary outcome description Fried frailty score secondary outcome time frame 15 days-90 days eligibility module eligibility criteria Inclusion Criteria: Kidney transplant recipients Recipient age ≥ 18 years Written Informed Consent and Consent for Processing Personal Data Vaccination with two doses of SARS-CoV-2 mRNA vaccine either before or after kidney transplantation. Exclusion Criteria: Active SARS-CoV-2 infection. Patients that received anti-SARS-CoV-2 monoclonal antibodies. Active infection after vaccination Monoclonal antibodies treatment ahead of antibody or cellular immunity screening healthy volunteers No gender All minimum age 18 Years maximum age 100 Years std age list std age Adult Older Adult study population Kidney transplant recipients vaccinated with 2 doses of SARS-CoV-2 mRNA vaccine either before or after kidney transplantation. sampling method Probability Sample contacts locations module overall official list overall official overall official name Ondrej Viklicky, Prof. overall official affiliation Institute for Clinical and Experimental Medicine overall official role Principal Investigator location list location location facility Institute for Clinical and Experimental Medicine location city Prague location zip 140 21 location country Czechia references module reference list reference reference p m i d 34999659 reference type derived reference citation Magicova M, Zahradka I, Fialova M, Neskudla T, Gurka J, Modos I, Hojny M, Raska P, Smejkal P, Striz I, Viklicky O. Determinants of Immune Response to Anti-SARS-CoV-2 mRNA Vaccines in Kidney Transplant Recipients: A Prospective Cohort Study. Transplantation. 2022 Apr 1;106(4):842-852. doi: 10.1097/TP.0000000000004044. derived section misc info module version holder December 02, 2022 intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M9336 intervention browse leaf name Immunoglobulins intervention browse leaf relevance low intervention browse leaf id M3377 intervention browse leaf name Antibodies intervention browse leaf relevance low intervention browse leaf id M16512 intervention browse leaf name Vaccines intervention browse leaf relevance low intervention browse leaf id M9274 intervention browse leaf name Immunoglobulin G intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04832841
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full study rank 61365 study protocol section identification module n c t id NCT04837417 org study id info org study id 24C021_2020 organization org full name Istituto Auxologico Italiano org class OTHER brief title Deficit in Quadriceps Voluntary Activation After Anterior Cruciate Ligament Reconstruction: Roles of the "Learned Non-use" Paradigm and the Interhemispheric Inhibition official title Deficit in Quadriceps Voluntary Activation After Anterior Cruciate Ligament Reconstruction: Roles of the "Learned Non-use" Paradigm and the Interhemispheric Inhibition acronym AQUARIUS status module status verified date August 2022 overall status Recruiting expanded access info has expanded access No start date struct start date July 14, 2021 start date type Actual primary completion date struct primary completion date November 30, 2022 primary completion date type Anticipated completion date struct completion date November 30, 2022 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date August 31, 2022 last update post date struct last update post date September 1, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Luigi Tesio, Prof responsible party investigator title MD, Director of the Department of Neuromotor Rehabilitation, Ospedale San Luca, Istituto Auxologico Italiano, IRCCS; Full Professor, Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy responsible party investigator affiliation Istituto Auxologico Italiano lead sponsor lead sponsor name Istituto Auxologico Italiano lead sponsor class OTHER collaborator list collaborator collaborator name ASST Gaetano Pini-CTO collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Anterior cruciate ligament (ACL) tear is mainly caused by sport injuries. 40% of injuries are attributed to noncontact mechanisms involving pivoting. Regaining quadriceps strength is a primary focus of patients pursuing a rehabilitation program after ACL reconstruction (ACLR). Unfortunately, despite rehabilitation programs aimed at reversing this muscle weakness, quadriceps strength deficits may persist for years. Moreover, this deficit leads to increased risk of sustaining another knee injury, and increased risk for developing posttraumatic osteoarthritis. At present, neither the optimal rehabilitative program nor the clinical and instrumental parameters to take into account at the time of return to activity have reached a consensus among clinicians. The investigators hypothesize that: a persistent deficit in voluntary activation, that is an inability to achieve complete activation of a muscle, is present after ACLR. this deficit in voluntary activation is associated with a phenomenon of "learned/acquired non-use" both in balance and during gait. This phenomenon will be demonstrated by investigating asymmetries in the recruitment of the injured lower limb in balance tests and during gait. the "learned/acquired non-use" paradigm is associated to asymmetries in the hemispheric cortical activity. This phenomenon will be investigated through transcranial magnetic stimulation. The primary endpoint is the demonstration that the quadriceps muscle weakness after ACLR may represent a case of "learned non-use". This behaviour looks automatic and unconscious, so that the adjective "acquired" seems preferable to "learned". It consists of the under recruitment of the impaired side, once healed, as a form of unconscious protection, which is adopted when the contralateral side may carry out the function. The secondary outcome is the investigation of the correlation among the deficits in voluntary activation, in balance tests, during gait, and in the neurophysiologic trials, with the clinical conditions of the patients. It is expected that the injured lower limb show a deficit in the activation of the quadriceps muscle with respect to the contralateral one and with respect to normative data. The impaired limb will present lower recruitment in balance tests and a deficit in power production during gait. The contralesional hemisphere will demonstrate higher interhemispheric inhibition, lower short-interval intracortical inhibition (SICI) and higher short-interval intracortical facilitation (SICF) with respect to the ipsilesional hemisphere. The evidence for an asymmetry between the two lower limbs would support the hypothesis that the "acquired non-use" paradigm has a role in the deficits following ACL lesions and that it is unspecific across asymmetric impairments, and independent of the underlying disease. Results from the present study will allow: the identification of clinical and instrumental criteria to guide the return-to-sport decision following ACLR. the estimate of the sample size for future experimental protocols and new rehabilitative programs. conditions module condition list condition Anterior Cruciate Ligament Injuries keyword list keyword Anterior cruciate ligament reconstruction acquired non-use voluntary activation quadriceps femoris rehabilitation design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 10 enrollment type Anticipated arms interventions module arm group list arm group arm group label Pathologic group arm group description At least 10 male participants who underwent anterior cruciate ligament arthroscopic reconstruction using semitendinosus and gracilis tendons graft, between 6 and 18 months before the tests arm group intervention list arm group intervention name Diagnostic Test: Pathologic group intervention list intervention intervention type Diagnostic Test intervention name Pathologic group intervention description Voluntary Activation level will be determined with the interpolate twitch technique (ITT), both during isometric contractions (knee at 40° flexion) and during isokinetic contraction at angular velocity equal to 100°/s. Vastus Medialis and Soleous H-reflex will be measured. Cortical excitability and interhemispheric connectivity will be measured through transcranial magnetic stimulation (TMS). Tests of balance in standing will be performed using the EquiTest platform. Individuals will be requested to perform three different tasks: Sensory Organization test, Adaptation Test upward/downward, Motor Control test backward/forward. Surface electromyography from lower limbs will be recorded. Through TMS driven by neuronavigation, the cortical representation of the Quadriceps muscle will be studied. Gait analysis will be performed on a treadmill mounted on force sensors. Participants will walk at increasing velocities from 0.4 m/s to 1.6 m/s. Speed will be increased of 0.2 m/s every 30 s. intervention arm group label list intervention arm group label Pathologic group outcomes module primary outcome list primary outcome primary outcome measure Voluntary Activation primary outcome description Voluntary Activation = [1 - (Interpolated Twitch/Resting Twitch)] percent, where Interpolated Twitch and Resting Twitch are the peak torques caused by the electric shock during the voluntary contraction and at rest, respectively. primary outcome time frame Day 1 secondary outcome list secondary outcome secondary outcome measure H-reflex minimal latency secondary outcome description H-reflex latency is defined as the time it takes for the H-reflex to appear on the EMG relative to the introduction of the stimulus. H-reflex minimal latency represents the minimal latency among the H-reflex amplitudes recorded at the different stimulus intensities. secondary outcome time frame Day 1 secondary outcome measure H/M ratio secondary outcome description H/M ratio is the ratio between H-reflex amplitude and M-wave amplitude. secondary outcome time frame Day 1 secondary outcome measure iSP (Ipsilateral Silent Period) durations secondary outcome description Eight stimuli are applied over the hotspot at an intensity of 140 percent of the stimulator output while subjects are performing a voluntary maximal contraction of the ipsilateral hand, with a figure-of-eight coil for transcranial magnetic stimulation (TMS). Both hemispheres are tested. ISP durations are determined by rectifying the EMG traces and averaging them among the 8 stimuli. Baseline EMG is defined as the average value of EMG in the 100 ms before the TMS stimulus. ISP onset is defined as the latency at which the averaged EMG activity became constantly (for at least 10 ms) smaller than the average baseline EMG. ISP offset is set at the first point after ISP onset at which the EMG activity regained the baseline activity for at least 10 ms. ISP duration is defined as: ISPduration = ISPoffset - ISPonset. secondary outcome time frame Day 1 secondary outcome measure iSP (Ipsilateral Silent Period) area secondary outcome description Eight stimuli are applied over the hotspot at an intensity of 140 percent of the stimulator output while subjects are performing a voluntary maximal contraction of the ipsilateral hand, with a figure-of-eight coil for transcranial magnetic stimulation (TMS). Both hemispheres are tested. ISParea is computed as the product between baseline EMG and iSP duration. secondary outcome time frame Day 1 secondary outcome measure SICI (Short interval IntraCortical Inhibition) secondary outcome description A paired pulse will be applied over the hand area of the motor cortex to evoke EMG responses in the contralateral muscle. The conditioning stimuli will be given at an intensity of 75 percent of the resting Motor Threshold (rMT) and the test stimuli will be given at an intensity of 120 percent of the rMT. The interstimulus intervals will be 3 and 5 ms. For each interstimulus interval, 8 stimuli will be applied in a random order. secondary outcome time frame Day 1 secondary outcome measure SICF (Short interval IntraCortical Facilitation) secondary outcome description A paired pulse will be applied over the hand area of the motor cortex to evoke EMG responses in the contralateral muscle. The conditioning stimuli will be given at an intensity of 75 percent of the resting Motor Threshold (rMT) and the test stimuli will be given at an intensity of 120 percent of the rMT. The interstimulus intervals will be 15 and 20 ms. For each interstimulus interval, 8 stimuli will be applied in a random order. secondary outcome time frame Day 1 secondary outcome measure SOT score secondary outcome description The patient's task is to maintain an upright stance during 3 20 s trials under six different conditions, including platform and visual surround 'tuned' with individual's sagittal oscillation. The SOT score will be calculated by comparing the sagittal oscillation of the body's centre of mass (COM) to the maximal sagittal oscillation. Score is averaged across the six conditions (range 0 - 100 the higher the score, the lower the oscillation, in each condition). secondary outcome time frame Day 1 secondary outcome measure Map area of quadriceps muscle secondary outcome description Transcranial magnetic stimulation (TMS) will be used to map cortical representation of quadriceps muscle. An optoelectronic neuronavigation system will be used to digitize the scalp stimulation coordinates, to guide the TMS coil to focus on a stimulation site, and to ensure spatial precision during the procedure. Two or three TMS stimuli will be delivered at each of the stimulated scalp sites. The largest peak-to-peak MEP amplitude (mean of three MEPs) across the positions making up the motor map was measured. The map area was defined as the number of scalp positions associated with the mean MEP amplitude larger than 100 μV. secondary outcome time frame Day 1 secondary outcome measure Ankle joint power secondary outcome description Joint kinematics will be recorded through an optoelectronic method as per the Davis anthropometric model. The 3D displacement of the markers will be captured using 10 near-infrared stroboscopic cameras. Joint power will be computed through the spatiotemporal synchronization of ground reaction force vectors and the joint centers of rotation. Only the sagittal plane will be considered for the analysis. Joint power will be computed as the product of joint torque and joint rotation speed. Power will be defined as positive or generated when the joint moment and rotation speed shared the same directions (i. e., when agonist muscles are contracting while shortening), as negative or absorbed otherwise. Positive work will be computed as the integral of the generated (positive) power over time. secondary outcome time frame Day 1 eligibility module eligibility criteria Inclusion Criteria: anterior cruciate ligament tear with arthroscopic reconstruction, between 6 and 18 months before the tests; Tegner activity level > 5; Body Mass Index between 18 and 25; voluntary knee extension of at least 70°; ability to understand the instructions; ability to wittingly sign the informed consent form. Exclusion Criteria: other previous knee injuries or surgical interventions; major procedures associated with the anterior cruciate ligament reconstruction: osteotomy, other ligaments reconstruction; meniscectomy, with surgical removal of more than 30% of the meniscal volume or removal of the meniscal root; comorbidities, such as: rheumatic diseases; other congenital or acquired neuromuscular pathologies; diabetes mellitus; osteoporosis; cancer; heart disease; history of epilepsy, endocranial hypertension; first degree relatives affected by epilepsy; current treatment with oral anticoagulant or antiplatelet therapy; drug therapy, which could induce epileptic crisis; history of high alcohol consumption; implanted electro-sensitive devices; implanted intracranial or intraocular metallic devices; history of retinal detachment; presence of cochlear implant. healthy volunteers No gender Male gender based Yes minimum age 18 Years maximum age 35 Years std age list std age Adult study population The participants will be recruited by ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO, Presidio Ospedaliero Gaetano Pini, among those who underwent the surgical interventions in the Centre. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Luigi Tesio, MD, Full Professor central contact role Contact central contact phone +39 02 58218151 central contact e mail l.tesio@auxologico.it central contact name Stefano Scarano, MD, Research Fellow central contact role Contact central contact phone +39 02 58218717 central contact e mail s.scarano@auxologico.it overall official list overall official overall official name Luigi Tesio, MD, Full professor overall official affiliation Istituto Auxologico Italiano overall official role Principal Investigator location list location location facility Istituto Auxologico Italiano location status Recruiting location city Milan location state MI location zip 20121 location country Italy location contact list location contact location contact name Stefano Scarano, MD, Research Fellow location contact role Contact location contact phone +39 02 58218717 location contact e mail s.scarano@auxologico.it location contact name Chiara Malloggi, PhD location contact role Sub-Investigator location contact name Viviana Rota, PhD location contact role Sub-Investigator location contact name Stefano Scarano, MD, Research Fellow location contact role Sub-Investigator location contact name Angela Rossetti, PhD location contact role Sub-Investigator location facility ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO, Presidio Ospedaliero Gaetano Pini location status Not yet recruiting location city Milan location country Italy location contact list location contact location contact name Pietro Simone Randelli, MD, Full Professor location contact role Contact location contact e mail pietro.randelli@unimi.it location contact name Paolo Ferrua, MD location contact role Contact location contact e mail paolo.ferrua@asst-pini-cto.it location contact name Paolo Ferrua, MD location contact role Sub-Investigator location contact name Alessandra Menon location contact role Sub-Investigator i p d sharing statement module i p d sharing Yes derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000070598 condition mesh term Anterior Cruciate Ligament Injuries condition ancestor list condition ancestor condition ancestor id D000007718 condition ancestor term Knee Injuries condition ancestor id D000007869 condition ancestor term Leg Injuries condition ancestor id D000014947 condition ancestor term Wounds and Injuries condition browse leaf list condition browse leaf condition browse leaf id M601 condition browse leaf name Anterior Cruciate Ligament Injuries condition browse leaf as found Anterior Cruciate Ligament Injuries condition browse leaf relevance high condition browse leaf id M9890 condition browse leaf name Knee Injuries condition browse leaf relevance low condition browse leaf id M10033 condition browse leaf name Leg Injuries condition browse leaf relevance low condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions
NCT04837417
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full study rank 61880 study protocol section identification module n c t id NCT04830722 org study id info org study id Sculptra-Aesthetic-2021 organization org full name Goldman, Butterwick, Fitzpatrick and Groff org class OTHER brief title Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Cellulite of the Buttocks and Thighs official title A Randomized Single Center, Double Blinded, Split-body Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Cellulite of the Buttocks and Thighs status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 9, 2021 start date type Actual primary completion date struct primary completion date April 1, 2022 primary completion date type Anticipated completion date struct completion date June 1, 2022 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 9, 2021 last update post date struct last update post date April 12, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Leslie Laser Aguilar responsible party investigator title Regulatory Affairs Administrator responsible party investigator affiliation Goldman, Butterwick, Fitzpatrick and Groff lead sponsor lead sponsor name Goldman, Butterwick, Fitzpatrick and Groff lead sponsor class OTHER collaborator list collaborator collaborator name Galderma R&D collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device Yes is u s export Yes description module brief summary clinical trial is to assess the safety, efficacy and patient satisfaction associated with the treatment of cellulite of the buttocks and thighs with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic detailed description Enrolled subjects will be randomized to 2 treatment groups: "Right side treated" and "Left side treated". All subjects will receive three, single-sided injections of Sculptra Aesthetic, performed 1 month apart. Treatments will be provided to one side randomly assigned to either "right side" or "left side". The non-treatment side will receive bacteriostatic water, injected in the same manner as Sculptra Aesthetic. Up to four (4) vials of Sculptra Aesthetic, diluted at 16 mL, will be used per treatment session. conditions module condition list condition Cellulite design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Enrolled subjects will be randomized to 2 treatment groups: "Right side treated" and "Left side treated". All subjects will receive three, single-sided injections of Sculptra Aesthetic, performed 1 month apart. Treatments will be provided to one side randomly assigned to either "right side" or "left side". The non-treatment side will receive bacteriostatic water, injected in the same manner as Sculptra Aesthetic. design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 20 enrollment type Anticipated arms interventions module arm group list arm group arm group label Sculptra Aesthetic Side arm group type Active Comparator arm group description the treatment area side (an area side is considered either buttock and/or thigh) (left or right-depends on randomization) will receive up to two vials of Sculptra Aesthetic, for a total of 4 vials in one treatment session if 2 areas qualify. arm group intervention list arm group intervention name Device: Sculptra Aesthetic arm group label Placebo side arm group type Placebo Comparator arm group description the treatment area side (an area side is considered either buttock and/or thigh) (left or right-depends on randomization) will receive 16 cc of bacteriostatic water, for up to 64 ccs of bacteriostatic water to match the volume injected on the active side arm group intervention list arm group intervention name Device: Sculptra Aesthetic intervention list intervention intervention type Device intervention name Sculptra Aesthetic intervention description One treatment side treated with Sculptra will be compared to the other side treated with bacteriostatic water (placebo) -same volume intervention arm group label list intervention arm group label Placebo side Sculptra Aesthetic Side outcomes module primary outcome list primary outcome primary outcome measure Assessing Safety primary outcome description Assessing safety of treatment of cellulite of the buttocks and thighs with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic (Galderma Laboratories, Fort Worth, TX) using Evaluation of side effects by subject and investigator primary outcome time frame 1 year primary outcome measure Assessing Efficacy primary outcome description Assessing efficacy of treatment of cellulite of the buttocks and thighs with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic (Galderma Laboratories, Fort Worth, TX) using Subject and Blinded Investigator GAIS and Blinded Investigator Hexsel Grading Scale, Galderma Cellulite Grading Scale, and end of study iodentification of correct treatment side using side by side photography before unblinding. primary outcome time frame 1 year primary outcome measure Assessing Patient Satisfaction primary outcome description Assessing patient satisfaction of treatment of cellulite of the buttocks and thighs with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic (Galderma Laboratories, Fort Worth, TX) using a patient satisfaction questionnaire primary outcome time frame 1 year eligibility module eligibility criteria Inclusion Criteria: Healthy adult females age 30 to 60 Both buttocks and/or both posterolateral thighs with a score of mild (1-5) to moderate (6-10 according to the Hexsel, Dal'Forno & Hexsel Cellulite Severity Scale (CSS), and a laxity score using the Hexsel, Dal'Forno & Hexsel Cellulite Severity Scale of 1 (slight) or 2 (moderate). Must be the same score on both sides of the same area (ie: if 1 on one buttock, must be 1 on the other buttock but can be a 2 on the thigh, as long as the other thigh is also a 2) Must be willing to give and sign an informed consent form and photographic release form. Must have had a stable body weight for at least 6 months prior to study entry. Must be willing to maintain usual sun exposure, diet, and exercise routines for the duration of the study. Subject agrees to avoid tanning or use of sunless tanner during the entire course of the study. Negative urine pregnancy test results at the time of study entry (if applicable). For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment participation. A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation. Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g. condoms and spermicide), abstinence and/or vasectomies of partner with a documented second acceptable method of birth control, should the subject become sexually activity. Must be willing to comply with study treatments and complete the entire course of the study. Cellulite that improves when the skin of the buttocks or thighs are stretched or distended superiorly. Exclusion Criteria: Use of any of the following for the treatment of cellulite on either thigh or either buttock within the timelines identified below or intends to use any of the following at any time during the course of the study: Liposuction during the 12-month period prior to study treatment. Injections (eg, mesotherapy, dermal fillers, biostimulatory fillers, clostridium collagenase histolyticum); radiofrequency device treatments; laser treatment; buttock or thigh implant treatment; cryolipolysis; or surgery (including subcision and/or powered subcision) during the 24-month period before injection of study treatment. Any investigational treatment for cellulite on a buttock or thigh during the 12-month period before the injection of study treatment. Endermologie or similar treatments during the 6 month period before injection of study treatment. Massage therapy during the 3-month period before injection of study treatment. Creams (eg, Tretinoin, Celluvera™, TriLastin®) and/or home therapies to prevent or treat cellulite during the two week period before injection of study treatment. Subjects with scarring in treatment areas. Has any of the following local conditions in the areas to be treated (both buttocks or both thighs): History of lower extremity thrombosis or post-thrombosis syndrome. Vascular disorder (eg, varicose veins) A subject with tattoos or permanent implants in the treatment areas. A subject with history of or the presence of any skin condition/disease in the treatment area that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis). Subject who spray tanned or used sunless tanner in the treatment area 4 weeks prior to study treatment. A subject with an active bacterial, fungal, or viral infection in the treatment area. A subject with a significant history or current evidence of a medical, psychological, or other disorder that, in the investigator's opinion, would preclude enrollment into the study. Any history of bleeding or coagulation disorders. History of lidocaine sensitivity deemed by the investigator to preclude patient from enrolling in the study. A subject planning any other cosmetic procedure to the study treatment area during the study period, other than the treatment that will be performed by the investigator. Presence of incompletely healed wound in treatment area. Non-Ablative laser to the treatment area in the last 3 months. A female subject who is pregnant, nursing an infant or planning a pregnancy during the study. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study. healthy volunteers Accepts Healthy Volunteers gender Female gender based Yes gender description Female adults age 30 to 60 who meet inclusion and exclusion criteria. minimum age 30 Years maximum age 60 Years std age list std age Adult contacts locations module central contact list central contact central contact name Sherif Research Director, MD central contact role Contact central contact phone 8586571004 central contact e mail SMikhail@clderm.com central contact name Leslie Aguilar, BA central contact role Contact central contact phone 18586571004 central contact e mail laguilar@clderm.com overall official list overall official overall official name Sabrina Fabi, MD overall official affiliation Cosmetic Laser Dermatology overall official role Principal Investigator location list location location facility Cosmetic Laser Dermatology/West Dermatology Research Center location status Recruiting location city San Diego location state California location zip 92121 location country United States location contact list location contact location contact name Leslie Aguilar, BA location contact role Contact location contact phone 858-657-1004 location contact e mail LAguilar@CLDerm.com location contact name Sherif Mikhail, MD location contact role Contact location contact phone 8586571004 location contact e mail SMikhail@clderm.com location contact name Sabrina Fabi, MD location contact role Principal Investigator references module reference list reference reference p m i d 31524350 reference type background reference citation Haddad A, Menezes A, Guarnieri C, Coimbra D, Ribeiro E, Sarubi J, Avelar LE, Del Nero MP, da Cunha MG, Mazzuco R, Kamamoto C, Cazerta C. Recommendations on the Use of Injectable Poly-L-Lactic Acid for Skin Laxity in Off-Face Areas. J Drugs Dermatol. 2019 Sep 1;18(9):929-935. reference p m i d 20159311 reference type background reference citation Narins RS, Baumann L, Brandt FS, Fagien S, Glazer S, Lowe NJ, Monheit GD, Rendon MI, Rohrich RJ, Werschler WP. A randomized study of the efficacy and safety of injectable poly-L-lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles. J Am Acad Dermatol. 2010 Mar;62(3):448-62. doi: 10.1016/j.jaad.2009.07.040. reference p m i d 28628686 reference type background reference citation Jabbar A, Arruda S, Sadick N. Off Face Usage of Poly-L-Lactic Acid for Body Rejuvenation. J Drugs Dermatol. 2017 May 1;16(5):489-494. Review. reference p m i d 30913048 reference type background reference citation Davis DS, Boen M, Fabi SG. Cellulite: Patient Selection and Combination Treatments for Optimal Results-A Review and Our Experience. Dermatol Surg. 2019 Sep;45(9):1171-1184. doi: 10.1097/DSS.0000000000001776. Review. reference p m i d 29432568 reference type background reference citation Uebel CO, Piccinini PS, Martinelli A, Aguiar DF, Ramos RFM. Cellulite: A Surgical Treatment Approach. Aesthet Surg J. 2018 Sep 14;38(10):1099-1114. doi: 10.1093/asj/sjy028. reference p m i d 26859651 reference type background reference citation Mazzuco R, Sadick NS. The Use of Poly-L-Lactic Acid in the Gluteal Area. Dermatol Surg. 2016 Mar;42(3):441-3. doi: 10.1097/DSS.0000000000000632. reference p m i d 31188150 reference type background reference citation Lin MJ, Dubin DP, Khorasani H. Poly-L-Lactic Acid for Minimally Invasive Gluteal Augmentation. Dermatol Surg. 2020 Mar;46(3):386-394. doi: 10.1097/DSS.0000000000001967. Review. see also link list see also link see also link label Accessed September 18th 2020 see also link u r l http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030050S002c.pdf derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000071697 condition mesh term Cellulite condition ancestor list condition ancestor condition ancestor id D000012877 condition ancestor term Skin Manifestations condition browse leaf list condition browse leaf condition browse leaf id M848 condition browse leaf name Cellulite condition browse leaf as found Cellulite condition browse leaf relevance high condition browse leaf id M14832 condition browse leaf name Skin Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions
NCT04830722
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full study rank 61849 study protocol section identification module n c t id NCT04831125 org study id info org study id IRB20-1601 organization org full name University of Chicago org class OTHER brief title Conduction System Pacing International Registry (CONSPIRE Registry) official title Conduction System Pacing International Registry (CONSPIRE Registry) status module status verified date June 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 4, 2021 start date type Actual primary completion date struct primary completion date April 2024 primary completion date type Anticipated completion date struct completion date April 2024 completion date type Anticipated study first submit date March 15, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date June 3, 2022 last update post date struct last update post date June 8, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Chicago lead sponsor class OTHER collaborator list collaborator collaborator name Biotronik SE & Co. KG collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this registry study is to collect information about routine clinical practices with device implantation to treat bradycardia and cardiac systolic dysfunction (heart rhythm disorders) across global centers of excellence in cardiac pacing. In particular, this study will examine the use of conduction system pacing (CSP) in clinical practice. Information collected in the registry will help researchers better characterize strengths and limitations of current technology and treatments. detailed description During this past decade, there has been a dramatic surge in interest in new physiologic pacing strategies which engage and take advantage of the intrinsic cardiac conduction system. These approaches include His bundle pacing (HBP) as well as approaches which seek to pace the proximal left conduction system (LCS), including left bundle branch area pacing (LBBAP) or pacing in the region of the left posterior fascicle. Left ventricular septal pacing (LVS) has also been proposed as another means to avoid dyssynchrony with early data suggestive of comparable electrical synchronization as biventricular pacing. These approaches utilize approved pacing systems and leads which are delivered to new targets in the His-Purkinje system or LV endocardial fibers. Despite the growing interest in HBP, LCS, and LVS, the majority of data are from disparate cohort studies and there has been a lack of uniformity in assembling data or analyzing and interpreting outcomes. The goal of the Conduction System Pacing International Registry (CONSPIRE) is to systematically and prospectively collect data across multiple centers of excellence on the early implementation of permanent conduction system pacing devices in order to characterize strengths and limitations of current technology. The study will evaluate patient selection, intraprocedural characteristics, and clinical outcomes among patients receiving conduction system pacing (CSP) as part of their routine clinical care. conditions module condition list condition Bradyarrhythmia Heart Failure keyword list keyword Conduction system pacing (CSP) His bundle pacing (HBP) Left ventricular septal pacing (LVS) Left bundle branch area pacing (LBBAP) Proximal left conduction system pacing (LCS) design module study type Observational patient registry Yes target duration 1 Year design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 1000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Individuals receiving conduction system pacing arm group intervention list arm group intervention name Other: Data collection intervention list intervention intervention type Other intervention name Data collection intervention description Data collection on the use of pacemaker, implantable cardioverter-defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices and leads that are approved for clinical use. intervention arm group label list intervention arm group label Individuals receiving conduction system pacing outcomes module primary outcome list primary outcome primary outcome measure Implant characteristics primary outcome description Data will be collected on CSP lead position based on reported anatomical position (e.g., His bundle location, left bundle branch area or left bundle branch pacing location, or left ventricular septal pacing location) primary outcome time frame Month 0, during procedure primary outcome measure QRS duration measured by electrocardiography at baseline primary outcome description Data will be collected on QRS duration (milliseconds) prior to implant primary outcome time frame Baseline, within 1 month prior to procedure primary outcome measure QRS morphology captured by surface electrocardiography at baseline primary outcome description Data will be collected on QRS morphology (e.g., narrow QRS, left bundle branch block, right bundle branch block, left anterior or posterior hemiblock, nonspecific intraventricular conduction delay, or predominantly paced QRS) prior to implant primary outcome time frame Baseline, within 1 month prior to procedure primary outcome measure QRS duration measured by electrocardiography after implant primary outcome description Data will be collected on QRS duration (milliseconds) after implant procedure primary outcome time frame Month 0, pre discharge primary outcome measure QRS morphology captured by surface electrocardiography after implant primary outcome description Data will be collected on QRS morphology [e.g., narrow QRS, left bundaloid QRS in V1, or right bundaloid QRS in V1] after implant procedure primary outcome time frame Month 0, pre discharge primary outcome measure Procedure-related complications primary outcome description Data will be collected to characterize procedure-related complications primary outcome time frame Through 12 months primary outcome measure Changes in left ventricular ejection fraction primary outcome description Data will be collected to characterize changes in left ventricular ejection fraction primary outcome time frame Through 12 months primary outcome measure Changes in chamber dimension primary outcome description Data will be collected to characterize changes in chamber dimension primary outcome time frame Through 12 months primary outcome measure Heart failure hospitalizations primary outcome description Data will be collected to characterize heart failure hospitalizations within the first 12 months after device implant primary outcome time frame Through 12 months primary outcome measure Any-cause mortalities primary outcome description Data will be collected to characterize any-cause mortalities within the first 12 months after device implant primary outcome time frame Through 12 months primary outcome measure Sustained ventricular arrhythmia occurrences primary outcome description Data will be collected to characterize sustained ventricular arrhythmia occurrences primary outcome time frame Through 12 months primary outcome measure System-related complications primary outcome description Data will be collected to characterize system-related complications primary outcome time frame Through 12 months primary outcome measure Lead-related complications primary outcome description Data will be collected to characterize lead-related complications primary outcome time frame Through 12 months eligibility module eligibility criteria Inclusion Criteria: Meets American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines for bradycardia, or Meets ACC/AHA/HRS guidelines for cardiac resynchronization therapy (CRT). Exclusion Criteria: Age < 18 years Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity Pregnancy Difficulty with follow-up healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population Individuals receiving conduction system pacing Any presence of symptomatic bradyarrhythmia requiring pacing therapy Any presence of heart failure (HF) with evidence of wide QRS or anticipated requirement for >40% ventricular pacing sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Tiffany Hart central contact role Contact central contact phone 773-702-0535 central contact e mail thart@medicine.bsd.uchicago.edu overall official list overall official overall official name Gaurav A Upadhyay, MD overall official affiliation University of Chicago overall official role Principal Investigator location list location location facility University of Chicago location status Recruiting location city Chicago location state Illinois location zip 60637 location country United States location facility Maastricht University Medical Center location status Recruiting location city Maastricht location country Netherlands location contact list location contact location contact name Kevin Vernooy, MD location contact role Contact location contact phone +31(0)433877095 location contact e mail kevin.vernooy@mumc.nl location contact name Kevin Vernooy, MD location contact role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001919 condition mesh term Bradycardia condition ancestor list condition ancestor condition ancestor id D000006331 condition ancestor term Heart Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000001145 condition ancestor term Arrhythmias, Cardiac condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M8573 condition browse leaf name Heart Failure condition browse leaf relevance low condition browse leaf id M9176 condition browse leaf name Hypertension condition browse leaf relevance low condition browse leaf id M4348 condition browse leaf name Bradycardia condition browse leaf as found Bradyarrhythmia condition browse leaf relevance high condition browse leaf id M8571 condition browse leaf name Heart Diseases condition browse leaf relevance low condition browse leaf id M3605 condition browse leaf name Arrhythmias, Cardiac condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology
NCT04831125
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full study rank 61686 study protocol section identification module n c t id NCT04833244 org study id info org study id PRO00018713 organization org full name Manhattan Physical Medicine and Rehabilitation, LLP org class OTHER brief title Automatic Multimodal Assessment of Occurrence and Intensity of Pain for Research and Clinical Use official title Automatic Multimodal Assessment of Occurrence and Intensity of Pain for Research and Clinical Use acronym MAP status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date May 1, 2017 start date type Actual primary completion date struct primary completion date December 31, 2020 primary completion date type Actual completion date struct completion date December 31, 2020 completion date type Actual study first submit date May 7, 2017 study first submit q c date April 3, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 3, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Manhattan Physical Medicine and Rehabilitation, LLP lead sponsor class OTHER collaborator list collaborator collaborator name Carnegie Mellon University collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary 170 patients with rotator cuff syndrome will be filmed abducting and flexing their arms before learning a simple maneuver that alleviates most of the pain 90% of the time. They will then be filmed performing the same abduction and flexion of their arms. The patients will rate their pain on the common 10-point pain scale after abducting and flexing their arms before and after the maneuver. detailed description Facial expression and truncal metrics correlate strongly with occurrence and intensity of pain. Rotator cuff syndrome almost invariably gives significant pain, especially with abduction and flexion of the arms. A simple maneuver that alleviates that pain 90% of the time, by activating the subscapularis to perform the function of the damaged supraspinatus muscle. This study strives to correlate facial and truncal characteristics with the ten-point pain scale by correlating the filmed changes in facial and truncal characteristics with the variations in patient-rated pain before and after the pain-controlling maneuver. Once effective, the maneuver may be repeated for a number of days, after which time patients generally remain pain-free permanently. conditions module condition list condition Rotator Cuff Injuries keyword list keyword Tree Number(s) C26.761.340 C26.803.063 C26.874.400 Unique ID D000070636 design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description This is a randomized, controlled study in which the patient and investigator are blinded. design primary purpose Diagnostic design masking info design masking Double design masking description After qualifying, patients are randomized into intervention or control groups. The investigator and care provider then film the patient, teach the interventional or sham maneuver, and film the patient again. The outcomes assessor then evaluates the patient responses and filmed behaviors, but is not informed about whether the patient received the interventional maneuver or the sham maneuver. design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 198 enrollment type Actual arms interventions module arm group list arm group arm group label Interventional arm group type Active Comparator arm group description Patients are taught to draw their shoulders away from their heads and necks, activating the subscapularis and pectoralis muscles. When asked immediately afterwards to abduct and flex their shoulders, these muscles perform the action that generally engages the injured supraspinatus muscle, causing significant pain. However, when these muscles are substituted for the injured supraspinatus, abduction and flexion subsequently occur painlessly. arm group intervention list arm group intervention name Behavioral: Triangular Forearm Support arm group label Control arm group type Placebo Comparator arm group description Patients are taught a sham maneuver that does little or nothing to alleviate the pain of abduction and flexion of the shoulders. Therefore their pain levels before and after learning the maneuver are likely to be similar. arm group intervention list arm group intervention name Behavioral: Placebo intervention list intervention intervention type Behavioral intervention name Triangular Forearm Support intervention description The intervention, the Triangular Forearm Support requires drawing the shoulders away from the subject's head and neck. This requires at least a mild force that this action can oppose. The most-favored maneuver is to have patients stand 2 feet away from a wall, interlock their fingers, and place their forearms to form two sides of an equilateral triangle against the wall. They then place their heads within the triangle, the backs of their heads close to or in on contact with the heels of their hands. Then, pressing against the wall with their elbows and forearms, they draw their shoulders as far away from the wall as possible, retaining contact between the wall and the tops of their heads. Subjects remain in this position for 45 seconds, at which time they stand erect and repeat the abduction and flexion maneuver. intervention arm group label list intervention arm group label Interventional intervention other name list intervention other name Modified Dolphin Pose, Modified Headstand intervention type Behavioral intervention name Placebo intervention description Patients will be asked to raise arms overhead for 45 seconds. intervention arm group label list intervention arm group label Control outcomes module primary outcome list primary outcome primary outcome measure Correlation between facial expression parameters and patient pain-scale ratings primary outcome description Changes in facial muscular activity with changes in pain status primary outcome time frame Outcome measured within 1 minute of intervention primary outcome measure Reduction of pain in abduction and flexion following the triangular forearm support. maneuver. primary outcome description Changes in Likert scale pain scores by patient and examinermaneuver abduction and flexion. primary outcome time frame Outcome measured within 1 minute of intervention eligibility module eligibility criteria Inclusion Criteria: Rotator cuff syndrome - Exclusion Criteria: Psychological or emotional instability Other orthopedic conditions of the shoulders Cosmetic facial surgery - healthy volunteers Accepts Healthy Volunteers gender All minimum age 21 Years std age list std age Adult Older Adult contacts locations module location list location location facility Cara Cipriano location city New York location state New York location zip 10022 location country United States references module reference list reference reference type background reference citation "Yoga-Based Maneuver Effectively Treats Rotator Cuff Syndrome." Fishman, Loren M.; Wilkins, Allen N.; Ovadia, Tova; Topics in Geriatric Rehabilitation . 27(2):151-161, April/June 2011. see also link list see also link see also link label Article describing efficacy of the TFS maneuver see also link u r l http://journals.lww.com/topicsingeriatricrehabilitation/pages/results.aspx?txtkeywords=a+simple+maneuver i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000070636 condition mesh term Rotator Cuff Injuries condition ancestor list condition ancestor condition ancestor id D000012421 condition ancestor term Rupture condition ancestor id D000014947 condition ancestor term Wounds and Injuries condition ancestor id D000070599 condition ancestor term Shoulder Injuries condition ancestor id D000013708 condition ancestor term Tendon Injuries condition browse leaf list condition browse leaf condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M624 condition browse leaf name Rotator Cuff Injuries condition browse leaf as found Rotator Cuff Injuries condition browse leaf relevance high condition browse leaf id M14393 condition browse leaf name Rupture condition browse leaf relevance low condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse leaf id M602 condition browse leaf name Shoulder Injuries condition browse leaf relevance low condition browse leaf id M15631 condition browse leaf name Tendon Injuries condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries
NCT04833244
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full study rank 61703 study protocol section identification module n c t id NCT04833023 org study id info org study id PalC-RG-20/P001 organization org full name Tan Tock Seng Hospital org class OTHER brief title HALO Trial: Haloperidol vs Olanzapine in Hyperactive Delirium in Palliative Care Patients; A Multi-Centre, Randomised-Controlled Trial official title HALO Trial: Haloperidol vs Olanzapine in Hyperactive Delirium in Palliative Care Patients; A Multi-Centre, Randomised-Controlled Trial status module status verified date October 2022 overall status Recruiting expanded access info has expanded access No start date struct start date May 18, 2022 start date type Actual primary completion date struct primary completion date April 2023 primary completion date type Anticipated completion date struct completion date April 2023 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date October 27, 2022 last update post date struct last update post date October 28, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Mervyn Koh Yong Hwang responsible party investigator title Senior Consultant responsible party investigator affiliation Tan Tock Seng Hospital lead sponsor lead sponsor name Tan Tock Seng Hospital lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary Background and Clinical Need: Delirium is common at the end of life and is challenging to control. There is a clinical need to study the benefits of commonly used drugs like Haloperidol and Olanzapine in the management of hyperactive delirium in advanced cancer or end-stage organ disease patients in a scientifically robust manner. Aims/Hypotheses: The investigators aim to study the effectiveness of Haloperidol compared with Olanzapine in the management of hyperactive delirium in advanced cancer or end-stage organ disease patients receiving palliative care. The investigators hypothesise that Olanzapine is as effective as Haloperidol in the control of hyperactive delirium. Methods: The investigators will conduct a pragmatic, multi-centre, (hospital, inpatient hospice, community hospital) open-label randomised-controlled trial comparing the use of Haloperidol versus Olanzapine in advanced cancer or end-stage organ disease patients with hyperactive delirium. The primary outcome is the change in Richmond Agitation and Sedation Scale (RASS) scores among patients in each treatment group at 8 hours post-drug administration. The secondary outcome is the control of hyperactive delirium at 24, 48 and 72 hours using either Haloperidol or Olanzapine. The mean doses of Haloperidol and Olanzapine used as well as the volume of rescue Midazolam required as well as side-effects of the study medications, survival after enrolment into study will also be studied. Significance to palliative care The results of this study will advance the knowledge of delirium management worldwide with regards to the efficacy of Haloperidol and Olanzapine in managing hyperactive delirium in patients with advanced cancer or end-stage organ disease. Haloperidol is used traditionally in palliative care for managing delirium. However, as a conventional anti-psychotic, it does cause extra-pyramidal side-effects. Olanzapine, a newer atypical anti-psychotic with a more favourable side-effect profile is being used increasingly in the control of delirium. These 2 commonly used drugs have never been compared head to head in a randomised-controlled, multi-centre study. detailed description (A) Background & Clinical Need Delirium is commonly encountered in palliative care with a prevalence of between 26-74% and rising to as high as 88% nearer the end of life (2). It negatively impacts patient care and leads to greater morbidity and mortality (3). There are 3 sub-types of delirium - hyperactive, mixed and hypoactive (4) with majority of well-designed studies in palliative care focusing on the management of delirium as a whole (5). However, recently published literature suggests that these delirium subtypes appear to have different trajectories and are also generally treated differently (6). Overall, the management of delirium in palliative care remains controversial. Agar had shown in a randomised controlled trial that supportive care may be superior to the use of anti-psychotics, even though the patients in Agar's study were only 'mildly' delirious and the overall doses of anti-psychotics used was lower than compared to common practice (9). Other studies have shown the benefits of anti-psychotics like haloperidol, olanzapine and aripiprazole in the management of delirium (10,11). Hui et al was the only study which looked at the management of hyperactive delirium in the palliative care setting (7). Patients with hyperactive delirium exhibit restlessness, agitation and even aggression towards their loved ones and to healthcare providers caring for them (8). To date, there have not been any multi-centre, randomised-controlled trial which has addressed the effectiveness of oral Haloperidol vs Olanzapine in the management of hyperactive delirium in the palliative care setting. (B) Specific Aims The investigators aim to study the effectiveness of Olanzapine vs Haloperidol in the management of hyperactive delirium in patients with advanced cancer or end-stage organ disease in 3 different settings. The primary outcome is the change in Richmond Agitation and Sedation Scale (RASS) scores among patients in each treatment group at 8 hours after the administration of Haloperidol or Olanzapine as measured using the Richmond Agitation and Sedation Scale (RASS). The secondary outcome is the change in Richmond Agitation and Sedation Scale (RASS) score at 24, 48 and 72 hours with the use of either Haloperidol or Olanzapine required. The mean doses of Haloperidol and Olanzapine used as well as the doses of rescue Midazolam required as well as side-effects of the study medications, survival after enrolment into study will also be studied. (C) Methods Study Design The investigators aim to conduct a multi-centre, randomised-controlled, open-label trial (Acute Hospital Palliative Care Unit, Palliative Care Unit in Community Hospital and Inpatient Hospice) comparing the use of haloperidol vs olanzapine in a 1:1 ratio in advanced cancer or end-stage organ disease patients with hyperactive delirium. Patients will be followed up for 3 days (72 hours) with regards to the response to study medications as well as other factors and outcomes as described below. Mortality data will also be collected. The study will be conducted in 3 different Palliative Care Centres in Singapore - 1. Tan Tock Seng Hospital Acute Palliative Care Unit, 2. Palliative Care Unit in St Andrews' Community Hospital and 3. Dover Park Hospice. This is to increase the pragmatic applicability and external validity in this study to different palliative care units in Singapore and internationally. Informed consent will be taken from the patient's legal representative according to the HBR Act as the patients recruited will be delirious and therefore will not able to provide informed consent adequately. conditions module condition list condition Haloperidol Advanced Cancer Hyperactive Delirium Olanzapine End-stage Organ Disease design module study type Interventional phase list phase Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design masking description The study statistician will be blinded to the treatment allocation and outcome assessments (for example, Richmond Agitation and Sedation Scale). design who masked list design who masked Outcomes Assessor enrollment info enrollment count 72 enrollment type Anticipated arms interventions module arm group list arm group arm group label Haloperidol Arm arm group type Active Comparator arm group description Haldol 2mg/ml oral solution arm group intervention list arm group intervention name Drug: Haldol 2mg/ml oral solution arm group label Olanzapine Arm arm group type Active Comparator arm group description Olanzapine Actavis 5mg orodispersible tablet arm group intervention list arm group intervention name Drug: Olanzapine Actavis 5mg orodispersible tablet intervention list intervention intervention type Drug intervention name Haldol 2mg/ml oral solution intervention description Starting dose: 1mg Maximum Dose within 24 hours: 6mg Doses can be escalated every 2 hourly to the maximum doses allowed within 24 hours. If maximum dose of Haloperidol has been reached for the day (within 24 hours), rescue dose of Midazolam 2mg can be used (2mg Q2H PRN). intervention arm group label list intervention arm group label Haloperidol Arm intervention type Drug intervention name Olanzapine Actavis 5mg orodispersible tablet intervention description Starting dose: 2.5mg Maximum Dose within 24 hours: 15mg Doses can be escalated every 2 hourly to the maximum doses allowed within 24 hours. If maximum dose of Olanzapine has been reached for the day (within 24 hours), rescue dose of Midazolam 2mg can be used (2mg Q2H PRN). intervention arm group label list intervention arm group label Olanzapine Arm outcomes module primary outcome list primary outcome primary outcome measure Change in Richmond Agitation and Sedation Scale (RASS) score primary outcome description The change in Richmond Agitation and Sedation Scale (RASS) score 8 hours after administration of either Haloperidol and Olanzapine. Minimum value is -5 which represents that the patient is in hypoactive delirium and is unarousable and maximum value is +4 with the higher score representing that the patient is in hyperactive delirium and is combative. The aim of the study is to reduce the hyperactive delirium to a score of 0 which represents patient is alert and calm. primary outcome time frame 8 hours secondary outcome list secondary outcome secondary outcome measure Comparing Patient and Family's concurrence on state of delirium with of the Diagnosis of Delirium from Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria for delirium. secondary outcome description There have not been any studies that looked at interviewing patients who are delirious about their acknowledgement and concurrence of their state of delirium. The investigators aim to interview patients by asking the patient 'Did you feel confused' and caregivers similarly by asking 'Do you feel that your loved one is Confused' as shown as an example below and compare this to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria for delirium. Please ask the Patient the following question "Do you feel that you are confused?" Yes/Sometimes No Not Sure/ Unable to answer Please ask the Family member or Caregiver the following question "Do you think the patient is confused?" 1) Yes/Sometimes 2) No 3) Not sure/ Unable to answer secondary outcome time frame 72 hours secondary outcome measure Mean dose used of Haloperidol and Olanzapine secondary outcome description Mean doses of Haloperidol and Olanzapine used at 8hours / D1 / D2 / D3 from the first time-point that the study medication is administered to the patients secondary outcome time frame 72 hours secondary outcome measure Mean Time to control of Hyperactive Delirium secondary outcome description Mean Time to control of Hyperactive Delirium secondary outcome time frame 72 hours secondary outcome measure Rescue Psychotropic (Mean Doses): Midazolam secondary outcome description Rescue Psychotropic (Mean Doses): Midazolam secondary outcome time frame 72 hours secondary outcome measure Side-effects of Study Medications secondary outcome description Side-effects of Study Medications secondary outcome time frame 72 hours secondary outcome measure Survival time in days secondary outcome description Survival time in days secondary outcome time frame 72 hours secondary outcome measure Edmonton Symptom Assessment Score revised (ESAS-r) secondary outcome description Edmonton Symptom Assessment Score revised (ESAS-r) - At the point of recruitment Minimum value for the scale is 0 and maximum value for the scale is 10 with the higher value representing worse outcome. secondary outcome time frame 1 hour secondary outcome measure Memorial Delirium Assessment Score (MDAS) secondary outcome description Memorial Delirium Assessment Score (MDAS) - At the point of recruitment and after 72 hours It is a scale comprising of 10 items with scores of 0-3 for each question. Add up the score for all 10 questions and scores with more than or equal to 13 point indicates delirium. secondary outcome time frame 72 hours secondary outcome measure Richmond Agitation and Sedation Scale (RASS) score secondary outcome description Richmond Agitation and Sedation Scale (RASS) score: 8hours / 24hours (Day 1) / 48 hours (Day 2) / 72 hours (Day 3) Minimum value is -5 which represents that the patient is in hypoactive delirium and is unarousable and maximum value is +4 with the higher score representing that the patient is in hyperactive delirium and is combative. The aim of the study is to reduce the hyperactive delirium to a score of 0 which represents patient is alert and calm. secondary outcome time frame 72 hours secondary outcome measure Caregiver and Nurses Perception on the control of hyperactive delirium secondary outcome description Caregiver and Nurses Perception on the control of hyperactive delirium (5-point Likert Scale). Kindly refer to the example of the question below. The patient is less agitated as compared to 72 hours ago? (Clinician/Nurse): - Strongly Disagree - Disagree - Neutral - Agree - Strongly Agree The patient is less agitated as compared to 72 hours ago? (Family/Caregiver): - Strongly Disagree - Disagree - Neutral - Agree - Strongly Agree secondary outcome time frame 72 hours eligibility module eligibility criteria Inclusion Criteria: Patients with advanced cancer or end-stage organ disease Age ≥ 21 years old Fulfil All Three Diagnosis of Delirium: Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria for delirium Memorial Delirium Assessment Scale (MDAS)©1996 >/= 13 Richmond Agitation-Sedation Scale (RASS) Score +1 to +3 Able to consume medications orally Prognosis > 48 hrs (Clinician Estimate) Exclusion Criteria: Parkinson's Disease or Vascular Parkinsonism Patient with dementia Chronic Schizophrenia on regular Anti-psychotic medications Taking any regular Benzodiazepines* or any Anti-psychotic** medications Known allergy to Haloperidol or Olanzapine History of Substance Abuse Known Prolonged corrected QT interval (QTc) Syndrome (In Patient's Medical History) Prognosis < 48 hours (Clinician's Estimate) Unable to consume oral medications Richmond Agitation and Sedation Scale (RASS) Score +4 (Too agitated and will require Parenteral Anti-psychotics and/or Benzodiazepines) Pregnancy * e.g. Lorazepam, Alprazolam, Clonazepam, Midazolam **e.g. Haloperidol, Risperidone, Quetiapine, Olanzapine healthy volunteers No gender All minimum age 21 Years maximum age 99 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Mervyn Koh central contact role Contact central contact phone +6597678996 central contact e mail mervyn_koh@ttsh.com.sg central contact name Allyn Hum central contact role Contact central contact phone +6581263205 central contact e mail allyn_hum@ttsh.com.sg overall official list overall official overall official name Mervyn Koh overall official affiliation Tan Tock Seng Hospital overall official role Principal Investigator location list location location facility Tan Tock Seng Hospital location status Recruiting location city Singapore location zip 308433 location country Singapore location contact list location contact location contact name Mervyn Koh location contact role Contact location contact phone +6597678996 location contact e mail mervyn_koh@ttsh.com.sg location facility Dover Park Hospice location status Recruiting location city Singapore location zip 308436 location country Singapore location contact list location contact location contact name Mervyn Koh location contact role Contact location contact phone +6597678996 location contact e mail mervyn_koh@ttsh.com.sg location facility St. Andrew's Community Hospital location status Recruiting location city Singapore location zip 529895 location country Singapore location contact list location contact location contact name Siew Chin Chia location contact role Contact location contact e mail siew_chin_chia@ttsh.com.sg references module reference list reference reference p m i d 22988044 reference type background reference citation Hosie A, Davidson PM, Agar M, Sanderson CR, Phillips J. Delirium prevalence, incidence, and implications for screening in specialist palliative care inpatient settings: a systematic review. Palliat Med. 2013 Jun;27(6):486-98. doi: 10.1177/0269216312457214. Epub 2012 Sep 17. reference p m i d 31184538 reference type background reference citation Watt CL, Momoli F, Ansari MT, Sikora L, Bush SH, Hosie A, Kabir M, Rosenberg E, Kanji S, Lawlor PG. The incidence and prevalence of delirium across palliative care settings: A systematic review. Palliat Med. 2019 Sep;33(8):865-877. doi: 10.1177/0269216319854944. Epub 2019 Jun 11. reference p m i d 31395002 reference type background reference citation Hui D. Delirium in the palliative care setting: "Sorting" out the confusion. Palliat Med. 2019 Sep;33(8):863-864. doi: 10.1177/0269216319861896. reference p m i d 16540616 reference type background reference citation Inouye SK. Delirium in older persons. N Engl J Med. 2006 Mar 16;354(11):1157-65. doi: 10.1056/NEJMra052321. No abstract available. Erratum In: N Engl J Med. 2006 Apr 13;354(15):1655. reference p m i d 31490322 reference type background reference citation Skelton L, Guo P. Evaluating the effects of the pharmacological and nonpharmacological interventions to manage delirium symptoms in palliative care patients: systematic review. Curr Opin Support Palliat Care. 2019 Dec;13(4):384-391. doi: 10.1097/SPC.0000000000000458. reference p m i d 31506133 reference type background reference citation Zipser CM, Knoepfel S, Hayoz P, Schubert M, Ernst J, von Känel R, Boettger S. Clinical management of delirium: The response depends on the subtypes. An observational cohort study in 602 patients. Palliat Support Care. 2020 Feb;18(1):4-11. doi: 10.1017/S1478951519000609. reference p m i d 28975307 reference type background reference citation Hui D, Frisbee-Hume S, Wilson A, Dibaj SS, Nguyen T, De La Cruz M, Walker P, Zhukovsky DS, Delgado-Guay M, Vidal M, Epner D, Reddy A, Tanco K, Williams J, Hall S, Liu D, Hess K, Amin S, Breitbart W, Bruera E. Effect of Lorazepam With Haloperidol vs Haloperidol Alone on Agitated Delirium in Patients With Advanced Cancer Receiving Palliative Care: A Randomized Clinical Trial. JAMA. 2017 Sep 19;318(11):1047-1056. doi: 10.1001/jama.2017.11468. reference p m i d 19109118 reference type background reference citation Breitbart W, Alici Y. Agitation and delirium at the end of life: "We couldn't manage him". JAMA. 2008 Dec 24;300(24):2898-910, E1. doi: 10.1001/jama.2008.885. reference p m i d 27918778 reference type background reference citation Agar MR, Lawlor PG, Quinn S, Draper B, Caplan GA, Rowett D, Sanderson C, Hardy J, Le B, Eckermann S, McCaffrey N, Devilee L, Fazekas B, Hill M, Currow DC. Efficacy of Oral Risperidone, Haloperidol, or Placebo for Symptoms of Delirium Among Patients in Palliative Care: A Randomized Clinical Trial. JAMA Intern Med. 2017 Jan 1;177(1):34-42. doi: 10.1001/jamainternmed.2016.7491. Erratum in: JAMA Intern Med. 2017 Feb 1;177(2):293. reference p m i d 21563866 reference type background reference citation Boettger S, Friedlander M, Breitbart W, Passik S. Aripiprazole and haloperidol in the treatment of delirium. Aust N Z J Psychiatry. 2011 Jun;45(6):477-82. doi: 10.3109/00048674.2011.543411. reference type background reference citation Lin CJ, Sun FJ, Fang CK. An open trial comparing haloperidol with olanzapine for the treatment of delirium in palliative and hospice center cancer patients. J Internal Med Taiwan 2008; 19:346-354. reference p m i d 24684942 reference type background reference citation Bush SH, Grassau PA, Yarmo MN, Zhang T, Zinkie SJ, Pereira JL. The Richmond Agitation-Sedation Scale modified for palliative care inpatients (RASS-PAL): a pilot study exploring validity and feasibility in clinical practice. BMC Palliat Care. 2014 Mar 31;13(1):17. doi: 10.1186/1472-684X-13-17. i p d sharing statement module i p d sharing No i p d sharing description There are no plans to make individual participant data available to other researchers. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003693 condition mesh term Delirium condition mesh id D000006948 condition mesh term Hyperkinesis condition mesh id D000011595 condition mesh term Psychomotor Agitation condition ancestor list condition ancestor condition ancestor id D000003221 condition ancestor term Confusion condition ancestor id D000019954 condition ancestor term Neurobehavioral Manifestations condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000019965 condition ancestor term Neurocognitive Disorders condition 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NCT04833023
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full study rank 61248 study protocol section identification module n c t id NCT04838938 org study id info org study id FINBA_critlab_4 organization org full name Fundación para la Investigación Biosanitaria del Principado de Asturias org class OTHER brief title Personalized Medicine in Patients With Infective Endocarditis official title Personalized Medicine in Patients With Infective Endocarditis status module status verified date March 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 1, 2021 start date type Actual primary completion date struct primary completion date March 1, 2022 primary completion date type Anticipated completion date struct completion date July 1, 2022 completion date type Anticipated study first submit date March 26, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Fundación para la Investigación Biosanitaria del Principado de Asturias lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The hypothesis underlying this work is the identification of different sub phenotypes of patients with infective endocarditis through the study of the host's response to infection. Furthemore, metagenomic sequencing may be a helpful supplement to IE diagnostic, especially when conventional tests fail to yield a diagnosis. detailed description Infective endocarditis is a life-threatening infection of heart valves and adjacent structures characterized by vegetations on valves and other endocardial surfaces, with tissue destruction and risk of embolization. The clinical variability, including the heterogeneous response to infection and the different antibiotic treatments make the identification of the underlying pathogens of infective endocarditis (IE) is critical for precision therapy. Virulence factors mediate tissue adherence, host infiltration, immune resistance/evasion, and dynamic stress responses and confer enhanced pathogen survival, proliferation, and host invasion in animal models of infective endocarditis. To identify the microorganism and simultaneously considered the response of the host to the infection could improve the management of the infective endocarditis. conditions module condition list condition Infective Endocarditis Response, Acute Phase Treatment design module study type Observational patient registry Yes target duration 1 Year design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective bio spec bio spec retention Samples With DNA bio spec description Samples with DNA for the study of the host's sub phenotypes Plasma and heart valves to make a metagenomic sequencing enrollment info enrollment count 60 enrollment type Anticipated outcomes module primary outcome list primary outcome primary outcome measure To characterize a cohort of patients diagnosed with infective endocarditis primary outcome description Clinical, microbiological and echocardiographic description of patients with infective endocarditis. primary outcome time frame 2 year secondary outcome list secondary outcome secondary outcome measure Identification of the underlying pathogens of infective endocarditis (IE) secondary outcome description We will employ next-generation sequencing for pathogens and antimicrobial resistance detection in IE patients. secondary outcome time frame 2 year secondary outcome measure Host response classification for infective endocarditis (IE) secondary outcome description Differential baseline expression of some genes may indicate resilience to infection. secondary outcome time frame 2 year secondary outcome measure Host response predictors of sepsis outcomes secondary outcome description We will develop and use advanced bioinformatic, metabolomic, proteomic and mRNA sequencing technologies to identify specific changes, or biomarkers, in patient blood samples that predict outcome in sepsis. secondary outcome time frame 2 year eligibility module eligibility criteria Inclusion Criteria: Diagnosis of active infective endocarditis according to the modified Duke criteria. Exclusion Criteria: Pregnancy healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population Patients with an active infective endocarditis sampling method Probability Sample contacts locations module central contact list central contact central contact name Raquel Rodríguez-García, MD, PhD central contact role Contact central contact phone 985652433 central contact e mail rrg@crit-lab.org overall official list overall official overall official name Guillermo Muñiz Albaiceta, MD, PhD overall official affiliation HUCA-FINBA, Universidad de Oviedo overall official role Study Director location list location location facility Hospital Universitario Central de Asturias location status Recruiting location city Oviedo location state Principado De Asturias location zip 33011 location country Spain location contact list location contact location contact name Raquel Rodríguez-García, MD location contact role Contact location contact phone 985652433 location contact e mail rrg@crit-lab.org i p d sharing statement module i p d sharing Yes i p d sharing description All datasets underlying the study are available upon request to the study principal investigator. All of the individual participant data collected during the trial, informed consent forms, study protocol, statistical analysis plan and raw data, are available under reasonable request, and after deindentification. i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code i p d sharing time frame Starting 3 month after publication i p d sharing access criteria Principal investigator will review requests of data to be provided. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000004697 condition mesh term Endocarditis, Bacterial condition mesh id D000004696 condition mesh term Endocarditis condition mesh id D000000210 condition mesh term Acute-Phase Reaction condition ancestor list condition ancestor condition ancestor id D000006331 condition ancestor term Heart Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000001424 condition ancestor term Bacterial Infections condition ancestor id D000001423 condition ancestor term Bacterial Infections and Mycoses condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000053821 condition ancestor term Cardiovascular Infections condition ancestor id D000007249 condition ancestor term Inflammation condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M7011 condition browse leaf name Endocarditis, Bacterial condition browse leaf as found Infective Endocarditis condition browse leaf relevance high condition browse leaf id M7010 condition browse leaf name Endocarditis condition browse leaf as found Endocarditis condition browse leaf relevance high condition browse leaf id M2718 condition browse leaf name Acute-Phase Reaction condition browse leaf as found Response, Acute Phase condition browse leaf relevance high condition browse leaf id M8571 condition browse leaf name Heart Diseases condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M3874 condition browse leaf name Bacterial Infections condition browse leaf relevance low condition browse leaf id M11288 condition browse leaf name Mycoses condition browse leaf relevance low condition browse leaf id M3873 condition browse leaf name Bacterial Infections and Mycoses condition browse leaf relevance low condition browse leaf id M26642 condition browse leaf name Cardiovascular Infections condition browse leaf relevance low condition browse leaf id M9445 condition browse leaf name Inflammation condition browse leaf relevance low condition browse leaf id T3065 condition browse leaf name Infective Endocarditis condition browse leaf as found Infective Endocarditis condition browse leaf relevance high condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04838938
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full study rank 61297 study protocol section identification module n c t id NCT04838301 org study id info org study id Allo-20-001 secondary id info list secondary id info secondary id R01AG063826 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/R01AG063826 organization org full name University of Arizona org class OTHER brief title Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease official title Safety and Efficacy of Allopregnanolone (Allo) as a Regenerative Therapeutic for Alzheimer's Disease: Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Clinical Trial acronym REGEN-BRAIN© status module status verified date May 2022 overall status Not yet recruiting expanded access info has expanded access No start date struct start date January 2023 start date type Anticipated primary completion date struct primary completion date January 2025 primary completion date type Anticipated completion date struct completion date June 2025 completion date type Anticipated study first submit date March 25, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date May 23, 2022 last update post date struct last update post date May 25, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Roberta Brinton responsible party investigator title Director, Center for Innovation in Brain Science; Professor, Departments of Pharmacology and Neurology responsible party investigator affiliation University of Arizona lead sponsor lead sponsor name University of Arizona lead sponsor class OTHER collaborator list collaborator collaborator name National Institute on Aging (NIA) collaborator class NIH collaborator name Syneos Health collaborator class OTHER collaborator name ADM Diagnostics, Inc. collaborator class UNKNOWN collaborator name University of Southern California collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary A phase 2, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of Allopregnanolone as a regenerative therapeutic for Alzheimer's disease. detailed description This is a proof-of-concept phase 2 clinical trial to investigate the long-term safety and efficacy of Allo to function as a regenerative therapeutic to restore structural integrity and cognitive function of the brain in participants with mild Alzheimer's disease (AD) dementia. Study participants will be male and female, APOE ε4 positive diagnosed with probable AD, Mini-Mental State Exam (MMSE) 20 to 26, ages 55 to 80 years old. After a 2-4-week screening period, participants will be randomized to 4 mg Allo (administered intravenously over 30 minutes, once per week, in clinic) or matching placebo, 1:1 allocation, for a period of 12 months. After 12 months, all participants in the placebo group will be crossed-over to receive Allo for the remainder of the study (6 month open-label phase). Brain imaging to evaluate the primary endpoint will be conducted at baseline, 6 and 12 months. conditions module condition list condition Alzheimer Dementia Late Onset Alzheimer Disease Neurodegenerative Diseases keyword list keyword Mild Alzheimer Disease Regenerative Therapeutic APOE ε4 Neurogenesis Allopregnanolone design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Participants are assigned to the active intervention or placebo in parallel for 12 months. After 12 months, all participants in the placebo group will be crossed-over to receive Allo for the remainder of the study (6 month open-label phase). design primary purpose Treatment design masking info design masking Quadruple design masking description After 12 months participants and study personnel will be aware of the open label phase, but initial randomization will remain blind during the entire length of the study (placebo-controlled and open-label periods); that is, all participants and study personnel are blinded to each participant's randomization to initial treatment group. design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 200 enrollment type Anticipated arms interventions module arm group list arm group arm group label Allo group arm group type Experimental arm group description Allopregnanolone 4mg IV 30-minute infusion once per week for 12 months. arm group intervention list arm group intervention name Drug: Allopregnanolone arm group label Control group arm group type Placebo Comparator arm group description Placebo (normal saline) IV 30-minute infusion once per week for 12 months. arm group intervention list arm group intervention name Other: Placebo intervention list intervention intervention type Drug intervention name Allopregnanolone intervention description Allopregnanolone 4mg IV via 30-minute infusion, once per week. intervention arm group label list intervention arm group label Allo group intervention other name list intervention other name Allo intervention type Other intervention name Placebo intervention description Normal saline solution IV via 30-minute infusion, once per week intervention arm group label list intervention arm group label Control group outcomes module primary outcome list primary outcome primary outcome measure Hippocampal volume primary outcome description mm3 primary outcome time frame Baseline to 12 months secondary outcome list secondary outcome secondary outcome measure Cambridge Cognition's Paired Associates Learning Test secondary outcome description Total errors score (adjusted) - number of errors made by the participant (range: 0 to ~120). Higher scores indicate poor performance. secondary outcome time frame Baseline to 12 months secondary outcome measure Cambridge Neuropsychological Test Automated Battery (CANTAB) secondary outcome description Composite score (higher score indicate better outcome) secondary outcome time frame Baseline to 12 months secondary outcome measure Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) 11 secondary outcome description Total score (range 0 to 70); higher scores indicate poor performance. secondary outcome time frame Baseline to 12 months secondary outcome measure Alzheimer's Disease Cooperative Study (ADCS) Instrumental Activities of Daily (iADL) Living (iADL) secondary outcome description iADL subscore (range 0-56): Lower score indicates greater severity secondary outcome time frame Baseline to 12 months secondary outcome measure Safety and tolerability secondary outcome description Frequency of adverse events and serious adverse events secondary outcome time frame Baseline to 12 months other outcome list other outcome other outcome measure Other regional brain volumes other outcome description Change in regional brain volumes (mm3) other outcome time frame Baseline to 12 and 18 months other outcome measure Diffusion tensor imaging (DTI) other outcome description Change in white matter tract diffusion (scalar values and/or mm2/sec) other outcome time frame Baseline to 12 and 18 months other outcome measure Resting state functional MRI other outcome description Change in functional connectivity (z transformed correlations) other outcome time frame Baseline to 12 and 18 months other outcome measure Arterial spin labeling (ASL) other outcome description Change in regional cerebral blood flow (mL/100g) other outcome time frame Baseline to 12 and 18 months other outcome measure Exploratory blood based biomarkers other outcome description Change from baseline in biomarkers of AD pathology, neurogenesis and inflammation other outcome time frame Baseline to 12 and 18 months other outcome measure Clinical Dementia Rating (CDR) other outcome description Sum of boxes score (CDR-SB): range 0-18 other outcome time frame Baseline to 12 and 18 months other outcome measure Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) 14 other outcome description Total score (range 0-90) other outcome time frame Baseline to 12 and 18 months other outcome measure Mini Mental State Examination (MMSE) other outcome description Total score (range 0-30) other outcome time frame Baseline to 12 and 18 months other outcome measure Neuropsychiatric Inventory-Questionnaire (NPI-Q) other outcome description Total score (range 0-36). Higher scores indicate greater symptom severity other outcome time frame Baseline to 12 and 18 months other outcome measure EuroQol 5-Dimension / 5-Level health-related quality of life scale scores (EQ-5D-5L) other outcome description Reported as frequency, percentage and index value. other outcome time frame Baseline to 12 and 18 months other outcome measure Quality of Life in Alzheimer's Disease scale (QoL-AD) other outcome description Total score (range 13-52). Higher score indicate better QoL other outcome time frame Baseline to 12 and 18 months other outcome measure Zarit Burden Interview (ZBI) other outcome description Total score (range 0-48). Higher scores indicate high burden other outcome time frame Baseline to 12 and 18 months eligibility module eligibility criteria Inclusion Criteria: Men and postmenopausal women Age 55 to 80 years old Meets NIA-AA criteria for probable AD dementia MMSE of 20-26 APOE ε4 positive Geriatric Depression Scale short form (GDS-S) score of ≤ 6 No medical contraindications to participation Capacity to provide informed consent at screening Exclusion Criteria: Dementia other than probable AD Use of benzodiazepines, anticonvulsants, antipsychotics, or other drugs that might interact with the GABA-A receptor complex History of stroke with a modified Hachinski Ischemic Scale score >4 History of seizure disorder, focal brain lesion, traumatic brain injury History within the last 5 years of a primary or recurrent malignant disease Unstable or clinically significant cardiovascular, kidney or liver disease MRI indicative of any other significant abnormality, including but not limited to one or more significant ARIA-E or macro-hemorrhage findings, or multiple microhemorrhages (>8), or Fazekas score of 3; encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions Any conditions that would contraindicate MRI studies. healthy volunteers No gender All minimum age 55 Years maximum age 80 Years std age list std age Adult Older Adult references module reference list reference reference p m i d 33344752 reference type background reference citation Hernandez GD, Solinsky CM, Mack WJ, Kono N, Rodgers KE, Wu CY, Mollo AR, Lopez CM, Pawluczyk S, Bauer G, Matthews D, Shi Y, Law M, Rogawski MA, Schneider LS, Brinton RD. Safety, tolerability, and pharmacokinetics of allopregnanolone as a regenerative therapeutic for Alzheimer's disease: A single and multiple ascending dose phase 1b/2a clinical trial. Alzheimers Dement (N Y). 2020 Dec 16;6(1):e12107. doi: 10.1002/trc2.12107. eCollection 2020. reference p m i d 23438839 reference type background reference citation Brinton RD. Neurosteroids as regenerative agents in the brain: therapeutic implications. Nat Rev Endocrinol. 2013 Apr;9(4):241-50. doi: 10.1038/nrendo.2013.31. Epub 2013 Feb 26. Review. reference p m i d 16842093 reference type background reference citation Brinton RD, Wang JM. Therapeutic potential of neurogenesis for prevention and recovery from Alzheimer's disease: allopregnanolone as a proof of concept neurogenic agent. Curr Alzheimer Res. 2006 Jul;3(3):185-90. Review. reference p m i d 35310526 reference type derived reference citation Raikes AC, Hernandez GD, Matthews DC, Lukic AS, Law M, Shi Y, Schneider LS, Brinton RD. Exploratory imaging outcomes of a phase 1b/2a clinical trial of allopregnanolone as a regenerative therapeutic for Alzheimer's disease: Structural effects and functional connectivity outcomes. Alzheimers Dement (N Y). 2022 Mar 14;8(1):e12258. doi: 10.1002/trc2.12258. eCollection 2022. Erratum In: Alzheimers Dement (N Y). 2022 Jul 26;8(1):e12300. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000000544 condition mesh term Alzheimer Disease condition mesh id D000019636 condition mesh term Neurodegenerative Diseases condition ancestor list condition ancestor condition ancestor id D000003704 condition ancestor term Dementia condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000024801 condition ancestor term Tauopathies condition ancestor id D000019965 condition ancestor term Neurocognitive Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M3037 condition browse leaf name Alzheimer Disease condition browse leaf as found Alzheimer's Disease condition browse leaf relevance high condition browse leaf id M6056 condition browse leaf name Dementia condition browse leaf relevance low condition browse leaf id M20711 condition browse leaf name Neurodegenerative Diseases condition browse leaf as found Neurodegenerative Diseases condition browse leaf relevance high condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M22155 condition browse leaf name Tauopathies condition browse leaf relevance low condition browse leaf id M20989 condition browse leaf name Neurocognitive Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse leaf id T2192 condition browse leaf name Familial Alzheimer Disease condition browse leaf as found Alzheimer's Disease condition browse leaf relevance high condition browse leaf id T312 condition browse leaf name Alzheimer Disease Type 2 condition browse leaf as found Late Onset Alzheimer Disease condition browse leaf relevance high condition browse leaf id T3320 condition browse leaf name Late-Onset Familial Alzheimer Disease condition browse leaf as found Late Onset Alzheimer Disease condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000011280 intervention mesh term Pregnanolone intervention ancestor list intervention ancestor intervention ancestor id D000000777 intervention ancestor term Anesthetics intervention ancestor id D000002492 intervention ancestor term Central Nervous System Depressants intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M21013 intervention browse leaf name Pharmaceutical Solutions intervention browse leaf relevance low intervention browse leaf id M13308 intervention browse leaf name Pregnanolone intervention browse leaf as found Cardiac monitoring intervention browse leaf relevance high intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev PhSol intervention browse branch name Pharmaceutical Solutions intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants
NCT04838301
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full study rank 61828 study protocol section identification module n c t id NCT04831398 org study id info org study id 13084 organization org full name University of Oklahoma org class OTHER brief title The Effects of Acute Melatonin Supplementation on Cardiovascular Responses to Sympathetic Activation official title The Effects of Acute Melatonin Supplementation on Cardiovascular Responses to Sympathetic Activation status module status verified date October 2022 overall status Not yet recruiting expanded access info has expanded access No start date struct start date January 1, 2023 start date type Anticipated primary completion date struct primary completion date May 1, 2024 primary completion date type Anticipated completion date struct completion date May 1, 2024 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date October 31, 2022 last update post date struct last update post date November 1, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Oklahoma lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary the purpose of this experiment is to determine if acute melatonin supplementation alters central and peripheral cardiovascular responses to a cold pressor test at rest and during dynamic exercise. detailed description After IRB approval, experiments will take place in the Human Circulation Research Laboratory in the Department of Health and Exercise on the University of Oklahoma Norman campus. All subjects will complete a total of 3 visits. The first is a screening visit to provide informed consent and to ensure the potential participant meets all inclusion criteria and no exclusion criteria. Once consented and enrolled, participants will be familiarized with experimental protocols. On separate days (visits 2 and 3), participants will complete placebo (PLA) and melatonin (MEL) in a randomly ordered, single-blind, counter-balanced design. PLA or MEL treatment will precede testing by 30min to maximize absorption into the circulation (Bartoli, 2013). All experiments (PLA/MEL) will begin with the subject lying supine for 5 min of quiet rest where baseline measurements are taken, followed by activation of the lower body negative pressure (LBNP) device causing suction at -20 mmHg. Following LBNP participants will be given 10 minutes of rest to recover all variables to pre-LBNP values. After which participants will be given a hand grip dynamometer to complete 7 minutes of exercise at an intensity of 20% MVC at a 1s contraction to 2s relaxation cycle paced by a metronome. During the final 2 minutes of the 7 minutes of exercise the LBNP device will be activated again to -20mmHg such that the participant will be completing LBNP during rhythmic grip exercise. After the completion of exercise, the subject will remain supine for 10min. Then the a Total Labile Signal (TLS) procedure will be conducted. Where the experimental limb is occluded using a blood pressure cuff for 5min. The cuff is then rapidly deflated. The lowest oxyhemoglobin measured during the occlusion is recorded. After the TLS procedure, the subject will be de-instrumented and will leave the laboratory. conditions module condition list condition Healthy design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Crossover Assignment design intervention model description This study is a single-blind crossover design. design primary purpose Basic Science design masking info design masking Single design masking description Participants will be blinded in two trials. Practitioners and operators will not be allowed to communicate with the participants concerning whether they are receiving placebo/melatonin. Outcome assessors and statisticians may not be blinded to experimental allocation. Our placebo should satisfy two conditions of an ideal placebo: a) it should be indistinguishable from the experimental supplement to blinded participants, and b) it should be physiologically inert. In this study, 1 microliter McCormicks Pure Mint Extract will be mixed with 29 ml of filtered water and given to participants as a sublingual spray. This mixture will be non-caloric and will mimic the taste and sensation of the commercially available melatonin spray that will be used in the study (Onnit Labs Inc., Mint Flavor). design who masked list design who masked Participant enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label Placebo arm group type Placebo Comparator arm group description Placebo (PLA) is 10 sublingual sprays of a diluted (1 microliter/29ml filtered water) mint extract. arm group intervention list arm group intervention name Other: Placebo arm group label Melatonin arm group type Experimental arm group description 5mg commercially available melatonin (MEL) spray will be given sublingually. arm group intervention list arm group intervention name Dietary Supplement: melatonin intervention list intervention intervention type Dietary Supplement intervention name melatonin intervention description A 5mg dose of melatonin spay will be delivered sublingually. intervention arm group label list intervention arm group label Melatonin intervention type Other intervention name Placebo intervention description 10 sprays of diluted mint extract. This mimics the sensation and taste of the melatonin spray intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Muscle Tissue Oxygenation primary outcome description Concentrations of Total, Oxy, and deoxyhemoglobin of Flexor Digitorum Profundus muscle of the forearm primary outcome time frame 7 minutes of rest and 7 minutes of exercise primary outcome measure Mean Arterial Pressure primary outcome description average pressure within the arteries primary outcome time frame 7 minutes of rest and 7 minutes of exercise secondary outcome list secondary outcome secondary outcome measure Cerebral Oxygenation secondary outcome description Concentrations of Total, Oxy, and deoxyhemoglobin of the Prefrontal Cortex of the brain secondary outcome time frame 7 minutes of rest and 7 minutes of exercise secondary outcome measure Heart Rate secondary outcome description number of heart beats per minute secondary outcome time frame 7 minutes of rest and 7 minutes of exercise secondary outcome measure Respiratory Rate secondary outcome description number of breaths per minute secondary outcome time frame 7 minutes of rest and 7 minutes of exercise secondary outcome measure Cardiac Output secondary outcome description volume of blood pumped by the heart per minute secondary outcome time frame 7 minutes of rest and 7 minutes of exercise secondary outcome measure Stroke Volume secondary outcome description volume of blood pumped by the heart per heart beat secondary outcome time frame 7 minutes of rest and 7 minutes of exercise secondary outcome measure Total peripheral resistance secondary outcome description amount of force affecting resistance to blood flow throughout the circulatory system secondary outcome time frame 7 minutes of rest and 7 minutes of exercise secondary outcome measure Heart Rate Variability secondary outcome description measure of the variation in time between each heart beat secondary outcome time frame 7 minutes of rest and 7 minutes of exercise eligibility module eligibility criteria Inclusion Criteria: Healthy men and women Women must be premenopausal with a regular menstrual cycle (26-30 days) Exclusion Criteria: History of autonomic dysfunction Cardiovascular diseases Diabetes Tobacco/nicotine use Systolic Pressure >= 130 mmHg Diastolic Pressure >= 85 mmHg Regular melatonin use >= 1 use/week Allergy to melatonin Cardiometabolic medication use (e.g. anti-hypertensives, insulin-sensitizing, statins) Sex hormone replacement medical use (e.g. testosterone, estrogen, progesterone) Pregnancy healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 35 Years std age list std age Adult contacts locations module central contact list central contact central contact name Jeremy M Kellawan, PhD central contact role Contact central contact phone 405 325 9028 central contact e mail kellawan@ou.edu central contact name Yair Pincu central contact role Contact central contact e mail ypincu@ou.edu overall official list overall official overall official name Jeremy M Kellawan overall official affiliation University of Oklahoma overall official role Principal Investigator location list location location facility Department of Health and Exercise Science location city Norman location state Oklahoma location zip 73019 location country United States i p d sharing statement module i p d sharing No i p d sharing description The is no plan to share IPD derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev Rare condition browse branch name Rare Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000008550 intervention mesh term Melatonin intervention ancestor list intervention ancestor intervention ancestor id D000000975 intervention ancestor term Antioxidants intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000020011 intervention ancestor term Protective Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000002492 intervention ancestor term Central Nervous System Depressants intervention browse leaf list intervention browse leaf intervention browse leaf id M10685 intervention browse leaf name Melatonin intervention browse leaf as found Squamous cell intervention browse leaf relevance high intervention browse leaf id M3444 intervention browse leaf name Antioxidants intervention browse leaf relevance low intervention browse leaf id M21022 intervention browse leaf name Protective Agents intervention browse leaf relevance low intervention browse leaf id T410 intervention browse leaf name Melatonin intervention browse leaf as found Squamous cell intervention browse leaf relevance high intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Ot intervention browse branch name Other Dietary Supplements
NCT04831398
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full study rank 61923 study protocol section identification module n c t id NCT04830150 org study id info org study id 95531838-663.05 organization org full name T.C. ORDU ÜNİVERSİTESİ org class OTHER brief title The Effect of Supportive Nursing Interventions of Mothers of Infants in Neonatal Intensive Care Unit official title The Effect of Supportive Nursing Interventions on Reducing Stress Levels of Mothers of Infants in Neonatal Intensive Care Unit: A Randomized Controlled Trial status module status verified date September 2021 overall status Completed expanded access info has expanded access No start date struct start date March 20, 2018 start date type Actual primary completion date struct primary completion date August 20, 2019 primary completion date type Actual completion date struct completion date December 11, 2019 completion date type Actual study first submit date March 30, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 2, 2021 study first post date type Actual last update submit date September 7, 2021 last update post date struct last update post date September 14, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Dilekkucu Kalemdar responsible party investigator title PhD, RN responsible party investigator affiliation T.C. ORDU ÜNİVERSİTESİ lead sponsor lead sponsor name T.C. ORDU ÜNİVERSİTESİ lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Objective: This study was conducted to determine the effects of supportive interventions on the stress levels of mothers of infants hospitalized in the Neonatal Intensive Care Unit (NICU). Backround: The inability to nurture the healthy baby dreamed of, disease and intensive care processes are situations causing a crisis for parents. The stress experienced by mothers may affect emotional status and the foundation of the mother-ınfant attachment. For this reason, mothers of infants hospitalized in the NICU need support to cope with the stressful events they experience. Design: This study was a prospective, pre-and post-test randomised controlled trial. Methods: The population of the research comprised mothers with neonates admitted to the NICU of a state hospital, abiding by the sample selection criteria and who accepted participation in the research. The research was completed with 85 mothers in two groups of 45 subjects and 40 controls selected at random. Data collection used the Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU), NICU Parent Belief Scale (NICU:PBS), State-Trait Anxiety Inventory (STAI TX-2) and saliva cortisol analysis. detailed description This study was performed with the aim of determining the effect of supportive interventions on maternal stress levels among mothers with infants hospitalized in the NICU. This was a randomized pre- and post-test controlled trial was conducted to determined the effect of planned educational and supportive nursing interventions given to mothers with infants in the NICU on the stress, anxiety and beliefs of mothers in the NICU of Women and Pediatrics Training and Research Hospital. This study was conducted at a state hospital's NICU in the east part of Turkey. According to the criteria of the T.R. Ministry of Health, the unit in which the study was performed was a Level I NICU. The unit had 10 incubators and 10 nurses were employed in the NICU. The nurses in the NICU worked in groups of three, in two shifts, providing care and treatment of the newborns in the unit. This part of Turkey is geographically located in a rural area in the east. The mothers with infants in the NICU were informed by the physicians and nurses on certain days of the week about the hours at which they were allowed to visit their infants. Power analysis of the sample number used the G*Power (v. 3.1.9.2) program and was based on previous studies. According to Jacob Cohen's effect size coefficients, assuming large effect size in assessments between two independent groups (d=0.40), with α=0.05 and 1-β=0.95 (90% power), each group was required to contain at least 39 people. Considering data loss, each group included 50 mothers. As saliva samples were insufficient in 10 mothers in the experiment group and 5 mothers in the control group, this data was excluded from the study. The research was completed with 85 mothers, comprising 40 subjects and 45 controls chosen at random (Fig. 1). 2.3. Randomization: sequence generation, type, allocation concealment mechanism, and implementation Randomization was performed using a computer program. The participants were randomised and assigned by a researcher into two groups using the Integer Generator free software (www.random.org), which produces random numbers in configurable intervals: 40 in intervention group and 45 in control group. Data collection used the "Mother and Neonate Descriptive Information Form", "Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU)", "NICU Parent Belief Scale (NICU PBS)", State-Trait Anxiety Inventory (STAI TX-2)" and "saliva cortisol analysis". Before the mothers first visits to their infants, the mother and neonate descriptive information form, PSS: NICU, STAI TX-2 and NICU Parent Belief scale were completed by the researcher during face-to-face interviews with the mother and first saliva samples were taken from mothers. Mothers in the group with supportive nursing interventions completed the PSS:NICU, NICU-Parent Belief Scale and STAI-TX-2 again and had the post-test saliva sample taken when their infants were discharged from the NICU. Supportive and educational nursing interventions about reducing maternal stress levels in the experimental group included the following: the NICU was physically described to mothers on the first day they visited their infants, mothers were introduced to team members, and given information about how to obtain information about their baby, visiting hours and conditions. Special tools and devices required for care like respiratory devices and monitors were described, and information was given about treatment of the neonate and general status. Mothers of neonates with appropriate clinical status were encouraged to touch their baby and hold their hand. Within the rules of the unit mothers were allowed to touch and hold their baby. Introduction to the NICU, informing about the baby and contact between mother and baby was completed within 30-45 minutes duration. As a guide to training, a 35-page "Care of your Baby in the Neonatal Intensive Care Unit" training booklet prepared by the researcher based on stress among families in the intensive care unit was given to mothers and included topics like the NICU environment, features of neonates born prematurely and at term, care, feeding, diseases, treatment methods, stress in the NICU, breastfeeding, preparation for discharge and baby care at home. After the information session on the first visiting day for mothers and babies, seven interactive trainings were held each lasting nearly 90 minutes during the neonate's admission to hospital. During interactive training, power point presentations prepared by the researcher were presented on a large screen in the education salon in the hospital and arranged in two 45-minute sessions allowing mothers to share their experiences, excitement, sadness and worries. Planned nursing interventions were standardised for each mother with a check-list. Mothers were given information training about the NICU environment, features of babies born prematurely and at term, care, feeding, disease, treatment methods, stress in the NICU, breastfeeding, preparation for discharge and baby care at home. The relevant topics were chosen after relevant literature search by the researcher (Konukbay & Arslan, 2011; Lonio et al. 2016; Uludağ & Ünlüoğlu, 2012) and the second author's personal experience with parents of infants in the NICU. In the second session, the researchers gave training about positive thinking, healthy lifestyle, knowing yourself, stress management and relaxation techniques developed in the context of the literature within the scope of supportive nursing interventions for mothers (Nasiri et al., 2018; Nasiri et al., 2018). Mothers were taught the simple but powerful relaxation technique which is easy and can be performed nearly everywhere of deep breathing (diaphragmatic respiration). Each session began with this exercise and they were encouraged to perform it throughout the day. During mothers first visits to their infants, mothers in this group had the mother and neonate descriptive information form, PSS: NICU, STAI TX-2 and NICU Parent Belief scale applied and first saliva samples were taken from mothers. Mothers did not have any other intervention applied by the researchers during routine operation while their infants were in the unit. When their infants were discharged from the NICU, mothers completed the PSS:NICU, NICU-Parent Belief Scale and STAI-TX-2 again and had the post-test saliva sample taken. conditions module condition list condition Stress, Psychological keyword list keyword cortisol mother neonatal intensive care neonate stress supportive intervention design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description This study was a prospective, pre-and post-test randomised controlled trial. design primary purpose Supportive Care design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 85 enrollment type Actual arms interventions module arm group list arm group arm group label supportive interventions group arm group type Experimental arm group description Supportive and educational nursing interventions about reducing maternal stress levels in the experimental group included the following: the NICU was physically described to mothers on the first day they visited their infants, mothers were introduced to team members, and given information about how to obtain information about their baby, visiting hours and conditions. arm group intervention list arm group intervention name Behavioral: Supportive interventions on the stress levels of mothers of infants hospitalized in the Neonatal Intensive Care Unit (NICU). arm group label control group arm group type No Intervention arm group description Mothers did not have any other intervention applied by the researchers during routine operation while their infants were in the unit. intervention list intervention intervention type Behavioral intervention name Supportive interventions on the stress levels of mothers of infants hospitalized in the Neonatal Intensive Care Unit (NICU). intervention description This study was conducted to determine the effects of supportive interventions on the stress levels of mothers of infants hospitalized in the Neonatal Intensive Care Unit (NICU). intervention arm group label list intervention arm group label supportive interventions group outcomes module primary outcome list primary outcome primary outcome measure Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) primary outcome description This scale was developed by Miles, Funk and Carlson (1993) with the aim of determining the perceptions of parents about stressors due to the physical and psychosocial environment in the NICU. The scale uses a 5-point Likert score grading from 1 (not stressful) to 5 (excessively stressful). primary outcome time frame Before the mothers first visits to their infants (the third day). primary outcome measure Neonatal Infant Care Unit Parent Belief Scale (NICU PBS) primary outcome description This scale developed by Melnyk et al. (2014) has three subdimensions (Parental Role Confidence, Parent-Baby Interaction, and Knowledge of the NICU) and includes a total of 18 items. primary outcome time frame Before the mothers first visits to their infants (the third day). primary outcome measure State-Trait Anxiety Scale (STAI TX-2) primary outcome description The scale developed by Spielberger et al. in 1970 was adapted to Turkish with validity and reliability studies completed by Öner and Le Comte in 1983. The scale comprises 40 questions, with 20 questions about state and 20 questions about trait anxiety levels. In the research, 20 questions measuring trait anxiety were used. Expressions on the trait anxiety scale have choices of nearly never (1), sometimes (2), often (3), and nearly all the time (4). Items 21, 26, 27, 39, 33, 36 and 39 are inverse statements. primary outcome time frame Before the mothers first visits to their infants (the third day). primary outcome measure Saliva Cortisol Measurement primary outcome description With the aim of determining cortisol levels in saliva, taking saliva samples with a kit is an easy and non-invasive method that does not cause stress (Kirschbaum & Hellhammer, 1994). Mothers were requested to avoid practices like eating-drinking and chewing gum for 30 minutes before the saliva collection procedure. Saliva samples were collected with special saliva test kits. Cotton from the kit is rotated within the mouth, cheeks and under the tongue for 1-2 minutes or chewed to complete the saliva collection procedure. Immediately after collecting saliva samples, they were centrifuged and stored at -20 degrees before transport to the laboratory. Saliva samples from mothers were taken from 08:00-10:00 in the morning. primary outcome time frame Before the mothers first visits to their infants (the third day). eligibility module eligibility criteria Inclusion Criteria: Being aged between 20-40, having no chronic physical and psychological problems, being literate, no previously receiving training about the care of infants hospitalised in the NICU. Exclusion Criteria: Having a gestational age of <28 and >37 weeks, Having a birth weight of 1500 grams less, healthy volunteers No gender All minimum age 28 Weeks maximum age 37 Weeks std age list std age Child contacts locations module overall official list overall official overall official name Dilek Küçük Alemdar, Phd overall official affiliation T.C. ORDU ÜNİVERSİTESİ overall official role Study Director location list location location facility Dilek alemdar location city Ordu location zip 52000 location country Turkey references module reference list reference reference p m i d 34555952 reference type derived reference citation Yilmaz G, Küçük Alemdar D. The Effect of Supportive Nursing Interventions on Reducing Stress Levels of Mothers of Infants in the Neonatal Intensive Care Unit: A Randomized Controlled Trial. Clin Nurs Res. 2022 Jun;31(5):941-951. doi: 10.1177/10547738211047359. Epub 2021 Sep 24. i p d sharing statement module i p d sharing No i p d sharing description This study was a prospective, pre-and post-test randomised controlled trial. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000013315 condition mesh term Stress, Psychological condition ancestor list condition ancestor condition ancestor id D000001526 condition ancestor term Behavioral Symptoms condition browse leaf list condition browse leaf condition browse leaf id M15257 condition browse leaf name Stress, Psychological condition browse leaf as found Stress, Psychological condition browse leaf relevance high condition browse leaf id M3970 condition browse leaf name Behavioral Symptoms condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M9064 intervention browse leaf name Hydrocortisone intervention browse leaf relevance low intervention browse leaf id M155022 intervention browse leaf name Hydrocortisone 17-butyrate 21-propionate intervention browse leaf relevance low intervention browse leaf id M228602 intervention browse leaf name Hydrocortisone acetate intervention browse leaf relevance low intervention browse leaf id M263157 intervention browse leaf name Hydrocortisone hemisuccinate intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infl intervention browse branch name Anti-Inflammatory Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04830150
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full study rank 61764 study protocol section identification module n c t id NCT04832230 org study id info org study id 2020PBMD02 secondary id info list secondary id info secondary id 2020-A01504-35 secondary id type Other Identifier secondary id domain IDRCB organization org full name Direction Centrale du Service de Santé des Armées org class OTHER brief title Study of Diagnostic Biomarkers of Acute Acoustic Trauma official title Study of Diagnostic Biomarkers of Acute Acoustic Trauma acronym BIOTSA status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 15, 2021 start date type Actual primary completion date struct primary completion date June 15, 2024 primary completion date type Anticipated completion date struct completion date June 15, 2024 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date November 16, 2022 last update post date struct last update post date November 17, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Direction Centrale du Service de Santé des Armées lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Every year, more than two thousand acute acoustic trauma occur in France, equally between the military and the civilian environment. Currently, acute acoustic trauma is a pathology with no specific validated treatment, and it is the cause of many handicapping situations. Improving the future of patients requires a better understanding of the neurophysiological mechanisms of noise-induced hearing impairment. They are multiple and pure tone audiometry, the only reference examination, does not allow to differentiate them. Moreover, in the aftermath of acute acoustic trauma, pure tone audiometry tends to improve spontaneously, but this recovery is misleading, as a number of studies in animals have shown that irreversible lesions remain. The hypothesis of this study is that it is possible to identify new entities, specific to the type of cochlear lesions, in order to clarify the diagnosis of acute acoustic trauma. These entities will be identified by the evaluation of noise-induced hearing impairment via a combination of molecular (proteomic and genomic), physiological and behavioral data. These diagnostic details may then be used to improve prevention or therapy. conditions module condition list condition Acoustic Trauma design module study type Observational patient registry No design info design observational model list design observational model Case-Control design time perspective list design time perspective Prospective enrollment info enrollment count 500 enrollment type Anticipated arms interventions module arm group list arm group arm group label Healthy individuals arm group description This group is composed of healthy individuals without previous noise exposure. arm group intervention list arm group intervention name Other: Hearing test Other: Questionnaire about previous noise exposure Other: Otoacoustic emission measurement Other: Electrocochleography Other: Speech audiometry in noise Other: Multi-frequency impedance measurement Biological: Blood sample collection arm group label Acute acoustic trauma patients arm group description This group is composed of patients suffering from acute acoustic trauma. arm group intervention list arm group intervention name Other: Hearing test Other: Questionnaire about previous noise exposure Other: Otoacoustic emission measurement Other: Electrocochleography Other: Speech audiometry in noise Other: Multi-frequency impedance measurement Other: Assessment of tinnitus severity Biological: Blood sample collection intervention list intervention intervention type Other intervention name Hearing test intervention description The hearing test is composed of several examinations: pure tone audiogram otoscopy tympanometry Healthy individuals: The hearing test will be performed at enrollment (Day 0). Patients: The hearing test will be performed at Day 1, Day 3, Day 7 and Day 30. intervention arm group label list intervention arm group label Acute acoustic trauma patients Healthy individuals intervention type Other intervention name Questionnaire about previous noise exposure intervention description The participant will have to fill in a questionnaire about his/her previous noise exposure at enrollment (Day 0). intervention arm group label list intervention arm group label Acute acoustic trauma patients Healthy individuals intervention type Other intervention name Otoacoustic emission measurement intervention description Healthy individuals: Otoacoustic emission will be measured at enrollment (Day 0). Patients: Otoacoustic emission will be measured at enrollment (Day 0), at Day 1, Day 3, Day 7 and Day 30. intervention arm group label list intervention arm group label Acute acoustic trauma patients Healthy individuals intervention type Other intervention name Electrocochleography intervention description Healthy individuals: Electrocochleography will be performed at enrollment (Day 0). Patients: Electrocochleography will be performed at Day 30. intervention arm group label list intervention arm group label Acute acoustic trauma patients Healthy individuals intervention type Other intervention name Speech audiometry in noise intervention description Healthy individuals: Speech audiometry in noise will performed at enrollment (Day 0). Patients: Speech audiometry in noise will performed at enrollment (Day 0), at Day 1, Day 3, Day 7 and Day 30. intervention arm group label list intervention arm group label Acute acoustic trauma patients Healthy individuals intervention type Other intervention name Multi-frequency impedance measurement intervention description Healthy individuals: Multi-frequency impedance will be measured at enrollment (Day 0). Patients: Multi-frequency impedance will be measured at Day 30. intervention arm group label list intervention arm group label Acute acoustic trauma patients Healthy individuals intervention type Other intervention name Assessment of tinnitus severity intervention description Tinnitus severity will be assessed using a visual analogic scale at enrollment (Day 0), at Day 1, Day 3, Day 7 and Day 30. intervention arm group label list intervention arm group label Acute acoustic trauma patients intervention type Biological intervention name Blood sample collection intervention description Healthy individuals: A blood sample will be collected at enrollment (Day 0). Patients: A blood sample will be collected at enrollment (Day 0), at Day 1, Day 3, Day 7 and Day 30. intervention arm group label list intervention arm group label Acute acoustic trauma patients Healthy individuals outcomes module primary outcome list primary outcome primary outcome measure Identification of diagnostic biomarkers of hearing impairment in patients suffering from acute acoustic trauma primary outcome description Machine learning analyses will be performed on the whole collected data to identify diagnostic biomarkers. primary outcome time frame Through study completion, an average of 3 years eligibility module eligibility criteria Inclusion Criteria: Age between 18 and 40 Healthy individuals: without hearing pathology Patients: acute acoustic trauma diagnosis within 72h Exclusion Criteria: History of hearing pathology History of severe head injury Ototoxic drug therapy Abnormal otoscopy and/or tympanometry healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 40 Years std age list std age Adult study population The study population is composed of healthy individuals who have never been exposed to noise and patients suffering from acute acoustic trauma. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Guillaume ANDEOL, MD, PhD central contact role Contact central contact phone 178651207 central contact phone ext +33 central contact e mail guillaume.andeol@intradef.gouv.fr location list location location facility 102e Antenne Médicale location status Recruiting location city Angoulême location zip 16021 location country France location contact list location contact location contact name Jérémy LE BOHEC, MD location contact role Contact location contact phone 545224222 location contact phone ext +33 location contact e mail jeremy.le-bohec@intradef.gouv.fr location facility 38e Antenne Médicale location status Recruiting location city Bitche location zip 57230 location country France location contact list location contact location contact name Amandine BERCHER, MD location contact role Contact location contact phone 387063214 location contact phone ext +33 location contact e mail amandine.bercher@intradef.gouv.fr location facility Hôpital d'Instruction des Armées Clermont-Tonnerre location status Recruiting location city Brest location zip 29240 location country France location contact list location contact location contact name Alexis MAFFERT, MD location contact role Contact location contact phone 298437428 location contact phone ext +33 location contact e mail alexis.maffert@intradef.gouv.fr location facility Laboratoire mobile d'Audition de l'Institut de Recherche Biomédicale des Armées location status Recruiting location city Brétigny-sur-Orge location zip 91223 location country France location contact list location contact location contact name Guillaume ANDEOL, MD, PhD location contact role Contact location contact phone 178651207 location contact phone ext +33 location contact e mail guillaume.andeol@intradef.gouv.fr location facility 171e Antenne Médicale location status Recruiting location city Caylus location zip 82160 location country France location contact list location contact location contact name Gwenaëlle DEMONT, MD location contact role Contact location contact phone 563245100 location contact phone ext +33 location contact e mail gwenaelle.demont@intradef.gouv.fr location facility Hôpital d'Instruction des Armées Percy location status Recruiting location city Clamart location zip 92140 location country France location contact list location contact location contact name Salomé MARTY, MD location contact role Contact location contact e mail salome.marty@intradef.gouv.fr location facility 41e Antenne Médicale location status Recruiting location city Dieuze location zip 57260 location country France location contact list location contact location contact name Sara CHERRIER, MD location contact role Contact location contact phone 387058959 location contact phone ext +33 location contact e mail sara.cherrier@intradef.gouv.fr location facility 123e Antenne Médicale location status Recruiting location city Guer location zip 56381 location country France location contact list location contact location contact name Aurélie MAILLE, MD location contact role Contact location contact phone 290404072 location contact phone ext +33 location contact e mail aurelie.maille@intradef.gouv.fr location facility Hôpital d'Instruction des Armées Laveran location status Recruiting location city Marseille location zip 13013 location country France location contact list location contact location contact name Pauline PODEUR, MD location contact role Contact location contact phone 491617265 location contact phone ext +33 location contact e mail pauline.podeur@intradef.gouv.fr location facility 13e Antenne Médicale location status Recruiting location city Montlhéry location zip 91310 location country France location contact list location contact location contact name Lenaig LE VOT, MD location contact role Contact location contact phone 164923589 location contact phone ext +33 location contact e mail lenaig.le-vot@intradef.gouv.fr location facility 109e Antenne Médicale location status Recruiting location city Saint-Maixent-l'École location zip 79400 location country France location contact list location contact location contact name Sylviane DE WILDE, MD location contact role Contact location contact phone 549765385 location contact phone ext +33 location contact e mail sylviane.de-wilde@intradef.gouv.fr location facility 43e Antenne Médicale location status Recruiting location city Sarrebourg location zip 57404 location country France location contact list location contact location contact name Sébastien MUTIN, MD location contact role Contact location contact phone 387234564 location contact phone ext +33 location contact e mail sebastien.mutin@intradef.gouv.fr location facility Hôpital d'Instruction des Armées Sainte-Anne location status Not yet recruiting location city Toulon location zip 83000 location country France location contact list location contact location contact name Damien RIVIERE, MD location contact role Contact location contact phone 483162584 location contact phone ext +33 location contact e mail damien.riviere@intradef.gouv.fr location facility 60e Antenne Médicale location status Recruiting location city Valdahon location zip 25800 location country France location contact list location contact location contact name Jordan LACHAUX, MD location contact role Contact location contact phone 381267413 location contact phone ext +33 location contact e mail jordan.lachaux@intradef.gouv.fr i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006317 condition mesh term Hearing Loss, Noise-Induced condition mesh id D000014947 condition mesh term Wounds and Injuries condition ancestor list condition ancestor condition ancestor id D000006319 condition ancestor term Hearing Loss, Sensorineural condition ancestor id D000034381 condition ancestor term Hearing Loss condition ancestor id D000006311 condition ancestor term Hearing Disorders condition ancestor id D000004427 condition ancestor term Ear Diseases condition ancestor id D000010038 condition ancestor term Otorhinolaryngologic Diseases condition ancestor id D000012678 condition ancestor term Sensation Disorders condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf as found Trauma condition browse leaf relevance high condition browse leaf id M23573 condition browse leaf name Hearing Loss condition browse leaf relevance low condition browse leaf id M5992 condition browse leaf name Deafness condition browse leaf relevance low condition browse leaf id M8558 condition browse leaf name Hearing Loss, Noise-Induced condition browse leaf as found Acoustic Trauma condition browse leaf relevance high condition browse leaf id M8559 condition browse leaf name Hearing Loss, Sensorineural condition browse leaf relevance low condition browse leaf id M8552 condition browse leaf name Hearing Disorders condition browse leaf relevance low condition browse leaf id M6753 condition browse leaf name Ear Diseases condition browse leaf relevance low condition browse leaf id M12113 condition browse leaf name Otorhinolaryngologic Diseases condition browse leaf relevance low condition browse leaf id M14642 condition browse leaf name Sensation Disorders condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC09 condition browse branch name Ear, Nose, and Throat Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04832230
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full study rank 61508 study protocol section identification module n c t id NCT04835558 org study id info org study id 29713 organization org full name Istanbul University org class OTHER brief title Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome official title Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome; Evaluation by Incremental Load Test status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date February 5, 2018 start date type Actual primary completion date struct primary completion date November 5, 2018 primary completion date type Actual completion date struct completion date January 24, 2019 completion date type Actual study first submit date March 28, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 4, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Goksen Kuran Aslan responsible party investigator title Assoc. Prof. responsible party investigator affiliation Istanbul University-Cerrahpasa lead sponsor lead sponsor name Istanbul University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Obesity hypoventilation syndrome (OHS) is defined as a combination of obesity [body mass index (BMI) ≥30 kg/m2], chronic daytime hypercapnia (PaCO2 >45 mm Hg), and sleep-apnea in the absence of other known causes of hypercapnia. Respiratory system compliance decreases and resistance increases in OHS. This causes increase in work of breathing and oxygen cost of breathing, which may result in respiratory muscle fatigue. Increase in respiratory workload and increase in resistance to respiration is expected to decrease in respiratory muscle endurance (RME) in subjects with OHS. detailed description In the literature, studies evaluating RME in subjects with OHS are limited. No study has been found to evaluate RME using the incremental load test in subjects with OHS. Accordingly, it was aimed to evaluate and compare respiratory muscle endurance in subjects with OHS and a control group, and to determine factors associated with respiratory muscle endurance. conditions module condition list condition Obesity Hypoventilation Syndrome (OHS) keyword list keyword Respiratory Muscle Endurance Sleep Fatigue Quality of Life design module study type Observational patient registry No design info design observational model list design observational model Case-Control design time perspective list design time perspective Prospective enrollment info enrollment count 60 enrollment type Actual arms interventions module arm group list arm group arm group label Group I arm group description Subjects with obesity hypoventilation sydrome (30 < body mass index < 40 kg/m2) arm group label Group II arm group description Subjects with obesity hypoventilation sydrome (body mass index > 40 kg/m2) arm group label Control Group arm group description Age and sex-matched obese subjects (30 < body mass index < 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score < 3) outcomes module primary outcome list primary outcome primary outcome measure Incremental load test primary outcome description Respiratory muscle endurance was evaluated by incremental load test. The incremental load test was performed using the electronic inspiratory loading device (PowerBreathe®-KHP2). primary outcome time frame 1 day secondary outcome list secondary outcome secondary outcome measure Mouth pressure measurements secondary outcome description Respiratory muscle strength was measured using mouth pressure measurements (Micro Medical MicroRPM). secondary outcome time frame 1 day secondary outcome measure 6 minute walk test secondary outcome description The 6 minute walk test was used to evaluate the functional exercise capacity of the subjects. secondary outcome time frame 1 day secondary outcome measure Epworth Sleepiness Scale secondary outcome description Excessive daytime sleepiness was assessed with the Epworth Sleepiness Scale. A score of >10 accepted as daytime sleepiness. secondary outcome time frame 1 day secondary outcome measure Pittsburg Sleep Quality Index secondary outcome description Sleep quality was assessed with the Pittsburg Sleep Quality Index. The total score were interpreted as follows: 0-5 indicated good sleep quality, > 5 indicated poor sleep quality, and >10 indicated the presence of a sleep disorder. secondary outcome time frame 1 day secondary outcome measure Fatigue Severity Scale secondary outcome description Fatigue severity was assessed with the Fatigue Severity Scale. This seven-likert scale was used for each item and final score was accepted as mean value of the 9 items. The higher scores indicated higher fatigue severity. secondary outcome time frame 1 day secondary outcome measure EQ-5D Health-Related Quality of Life Questionnaire secondary outcome description Quality of life was assessed with the EQ-5D Health-Related Quality of Life Questionnaire. The maximum score of 1 indicates the best health state, and higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status in which 100 indicates the best health status. secondary outcome time frame 1 day secondary outcome measure Obesity and Weight Loss Quality of Life Instrument secondary outcome description Quality of life specific to obesity was assessed with the Obesity and Weight Loss Quality of Life Instrument. As the total score from the scale approaches 0, the quality of life decreases, and as it approaches 100, the quality of life increases. secondary outcome time frame 1 day eligibility module eligibility criteria Inclusion Criteria: Diagnosed with OHS Obese subjects (30 < body mass index < 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score < 3) Exclusion Criteria: Severe respiratory disease Subjects with orthopeadic and/or neurologic disorders that could limit exercise tests healthy volunteers No gender All minimum age 24 Years maximum age 69 Years std age list std age Adult Older Adult study population All subjects who had polysomnography performed in the sleep laboratory and were diagnosed with OHS were screened. Age and sex-matched obese subjects (30 < body mass index < 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score < 3) included in the study as the control group. sampling method Probability Sample contacts locations module location list location location facility Istanbul University location city Istanbul location country Turkey derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007040 condition mesh term Hypoventilation condition mesh id D000010845 condition mesh term Obesity Hypoventilation Syndrome condition mesh id D000009765 condition mesh term Obesity condition mesh id D000013577 condition mesh term Syndrome condition ancestor list condition ancestor condition ancestor id D000004194 condition ancestor term Disease condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000044343 condition ancestor term Overnutrition condition ancestor id D000009748 condition ancestor term Nutrition Disorders condition ancestor id D000050177 condition ancestor term Overweight condition ancestor id D000001835 condition ancestor term Body Weight condition ancestor id D000012131 condition ancestor term Respiratory Insufficiency condition ancestor id D000012120 condition ancestor term Respiration Disorders condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition ancestor id D000012818 condition ancestor term Signs and Symptoms, Respiratory condition ancestor id D000020181 condition ancestor term Sleep Apnea, Obstructive condition ancestor id D000012891 condition ancestor term Sleep Apnea Syndromes condition ancestor id D000001049 condition ancestor term Apnea condition ancestor id D000020919 condition ancestor term Sleep Disorders, Intrinsic condition ancestor id D000020920 condition ancestor term Dyssomnias condition ancestor id D000012893 condition ancestor term Sleep Wake Disorders condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf as found Syndrome condition browse leaf relevance high condition browse leaf id M11853 condition browse leaf name Obesity condition browse leaf as found Obesity condition browse leaf relevance high condition browse leaf id M7516 condition browse leaf name Fatigue condition browse leaf relevance low condition browse leaf id M9242 condition browse leaf name Hypoventilation condition browse leaf as found Hypoventilation condition browse leaf relevance high condition browse leaf id M12892 condition browse leaf name Obesity Hypoventilation Syndrome condition browse leaf as found Obesity Hypoventilation Syndrome condition browse leaf relevance high condition browse leaf id M24460 condition browse leaf name Overnutrition condition browse leaf relevance low condition browse leaf id M11836 condition browse leaf name Nutrition Disorders condition browse leaf relevance low condition browse leaf id M25339 condition browse leaf name Overweight condition browse leaf relevance low condition browse leaf id M4266 condition browse leaf name Body Weight condition browse leaf relevance low condition browse leaf id M14120 condition browse leaf name Respiratory Insufficiency condition browse leaf relevance low condition browse leaf id M14109 condition browse leaf name Respiration Disorders condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id M14775 condition browse leaf name Signs and Symptoms, Respiratory condition browse leaf relevance low condition browse leaf id M3513 condition browse leaf name Apnea condition browse leaf relevance low condition browse leaf id M14846 condition browse leaf name Sleep Apnea Syndromes condition browse leaf relevance low condition browse leaf id M21163 condition browse leaf name Sleep Apnea, Obstructive condition browse leaf relevance low condition browse leaf id M21395 condition browse leaf name Parasomnias condition browse leaf relevance low condition browse leaf id M21807 condition browse leaf name Sleep Disorders, Intrinsic condition browse leaf relevance low condition browse leaf id M21808 condition browse leaf name Dyssomnias condition browse leaf relevance low condition browse leaf id M14848 condition browse leaf name Sleep Wake Disorders condition browse leaf relevance low condition browse leaf id T6034 condition browse leaf name Quality of Life condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders
NCT04835558
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full study rank 61567 study protocol section identification module n c t id NCT04834791 org study id info org study id CCR organization org full name Tanta University org class OTHER brief title Letrozole Versus Gonadotropins in Clomiphene Citrate Resistance official title Letrozole Versus Gonadotropins for Ovulation Induction in Clomiphene Citrate Resistance: A Randomized Controlled Study status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date March 1, 2019 start date type Actual primary completion date struct primary completion date October 31, 2019 primary completion date type Actual completion date struct completion date October 31, 2019 completion date type Actual study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 4, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ayman S Dawood, MD responsible party investigator title Assistant professor responsible party investigator affiliation Tanta University lead sponsor lead sponsor name Tanta University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Clomiphene citrate resistance (CCR) occur in 15-40% in women with PCOS. Several studies have shown that letrozole is superior to CC regarding side effects, ovulation, and pregnancy rates. Letrozole or gonadotropins use for ovulation induction in CCR is not well established which is superior and most safe. detailed description This study included 70 patients enrolled according inclusion and exclusion criteria. The inclusion criteria were (a) Infertility lasting one year or more in presence of regular intercourse, (b) Patients' age between 20-35years (c) Normal semen analysis according to WHO 2010 (d) Patent fallopian tubes (e) Normal prolactin and TSH. (e) Anovulatory cycles confirmed by mid-luteal progesterone ≤ 3 ng/ml and (f) Clomiphene citrate resistance for 3 cycles of 150mg. Exclusion Criteria were (a) Any hormonal disturbances eg. hyperprolactinemia, (b) Immunological causes of infertility, (c) Coital errors, (d) Metabolic disorders and (e) Poor patient compliance. Sample size calculation: The minimum sample size calculated using Epi info program version 7 for unmatched case control study; 80% power and 95% Confidence interval was 22 for each group. For better accuracy and validity of results the sample size was increased by 10%=3 in each group. The total number of cases was 50 and 25 for each group. Randomization and allocation: It was a prospective quesi-randomization. Based on the attendance order, patients with odd numbers were considered group I (Letrozole group) and those with even numbers were considered group II (Gonadotropin group). Allocation was equal 1:1. Intervention: Group I (Letrozole Group n=25): These patients were treated with letrozole (Femara®, Novartis New York, NY, USA) in a dose 2.5 mg (one tablet daily) orally began on the 3rd day to the 7th day of the cycle. If ovulation is not achieved dose is increased by 2.5 mg in next cycle till 3 cycles. If hyperstimulation occurred, the cycle was cancelled and the patients were excluded from the study. Group II (Gonadotropin Group n=25) These patients were given urofollitropin (fostimon ®, IBSA, Lugano, Switzerland) in a dose of 75 IU/mL I.M from day 3rd to day 7th of the cycle beginning by one ampoule per day and the dose had been modulated according to response. If hyperstimulation occurred, the cycle was cancelled and the patients were excluded from the study. Methods: Proper history taking including age, gravidity, parity, infertility duration, history of laparoscopic surgery, previous induction of ovulation in the last 6 months. Examination was done to assess weight, height (BMI), signs of androgen excess, thyroid gland and breast examination. Serum FSH, LH, testosterone level, prolactin level and thyroid stimulating hormone on day 3 of spontaneous menstrual cycle were done. Serum Progesterone (P4) was done on day 22 (midluteal) to confirm ovulation if ≥ 10ng/ml. Basal transvaginal U/S on day3 of the cycle to detect criteria of PCOS and count number of antral follicles in both ovaries and to exclude of any basal ovarian cyst. Transvaginal ultrasound was also used to follow follicular growth and endometrial thickness starting on day 8 and then every other day till assuming good ovulatory response when one or more follicles is ≥ 18mm and endometrial thickness ≥ 6mm. Human Chorionic Gonadotropin (choriomon®, IBSA, Lugano, Switzerland) 10.000IU/I.M was administered when good ovulatory response was assumed. The intercourse was advised on the day of HCG injection and every other day for 4 days after injection HCG. Number and size of Dominant follicles, endometrial thickness were recorded. Clinical pregnancy was detected by serum pregnancy test and by presence of intrauterine gestational sac with fetal pulsation. Outcome measures: Primary outcomes was ovulation rate. Secondary outcomes were pregnancy rate. conditions module condition list condition Clomiphene Citrate Resistance Ovulation Induction Letrozole Gonadotropins design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 70 enrollment type Actual arms interventions module arm group list arm group arm group label Letrozole arm group type Experimental arm group description These patients were treated with letrozole (Femara®, Novartis New York, NY, USA) in a dose 2.5 mg (one tablet daily) orally began on the 3rd day to the 7th day of the cycle. If ovulation is not achieved dose is increased by 2.5 mg in next cycle till 3 cycles. arm group intervention list arm group intervention name Drug: Letrozole 2.5mg arm group label Gonadotropins arm group type Active Comparator arm group description These patients were given urofollitropin (fostimon ®, IBSA, Lugano, Switzerland) in a dose of 75 IU/mL I.M from day 3rd to day 7th of the cycle beginning by one ampoule per day and the dose had been modulated according to response. arm group intervention list arm group intervention name Drug: Gonadotropin intervention list intervention intervention type Drug intervention name Letrozole 2.5mg intervention description These patients were treated with letrozole (Femara®, Novartis New York, NY, USA) in a dose 2.5 mg (one tablet daily) orally began on the 3rd day to the 7th day of the cycle. If ovulation is not achieved dose is increased by 2.5 mg in next cycle till 3 cycles intervention arm group label list intervention arm group label Letrozole intervention type Drug intervention name Gonadotropin intervention description These patients were given urofollitropin (fostimon ®, IBSA, Lugano, Switzerland) in a dose of 75 IU/mL I.M from day 3rd to day 7th of the cycle beginning by one ampoule per day and the dose had been modulated according to response. intervention arm group label list intervention arm group label Gonadotropins outcomes module primary outcome list primary outcome primary outcome measure Ovulation rate primary outcome description Number of mature follicles in each ovary>18mm primary outcome time frame 6 months secondary outcome list secondary outcome secondary outcome measure Pregnancy rate secondary outcome description Number of pregnant women evidenced by serum HCG and gestational sac inside the uterus secondary outcome time frame 6 months eligibility module eligibility criteria Inclusion Criteria: Infertility lasting one year or more in presence of regular intercourse, Patients' age between 20-35years Normal semen analysis according to WHO 2010 Patent fallopian tubes (e) Normal prolactin and TSH. Anovulatory cycles confirmed by mid-luteal progesterone ≤ 3 ng/ml and Clomiphene citrate resistance for 3 cycles of 150mg. Exclusion Criteria: Any hormonal disturbances eg. hyperprolactinemia, Immunological causes of infertility, Coital errors, Metabolic disorders and Poor patient compliance. healthy volunteers No gender Female minimum age 20 Years maximum age 35 Years std age list std age Adult contacts locations module overall official list overall official overall official name Ayman Dawood, MD overall official affiliation Assistant professor overall official role Principal Investigator location list location location facility Ayman Shehata Dawood location city Tanta location state Gharbia location zip 31111 location country Egypt i p d sharing statement module i p d sharing Yes i p d sharing description on request i p d sharing info type list i p d sharing info type Study Protocol i p d sharing time frame 3 months derived section misc info module version holder December 02, 2022 intervention browse module intervention mesh list intervention mesh intervention mesh id D000077289 intervention mesh term Letrozole intervention ancestor list intervention ancestor intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000047072 intervention ancestor term Aromatase Inhibitors intervention ancestor id D000065088 intervention ancestor term Steroid Synthesis Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000004965 intervention ancestor term Estrogen Antagonists intervention ancestor id D000006727 intervention ancestor term Hormone Antagonists intervention ancestor id D000006730 intervention ancestor term Hormones, Hormone Substitutes, and Hormone Antagonists intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M1743 intervention browse leaf name Letrozole intervention browse leaf as found Non-Small Cell Lung Cancer intervention browse leaf relevance high intervention browse leaf id M20473 intervention browse leaf name Citric Acid intervention browse leaf relevance low intervention browse leaf id M1837 intervention browse leaf name Sodium Citrate intervention browse leaf relevance low intervention browse leaf id M239056 intervention browse leaf name Lactitol intervention browse leaf relevance low intervention browse leaf id M5380 intervention browse leaf name Clomiphene intervention browse leaf relevance low intervention browse leaf id M29514 intervention browse leaf name Enclomiphene intervention browse leaf relevance low intervention browse leaf id M29515 intervention browse leaf name Zuclomiphene intervention browse leaf relevance low intervention browse leaf id M24922 intervention browse leaf name Aromatase Inhibitors intervention browse leaf relevance low intervention browse leaf id M7268 intervention browse leaf name Estrogens intervention browse leaf relevance low intervention browse leaf id M7266 intervention browse leaf name Estrogen Antagonists intervention browse leaf relevance low intervention browse leaf id M29636 intervention browse leaf name Estrogen Receptor Antagonists intervention browse leaf relevance low intervention browse leaf id M8941 intervention browse leaf name Hormones intervention browse leaf relevance low intervention browse leaf id M8940 intervention browse leaf name Hormone Antagonists intervention browse leaf relevance low intervention browse leaf id T382 intervention browse leaf name Citrate intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev AnCoag intervention browse branch name Anticoagulants intervention browse branch abbrev Gast intervention browse branch name Gastrointestinal Agents intervention browse branch abbrev Repr intervention browse branch name Reproductive Control Agents intervention browse branch abbrev Ot intervention browse branch name Other Dietary Supplements
NCT04834791
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full study rank 61348 study protocol section identification module n c t id NCT04837638 org study id info org study id FH-CAC (MP-20-2021-5767) organization org full name Laval University org class OTHER brief title Diet Quality and Coronary Artery Calcification in Adults With Heterozygous Familial Hypercholesterolemia official title Diet Quality and Coronary Artery Calcification in Adults With Heterozygous Familial Hypercholesterolemia acronym FH-CAC status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date July 1, 2021 start date type Actual primary completion date struct primary completion date December 1, 2022 primary completion date type Anticipated completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 22, 2022 last update post date struct last update post date April 29, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Jean-Philippe Drouin-Chartier responsible party investigator title Professor responsible party investigator affiliation Laval University lead sponsor lead sponsor name Laval University lead sponsor class OTHER collaborator list collaborator collaborator name Centre de Recheche du Centre Hospitalier Université Laval collaborator class OTHER collaborator name Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The overarching objective is to evaluate the relationship between diet and coronary artery calcification in patients with heterozygous familial hypercholesterolemia (HeFH). We will recruit adults with HeFH. They will have to complete questionnaires on diet, medication and lifestyle. Coronary artery calcification will be measured in each patient using a CT scan. Physiological and biochemical data will be collected. detailed description The proposed research will deploy as cross-sectional study including treated adults with genetically-defined HeFH. Once recruited, participants will be asked to complete web-based questionnaires on diet, medication and lifestyle. They will thereafter complete a clinical assessment at the Clinical Investigation Unit of the NUTRISS-INAF Research Centre. Study staff will measure participants' height, weight, and waist circumference. Participants' blood pressure will be measured using an automatic blood pressure monitor (BP Thru, Omron) after sitting quietly for 10 minutes. Three sequential readings will be taken with three minutes between readings. Fasting blood samples (10 mL) will be collected from an antecubital vein. Body composition will be assessed with dual-energy X-ray absorptiometry (DEXA). Finally, participants will be asked to provide the full list of medication they are using, including type, dose and duration of use. Later on the same day, participants will undergo the non-contrast CT scan at the Quebec Heart and Lung Institute. Multidetector CT scans without contrast will be performed using a 256 slices helical scanner (Brilliance iCT, Philips). conditions module condition list condition Hypercholesterolemia, Familial Calcification; Heart Diet Habit design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Cross-Sectional bio spec bio spec retention Samples Without DNA bio spec description Serum and plasma. enrollment info enrollment count 258 enrollment type Anticipated arms interventions module arm group list arm group arm group label Adults with HeFH arm group description Adult men and women aged 18 to 65 years with genetically-defined HeFH. arm group intervention list arm group intervention name Behavioral: Diet intervention list intervention intervention type Behavioral intervention name Diet intervention description No intervention. Cross-section assessment of the relationship between diet, medication, lifestyle and coronary artery calcification. intervention arm group label list intervention arm group label Adults with HeFH outcomes module primary outcome list primary outcome primary outcome measure Relationship between diet quality and coronary artery calcification (CAC) primary outcome description Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Higher scores reflect higher diet quality, except for the uPDI which reflect lower diet quality. CAC will be measured using non-constrat CT scan. CAC scores will be quantified with the Agatston scoring method. Higher CAC scores reflect higher CAC. primary outcome time frame Diet questionnaire completion and CAC measurement will be completed with a 3 weeks period. secondary outcome list secondary outcome secondary outcome measure Relationship between diet quality and LDL-cholesterol. secondary outcome description Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Higher scores reflect higher diet quality, except for the uPDI which reflect lower diet quality. LDL-cholesterol will be measured using standard procedures from the fasting blood sample collected on the same day of the CT-scan. secondary outcome time frame Diet questionnaire completion and CVD risk factor measurement will be completed with a 3 weeks period. secondary outcome measure Relationship between diet quality and Lipoprotein (a). secondary outcome description Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Higher scores reflect higher diet quality, except for the uPDI which reflect lower diet quality. Lipoprotein (a) will be measured using standard procedures from the fasting blood sample collected on the same day of the CT-scan. secondary outcome time frame Diet questionnaire completion and CVD risk factor measurement will be completed with a 3 weeks period. secondary outcome measure Relationship between diet quality and intuitive eating. secondary outcome description Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Higher scores reflect higher diet quality, except for the uPDI which reflect lower diet quality. Intuitive eating will be measured using the Intuitive Eating Scale. secondary outcome time frame Diet questionnaire completion and psychological aspects of eating measurement will be completed with a 3 weeks period. secondary outcome measure Relationship between diet quality and physical activity secondary outcome description Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Physical activity will be assessed using the Godin physical activity questionnaire. secondary outcome time frame Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period. secondary outcome measure Relationship between diet quality and sleep. secondary outcome description Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Sleep will be assessed using the Pittsburgh Sleep Quality Index. secondary outcome time frame Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period. secondary outcome measure Relationship between diet quality and substance use. secondary outcome description Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). substance use will be assessed in a self-reported fashion using a questionnaire. secondary outcome time frame Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period. secondary outcome measure Relationship between diet quality and alcohol consumption. secondary outcome description Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Alcohol consumption will be assessed from the food frequency questionnaire. secondary outcome time frame Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period. secondary outcome measure Relationship between diet quality and medication adherence. secondary outcome description Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Medication adherence will be assessed using the Medication Adherence Report Scale. secondary outcome time frame Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period. eligibility module eligibility criteria Inclusion Criteria: - Genetically-defined heterozygous familial hypercholesterolemia Exclusion criteria: Homozygous FH Personal history of cardiovascular disease Personal history of cancer healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 99 Years std age list std age Adult Older Adult study population Adult men and women with genetically-defined HeFH sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Jean-Philippe Drouin-Chartier central contact role Contact central contact phone 418-656-2131 central contact phone ext 404072 central contact e mail jean-philipe.drouin-chartier@pha.ulaval.ca central contact name Valérie Guay central contact role Contact central contact phone 418-656-2131 central contact phone ext 404005 central contact e mail valerie.guay@fsaa.ulaval.ca overall official list overall official overall official name Jean-Philippe Drouin-Chartier overall official affiliation Laval University overall official role Study Director overall official name Jean-Philippe Drouin-Chartier overall official affiliation Laval University overall official role Principal Investigator location list location location facility Institute of nutrition and functional foods, Laval University location status Recruiting location city Québec location zip G1V0A6 location country Canada location contact list location contact location contact name Valérie Guay location contact role Contact location contact phone 418-656-2131 location contact phone ext 404005 location contact e mail valerie.guay@fsaa.ulaval.ca location contact name Jean-Philippe Drouin-Chartier location contact role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006938 condition mesh term Hyperlipoproteinemia Type II condition mesh id D000006937 condition mesh term Hypercholesterolemia condition mesh id D000002114 condition mesh term Calcinosis condition ancestor list condition ancestor condition ancestor id D000006949 condition ancestor term Hyperlipidemias condition ancestor id D000050171 condition ancestor term Dyslipidemias condition ancestor id D000052439 condition ancestor term Lipid Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000002128 condition ancestor term Calcium Metabolism Disorders condition ancestor id D000008052 condition ancestor term Lipid Metabolism, Inborn Errors condition ancestor id D000008661 condition ancestor term Metabolism, Inborn Errors condition ancestor id D000030342 condition ancestor term Genetic Diseases, Inborn condition ancestor id D000006951 condition ancestor term Hyperlipoproteinemias condition browse leaf list condition browse leaf condition browse leaf id M9140 condition browse leaf name Hypercholesterolemia condition browse leaf as found Hypercholesterolemia condition browse leaf relevance high condition browse leaf id M4529 condition browse leaf name Calcinosis condition browse leaf as found Calcification condition browse leaf relevance high condition browse leaf id M9152 condition browse leaf name Hyperlipidemias condition browse leaf relevance low condition browse leaf id M9154 condition browse leaf name Hyperlipoproteinemias condition browse leaf relevance low condition browse leaf id M9141 condition browse leaf name Hyperlipoproteinemia Type II condition browse leaf as found Hypercholesterolemia, Familial condition browse leaf relevance high condition browse leaf id M25334 condition browse leaf name Dyslipidemias condition browse leaf relevance low condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M26182 condition browse leaf name Lipid Metabolism Disorders condition browse leaf relevance low condition browse leaf id M4543 condition browse leaf name Calcium Metabolism Disorders condition browse leaf relevance low condition browse leaf id M10793 condition browse leaf name Metabolism, Inborn Errors condition browse leaf relevance low condition browse leaf id M10206 condition browse leaf name Lipid Metabolism, Inborn Errors condition browse leaf relevance low condition browse leaf id M22839 condition browse leaf name Genetic Diseases, Inborn condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth
NCT04837638
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full study rank 61843 study protocol section identification module n c t id NCT04831203 org study id info org study id METC 20-092 organization org full name Maastricht University Medical Center org class OTHER brief title NWT-03 and Brain Function official title An Egg-protein Hydrolysate (NWT-03) to Boost Brain Function - Mind Your Blood Vessels status module status verified date August 2022 overall status Completed expanded access info has expanded access No start date struct start date April 23, 2021 start date type Actual primary completion date struct primary completion date October 24, 2022 primary completion date type Actual completion date struct completion date October 24, 2022 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date November 8, 2022 last update post date struct last update post date November 9, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Maastricht University Medical Center lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Age-related chronic diseases including dementia, type II diabetes mellitus (T2DM) and cardiovascular disease (CVD) become more prevalent and of increasing societal concern. Common denominators of these co-morbidities are insulin-resistance and impaired vascular function. Animal and short-term human studies now suggest that NWT-03 - an egg-protein hydrolysate - improves insulin-sensitivity and peripheral vascular function, which are risk markers for the development of T2DM and CVD. Insulin-resistance is also associated with cognitive decline, while impaired brain vascular function is an important event preceding the development of impaired cognitive performance. The investigators have already shown in a shorter-term trial (12 weeks) beneficial effects of a daily dose of 5.0 g of NWT-03 on cognitive performance. However, underlying mechanisms have not yet been addressed, while the long-term effects remain unknown. Thus, the investigators now hypothesize that NWT-03 beneficially affects cognitive performance and brain vascular function following long-term daily intake. The primary objectives of this trial are to evaluate in overweight or obese adults (aged 60-75) with subjective cognitive decline (SCD) the effects of a 36-weeks NWT-03 intervention on (1) cognitive performance using a neurophysiological test battery, and (2) cerebral blood flow, as quantified by the current non-invasive gold standard magnetic resonance imaging (MRI) perfusion method Arterial Spin Labeling (ASL). Secondary study objectives are to examine effects on insulin-sensitivity and peripheral vascular function. This intervention study will have a randomized, controlled, parallel design. The total study duration will be 36 weeks. Forty-four older adults (aged 60-75 years) with a Body Mass Index (BMI) between 25-35 kg/m2 (overweight or obese) and subjective cognitive decline (SCD), as assessed with the cognitive failure questionnaire, will participate. These study individuals are known to be at increased risk of cognitive impairment, allowing for improvement by the intervention. During the study, subjects will receive daily (in the morning) 5.0 g NWT-03 or placebo powders for 36 weeks. detailed description Due to the aging population, the number of people with cognitive impairment will have doubled by the year 2035. Also, the number of individuals with type-2 diabetes mellitus (T2DM) and cardiovascular disease (CVD) will have increased substantially. Common denominators of these age-related co-morbidities in humans are insulin-resistance and an impaired vascular function. Newtricious (NWT)-03 is a novel dietary egg-protein hydrolysate that has proven benefits on glucose and insulin metabolism, as the investigators have recently shown in overweight or obese individuals with T2DM or impaired glucose tolerance. Furthermore, peripheral vascular function was improved. The potential explanation of these effects may arise from the finding that NWT-03 blocks the enzyme dipeptidyl peptidase (DPP)-IV (7) - a pharmaceutical target for the treatment of T2DM and CVD - that beneficially affects insulin metabolism. Compared to the wealth of knowledge about the impact of insulin-sensitivity and peripheral vascular function on the risk of T2DM and CVD, emerging evidence also indicates that these risk markers affect cognitive performance. This is of great interest, since the brain is an insulin sensitive organ and insulin-resistance is associated with cognitive decline, while impaired brain vascular function is a key pathophysiological event preceding the development of an impaired cognitive performance. A study in mice also showed effects of NWT-03 on neuro-inflammation and oxidative stress in the brain. In fact, a decreased expression of TNF-α and improved expression of enzymes involved in anti-oxidative processes were observed. The investigators have also shown in a similar - but shorter-term (12 weeks) - trial beneficial effects of NWT-03 on executive function, as the latency of response was reduced (manuscripts in preparation). In addition, the hen egg-white hydrolysate (i.e. LumiVida) also improved reaction time in middle-aged women. Underlying mechanisms of these hydrolysates on cognitive performance were however not addressed. In our review the investigators summarized the impact of dietary factors and exercise on brain vascular function in adults and discussed the relation between these effects with changes in cognitive performance. It was concluded that studies on the longer-term effects of lifestyle factors, including diet and physical exercise, can improve brain vascular function, which may contribute to the beneficial effects observed on cognitive performance. In addition, longer-term effects remain unknown and only a limited number of parameters related to cognitive performance were studied. Therefore, the investigators propose to perform a long-term placebo-controlled double blind intervention study including functional outcome parameters and study in vivo effects of NWT-03 on brain vascular function, which is a potential target to prevent or slow-down cognitive impairments, and improve cognitive performance. Focus will be on older adults (aged 60-75 years) with a Body Mass Index (BMI) between 25-35 kg/m2 (overweight or obese) and subjective cognitive decline (SCD), as assessed with the cognitive failure questionnaire. These individuals are known to be at increased risk of cognitive impairment, allowing for improvement by the intervention. Secondary study endpoints are effects on insulin-sensitivity and peripheral vascular function, which are risk markers that may affect cognitive performance. Finally, the investigators will focus on other potential mechanisms underlying effects on brain function (i.e. ambulatory blood pressure, structural brain status, humoral factors, and the more conventional cardiometabolic risk markers) and other perceivable benefits, including general well-being (quality of life, sleep characteristics and mood) and physical fitness. Effects will be investigated using innovative and emerging non-invasive brain magnetic resonance imaging (MRI)-perfusion methods, while focusing on whole brain and cognitive-control brain areas plus cognitive performance tests. Furthermore, the investigators have reviewed that cerebral blood flow in gray matter is a sensitive and straightforward marker of brain vascular function, which correlates with cognitive performance. Of note, lower cerebral blood flow is associated with accelerated cognitive decline and increased risk of dementia in the general population based on results of the Rotterdam prospective cohort study. Cerebral blood flow changes will be quantified on a Siemens 3 Tesla Magnetom Prisma Fit scanner at the Scannexus research facilities by the non-invasive gold standard approach: the MRI perfusion method pseudo-continuous Arterial Spin Labeling.Cognitive performance will be assessed using CANTAB (i.e. Cambridge Neuropsychological Test Automated Battery). These validated assessments for state-of-the-art cognitive testing focus on the main cognitive domains (i.e. executive function, attention and memory). Brain vascular function will be investigated using innovative and emerging non-invasive brain magnetic resonance imaging (MRI)-perfusion methods, while focusing on whole brain and cognitive-control brain areas plus cognitive performance tests. Furthermore, the investigators have reviewed that cerebral blood flow in gray matter is a sensitive and straightforward marker of brain vascular function, which correlates with cognitive performance. Of note, lower cerebral blood flow is associated with accelerated cognitive decline and increased risk of dementia in the general population based on results of the Rotterdam prospective cohort study. Cerebral blood flow changes will be quantified on a Siemens 3 Tesla Magnetom Prisma Fit scanner at the Scannexus research facilities by the non-invasive gold standard approach: the MRI perfusion method pseudo-continuous Arterial Spin Labeling. Considering the background information given in the previous paragraph, the following research questions are formulated: Primary research question: What are the effects in older adults with a BMI between 25-35 kg/m2 and SCD of a 36-weeks NWT-03 intervention on (i) cognitive performance using a neurophysiological test battery, and (ii) cerebral blood flow, as quantified by the MRI-perfusion method Arterial Spin Labelling? Major null hypotheses, H0: A 36-weeks NWT-03 intervention does not significantly affect cognitive performance in older adults with a BMI between 25-35 kg/m2 and SCD. A 36-weeks NWT-03 intervention does not significantly affect cerebral blood flow, as assessed by Arterial Spin Labelling, in older adults with a BMI between 25-35 kg/m2 and SCD. Major alternate hypotheses, Ha: A 36-weeks NWT-03 intervention significantly affects cognitive performance in older adults with a BMI between 25-35 kg/m2 and SCD. A 36-weeks NWT-03 intervention significantly affects cerebral blood flow, as assessed by Arterial Spin Labelling, in older adults with a BMI between 25-35 kg/m2 and SCD. Secondary research question: What are the effects in older adults with SCD of a 36-weeks NWT-03 intervention on insulin sensitivity and peripheral vascular function, which are risk markers for T2DM and CVD? Exploratory research questions: What are the effects in older adults with subjective cognitive decline (SCD) of a 36-weeks NWT-03 intervention on; mechanisms underlying effects on brain function, including structural brain status, humoral factors, and the more conventional cardiometabolic risk markers; perceivable (consumer) benefits, including physical fitness and general well-being. A randomized, placebo-controlled trial with a parallel design will be conducted. Before screening, subjects will be informed about the procedures and informed consent will be obtained. Following screening, study participants that fulfill all inclusion criteria and are willing to participate will be asked to participate in this study. Subjects will be informed about their screening results, including anthropometric measures (weight, length, body mass index), systolic and diastolic blood pressure (SBP and DBP), serum total cholesterol and triacylglycerol concentrations, and plasma glucose concentrations. When treatment with drugs or lifestyle interventions is indicated according to the Standards of the Dutch general practitioners' community (NHG), subjects will be advised to consult their general practitioner. Study results obtained during the intervention trial (i.e. brain vascular function) will be reported in a descriptive way at a group level, for example: "brain vascular function is improved". because no accepted normal ranges exist for these measurements. On the days before blood sampling, adults are asked not to perform any strenuous physical exercise or to consume alcoholic beverages. On the morning of blood sampling - after a 12-hour overnight fast (from 8.00 PM) - study subjects are only allowed to drink a glass of water. Subjects are also asked not to change their habitual diet during the study. Finally, subjects are asked to come to the Metabolic Research Unit (MRUM) by public transport or car (and not by foot or bike) to standardize research measurements as much as possible At baseline and after 18 weeks, anthropometric measurements will be performed, and a fasting blood sample will be drawn. At baseline and after 36 weeks, subjects have to attend two times the research facilities to perform the follow-up measurements: once for the "Day A" measurements and once for the "Day B" measurements. During these tests, study participants have to stay at the university and are not allowed to eat. These test days will take place with an interval of three days. conditions module condition list condition Brain Vascular Function Cognition keyword list keyword Cerebral Blood Flow Cognitive Performance design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking Double design who masked list design who masked Participant Investigator enrollment info enrollment count 44 enrollment type Actual arms interventions module arm group list arm group arm group label Protein-hydrolysate arm group type Experimental arm group description Dietary supplement: an egg-protein hydrolysate (NWT-03) Study volunteers will receive a daily powder of 5 g of protein hydrolysate to mix with 200 mL of water for 36 weeks. arm group intervention list arm group intervention name Dietary Supplement: An egg-protein hydrolysate (NWT-03) arm group label Control arm group type Placebo Comparator arm group description Control: 5 g of maltodextrin powder mixed with 250 mL of water for 36 weeks. arm group intervention list arm group intervention name Dietary Supplement: Placebo intervention list intervention intervention type Dietary Supplement intervention name An egg-protein hydrolysate (NWT-03) intervention description As described in the experimental arm intervention arm group label list intervention arm group label Protein-hydrolysate intervention type Dietary Supplement intervention name Placebo intervention description As described in the Control arm intervention arm group label list intervention arm group label Control outcomes module primary outcome list primary outcome primary outcome measure Brain Vascular Function primary outcome description Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL) primary outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period primary outcome measure Cognitive performance primary outcome description Cambridge Neuropsychological Test Automated Battery (CANTAB) primary outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period secondary outcome list secondary outcome secondary outcome measure Glucose metabolism secondary outcome description Oral Glucose Tolerance Test (OGTT) secondary outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period secondary outcome measure Peripheral vascular function (1) secondary outcome description Flow-mediated vasodilation (FMD) secondary outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period secondary outcome measure Peripheral vascular function (2) secondary outcome description Carotid artery reactivity (CAR) secondary outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period secondary outcome measure Peripheral vascular function (3) secondary outcome description Pulse wave analysis (PWA) secondary outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period secondary outcome measure Peripheral vascular function (4) secondary outcome description Pulse wave velocity (PWV) secondary outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period secondary outcome measure Peripheral vascular function (5) secondary outcome description Retinal microvascular calibers secondary outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period other outcome list other outcome other outcome measure Systolic and Diastolic Blood pressure other outcome description Office and 24-hour ambulatory blood pressure other outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period other outcome measure Advanced glycation endproducts other outcome description Serum protein-bound advanced glycation endproducts (AGEs) other outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period other outcome measure Blood lipids other outcome description Lipids and Lipoproteins other outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period other outcome measure Blood glucose other outcome description Glucose other outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period other outcome measure Blood Insulin other outcome description insulin other outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period other outcome measure Blood markers for low-grade systemic inflammation other outcome description Markers for low-grade systemic inflammation (IL-6, TNF-alpha) other outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period other outcome measure Blood markers for microvascular function other outcome description Markers for microvascular function (sCAM-1, vWf, cGMP) other outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period other outcome measure Blood marker of neurogenesis other outcome description Brain-derived neurotrophic factor other outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period other outcome measure Structural brain status other outcome description MRI Structural MPRAGE scan other outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period other outcome measure Other perceivable benefits: Quality of Life other outcome description The Quality of life will be assessed using a 32-item questionnaire other outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period other outcome measure Other perceivable benefits: Physical fitness (1) other outcome description Timed up-and-go test (TUGT) other outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period other outcome measure Other perceivable benefits: Physical fitness (2) other outcome description The 6-minute walk test (6 MWT) other outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period other outcome measure Other perceivable benefits: Physical fitness (4) other outcome description Muscle strength test, as measured using the Biodex system other outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period other outcome measure Weight other outcome description Weight in kg other outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period other outcome measure Height other outcome description Height in kg other outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period other outcome measure Waist circumference other outcome description Waist circumference in centimeters other outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period other outcome measure Hip circumference other outcome description Hip circumference in centimeters other outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period other outcome measure Indirect fat distribution other outcome description Measured by skinfold measurements other outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period other outcome measure Food intake other outcome description Food intake will be assessed using the Food Frequency Questionnaire other outcome time frame Change in outcomes at the end of a 36-week protein hydrolysate intervention and 36-week control period eligibility module eligibility criteria Inclusion Criteria: Men and women, aged between 60-75 years Subjective cognitive decline (SCD) BMI between 25-35 kg/m2 Fasting plasma glucose < 7.0 mmol/L Fasting serum total cholesterol < 8.0 mmol/L (further testing will be performed for excessive hyperlipidemia [serum total cholesterol ≥ 8.0 mmol/L] according to the Standard for cardiovascular risk management of NHG) Fasting serum triacylglycerol < 4.5 mmol/L Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg Stable body weight (weight gain or loss < 3 kg in the past three months) Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study No difficult venipuncture as evidenced during the screening visit Exclusion Criteria: Left-handedness Current smoker, or smoking cessation < 12 months Diabetic patients Familial hypercholesterolemia Abuse of drugs More than 3 alcoholic units per day Use of vitamin or mineral supplements known to interfere with the main outcomes as judged by the principal investigators within the previous 1-month Use of medication to treat blood pressure, lipid or glucose metabolism Use of an investigational product within another trial within the previous 1-month Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident Contra-indications for MRI imaging (e.g. pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia) healthy volunteers Accepts Healthy Volunteers gender All minimum age 60 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Peter J Joris, PhD overall official affiliation Maastricht University overall official role Principal Investigator location list location location facility Maastricht University location city Maastricht location state Limburg location zip 6211 LK location country Netherlands derived section misc info module version holder December 02, 2022
NCT04831203
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full study rank 61743 study protocol section identification module n c t id NCT04832503 org study id info org study id RF-2016-02361560 organization org full name IRCCS Fondazione Stella Maris org class OTHER brief title Childhood Apraxia of Speech: Experience Dependent Changes Induced by Treatment official title Childhood Apraxia of Speech: Neurobiological and Behavioural Markers and Experience Dependent Changes of Neural Connectivity Induced by Treatment acronym CAS status module status verified date March 2022 overall status Enrolling by invitation expanded access info has expanded access No start date struct start date September 30, 2018 start date type Actual primary completion date struct primary completion date July 30, 2022 primary completion date type Anticipated completion date struct completion date July 30, 2022 completion date type Anticipated study first submit date February 20, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date March 28, 2022 last update post date struct last update post date March 29, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Anna Chilosi responsible party investigator title MD, PhD Head of Neurolinguistic and Neuropsychological Research Laboratory. Coordinator of the Clinical Neuropsichological Unit responsible party investigator affiliation IRCCS Fondazione Stella Maris lead sponsor lead sponsor name IRCCS Fondazione Stella Maris lead sponsor class OTHER collaborator list collaborator collaborator name Ministry of Health, Italy collaborator class OTHER_GOV oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Childhood Apraxia of Speech (CAS) is a severe speech-language disorder whose aetiological, neuroanatomical correlates are largely unknown. Furthermore, little is known about the neuroplastic effects induced by different treatment approaches and their relationships with the potential changes in the speech behavioural features that express the core deficit of CAS. Twenty four children with idiopathic CAS will be enrolled in a multidisciplinary study aimed at analysing the behavioural and neuroanatomical effects of a specific rehabilitative approach, PROMPT (PROMPTs for Restructuring Oral Muscular Phonetic Targets), that employs tactile-kinesthetic-proprioceptive cues vs a traditional speech-language treatment. The children will be allocated in two arms, one receiving a seven month cycle of individual PROMPT treatment, the other a traditional speech and language treatment for the same amount of time.The pre- and post-treatment speech and language performances and DTI and volumetric MR data will be compared in the two groups. detailed description Background: Childhood Apraxia of Speech (CAS) is a severe speech-language disorder whose etiological, neuroanatomical and genetic correlates are largely unknown. In this trial the effects of an innovative rehabilitative approach, PROMPT (PROMPTS for Restructuring Oral Muscular Phonetic Targets) will be evaluated from a behavioral and neuroanatomical point of view. Objective: the current study is aimed to assess speech-language and white matter microstructure and volumetric changes induced by the PROMPT treatment. Participants: Twenty-two Children with CAS aged 4 -12 years are enrolled and assigned to a PROMPT treatment (PROMPT-t ) or a Language and Non-Speech Oral Motor-treatment group (LNSOM-t). Methods: All children with CAS will undergo a comprehensive clinical, neurological and speech-language assessment. The following procedures will be applied: a) anamnestic interview b) oral non verbal and verbal movements eveluation c) phonetic inventory, accuracy and consistency of speech d) DDK (Diadochokinetic rate, receptive and expressive vocabulary and grammar tests; f) spontaneous language analysis. These multiple measurements were aggregated and converted into a speech and language composite score. MRI data will be acquired using a 1.5 T MR scanner. Structural images obtained with a 3D isotropic T1 weighted sequence will be analysed to evaluate volumetric alterations, to investigate cortical thickness and automatically delineate various Regions of Interest (ROIs). HARDI images will be acquired using 32 gradient directions and will be processed using tools available in FSL and MRtrix. Tract-based spatial statistics (TBSS) will be used to statistically analyse images of FA and mean diffusivity. Fiber tracts will be calculated using constrained spherical deconvolution and probabilistic tractography. Connectomes will be calculated by combining ROIs obtained from the structural images with tractography. Network-based analysis will be used to statistically analyse connectomes. Speech and language assessment and brain MRI VBM and DTI analysis will be performed at baseline and at the end of the treatment. Statistical analysis: Paired t-test on pre and post treatment behavioural and MRI/DTI measures will be performed to assess the changes within each of the two groups. Moreover, comparisons between the two groups at T0 and T1 will be performed by means of non parametric tests. Evaluation of potentially training-induced changes of brain structural connectivity may provide further support to the hypothesis that CAS is due to a disruption of networks subserving the speech production system. conditions module condition list condition Childhood Apraxia of Speech keyword list keyword Treatment induced speech changes PROMPT MRI Neuroplasticity design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Prospective enrollment info enrollment count 24 enrollment type Anticipated arms interventions module arm group list arm group arm group label Group 1 arm group description The PROMPT-treated group will include 12 children with idiopathic CAS. The pre-treatment assessment is aimed at evaluating the baseline speech and language level and at treatment planning. During a PROMPT session tactile-kinesthetic-proprioceptive inputs are consistently provided in order to shape speech movements, to give information on sequencing and timing, and to introduce constraints for the reduction of the degrees of freedom at the articulators' level in favour of motor control. In a PROMPT session the syllables, words and phrases are produced within a communicative context in play. Speech motor goals are, as soon as possible, integrated in goals for language and functional communication. arm group intervention list arm group intervention name Behavioral: PROMPT- treatment arm group label GROUP 2 arm group description The LNSOM-treated group will include 12 children with idiopathic CAS. The pre-treatment assessment is aimed at evaluating the baseline speech and language level and at the treatment planning. None of the SLTs treating this group are PROMPT trained. According to the standard care methods used in Italy, the intervention consists of a linguistic and articulatory approach that includes auditory discrimination of phonemic categories at the syllable and word level and non-speech oral motor exercises. Receptive and expressive lexicon and morphosyntax are targeted depending on the children's linguistic profile.Differently from the PROMPT, selection of speech sounds to be targeted, is based on developmental speech sounds acquisition rather than motor criteria. According to this treatment approach, the motor goal is usually identified with the placement of the main articulator involved in the production of a speech sound. arm group intervention list arm group intervention name Behavioral: LNSOM-treatment intervention list intervention intervention type Behavioral intervention name PROMPT- treatment intervention description PROMPTs for Restructuring Oral Muscolar Phonetic Targets intervention arm group label list intervention arm group label Group 1 intervention type Behavioral intervention name LNSOM-treatment intervention description Language Non-Speech Oral Motor Treatment intervention arm group label list intervention arm group label GROUP 2 outcomes module primary outcome list primary outcome primary outcome measure Speech Composite Severity Score changes after 7 months of treatment primary outcome description Speech Severity Score aggregates measures of DDK, inaccuracy, inconsistency, Phonetic inventory, Syllable Omissions. Score ranges form: 0 (normal) to 5 (severely impaired) primary outcome time frame At baselin and at 7 months of individual speech and language training secondary outcome list secondary outcome secondary outcome measure Post treatment Diffusion Weighed Imaging (DWI) metrics secondary outcome description Fractional Anisotropy (FA) secondary outcome time frame At baseline and at 7 months of speech and language training secondary outcome measure Post treatment Diffusion Weighed Imaging (DWI) changes secondary outcome description MD (Mean Diffusivity) secondary outcome time frame At baseline and at 7 months of speech and language training secondary outcome measure Post treatment cortical volumes modifications secondary outcome description Cortical thickness secondary outcome time frame At baseline and at 7 months of speech and language training secondary outcome measure Post treatment cortical volumes changes secondary outcome description Volumes analysis secondary outcome time frame At baseline and at 7 months of speech and language training eligibility module eligibility criteria Inclusion Criteria: Diagnosis of idiopathic CAS based on the presence of specific diagnostic features of apraxia of speech (see ASHA and Strand et al's criteria) and on a comprehensive clinical and neurological assessment. Non-verbal IQ within the normal range at standardized tests of intelligence. Normal structural brain MRI. Acquisition of parents' informed consent to the execution of behavoiural and neuroradiological assessment at baseline and to perform speech/language treatment. Exclusion Criteria: Orofacial structural abnormalities. Known pathologies of neurological, neurometabolical and genetic etiologies. Audiological deficits. Epilepsy. Intellectual disability. Autism spectrum disorder. gender All minimum age 4 Years maximum age 16 Years std age list std age Child study population 24 children with idiopathic CAS aged between 4 and 12 years. All the chidren are able to collaborate during MRI acquisition and behavioural assessment and to actively participate in the treatment sessions. To facilitate children's collaboration during MRI execution, a 0 Tesla simulator, reproducing the MRI setting of evaluation will be applied. Moreover during MRI acquisition children will be invited to watch cartoons through special glasses sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Anna Chilosi overall official affiliation IRCCS Stella Maris Foundation overall official role Principal Investigator location list location location facility IRCCS Fondazione Stella Maris location city Marina di Pisa-Tirrenia-Calambrone location state Toscana location zip 56128 location country Italy references module reference list reference reference p m i d 23974724 reference type background reference citation Kadis DS, Goshulak D, Namasivayam A, Pukonen M, Kroll R, De Nil LF, Pang EW, Lerch JP. Cortical thickness in children receiving intensive therapy for idiopathic apraxia of speech. Brain Topogr. 2014 Mar;27(2):240-7. doi: 10.1007/s10548-013-0308-8. Epub 2013 Aug 24. reference p m i d 27882295 reference type background reference citation Fiori S, Guzzetta A, Mitra J, Pannek K, Pasquariello R, Cipriani P, Tosetti M, Cioni G, Rose SE, Chilosi A. Neuroanatomical correlates of childhood apraxia of speech: A connectomic approach. Neuroimage Clin. 2016 Nov 4;12:894-901. eCollection 2016. reference p m i d 24617702 reference type background reference citation Square PA, Namasivayam AK, Bose A, Goshulak D, Hayden D. Multi-sensory treatment for children with developmental motor speech disorders. Int J Lang Commun Disord. 2014 Sep-Oct;49(5):527-42. doi: 10.1111/1460-6984.12083. Epub 2014 Mar 12. reference p m i d 29705112 reference type background reference citation Morgan AT, Su M, Reilly S, Conti-Ramsden G, Connelly A, Liégeois FJ. A Brain Marker for Developmental Speech Disorders. J Pediatr. 2018 Jul;198:234-239.e1. doi: 10.1016/j.jpeds.2018.02.043. Epub 2018 Apr 25. reference p m i d 23813194 reference type background reference citation Dale PS, Hayden DA. Treating speech subsystems in childhood apraxia of speech with tactual input: the PROMPT approach. Am J Speech Lang Pathol. 2013 Nov;22(4):644-61. doi: 10.1044/1058-0360(2013/12-0055). Epub 2013 Jun 28. reference p m i d 32357364 reference type background reference citation Namasivayam AK, Huynh A, Granata F, Law V, van Lieshout P. PROMPT intervention for children with severe speech motor delay: a randomized control trial. Pediatr Res. 2021 Feb;89(3):613-621. doi: 10.1038/s41390-020-0924-4. Epub 2020 May 1. i p d sharing statement module i p d sharing Undecided i p d sharing description The results of each individual participant's evaluations will be coded and entered in a computerized database. Descriptive statistical analyses may be shared with other researchers on request . derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001072 condition mesh term Apraxias condition ancestor list condition ancestor condition ancestor id D000011596 condition ancestor term Psychomotor Disorders condition ancestor id D000019954 condition ancestor term Neurobehavioral Manifestations condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M3536 condition browse leaf name Apraxias condition browse leaf as found Apraxia condition browse leaf relevance high condition browse leaf id M13605 condition browse leaf name Psychomotor Disorders condition browse leaf relevance low condition browse leaf id M20979 condition browse leaf name Neurobehavioral Manifestations condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id T465 condition browse leaf name Apraxia condition browse leaf as found Apraxia condition browse leaf relevance high condition browse leaf id T1135 condition browse leaf name Childhood Apraxia of Speech condition browse leaf as found Childhood Apraxia of Speech condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04832503
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full study rank 61447 study protocol section identification module n c t id NCT04836351 org study id info org study id WesternNorwayUAS organization org full name Western Norway University of Applied Sciences org class OTHER brief title Rehabilitation for Patients With Persistent Symptoms Post COVID-19 official title Feasibility, Usefulness and Evaluation of a Concentrated Rehabilitation for Patients With Persistent Symptoms Post COVID-19 status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 1, 2021 start date type Actual primary completion date struct primary completion date December 30, 2023 primary completion date type Anticipated completion date struct completion date December 30, 2023 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Kiri Lovise Njøten responsible party investigator title Ph.d student responsible party investigator affiliation Western Norway University of Applied Sciences lead sponsor lead sponsor name Western Norway University of Applied Sciences lead sponsor class OTHER collaborator list collaborator collaborator name Helse-Bergen HF collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary A large proportion of persons who have had COVID-19 have reported persisted symptoms as fatigue and dyspnea months post infection which affect activities of daily living. The aim of the study is to examine the feasibility and safety of a concentrated rehabilitation program with a mobile application follow-up for persons with persistent symptoms post COVID-19 infection. We will examine recruitment availability, adherence to the program, goal achievement, and resources requirements. Methods: A feasibility study with one group pre-post test design with 10-20 persons between 18-67 years, with persistent symptoms post COVID-19 will be included. The intervention is 3+ 1-2 days concentrated rehabilitation with a mobile application follow-up for 3 months. Following assessments wil be used: Cardiopulmonary exercise testing, lung function, functional performance tests, questionnaires regarding dyspnea, fatigue, anxiety, depression, work-status, health status, sleep behavior, physical activity level. Demographic data before and after the intervention will be presented. Focus group interview will be done with the participants. The interview will be analysed using systematic text condensation. detailed description In March 2020, the World Health Organization (WHO) declared the COVID-19 outbreak to be a pandemic, and a year later more than 120 000 000 people are confirmed with the disease. The disease has caused more than 2 700 000 deaths globally. Norway has a low mortality rate compared to rest of the world. However, a large proportion (10-33%) of the patients worldwide have reported persistent symptoms, such as dyspnea, reduced exercise capacity, loss of taste/smell and fatigue months after the infection. Persistent symptoms are also found in younger populations and in persons with an initially mild disease. The intervention will take place at "Helse i Hardanger" (HiH)(Health center in Hardanger, Norway). The participants will stay for a 3 -day rehabilitation intervention, if needed, another 1 or 2-day stay will be offered about a month later. The concentrated treatment will be given by an interdisciplinary team, including doctors, physiotherapists, nutritionists, pharmacists, psychologists/psychiatrists, and nurses. The intervention is an individualized group treatment based on behavioural change. conditions module condition list condition Covid19 keyword list keyword long COVID post-acute COVID syndrome persistent symptoms post COVID-19 design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design intervention model description Feasibility study, one group pre-post design design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 20 enrollment type Anticipated arms interventions module arm group list arm group arm group label Concentrated rehabilitation arm group type Experimental arm group description 3+ 1-2 day concentrated rehabilitation for patients with persistent symptoms post COVID-19. arm group intervention list arm group intervention name Other: Concentrated rehabilitation for patients with persistent symptoms post COVID-19 intervention list intervention intervention type Other intervention name Concentrated rehabilitation for patients with persistent symptoms post COVID-19 intervention description 3+ 1-2 days concentrated rehabilitation for patients with persistent symptoms post COVID-19 with a mobile application follow-up and physical consultations at 3 months post intervention. intervention arm group label list intervention arm group label Concentrated rehabilitation outcomes module primary outcome list primary outcome primary outcome measure Cardiopulmonary exercise test (CPET) primary outcome description CPET performed at treadmill primary outcome time frame 4 months primary outcome measure Chalder Fatigue Questionnaire (CFQ) primary outcome description Assessing fatigue primary outcome time frame 4 months secondary outcome list secondary outcome secondary outcome measure International Physical Activity Questionnaire (IPAQ) secondary outcome description Assessing physical activity secondary outcome time frame 4 months secondary outcome measure Generalized Anxiety Disorder (GAD-7) secondary outcome description Evaluation of mental disorders secondary outcome time frame 4 months secondary outcome measure Patient Health Questionnaire (PHQ-9) secondary outcome description Assessing health status secondary outcome time frame 4 months secondary outcome measure Bergen Insomnia Scale (BIS) secondary outcome description Assessing sleep behavior secondary outcome time frame 4 months secondary outcome measure Client Satisfaction Questionnaire (CSQ-8) secondary outcome description Assessing client satisfaction with the treatment secondary outcome time frame 3 months secondary outcome measure Work and Social Adjustment Scale (WSAS) secondary outcome description Assessing ability to work and leisure activities. secondary outcome time frame 4 months secondary outcome measure The Brief Illness Perception Questionnaire (BIPQ) secondary outcome description Assessing the cognitive and emotional representations of illness. secondary outcome time frame 4 months secondary outcome measure Modified Medical Research Council Dyspnea Scale (mMRC) secondary outcome description Assessing dyspnea secondary outcome time frame 4 months secondary outcome measure Dyspnea-12 secondary outcome description Assessing dyspnea secondary outcome time frame 4 months secondary outcome measure Stair Climbing Test (SCT) secondary outcome description Evaluation of functional exercise capacity secondary outcome time frame 4 months secondary outcome measure 30 second sit to stand test (30STST) secondary outcome description Evaluation of functional exercise capacity secondary outcome time frame 4 months secondary outcome measure Spirometry, plethysmography and maximal voluntary ventilation secondary outcome description Evaluation of lung function secondary outcome time frame 4 months secondary outcome measure Bioimpedance measurement secondary outcome description Assessment of body composition secondary outcome time frame 4 months eligibility module eligibility criteria Inclusion Criteria: persistent symptoms minimum 2 months post COVID-19 infection reduced exercise capacity level symptoms of dyspnea and/or fatigue Exclusion Criteria: diseases where exercise is contraindicated (e.g. unstable angina pectoris) drug abuse, severe mental illness where treatment in groups are contraindicated. healthy volunteers No gender All minimum age 18 Years maximum age 67 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Bente Frisk, PhD central contact role Contact central contact phone +4797003111 central contact e mail bente.frisk@hvl.no central contact name Kiri L Njøten, MSc central contact role Contact central contact phone +4797519412 central contact e mail kilon@hvl.no overall official list overall official overall official name Gerd Kvale, PhD overall official affiliation University of Bergen overall official role Study Chair location list location location facility Helse i Hardanger location status Recruiting location city Øystese location state Kvam Herad location zip 5610 location country Norway i p d sharing statement module i p d sharing No i p d sharing description In accordance with the approvals granted for this study by The Regional Committee on Medical Research Ethics and The Norwegian Data Inspectorate, the data files are stored securely and in accordance with the Norwegian Law of Privacy Protection. A subset of the data file with anonymized data can be made available to interested researchers upon reasonable request to Bente Frisk providing Norwegian privacy legislation and General Data Protection Regulation (GDPR) are respected, and that permission is granted from The Norwegian Data Inspectorate and the data protection officer Western Norway University og Applied Sciences derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04836351
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full study rank 61930 study protocol section identification module n c t id NCT04830059 org study id info org study id THU2021 organization org full name Tsinghua University org class OTHER brief title The Joint Effect of Air Pollution and Exercise on Cognitive Function official title The Joint Effect of Air Pollution and Exercise on Cognitive Function status module status verified date April 2021 overall status Active, not recruiting expanded access info has expanded access No start date struct start date November 1, 2020 start date type Actual primary completion date struct primary completion date June 10, 2021 primary completion date type Anticipated completion date struct completion date July 10, 2021 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 2, 2021 study first post date type Actual last update submit date April 1, 2021 last update post date struct last update post date April 2, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Jianxiu Liu responsible party investigator title Research staff responsible party investigator affiliation Tsinghua University lead sponsor lead sponsor name Tsinghua University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary A double-blind randomized controlled trial design is used in this study. A mixed design of 2 (pollution reduction group vs. no pollution reduction group) × 3 (high intensity intermittent exercise [HIIT], moderate intensity of aerobic exercise [MICT] and control group [CONT]) is used. 93 subjects recruited by advertising will be randomly divided into 6 groups: high intensity exercise group (pollution reduction vs no pollution reduction), moderate intensity aerobic exercise group (pollution reduction vs no pollution reduction) and Stretching group (Control) (pollution reduction vs no pollution reduction). detailed description Environmental intervention program In the pollution reduction groups, the air purification system is used 2 hours before the subjects entered the room to minimize the indoor PM2.5 and PM10. Exercise intervention program including HIIT, MICT and Stretching (Control) group : The VO2max of all subjects are measured one week before the experiment. HIIT program: 20 minutes exercise of HIIT (1min of 100% VO2max and 1min of 50% VO2max alternately) and 10 minutes of warm-up and relaxation. MICT program: 20 minutes exercise of 70-75% VO2max and 10 minutes of warm-up and relaxation. Stretching control group: 30 minutes of stretching, posture adjustment and rehabilitation courses taught by professional therapists. conditions module condition list condition Exercise Air Pollution Cognition Health Promotion design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Double blind randomized controlled trial design primary purpose Treatment design masking info design masking Triple design masking description Participants and investigators are blinded, and part of the outcome assessors are blinded. design who masked list design who masked Participant Investigator Outcomes Assessor enrollment info enrollment count 93 enrollment type Anticipated arms interventions module arm group list arm group arm group label High intensity intermittent training arm group type Experimental arm group description HIIT exercise program: 20 minutes HIIT exercise (1min 100% VO2max and 1min 50% VO2max alternately), and warm-up and relaxation before and after exercise for 10 minutes. arm group intervention list arm group intervention name Behavioral: Exercise arm group label HIIT with pollution reduction arm group type Experimental arm group description HIIT program: 20 minutes HIIT exercise (1min 100% VO2max and 1min 50% VO2max alternately), and warm-up and relaxation before and after exercise for 10 minutes; Environmental pollution intervention program: air purification system is used order to reduce the PM2.5 and PM10. arm group intervention list arm group intervention name Behavioral: Exercise Behavioral: Air purification arm group label Moderate intensity continuous training arm group type Experimental arm group description MICT program: 20 minutes of 70-75% VO2max exercise and 10 minutes of warm-up and relaxation before and after exercise. arm group intervention list arm group intervention name Behavioral: Exercise arm group label MICT with pollution reduction arm group type Experimental arm group description MICT program: 20 minutes of 70-75% VO2max exercise and 10 minutes of warm-up and relaxation before and after exercise; Environmental pollution intervention program: air purification system is used order to reduce the PM2.5 and PM10. arm group intervention list arm group intervention name Behavioral: Exercise Behavioral: Air purification arm group label Stretch control group arm group type Experimental arm group description Stretching control group: 30 minutes stretching, posture adjustment and rehabilitation courses is taught by professional therapist. arm group intervention list arm group intervention name Behavioral: Exercise arm group label Control with pollution reduction arm group type Experimental arm group description Stretching control group: 30 minutes stretching, posture adjustment and rehabilitation courses is taught by professional therapist. Environmental pollution intervention program: air purification system is used order to reduce the PM2.5 and PM10. arm group intervention list arm group intervention name Behavioral: Exercise Behavioral: Air purification intervention list intervention intervention type Behavioral intervention name Exercise intervention description Two types of exercise intervention and control group intervention arm group label list intervention arm group label Control with pollution reduction HIIT with pollution reduction High intensity intermittent training MICT with pollution reduction Moderate intensity continuous training Stretch control group intervention type Behavioral intervention name Air purification intervention description Air purification in order to reduce the PM2.5 and PM10 intervention arm group label list intervention arm group label Control with pollution reduction HIIT with pollution reduction MICT with pollution reduction outcomes module primary outcome list primary outcome primary outcome measure Change of cognitive function primary outcome description Cognitive function measured by computer-based tasks including executive function primary outcome time frame Before and after acute exercise (about 30 minutes). primary outcome measure Change of biomarkers primary outcome description The cognitive-related biomarkers including brain derived neurotrophic factor primary outcome time frame Before and after acute exercise (about 30 minutes). primary outcome measure Change of oxyhemoglobin primary outcome description Mearsurement of oxyhemoglobin using fNIRS primary outcome time frame Before and after acute exercise (about 30 minutes). primary outcome measure Change of transcriptions primary outcome description The molecular response of exercise and environment through the measurement of peripheral blood primary outcome time frame Before and after acute exercise (about 30 minutes). primary outcome measure Change of metabonomics primary outcome description The molecular response of exercise and environment through the measurement of peripheral blood primary outcome time frame Before and after acute exercise (about 30 minutes). primary outcome measure Change of cerebral blood flow primary outcome description The blood flow of middle cerebral artery measured by ultrasonic doppler primary outcome time frame Before and after acute exercise (about 30 minutes). secondary outcome list secondary outcome secondary outcome measure Change of cognitive function secondary outcome description Cognitive function measured by computer-based tasks including executive function secondary outcome time frame Three months (from baseline to the third month) secondary outcome measure Change of aerobic capacity secondary outcome description The aerobic capacity measured by the gas metabolism analyzer secondary outcome time frame Three months (from baseline to the third month) secondary outcome measure Change of cerebral blood flow secondary outcome description The blood flow of middle cerebral artery measured by ultrasonic doppler secondary outcome time frame Three months (from baseline to the third month) secondary outcome measure Change of biomarkers secondary outcome description The cognitive-related biomarkers including brain derived neurotrophic factor secondary outcome time frame Three months (from baseline to the third month) secondary outcome measure Change of oxyhemoglobin secondary outcome description Mearsurement of oxyhemoglobin using functional near infrared spectroscopy secondary outcome time frame Three months (from baseline to the third month) secondary outcome measure Change of metabonomics secondary outcome description The molecular response of exercise through the measurement of peripheral blood secondary outcome time frame Three months (from baseline to the third month) secondary outcome measure Change of transcriptions secondary outcome description The molecular response of exercise through the measurement of peripheral blood secondary outcome time frame Three months (from baseline to the third month) eligibility module eligibility criteria Inclusion Criteria: No regular exercise in the past six months; Healthy people without history of disease; Aged between 20 and 30 years old. Exclusion Criteria: Professional athletes; Regular exercise in the past six months; People who are injured or have a history of disease in the past six months; People who have a history of taking medicine in the past six months. healthy volunteers Accepts Healthy Volunteers gender All minimum age 20 Years maximum age 30 Years std age list std age Adult contacts locations module overall official list overall official overall official name Qian Di, Sc.D. overall official affiliation Wanke School of public health, Tsinghua University overall official role Study Director overall official name Xindong Ma, PhD overall official affiliation Department of physical education, Tsinghua University overall official role Study Chair location list location location facility Tsinghua University location city Beijing location state Beijing location zip 100084 location country China derived section misc info module version holder December 02, 2022
NCT04830059
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full study rank 61502 study protocol section identification module n c t id NCT04835636 org study id info org study id OHTU2021 organization org full name Ohio University org class OTHER brief title Modified Diabetes Prevention Program in Ecuador official title A Pilot of a Modified Diabetes Prevention Program in Quito, Ecuador status module status verified date April 2022 overall status Completed expanded access info has expanded access No start date struct start date January 1, 2016 start date type Actual primary completion date struct primary completion date September 1, 2016 primary completion date type Actual completion date struct completion date September 1, 2016 completion date type Actual study first submit date April 4, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 21, 2022 last update post date struct last update post date April 29, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Ohio University lead sponsor class OTHER collaborator list collaborator collaborator name Touro University, California collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This pilot study will evaluate the use of a modified (cultural and language) adaptation of the National Diabetes Prevention Program in a cohort in Quito Ecuador. detailed description This pilot study will evaluate the use of a modified (cultural and language) adaptation of the National Diabetes Prevention Program in a cohort in Quito Ecuador. People who took the program had the option to participate in the research component. All participants selected the research component. Adaptations- the coaches will be physicians from PUCE and they will administer this program for eligible employees who have biochemical prediabetes. The program will be modified to be able to fit within the school curriculum. The diabetes prevention program will be offered in Spanish and the content modified to better fit the cultural norms for the Quito Ecuador population. Participants will be adults with prediabetes as screened by the CDC Diabetes Risk Test and confirmed by HbA1c. Outcome measures will include change in mean HbA1c, change in weight, physical activity, and attendance to the program. conditions module condition list condition PreDiabetes design module study type Observational patient registry Yes target duration 6 Months design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 33 enrollment type Actual arms interventions module intervention list intervention intervention type Behavioral intervention name Diabetes Prevention Program intervention description This program is a 1 year lifestyle modification program focused on reducing calories and fat calories and increasing physical activity to achieve a 7% weight loss. This study utilized the first 16 sessions (6 months) of the program outcomes module primary outcome list primary outcome primary outcome measure HbA1c primary outcome description measure of glucose over 90-120 days primary outcome time frame 90-120 days secondary outcome list secondary outcome secondary outcome measure Weight change secondary outcome description change in weight over the 6 month program secondary outcome time frame 6 months eligibility module eligibility criteria Inclusion Criteria: Adults who worked at the university and had biochemical prediabetes. - Exclusion Criteria: Those with known diabetes, those unwilling to complete a 6 month intervention. - gender All minimum age 18 Years std age list std age Adult Older Adult study population The faculty and staff at PUCE University in Quito Ecuador were invited to participate in the study. sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Jay H Shubrook, DO overall official affiliation Ohio University/Touro University California overall official role Study Director i p d sharing statement module i p d sharing No i p d sharing description We will not share any patient identifier information with anyone outside the study. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000011236 condition mesh term Prediabetic State condition ancestor list condition ancestor condition ancestor id D000003920 condition ancestor term Diabetes Mellitus condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition browse leaf list condition browse leaf condition browse leaf id M13269 condition browse leaf name Prediabetic State condition browse leaf as found Prediabetes condition browse leaf relevance high condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf relevance low condition browse leaf id M19447 condition browse leaf name Glucose Intolerance condition browse leaf relevance low condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04835636
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full study rank 61523 study protocol section identification module n c t id NCT04835363 org study id info org study id EOTIHDAS2021 organization org full name University of Malaga org class OTHER brief title Early Occupational Therapy Intervention in the Hospital Discharge After Stroke official title Early Occupational Therapy Intervention in the Hospital Discharge After Stroke: Study Protocol for a Randomized Controlled Trial status module status verified date November 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date May 1, 2021 start date type Actual primary completion date struct primary completion date December 1, 2022 primary completion date type Anticipated completion date struct completion date December 25, 2022 completion date type Anticipated study first submit date March 25, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date November 4, 2022 last update post date struct last update post date November 7, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Patricia García Perez responsible party investigator title Principal Investigator responsible party investigator affiliation University of Malaga lead sponsor lead sponsor name University of Malaga lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The general objective of this study is to determine if an early occupational therapy intervention together with the usual care at hospital discharge after suffering a stroke has a positive effect on the functional independence of the patient, compared with the control group that will have the usual care and rehabilitation. We designed a four-week OT intervention program with the support of the main caregiver in patients who have suffered a stroke with the aim of improving the functional result and facilitating the return home by providing knowledge to the caregiver about specific care and neurorehabilitation. detailed description Background: Stroke is the leading cause of acquired disability in adults, being a cerebrovascular disease of great impact in health and social terms, due not only to its prevalence and incidence, but to the great repercussion in terms of dependence and its consequent impact on the life of the patient and family. General and specific objectives: The general objective of this study is to determine if an early occupational therapy intervention together with the usual care at hospital discharge after suffering a stroke has a positive effect on the functional independence of the patient, compared with the control group that will have the usual care and rehabilitation. We designed a four-week OT intervention program with the support of the main caregiver in patients who have suffered a stroke with the aim of improving the functional result and facilitating the return home by providing knowledge to the caregiver about specific care and neurorehabilitation. Primary outcome: functional independence of the patient and support needs in activities of daily living. Secondary outcomes: improvement in sensory-motor skills, perceptual-cognitive skills, communication skills, quality of life and levels of anxiety and depression of the patient, as well as caregiver coping strategies and burden. The final results are evaluated three months after discharge. At the same time, data are collected on readmissions to the hospital, mortality, return to work and return to driving, as well as an economic health analysis. Interviews and evaluations will be conducted with all patients and caregivers before discharge and three months after. Study Design: This is a prospective, randomized, controlled clinical trial. The sample size is made up of 60 patients who will be divided into two groups: the control group, with 30 users, and the experimental group, with another 30 users. The sample will be made up of patients who have suffered a stroke and have been discharged from the neurology service of a second-level hospital in Málaga Oeste (Spain), being referred to the rehabilitation service by joint decision of the neurology and rehabilitation department. Patients and their caregivers assigned to the experimental group are included in an early occupational therapy intervention program and compared with a control group that receives usual care and rehabilitation. conditions module condition list condition Stroke keyword list keyword patient discharge occupational therapy rehabilitation caregivers design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 62 enrollment type Actual arms interventions module arm group list arm group arm group label Control group arm group type No Intervention arm group description Usual care. arm group label OT intervention. arm group type Experimental arm group description Patients and their caregivers assigned to the experimental group are included in an early occupational therapy intervention program. arm group intervention list arm group intervention name Other: Early Occupational Therapy intervention intervention list intervention intervention type Other intervention name Early Occupational Therapy intervention intervention description four-week OT intervention program with the support of the main caregiver in patients who have suffered a stroke with the aim of improving the functional result and facilitating the return home by providing knowledge to the caregiver about specific care and neurorehabilitation. intervention arm group label list intervention arm group label OT intervention. outcomes module primary outcome list primary outcome primary outcome measure Patient functional independence assessed with Barthel Index primary outcome description The main unit of measure is the result of Barthel Index (from 0 to 100), 0 meaning disability and 100 meaning independence, therefore, higher score, better outcome. The main goal of this research is to assess independence of the patient and support needs in activities of daily living. The Barthel index measures the extent to which someone can function independently during basic activities of daily living. primary outcome time frame 3 months primary outcome measure Patient functional independence assessed with Stroke Impact Scale-16 primary outcome description Unit of measure will be the result of this assessment. The score goes from 16 to 80, 80 meaning independence (higher score, better outcome). The usefulness of this scale is similar to that of the Barthel Index, although it is more sensitive than the latter to discriminate between patients with mild disabilities. primary outcome time frame 3 months primary outcome measure Patient disability assessed with Modified Rankin Scale (mRs) primary outcome description The mRS is used to describe disability in general. Unit of measure will be the result of this assessment. The score goes from 0 to 6, 0 meaning no symptoms and 6 meaning death (higher score, worse outcome). primary outcome time frame 3 months secondary outcome list secondary outcome secondary outcome measure Patient's sensory-motor skills secondary outcome description Assessed with Fugl-Meyer sensory motor assessment (FMA). It evaluates the upper limb (maximum score of 66 corresponding to normal motor function) and lower extremity (maximum score of 34). Unit of measure will be the result of this assessment. It has four categories with different scores: total motor skills of the upper limb (from 0 to 66, higher score, better outcome), sensitivity (0 to 12, higher score, better outcome), passive joint movement (0 to 24, higher score, better outcome) and joints pain (0 to 24, higher score, better outcome). secondary outcome time frame 3 months secondary outcome measure Caregiver coping strategies secondary outcome description Assessed with Inventory of coping strategies (CSI). As it describes, the main purpose of this scale is to find the type of situations that cause problems for people in their daily lives and how they deal with these problems. Unit of measure will be the result of this assessment. It has different categories and the final score is deducted using correction keys and a scale. In general, higher score means better outcome. secondary outcome time frame 3 months secondary outcome measure Patient perceptual-cognitive skills secondary outcome description Assessed with Montreal Cognitive Assessment (MoCA). MoCA has been proposed as a screening tool that promises good sensitivity to deficits that result from stroke and vascular cognitive impairment. The MoCA includes sections on visuospatial / executive functions, nomenclature, attention, language, abstraction, memory, and orientation. Unit of measure will be the result of this assessment.The final score goes from 0 to 30 (higher score, better outcome). secondary outcome time frame 3 months secondary outcome measure Patient communication skills secondary outcome description Assessed wit Communicative Activity Log (CAL). Scale that allows obtaining information on communication skills in activities of daily life referring to comprehensive and expressive aspects of language. Unit of measure will be the result of this assessment. Final score goes from 0 to 190 (higher score, better outcome). secondary outcome time frame 3 months secondary outcome measure Stroke and Aphasia Quality of life scale, evaluating physical skills, psychosocial skills, communication and energy secondary outcome description Assessed with Stroke and aphasia quality of life scale-39 (SAQOL-39). The SAQOL-39 was derived from the Stroke Specific Quality of Life Scale and four additional items specifically targeting aphasia patients, spanning four domains: physical, psychosocial, communication, and energy. Unit of measure will be the result of this assessment. Final score goes from 0 to 195 (higher score, better outcome). secondary outcome time frame 3 months secondary outcome measure Depression of the patient secondary outcome description Assessed with Beck Depression Inventory (BDI-2). It is one of the most commonly used instruments to measure the severity of depression. Unit of measure will be the result of this assessment. Final score goes from 0 to 63 (lower score, better outcome). secondary outcome time frame 3 months secondary outcome measure Caregiver burden secondary outcome description Assessed with Caregiver Burden Scale (CBS). The CBS is a questionnaire with 22 questions (answered in writing by the caregiver) on the burden of health aspects of the caregiver, the feeling of psychological well-being, relationships, the social network, physical workload and environmental aspects they can be important. Unit of measure will be the result of this assessment. Final score goes from 0 to 88 (lower score, better outcome). secondary outcome time frame 3 months secondary outcome measure Patient mobility secondary outcome description Assessed with Time up and go (TUG). The TUG assesses basic mobility, timing the time required for a person to get up from a standardized chair, walk a distance of three meters, turn, return to the chair, and sit down again. Unit of measure will be the result of this assessment, which is the time in seconds. Shorter time means better performance. secondary outcome time frame 3 months secondary outcome measure Patient functional balance secondary outcome description Assessed with Berg Balance Scale (BBS) which evaluates assesses functional balance. Unit of measure will be the result of this assessment. Final score goes from 0 to 56 (higher score, better outcome). secondary outcome time frame 3 months secondary outcome measure Anxiety of the patient secondary outcome description Assessed with Hamilton anxiety scale. This scale assesses the severity of anxiety globally in patients who meet criteria for anxiety or depression. Unit of measure will be the result of this assessment. Final score goes from 0 to 56 (lower score, better outcome). secondary outcome time frame 3 months eligibility module eligibility criteria Inclusion Criteria: Clinical diagnosis of stroke with single or multiple vascular lesions that have occurred in the same time period, demonstrated by neuroimaging tests (CT or MRI). 18 years of age or older. Patient must live a maximum of 30 minutes away from the hospital center. Must present > 2 or <26 points on the National Institute of Health scale (NIHSS) and 45-100 points on the Barthel Index (BI) on the second day of the stroke (with BI 100, the patient can be included if the Montreal Cognitive Assessment is <26). Patient must present some motor deficit that makes it difficult to carry out his ADL. Inclusion in the study occurs prior to hospital discharge. Exclusion Criteria: NIHSS> 26 and BI <45. Life expectancy <1 year. Previous stroke, dementia or other types of illnesses associated with dementia and other neurological, psychiatric or medical illnesses (for example, severe epilepsy, head trauma, schizophrenia, COPD, severe or unstable heart disease, sleep apnea) that could alter cognitive function. Does not understand Spanish or English. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name PATRICIA GARCIA PEREZ overall official affiliation University of Malaga overall official role Principal Investigator location list location location facility Hospital Universitario Virgen de la Victoria location city Málaga location zip 29010 location country Spain i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000020521 condition mesh term Stroke condition ancestor list condition ancestor condition ancestor id D000002561 condition ancestor term Cerebrovascular Disorders condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M21459 condition browse leaf name Stroke condition browse leaf as found Stroke condition browse leaf relevance high condition browse leaf id M4962 condition browse leaf name Cerebrovascular Disorders condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04835363
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full study rank 61446 study protocol section identification module n c t id NCT04836364 org study id info org study id 19-03-1700 organization org full name Franklin Health Research org class OTHER brief title Skincare Products and Environmental Health official title Prevalence of Endocrine Disorders Among Children Exposed to Lavender Essential Oil and Tea Tree Essential Oils status module status verified date October 2021 overall status Recruiting expanded access info has expanded access No start date struct start date January 14, 2019 start date type Actual primary completion date struct primary completion date June 30, 2022 primary completion date type Anticipated completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 29, 2021 last update post date struct last update post date November 1, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Franklin Health Research lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this study is to explore the potential for an association between the development of prepubertal gynecomastia and history exposure to lavender essential oil, tea tree essential oil, and other essential oils. detailed description After being informed about the study and privacy, parents will give informed consent and complete the APICHS (Aromatic Plant Ingredient & Child Health Survey), a validated measurement tool for determining exposure to plant-based ingredients in pediatric personal care products. conditions module condition list condition Gynecomastia Endocrine System Diseases keyword list keyword Prepubertal Gynecomastia Essential Oils Lavender Tea Tree Endocrine Disruption Pediatric Environmental Health design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Cross-Sectional enrollment info enrollment count 2000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Pediatric Cohort arm group description Parents of children ages 2 to 15 years old will provide data using the APICHS. arm group intervention list arm group intervention name Other: No Intervention intervention list intervention intervention type Other intervention name No Intervention intervention description There is no intervention; observation only. intervention arm group label list intervention arm group label Pediatric Cohort outcomes module primary outcome list primary outcome primary outcome measure Lifetime prevalence of prepubertal gynecomastia primary outcome description The number of participants who were exposed to lavender and tea tree essential oils and had ever experienced prepubertal gynecomastia primary outcome time frame Baseline primary outcome measure Lifetime prevalence of precocious puberty primary outcome description The number of participants who were exposed to lavender and tea tree essential oils and experienced prepubertal gynecomastia primary outcome time frame Baseline primary outcome measure Endocrine Disruption - Comparison between exposed and unexposed primary outcome description The difference in rates of endocrine disorders between children who were exposed to lavender or tea tree essential oil and those who were not. Exposure is measured using the Aromatic Plant Ingredient and Child Health Survey (APICHS), which measures total exposure, providing a continuous variable ranging from 0 to unlimited exposures, and a dichotomous yes/no exposure outcome variable. primary outcome time frame Baseline eligibility module eligibility criteria Inclusion Criteria: Parent of child aged 2-15 living in the United States Exclusion Criteria: none gender All minimum age 2 Years maximum age 15 Years std age list std age Child study population Parents of children aged 2 to 15 years old who live in the United States will be recruited for this study. Emphasis is placed on obtaining a diverse sample which all states and territories, in addition to a racially and SES diverse sample. sampling method Non-Probability Sample contacts locations module location list location location facility Franklin Health Research Center location status Recruiting location city Franklin location state Tennessee location zip 37067 location country United States location contact list location contact location contact name Jessie Hawkins, PhD location contact role Contact location contact phone 615-642-1919 location contact e mail j.hawkins@franklinhealth.org i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006177 condition mesh term Gynecomastia condition mesh id D000004700 condition mesh term Endocrine System Diseases condition ancestor list condition ancestor condition ancestor id D000001941 condition ancestor term Breast Diseases condition ancestor id D000012871 condition ancestor term Skin Diseases condition browse leaf list condition browse leaf condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf as found Endocrine System Diseases condition browse leaf relevance high condition browse leaf id M8423 condition browse leaf name Gynecomastia condition browse leaf as found Gynecomastia condition browse leaf relevance high condition browse leaf id M4370 condition browse leaf name Breast Diseases condition browse leaf relevance low condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id T312 intervention browse leaf name Tea intervention browse leaf relevance low intervention browse leaf id T141 intervention browse leaf name English Lavender intervention browse leaf relevance low intervention browse leaf id T313 intervention browse leaf name Tea Tree intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev HB intervention browse branch name Herbal and Botanical intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04836364
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full study rank 61667 study protocol section identification module n c t id NCT04833491 org study id info org study id xuwen2021-0189 organization org full name Second Affiliated Hospital, School of Medicine, Zhejiang University org class OTHER brief title Study of the Correlation Between Preoperative Precise Biometrics, Spatial Assessment and Postoperative Visual Quality in Cataract Patients official title Study of the Correlation Between Preoperative Precise Biometrics, Spatial Assessment and Postoperative Visual Quality in Cataract Patients status module status verified date March 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 20, 2021 start date type Actual primary completion date struct primary completion date December 31, 2026 primary completion date type Anticipated completion date struct completion date December 31, 2026 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date May 6, 2021 last update post date struct last update post date May 10, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Second Affiliated Hospital, School of Medicine, Zhejiang University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This study summarizes the experience of precision treatment and postoperative management of various types of cataract, and intend to further improve the quality of Clinical Cataract diagnosis and treatment. detailed description Based on the existing cataract surgery methods, through prospective follow-up study, this study summarizes the experience of precision treatment and postoperative management of various types of cataract, and intends to further improve the quality of Clinical Cataract diagnosis and treatment. conditions module condition list condition Recruitment of Participants keyword list keyword refractive cataract surgery intraocular lens design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Retrospective enrollment info enrollment count 1000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Senile cataract arm group label Traumatic cataract arm group label Congenital cataract arm group label Lens dislocation group arm group label Complicated cataract outcomes module primary outcome list primary outcome primary outcome measure Best Corrected Visual Acuity primary outcome description The BCVA was measured by the same optometrist at each visit primary outcome time frame 1 week postoperatively primary outcome measure Best Corrected Visual Acuity primary outcome description The BCVA was measured by the same optometrist at each visit primary outcome time frame 1 month postoperatively primary outcome measure Best Corrected Visual Acuity primary outcome description The BCVA was measured by the same optometrist at each visit primary outcome time frame 3 months postoperatively primary outcome measure Uncorrected distance visual acuity primary outcome description The UCVA was measured by the same optometrist at each visit primary outcome time frame 1 week postoperatively primary outcome measure Uncorrected distance visual acuity primary outcome description The UCVA was measured by the same optometrist at each visit primary outcome time frame 1 month postoperatively primary outcome measure Uncorrected distance visual acuity primary outcome description The UCVA was measured by the same optometrist at each visit primary outcome time frame 3 months postoperatively primary outcome measure Intraocular pressure primary outcome description Intraocular pressure measured using non-contact tonometer primary outcome time frame 1 week postoperatively primary outcome measure Intraocular pressure primary outcome description Intraocular pressure measured using non-contact tonometer primary outcome time frame 1 month postoperatively primary outcome measure Intraocular pressure primary outcome description Intraocular pressure measured using non-contact tonometer primary outcome time frame 3 months postoperatively primary outcome measure Tear Breakup Time primary outcome description Tear Breakup Time was performed to assess tear film stability primary outcome time frame 1 week postoperatively primary outcome measure Tear Breakup Time primary outcome description Tear Breakup Time was performed to assess tear film stability primary outcome time frame 1 month postoperatively primary outcome measure Tear Breakup Time primary outcome description Tear Breakup Time was performed to assess tear film stability primary outcome time frame 3 months postoperatively primary outcome measure Endothelial cell density primary outcome description Endothelial cell density was measured by specular microscopy primary outcome time frame 1 month postoperatively primary outcome measure Contrast sensitivity primary outcome description The contrast sensitivity was recorded in dark environment, glare dark environment, light environment, glare light environment primary outcome time frame 1 month postoperatively primary outcome measure Defocusing curve primary outcome description From +2.00d to -4.00d, 13 different diopter states were obtained by decreasing the spherical lens degree of +0.50d, and the defocus curve was formed primary outcome time frame 1 month postoperatively primary outcome measure Stereoscopic vision primary outcome description The binocular diopter was not corrected. The stereopsis test card was used to record the arc seconds of random points, animals and circles primary outcome time frame 1 month postoperatively primary outcome measure Glasses usage frequency primary outcome description The frequency of long / medium / short distance use of corrective glasses was scored as 0%, 25%, 50%, 75% and 100% primary outcome time frame 3 months postoperatively primary outcome measure Optical visual quality questionnaire primary outcome description Glare, halos, starburst and other visual quality problems were graded as mild（1 score), moderate（2 score) and severe（3 score) primary outcome time frame 3 months postoperatively primary outcome measure Visual satisfaction primary outcome description The visual acuity satisfaction of distance / middle / near distance was scored from 0 (totally dissatisfied) to 10 (totally satisfied) primary outcome time frame 3 months postoperatively eligibility module eligibility criteria Inclusion Criteria: Patients with monocular or binocular cataract, lens opacity or abnormal position, need surgery Exclusion Criteria: The history of systemic diseases and medication affecting vision, diabetic patients with systemic conditions complicated with retinopathy, uncontrolled blood glucose, severe eye diseases, eye trauma, eye surgery, severe dry eye and ocular surface diseases, strabismus and amblyopia were identified healthy volunteers Accepts Healthy Volunteers gender All minimum age 2 Years maximum age 90 Years std age list std age Child Adult Older Adult study population Cataract surgery was performed in ophthalmic hospital affiliated to Medical College of Zhejiang University sampling method Probability Sample contacts locations module central contact list central contact central contact name Wen Xu central contact role Contact central contact phone +86-13858185223 central contact e mail xuwen2003@zju.edu.cn location list location location facility Second Affiliated Hospital, Zhejiang University School of Medicine location status Recruiting location city Hangzhou location country China location contact list location contact location contact name Wen Xu location contact role Contact derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002386 condition mesh term Cataract condition ancestor list condition ancestor condition ancestor id D000007905 condition ancestor term Lens Diseases condition ancestor id D000005128 condition ancestor term Eye Diseases condition browse leaf list condition browse leaf condition browse leaf id M4790 condition browse leaf name Cataract condition browse leaf as found Cataract condition browse leaf relevance high condition browse leaf id M10069 condition browse leaf name Lens Diseases condition browse leaf relevance low condition browse leaf id M7423 condition browse leaf name Eye Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC11 condition browse branch name Eye Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04833491
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full study rank 61731 study protocol section identification module n c t id NCT04832659 org study id info org study id 2021P000004/MGH secondary id info list secondary id info secondary id R01CA248742 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/R01CA248742 organization org full name Massachusetts General Hospital org class OTHER brief title Assessment of Biomarkers in Children to Help Parents Quit Tobacco official title Assessment of Biomarkers in Children to Help Parents Quit Tobacco acronym ABC Quit status module status verified date November 2022 overall status Not yet recruiting expanded access info has expanded access No start date struct start date December 2022 start date type Anticipated primary completion date struct primary completion date February 2026 primary completion date type Anticipated completion date struct completion date February 2026 completion date type Anticipated study first submit date March 25, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date November 8, 2022 last update post date struct last update post date November 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Jonathan P. Winickoff, MD, MPH responsible party investigator title Professor responsible party investigator affiliation Massachusetts General Hospital lead sponsor lead sponsor name Massachusetts General Hospital lead sponsor class OTHER collaborator list collaborator collaborator name National Institutes of Health (NIH) collaborator class NIH collaborator name National Cancer Institute (NCI) collaborator class NIH collaborator name University of Minnesota collaborator class OTHER collaborator name American Academy of Pediatrics collaborator class OTHER collaborator name Mississippi State University collaborator class OTHER collaborator name University of Rochester collaborator class OTHER collaborator name Icahn School of Medicine at Mount Sinai collaborator class OTHER collaborator name The MetroHealth System collaborator class UNKNOWN oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This randomized controlled trial will test whether adding biomarker measurement and informed outreach for tobacco smoke exposure as part of routine practice increases identification and improves treatment, effectiveness, and sustainability of a parental tobacco control intervention that will be integrated into pediatric practice. detailed description This trial will examine the effectiveness of systematic cotinine testing of children 12 years old or younger using blood already collected at any visit to a practice that sees pediatric patients where there is a clinically indicated blood draw. We hypothesize that providing cotinine biomarker results to pediatricians, personalized cotinine feedback to parents about their child's toxin exposure, and offering support to all household tobacco users to quit tobacco use (Biomarker Informed Outreach (BIO)) when added to the Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention will increase delivery of tobacco cessation assistance, increase household cessation, reduce tobacco smoke exposure in children, and be cost-effective. This is a 2-arm randomized controlled trial with family-level randomization to either CEASE+BIO or CEASE arms at the time of the child's baseline visit. To compare the effectiveness of CEASE+BIO vs. CEASE, we will follow-up with enrolled parents 12 months later to assess parental quit rate and children's tobacco smoke exposure. conditions module condition list condition Tobacco Dependence keyword list keyword tobacco control tobacco treatment pediatrics parents design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 868 enrollment type Anticipated arms interventions module arm group list arm group arm group label CEASE arm group type Active Comparator arm group description Those assigned to the Active Comparator arm will receive the CEASE intervention. arm group intervention list arm group intervention name Behavioral: CEASE arm group label CEASE + BIO arm group type Experimental arm group description Those assigned to the Experimental CEASE + BIO arm will receive the CEASE intervention plus Biomarker Informed Outreach (BIO). arm group intervention list arm group intervention name Behavioral: CEASE Behavioral: CEASE + BIO intervention list intervention intervention type Behavioral intervention name CEASE intervention description The CEASE intervention is considered the accepted standard of care according to national treatment guidelines. Parents of a child scheduled to be seen at a participating pediatric practice will be provided with a brief intake survey. Office staff and clinicians will be trained how to utilize the intake survey system and how to provide evidence-based cessation assistance to parents who smoke. The brief intake survey will conduct screening to identify household smoking. The CEASE system will provide (1) Automatic documentation of smoking cessation services requested; (2) Automatically generated prescription for nicotine replacement therapy for parents who smoke (unless they opt out of receiving the prescription); (3) Automated enrollment in the state's free tobacco Quitline and the SmokeFreeTXT program, a text message program offered by the National Cancer Institute. intervention arm group label list intervention arm group label CEASE CEASE + BIO intervention type Behavioral intervention name CEASE + BIO intervention description Children randomized to the CEASE + BIO group will have leftover blood from an already collected blood sample that was taken for a clinically indicated blood draw analyzed for cotinine. Parents of children in the CEASE +BIO group will receive a report of biomarker results followed by proactive outreach from a BIO counselor. The BIO counselor will explain the laboratory results and refer all parents in the household who smoke to tobacco treatment through the parent's primary care provider and/or the state quitline. The BIO counselor will troubleshoot any barriers to obtaining nicotine replacement therapy that may have been prescribed as part of the CEASE protocol and will promote strict smoke-free and vape-free home and car policies. BIO counselors will conduct a maximum of 6 calls per enrolled smoker. intervention arm group label list intervention arm group label CEASE + BIO outcomes module primary outcome list primary outcome primary outcome measure Parental quit rate primary outcome description Parental 7-day point-prevalence tobacco abstinence at 12-month follow-up, biochemically confirmed primary outcome time frame 12 months secondary outcome list secondary outcome secondary outcome measure Screening for tobacco use secondary outcome description Rates of parents receiving screening for tobacco use, assessed by validated surveys of parents secondary outcome time frame 12 months secondary outcome measure Counseling about cessation secondary outcome description Rates of receiving counseling about smoking cessation, assessed by validated surveys of parents secondary outcome time frame 12 months secondary outcome measure Counseling about smoke-free/vape-free homes and cars secondary outcome description Rates of receiving counseling about smoke-free and vape-free homes and cars, assessed by validated surveys of parents secondary outcome time frame 12 months secondary outcome measure Nicotine replacement therapy prescriptions secondary outcome description Rates of delivery of nicotine replacement therapy prescriptions, assessed by validated surveys of parents secondary outcome time frame 12 months secondary outcome measure State quitline referrals secondary outcome description Rates of referrals to the state quitline, assessed by validated surveys of parents secondary outcome time frame 12 months secondary outcome measure Children's tobacco smoke exposure secondary outcome description Child's tobacco smoke exposure, assessed by child's blood cotinine level secondary outcome time frame 12 months secondary outcome measure Smoke-free and vape-free homes and cars secondary outcome description Smoking and vaping inside homes and cars, strictly enforced rules prohibiting smoking and vaping in homes and cars, assessed by validated surveys of parents secondary outcome time frame 12 months secondary outcome measure Identification of other household smokers secondary outcome description Rate of identifying other household members who smoke, assessed by self-report of the enrolled parents secondary outcome time frame 12 months secondary outcome measure Smoking cessation among other household members secondary outcome description Quit rate among other household members who had smoked, assessed by self-report of the enrolled parents secondary outcome time frame 12 months other outcome list other outcome other outcome measure Cost per quit other outcome description The cost per quit of CEASE+BIO relative to CEASE will compare favorably to other health system tobacco cessation interventions (< $5,000 per quit) other outcome time frame 45 months eligibility module eligibility criteria Inclusion Criteria: Child 12 years old or younger presenting for a visit. Child scheduled for or has had a clinically indicated blood draw at that visit Parent/legal guardian of the child. Parent/legal guardian is a current smoker (past 7 days). Exclusion Criteria: Parent/legal guardian is non-English speaking. Parent/legal guardian is less than 18 years of age. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Jeremy E Drehmer, MPH central contact role Contact central contact phone 617-726-3419 central contact e mail jdrehmer@mgh.harvard.edu overall official list overall official overall official name Jonathan P Winickoff, MD, MPH overall official affiliation Massachusetts General Hospital overall official role Principal Investigator location list location location facility Massachusetts General Hospital location city Boston location state Massachusetts location zip 02114 location country United States i p d sharing statement module i p d sharing Yes i p d sharing description The study dataset will be made publicly available with the approval the Institutional Review Board of record at Massachusetts General Hospital and Health Information Services Group (responsible for ensuring HIPPA compliance). The data will be de-identified and validated. The dataset will include a codebook that defines the variables and describes the structure of the dataset. i p d sharing time frame Data will become available at the conclusion of the study, after the research findings have been published. i p d sharing access criteria The dataset will be made publicly available. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000014029 condition mesh term Tobacco Use Disorder condition ancestor list condition ancestor condition ancestor id D000019966 condition ancestor term Substance-Related Disorders condition ancestor id D000064419 condition ancestor term Chemically-Induced Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M15937 condition browse leaf name Tobacco Use Disorder condition browse leaf as found Tobacco Dependence condition browse leaf relevance high condition browse leaf id M20990 condition browse leaf name Substance-Related Disorders condition browse leaf relevance low condition browse leaf id M29455 condition browse leaf name Chemically-Induced Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC25 condition browse branch name Substance Related Disorders condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M11630 intervention browse leaf name Nicotine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04832659
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full study rank 61314 study protocol section identification module n c t id NCT04838080 org study id info org study id ALP-2020-FZ-01-PK-537-2 organization org full name Kocak Farma org class INDUSTRY brief title Safety and Immunogenicity of the Inactivated Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine Compared to Placebo official title Phase 1 Study for the Determination of Safety and Immunogenicity of Different Strengths of Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine, Given Twice Intramuscularly to Healthy Volunteers, in a Placebo Controlled Study Design. status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 19, 2021 start date type Actual primary completion date struct primary completion date June 1, 2021 primary completion date type Anticipated completion date struct completion date October 20, 2021 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 10, 2021 last update post date struct last update post date April 13, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Kocak Farma lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The objective of this study is to determine the safety and immunogenicity of two different strengths (4 µg and 6 µg) of an inactivated COVID-19 Vaccine compared to placebo so that to demonstrate the safety and efficacy in prophylaxis of COVID-19 conditions module condition list condition COVID-19 Vaccine keyword list keyword COVID-19 Vaccine Inactive Phase 1 design module study type Interventional phase list phase Phase 1 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking Double design who masked list design who masked Participant Investigator enrollment info enrollment count 38 enrollment type Anticipated arms interventions module arm group list arm group arm group label Low dose vaccine arm group type Experimental arm group description Inactivated COVID-19 Vaccine 4 µg/0.5 ml arm group intervention list arm group intervention name Biological: Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 4 µg/0.5 ml Vaccine arm group label High Dose Vaccine arm group type Experimental arm group description Inactivated COVID-19 Vaccine 6 µg/0.5 ml arm group intervention list arm group intervention name Biological: Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 6 µg/0.5 ml Vaccine arm group label Placebo arm group type Placebo Comparator arm group description 0.9 % NaCl arm group intervention list arm group intervention name Biological: Placebo intervention list intervention intervention type Biological intervention name Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 4 µg/0.5 ml Vaccine intervention description Two applications on Days 0 and 21 intervention arm group label list intervention arm group label Low dose vaccine intervention type Biological intervention name Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 6 µg/0.5 ml Vaccine intervention description Two applications on Days 0 and 21 intervention arm group label list intervention arm group label High Dose Vaccine intervention type Biological intervention name Placebo intervention description Two applications on Days 0 and 21 intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Adverse Events primary outcome description Questioning adverse events and examination of laboratory safety data primary outcome time frame From day 0 until the end of follow up period (6 months) secondary outcome list secondary outcome secondary outcome measure Serum immunoglobulin G (IgG) antibody levels secondary outcome description Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) secondary outcome time frame From screening until the end of follow up period (6 months) secondary outcome measure Neutralizing antibodies secondary outcome description Measurement of SARS-CoV-2-specific neutralizing antibodies secondary outcome time frame From screening until the end of follow up period (6 months) secondary outcome measure Blood levels of cytokines secondary outcome description TNF-alpha, IFN-γ, IL-2, IL-4, IL-5 and IL-6 secondary outcome time frame From screening until the end of follow up period eligibility module eligibility criteria Inclusion Criteria: healthy Caucasian origin male or female age between 18 and 55 years accepting not to participate in another COVID-19 vaccine study until the end of the study volunteers who do not plan to get a child in the next one year; the volunteer and the partner should use a reliable form of contraception (abstinence, condom, birth control implant, birth control pills used or IUD used by the partner) during the study for at least 1 year female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months) must agree to be heterosexually inactive through 12 months after the first vaccination OR agree to consistently use any of the described methods of contraception from through 12 months after the first vaccination. male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial); life style and habits (consumption of alcohol, nicotine, coffee, tea, coke, special diet, drug abuse) should be normal/acceptable body temperature, pulse rate, blood pressure, respiratory rate and 12 lead ECG should be normal/acceptable. physical examination (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, Lymph nodes, skin, and neurological/psychiatric) should be normal/acceptable laboratory examination (blood/serum examination: sodium, potassium, calcium, chloride, total protein, albumin, glucose, creatinine, BUN, uric acid, total bilirubin, direct and indirect bilirubin, lipid panel (total cholesterol, triglyceride, HDL, LDL), AST, ALT, GGT, ALP, haemoglobin, haematocrit, erythrocytes, Leukocytes, platelet count, prothrombin time (PT) and activated partial thromboplastin time (aPTT); HBsAg, HIV-Ab, HCV-Ab; urine examination: urine color, appearance, specific gravity, pH, protein, glucose, ketones, blood, leukocytes, bilirubin, urobilinogen, nitrites and sediment if erythrocytes or leucocytes are out of the limits ) should be normal/acceptable. antiSARS CoV 2 total antibody (including COVID-19 IgG and/or IgM) negative in serum. drug screening negative (amphetamines, cannabinoids, benzodiazepines, cocaine, opioids, barbiturates) normal body weight in relation to height and age according to BMI = weight(kg) / height (m)2 (accepted range 18.5 and 30 kg/m2) Informed consent given in written form according to section 15.3. agree not to participate in another vaccine clinical trial until the end of the study. agree to remain in the study area for the entire duration of the study. Exclusion Criteria: women with a positive blood (β-HCG) pregnancy test lactating women history of COVID-19 infection or showing COVID-19 infection symptoms having had contact to people with known COVID-19 infection in the last 14 days having fever (> 37.4oC in the last 24 hours), dry cough or feeling tired and having aches and pains, nasal congestion, runny nose, sore throat and diarrhea. positive real time RT-PCR COVID-19 test. leukemia or neoplasm in history. persons with autoimmune diseases allergic diathesis or any clinically significant allergic disease (i.e. asthma) any condition that might impair the immune response recent or current immunosuppressive medication any other vaccine application 30 days before the first dose presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, haematological, gastrointestinal, neurological, psychiatric or other major diseases; disruption of platelets or other blood clotting disorders, which may cause contraindications to intramuscular administration clinically significant illness within 4 weeks before the start of the study. Especially any acute or chronic illness seizures. any regular intake or administration of any prescribed systemic or topical medication within 2 weeks prior to the start of the study; in the case of intake or administration of any prescribed systemic or topical medication within 4 weeks before the start of the study because of an insignificant illness, this should be stated in the CRF. intake or administration of OTC medication (including herbal remedies) which may have an effect on the study according to the investigator within 2 weeks prior to the start of the study volunteers who received antiviral drugs, immunoglobulins or blood transfusions or any other investigational drug within 4 weeks prior to the first study product administration concomitant intake or administration of any systemic or topical drugs (including herbal remedies) on the application days treatment with any investigational drug (i.e., drug not yet approved) in the last 4 weeks before beginning of the trial medication with drugs known to alter organs or systems such as barbiturates, phenothiazines, cimetidine, omeprazole etc. within the last 1 month (4 weeks) donation of blood or plasma more than 450 ml within the last 2 months (8 weeks) or any amount within the last month (4 weeks) supine blood pressure, after resting for 5 min, higher than 140/90 or lower than 100/60 mmHg supine pulse rate, after resting for 5 min, outside the range of 50 - 100 beats/min supine respiratory rate, after resting for 5 min, outside the range of 15 - 18 breathings / min any clinically significant abnormality of the ECG (12 leads) recorded in rest laboratory values (appendix 5) outside normal range with clinical relevance at entry examination alcohol abuse i.e. regular use of more than 2 units of alcohol per day or a history of alcoholism or drug/chemical abuse (one unit of alcohol equals ½ l of beer, 200 ml wine or 50 ml of spirits) or recovered alcoholics caffeine abuse i.e. regular use of more than 750 mg/day caffeine alcoholic or methylxanthine-containing beverages or foods (coffee, tea, coke, chocolate) and fruit-juice from 24 hours prior to each application until the end of hospitalization grapefruit products from 7 days prior to the first application until the end of hospitalization smoking of more than 10 cigarettes or equivalent per day, no smoking allowed during hospitalization in the clinical unit vegetarian or any special diet due to any reason knowledge to have any type of parenterally transmitted hepatitis or carrier of the HBsAg (HBsAg test positive) HIV-Ab test positive Test on anti-HCV antibodies positive positive drug screen or history of drug abuse (amphetamines, cannabinoids, benzodiazepines, cocaine, opioids, barbiturates) legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study evidence of an uncooperative attitude. healthy volunteers Accepts Healthy Volunteers gender All gender based Yes gender description Non-pregnant women minimum age 18 Years maximum age 55 Years std age list std age Adult contacts locations module central contact list central contact central contact name Turgay Celik, Prof. central contact role Contact central contact phone + 90 (216) 578 0000 central contact e mail turgay.celik@yeditepe.edu.tr overall official list overall official overall official name Aydin Erenmemisoglu, Prof. overall official affiliation Legal representative overall official role Study Director overall official name Turgay Celik, Prof. overall official affiliation Principal Investigator overall official role Principal Investigator location list location location facility Yeditepe AR-GE ve Analiz Merkezi İyi Klinik Uygulamaları Merkezi (Center for GCP) location status Recruiting location city Istanbul location zip 34718 location country Turkey location contact list location contact location contact name Turgay Celik, Prof. Dr. location contact role Contact location contact phone + 90 (216) 578 0000 location contact e mail turgay.celik@yeditepe.edu.tr location contact name Meral Sonmez, Prof. Dr. location contact role Sub-Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention mesh list intervention mesh intervention mesh id D000014612 intervention mesh term Vaccines intervention ancestor list intervention ancestor intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M16512 intervention browse leaf name Vaccines intervention browse leaf as found Comparator intervention browse leaf relevance high intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04838080
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full study rank 61800 study protocol section identification module n c t id NCT04831762 org study id info org study id 2020-A03209-30 organization org full name University Hospital, Caen org class OTHER brief title Markers of Executive Attention Development in Preschoolers - Behavioral Measures in Various Populations official title MARQUEURS DE DEVELOPPEMENT DE L'ATTENTION EXECUTIVE CHEZ L'ENFANT : POPULATIONS VARIEES acronym MEDiATE-PRV status module status verified date March 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 1, 2021 start date type Actual primary completion date struct primary completion date October 1, 2023 primary completion date type Anticipated completion date struct completion date December 31, 2023 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date March 8, 2022 last update post date struct last update post date March 9, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University Hospital, Caen lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Executive attention is essential for emotional and behavioral self-regulation. There is inter-individual variability in the level of efficiency of executive attention from kindergarten entry, and this variability predicts children's academic performance at entry to elementary school and beyond. It is therefore essential to better understand the early stages of executive attention development and self-regulation from an early age in order to develop tools for early detection of executive attention disorders, so that school accommodations can be proposed as early as possible. In previous work, we have identified early tactile information processing skills that underpin the development of executive attention. We would like to extend this work to a diverse population of preschool children, in order to consider new tools for the early detection of attention disorders. The MEDiATE-PRV project aims to compare the performance obtained in a validated attentional task in preschool children with assessments of tactile information processing, in relation to the psychomotor and executive development of the child. We will include 200 children aged 4 years to 5 years 11 months with different risk factors for ADHD. conditions module condition list condition Attention Deficit design module study type Observational patient registry No design info design observational model list design observational model Ecologic or Community design time perspective list design time perspective Cross-Sectional enrollment info enrollment count 200 enrollment type Anticipated arms interventions module intervention list intervention intervention type Behavioral intervention name Attention Network task (computerized) intervention description Computer-based game challenging orienting and executive attention. The subject must chose which side an animal is going, using left and right buttons, depending on the validity of a cue and the congruency of flankers. intervention other name list intervention other name Child ANT, flankers task intervention type Behavioral intervention name Head-toes-knees-schoulders intervention description Following motor commands such as touch your head when they are congruent or incongruent. intervention other name list intervention other name HTKS intervention type Behavioral intervention name Laby 5-12 intervention description Test of motor planning using labyrinths intervention type Behavioral intervention name M-ABC 2 intervention description Test of motor functions using various subtests of gross and fine motor function. intervention type Behavioral intervention name Stroop animals intervention description Stroop test for preK children using animals instead of words outcomes module primary outcome list primary outcome primary outcome measure ANT performance primary outcome description Reaction time in ms to ANT trials with a correct answer primary outcome time frame 48 to 71 months of age primary outcome measure Tactile processing score primary outcome description Score to the sensory profile tactile subtest primary outcome time frame 48 to 71 months of age eligibility module eligibility criteria Inclusion Criteria: Attending preschool Parental informed consent Exclusion Criteria: - None healthy volunteers Accepts Healthy Volunteers gender All minimum age 48 Months maximum age 71 Months std age list std age Child study population Preschoolers 48 to 71 months of age. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Nadege Roche-Labarbe, PhD central contact role Contact central contact phone +33(0)649922568 central contact e mail nadege.roche@unicaen.fr location list location location facility Comete U1075 Inserm Unicaen location status Recruiting location city Caen location zip 14032 location country France location contact list location contact location contact name Nadege Roche-Labarbe, PhD location contact role Contact derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001289 condition mesh term Attention Deficit Disorder with Hyperactivity condition ancestor list condition ancestor condition ancestor id D000019958 condition ancestor term Attention Deficit and Disruptive Behavior Disorders condition ancestor id D000065886 condition ancestor term Neurodevelopmental Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M3746 condition browse leaf name Attention Deficit Disorder with Hyperactivity condition browse leaf as found Attention Deficit condition browse leaf relevance high condition browse leaf id M9151 condition browse leaf name Hyperkinesis condition browse leaf relevance low condition browse leaf id M20983 condition browse leaf name Attention Deficit and Disruptive Behavior Disorders condition browse leaf relevance low condition browse leaf id M29797 condition browse leaf name Neurodevelopmental Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology
NCT04831762
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full study rank 61196 study protocol section identification module n c t id NCT04839614 n c t id alias list n c t id alias NCT04278183 org study id info org study id 19-419 organization org full name Dana-Farber Cancer Institute org class OTHER brief title Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia official title Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia status module status verified date August 2022 overall status Recruiting expanded access info has expanded access No start date struct start date August 1, 2021 start date type Actual primary completion date struct primary completion date June 30, 2023 primary completion date type Anticipated completion date struct completion date June 30, 2024 completion date type Anticipated study first submit date April 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date August 2, 2022 last update post date struct last update post date August 4, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Colleen Feltmate responsible party investigator title Principal Investigator responsible party investigator affiliation Brigham and Women's Hospital lead sponsor lead sponsor name Dana-Farber Cancer Institute lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary To assess the feasibility of an expedited referral process for the obese endometrial cancer or EIN patient from her gynecologic oncologist to the Brigham Center for Metabolic and Bariatric Surgery (CMBS) in order to undergo concurrent weight loss surgery and hysterectomy within 8 weeks of first appointment with a gynecologic oncologist (or 12 weeks for EIN patients). detailed description The most common risk factor for endometrial cancer is obesity. However, because early-stage endometrial cancer has a very high survival rate, patients more often suffer from long-term issues related to their weight, like heart disease, stroke, and diabetes. Weight loss surgery has been shown to help patients lose weight and also decrease their risk for obesity-related diseases. This research study is a Feasibility Study. This is the first-time investigators are studying both 1) the referral process of patients with endometrial cancer to the Center for Metabolic and Bariatric Surgery without delaying curative treatment of endometrial cancer 2) the combined surgery of both hysterectomy and weight loss surgery. The combined surgery of hysterectomy and weight loss surgery has been performed both at this institution and others without increased complications, but it has not been formally studied. Approximately 30 patients are expected to participate in this study at Brigham and Women's Hospital (BWH). conditions module condition list condition Endometrial Carcinoma Obesity EIN Endometrial Intraepithelial Neoplasia Endometrial Cancer Stage I keyword list keyword Endometrial Carcinoma Obesity EIN Endometrial Intraepithelial Neoplasia Endometrial Cancer Stage I Weight Loss Surgery Bariatric Surgery design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Health Services Research design masking info design masking None (Open Label) enrollment info enrollment count 30 enrollment type Anticipated arms interventions module arm group list arm group arm group label CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY arm group type Experimental arm group description Upon enrollment in the study at first appointment with gynecologic oncologist, referral to the BWH Center for Metabolic and Bariatric Surgery (CMBS). Schedule a series of appointments with a bariatric surgeon, nutritionist and psychologist, which is part of the approval process for weight loss surgery. Hysterectomy and weight loss surgery will then be scheduled on the same day within 8 weeks from first visit with the gynecologic oncologist for endometrial cancer or 12 weeks if you have endometrial pre-cancer. Series of post-operative visits with the bariatric surgeon and gynecologic oncologic surgeon as well as the nutritionist and psychologist. arm group intervention list arm group intervention name Other: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral intervention list intervention intervention type Other intervention name CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral intervention description See arm description intervention arm group label list intervention arm group label CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY outcomes module primary outcome list primary outcome primary outcome measure proportion of patients who schedule an appointment and speak with a surgeon 1-2 weeks after enrollment primary outcome description 50% of the patients utilize the referral system and attend an initial consultation, it will be considered feasible primary outcome time frame 2 Weeks primary outcome measure proportion of patients who undergo the concurrent surgeries within 8 weeks of diagnosis (12 weeks for EIN patients) primary outcome description concurrent surgery will be considered feasible if 50% (7-8 patients) of patients who undergo an initial consultation at the CMBS actually undergo concurrent surgery within 8 weeks of diagnosis (or 12 weeks for EIN). primary outcome time frame up 12 weeks secondary outcome list secondary outcome secondary outcome measure Safety of the concurrent surgeries secondary outcome description compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population secondary outcome time frame 3 weeks secondary outcome measure Postoperative complications secondary outcome description compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population secondary outcome time frame 3 weeks secondary outcome measure Time under anesthesia secondary outcome description compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population secondary outcome time frame 1 Day secondary outcome measure Total time in operating room secondary outcome description compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population secondary outcome time frame 1 Day secondary outcome measure Postoperative weight loss secondary outcome description Paired t-test or Wilcoxon rank sum test will be used to compare pre- and post-surgical outcomes and survey responses secondary outcome time frame 6 months, 1 year secondary outcome measure Changes in lab values reflecting comorbid conditions secondary outcome description Paired t-test or Wilcoxon rank sum test will be used to compare pre- and post-surgical outcomes and survey responses secondary outcome time frame 6 months, 1 year secondary outcome measure Post Operative 12-item Short Form Healthy Survey (SF-12) Survey secondary outcome description 12-item Short Form Healthy Survey (SF-12) Survey secondary outcome time frame 6 months eligibility module eligibility criteria Inclusion Criteria: Female adults at least 18 years of age A BMI of 35-39.99 and 1 or more severe obesity-related co-morbidities --including T2D,112 hypertension, hyperlipidemia, obstructive sleep apnea (OSA), obesity-hypoventilation syndrome (OHS), Pickwickian syndrome (a combination of OSA and OHS), nonalcoholic 4 fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH), pseudotumor cerebri, gastroesophageal reflux disease (GERD), asthma, venous stasis disease, severe urinary incontinence, debilitating arthritis, or considerably impaired quality of life) OR a BMI ≥ 40 Tissue diagnosis (usually endometrial biopsy) of grade 1 endometrial carcinoma or EIN. Exclusion Criteria: Younger than 18 years old BMI < 35 Without a tissue diagnosis, or with a grade 2 or greater endometrial cancer tissue diagnosis Pregnant participants will be excluded from this study. Patients with contraindications to bariatric surgery will also be excluded. --This includes active smokers, prior bariatric surgery, active substance abuse, recent suicide attempt, bulimia nervosa, large abdominal hernias, or poorly controlled psychiatric illness include inability to read an English informed consent form, and unwillingness to provide informed consent. healthy volunteers No gender Female minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Colleen Feltmate, MD central contact role Contact central contact phone 617-732-8840 central contact e mail cfeltmate@bwh.harvard.edu overall official list overall official overall official name Colleen Feltmate, MD overall official affiliation Brigham and Women's Hospital overall official role Principal Investigator location list location location facility Brigham and Women's Hospital location status Recruiting location city Boston location state Massachusetts location zip 02115 location country United States location contact list location contact location contact name Colleen Feltmate, MD location contact role Contact location contact name Colleen Feltmate, MD location contact role Principal Investigator location facility Dana-Farber Cancer Institute location status Recruiting location city Boston location state Massachusetts location zip 02215 location country United States location contact list location contact location contact name Colleen Feltmate, MD location contact role Principal Investigator i p d sharing statement module i p d sharing Yes i p d sharing description The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research. i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) i p d sharing time frame Data can be shared no earlier than 1 year following the date of publication i p d sharing access criteria Contact the Partners Innovations team at http://www.partners.org/innovation derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002277 condition mesh term Carcinoma condition mesh id D000016889 condition mesh term Endometrial Neoplasms condition mesh id D000009369 condition mesh term Neoplasms condition mesh id D000002278 condition mesh term Carcinoma in Situ condition mesh id D000004714 condition mesh term Endometrial Hyperplasia condition mesh id D000015431 condition mesh term Weight Loss condition ancestor list condition ancestor condition ancestor id D000009375 condition ancestor term Neoplasms, Glandular and Epithelial condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000001835 condition ancestor term Body Weight condition ancestor id D000001836 condition ancestor term Body Weight Changes condition ancestor id D000014594 condition ancestor term Uterine Neoplasms condition ancestor id D000005833 condition ancestor term Genital Neoplasms, Female condition ancestor id D000014565 condition ancestor term Urogenital Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000014591 condition ancestor term Uterine Diseases condition browse leaf list condition browse leaf condition browse leaf id M17254 condition browse leaf name Weight Loss condition browse leaf as found Weight Loss condition browse leaf relevance high condition browse leaf id M4686 condition browse leaf name Carcinoma condition browse leaf as found Carcinoma condition browse leaf relevance high condition browse leaf id M4266 condition browse leaf name Body Weight condition browse leaf relevance low condition browse leaf id M11853 condition browse leaf name Obesity condition browse leaf relevance low condition browse leaf id M18387 condition browse leaf name Endometrial Neoplasms condition browse leaf as found Endometrial Carcinoma condition browse leaf relevance high condition browse leaf id M4687 condition browse leaf name Carcinoma in Situ condition browse leaf as found Intraepithelial Neoplasia condition browse leaf relevance high condition browse leaf id M7028 condition browse leaf name Endometrial Hyperplasia condition browse leaf as found Endometrial Intraepithelial Neoplasia condition browse leaf relevance high condition browse leaf id M9168 condition browse leaf name Hyperplasia condition browse leaf relevance low condition browse leaf id M11472 condition browse leaf name Neoplasms, Glandular and Epithelial condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M4267 condition browse leaf name Body Weight Changes condition browse leaf relevance low condition browse leaf id M16494 condition browse leaf name Uterine Neoplasms condition browse leaf relevance low condition browse leaf id M8097 condition browse leaf name Genital Neoplasms, Female condition browse leaf relevance low condition browse leaf id M16467 condition browse leaf name Urogenital Neoplasms condition browse leaf relevance low condition browse leaf id M16491 condition browse leaf name Uterine Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions
NCT04839614
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full study rank 61299 study protocol section identification module n c t id NCT04838275 org study id info org study id STUDY00012537 organization org full name University of Washington org class OTHER brief title IPF mHealth Exercise official title A Mobile Health Exercise Prescription to Enhance Effectiveness of Antifibrotic Therapy in Patients With Idiopathic Pulmonary Fibrosis (IPF) status module status verified date October 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date March 31, 2023 primary completion date type Anticipated completion date struct completion date March 31, 2023 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date October 4, 2021 last update post date struct last update post date October 11, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Mary Beth Brown responsible party investigator title Associate Professor responsible party investigator affiliation University of Washington lead sponsor lead sponsor name University of Washington lead sponsor class OTHER collaborator list collaborator collaborator name Genentech, Inc. collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Patients with idiopathic pulmonary fibrosis (IPF) who are stable on antifibrotic therapy at least 3 months will be randomized to complete a 12-week home exercise intervention using an mHealth platform, plus a pre- and post-intervention monitoring period (4 weeks each) and in-person study assessments. detailed description Contemporary walk test endpoints in IPF trials may under-represent patient functional gains with antifibrotic therapy, which may be more effectively captured with long-term activity monitoring. Traditional pulmonary rehabilitation centers create a barrier to patient exercise accessibility and compliance, which is eliminated in a mobile health (mHealth) exercise training approach. In this study, 30 patients with IPF will be randomized into one of two arms. The exercise arm will receive a 12-week home exercise intervention using an mHealth platform plus pre- and post-intervention monitoring (4 weeks each). The non-exercise arm will be monitored for the same study duration. The primary end point is change from baseline in daily physical activity as a number of weekly exercise minutes qualifying as moderate to vigorous physical activity (MVPA), METS*minutes of exercise per week, and sedentary time minutes. Assessments will be performed primarily via in-person study visits at week 4 and week 16, as well as via daily recordings from mHealth monitoring devices. conditions module condition list condition Idiopathic Pulmonary Fibrosis design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 30 enrollment type Anticipated arms interventions module arm group list arm group arm group label Exercise Arm arm group type Experimental arm group description antifibrotic therapy + mHealth monitoring + 12-wk mHealth home exercise prescription arm group intervention list arm group intervention name Behavioral: 12-week mHealth home exercise prescription arm group label Non-Exercise Arm arm group type No Intervention arm group description antifibrotic therapy + mHealth monitoring intervention list intervention intervention type Behavioral intervention name 12-week mHealth home exercise prescription intervention description 3x/week home walking protocol, 2x/week resistance exercise program intervention arm group label list intervention arm group label Exercise Arm outcomes module primary outcome list primary outcome primary outcome measure Daily Physical Activity primary outcome description Daily activity as step counts, intensity (metabolic equivalents), and duration (METS*min) of activity to identify number of minutes spent in moderate-to-vigorous physical activity (MVPA) vs. sedentary time primary outcome time frame 20 weeks secondary outcome list secondary outcome secondary outcome measure Oxygen Saturation (SpO2) secondary outcome description To monitor pulse oximetry second-by-second during exercise secondary outcome time frame 12 weeks secondary outcome measure Cardiopulmonary Exercise Testing (CPET) secondary outcome description To assess for peak oxygen consumption, peak watts, and time to peak, resting/ peak/recovery heart rate, resting and exercise SpO2, and other variables secondary outcome time frame Week 4, Week 16 secondary outcome measure Pulmonary Function Tests (PFT) with DLCO secondary outcome description To assess lung volumes and capacities indicative of pulmonary function secondary outcome time frame Week 4, Week 16 secondary outcome measure Six Minute Walk Test (6MWT) secondary outcome description To assess walking distance and oxygen desaturation during submaximal exercise secondary outcome time frame Week 4, Week 16 secondary outcome measure Seated Knee Extension Maximal Force and Fatigue Curve Test secondary outcome description With computerized dynamometer (Noraxon) secondary outcome time frame Week 4, Week 16 secondary outcome measure Lower Extremity Power Test secondary outcome description With computerized dynamometer and interfacing force platform (Noraxon) secondary outcome time frame Week 4, Week 16 secondary outcome measure Wall Squat Functional Strength Test secondary outcome description Functional strength testing of the lower extremities secondary outcome time frame Week 4, Week 16 secondary outcome measure Borg Rating of Perceived Dyspnea Scale secondary outcome description Survey dyspnea at rest and during exertion on a likert scale, with a range of 0-10. Higher scores indicate more severe shortness of breath. secondary outcome time frame 20 weeks secondary outcome measure IPF-specific version of the St. George Respiratory Questionnaire (SGRQ-I) secondary outcome description An idiopathic pulmonary fibrosis-specific health-related quality of life (HRQL) questionnaire. Domain and total scores are transformed to a range of 0-100, with higher scores indicating more impaired HRQL. secondary outcome time frame Week 4, Week 16, Week 20 secondary outcome measure King's Brief Interstitial Lung Disease (KBILD) Questionnaire secondary outcome description An interstitial lung disease-specific, health-related quality of life (HRQL) questionnaire. KBILD domain and total scores are transformed to a range of 0-100. Higher scores indicate less impaired HRQL. A score of 100 = best health state. secondary outcome time frame Week 4, Week 16, Week 20 eligibility module eligibility criteria Inclusion Criteria: Age 40-80 yrs at randomization Diagnosis of idiopathic pulmonary fibrosis (IPF), consistent with the ATS 2018 Guidelines Percent Forced Vital Capacity (%FVC) ≥50% and ≤90% Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30% and ≤90% Willing and able to participate in an exercise regimen Ambulatory without the use of an assistive device Stable on antifibrotic therapy (pirfenidone or nintedanib) at least 3 months No changes in other medication for at least 4 wks before enrollment Must be able to read, write, and verbally communicate in English Exclusion Criteria: Forced expiratory volume in one second (FEV1)/FVC ratio <0.7 after administration of bronchodilator at screening Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization Known explanation for interstitial lung disease History of asthma or chronic obstructive pulmonary disease Active infection Ongoing IPF treatments including investigational therapy, immunosuppresents (other than prednisone 20 mg daily and below) and cytokine modulating agents Participation in a supervised exercise program including pulmonary rehab within the previous 12 months History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months Major orthopedic, psychiatric, neurological, or other conditions that would impair performance of the study exercise outcomes Require >5LPM supplemental O2 at rest Currently pregnant healthy volunteers No gender All minimum age 40 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Beth Brown, PT, PhD central contact role Contact central contact phone 206-685-3852 central contact e mail mbbrown1@uw.edu overall official list overall official overall official name Mary Beth Brown, PT, PhD overall official affiliation University of Washington overall official role Principal Investigator location list location location facility University of Washington location status Recruiting location city Seattle location state Washington location zip 98195 location country United States location contact list location contact location contact name Beth Brown, PT, PhD location contact role Contact location contact phone 206-685-3852 location contact e mail mbbrown1@uw.edu location contact name Claire Child, DPT, MPH location contact role Contact location contact phone 858-395-7932 location contact e mail cechild@uw.edu derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000011658 condition mesh term Pulmonary Fibrosis condition mesh id D000054990 condition mesh term Idiopathic Pulmonary Fibrosis condition mesh id D000005355 condition mesh term Fibrosis condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M13664 condition browse leaf name Pulmonary Fibrosis condition browse leaf as found Pulmonary Fibrosis condition browse leaf relevance high condition browse leaf id M7637 condition browse leaf name Fibrosis condition browse leaf as found Fibrosis condition browse leaf relevance high condition browse leaf id M27142 condition browse leaf name Idiopathic Pulmonary Fibrosis condition browse leaf as found Idiopathic Pulmonary Fibrosis condition browse leaf relevance high condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id T3003 condition browse leaf name Idiopathic Pulmonary Fibrosis condition browse leaf as found Idiopathic Pulmonary Fibrosis condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04838275
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full study rank 61766 study protocol section identification module n c t id NCT04832204 org study id info org study id BeijingHY2020-02-07 organization org full name Beijing Hospital org class OTHER_GOV brief title Apatinib Combined With SHR-1210 as Second-line Treatment in Solid Tumors With Only Liver Metastases official title An Exploratory Study of Apatinib Combined With SHR-1210 as Second-line Treatment in Solid Tumors With Only Liver Metastases status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 25, 2021 start date type Anticipated primary completion date struct primary completion date April 1, 2023 primary completion date type Anticipated completion date struct completion date April 2024 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 2, 2021 last update post date struct last update post date April 5, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Yingying Huang responsible party investigator title Associate Chief Physician responsible party investigator affiliation Beijing Hospital lead sponsor lead sponsor name Beijing Hospital lead sponsor class OTHER_GOV collaborator list collaborator collaborator name Chinese Society of Clinical Oncology collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Apatinib and SHR-1210 are new drugs produced by jiangsu hengrui pharmaceutical co., LTD. Both are listed in China. The investigators want to design a trial to explore the efficacy and safety of Apatinib and SHR-1210 in patients with solid tumors with only liver metastasis (as second-line treatment). The main purpose is to evaluate the disease progression-free survival (PFS) of Apatinib and SHR-1210 in patients with solid tumors with only liver metastasis (progress after first-line treatment). The secondary purpose is to compare the total survival period (OS); 1-year survival rate, 2-year survival rate; evaluation of drug safety; exploration of related biomarkers in specific subgroups to predict effectiveness or adverse reactions. detailed description Any solid tumor in the presence of liver metastasis indicates poor prognosis, short overall survival, immunotherapy combination with anti-tumor angiogenesis agents have some curative effection according to recent studies. It seems there has been clinical evidence to improve the immune microenvironment of the tumor, while in the case of only liver metastasis, the tumor's characteristics may not be consistent with other tumors. This study was to investigate the efficacy and safety of such patients by combining Apatinib and SHR-1210. This study will include approximately 20 patients with solid tumors with only liver metastases (progression after first-line treatment). The investigators will evaluate the efficacy and safety of Apatinib combined with SHR-1210 in these patients. If possible we would check the patients' ctDNA and some infection factors. conditions module condition list condition Solid Tumor keyword list keyword After first-line treatment failed only liver metastases design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 20 enrollment type Anticipated arms interventions module arm group list arm group arm group label solid tumor with only liver metastases after first line treatment arm group type Experimental arm group description Apatinib 250mg, Qd, oral administration,SHR-1210 200mg, q3w one week later, intravenous administration, continuous administration until the disease progresses or an intolerable adverse reaction occurs. arm group intervention list arm group intervention name Drug: Apatinib and Camrelizumab for Injection intervention list intervention intervention type Drug intervention name Apatinib and Camrelizumab for Injection intervention description Apatinib 250mg, Qd, oral administration,SHR-1210 200mg, q3w one week later, intravenous administration, continuous administration until the disease progresses or an intolerable adverse reaction occurs. intervention arm group label list intervention arm group label solid tumor with only liver metastases after first line treatment intervention other name list intervention other name Apatinib and SHR-1210 outcomes module primary outcome list primary outcome primary outcome measure progression-free survival primary outcome description From date of registration until the date of disease progresssion or death resulting from any cause. primary outcome time frame Patients will be followed for an average period of 1 year secondary outcome list secondary outcome secondary outcome measure overall survival secondary outcome description From date of registration until the date of death from any cause or the last follow-up visit. secondary outcome time frame Patients will be followed for an average period of 1 year other outcome list other outcome other outcome measure 1-year survival rate other outcome description Percentage of patients alive at 1 year. other outcome time frame 12 months other outcome measure 2-year survival rate other outcome description Percentage of patients alive at 2 year. other outcome time frame 24 months other outcome measure Safety and tolerability as measured by number and grade of toxicity events other outcome description Overall Safety Profile by CTCAE V4.0 other outcome time frame 12 months eligibility module eligibility criteria Inclusion Criteria: age: ≥18 years old, both male and female; after pathological diagnosis and first-line treatment failure of advanced solid tumor with liver metastasis only after consultation by MDT team, the patient had measurable lesions (helical CT scan ≥10mm, meeting the RECIST 1.1 standard); ECOG PS: 0 ~ 1; subjects' baseline blood routine and biochemical indicators shall meet the following standards: Hemoglobin ≥80g/L, Absolute neutrophils count (ANC) ≥1.5×109/L, Platelet ≥90×109/L, ALT and AST≤2.5 times normal upper limit, and liver metastasis ≤5 times normal upper limit Serum total bilirubin ≤1.5 times normal upper limit, Serum creatinine ≤1.5 times normal upper limit, Serum albumin ≥30g/L; 6) expected survival period ≥3 months; 7) women of child-bearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and the result is negative, and be willing to use appropriate methods of contraception during the trial and 8 weeks after the last dose of the test drug.For men, either surgical sterilization or consent to appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial drug; 8) subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up. Exclusion Criteria: proven allergic to apatinib and/or its excipients; patients with hypertension and unable to reduce to the normal range after antihypertensive drug treatment (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), coronary heart disease at or above grade I, grade I arrhythmia (including QTc interphase prolonging > 450 ms in males and > 470 ms in females) and grade I cardiac dysfunction;Patients with positive urinary protein; there are multiple factors affecting oral drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); patients with a clear tendency of gastrointestinal bleeding, including the following: local active ulcer lesions, and fecal occult blood (++) is not included in the group;A history of black stool or hematemesis within 2 months;For patients with fecal occult blood (+) and no surgical resection of the primary gastric tumor, gastroscopy is required. abnormal coagulation function (INR>1.5, APTT>1.5 ULN), with bleeding tendency; patients with central nervous system metastasis; pregnant or nursing women; patients with other malignant tumors within 5 years; patients who have a history of psychotropic substance abuse and cannot be cured or have mental disorders; patients who have participated in clinical trials of other drugs within 4 weeks; according to the judgment of the researcher, patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study; not suitable for inclusion. healthy volunteers No gender All minimum age 18 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Yingying Huang central contact role Contact central contact phone 86-10-85136715 central contact e mail xiaoyudianhh@126.com overall official list overall official overall official name Yingying Huang overall official affiliation Beijing Hospital overall official role Principal Investigator location list location location facility Beijing Hospital location status Recruiting location city Beijing location state Beijing location zip 100005 location country China location contact list location contact location contact name yingying huang location contact role Contact location contact phone 86 01085136715 location contact e mail xiaoyudianhh@126.com location facility Beijing Hospital location status Not yet recruiting location city Beijing location state Beijing location zip 100730 location country China location contact list location contact location contact name Yingying Huang location contact role Contact location contact phone 86-10-85136715 location contact e mail xiaoyudianhh@126.com i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009362 condition mesh term Neoplasm Metastasis condition ancestor list condition ancestor condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000009385 condition ancestor term Neoplastic Processes condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M11459 condition browse leaf name Neoplasm Metastasis condition browse leaf as found Metastases condition browse leaf relevance high condition browse leaf id M11482 condition browse leaf name Neoplastic Processes condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id C000553458 intervention mesh term Apatinib intervention ancestor list intervention ancestor intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000047428 intervention ancestor term Protein Kinase Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention browse leaf list intervention browse leaf intervention browse leaf id M288215 intervention browse leaf name Apatinib intervention browse leaf as found Immunogenicity intervention browse leaf relevance high intervention browse leaf id M10262 intervention browse leaf name Liver Extracts intervention browse leaf relevance low intervention browse leaf id M24973 intervention browse leaf name Protein Kinase Inhibitors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Hemat intervention browse branch name Hematinics
NCT04832204
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full study rank 61168 study protocol section identification module n c t id NCT04839978 org study id info org study id STUDY00000404 secondary id info list secondary id info secondary id UH3DA050234 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/UH3DA050234 secondary id UG3DA050234 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/UG3DA050234 organization org full name Emory University org class OTHER brief title Community Trial in the Cherokee Nation official title Community Randomized Trial in the Cherokee Nation: Connect and CMCA for Preventing Drug Misuse Among Older Adolescents status module status verified date January 2022 overall status Enrolling by invitation expanded access info has expanded access No start date struct start date September 29, 2021 start date type Actual primary completion date struct primary completion date August 2024 primary completion date type Anticipated completion date struct completion date August 2024 completion date type Anticipated study first submit date April 8, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date January 11, 2022 last update post date struct last update post date January 26, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Kelli Komro responsible party investigator title Professor responsible party investigator affiliation Emory University lead sponsor lead sponsor name Emory University lead sponsor class OTHER collaborator list collaborator collaborator name National Institute on Drug Abuse (NIDA) collaborator class NIH oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The target population is students attending high schools in small rural towns in the 14 counties that partially or fully fall within the Cherokee Nation reservation. Following recruitment of 20 school-based clusters, clusters are allocated to either the intervention condition or delayed-intervention control condition using constrained randomization. Constrained randomization helps to ensure balanced cluster sizes as well as similar levels of risk between the intervention and control at baseline. Study participants include all10th grade students enrolled in the participating study high schools and students will be followed into the first year after their expected graduation. detailed description The national public health opioid crisis has disproportionately burdened rural White populations, and disproportionately burdened American Indian populations. Therefore, the Cherokee Nation (CN) and Emory University public health scientists have designed an opioid prevention trial to be conducted in at-risk rural communities in the CN (in northeast Oklahoma) with primarily White and American Indian adolescents and young adults. The goal of this study is to implement and evaluate a theory-based, integrated multi-level community intervention designed to prevent the onset and escalation of opioid and other drug misuse. The researchers propose a cluster randomized trial building directly on the success of their most recent previous trial, which demonstrated that the intervention effectively reduced alcohol and other drug use among American Indian and other youth living within the CN. Two distinct intervention approaches-community organizing as implemented in the established Communities Mobilizing for Change and Action (CMCA) intervention protocol, and universal school-based brief intervention and referral as implemented in the established Connect intervention protocol -will be expanded and integrated to further enhance effects in preventing and reducing opioid misuse. The CMCA and Connect interventions were originally designed to target adolescent alcohol use, but nevertheless showed significant beneficial effects on use of other drugs, including prescription drug misuse. The proposed study will: (1) further improve the design of the interventions with increased focus on opioids, (2) test the expanded, integrated versions in a cluster randomized trial, and (3) design and test new systems for sustained implementation within existing structures of the Cherokee Nation. Building upon the extant prevention science evidence, this study will respond to a gap in evidence concerning opioid misuse prevention among at-risk adolescents transitioning to young adulthood among American Indian and other rural youth. conditions module condition list condition Opioid Abuse keyword list keyword American Indian Cherokee Nation Community intervention design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Sixteen to 20 high schools and surrounding towns within the 14 counties that partially or fully fall within the Cherokee Nation reservation in northeast Oklahoma will be randomly assigned to receive the intervention right away or later. A total of 800 to 1200 students are expected to enroll from the randomized sites. design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 1000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Preventive Intervention arm group type Experimental arm group description Students in schools assigned to the preventive intervention study condition will take part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention. arm group intervention list arm group intervention name Behavioral: Connect Program Behavioral: Communities Mobilizing for Change and Action (CMCA) arm group label Delayed Intervention Control Group arm group type No Intervention arm group description Students in schools assigned to the control group will not receive the Connect and CMCA interventions. Schools in the control group will receive usual school and community prevention and be offered the trial's programs after this three-year study ends. intervention list intervention intervention type Behavioral intervention name Connect Program intervention description The Connect program includes school-based screening, brief intervention and referral, and will be treated as part of the participating schools' prevention programs. A computer-based screening and brief intervention will be supported by Cherokee Nation Behavioral Health (CNBH) supervised Connect coaches universally, to reduce potential stigma associated with speaking to a Connect coach and to reinforce drugfree norms among all students. Follow-up of moderate to high-risk youth will be conducted by a Connect Coach through Zoom, other electronic communication, or in-person visits, with referral to Cherokee Nation or community services if deemed necessary. intervention arm group label list intervention arm group label Preventive Intervention intervention type Behavioral intervention name Communities Mobilizing for Change and Action (CMCA) intervention description The community-level intervention Communities Mobilizing for Change and Action (CMCA) will involve educating and organizing of adult volunteers and consent will be assumed by their participation. We will provide trainings and tools, including Family Action Kits, to support local families, community organizations and citizens, including information on national and local opioid and other drug use, evidence-based policies, programs and practices, and how to motivate and create family and local action for drug prevention. intervention arm group label list intervention arm group label Preventive Intervention outcomes module primary outcome list primary outcome primary outcome measure Change in Number of Days of Alcohol Use primary outcome description The number of days of alcohol use in the past 30 days will be compared between study arms. primary outcome time frame Baseline up to 6 Months Post-Graduation primary outcome measure Change in Number of Days of Heavy Alcohol Use primary outcome description The number of days of heavy alcohol use in the past 30 days will be compared between study arms. Heavy alcohol use is defined as having at least four (among young women) or five (among young men) alcoholic drinks within a couple of hours. primary outcome time frame Baseline up to 6 Months Post-Graduation primary outcome measure Change in Number of Days of Marijuana Use primary outcome description The number of days of marijuana use in the past 30 days will be compared between study arms. primary outcome time frame Baseline up to 6 Months Post-Graduation primary outcome measure Change in Number of Days of Opioid Drug Misuse primary outcome description The number of days of prescription opioid misuse in the past 30 days will be compared between study arms. primary outcome time frame Baseline up to 6 Months Post-Graduation secondary outcome list secondary outcome secondary outcome measure Change in Social Support secondary outcome description Social support from parents/caregivers, friends, teachers, and community members is assessed with 24 items which are responded to on a 4-point scale where 0 = never and 3 = often. Total scores range from 0 to 72 and higher scores indicate greater support. secondary outcome time frame Baseline up to 6 Months Post-Graduation secondary outcome measure Change in Perceived Availability of Drugs secondary outcome description Ease or difficulty in accessing alcohol, marijuana, and prescription opioids is assessed with 12 items using a 4-point scale where 0 = very difficult to get and 3 = very easy to get. Total scores range from 0 to 36, with higher scores indicating greater ease of availability. secondary outcome time frame Baseline up to 6 Months Post-Graduation secondary outcome measure Change in Social Normative Beliefs about Drug Use secondary outcome description Participants will be asked 12 items to assess if they think various social groups disapprove of young people drinking alcohol, using marijuana, and prescription opioid misuse (parents, community adults, peers, self). Responses are given as 0 = don't disapprove, 1 = disapprove, and 2 = strongly disapprove. Total scores range from 0 to 24 with higher scores indicating stronger disapproval. secondary outcome time frame Baseline up to 6 Months Post-Graduation secondary outcome measure Change in Self-Efficacy secondary outcome description Self-efficacy is assessed with 4 items asking how easy or hard it would be for participants to ask for help or refuse alcohol or drugs. Responses given on a 4-point scale, where 0 = very easy and 3 = very hard. Total scores range from 0 to 12 and lower scores indicate increased self-efficacy. secondary outcome time frame Baseline up to 6 Months Post-Graduation secondary outcome measure Change in Normative Estimates of Peer Drug Use secondary outcome description Normative estimates of peer drug use (alcohol, marijuana, prescription opioid misuse) are assessed with 3 items asking about how many of their peers in school used drugs in the past year. Possible responses are 0 = none or almost none, 1 = less than half, 2 = about half, 3 = more than half, and 4 = almost all or all. Total scores range from 0 to 12 and higher scores indicate higher normative estimates of peer drug use. secondary outcome time frame Baseline up to 6 Months Post-Graduation eligibility module eligibility criteria Inclusion Criteria: Tenth grade students enrolled in the participating high schools Exclusion Criteria: unable to understand written or verbal English Inclusion criteria for high schools: Counties that partially or fully fall within the Cherokee Nation reservation Town population of 3,000 or less Class size between 30 to 100 students Exclusion criteria for high schools: Metropolitan and micropolitan cores (Rural-Urban Commuting Area codes of 1 and 4) Existence of a community drug prevention coalition healthy volunteers No gender All minimum age 15 Years maximum age 17 Years std age list std age Child contacts locations module overall official list overall official overall official name Kelli Komro, PhD overall official affiliation Emory University overall official role Principal Investigator location list location location facility Cherokee Nation Reservation location city Tahlequah location state Oklahoma location zip 74464 location country United States references module reference list reference reference p m i d 35197100 reference type derived reference citation Komro KA, Kominsky TK, Skinner JR, Livingston MD, Livingston BJ, Avance K, Lincoln AN, Barry CM, Walker AL, Pettigrew DW, Merlo LJ, Cooper HLF, Wagenaar AC. Study protocol for a cluster randomized trial of a school, family, and community intervention for preventing drug misuse among older adolescents in the Cherokee Nation. Trials. 2022 Feb 23;23(1):175. doi: 10.1186/s13063-022-06096-0. i p d sharing statement module i p d sharing Yes i p d sharing description Deidentified participant data will be available for sharing, provided all data requests are reviewed and approved by the Cherokee Nation Institutional Review Board (IRB). Data and associated documentation sharing requires a negotiated data-sharing agreement that provides for: 1) review and approval of the data request and study protocol by the Cherokee Nation IRB, 2) a commitment to using the data only for research purposes, 3) restrictions against attempting to identify study participants, 4) a commitment to securing the data using secure computer technology, 5) a commitment to destroying data after the specific requested analyses are completed, 6) agreement to submit all presentations and manuscripts to the appropriate tribal authorities for review and approval prior to public dissemination and publication, 7) reporting responsibilities to the Cherokee Nation, 8) restrictions on redistribution of the data to third parties, and 9) proper acknowledgement of the source of the data. i p d sharing time frame Data will available for sharing following publication of the study findings. i p d sharing access criteria It is the responsibility of any external party requesting access to project data to request in writing to the project PI the specific data requested, and to apply to the Cherokee Nation IRB for such access according to procedures promulgated by the Cherokee Nation. Further, any such access is conditional on meeting all requirements specified by the Cherokee Nation IRB. Persons interested in using the data should contact the PI listed on manuscripts and publications as a means of facilitating access to the data. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009293 condition mesh term Opioid-Related Disorders condition ancestor list condition ancestor condition ancestor id D000079524 condition ancestor term Narcotic-Related Disorders condition ancestor id D000019966 condition ancestor term Substance-Related Disorders condition ancestor id D000064419 condition ancestor term Chemically-Induced Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M11396 condition browse leaf name Opioid-Related Disorders condition browse leaf as found Opioid Abuse condition browse leaf relevance high condition browse leaf id M2057 condition browse leaf name Narcotic-Related Disorders condition browse leaf relevance low condition browse leaf id M20990 condition browse leaf name Substance-Related Disorders condition browse leaf relevance low condition browse leaf id M29455 condition browse leaf name Chemically-Induced Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC25 condition browse branch name Substance Related Disorders condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3185 intervention browse leaf name Analgesics, Opioid intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04839978
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full study rank 61724 study protocol section identification module n c t id NCT04832750 org study id info org study id DREAMS organization org full name University of Oldenburg org class OTHER brief title Depression-Reduction by Accelerated Personalized NeuroModulation and Its Effects on Sleep official title Depression-Reduction by Accelerated Personalized NeuroModulation and Its Effects on Sleep acronym DREAMS status module status verified date May 2021 overall status Enrolling by invitation expanded access info has expanded access No start date struct start date May 3, 2021 start date type Actual primary completion date struct primary completion date October 2023 primary completion date type Anticipated completion date struct completion date February 2024 completion date type Anticipated study first submit date March 26, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date May 19, 2021 last update post date struct last update post date May 20, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Dirk Scheele responsible party investigator title Deputy Lab Head responsible party investigator affiliation University of Oldenburg lead sponsor lead sponsor name University of Oldenburg lead sponsor class OTHER collaborator list collaborator collaborator name Marc Onken, M.Sc. collaborator class UNKNOWN collaborator name Christina Mueller, M.Sc. collaborator class UNKNOWN oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device Yes is u s export No description module brief summary Advances in repetitive transcranial magnetic stimulation (rTMS) protocols with intermittent theta-burst stimulation (iTBS) have significantly decreased the duration for one single session and thereby enabled accelerated treatment plans with multiple sessions per day, potentially reducing the total treatment duration. This randomized, placebo-controlled study investigates the effects of accelerated iTBS treatment with connectivity-informed neuronavigation on symptom severity, sleep, interoception, and cognitive control in patients with major depressive disorder and with or without comorbid borderline personality disorder using magnetic resonance imaging (MRI). detailed description Repetitive transcranial magnetic stimulation (rTMS) is a safe and efficacious treatment option for treatment-resistant depression. Advances in rTMS protocols with intermittent theta-burst stimulation (iTBS) have significantly decreased the duration for one single session and thereby enabled accelerated treatment plans with multiple sessions per day, potentially reducing the total treatment duration. Major depressive disorder (MDD) is characterized by impairments in various domains including sleep, impulse control, and interoception. Borderline personality disorder (BPD) is characterized by fear of abandonment, mood swings, and an unstable perception of self and often occurs with comorbid MDD. This comorbidity frequently impedes treatment of the BPD. In this randomized, placebo-controlled study, 60 patients with treatment-resistant MDD (30 verum group, 30 sham group) and 60 patients with treatment-resistant MDD and comorbid BPD (30 verum group, 30 sham group) will receive two weeks of connectivity-informed iTBS of the left dorsolateral prefrontal cortex (DLPFC; 3 sessions per day, 5 days per week). Before and after the treatment phase, (functional) magnetic resonance imaging (fMRI) will be performed. The effects of iTBS will be tested in four domains: (1) symptom severity (MDD and BPD symptoms), (2) sleep quality (sleep questionnaires and various sleep parameters monitored via an electroencephalography (EEG) headband), (3) neurocognitive effects (vigilance and response inhibition measured with behavioral and fMRI tasks), and (4) interoception (interoceptive attention measured with behavioral and fMRI tasks). Furthermore, before the start of the two-weeks treatment, a single iTBS session ("forecaster session") will be conducted to explore the validity of early symptom/mood responses and hormonal changes for the prediction of the the treatment outcome. Treatment effects will be analyzed within and across patient groups (MDD and MDD + BPD). In addition, domain-specific treatment effects will be analyzed as a function of distinct iTBS targets within the DLPFC.To evaluate pathological biases, the investigators will compare the patients' data with a control group of 30 healthy participants who will also be tested twice (without iTBS). conditions module condition list condition Major Depressive Episode Major Depressive Disorder Borderline Personality Disorder keyword list keyword rTMS Theta Burst Stimulation Neuronavigation Major Depressive Episode Borderline Personality Disorder Sleep Interoception Cognitive Control fMRI design module study type Observational patient registry Yes target duration 6 Weeks design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective bio spec bio spec retention Samples Without DNA bio spec description Blood samples without DNA analysis Saliva samples without DNA analysis enrollment info enrollment count 150 enrollment type Anticipated arms interventions module arm group list arm group arm group label Major Depressive Episode arm group description At least one failed pharmaco trial in current episode arm group intervention list arm group intervention name Device: intermittent theta burst stimulation (iTBS) or sham stimulation arm group label Major Depressive Episode with comorbid Borderline Personality Disorder arm group description At least one failed pharmaco trial in current episode arm group intervention list arm group intervention name Device: intermittent theta burst stimulation (iTBS) or sham stimulation arm group label Healthy Controls intervention list intervention intervention type Device intervention name intermittent theta burst stimulation (iTBS) or sham stimulation intervention description 30 sessions of iTBS over 2 weeks (3 sessions per day, 5 days per week) intervention arm group label list intervention arm group label Major Depressive Episode Major Depressive Episode with comorbid Borderline Personality Disorder outcomes module primary outcome list primary outcome primary outcome measure Change in depression severity after the treatment phase primary outcome description Measured with the Montgomery Asberg Rating Scale (MARDS). Remission defined as MADRS score (range: 0 to 60) of less than or equal to 10. Response defined as a reduction of at least 50 percent from baseline in MADRS score. primary outcome time frame Up to 5 weekdays after the last iTBS treatment session primary outcome measure Change in BPD severity after the treatment phase primary outcome description Measured by the Zanarini rating scale for BPD (Zan-BPD, range 0-36). Remission is defined as score of 9 or less. Response defined as a decrease from baseline in Zan-BPD score of at least 20 percent of the scoring range, i.e. a reduction of 8 points or more. primary outcome time frame Up to 5 weekdays after the last iTBS treatment session primary outcome measure Changes in neural responses in an interoception task before the first and after the last treatment session primary outcome description Measured with functional magnetic resonance imaging (fMRI) while performing an interoception task primary outcome time frame Up to 5 weekdays before the first and after the last treatment session primary outcome measure Changes in neural responses in a cognitive control task before the first and after the last treatment session primary outcome description Measured with functional magnetic resonance imaging (fMRI) while performing a cognitive control task primary outcome time frame Up to 5 weekdays before the first and after the last treatment session primary outcome measure Changes in behavioral responses in an interoception task before the first and after the last treatment session primary outcome description Measured as performance in an interoception task during fMRI primary outcome time frame Up to 5 weekdays before the first and after the last treatment session primary outcome measure Changes in behavioral responses in a cognitive control task before the first and after the last treatment session primary outcome description Measured as performance in a cognitive control task during fMRI primary outcome time frame Up to 5 weekdays before the first and after the last treatment session primary outcome measure Changes in sleep staging over the treatment course primary outcome description electroencephalography (EEG)-based sleep staging measured with a headband device with accelerometer and pulseoximeter primary outcome time frame 2 days of baseline measurement before the first iTBS session, daily over the treatment course for 10 days secondary outcome list secondary outcome secondary outcome measure Changes in brain connectivity measures secondary outcome description Structural and functional connectivity measured with MRI including graph measures secondary outcome time frame Up to 5 weekdays before the first and after the last treatment session secondary outcome measure Changes in vigilance over the treatment course secondary outcome description Vigilance measured by Psychomotor Vigilance Task (PVT) secondary outcome time frame Baseline immediately before the first iTBS session, daily over the treatment course for 10 days secondary outcome measure Changes in symptom severity over treatment course secondary outcome description Measured by the MADRS secondary outcome time frame Baseline immediately before the first iTBS session, after 1 week of treatment, after 2 weeks of treatment, and at the follow-up 6 weeks after treatment secondary outcome measure Changes in self-reported symptom severity over treatment course and at follow-up secondary outcome description measured by the Beck Depression Inventory (BDI-II) secondary outcome time frame Baseline immediately before the first iTBS session, daily over the treatment course for 10 days, 6 weeks after last iTBS session at the follow-up secondary outcome measure Changes in Cortisol Awakening Response (CAR) from saliva concentrations secondary outcome description 3 measurements after awakening (0,20, and 40 minutes) secondary outcome time frame Up to 5 weekdays before the first and after the last treatment session secondary outcome measure Changes in blood parameters secondary outcome description Pro- and anti-inflammatory cytokines, and growth factors secondary outcome time frame Before the first and after the last treatment session secondary outcome measure Association between changes induced by the Forecaster session and treatment outcome secondary outcome description Changes in biomarkers before and after the forecaster iTBS session secondary outcome time frame Immediately before and after the forecaster iTBS session secondary outcome measure Changes in self-reported BPD symptom severity over treatment course and at follow-up secondary outcome description Measured by the Borderline Symptom List (BSL-23) (range 0-4) secondary outcome time frame Baseline immediately before the first iTBS session, daily over the treatment course for 10 days, 6 weeks after last iTBS session at follow-up secondary outcome measure Changes in BPD symptom severity over treatment course and at follow-up secondary outcome description Measured by Zan-BPD secondary outcome time frame Baseline immediately before the first iTBS session, after 1 week of treatment, and after 2 weeks of treatment secondary outcome measure Changes in food craving secondary outcome description Measured by a behavioral food craving task secondary outcome time frame Up to 5 weekdays before the first and after the last treatment session eligibility module eligibility criteria Inclusion Criteria: Participant is able to provide consent. Diagnosis of major depressive disorder (MDD) according to DSM-V criteria. During the current episode, treatment-resistant MDD (at least one failed pharmacological trial of adequate dose and duration) For the MDD group with comorbid borderline personality disorder (BPD): diagnosis of BPD according to the Diagnotic Statistical Manual V (DSM-V) criteria. For healthy controls: no psychiatric or neurological illness. Exclusion Criteria: For the MDD group without BPD: BPD diagnosis The participant does not fulfill requirements for iTBS treatment according to safety guidelines. The participant does not fulfill requirements for MRI measurements according to safety guidelines. Pregnancy or breast-feeding. Acute suicidality. Neurological illness (e.g. dementia, Parkinson's disease, chorea huntington, multiple sclerosis). increased current risk for epileptic seizure. comorbid diagnosis of schizophrenia or psychotic symptoms, bipolar disorder, and substance use disorder within the last 6 months. Conditions related to increased intracranial pressure. Brain injury or stroke. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult study population Patients at the Department of Psychiatry, University of Oldenburg. The patients' diagnosis of MDD and BPD will be verified via the structured clinical interview for DSM-V. Healthy controls will be matched to the patient sample. sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name René Hurlemann, Prof. overall official affiliation Department of Psychiatry, University of Oldenburg overall official role Principal Investigator overall official name Dirk Scheele, Dr. overall official affiliation Department of Psychiatry, University of Oldenburg overall official role Principal Investigator overall official name Christina Mueller, M.Sc. overall official affiliation Department of Psychiatry, University of Oldenburg overall official role Study Director overall official name Marc Onken, M.Sc. overall official affiliation Department of Psychiatry, University of Oldenburg overall official role Study Director location list location location facility Department of Psychiatry, University of Oldenburg location city Bad Zwischenahn location zip 26160 location country Germany references module reference list reference reference p m i d 29726344 reference type background reference citation Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26. Erratum in: Lancet. 2018 Jun 23;391(10139):e24. reference p m i d 19170404 reference type background reference citation Franzen PL, Buysse DJ. Sleep disturbances and depression: risk relationships for subsequent depression and therapeutic implications. Dialogues Clin Neurosci. 2008;10(4):473-81. doi: 10.31887/DCNS.2008.10.4/plfranzen. reference p m i d 30917990 reference type background reference citation Mutz J, Vipulananthan V, Carter B, Hurlemann R, Fu CHY, Young AH. Comparative efficacy and acceptability of non-surgical brain stimulation for the acute treatment of major depressive episodes in adults: systematic review and network meta-analysis. BMJ. 2019 Mar 27;364:l1079. doi: 10.1136/bmj.l1079. reference p m i d 24168753 reference type background reference citation Rock PL, Roiser JP, Riedel WJ, Blackwell AD. Cognitive impairment in depression: a systematic review and meta-analysis. Psychol Med. 2014 Jul;44(10):2029-40. doi: 10.1017/S0033291713002535. Epub 2013 Oct 29. Review. reference p m i d 16259539 reference type background reference citation Tsuno N, Besset A, Ritchie K. Sleep and depression. J Clin Psychiatry. 2005 Oct;66(10):1254-69. doi: 10.4088/jcp.v66n1008. i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000004194 condition mesh term Disease condition mesh id D000003866 condition mesh term Depressive Disorder condition mesh id D000003865 condition mesh term Depressive Disorder, Major condition mesh id D000010554 condition mesh term Personality Disorders condition mesh id D000001883 condition mesh term Borderline Personality Disorder condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000019964 condition ancestor term Mood Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf relevance low condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf as found Depressive Disorder condition browse leaf relevance high condition browse leaf id M6212 condition browse leaf name Depressive Disorder, Major condition browse leaf as found Major Depressive Disorder condition browse leaf relevance high condition browse leaf id M12614 condition browse leaf name Personality Disorders condition browse leaf as found Personality Disorder condition browse leaf relevance high condition browse leaf id M4313 condition browse leaf name Borderline Personality Disorder condition browse leaf as found Borderline Personality Disorder condition browse leaf relevance high condition browse leaf id M20988 condition browse leaf name Mood Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions
NCT04832750
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full study rank 61884 study protocol section identification module n c t id NCT04830657 org study id info org study id Mersin Univer organization org full name Mersin University org class OTHER brief title The Effect of Reiki on Fatigue and Comfort official title The Effect of Reiki on Fatigue and Comfort in Hemodialysis Patients status module status verified date April 2022 overall status Completed expanded access info has expanded access No start date struct start date December 21, 2020 start date type Actual primary completion date struct primary completion date March 2, 2022 primary completion date type Actual completion date struct completion date March 2, 2022 completion date type Actual study first submit date March 31, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 5, 2022 last update post date struct last update post date April 13, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Melek Yesil Bayulgen responsible party investigator title Prelector- The Effect of Reiki on Fatigue and Comfort in Hemodialysis Patients responsible party investigator affiliation Mersin University lead sponsor lead sponsor name Mersin University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary This study is a single blind, randomized parallel controlled experimental study planned to determine the effect of distant reiki, which is one of the non-pharmacological methods, on fatigue and comfort level in hemodialysis patients. The hypothesis of the study is that distant reiki increases patients comfort and reduces fatigue. detailed description Methods: In order to determine the sample size of the study, before starting the research, power analysis was performed by taking the information of the statistician and previous studies as a reference in order to determine the number of patients to be included in the reiki and control groups. As a result of the analysis performed by taking effect size 0.35, type 1 error 0.05, power 0.80 and correlation between repeated measurements 0.50, it is planned to study with a total of 46 patients, including at least 31 patients in each group. The remote reiki group will be given remote reiki 3 times a week for 4 weeks by the researcher who has a reiki application certificate. Remote reiki sessions will be performed by the reiki practitioner the night before the hemodialysis day of the patient, and the session duration will take approximately 36-40 minutes. After the individuals receive 12 sessions of remote reiki (1 month later), the questionnaire will be filled in for the second measurement. In order to determine whether reiki has an effect in the long term, 4 weeks (1 month) after the second measurement, the questionnaire for the third measurement will be completed and the research will be completed. Patients will receive routine treatment in accordance with the institution policy without any intervention in the control group. The control group will be filled in the questionnaire after the first measurement, in the 4th (1st month) and 8th (2nd month) weeks. At the end of the study, remote reiki sessions will be applied by the researcher, since the patients in the control group have equal ethical rights. The primary expected result of the study is the effect of distant reiki on fatigue in hemodialysis patients. The second expected result of the study is to determine the effect of distant reiki on comfort. conditions module condition list condition Hemodialysis Fatigue keyword list keyword Hemodialysis Reiki Fatigue General Comfort Nursing design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Prospective, parallel, two arm, randomized controlled clinical trial, single masking design primary purpose Supportive Care design masking info design masking Single design masking description Two groups (n = 31) will be determined by randomization created in computer environment by an independent researcher who is not involved in the study, and patients will be assigned to groups A or B created in computer environment. In determining the groups, lots were made with coins and group A was determined as the control group and group B as the remote reiki group. The information showing that the patients included in the study sample were assigned to the A and B groups according to the randomization table was put in an opaque envelope. This envelope will be kept by the coordinator researcher (MG) and when the researcher (MYB), who has a certificate of reiki application, goes to the patient for the application, he will fill in the "Informed Consent Form" and open the envelope to find out which group the patient is in. If the reiki group far from weakness comes out, the questionnaires will be filled out after verbal consent is obtained from the patient. design who masked list design who masked Participant enrollment info enrollment count 61 enrollment type Actual arms interventions module arm group list arm group arm group label Distant reiki group arm group type Experimental arm group description The application will be carried out by the researcher who has received level 2 reiki training. Reiki energy will be sent to the individuals who have undergone hemodialysis with the intention of healing. The Reiki practitioner is enabled to send the Reiki remotely in a quiet and lonely room. The practitioner moves to the right side of the individual, imagining as if he is next to the individual, and his aura (the energy that exists around the body) is corrected 3 times from above and from the head to the feet. The practitioner's hands are held side by side. Starting from the beginning of the application, reiki energy is sent to the 7 main chakras in an average of 3 minutes, from top to bottom. Each session is approximately 21-25 minutes. After the session, the chakra equalization process is applied to help the frequencies of the chakras to work in harmony with each other. 15 minutes in total. Balancing is done. arm group intervention list arm group intervention name Other: Distant reiki arm group label Control arm group type Other arm group description Patients will receive routine treatment in accordance with the institution policy without any intervention in the control group. arm group intervention list arm group intervention name Other: Distant reiki intervention list intervention intervention type Other intervention name Distant reiki intervention description In order to determine the sample size of the study, it is planned to study with a total of 62 patients, including at least 31 patients in each group, in the power analysis based on the statistics of the statistician and previous studies. The remote reiki group will be given remote reiki 3 times a week for 4 weeks by the researcher who has a reiki application certificate. Remote reiki sessions will be performed by the reiki practitioner the night before the hemodialysis day of the patient, and the session duration will take approximately 36-40 minutes. After the individuals receive 12 sessions of remote reiki (1 month later), the questionnaire will be filled in for the second measurement. In order to determine whether reiki has an effect in the long term, 4 weeks (1 month) after the second measurement, the questionnaire for the third measurement will be completed and the research will be completed. intervention arm group label list intervention arm group label Control Distant reiki group outcomes module primary outcome list primary outcome primary outcome measure Fatigue evaluated using the Fatigue Intensity Index primary outcome description The Fatigue Severity Scale will be used to measure the severity of fatigue. The Turkish validity and reliability of the scale, which was developed by Krupp et al in 1989, was carried out in 2007 by Armutlu et al. Each item is scored between 1 and 7 (1 = strongly disagree, 7 = totally agree) in the scale consisting of 9 items that can be applied by individuals in a simple way. The total score range of the scale is 9-63. The total score is calculated by taking the average of 9 items. Accordingly, the lowest average score to be obtained is 1, and the highest average score is 7. The cut-off value was set at 4 and above to diagnose pathological fatigue. The lower the total score, the less fatigue. primary outcome time frame Change from before implementation, 4th week and 8th week of practice secondary outcome list secondary outcome secondary outcome measure Comfort evaluated using the General Comfort Scale secondary outcome description The Turkish validity and reliability of the scale, which was developed by Kolcaba in 2006, was carried out by Kuğuoğlu and Karabacak in 2008. The scale is 4-point Likert type with 48 items. Comfort theory includes the sub-dimensions of relaxation (9 items), relaxation (9 items) and coping with problems (10 items). There are negative and positive items in the scale. Reverse coding process is applied for negative items, and the lowest total score obtained from the scale is 48 and the highest total score is 192. The mean score of the scale is calculated by dividing the total score obtained from the scale by the number of items. 1 point from the questionnaire indicates low comfort and 4 points indicate high comfort. While Cronbach's alpha reliability coefficient was 0.88 in the reliability study conducted by Kolcaba, it was calculated as 0.85 in the study of Kuğuoğlu and Karabacak who conducted the Turkish validity and reliability study. secondary outcome time frame Change from before implementation, 4th week and 8th week of practice eligibility module eligibility criteria Inclusion Criteria: Over the age of 18 In patients over the age of 65, the Standardized Mini Mental Test (SMMT) score is 26 and above, Having hemodialysis three days / times a week for 6 months or longer with the diagnosis of chronic renal failure, Can speak and understand Turkish, General condition is good and comfortable (whose life findings are within normal limits) Do not have any problem that prevents cognitive, affective and verbal communication, Do not use any sedative drugs, Do not have any psychiatric illness, Those who sign the informed consent form will be included in the sample. Exclusion Criteria: - who do not agree to participate in the study, younger than 18, In patients over 65 years of age, whose SMMT value is below 24 points Patients undergoing hemodialysis without a diagnosis of chronic renal failure, Receiving hemodialysis treatment for less than 6 months and once or twice a week, Can't speak Turkish, General condition unstable (shortness of breath, arrhythmia, fluctuations in blood pressure), Diagnosed with anxiety, panic attack and using medication for anxiety, Using any sedative medication, Have any problem that prevents cognitive, affective and verbal communication, Any psychiatric illness, Those who do not sign the informed volunteer consent form will not be included in the study. Study termination criteria: Who want to leave the research, Changing institution / province, If the patient dies, the study will be terminated. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility Mersin University location city Mersin location state Yenişehir location zip 33110 location country Turkey i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000005221 condition mesh term Fatigue condition browse leaf list condition browse leaf condition browse leaf id M7516 condition browse leaf name Fatigue condition browse leaf as found Fatigue condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions
NCT04830657
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full study rank 61548 study protocol section identification module n c t id NCT04835038 org study id info org study id ChiCTR2100044465 organization org full name Tongji Hospital org class OTHER brief title Effects of BRS and LRS on Postoperative Acute Kidney Injury official title Effects of Sodium Bicarbonate Ringer's Injection and Sodium Lactated Ringer's Injection on Postoperative Acute Kidney Injury in Patients Undergoing Major Abdominal Surgery: a Randomized, Controlled, Open-label Clinical Study acronym BRS/LRS status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date June 1, 2021 start date type Actual primary completion date struct primary completion date October 2022 primary completion date type Anticipated completion date struct completion date February 2023 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 15, 2022 last update post date struct last update post date April 18, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Shiyong Li responsible party investigator title Principal Investigator, Associate professor responsible party investigator affiliation Tongji Hospital lead sponsor lead sponsor name Tongji Hospital lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Title: Effects of Sodium Bicarbonate Ringer's Injection and Sodium Lactated Ringer's Injection on postoperative acute kidney injury in patients undergoing major abdominal surgery: a randomized, controlled, open-label clinical study Objective: To evaluate the effect of BRS and LRS infusion on acute renal injury in patients undergoing major abdominal surgery Primary outcome: Incidence of AKI at 28 days postoperative (defined as acute kidney injury, according to Kidgo 2012 definition and classification). Study Design: Randomized, controlled, open-label clinical study. detailed description Subjects: patients who planned to undergo elective major abdominal surgery. Study data collection period: Subjects signed the consent form until 28 days after discharge or died in hospital or withdrew from the study. Number of research centers/sample size: 3400 patients were planned to be included. Study process: Among patients undergoing elective surgery, the researchers will include patients who meet the inclusion criteria for elective major abdominal surgery and agree to participate in the study. The data to be collected in this study will be recorded by the researcher in the eCRF, including: (1) Data to be collected during the screening period and preoperatively: patients' basic characteristics and demographic data (2) Data to be recorded during and/or after surgery: primary study indicators, secondary indicators, and other indicators. conditions module condition list condition Acute Kidney Injury design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 3400 enrollment type Anticipated arms interventions module arm group list arm group arm group label Sodium Bicarbonate Ringer's Injection group arm group type Experimental arm group description Intraoperative fluid therapy performed with BRS (Sodium Bicarbonate Ringer's Injection) arm group intervention list arm group intervention name Drug: Sodium Bicarbonate Ringer's Injection arm group label Sodium Lactated Ringer's Injection group arm group type Active Comparator arm group description Intraoperative fluid therapy performed with LRS (Sodium Lactated Ringer's Injection) arm group intervention list arm group intervention name Drug: Sodium Lactated Ringer's Injection intervention list intervention intervention type Drug intervention name Sodium Bicarbonate Ringer's Injection intervention description Intraoperative fluid therapy performed with BRS (Sodium Bicarbonate Ringer's Injection) intervention arm group label list intervention arm group label Sodium Bicarbonate Ringer's Injection group intervention type Drug intervention name Sodium Lactated Ringer's Injection intervention description Intraoperative fluid therapy performed with LRS (Sodium Lactated Ringer's Injection) intervention arm group label list intervention arm group label Sodium Lactated Ringer's Injection group outcomes module primary outcome list primary outcome primary outcome measure Postoperative acute renal injury primary outcome description The incidence of AKI at 28 days after surgery (Acute kidney injury is defined and graded according to KIDGO 2012) primary outcome time frame 28 days after surgery eligibility module eligibility criteria Inclusion Criteria: ASA grade Ⅰ-Ⅲ. patients aged between 20 and 70, signed informed consent form, and are willing to participate in the study. BMI ≤ 30kg/m2. elective major abdominal surgery for the first time (radical resection of ovarian cancer, radical resection of cervical cancer, radical resection of gastric cancer, radical resection of colorectal cancer, radical resection of bladder tumor and radical resection of prostate tumor). NYHA cardiac function grade Ⅰ-Ⅲ. the function of liver and kidney is normal before operation. the blood coagulation function was normal before operation. hemoglobin > 70g/L. sinus rhythm was detected by electrocardiogram and there were no other malignant arrhythmias. Exclusion Criteria: Emergency surgery. liver and kidney surgery. complicated with chronic respiratory diseases and FEV1/FVC < 70%. the operation time is less than 2 hours. patients with mental illness or cognitive impairment. uncontrolled hypertension with blood pressure higher than 180 × 100mmHg. patients with hypothyroidism. pregnant or lactating patients. - healthy volunteers No gender All minimum age 20 Years maximum age 70 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Shiyong Li central contact role Contact central contact phone 18062154189 central contact e mail shiyongli@hust.edu.cn overall official list overall official overall official name Shiyong Li overall official affiliation Tongji Hospital overall official role Principal Investigator location list location location facility Tongji hospital location status Recruiting location city Wuhan location state Hubei location zip 27-430030 location country China location contact list location contact location contact name Pu Zhou, Phd location contact role Contact location contact phone 86-27-83663250 i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000058186 condition mesh term Acute Kidney Injury condition mesh id D000014947 condition mesh term Wounds and Injuries condition ancestor list condition ancestor condition ancestor id D000051437 condition ancestor term Renal Insufficiency condition ancestor id D000007674 condition ancestor term Kidney Diseases condition ancestor id D000014570 condition ancestor term Urologic Diseases condition browse leaf list condition browse leaf condition browse leaf id M28151 condition browse leaf name Acute Kidney Injury condition browse leaf as found Acute Kidney Injury condition browse leaf relevance high condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf as found Injury condition browse leaf relevance high condition browse leaf id M25871 condition browse leaf name Renal Insufficiency condition browse leaf relevance low condition browse leaf id M9850 condition browse leaf name Kidney Diseases condition browse leaf relevance low condition browse leaf id M16471 condition browse leaf name Urologic Diseases condition browse leaf relevance low condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04835038
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full study rank 61217 study protocol section identification module n c t id NCT04839341 org study id info org study id APL-106-01 organization org full name Apollomics Inc. org class INDUSTRY brief title Study to Evaluate PK and Safety With Uproleselan Combined With Chemotherapy to Treat Chinese R/R AML Patients official title A Phase I, Open-labeled Multicenter Study to Determine Pharmacokinetics, Safety, Tolerability and Efficacy of Uproleselan in Combination With Chemotherapy in Chinese Patients With Relapsed/Refractory Acute Myeloid Leukemia status module status verified date September 2021 overall status Recruiting expanded access info has expanded access No start date struct start date February 24, 2021 start date type Actual primary completion date struct primary completion date December 31, 2022 primary completion date type Anticipated completion date struct completion date February 28, 2023 completion date type Anticipated study first submit date March 22, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date September 14, 2021 last update post date struct last update post date September 16, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Apollomics Inc. lead sponsor class INDUSTRY collaborator list collaborator collaborator name Zhejiang CrownMab Biotech Co. Ltd collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This study will evaluate the safety and tolerability of uproleselan(GMI-1271), a specific E-selectin antagonist, and characterize the pharmacokinetic (PK) profile of uproleselan, in combination with chemotherapy to treat Chinese relapsed/refractory AML patients. detailed description This study is a multicenter open-labelled study conducted in subjects with relapsed or refractory AML in China. The study includes the following phases: screening phase, induction phase, consolidation phase baseline, consolidation phase and follow-up period. Screening phase: This study will enroll 12 subjects, who are 18 to 60 years (inclusive) at the time of signing the Informed Consent Form (ICF), and with the diagnosis as relapsed or refractory AML. Screening is conducted 21 days to 2 days before administration, and signed ICF by the subject must be obtained before screening. Baseline period: The baseline period is 1 day before study drug administration. Induction treatment: During the induction phase, subjects will receive 8 consecutive days of uproleselan treatment and 5 consecutive days of MEC (mitoxantrone, etoposide, and cytarabine combined regimen) chemotherapy. Consolidation baseline: The baseline of the consolidation phase is 1 day before the treatment administration of the consolidation phase. Consolidation treatment: Subjects who met the criteria for consolidation treatment started the consolidation period at the 29th day of the previous treatment cycle at the earliest and the 65th day at the latest. Follow-up period: Each subject should complete the following follow-up stage: (1) Response evaluation to determine remission to the induction treatment (induction period); (2) EOT assessment after completing the last consolidation treatment cycle; (3) Death. Survival and long-term follow-up, including initiation of new anti-leukemia treatment (within 6 months after the last uproleselan/placebo administration), recurrence, HSCT and survival events, monthly (±14 days) for 2 years after the end of treatment, and afterwards quarterly (±14 days). The longest survival follow-up time is 3 years (calculated from the start of treatment). conditions module condition list condition Relapsed/Refractory AML keyword list keyword AML design module study type Interventional phase list phase Phase 1 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 12 enrollment type Anticipated arms interventions module arm group list arm group arm group label A Phase I, open-labeled multicenter study arm group type Experimental arm group description Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) arm group intervention list arm group intervention name Drug: Uproleselan intervention list intervention intervention type Drug intervention name Uproleselan intervention description A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin intervention arm group label list intervention arm group label A Phase I, open-labeled multicenter study intervention other name list intervention other name GMI-1271 outcomes module primary outcome list primary outcome primary outcome measure Peak plasma concentration (Tmax) primary outcome description To assess the pharmacokinetic profile in patients with relapsed/refractory AML. primary outcome time frame 14 days primary outcome measure Peak plasma concentration (Cmax) primary outcome description To assess the pharmacokinetic profile in patients with relapsed/refractory AML. primary outcome time frame 14 days primary outcome measure Area under the plasma concentration-time curve from time zero to 12 hours (AUC0-12) primary outcome description To assess the pharmacokinetic profile in patients with relapsed/refractory AML. primary outcome time frame 14 days primary outcome measure The area under the plasma concentration-time curve (AUC0-t) from time zero to the last measurable time point primary outcome description To assess the pharmacokinetic profile in patients with relapsed/refractory AML. primary outcome time frame 14 days primary outcome measure The Incidence of Adverse Events primary outcome description Number of participants with an AE. primary outcome time frame Up to 10 months primary outcome measure The tolerance of participants with relapsed/refractory AML. primary outcome description Number of participants could tolerate the Uproleselan combined with chemotherapy. primary outcome time frame Up to 10 months secondary outcome list secondary outcome secondary outcome measure OS secondary outcome description Defined as the period from when the subject receives the first dose of the study drug to death from any cause; secondary outcome time frame Up to 3 years secondary outcome measure Remission rate (rate of CR, CR/CRi and CR/CRh) secondary outcome description Defined as the rate of subjects who reach CR, CR/CRi and CR/CRh; secondary outcome time frame Up to 60 days secondary outcome measure CTCAE grade 3 and 4 oral mucositis secondary outcome description The incidence of CTCAE grade 3 and 4 oral mucositis during the treatment duration. secondary outcome time frame Up to 254 days eligibility module eligibility criteria Inclusion Key Criteria: ≥18 years and ≤60 years in age AML (including secondary AML) diagnosed as per WHO standards (2008). For refractory AML, only cytarabine/daunorubicin(or Idarubicin) as can be applied repeatedly(maximal twice) as induction, no other chemotherapy are allowed to be applied Venatoclax /hypomethylation drug [HMA] can be used before and after chemotherapy. For relapse AML, it must be the first or second relapse, and remain untreated. Certain regimens (Venatoclax/HMA, Venetoclax/LDAC, HMA single agent) and FLT3 inhibitors, tyrosine kinase inhibitors, IDH1/IDH2 inhibitors or similar targeted inhibitors used alone are not considered cytotoxic chemotherapy are allowed. ECOG performance status score is 0 to 2. Stable hemodynamics and good organ function and good organ function. Exclusion key Criteria: Patients with acute promyelocytic leukemia, acute leukemia of ambiguous lineage (biphenotypic leukemia), chronic myeloid leukemia with myeloid blast crisis, or secondary refractory AML. Active signs or symptoms of CNS involvement by malignancy. Stem cell transplantation ≤4 months prior to dosing. Any immunotherapy or radiotherapy therapy within 28 days of dosing; any other experimental therapy or chemotherapy within 14 days of dosing. Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing. Inadequate organ function. Abnormal liver function. Known active infection with hepatitis A, B, or C, or human immunodeficiency virus. Moderate kidney dysfunction (glomerular filtration rate <45 mL/min). Uncontrolled acute life-threatening bacterial, viral, or fungal infection. Clinically significant cardiovascular disease. Major surgery within 4 weeks of dosing. healthy volunteers No gender All minimum age 18 Years maximum age 60 Years std age list std age Adult contacts locations module central contact list central contact central contact name Zhejiang CrownMab Ltd. central contact role Contact central contact phone 0571-83521933 central contact e mail ClinicalTrialsChina@apollomicsinc.com central contact name Qian Li central contact role Contact central contact phone 0571-83521933 central contact e mail Qian.li@apollomicsinc.com overall official list overall official overall official name Jianxiang Wang, Phd overall official affiliation Investigator overall official role Principal Investigator location list location location facility Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College location status Recruiting location city Tianjin location state Tianjin location zip 300020 location country China location contact list location contact location contact name Jianxiang Wang, Phd location contact role Contact location contact phone 022-23909120 location contact e mail wangjx@medmail.com.cn location facility The First Affiliated Hospital of Zhejiang University location status Recruiting location city Hangzhou location country China location contact list location contact location contact name Jie Jin, PhD location contact role Contact location contact phone 057187236685 location contact e mail jiej0503@zju.edu.cn i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M10097 condition browse leaf name Leukemia condition browse leaf relevance low condition browse leaf id M10107 condition browse leaf name Leukemia, Myeloid condition browse leaf relevance low condition browse leaf id M17279 condition browse leaf name Leukemia, Myeloid, Acute condition browse leaf relevance low condition browse leaf id T3995 condition browse leaf name Myeloid Leukemia condition browse leaf relevance low condition browse leaf id T182 condition browse leaf name Acute Myeloid Leukemia condition browse leaf relevance low condition browse leaf id T188 condition browse leaf name Acute Non Lymphoblastic Leukemia condition browse leaf relevance low condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M5918 intervention browse leaf name Cytarabine intervention browse leaf relevance low intervention browse leaf id M7343 intervention browse leaf name Etoposide intervention browse leaf relevance low intervention browse leaf id M341694 intervention browse leaf name Etoposide phosphate intervention browse leaf relevance low intervention browse leaf id M11060 intervention browse leaf name Mitoxantrone intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Analg intervention browse branch name Analgesics
NCT04839341
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full study rank 61684 study protocol section identification module n c t id NCT04833270 org study id info org study id JS-CT-2021-01 organization org full name Jaseng Hospital of Korean Medicine org class OTHER brief title Pragmatic Randomized Controlled Trial of Non-pharmacological Treatment for Lumbar Disc Herniation : A Pilot Study official title Pragmatic Randomized Controlled Trial of Non-pharmacological Treatment for Lumbar Disc Herniation : A Pilot Study status module status verified date September 2022 overall status Completed expanded access info has expanded access No start date struct start date July 9, 2021 start date type Actual primary completion date struct primary completion date June 28, 2022 primary completion date type Actual completion date struct completion date June 28, 2022 completion date type Actual study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date September 26, 2022 last update post date struct last update post date September 27, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Kyoung Sun Park responsible party investigator title Chief, Clinical study center responsible party investigator affiliation Jaseng Hospital of Korean Medicine lead sponsor lead sponsor name Jaseng Hospital of Korean Medicine lead sponsor class OTHER collaborator list collaborator collaborator name Korea Institute of Oriental Medicine collaborator class OTHER_GOV oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary This is a 2-arm parallel pragmatic randomized controlled trial that will compare non-pharmacological treatment with pharmacological therapy for lumbar disc herniation. detailed description Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (15:15) for non-pharmacological treatment and pharmacological treatment group. Participants of each group will receive twice a week for total 8 weeks of intervention. This is a pragmatic randomized controlled trial, so physicians will have medical decision making according to each participant's conditions and choose the specific intervention and dosage of pharmacological and non-pharmacological treatment. conditions module condition list condition Lumbar Disc Prolapse With Radiculopathy design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Outcomes Assessor enrollment info enrollment count 30 enrollment type Actual arms interventions module arm group list arm group arm group label KM non-pharmacological treatment group arm group type Experimental arm group description Non-pharmacological treatment including Korean medicine will be implemented to the participants twice a week for total 8 weeks. The specific intervention will be determined according to the physician's choice, and information will be recorded in the case report form. arm group intervention list arm group intervention name Other: KM non-pharmacological treatment group arm group label Pharmacological treatment group arm group type Active Comparator arm group description Pharmacological treatment will be implemented to the participants twice a week for total 8 weeks. The specific intervention will be determined according to the physician's choice, and information will be recorded in the case report form. arm group intervention list arm group intervention name Other: Pharmacological treatment group intervention list intervention intervention type Other intervention name KM non-pharmacological treatment group intervention description This is a pragmatic setting, and specific intervention is not determined prior to the study. Non-pharmacological treatment including Korean medicine, such as acupuncture, electroacupuncture and chuna, etc, will be chosen by professional physician according to the medical condition of each subject. intervention arm group label list intervention arm group label KM non-pharmacological treatment group intervention type Other intervention name Pharmacological treatment group intervention description This is a pragmatic setting, and specific intervention is not determined prior to the study. The pharmacological treatment will be chosen by professional physician according to the medical condition of each subject. intervention arm group label list intervention arm group label Pharmacological treatment group outcomes module primary outcome list primary outcome primary outcome measure Numeric rating scale (NRS) of radiating pain in lower extremities primary outcome description NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'. primary outcome time frame week 9 secondary outcome list secondary outcome secondary outcome measure Numeric rating scale (NRS) of radiating pain in lower extremities secondary outcome description NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'. secondary outcome time frame week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27 secondary outcome measure Numeric rating scale (NRS) of low-back pain secondary outcome description NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'. secondary outcome time frame week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27 secondary outcome measure Visual analogue scale (VAS) of leg radiating pain secondary outcome description Visual analogue scale of radiating leg pain, minimum 0 to maximum 100,which is a higher score means a worse outcome. secondary outcome time frame week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27 secondary outcome measure Visual analogue scale (VAS) of low-back pain secondary outcome description Visual analogue scale of radiating leg pain, minimum 0 to maximum 100,which is a higher score means a worse outcome. secondary outcome time frame week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27 secondary outcome measure Oswestry Disability Index (ODI) secondary outcome description ODI is a functional disability questionnaire. The possible range of eachitem score is 0 to 5. Total score range is 0 (better outcome) to 100 (worse outcome) secondary outcome time frame week 1, 5, 9, 14, 27 secondary outcome measure Fear-Avoidance Beliefs Questionnaire (FABQ) secondary outcome description FABQ is one of pateint-reported outcome questionnaire which consists of total 16 questions. Through FABQ, the investigator can evaluate fear avoidance responses, especially in physical and occupational activity domain for patients with low-back pain secondary outcome time frame week 1, 9, 14, 27 secondary outcome measure Patient Global Impression of Change (PGIC) secondary outcome description Participants rate the improvement after treatment on a 7-point Likert scale(1, very much improved; 2, much improved; 3, minimally improved; 4, nochange; 5, minimally worse; 6, much worse; or 7, very much worse.) secondary outcome time frame week 9, 14, 27 secondary outcome measure Short Form-12 Health Survey version 2 (SF-12 v2) secondary outcome description The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life. secondary outcome time frame week 1, 5, 9, 14, 27 secondary outcome measure EuroQol-5 Dimension (EQ-5D-5L) secondary outcome description The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about) secondary outcome time frame week 1, 5, 9, 14, 27 eligibility module eligibility criteria Inclusion Criteria: Numeric rating scale (NRS) score of radiating pain 5 or more for recent 3 serial days. Onset time of radiating pain occurred within 12 weeks. Radiologically diagnosed with lumbar disc herniation in lumbar spine magnetic resonance imaging (L-spine MRI) 19-70 years old participants who agreed and signed informed consent form Exclusion Criteria: Spine metastasis of cancer, acute fracture of spine, or spine dislocation Progressive neurologic deficits or severe neurologic deficits Soft tissue diseases that can induce low back pain(ie. cancer, fibromyalgia, rheumatoid arthritis, gout,etc) Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc) Concurrent use of steroids, immunosuppressants, orpsychotropic medications or any other medication that can interrupt the study result Hemorrhagic disease, severe diabetes or taking anticoagulant drug Participants who took NSAIDs or pharmacopuncture within 1 week Pregnant or lactating women Participants who had undergone lumbar surgery within 3 months Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial Participants who can not write informed consent Participants who is difficult to participate in the trial according to investigator's decision healthy volunteers No gender All minimum age 19 Years maximum age 70 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Kyoung Sun Park, KMD,Ph.D overall official affiliation Jaseng Hospital of Korean Medicine overall official role Principal Investigator location list location location facility Jaseng Hospital of Korean Medicine location city Seoul location zip 06110 location country Korea, Republic of i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007405 condition mesh term Intervertebral Disc Displacement condition mesh id D000011843 condition mesh term Radiculopathy condition mesh id D000011391 condition mesh term Prolapse condition ancestor list condition ancestor condition ancestor id D000020763 condition ancestor term Pathological Conditions, Anatomical condition ancestor id D000010523 condition ancestor term Peripheral Nervous System Diseases condition ancestor id D000009468 condition ancestor term Neuromuscular Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000006547 condition ancestor term Hernia condition ancestor id D000013122 condition ancestor term Spinal Diseases condition ancestor id D000001847 condition ancestor term Bone Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition browse leaf list condition browse leaf condition browse leaf id M9591 condition browse leaf name Intervertebral Disc Displacement condition browse leaf as found Disc Prolapse condition browse leaf relevance high condition browse leaf id M8777 condition browse leaf name Hernia condition browse leaf relevance low condition browse leaf id M13413 condition browse leaf name Prolapse condition browse leaf as found Prolapse condition browse leaf relevance high condition browse leaf id M13841 condition browse leaf name Radiculopathy condition browse leaf as found Radiculopathy condition browse leaf relevance high condition browse leaf id M21672 condition browse leaf name Pathological Conditions, Anatomical condition browse leaf relevance low condition browse leaf id M12584 condition browse leaf name Peripheral Nervous System Diseases condition browse leaf relevance low condition browse leaf id M11563 condition browse leaf name Neuromuscular Diseases condition browse leaf relevance low condition browse leaf id M15071 condition browse leaf name Spinal Diseases condition browse leaf relevance low condition browse leaf id M4278 condition browse leaf name Bone Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases
NCT04833270
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full study rank 61334 study protocol section identification module n c t id NCT04837820 org study id info org study id 20-124 organization org full name Memorial Sloan Kettering Cancer Center org class OTHER brief title The Effect of Acupuncture on Cancer-Related Cognitive Difficulties official title Effect and Mechanism of Acupuncture for Cancer-related Cognitive Difficulties (ENHANCE) status module status verified date October 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 6, 2021 start date type Actual primary completion date struct primary completion date April 2025 primary completion date type Anticipated completion date struct completion date April 2025 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 19, 2022 last update post date struct last update post date October 21, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Memorial Sloan Kettering Cancer Center lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this study is to test whether acupuncture can improve cognitive difficulties and insomnia in survivors of breast cancer. Researchers will compare the effects of real acupuncture with those of placebo acupuncture and wait-list acupuncture. This study will also look at insomnia's link to cognitive difficulties. All study participants (receiving real acupuncture, placebo acupuncture, or wait-list acupuncture) will complete study questionnaires and/or have cognitive testing at Weeks 0, 4, 10, 14 and 26. After the Week 26 visit, your participation in this study will end. If you are assigned to receive placebo acupuncture or wait-list acupuncture, you will have the option of receiving up to 10 real acupuncture treatments within the six months after the study finishes. conditions module condition list condition Breast Cancer keyword list keyword Acupuncture Cancer-Related Cognitive Difficulties 20-124 design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description 3-arm, parallel, randomized controlled trial comparing acupuncture vs. sham acupuncture vs. wait-list control. design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 260 enrollment type Anticipated arms interventions module arm group list arm group arm group label Acupuncture arm group type Experimental arm group description The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol. arm group intervention list arm group intervention name Procedure: Acupuncture Other: Questionnaires arm group label Sham Acupuncture (SA) arm group type Placebo Comparator arm group description The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol. arm group intervention list arm group intervention name Procedure: Sham Acupuncture Other: Questionnaires arm group label Wait-List Control arm group type Experimental arm group description During the 26-week waiting period, the CRC will contact patients in the WLC group at the same frequency as the acupuncture groups with respect to data collection. Patients in the WLC group will continue to receive their standard medical care as prescribed by their oncologists/primary care physicians. WLC patients will be compensated with real acupuncture treatments after Week 26 (end of study). arm group intervention list arm group intervention name Other: Wait-List Control (WLC) Other: Questionnaires intervention list intervention intervention type Procedure intervention name Acupuncture intervention description Each participant will receive 10 treatments of acupuncture (real or sham) over the course of 10 weeks (i.e. one treatment a week) with a +/- 14-day window. intervention arm group label list intervention arm group label Acupuncture intervention type Procedure intervention name Sham Acupuncture intervention description Each participant will receive 10 treatments of acupuncture (real or sham) over the course of 10 weeks (i.e. one treatment a week) with a +/- 14-day window. intervention arm group label list intervention arm group label Sham Acupuncture (SA) intervention type Other intervention name Wait-List Control (WLC) intervention description Patients in the WLC group will continue to receive their standard medical care as prescribed by their oncologists/primary care physicians. intervention arm group label list intervention arm group label Wait-List Control intervention type Other intervention name Questionnaires intervention description Will follow patients for 26 weeks from baseline and collect assessments at baseline and Weeks 4, 10, 14, and 26. Average time to complete the surveys is 30 minutes, which has been judged to be acceptable with minimal missing data. intervention arm group label list intervention arm group label Acupuncture Sham Acupuncture (SA) Wait-List Control outcomes module primary outcome list primary outcome primary outcome measure cognitive difficulties primary outcome description measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) instrument. FACT-Cog is a 37-item questionnaire with 4 subscales: perceived cognitive difficulties, impact on quality of life, comments from others, and perceived cognitive abilities. The FACT-Cog perceived cognitive impairment subscale (Cronbach's α 0.94) will be the primary outcome for the study. A subscale score is calculated by summing the 18 items of the subscale. The subscale score ranges from 0 to 72. primary outcome time frame 26 weeks eligibility module eligibility criteria Inclusion Criteria: English-proficient adult women with a history of stage 0, I, II, or III breast cancer Free of oncologic disease by clinical examination or history Moderate or greater CRCD as indicated by a score of "quite a bit" or "very much" on at least one of the two items that specifically assess concentration and memory on the EORTC QLQ-C30 (version 3.0) Report that cognitive functions worsened since cancer diagnosis by replying "Yes" to all 3 questions Do you think or feel that your memory or mental ability has gotten worse since your cancer diagnosis? Do you think your mind isn't as sharp now as it was before your cancer diagnosis? Do you feel like these problems have made it harder to function on your job or take care of things around the home? Presence of insomnia symptoms as indicated by a score ≥8 on the ISI134 Willing to adhere to all study-related procedures, including randomization to one of the 3 possible choices: acupuncture, sham acupuncture, or wait-list control Exclusion Criteria: Metastatic breast cancer (stage IV) Less than 1 month since completion of surgery, chemotherapy or radiation therapy Greater than 10 years since most recent breast cancer diagnosis Use of acupuncture for sleep or cognitive symptom management within the past 3 months Diagnosis of Alzheimer's disease, vascular dementia, Parkinson disease, or other organic brain disorder Score of >10 indicative of overt dementia on the Blessed Orientation-Memory-Concentration (BOMC)135 Primary psychiatric disorder not in remission As per medical record or self-report, history of stroke or head injury requiring visit to the emergency room or hospitalization, with confirmed structural lesion on neuroimaging, persistent cognitive difficulties impacting work or daily life, or required cognitive rehabilitation. Pre-existing, uncorrectable visual or auditory impairment that would preclude ability to complete the assessments Initiation or change in hormonal or targeted therapy within the past 4 weeks Plans to initiate or change hormonal or targeted therapy in the coming 8 weeks Altered dose of somnogenic medication (e.g. hypnotics, sedatives, antidepressants) in past 8 weeks Enrolled or plans to enroll on another MSK neurocognitive study Unable to provide informed consent for himself/herself healthy volunteers No gender Female gender based Yes gender description Breast Cancer minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Jun Mao, MD,MSCE central contact role Contact central contact phone 646-888-0866 central contact e mail maoj@mskcc.org central contact name Kevin Liou, MD central contact role Contact central contact phone 646-888-0864 overall official list overall official overall official name Jun Mao, MD, MSCE overall official affiliation Memorial Sloan Kettering Cancer Center overall official role Principal Investigator location list location location facility Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) location status Recruiting location city Commack location state New York location zip 11725 location country United States location contact list location contact location contact name Jun Mao, MD, MSCE location contact role Contact location contact phone 646-888-0866 location facility Memorial Sloan Kettering Westchester (Limited Protocol Activities) location status Recruiting location city Harrison location state New York location zip 10604 location country United States location contact list location contact location contact name Jun Mao, MD, MSCE location contact role Contact location contact phone 646-888-0863 location facility Memorial Sloan Kettering Cancer Center location status Recruiting location city New York location state New York location zip 10065 location country United States location contact list location contact location contact name Jun Mao, MD, MSCE location contact role Contact location contact phone 646-888-0866 location contact name Kevin Liou, MD location contact role Contact location contact phone 646-888-0864 location facility Memorial Sloan Kettering Nassau (Limited Protocol Activities) location status Recruiting location city Uniondale location state New York location zip 11553 location country United States location contact list location contact location contact name Jun Mao, MD, MSCE location contact role Contact location contact phone 646-888-0866 references module see also link list see also link see also link label Memorial Sloan Kettering Cancer Center see also link u r l http://www.mskcc.org/mskcc/html/44.cfm i p d sharing statement module i p d sharing Yes i p d sharing description Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org. derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M4372 condition browse leaf name Breast Neoplasms condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04837820
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full study rank 61745 study protocol section identification module n c t id NCT04832477 org study id info org study id H20-0117 organization org full name University of Connecticut org class OTHER brief title Assessing the PrEP Care Cascade Among Black Men and Transwomen in the Southeastern US official title PrEP Connected Study status module status verified date January 2022 overall status Recruiting expanded access info has expanded access No start date struct start date September 30, 2021 start date type Actual primary completion date struct primary completion date September 30, 2023 primary completion date type Anticipated completion date struct completion date September 30, 2024 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date January 11, 2022 last update post date struct last update post date January 13, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Lisa Eaton responsible party investigator title Professor responsible party investigator affiliation University of Connecticut lead sponsor lead sponsor name University of Connecticut lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The proposed research aims to assess the multiple forms and paths of stigma and substance use as they relate to pre-exposure prophylaxis (PrEP) use for HIV prevention. How stigma and an evolving public health landscape impact PrEP use among Black sexual minorit men who use substances is unknown. The current application focuses on addressing critical and novel questions to improving the essential building blocks of biomedical prevention approaches by providing crucial information for enhancing interventions to lower HIV prevalence among substance using Black sexual minority men. detailed description HIV incidence among Black men who have sex with men (BMSM) in the southeastern United States is one of the highest in the world. Our research team has conducted studies with BMSM in Atlanta that have demonstrated 35% HIV prevalence and over 5% annual HIV incidence. Although PrEP is highly effective for preventing HIV transmission, it is not reaching BMSM. The failures in our ability to engage BMSM in PrEP use are highly problematic given the alarming rates of HIV transmission among this group. Of particular concern is the impact of substance use as a barrier in PrEP linkage, uptake, adherence, and persistence. Substance use is common among BMSM in our study, with 43% (n=204/474) reporting recent substance use. Further complicating PrEP use is the potential impact of COVID-19 on health care access, health care infrastructure, and sex behavior. The need to better understand PrEP use in the context of our new health care landscape is critical to making advances in PrEP use. At this point, assessing how substance use impacts PrEP use is challenging because PrEP implementation is so low among this group. The current study aims to provide substance using BMSM with evidence-based PrEP engagement counseling to address barriers to accessing PrEP (not for intervention testing, but for facilitating PrEP use) and to assess the multiple forms and paths of stigma and substance use as they relate to PrEP linkage, uptake, adherence, and persistence. The investigators propose using the HIV Stigma Framework as a conceptual model for investigating the intersecting pathways of stigma drivers and stigma mechanisms as they relate to PrEP use among substance using BMSM. Aim 1: Enroll a prospective cohort of N=500 BMSM who test HIV negative and test substance use positive on toxicology testing, and provide evidence-based PrEP engagement counseling to facilitate access to PrEP care. Aim 2: Conduct psychosocial and health care access assessments every 2-months for 18-months, and conduct HIV/STI testing and dried blood spot testing for TFV-DP every 3-months for 18-months. Aim 3: Using data collected from Aims 1 and 2, model stigma pathways of advancing and reverting along the PrEP cascade (i.e., linkage, uptake, adherence, persistence), with these pathways mediated by health care access and moderated by substance use. Achieving the aims will provide critical insight for translating and adapting interventions to enhance potency and durability for individuals at exceedingly elevated risk for HIV. conditions module condition list condition HIV Seropositivity Substance Use STI Stigma, Social design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 500 enrollment type Anticipated arms interventions module arm group list arm group arm group label Stigma Counseling for PrEP Access arm group type Other arm group description Behavioral counseling arm group intervention list arm group intervention name Behavioral: Stigma counseling for PrEP use intervention list intervention intervention type Behavioral intervention name Stigma counseling for PrEP use intervention description This counseling consists of a single-session (45 minute) delivered by trained peer counselors. The primary aims and relevant content areas for counseling are: (1) Assessing and discussing factors known to be drivers of emotional barriers to accessing health care. This counseling aim has two main sub-components: (a) participants will be asked about their prior experiences with accessing health care and their concerns regarding future access, and (b) the counseling will focus on creating personal agency around needing to prioritize one's health. (2) Evaluating concerns around discussing PrEP with health care providers. The counseling combines motivational interviewing with medical decisional balance, which focuses on points to consider when evaluating PrEP. (3) Promoting resiliency beliefs and positive adaptation. For this objective the counselor works with the participant to establish PrEP use goals and problem-solving strategies. intervention arm group label list intervention arm group label Stigma Counseling for PrEP Access outcomes module primary outcome list primary outcome primary outcome measure PrEP Use primary outcome description TFV-DP (Tenofovir Diphosphate) biological testing for PrEP pill taking will be assessed. TFV-DP measured at >700 fmol will be interpreted as having taken ≥4 doses/week, and TFV-DP measured at >700 fmol over two consecutive time points will be interpreted as persistence to taking PrEP. The lower scale limit is 0 and upper scale limit is approximately around 2500. Higher values indicate greater medication adherence to PrEP pills. primary outcome time frame 12 months secondary outcome list secondary outcome secondary outcome measure PrEP stigma secondary outcome description Questionnaire to assess stigma related psychosocial variables will be used to assess secondary outcomes. This questionnaire is based measures provided in the HIV Stigma Framework for assessing HIV related stigma (i.e., prejudice, stereotypes, discrimination, enacted stigma, anticipated stigma, and internalized stigma). Responses to the scale items range from 1=strongly disagree to 6=strongly agree, with higher scores indicating a higher number of experiences of stigma. secondary outcome time frame 12 months eligibility module eligibility criteria Inclusion Criteria: Men (based on male sex assignment at birth) Age 18 or older Identify as Black, African-American, Afro-Brazilian, Afro-Carribean, or African diaspora, Report condomless anal sex with man in past six months Test HIV negative Report recent (<3 months) substance use Positive drug toxicology for substance use Exclusion Criteria: - healthy volunteers Accepts Healthy Volunteers gender Male minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Moira Kalichman, MSW central contact role Contact central contact phone 404-892-3500 central contact e mail moira.kalichman@perceptionsprogram.org central contact name Lisa Eaton, PhD central contact role Contact central contact e mail lisa.eaton@uconn.edu overall official list overall official overall official name Lisa A Eaton, PhD overall official affiliation University of Connecticut overall official role Principal Investigator location list location location facility SHARE Project location status Recruiting location city Atlanta location state Georgia location zip 30303 location country United States location contact list location contact location contact name Ayeisha Cole location contact role Contact location contact e mail ayeisha.cole@perceptionprograms.org i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006679 condition mesh term HIV Seropositivity condition mesh id D000019966 condition mesh term Substance-Related Disorders condition ancestor list condition ancestor condition ancestor id D000064419 condition ancestor term Chemically-Induced Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition ancestor id D000015658 condition ancestor term HIV Infections condition ancestor id D000086982 condition ancestor term Blood-Borne Infections condition ancestor id D000003141 condition ancestor term Communicable Diseases condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000015229 condition ancestor term Sexually Transmitted Diseases, Viral condition ancestor id D000012749 condition ancestor term Sexually Transmitted Diseases condition ancestor id D000016180 condition ancestor term Lentivirus Infections condition ancestor id D000012192 condition ancestor term Retroviridae Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000007153 condition ancestor term Immunologic Deficiency Syndromes condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M17402 condition browse leaf name HIV Infections condition browse leaf relevance low condition browse leaf id M2674 condition browse leaf name Acquired Immunodeficiency Syndrome condition browse leaf relevance low condition browse leaf id M8894 condition browse leaf name HIV Seropositivity condition browse leaf as found HIV Seropositivity condition browse leaf relevance high condition browse leaf id M20990 condition browse leaf name Substance-Related Disorders condition browse leaf as found Substance Use condition browse leaf relevance high condition browse leaf id M29455 condition browse leaf name Chemically-Induced Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M2595 condition browse leaf name Blood-Borne Infections condition browse leaf relevance low condition browse leaf id M14710 condition browse leaf name Sexually Transmitted Diseases condition browse leaf relevance low condition browse leaf id M17085 condition browse leaf name Sexually Transmitted Diseases, Viral condition browse leaf relevance low condition browse leaf id M17792 condition browse leaf name Lentivirus Infections condition browse leaf relevance low condition browse leaf id M14178 condition browse leaf name Retroviridae Infections condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M9351 condition browse leaf name Immunologic Deficiency Syndromes condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC25 condition browse branch name Substance Related Disorders condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions
NCT04832477
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full study rank 61588 study protocol section identification module n c t id NCT04834518 org study id info org study id 018620RMC & 18420COM organization org full name Rabin Medical Center org class OTHER brief title Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus official title Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus acronym ADIR status module status verified date February 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date March 31, 2027 primary completion date type Anticipated completion date struct completion date March 31, 2027 completion date type Anticipated study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date August 8, 2022 last update post date struct last update post date August 11, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Rabin Medical Center lead sponsor class OTHER collaborator list collaborator collaborator name JDRF collaborator class UNKNOWN oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary A national screening program for children aged 9-18 months that will be tested for the presence of islet autoantibodies.Up to 50,000 Children will be screened by their primary care physician all over Israel. The initial screening will be done at the age of 1 year (in conjunction with the routinely collection of blood for CBC ) and repeated at ages 2-5 years. Antibodies will be measured in capillary blood samples using the Ultrasensitive Antibody Detection by Agglutination-PCR (ADAP) technology developed by Enable Biosciences, which is 1,000-10,000 times more analytically sensitive than currently used methods. By using this innovative technology in such a large cohort, the study is anticipated to detect antibodies at an unprecedented earlier age.When positive in the screening, multiple antibodies will be confirmed by a second sample analyzed by the ADAP technology. In addition, multiple antibodies will be also measured using a radio-binding assay (RBA) of a venous blood sample for investigational purpose only. Children with confirmed multiple antibodies (stage 1 or 2 T1D) will be followed up routinely for the appearance of clinical signs of diabetes (HbA1c, repeated OGTT, monitoring of urine and blood glucose where indicated) and will be invited along with their families to attend an educational program. This program will include diabetes education emphasizing on DKA prevention as well as stress assessment for the families involved and stress alleviating interventions. The analysis and storage of the samples will be done in a single screening center at Schneider Children's Medical Center of Israel. conditions module condition list condition Type1diabetes keyword list keyword autoantibodies screening design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 50000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Negative result at the first autoantibodies screening test arm group description Participants will be invited to repeat the screening test at the age of 2-5 years old arm group label Positive result at the first or second autoantibodies screening test arm group description Participants will be monitored annually for risk of type 1 diabetes. (HbA1c, repeated OGTT, monitoring of urine and blood glucose where indicated) Families will attend diabetes-educational program emphasizing on DKA prevention Stress assessment for the families involved and stress alleviating interventions when required. outcomes module primary outcome list primary outcome primary outcome measure Diagnosis of presymptomatic type 1 diabetes primary outcome description Presymptomatic type 1 diabetes, defined as positive for 2 or more islet autoantibodies (GADA, IA-2A, and IAA) or those with high levels of a single antibody in both the screening and confirmation samples or in the screening sample plus a diagnosis of diabetes prior to obtaining the conformation sample. Presymptomatic type 1 diabetes will be classified as stage 1, 2, or 3: Stage 1 will be defined as 2 or more islet autoantibodies or high levels of a single antibody and normal glucose tolerance based on OGTT results. (not including patients with only a single antibody who have first degree relative with type 1 diabetes) Stage 2 will be defined as 1 or more islet autoantibodies accompanied by dysglycemia (fasting plasma glucose of 110-125 mg/dL or impaired 2-hour plasma glucose of 140- 199 mg/dL and/or plasma glucose ≥200 mg/dL at intermediate time points [30, 60, 90 minutes]) based on OGTT results. Stage 3 will be defined according to the American Diabetes Association criteria primary outcome time frame End of screening and follow-up period-4 years after obtaining the first screening test primary outcome measure Frequency of Diabetic Ketoacidosis on the clinical presentation of Type 1 Diabetes primary outcome time frame End of screening and follow-up period-4 years after obtaining the first screening test secondary outcome list secondary outcome secondary outcome measure The average age of islet autoantibody seroconversion secondary outcome time frame End of screening and follow-up period-4 years after obtaining the first screening test secondary outcome measure The rate of islet autoantibody seroconversion secondary outcome time frame End of screening and follow-up period-4 years after obtaining the first screening test secondary outcome measure The rate of progression from pre-symptomatic T1D to clinical diabetes secondary outcome time frame End of screening and follow-up period-4 years after obtaining the first screening test eligibility module eligibility criteria Inclusion Criteria: Informed consent obtained before any trial-related activities Children aged 9-18 months at first screening. Exclusion Criteria: Known diagnosis of diabetes (Type 1 or other) gender All minimum age 9 Months maximum age 18 Months std age list std age Child study population Children from the general population of all over Israel, aged 9-18 months arriving to the routine blood test for CBC or to any other routine visit to the community pediatrician. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Moshe Phillip, Prof central contact role Contact central contact phone 972-544-795-995 central contact e mail moshe.phillip@phillipmd.com central contact name Alona Hamou, MSc central contact role Contact central contact phone 972-545-950-277 central contact e mail alonah@clalit.org.il overall official list overall official overall official name Moshe Phillip, Prof overall official affiliation Schneider Children's Medical Center overall official role Study Director location list location location facility Soroka Medical Center location status Recruiting location city Beer-Sheva location country Israel location contact list location contact location contact name Eli Hershkovitz, Prof location contact role Contact location contact e mail EliH@clalit.org.il location contact name Eli Hershkovitz, Prof location contact role Principal Investigator location facility Rambam Medical Center location status Not yet recruiting location city Haifa location country Israel location contact list location contact location contact name Naim Shehadeh, Prof location contact role Contact location contact e mail n_shehadeh@rambam.health.gov.il location contact name Naim Shehadeh, Prof location contact role Principal Investigator location facility Hadassah medical Center location status Not yet recruiting location city Jerusalem location country Israel location contact list location contact location contact name David Zangen, Dr location contact role Contact location contact e mail ZANGEND@hadassah.org.il location contact name David Zangen, Dr location contact role Principal Investigator location facility Schneider Children Medical Center of Israel location status Recruiting location city Petach-Tikva location country Israel location contact list location contact location contact name Alona Hamou, MSc location contact role Contact location contact phone 972-545-950-277 location contact e mail alonah@clalit.org.il location contact name Moshe Phillip, Prof location contact role Principal Investigator location contact name Tal Oron, Dr. location contact role Sub-Investigator location facility Child Health Centers all over Israel (clalit Health Services) location status Recruiting location city Petah-Tikva location country Israel location contact list location contact location contact name Avner Cohen, Prof location contact role Contact location contact phone 972-523-870-827 location contact e mail hermanc@tauex.tau.ac.il location contact name Avner Cohen, Prof location contact role Principal Investigator location facility Sheba Medical Center location status Not yet recruiting location city Ramat-Gan location country Israel location contact list location contact location contact name Orit Hamiel, Prof location contact role Contact location contact e mail Orit.Hamiel@sheba.health.gov.il location contact name Orit Hamiel, Prof location contact role Principal Investigator location facility Dana-Duek children's hospital location status Not yet recruiting location city Tel-Aviv location country Israel location contact list location contact location contact name Yael Lebenthal, Prof location contact role Contact location contact e mail yaelleb@tlvmc.gov.il location contact name Yael Lebenthal, Prof location contact role Principal Investigator i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003920 condition mesh term Diabetes Mellitus condition mesh id D000003922 condition mesh term Diabetes Mellitus, Type 1 condition ancestor list condition ancestor condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf as found Diabetes Mellitus condition browse leaf relevance high condition browse leaf id M6269 condition browse leaf name Diabetes Mellitus, Type 1 condition browse leaf as found Type 1 Diabetes condition browse leaf relevance high condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3777 intervention browse leaf name Autoantibodies intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04834518
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full study rank 61529 study protocol section identification module n c t id NCT04835285 org study id info org study id NCPHOI-2019-09 organization org full name Federal Research Institute of Pediatric Hematology, Oncology and Immunology org class OTHER brief title MRI T2* Mapping of Myocardium, Liver, Pancreas and Pituitary Gland official title Clinical Study of MRI Assessment of Iron in the Myocardium, Liver, Pancreas and Pituitary Gland in Patients With High Transfusion Dependence on the Packed Red Blood Cells status module status verified date March 2021 overall status Recruiting expanded access info has expanded access No start date struct start date January 21, 2020 start date type Actual primary completion date struct primary completion date January 21, 2023 primary completion date type Anticipated completion date struct completion date January 21, 2023 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Federal Research Institute of Pediatric Hematology, Oncology and Immunology lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary All patients were investigated using a 3T MRI and 1,5 T MRI scanners. For myocardium, pancreas and pituitary gland iron overload quantification in children we have used special sequences for T2*-mapping. Miocardium, pancreas and pituitary gland T2* relaxometry maps were calculated automatically by commertial application ReportCARD Functool (GE Healthcare) and integrated Philips T2* maps. Then for selected ROI T2* data acquisition in milisecond [ms] were performed and calculated automatically. detailed description All patients were investigated using a 3T MRI scanner (Philips Achieva) and 1,5 T MRI scanner (GE Signa) with 8-channel surface coil for body scanning. For myocardium, pancreas and pituitary gland iron overload quantification in children we have used special sequences for T2*-mapping based on fast gradient echo sequences - multi-phase fast gradient echo and ultrashort gradient echo (uTE) in axial and coronary plane. For breath-hold acquisition due to failure of communication and invariable behavior some children received anaesthetic support with mechanical ventilation. Miocardium, pancreas and pituitary gland T2* relaxometry maps were calculated automatically by commertial application ReportCARD Functool (GE Healthcare) and integrated Philips T2* maps. The placement of region of interest (ROI) in target organ were performed by following criterion: for the myocardium - in the interventricular septum in short axis plane; for the pancreas - in corpus in axial plane; for the pituitary gland - in adenohypophysis; for all organs the area of large and small blood vessels, which can introduce distortions of the obtained results were excluded. Then for selected ROI T2* data acquisition in milisecond [ms] were performed and calculated automatically by approximating the attenuation curve with the highest likelihood method. conditions module condition list condition Iron Overload keyword list keyword Iron T2* mapping MRI relaxometry transfusion design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Diagnostic design masking info design masking None (Open Label) enrollment info enrollment count 152 enrollment type Anticipated arms interventions module intervention list intervention intervention type Diagnostic Test intervention name Npf. intervention description 3T MRI and 1,5 T MRI scanners. For myocardium, pancreas and pituitary gland iron overload outcomes module primary outcome list primary outcome primary outcome measure Compare and contrast T2* values in pancreas, myocardium, and pituitary gland in patients with transfusion-dependent anemia using 1.5T and 3T MRI scanner. primary outcome time frame Initially, after one month of chelation therapy primary outcome measure Compare and contrast T2* values in pancreas, myocardium, and pituitary gland in patients with transfusion-dependent anemia using 1.5T and 3T MRI scanner. primary outcome time frame up to 1 week after the end of chelation therapy secondary outcome list secondary outcome secondary outcome measure To calculate the T2* values in the pancreas, myocardium and pituitary gland in patients with transfusion-dependent anemia on the 3T scanner. secondary outcome time frame point1: Initially, after one month of chelation therapy; point 2: every week during 1 month for the stability checking point 3: ut to 1 week at the end of the study secondary outcome measure To develop a control method for iron assessment using aqueous solutions of iron nanoparticles by calculating T2* values on 3T and 1,5T scanners. secondary outcome time frame point1: Initially, after one month of chelation therapy; point 2: every week during 1 month for the stability checking point 3: ut to 1 week at the end of the study secondary outcome measure Draw up T2* values recalculating tables for a 3T scanner based on the distribution of T2* values for a 1.5T scanner in pancreas, myocardium, and pituitary gland in patients with transfusion-dependent anemia. secondary outcome time frame point1: Initially, after one month of chelation therapy; point 2: every week during 1 month for the stability checking point 3: ut to 1 week at the end of the study eligibility module eligibility criteria Inclusion criteria: Age under 25 y.o.; A history of transfusion-dependent anemia of various origins. indications for the appointment of chelation therapy Non-inclusion criteria: Age over 25 y.o. The number of RBC transfusions previously received by the patient is less than 10 Exclusion criteria: Absolute contraindications to magnetic resonance imaging (pacemaker, ferromagnetic implants, etc.); Refusal to sign the informed consent. healthy volunteers No gender All minimum age 6 Years maximum age 25 Years std age list std age Child Adult contacts locations module central contact list central contact central contact name Evelina f Nazarova central contact role Contact central contact phone +79161133945 central contact e mail evelina.nazarova@fccho-moscow.ru overall official list overall official overall official name Galina f Tereshchenko, PhD overall official affiliation Chief radiology department overall official role Study Director location list location location facility Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology location status Recruiting location city Moscow location state Samory-Mashela,1 location zip 11198 location country Russian Federation location contact list location contact location contact name Evelina f Nazarova location contact role Contact location contact phone +79161133945 location contact e mail evelina.nazarova@fccho-moscow.ru i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000019190 condition mesh term Iron Overload condition ancestor list condition ancestor condition ancestor id D000019189 condition ancestor term Iron Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition browse leaf list condition browse leaf condition browse leaf id M12943 condition browse leaf name Pituitary Diseases condition browse leaf relevance low condition browse leaf id M20331 condition browse leaf name Iron Overload condition browse leaf as found Iron Overload condition browse leaf relevance high condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M20330 condition browse leaf name Iron Metabolism Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M9685 intervention browse leaf name Iron intervention browse leaf relevance low intervention browse leaf id M21707 intervention browse leaf name Pancrelipase intervention browse leaf relevance low intervention browse leaf id M12266 intervention browse leaf name Pancreatin intervention browse leaf relevance low intervention browse leaf id M10262 intervention browse leaf name Liver Extracts intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Micro intervention browse branch name Micronutrients intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Gast intervention browse branch name Gastrointestinal Agents intervention browse branch abbrev Hemat intervention browse branch name Hematinics
NCT04835285
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full study rank 61663 study protocol section identification module n c t id NCT04833543 org study id info org study id HSC-MH-20-0834 organization org full name Memorial Hermann Health System org class OTHER brief title Verticalization Robotic Exoskeleton DoC official title Verticalization With Vestibular Stimulation for Patients With Severe Disorders of Consciousness: A Novel Application of a Robotic Exoskeleton status module status verified date August 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 21, 2021 start date type Actual primary completion date struct primary completion date December 2021 primary completion date type Anticipated completion date struct completion date December 2021 completion date type Anticipated study first submit date March 23, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date August 31, 2021 last update post date struct last update post date September 1, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Memorial Hermann Health System lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Mobilization, specifically verticalization, has been shown to play a role in enhancing consciousness. Vestibular stimulation has the potential to influence the neural substrate of consciousness, but this modality has not been thoroughly explored. The primary aim of this study is to compare the influence of verticalization with and without vestibular input on level of consciousness in patients experiencing disorders of consciousness (DoC). conditions module condition list condition Brain Injuries Disorder of Consciousness design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Outcomes Assessor enrollment info enrollment count 10 enrollment type Anticipated arms interventions module arm group list arm group arm group label Tilt Table arm group type Active Comparator arm group intervention list arm group intervention name Other: Tilt Table arm group label Robotic Mobility Device (REX) arm group type Experimental arm group intervention list arm group intervention name Other: Robotic Mobility Device (REX) intervention list intervention intervention type Other intervention name Robotic Mobility Device (REX) intervention description A self supporting robotic mobility device (REX) will be utilized. It is a Class I device, and it is classified as powered exercise equipment meant for anyone that requires use of a wheelchair for mobility who has difficulty with standing and walking. The participant will be supported securely within the device using a pelvic harness, and thigh and calf cuffs. The device will be operated under the supervision of a device trained physical therapist and therapy technician. The participant will be transferred into the device in a seated position. Once aligned properly and strapped in, the participant will be passively moved by the device into standing and walking positions. To provide constant vestibular input, a variety of mobility functions will be performed including standing, sitting, walking, turning, shuffling (side-stepping), and backwards stepping. intervention arm group label list intervention arm group label Robotic Mobility Device (REX) intervention type Other intervention name Tilt Table intervention description A tilt table is a table with a footplate that can be tilted at different angles. The participant will lie flat on the table and straps will be placed to stabilize the trunk and lower extremities. The inclination of the tilt table will be adjusted from a horizontal to a vertical position to allow the participant to attain and maintain a standing or partial-standing position. Sessions will be supervised by a physical therapist and therapy technician. intervention arm group label list intervention arm group label Tilt Table outcomes module primary outcome list primary outcome primary outcome measure Coma Recovery Scale-Revised (CRS-R) primary outcome description scores range from 0-23; higher scores mean a better outcome primary outcome time frame through study completion; an average of 8 weeks secondary outcome list secondary outcome secondary outcome measure Modified Ashworth Scale (MAS) secondary outcome description scores range from 0-4; lower scores mean a better outcome secondary outcome time frame through study completion; an average of 8 weeks eligibility module eligibility criteria Inclusion Criteria: unresponsive wakefulness syndrome/vegetative state (UWS/VS) or minimally conscious state (MCS) following traumatic brain injury (TBI), intracerebral bleeding, ischemic infarction, or hypoxic brain injury Medical clearance by a physician 18-75 years old Mobilization into standing for at least 10 minutes without signs of orthostasis Exclusion Criteria: Time since injury less than 4 weeks or more than 6 months Mobilization into standing lasts more than 30 minutes Severe osteoporosis Muscle tone that prevents joint motion (Modified Ashworth Scale (MAS) 4) Unstable fractures Decubiti on areas contacted by robotic mobility device (i.e. heels, tibia, greater trochanter, ischial tuberosity, sacrum) Inability to fit device requirements* Height 4'8"-6'4", Weight 88-222 lbs., Hip Flexion 0-90˚, Knee Flexion 0-90˚, Plantigrade healthy volunteers No gender All minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module location list location location facility TIRR Memorial Hermann location status Recruiting location city Houston location state Texas location zip 77030 location country United States location contact list location contact location contact name Elizabeth Anderl location contact role Contact location contact phone 713-797-7370 location contact e mail elizabeth.anderl@memorialhermann.org derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001930 condition mesh term Brain Injuries condition mesh id D000003244 condition mesh term Consciousness Disorders condition ancestor list condition ancestor condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000006259 condition ancestor term Craniocerebral Trauma condition ancestor id D000020196 condition ancestor term Trauma, Nervous System condition ancestor id D000014947 condition ancestor term Wounds and Injuries condition ancestor id D000019954 condition ancestor term Neurobehavioral Manifestations condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000019965 condition ancestor term Neurocognitive Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M4359 condition browse leaf name Brain Injuries condition browse leaf as found Brain Injury condition browse leaf relevance high condition browse leaf id M5620 condition browse leaf name Consciousness Disorders condition browse leaf as found Disorders of Consciousness condition browse leaf relevance high condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse leaf id M8501 condition browse leaf name Craniocerebral Trauma condition browse leaf relevance low condition browse leaf id M21176 condition browse leaf name Trauma, Nervous System condition browse leaf relevance low condition browse leaf id M20979 condition browse leaf name Neurobehavioral Manifestations condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id M20989 condition browse leaf name Neurocognitive Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M4006 intervention browse leaf name Benzocaine intervention browse leaf relevance low intervention browse leaf id T433 intervention browse leaf name Tannic Acid intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Ot intervention browse branch name Other Dietary Supplements
NCT04833543
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full study rank 61649 study protocol section identification module n c t id NCT04833725 org study id info org study id 2020-2Z40917 organization org full name Peking University Third Hospital org class OTHER brief title Screening and Early Warning of Chronic Obstructive Pulmonary Disease Combined With Sleep Respiratory Disease Based on Medical Internet of Things official title Screening and Early Warning of Chronic Obstructive Pulmonary Disease Combined With Sleep Respiratory Disease Based on Medical Internet of Things status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date January 1, 2020 start date type Actual primary completion date struct primary completion date December 31, 2021 primary completion date type Anticipated completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 2, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Peking University Third Hospital lead sponsor class OTHER collaborator list collaborator collaborator name Beijing Municipal Health Commission collaborator class OTHER_GOV collaborator name BOE Technology Group Co. Ltd. collaborator class UNKNOWN oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Chronic obstructive pulmonary disease (COPD) is a common disease that endangers people's health, causing severe economic and treatment burdens. Sleep breathing disease, as a complication of COPD, increases the hospitalization rate and mortality of COPD. At present, community doctors have insufficient knowledge of COPD and its complications, and they also lack standardized screening and related disease management capabilities. This trail intends to use IoT medical technology to screen for COPD combined with sleep breathing diseases. It can establish a two-way referral channel between primary community hospitals and higher-level hospitals, which provides early warning services for COPD combined with sleep breathing diseases. This trial explores the impact of sleep breathing disease on COPD's acute exacerbation, which improves the understanding of COPD patients combined with sleep breathing diseases. It also improves COPD management and its complications control at the community-level and reduces COPD patients' potential risks and treatment burdens. It also explores tiered diagnosis and treatment models for COPD, promotes the construction of intelligent IoT infrastructure, and enhances standardized diagnosis and treatment of COPD at the grassroots level in China. detailed description This study is a multi-center joint study, which mainly consists of two parts. First, a cross-sectional observational study was adopted to recruit patients with stable COPD in multiple centers. The COPD's diagnostic criteria follow diagnostic guidelines in China, and the patients were selected among 40-80 years old. Note that we excluded patients who cannot use IoT's mobile applications and cannot complete sleep monitoring and follow-up visits. All patients collect sleep monitoring information through wearable devices, together with demographic characteristics, pulmonary function tests, blood routines, biochemistry, electrocardiogram, chest radiograph, COPD assessment scale, modified British Medical Research Association dyspnea index, St. George's Quality of Life Questionnaire, Sleep Apnea Clinical Score, Berlin Questionnaire, Epworth Sleepiness Scale, Etc. This study estimates patient health status from the collected information, then diagnoses sleep apnea and calculates sleep apnea prevalence. Specifically, we build standards from the analysis of sleep monitoring information, and we form an OSA screening model by applying machine learning algorithms. Second, we establish a COPD cohort joined with sleep breathing disease, where we select COPD patients meeting the diagnostic criteria for sleep breathing disease. All patients use wearable devices and IoT technology for information collection and data management. We also build the early warning platform, and it allows flexible adjustment on the COPD plan according to individual differences and community differences. This tudy requires followed up visit once a month. By observing the number of hospitalizations, the incidence of acute exacerbations, and other secondary observation indicators of COPD patients, the early warning platform can analyze COPD's acute exacerbations combined with sleep respiratory disease. We develop the disease and prognosis model for COPD patients with SAO by applying machine learning algorithms on the previous platform. conditions module condition list condition COPD Osa Syndrome design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 680 enrollment type Anticipated arms interventions module arm group list arm group arm group label COPD combined with OSA arm group description All patients collect sleep monitoring information through wearable devices, together with demographic characteristics, pulmonary function tests, blood routines, biochemistry, electrocardiogram, chest radiograph, COPD assessment scale, modified British Medical Research Association dyspnea index, St. George's Quality of Life Questionnaire, Sleep Apnea Clinical Score, Berlin Questionnaire, Epworth Sleepiness Scale, Etc. This study estimates patient health status from the collected information, then diagnoses sleep apnea and calculates sleep apnea prevalence. arm group intervention list arm group intervention name Device: wearable devices intervention list intervention intervention type Device intervention name wearable devices intervention description All patients use wearable devices and IoT technology for information collection and data management. Specifically, we build standards from the analysis of sleep monitoring information, and we form an OSA screening model by applying machine learning algorithms. intervention arm group label list intervention arm group label COPD combined with OSA outcomes module primary outcome list primary outcome primary outcome measure Build the screening model of COPD combined with OSA - 12 months primary outcome description We build the screening model of COPD combined with OSA by applying machine learning techniques to the monitoring information. And we evaluate its effectiveness on the patient status estimation, where the morbidity of COPD with OSA is measured through the screening model. primary outcome time frame 12 months primary outcome measure Build the prognosis model of COPD combined with OSA - 12 months primary outcome description We build the prognosis model of COPD combined with OSA and integrate it into the early warning platform. It observes the incidence rate of acute exacerbation COPD and other indexes primary outcome time frame 12 months eligibility module eligibility criteria Inclusion Criteria: The diagnostic criteria for COPD are in line with the diagnostic guidelines for COPD in China from 40 to 80 years old. Exclusion Criteria: Patients who cannot use IoT's mobile applications and cannot complete sleep monitoring and follow-up visits. healthy volunteers No gender All minimum age 40 Years maximum age 80 Years std age list std age Adult Older Adult study population Patients with stable COPD from Peking University Third Hospital, Beijing Haidian Hospital, Beijing Zhongguancun Hospital, Beixiaguan Community Health Service Center and Huayuan Road Community Health Service Center. sampling method Non-Probability Sample contacts locations module location list location location facility Peking University Third Hospital location status Recruiting location city Beijing location country China location contact list location contact location contact name Yahong Chen location contact role Contact location contact phone +8601082266699 location contact e mail chenyahong@vip.sina.com i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000008173 condition mesh term Lung Diseases, Obstructive condition mesh id D000029424 condition mesh term Pulmonary Disease, Chronic Obstructive condition mesh id D000012120 condition mesh term Respiration Disorders condition mesh id D000012140 condition mesh term Respiratory Tract Diseases condition ancestor list condition ancestor condition ancestor id D000008171 condition ancestor term Lung Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M22602 condition browse leaf name Pulmonary Disease, Chronic Obstructive condition browse leaf as found Chronic Obstructive Pulmonary Disease condition browse leaf relevance high condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M10322 condition browse leaf name Lung Diseases, Obstructive condition browse leaf as found Obstructive Pulmonary Disease condition browse leaf relevance high condition browse leaf id M14109 condition browse leaf name Respiration Disorders condition browse leaf as found Respiratory Disease condition browse leaf relevance high condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf as found Respiratory Disease condition browse leaf relevance high condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04833725
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full study rank 61429 study protocol section identification module n c t id NCT04836585 org study id info org study id 2020-0090-B organization org full name Women's College Hospital org class OTHER brief title eMBC for Perinatal Depression and Anxiety official title Technology-Enabled (Electronic) Measurement Based Care(MBC) for Perinatal Depression and Anxiety: A Pilot Randomized Controlled Trial acronym eMBC status module status verified date February 2022 overall status Recruiting expanded access info has expanded access No start date struct start date January 4, 2022 start date type Actual primary completion date struct primary completion date November 2022 primary completion date type Anticipated completion date struct completion date December 2022 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date February 3, 2022 last update post date struct last update post date February 4, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Simone Vigod responsible party investigator title Chief, Department of Psychiatry responsible party investigator affiliation Women's College Hospital lead sponsor lead sponsor name Women's College Hospital lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Depression and anxiety that occur around the time of pregnancy can adversely impact a person's health and well-being, and their child's health and development. Fewer than 20% of affected people are adequately treated, often because of under-use of medications. Measurement based care (MBC) is a model of care where psychiatric symptoms are routinely tracked and reviewed together by a patient and their doctor to better manage symptoms. It has not been systematically evaluated for perinatal depression and anxiety. The overall objective of this study is to test the feasibility of MBC in this population to inform a future large randomized controlled trial for definitive evaluation. In order to avoid known barriers to MBC, electronic MBC (eMBC) will be used. With eMBC, patients can enter their symptoms into their electronic medical records before their appointment so that they can be evaluated by their doctor during the appointment. In this pilot study, the feasibility of recruitment for a future efficacy trial, including feasibility of recruitment, and retention, acceptability and adherence to a trial protocol will be evaluated. detailed description A parallel group randomized controlled trial (RCT) will be conducted. Eligible and consenting patients with depression and/or anxiety will be randomized in a 1:1 ratio to either the eMBC condition or a control condition. The study will be stratified by diagnosis (major depressive disorder vs generalized anxiety disorder). 80 patient participants will be recruited from the Reproductive Life Stages (RLS) Program at Women's College Hospital. The active treatment phase of the study is 12 weeks. Outcomes will be measured online and by phone at 4-, 8-, and 12- weeks post-randomization. Following the completion of the study, some participants will be asked to participate in follow-up interviews. RLS psychiatrists whose patients participated in the study will participate in a focus group. conditions module condition list condition Depression, Postpartum Anxiety keyword list keyword Measurement based care design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Health Services Research design masking info design masking Double design masking description The RA randomizing the participant will be not be blinded to the treatment allocation because they have to inform the provider of the treatment allocation. This RA will not be collecting outcome measures. The RA collecting outcome measures will be blinded to the treatment allocation. design who masked list design who masked Investigator Outcomes Assessor enrollment info enrollment count 80 enrollment type Anticipated arms interventions module arm group list arm group arm group label Care As Usual arm group type No Intervention arm group description Participants in the control condition are followed by their RLS psychiatrists during the study as per usual care. arm group label eMBC Intervention arm group type Experimental arm group description Participants in the intervention arm are followed by their RLS psychiatrists during the study at clinically appropriate intervals with the addition of eMBC. arm group intervention list arm group intervention name Other: eMBC Intervention intervention list intervention intervention type Other intervention name eMBC Intervention intervention description The treating psychiatrist sets a flag in the patient's electronic chart that prompts them to complete self-report scales prior to each appointment: Edinburgh Postnatal Depression Scale (EPDS) for symptoms of depression and anxiety PROMIS Neuro-QOL and PROMIS ASCQ-Me Social Functioning Short form for measures of functional capacity Adapted Frequency, Intensity, and Burden Side Effects Rating (FIBSER) Scale for participants taking antidepressant medication to measure side effects Patient participants and providers can view the questionnaire results over time in the electronic chart item by item, and/or see them in graphical format. During the clinical encounter, the provider and patient participant review the results of the scales, as part of a collaborative re-evaluation of the treatment plan. intervention arm group label list intervention arm group label eMBC Intervention outcomes module primary outcome list primary outcome primary outcome measure Feasibility of the trial protocol: Recruitment primary outcome description Measures of recruitment include rate of recruitment and reason for non-participation. primary outcome time frame 12 weeks post randomization primary outcome measure Feasibility of the trial protocol: Participant Acceptability primary outcome description Surveys and interviews will be used to capture data relating to perceived usefulness and acceptability of technology and its perceived benefit. These will be combined to capture an overall acceptability measure. primary outcome time frame 12 weeks post randomization primary outcome measure Feasibility of the trial protocol: Provider Acceptability primary outcome description Surveys and focus groups will be used to capture data relating to usability and tolerability of eMBC in clinical practice. primary outcome time frame 12 weeks post randomization primary outcome measure Feasibility of the trial protocol: Adherence primary outcome description Chart review will be used to measure the number of visits, the proportion of visits with completed scales and which scales were completed, proportion of visits where review of symptom scales was documented in the patient record, the proportion of visits where providers recorded that they used the data from symptom scales to inform the treatment, and proportion of visits where medication was started, changed, dose adjusted or stopped. These will be combined to provide an overall measure of how closely the intervention protocol was followed. primary outcome time frame 12 weeks post randomization secondary outcome list secondary outcome secondary outcome measure Clinical outcomes - clinician-assessed depression symptoms secondary outcome description The Montgomery-Asberg Depressive Rating Scale (MADRS) is a standard clinician-administered measure of depressive symptoms with good reliability and validity in clinical populations. The MADRS has good responsiveness to the effect of anti-depressant treatments. The 17-items are rated on a 7-point (0-6) (score range 0-60), with lower scores indicating fewer symptoms of depression and higher scores indicating a higher degree of symptoms. secondary outcome time frame 4, 8, and 12 weeks post randomization secondary outcome measure Clinical outcomes - self-report depression symptoms secondary outcome description Depressive symptoms will be measured using the Edinburgh Postnatal Depressive Scale (EPDS), a self-report scale that has been validated for use in pregnancy and postpartum. EPDS scores range from 0 to 30. EPDS scores >12 are predictive of a diagnosis of depression, with higher scores indicating more severe symptoms. secondary outcome time frame each clinical appointment up to 12 weeks post randomization secondary outcome measure Clinical outcomes - anxiety symptoms secondary outcome description The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-rated measure that assesses the severity of symptoms of anxiety. The HAM-A has good reliability and validity in populations with depression and anxiety. The 14-items are rated on a 5-point scale (0-4) with scores ranging from 0-56. Scores <17 indicate mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe symptoms. secondary outcome time frame 4, 8, and 12 weeks post randomization secondary outcome measure Clinical outcomes - functional capacity secondary outcome description The PROMIS Neuro-QOL - Ability to Participate in Social Roles and Activities - Short Form is a brief self-report tool used to measure functional capacity. secondary outcome time frame each clinical appointment up to 12 weeks post randomization secondary outcome measure Clinical outcomes - social functioning secondary outcome description PROMIS ASCQ-Me Social Functioning - Short Form is a brief self-report tool used to measure functional capacity. secondary outcome time frame each clinical appointment up to 12 weeks post randomization secondary outcome measure Clinical outcomes - antidepressant side effects secondary outcome description The Frequency, Intensity, and Burden Side Effects Rating (FIBSER) Scale is a brief 3-item scale used to measure three domains of anti-depressant side effects including frequency, intensity, and burden of antidepressant medication. The last question relating to burden is scored 0-6 with low scores indicating no medication adjustment is needed, and high scores indicating that the dose needs to be decreased or the medication changed. secondary outcome time frame each clinical appointment up to 12 weeks post randomization other outcome list other outcome other outcome measure Co-variates: Participants other outcome description Sociodemographic, obstetrical, and psychiatric history data will be collected on the Baseline Questionnaire. A diagnostic phone interview using the Mini International Neuropsychiatric Interview (MINI) will be conducted for major depressive disorder, obsessive-compulsive disorder, panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder and post-traumatic stress disorder. other outcome time frame Baseline other outcome measure Co-variates: Providers other outcome description Provider co-variates including age, number of years in practice, familiarity with technology, use of technology in their practice, and use of MBC prior to this study. other outcome time frame Baseline eligibility module eligibility criteria Inclusion Criteria: Age ≥18 Currently pregnant or mother* of a live infant 0-12 months of age and living at the same residence *Through natural birth, adoption, surrogacy, including cis women, non-binary and transgender people in all their diversity Major depressive disorder or generalized anxiety disorder confirmed by RLS psychiatrist EPDS >12 at enrollment Recommended antidepressant medication for major depressive disorder or generalized anxiety disorder by the treating RLS psychiatrist Are expected to be under the care of a RLS psychiatrist and have 3+ RLS psychiatric visits in the upcoming 12 weeks Exclusion Criteria: Active suicidal ideation, substance abuse or dependence Current or past mania or psychosis or current major depressive episode with psychosis 4. Incapable of consenting to participation 5. Unable to read or unable to speak English healthy volunteers No gender Female minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Simone Vigod, MD, MSc central contact role Contact central contact phone 416-323-6400 central contact phone ext 4080 central contact e mail simone.vigod@wchospital.ca overall official list overall official overall official name Renu Gupta, MD overall official affiliation Women's College Hospital overall official role Principal Investigator location list location location facility Women's College Hospital location status Recruiting location city Toronto location state Ontario location zip M5S 1B2 location country Canada location contact list location contact location contact name Simone Vigod location contact role Contact location contact phone 4163236400 location contact phone ext 4080 location contact e mail simone.vigod@wchospital.ca location contact name Simone Vigod location contact role Principal Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000019052 condition mesh term Depression, Postpartum condition mesh id D000003863 condition mesh term Depression condition mesh id D000003866 condition mesh term Depressive Disorder condition mesh id D000001008 condition mesh term Anxiety Disorders condition ancestor list condition ancestor condition ancestor id D000001526 condition ancestor term Behavioral Symptoms condition ancestor id D000019964 condition ancestor term Mood Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition ancestor id D000011644 condition ancestor term Puerperal Disorders condition ancestor id D000011248 condition ancestor term Pregnancy Complications condition browse leaf list condition browse leaf condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf as found Depression condition browse leaf relevance high condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf as found Depression condition browse leaf relevance high condition browse leaf id M3476 condition browse leaf name Anxiety Disorders condition browse leaf as found Anxiety condition browse leaf relevance high condition browse leaf id M20229 condition browse leaf name Depression, Postpartum condition browse leaf as found Depression, Postpartum condition browse leaf relevance high condition browse leaf id M3970 condition browse leaf name Behavioral Symptoms condition browse leaf relevance low condition browse leaf id M20988 condition browse leaf name Mood Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse leaf id M13651 condition browse leaf name Puerperal Disorders condition browse leaf relevance low condition browse leaf id M13279 condition browse leaf name Pregnancy Complications condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3399 intervention browse leaf name Antidepressive Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev PsychDr intervention browse branch name Psychotropic Drugs intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04836585
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full study rank 61261 study protocol section identification module n c t id NCT04838769 org study id info org study id U0693 organization org full name Boston Scientific Corporation org class INDUSTRY brief title REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men official title Water Vapor Thermotherapy vs. Combination Pharmacotherapy for Symptomatic Benign Prostatic Hyperplasia Refractory to Alpha Blocker Monotherapy in Sexually Active Men: A Multicenter Randomized Controlled Trial acronym VAPEUR RCT status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date September 15, 2021 start date type Actual primary completion date struct primary completion date January 2025 primary completion date type Anticipated completion date struct completion date January 2026 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date November 28, 2022 last update post date struct last update post date November 30, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Boston Scientific Corporation lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device Yes is u s export Yes description module brief summary The study objective is to compare water vapor thermotherapy with the REZŪM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monotherapy in sexually active men. detailed description STUDY OBJECTIVE - To compare water vapor thermotherapy with the REZŪM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monotherapy in sexually active men. STUDY DESIGN - Multicenter open-label randomized controlled parallel-group post-market trial. STUDY TREATMENTS AND RANDOMIZATION - Subjects will be randomly assigned to REZŪM or dual drug therapy treatments; 1:1 randomization via the electronic data capture (EDC) system. Both treatments are commercially available. Subjects randomized to receive the REZŪM treatment will receive standardized treatment and subjects randomized to dual drug therapy will receive the local formulary preferred choice of urinary selective alpha blocker and 5-alpha reductase inhibitor. VISIT SCHEDULE - Study visits are at: enrollment/baseline, treatment, 3 months, 6 months, and yearly follow-up through 2 years. conditions module condition list condition Benign Prostatic Hyperplasia (BPH) keyword list keyword Prostate REZŪM Water vapor thermotherapy Lower urinary tract symptoms BPH LUTS design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 394 enrollment type Anticipated arms interventions module arm group list arm group arm group label REZŪM arm group type Active Comparator arm group description Subjects randomized to receive the REZŪM treatment will receive standardized treatment, following the Instruction for Use (IFU). The REZŪM System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men with a prostate volume ≥ 30 ml. The REZŪM System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe. 1:1 randomization will occur via the electronic data capture (EDC) system. arm group intervention list arm group intervention name Device: REZŪM arm group label Dual Drug Therapy arm group type Active Comparator arm group description Subjects assigned to dual drug therapy will be treated with the local formulary preferred choice of commercially available urinary selective alpha blocker and 5-alpha reductase inhibitor. This arm will therefore represent local standard of care. arm group intervention list arm group intervention name Drug: alpha blocker and 5-alpha reductase inhibitor intervention list intervention intervention type Device intervention name REZŪM intervention description Subjects randomized to receive the REZŪM treatment will receive standardized treatment, following the Instruction for Use. intervention arm group label list intervention arm group label REZŪM intervention type Drug intervention name alpha blocker and 5-alpha reductase inhibitor intervention description Subjects assigned to dual drug therapy will be treated with the local formulary preferred choice of commercially available urinary selective alpha blocker and 5-alpha reductase inhibitor. This arm will therefore represent local standard of care. intervention arm group label list intervention arm group label Dual Drug Therapy intervention other name list intervention other name Dual Drug Therapy outcomes module primary outcome list primary outcome primary outcome measure International Prostate Symptom Score (IPSS) change primary outcome description Primary Statistical Hypothesis: Change in IPSS score will be compared between groups. IPSS score ranges from 0 to 35 with higher scores indicating worse symptoms. primary outcome time frame From Baseline to 12 months primary outcome measure Male Sexual Health Questionnaire (MSHQ) total score change primary outcome description Change in MHSQ score will be compared between groups. MHSQ score ranges from 0 to 125 with higher scores indicating better outcomes. primary outcome time frame From Baseline to 12 months secondary outcome list secondary outcome secondary outcome measure Disease Progression secondary outcome description Disease progression, defined as occurrence of any of the following: Surgical retreatment for LUTS/BPH Urinary retention requiring urinary catheterization after 90 days post-treatment IPSS increase from baseline by ≥ 4 points Introduction of a new drug agent to treat LUTS/BPH secondary outcome time frame End of available follow-up, up to 24 months eligibility module eligibility criteria Inclusion Criteria: Sexually active male subjects ≥ 45 years of age who have persistent non-neurogenic lower urinary tract symptoms refractory to first-line treatment with single agent Alpha Adrenoceptor Antagonist therapy Subject is willing and able to answer all domains of MSHQ Completed IPSS questionnaire with score ≥ 13 within 6 months prior to enrollment Peak urinary flow rate (Qmax): ≤ 15 ml/sec with minimum voided volume of ≥ 150 ml within 6 months prior to enrollment Post-void residual (PVR) ≤250 ml within 6 months prior to enrollment Prostate volume ≥ 30 ml as measured by transrectal ultrasound or Magnetic Resonance Imaging within 3 months prior to enrollment Subject is willing and capable of providing informed consent Subject is willing and capable of participating in all visits associated with this study at an approved clinical study site and at the intervals defined by this Clinical Investigational Plan (CIP) France subjects only: subjects must be affiliated to national security insurance Exclusion Criteria: Inability to participate in full duration of study Prior surgical treatment for BPH Increased risk of bleeding Presence of Genitourinary Cancer or other pelvic cancer Functional issues with bladder Presence of active infection in genitourinary tract Structural and Anatomic issues with urinary tract and renal function Concomitant Drug Therapy Temporal restraints and risks for general anaesthesia or comorbidity that would elevate risk of participation healthy volunteers No gender Male gender based Yes gender description Sexually active male subjects minimum age 45 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Caroline Beaudoint central contact role Contact central contact phone +32479904163 central contact e mail Caroline.Beaudoint@bsci.com central contact name Teresa Takle-Flach central contact role Contact central contact phone +19529306000 central contact e mail Teresa.Takle-Flach@bsci.com overall official list overall official overall official name Romain Mathieu, Professor overall official affiliation CHU Rennes, Hôpital Pontchaillou overall official role Principal Investigator overall official name Evanguelos Xylinas, Ass. Prof. overall official affiliation Hôpital Bichat overall official role Principal Investigator location list location location facility Centre Hospitalier du Pays d'Aix location status Recruiting location city Aix-en-Provence location country France location contact list location contact location contact name Marc Fourmarier, Dr. location contact role Principal Investigator location facility CHU de Bordeaux location status Not yet recruiting location city Bordeaux location country France location contact list location contact location contact name Grégoire Robert, Pr. location contact role Principal Investigator location facility CHU Henri Mondor location status Not yet recruiting location city Créteil location country France location contact list location contact location contact name Alexandre de la Taille, Pr. location contact role Principal Investigator location facility CHU Grenoble location status Not yet recruiting location city Grenoble location country France location contact list location contact location contact name Jean-Alexandre Long, Pr. location contact role Principal Investigator location facility Centre Hospitalier Universitaire de Lille location status Not yet recruiting location city Lille location country France location contact list location contact location contact name Jonathan Olivier, Dr. location contact role Principal Investigator location facility Hospices Civils de Lyon location status Recruiting location city Lyon location country France location contact list location contact location contact name Hakim Fassi-Fehri, Dr. location contact role Principal Investigator location facility CHU de Nice location status Not yet recruiting location city Nice location country France location contact list location contact location contact name Matthieu Durand, Pr. location contact role Principal Investigator location facility Hôpital Bichat location status Recruiting location city Paris location country France location contact list location contact location contact name Evanguelos Xylinas, Pr. location contact role Principal Investigator location facility Hôpital Cochin location status Not yet recruiting location city Paris location country France location contact list location contact location contact name Nicolas Barry Delongchamps, Pr. location contact role Principal Investigator location facility Institut Mutualiste Montsouris location status Recruiting location city Paris location country France location contact list location contact location contact name Eric Barret, Dr. location contact role Principal Investigator location facility Hôpital privé Francheville location status Recruiting location city Perigueux location country France location contact list location contact location contact name Richard Mallet, Dr. location contact role Principal Investigator location facility Clinique La Croix du Sud location status Recruiting location city Quint-Fonsegrives location country France location contact list location contact location contact name Ambroise Salin, Dr. location contact role Principal Investigator location facility CHU de Rennes location status Recruiting location city Rennes location country France location contact list location contact location contact name Romain Mathieu, Pr. location contact role Principal Investigator location facility Clinique Saint Hilaire location status Recruiting location city Rouen location country France location contact list location contact location contact name Ismaël Galliot, Dr. location contact role Principal Investigator location facility Centre Hospitalier Privé Saint Grégoire location status Recruiting location city Saint-Grégoire location country France location contact list location contact location contact name Sébastien Vincendeau, Dr. location contact role Principal Investigator location facility CHU de Toulouse location status Not yet recruiting location city Toulouse location country France location contact list location contact location contact name Florian Laclergerie, Dr. location contact role Principal Investigator location facility Clinique Pasteur location status Recruiting location city Toulouse location country France location contact list location contact location contact name Vincent Misrai, Dr. location contact role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000011470 condition mesh term Prostatic Hyperplasia condition mesh id D000006965 condition mesh term Hyperplasia condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000011469 condition ancestor term Prostatic Diseases condition browse leaf list condition browse leaf condition browse leaf id M9168 condition browse leaf name Hyperplasia condition browse leaf as found Hyperplasia condition browse leaf relevance high condition browse leaf id M28617 condition browse leaf name Lower Urinary Tract Symptoms condition browse leaf relevance low condition browse leaf id M13486 condition browse leaf name Prostatic Hyperplasia condition browse leaf as found Prostatic Hyperplasia condition browse leaf relevance high condition browse leaf id M13485 condition browse leaf name Prostatic Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000000317 intervention mesh term Adrenergic alpha-Antagonists intervention mesh id D000058891 intervention mesh term 5-alpha Reductase Inhibitors intervention ancestor list intervention ancestor intervention ancestor id D000018674 intervention ancestor term Adrenergic Antagonists intervention ancestor id D000018663 intervention ancestor term Adrenergic Agents intervention ancestor id D000018377 intervention ancestor term Neurotransmitter Agents intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000065088 intervention ancestor term Steroid Synthesis Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000006727 intervention ancestor term Hormone Antagonists intervention ancestor id D000006730 intervention ancestor term Hormones, Hormone Substitutes, and Hormone Antagonists intervention browse leaf list intervention browse leaf intervention browse leaf id M2821 intervention browse leaf name Adrenergic alpha-Antagonists intervention browse leaf as found Drug concentration intervention browse leaf relevance high intervention browse leaf id M28427 intervention browse leaf name 5-alpha Reductase Inhibitors intervention browse leaf as found CAZ-AVI intervention browse leaf relevance high intervention browse leaf id M19899 intervention browse leaf name Adrenergic Agents intervention browse leaf relevance low intervention browse leaf id M19908 intervention browse leaf name Adrenergic Antagonists intervention browse leaf relevance low intervention browse leaf id M19657 intervention browse leaf name Neurotransmitter Agents intervention browse leaf relevance low intervention browse leaf id M8941 intervention browse leaf name Hormones intervention browse leaf relevance low intervention browse leaf id M8940 intervention browse leaf name Hormone Antagonists intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04838769
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full study rank 61603 study protocol section identification module n c t id NCT04834323 org study id info org study id Said Negm organization org full name Zagazig University org class OTHER_GOV brief title Short Term Outcome Of Distal Mesogastric Fixation After Laparoscopic Sleeve Gastrectomy; official title Short Term Outcome Of Distal Mesogastric Fixation After Laparoscopic Sleeve Gastrectomy; A Randomized Control Trial status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date December 1, 2019 start date type Actual primary completion date struct primary completion date December 1, 2020 primary completion date type Actual completion date struct completion date January 1, 2021 completion date type Actual study first submit date March 26, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Said Mohamed Said Abdou Negm responsible party investigator title lecturer of general surgery responsible party investigator affiliation Zagazig University lead sponsor lead sponsor name Zagazig University lead sponsor class OTHER_GOV oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This study included patients who were admitted to investigator's center to do laparoscopic sleeve gastrectomy . Cases were collected in the period from December 2019 to December 2020. Sample size was 84 patients divided into 2 equal groups . Group 1: included 42 patients who were subjected to distal mesogastric fixation after laparoscopic sleeve gastrectomy. Group 2: included 42 patients who were subjected to laparoscopic sleeve gastrectomy alone without distal mesogastric fixation. detailed description Laparoscopic sleeve gastrectomy is one of weight loss operations and widely performed all over the world . although its widely performed ,it has serious complications like leakage and bleeding . The proposed etiology behind leakage after laparoscopic sleeve gastrectomy may be the axial rotation of the stomach owing to loss of abdominal ligament fixation along the greater curvature of the stomach . The mechanism of increased intra-gastric pressure due to axial gastric rotation may put a lot of stress on the staple lines with increased incidence of leakage. Other complications may occur such as vomiting, food intolerance or persistent reflux. Objectives: To assess the effect of distal mesogastric fixation after laparoscopic sleeve gastrectomy to minimize gastric axial rotation and subsequent leakage and other related complications. Patients and methods: investigators included all patients who were subjected to laparoscopic sleeve gastrectomy at investigators' center between December 2019 to December 2020. The study was approved by the research and Ethics committee of our university and performed in accordance with the code of ethics of the world medical association (Declaration of Helsinki) for studies involving humans. A written informed consent was obtained from all participants. Sample size The sample size was calculated using open Epi program using the following data ; confidence interval 95% , power of test 80% , the percent of patients without leak after LSG was 66.6% while after new technique expected to be 95% , odd ratio 9.5% and ratio between two group 1:1; so the calculated sample size was 72 patients , taking into consideration 20% drop outs so the final sample size will be 84 patients divided into 2 equal groups . Group 1: included 42 patients who were subjected to distal mesogastric fixation after laparoscopic sleeve gastrectomy. Group 2: included 42 patients who were subjected to laparoscopic sleeve gastrectomy alone without distal mesogastric fixation. Patients who had no contraindication for laparoscopic surgery (such as patients with no history of abdominal operations), good general condition with American society of anesthesiology (ASA) I & II, and patients with body mass index above 35 were included. investigators excluded patients who had bad general condition (ASA ≥3), patients with gastro esophageal reflux or hiatal hernia. Perioperative measures: In this prospective randomized control trials , all patients were subjected to the followings: patients were selected by randomization method , Full history taking , Complete physical examination , laboratory investigations ( complete blood picture , liver and kidney functions , coagulation profile ) , radiological investigations ( chest x- ray , CT with oral and I.V contrast ) & patients were subjected to upper GI endoscopy. Surgical techniques : investigators performed traditional laparoscopic sleeve gastrectomy then investigators fixed the greater omentum & mesocolon that were cut during gastrectomy to the remaining gstric pouch along the new greater curvature as high as possible along the stable line then we plicated the remaining staple line till angle of His. (the greater omentum & mesocolon not reach this part of staple line) , so the remaining gastric pouch remained tension free and was returned to original position and this may prevent the axial gastric rotation as in figures . Follow up after surgery and discharge from the hospital: investigators examined the patients clinically, made routine laboratory investigations , made follow up CT with oral and I.V contrast in first week after the operation if suspected leakage & patients were subjected to upper GI endoscopy in first week after the operation if suspected leakage. The patients were followed up for one week, two weeks and one month, 6months post operatively. Statistical analysis: The collected data were analyzed by computer using Statistical Package of Social Services version 22 (SPSS), Data were represented in tables and graphs, Continuous Quantitative variables e.g. age were expressed as the mean ± SD & (range), and categorical qualitative variables were expressed as absolute frequencies (number) & relative frequencies (percentage). Suitable statistical tests of significance were used after checked for normality. Categorical data were cross tabulated and analyzed by the Chi-square test or Fisher's Exact Test; Continuous data were evaluated by student t- test. The results were considered statistically significant when the significant probability was less than 0.05 (P < 0.05). P-value < 0.001 was considered highly statistically significant (HS), and P-value ≥ 0.05 was considered statistically insignificant (NS). conditions module condition list condition Bariatric Surgery Candidate keyword list keyword Laparoscopic Sleeve Gastrectomy design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description This study included patients who were admitted to our center to do laparoscopic sleeve gastrectomy . Cases were collected in the period from December 2019 to December 2020. Sample size was 84 patients divided into 2 equal groups . Group 1: included 42 patients who were subjected to distal mesogastric fixation after laparoscopic sleeve gastrectomy. Group 2: included 42 patients who were subjected to laparoscopic sleeve gastrectomy alone without distal mesogastric fixation. design primary purpose Prevention design masking info design masking None (Open Label) design masking description no masking enrollment info enrollment count 84 enrollment type Actual arms interventions module arm group list arm group arm group label group (1) arm group type Active Comparator arm group description included 42 patients who were subjected to distal mesogastric fixation after laparoscopic sleeve gastrectomy arm group intervention list arm group intervention name Procedure: distal mesogastric fixation after sleeve gastrectomy arm group label group (2) arm group type No Intervention arm group description included 42 patients who were subjected to laparoscopic sleeve gastrectomy alone without distal mesogastric fixation intervention list intervention intervention type Procedure intervention name distal mesogastric fixation after sleeve gastrectomy intervention description Investigators performed traditional laparoscopic sleeve gastrectomy then we fixed the greater omentum & mesocolon that were cut during gastrectomy to the remaining gstric pouch along the new greater curvature as high as possible along the stable line then we plicated the remaining staple line till angle of His. (the greater omentum & mesocolon not reach this part of staple line) , so the remaining gastric pouch remained tension free and was returned to original position and this may prevent the axial gastric rotation intervention arm group label list intervention arm group label group (1) outcomes module primary outcome list primary outcome primary outcome measure Efficacy of distal mesogasric fixation after laparoscopic sleeve gastrectomy in prevention of Axial gastric rotation. primary outcome description Incidence of Axial gastric rotation after the operation primary outcome time frame Within one week after the operation primary outcome measure Efficacy of distal mesogasric fixation after laparoscopic sleeve gastrectomy in prevention of gastric leakage . primary outcome description Percentage of patients developed gastric leakage after the operation primary outcome time frame Within one week after the operation secondary outcome list secondary outcome secondary outcome measure Quality of life after distal mesogasric fixation after laparoscopic sleeve gastrectomy secondary outcome description Incidence of side effects of distal mesogasric fixation after laparoscopic sleeve gastrectomy e.g bleeding , vomiting. secondary outcome time frame Within one month after the operation eligibility module eligibility criteria Inclusion Criteria: Patients who had no contraindication for laparoscopic surgery. patients with good general condition with American society of anesthesiology (ASA) I & II. patients with body mass index above 35 were included. Exclusion Criteria: 1 - patients who had bad general condition (ASA ≥3). 2- patients with gastro esophageal reflux or hiatal hernia. healthy volunteers No gender All minimum age 18 Years maximum age 60 Years std age list std age Adult contacts locations module overall official list overall official overall official name Said Mohamed Negm, MD overall official affiliation ZAGAZIG UNIVERSITY HOSPITALS overall official role Principal Investigator location list location location facility Zagazig University Hospitals location city Zagazig location state Sharqua location zip 1185 location country Egypt references module reference list reference reference p m i d 30121858 reference type background reference citation Angrisani L, Santonicola A, Iovino P, Vitiello A, Higa K, Himpens J, Buchwald H, Scopinaro N. IFSO Worldwide Survey 2016: Primary, Endoluminal, and Revisional Procedures. Obes Surg. 2018 Dec;28(12):3783-3794. doi: 10.1007/s11695-018-3450-2. reference p m i d 28078641 reference type background reference citation Benedix F, Poranzke O, Adolf D, Wolff S, Lippert H, Arend J, Manger T, Stroh C; Obesity Surgery Working Group Competence Network Obesity. Staple Line Leak After Primary Sleeve Gastrectomy-Risk Factors and Mid-term Results: Do Patients Still Benefit from the Weight Loss Procedure? Obes Surg. 2017 Jul;27(7):1780-1788. doi: 10.1007/s11695-017-2543-7. reference p m i d 25320526 reference type background reference citation Abou Rached A, Basile M, El Masri H. Gastric leaks post sleeve gastrectomy: review of its prevention and management. World J Gastroenterol. 2014 Oct 14;20(38):13904-10. doi: 10.3748/wjg.v20.i38.13904. reference p m i d 25224165 reference type background reference citation Gagner M. Decreased incidence of leaks after sleeve gastrectomy and improved treatments. Surg Obes Relat Dis. 2014 Jul-Aug;10(4):611-2. doi: 10.1016/j.soard.2014.04.002. Epub 2014 Apr 14. No abstract available. reference p m i d 26071239 reference type background reference citation Nimeri A, Ibrahim M, Maasher A, Al Hadad M. Management Algorithm for Leaks Following Laparoscopic Sleeve Gastrectomy. Obes Surg. 2016 Jan;26(1):21-5. doi: 10.1007/s11695-015-1751-2. reference p m i d 29605723 reference type background reference citation Alizadeh RF, Li S, Inaba C, Penalosa P, Hinojosa MW, Smith BR, Stamos MJ, Nguyen NT. Risk Factors for Gastrointestinal Leak after Bariatric Surgery: MBASQIP Analysis. J Am Coll Surg. 2018 Jul;227(1):135-141. doi: 10.1016/j.jamcollsurg.2018.03.030. Epub 2018 Mar 30. reference p m i d 23023201 reference type background reference citation Parikh M, Issa R, McCrillis A, Saunders JK, Ude-Welcome A, Gagner M. Surgical strategies that may decrease leak after laparoscopic sleeve gastrectomy: a systematic review and meta-analysis of 9991 cases. Ann Surg. 2013 Feb;257(2):231-7. doi: 10.1097/SLA.0b013e31826cc714. reference p m i d 18294924 reference type background reference citation Al-Sabah S, Ladouceur M, Christou N. Anastomotic leaks after bariatric surgery: it is the host response that matters. Surg Obes Relat Dis. 2008 Mar-Apr;4(2):152-7; discussion 157-8. doi: 10.1016/j.soard.2007.12.010. Epub 2008 Mar 4. reference p m i d 35099602 reference type derived reference citation Negm S, Amin M, Shafiq A, Atef B, Yassin M, Farag A. The short-term outcome of distal mesogastric fixation after laparoscopic sleeve gastrectomy: a randomized controlled trial. Surg Today. 2022 Mar;52(3):510-513. doi: 10.1007/s00595-022-02459-x. Epub 2022 Jan 31. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022
NCT04834323
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full study rank 61222 study protocol section identification module n c t id NCT04839276 org study id info org study id THT02 organization org full name Fakultas Kedokteran Universitas Indonesia org class OTHER brief title Administration of Platelet-rich Fibrin to Autologous Fat Tissue in Injection Laryngoplasty for Vocal Cord Paralysis official title The Effect of Administering Platelet-rich Fibrin to Autologous Fat Tissue in Injection Laryngoplasty for Unilateral Adductor Vocal Cord Paralysis status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date January 1, 2018 start date type Actual primary completion date struct primary completion date June 1, 2018 primary completion date type Actual completion date struct completion date February 1, 2019 completion date type Actual study first submit date March 29, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 18, 2021 last update post date struct last update post date April 20, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Fakultas Kedokteran Universitas Indonesia lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The study tries to see the effect of using a combination of platelet-rich fibrin (PRF) and autologous fat as a filler for injection laryngoplasty procedures to treat unilateral adductor vocal cord paralysis. detailed description The vocal cord in humans is essential in producing voice used in communication and interaction between us. Vocal cord paralysis causes dysphonia, which interferes with communication, causing disruptions towards social activity and daily activities. One of the managements for vocal cord paralysis is medialisation and augmentation of the vocal cord through injection laryngoplasty. Autologous fat is one of the best fillers that can be used in this procedure, but it is highly absorbable and can be reabsorbed very quickly when injected to body tissues. Platelet Rich Fibrin (PRF) is a biomaterial consisting of growth factors that are thought to improve fat tissue longevity through increase of adipogenesis and angiogenesis. Improvement in fat longevity will improve clinical outcomes after laryngoplasty procedure potentially reducing number of repeated injections needed to achieve satisfactory resolution to vocal cord paralysis. The study evaluates a combination of PRF and autologous microlobular fat compared with autologous microlobular fat alone on laryngoplasty. Subjective evaluation was done by using Voice Handicap Index (VHI-30) questionnaire, while objective evaluation was conducted via computerized acoustic analysis/Multidimensional Voice Program (MDVP), videostroboscopy, and maximum phonation time. conditions module condition list condition Vocal Cord Paralysis keyword list keyword platelet-rich fibrin vocal cord paralysis dysphonia injection laryngoplasty design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description The intervention group will receive injection laryngoplasty with a combination of PRF and microlobular autograph fat, while the control group will receive injection laryngoplasty with microlobular autograph fat. design primary purpose Supportive Care design masking info design masking Single design masking description The participants of the study know that they are being assigned to injection laryngoplasty procedures, but they didn't know whether PRF is being added to the autologous fat injection filler. The researchers are fully aware which participants are assigned to which procedures. design who masked list design who masked Participant enrollment info enrollment count 19 enrollment type Actual arms interventions module arm group list arm group arm group label Injection Laryngoplasty with PRF and Autologous Fat arm group type Experimental arm group description Autologous microlobular fat is harvested from abdominal fat (area under the umbilical). 4 mL of microlobular fat is added to 4 mL of PRF and is smoothed by pushing it back and forth 15 times on a 2-tube 10 mL piston tube connected to a three-way connector. 3 mL of the mixture of fat and PRF is injected using a 12 G laryngoplasty syringe until medialization is achieved. arm group intervention list arm group intervention name Combination Product: Injection Laryngoplasty with Platelet-rich Fibrin and Autologous Fat arm group label Injection Laryngoplasty with Autologous Fat arm group type Active Comparator arm group description Autologous microlobular fat is harvested from abdominal fat (area under the umbilical). 4 mL of microlobular fat is mashed by pushing it back and forth 15 times in a container of 2 piston tubes (10 mL) connected to a three-way connector. The crushed fat is injected as much as 3 mL using a 12 G laryngoplasty syringe until medialization is achieved. arm group intervention list arm group intervention name Procedure: Injection Laryngoplasty with Autologous Fat intervention list intervention intervention type Combination Product intervention name Injection Laryngoplasty with Platelet-rich Fibrin and Autologous Fat intervention description Injection Laryngoplasty with a combination of Platelet-rich Fibrin (PRF) and Autologous Fat. The PRF was made by taking 10 mL of peripheral blood from a healthy donor. Blood is then put inside the tube from the Regen lab kit. The tube was centrifuged with a force of 1,500 g (3000 rpm) for 5 minutes producing platelet-rich plasma (PRP). 4 mL of the aforementioned PRP was transferred to a 10 mL test tube, 1 M CaCl2 was added with a micropipette until final concentration of 25 mM was, reached producing PRF. Autologous fat harvested from the patient's abdomen was then mixed with the PRF solution to create the filler for injection laryngoplasty procedures. The injection procedures are done by placing the patient in a sniffing position followed by intraoral Kleinsasser laryngoscope insertion through the uvula, posterior pharyngeal wall, and epiglottis until the vocal cords are visible. Injection of the filler is then done to the paralyzed vocal cords. intervention arm group label list intervention arm group label Injection Laryngoplasty with PRF and Autologous Fat intervention other name list intervention other name RegenKit PRP Tube (Regen Lab) intervention type Procedure intervention name Injection Laryngoplasty with Autologous Fat intervention description Injection Laryngoplasty with autologous microlobular fat harvested from the patient's abdominal fat. Lidocaine was infiltrated under the umbilicus and then an incision was made in the area followed by fat removal using scissors. The fat was cleaned with 0.9% NaCl solution and then sheared into microlobular form. The injection procedures are done by placing the patient in a sniffing position followed by intraoral Kleinsasser laryngoscope insertion through the uvula, posterior pharyngeal wall, and epiglottis until the vocal cords are visible. Injection of the filler is then done to the paralyzed vocal cords. intervention arm group label list intervention arm group label Injection Laryngoplasty with Autologous Fat intervention other name list intervention other name Lipid Autograft outcomes module primary outcome list primary outcome primary outcome measure Change in Voice Handicap Index-30 (VHI-30) questionnaire score primary outcome description The Voice Handicap Index Questionnaire-30 (VHI-30) is a subjective examination that can be used to assess the severity of voice disorders and their impact on social life. The VHI-30 categorizes handicaps into mild, moderate, and severe. This study assessed the VHI-30 score as a numerical scale so that the median value for the treatment and control groups can be obtained. The assessment was carried out based on the patient's perception by addressing complaints for each question (0 = never, 1 = almost never, 2 = sometimes, 3 = almost always, 4 = always). Patients with severe voice disorders will achieve a higher VHI-30 score. Interpretation of the total value of the VHI-30 includes mild disability values of 0 - 30; moderate disability of 31 - 60; and a severe disability of 61-120. Changes in VHI-30 score are recorded and statistically analysed. primary outcome time frame Before injection, 1 week, 4 week, 8 week post-injection primary outcome measure Changes in Maximum Phonation Time primary outcome description Maximum phonation time describes the quality of the strength of the vocal cords when oscillating. The calculation of the phonation time will represent objective assessment of voice. Changes in maximum phonation time are recorded and statistically analysed. primary outcome time frame Before injection, 1 week, 4 week, 8 week post-injection primary outcome measure Changes in Average Fundamental Frequency (F0) primary outcome description The Average Fundamental Frequency (F0) is a parameter in MDVP that represents the number of vocal cord vibration cycles in one second. The mean frequency ranges from 120 Hz for men and 200 Hz for women, but this is also influenced by age, smoking and accent language. The average fundamental frequency reflects the biochemical characteristics of the vocal cords when interacting with the air flow in its path, these biochemical properties are influenced by the structure of the larynx and muscle tone. Changes in F0 are recorded and statistically analysed. primary outcome time frame Before injection, 1 week, 4 week, 8 week post-injection primary outcome measure Changes in Jitter and Shimmer primary outcome description Jitter and Shimmer is a parameter in MDVP that represents variations that occur in the basic frequency. Jitter denotes the chaos of sound wave frequency caused by a lack of control over the vibration of the vocal cords. Shimmer shows the chaos of sound wave amplitude which is influenced by decreased resistance of the glottis and presence of mass lesions of the vocal cords, associated with inadequate adduction of the vocal cords and irregularity of the surface of the vocal cords. Presence of jitter and shimmer denotes that there are disruption in phonation quality caused by problems in vocal cords. Changes in jitter and shimmer are recorded and statistically analysed. primary outcome time frame Before injection, 1 week, 4 week, 8 week post-injection primary outcome measure Changes in Noise to Harmonic Ratio (NHR) primary outcome description NHR is a parameter in MDVP that represents ratio of non-harmonic and harmonic waves in a certain sound wave period. NHR describes the quality of the amount of noise in the sound. Inadequate closure of the vocal cords and periodic vibrations of the vocal cords cause excessive air flow as it passes through the vocal cords, causing turbulence and noise. Normal and periodic sound signals will have a small NHR, while dysphonia sound signals will have a large NHR value. Changes in NHR are recorded and statistically analysed. primary outcome time frame Before injection, 1 week, 4 week, 8 week post-injection primary outcome measure Changes in Voice Turbulence Index (VTI) primary outcome description VTI (Voice Turbulence Index) is a parameter in MDVP that represents the ratio between non-harmonic waves at high frequencies of 2800 - 5800 Hz and harmonic waves at frequencies of 70 - 4500 Hz. This parameter assesses the energy level of high frequency noise and is largely related to the turbulence of sound caused due to loss of adduction motion. This parameter also relates to variations in the frequency or amplitude of sound, where the turbulence of sound occurs due to changes in muscle control. Changes in VTI are recorded and statistically analysed. primary outcome time frame Before injection, 1 week, 4 week, 8 week post-injection primary outcome measure Changes in Amplitude Tremor Intensity Index (ATRI) primary outcome description ATRI is a parameter in MDVP that represents the mean ratio of the low frequency amplitude to the total amplitude of the sound being examined. This parameter indicates the stability and strength of the vocal cords during phonation. Changes in ATRI are recorded and statistically analysed. primary outcome time frame Before injection, 1 week, 4 week, 8 week post-injection primary outcome measure Changes in Vocal Cord Closure Pattern primary outcome description The closure pattern of the vocal cords is one of the parameters in videostroboscopy. This examination looks at the pattern and medial edge of the vocal cords when closed and insulated. Changes in Vocal Cord Closure Pattern are recorded and statistically analysed. primary outcome time frame Before injection, 1 week, 4 week, 8 week post-injection primary outcome measure Changes in Amplitude primary outcome description The amplitude is one of the parameters in videostroboscopy. Amplitude is the amount of horizontal movement of the vocal cords. The magnitude of the amplitude is assessed by dividing the horizontal line into 5 sections from medial to lateral of the vocal cords. Changes in amplitude are recorded and statistically analysed. primary outcome time frame Before injection, 1 week, 4 week, 8 week post-injection primary outcome measure Changes in Mucosal Waves primary outcome description The mucosal waves is one of the parameters in videostroboscopy. Mucosal waves are the movement of the vocal cords from an inferior to a superior direction following the glottic cycle on the vertical axis. Changes in mucosal waves are recorded and statistically analysed. primary outcome time frame Before injection, 1 week, 4 week, 8 week post-injection primary outcome measure Changes in Vertical Level primary outcome description The vertical level is a parameter of the vocal cords on videostroboscopy that describes the difference in the height of the vocal cords that meet and are seen in the medial of the vocal cords. Changes in vertical level are recorded and statistically analysed. primary outcome time frame Before injection, 1 week, 4 week, 8 week post-injection primary outcome measure Changes in Supraglottic Activity primary outcome description The supraglottic activity is one of the parameters in videostroboscopy. Supraglottic activity describes a narrowing of the supraglottic structure wherein one of them is a collapsed arytenoid. Changes in supraglottic activity are recorded and statistically analysed. primary outcome time frame Before injection, 1 week, 4 week, 8 week post-injection primary outcome measure Changes in Non-vibrating Parts primary outcome description The non-vibrating parts is one of the parameters in videostroboscopy. The non-vibrating part is the part of the vocal cords that does not experience vibrations due to tissue rigidity. Assessment of this parameter is by dividing the right and left vocal cords into 10 regions each with an oval line. Changes in non-vibrating parts are recorded and statistically analysed. primary outcome time frame Before injection, 1 week, 4 week, 8 week post-injection primary outcome measure Changes in Free Edge Contours primary outcome description The free edge contours is one of the parameters in videostroboscopy. This parameter represents the free edge of the medial side of the vocal cords at maximal abduction. Changes in free edge contours are recorded and statistically analysed. primary outcome time frame Before injection, 1 week, 4 week, 8 week post-injection primary outcome measure Changes in Symmetrical Pattern primary outcome description This parameter assesses the symmetrical movement of the right and left vocal cords during oscillation using videostroboscopy. The results of the assessment on this parameter are symmetrical or asymmetrical. Changes in symmetrical pattern are recorded and statistically analysed. primary outcome time frame Before injection, 1 week, 4 week, 8 week post-injection primary outcome measure Changes in Closure Phase primary outcome description The closure phase is a parameter that compares the amount of closure and opening of the vocal cords in one glottic cycle. Assessment is done by looking at a collection of pictures from videostroboscopy when the vocal cords oscillate. Changes in closure phase are recorded and statistically analysed. primary outcome time frame Before injection, 1 week, 4 week, 8 week post-injection primary outcome measure Changes in The Stability of The Vocal Cords primary outcome description The stability of the vocal cords is a parameter that measures the vibration and amplitude of the vocal cords that are oscillating in one glottic cycle Assessment of this parameter where done through videostroboscopy. Changes in the stability of the vocal cords are recorded and statistically analysed. primary outcome time frame Before injection, 1 week, 4 week, 8 week post-injection eligibility module eligibility criteria Inclusion Criteria: Subject is diagnosed with unilateral vocal cord paralysis in paramedian position or 3 months lateral onset without movement and mucosal waves of the vocal cords on videostroboscopy. Willing to give consent Exclusion Criteria: Has a history of malignancy of the larynx or lung Subject isn't able to undergo injection laryngoplasty procedure under general anesthesia Subject with thrombositopenia healthy volunteers No gender All minimum age 18 Years maximum age 70 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Mirta H Reksodiputro, SpTHT-KL(K) overall official affiliation Department of ENT, Faculty of Medicine, University of Indonesia overall official role Study Chair overall official name Syahrial M Hutauruk, SpTHT-KL(K) overall official affiliation Department of ENT, Faculty of Medicine, University of Indonesia overall official role Study Chair overall official name Trimartani Koento, SpTHT-KL(K) overall official affiliation Department of ENT, Faculty of Medicine, University of Indonesia overall official role Study Chair overall official name Fauziah Fardizza, SpTHT-KL(K) overall official affiliation Department of ENT, Faculty of Medicine, University of Indonesia overall official role Study Chair overall official name Razki YM Hakim, SpTHT-KL overall official affiliation Department of ENT, Faculty of Medicine, University of Indonesia overall official role Principal Investigator overall official name Sacha Audindra, M.D, BMedSci overall official affiliation Department of ENT, Faculty of Medicine, University of Indonesia overall official role Principal Investigator overall official name Mikhael Yosia, M.D, DTM&H overall official affiliation Department of ENT, Faculty of Medicine, University of Indonesia overall official role Principal Investigator location list location location facility Fakultas Kedokteran Universitas Indonesia location city Jakarta Pusat location state DKI Jakarta location zip 10450 location country Indonesia references module reference list reference reference p m i d 29494316 reference type background reference citation Stachler RJ, Francis DO, Schwartz SR, Damask CC, Digoy GP, Krouse HJ, McCoy SJ, Ouellette DR, Patel RR, Reavis CCW, Smith LJ, Smith M, Strode SW, Woo P, Nnacheta LC. Clinical Practice Guideline: Hoarseness (Dysphonia) (Update) Executive Summary. Otolaryngol Head Neck Surg. 2018 Mar;158(3):409-426. doi: 10.1177/0194599817751031. Erratum in: Otolaryngol Head Neck Surg. 2018 Aug;159(2):403. reference p m i d 17765698 reference type background reference citation Rubin AD, Sataloff RT. Vocal fold paresis and paralysis. Otolaryngol Clin North Am. 2007 Oct;40(5):1109-31, viii-ix. Review. reference p m i d 29398504 reference type background reference citation Mattei A, Desuter G, Roux M, Lee BJ, Louges MA, Osipenko E, Sadoughi B, Schneider-Stickler B, Fanous A, Giovanni A. International consensus (ICON) on basic voice assessment for unilateral vocal fold paralysis. Eur Ann Otorhinolaryngol Head Neck Dis. 2018 Feb;135(1S):S11-S15. doi: 10.1016/j.anorl.2017.12.007. Epub 2018 Feb 3. Review. reference p m i d 24753832 reference type background reference citation Seyed Toutounchi SJ, Eydi M, Golzari SE, Ghaffari MR, Parvizian N. Vocal cord paralysis and its etiologies: a prospective study. J Cardiovasc Thorac Res. 2014;6(1):47-50. doi: 10.5681/jcvtr.2014.009. Epub 2014 Mar 4. reference p m i d 15548914 reference type background reference citation Kwon TK, Buckmire R. Injection laryngoplasty for management of unilateral vocal fold paralysis. Curr Opin Otolaryngol Head Neck Surg. 2004 Dec;12(6):538-42. Review. reference p m i d 21994176 reference type background reference citation Graboyes EM, Bradley JP, Meyers BF, Nussenbaum B. Efficacy and safety of acute injection laryngoplasty for vocal cord paralysis following thoracic surgery. Laryngoscope. 2011 Nov;121(11):2406-10. doi: 10.1002/lary.22178. Epub 2011 Oct 12. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000014826 condition mesh term Vocal Cord Paralysis condition mesh id D000010243 condition mesh term Paralysis condition ancestor list condition ancestor condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000007818 condition ancestor term Laryngeal Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition ancestor id D000010038 condition ancestor term Otorhinolaryngologic Diseases condition ancestor id D000020421 condition ancestor term Vagus Nerve Diseases condition ancestor id D000003389 condition ancestor term Cranial Nerve Diseases condition browse leaf list condition browse leaf condition browse leaf id M12309 condition browse leaf name Paralysis condition browse leaf as found Paralysis condition browse leaf relevance high condition browse leaf id M27211 condition browse leaf name Dysphonia condition browse leaf relevance low condition browse leaf id M8900 condition browse leaf name Hoarseness condition browse leaf relevance low condition browse leaf id M16721 condition browse leaf name Vocal Cord Paralysis condition browse leaf as found Vocal Cord Paralysis condition browse leaf relevance high condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id M9987 condition browse leaf name Laryngeal Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id M12113 condition browse leaf name Otorhinolaryngologic Diseases condition browse leaf relevance low condition browse leaf id M21370 condition browse leaf name Vagus Nerve Diseases condition browse leaf relevance low condition browse leaf id M5757 condition browse leaf name Cranial Nerve Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev BC09 condition browse branch name Ear, Nose, and Throat Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M21013 intervention browse leaf name Pharmaceutical Solutions intervention browse leaf relevance low intervention browse leaf id M10166 intervention browse leaf name Lidocaine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev PhSol intervention browse branch name Pharmaceutical Solutions intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev AnArAg intervention browse branch name Anti-Arrhythmia Agents intervention browse branch abbrev ChanBlk intervention browse branch name Channel Blockers intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants
NCT04839276
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full study rank 61284 study protocol section identification module n c t id NCT04838470 org study id info org study id 202001285B0 organization org full name Chang Gung Memorial Hospital org class OTHER brief title Prognosis Predictors for Heart Failure official title Looking for Prognostic Factors That Affect the Survival of Patients With Heart Failure status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date January 1, 2010 start date type Actual primary completion date struct primary completion date June 30, 2020 primary completion date type Actual completion date struct completion date March 30, 2021 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Chang Gung Memorial Hospital lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This study is looking for the predictors of the survival or rehospitalization of patients with heart failure with reduced ejection fraction. Participants who are discharged from an acute heart failure hospitalization are enrolled. detailed description This study is looking for the predictors of the survival or rehospitalization of patients with heart failure with reduced ejection fraction. Participants who are discharged from an acute heart failure hospitalization are enrolled. The prognostic factors provide information about the treatment of this disease in the future. This study is a retrospective observational study. Investigators will collect data from May 2014 to July 2019 in the heart failure center of Kaohsiung Chang Gung Memorial Hospital. A follow-up is conducted at the Kaohsiung HF center until August 2020. Investigators want to know whether the risk factors such as atrial fibrillation, diabetes, nephropathy, and some biochemical indexes can be an index that predicts future survival or rehospitalization of these patients. Besides, investigators will also explore the cardiac rehabilitation can also effectively improve the survival rate of such patients. conditions module condition list condition Heart Failure Rehabilitation Morality Hospitalization Life Quality keyword list keyword cardiac rehabilitation multidisciplinary program heart failure mortality renin-angiotensin-aldosterone system design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Retrospective enrollment info enrollment count 792 enrollment type Actual arms interventions module intervention list intervention intervention type Other intervention name cardiac rehabilitation intervention description multidisciplinary disease management program outcomes module primary outcome list primary outcome primary outcome measure all-cause mortality primary outcome description Number of participants that had occurrence of the mortality which is defined as all-cause mortality primary outcome time frame May, 2014 ~ August 2020 secondary outcome list secondary outcome secondary outcome measure first heart failure rehospitalization secondary outcome description Number of Participants That Had Occurrence of the Endpoint, Which is Defined as First Heart Failure (HF) Hospitalization secondary outcome time frame May, 2014 ~ August 2020 secondary outcome measure Change From Baseline to Month 6 and Month 12 for the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ 12) Clinical Summary Score secondary outcome description Change from baseline to Month 6 and month 12 for the Kansas City Cardiomyopathy Questionnaire short form (KCCQ12) clinical summary score. KCCQ12 is a 12-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ12 clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. secondary outcome time frame May , 2014 ~ August 2020 eligibility module eligibility criteria Inclusion Criteria: inpatient, age >= 20 years old, male or female patient with heart failure with a reduced ejection fraction and discharged alive from the hospital received heart failure disease management program Exclusion Criteria: Estimated survival time < 6 months Long-term bedridden for more than 3 months Cannot tolerance exercise test due to muscular-skeletal disorder Cannot co-operate all functional studies Ventilator dependent Terminal heart status The family reject to participate in this project gender All minimum age 20 Years std age list std age Adult Older Adult study population A total of 792 patients were recruited between May 2014 and July 2019 and follow-up conducted at the Kaohsiung HF center until August 2020. All patients were introduced to a multidisciplinary HF disease management program (HFDMP). sampling method Non-Probability Sample i p d sharing statement module i p d sharing Undecided i p d sharing description individual participant data sharing plan will be discussed with other investigators. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006333 condition mesh term Heart Failure condition ancestor list condition ancestor condition ancestor id D000006331 condition ancestor term Heart Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M8573 condition browse leaf name Heart Failure condition browse leaf as found Heart Failure condition browse leaf relevance high condition browse leaf id M8571 condition browse leaf name Heart Diseases condition browse leaf relevance low condition browse leaf id T6034 condition browse leaf name Quality of Life condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders
NCT04838470
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full study rank 61438 study protocol section identification module n c t id NCT04836468 org study id info org study id 4 organization org full name Clínica Dr. Francisco Selva org class OTHER brief title Changes in Blood Flow in the Application of Magnetic Tape in Patients With Low Back Pain. RCT official title Changes in Blood Flow in the Lower Limb With the Application of Magnetic Tape in Patients With Low Back Pain. Double-blinded Clinical Trial. status module status verified date January 2022 overall status Completed expanded access info has expanded access No start date struct start date June 28, 2021 start date type Actual primary completion date struct primary completion date July 28, 2021 primary completion date type Actual completion date struct completion date August 6, 2021 completion date type Actual study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date January 27, 2022 last update post date struct last update post date February 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Francisco Selva responsible party investigator title PhD physiotherapy responsible party investigator affiliation Clínica Dr. Francisco Selva lead sponsor lead sponsor name Francisco Selva lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary A tape is applied over the lumbar 4th and lumbar 5th levels crosswise in people with low back pain. The possible variation of the arterial flow of the femoral artery is measured with ultrasound. A kinesiology tape was used as placebo tape and Magnetic Tape was used as experimental randomly. detailed description A double-blind randomized clinical trial is designed where subjects with low back pain will be selected and blinded to recieve the Magnetic Tape® (tape with magnetic effects of less than 2 Gauss) or placebo Tape. Likewise, the evaluator who puts the Magnetic Tape® does not know what material he is using, as it is supplied by another researcher. The sonographer also does not know if the patient has low back pain or not or what tape will be placed on him. The recommendations of the "Consolidated Standards of Reporting Trials" (CONSORT) will be followed. All participants will receive a participant information sheet and sign informed consent. Patients aged 18 to 65 years with low back pain will be recruited from different private clinics in the city of Valencia, Spain. The hypothesis is that when Magnetic Tape® comes into contact with electromagnetic fields such as those generated by living beings, due to the movement of electrical charges (ions), as defined by Ampere's Law, the domains of the tape are oriented or aligned in parallel with the external magnetic field creating a magnetic flux with a north pole and a south pole. This generated field in turn produces a magnetic induction proportional to the variation of the magnetic flux, as defined by the Faraday Law. This electric potential produces a redistribution of the electric charge (ions) generating a magnetic field due to the orientation of the tape domains, then exerting a force on the moving charges within the electrolyte. Physiological, Lorentz's Law, regulating Magnetic Tape® aberrant electromagnetic fields. The protocol for data collection will be as follows: After signing the informed consent and data protection, the groups with low back pain will be formed that will receive the application of both Magnetic Tape® and the intervention of a placebo tape. To avoid that the order of the intervention influences the results of the study, the subjects will be randomized into two different groups, Group A and Group B. Group A will receive Magnetic tape® and Group B will do the opposite. To standardize the location of the tape application, the patient will be placed in the prone position and the L4 spinous processes will be identified by marking them with a pen. Once L4 is located at the level of the iliac crests, the therapist will palpate the next spinous process down to the level of L5, and then it will be marked. The tape will be applied transversely covering the paravertebral skin at both levels. Afte this protocol ultrasound will be applied, evaluating the characteristics of blood flow by means of ultrasound in the common femoral artery using pulsed power doppler. An Alpinion ECube 12 ultrsound machine with a L3-12H linear probe with a 64 mm footprint will be used. The variables of Peak systolic PS velocity in (cm/s), peak diastolic velocity (DF) in (cm/s), the difference between distolic an systolic (S/D), the pulsatility index (PI), the resistance index (IR) and the artery diameter in (cm) will be taken. To assess pressure pain in the spinous processes, a Wagner Force Dial - FDK 20 algometer with a circular contact surface of 1 cm2 will be used. The sensation of perceived pain will be performed on the paravertebral skin of each level using the pinch technique and assessing it with the VAS scale. Both the algometer and pinch measurements will be repeated twice at each level leaving at least 1 minute between measurements. During the pain measurement phase, each participant will be in the prone position where assessments will be made from L1 to S4. Afterwards, they will be placed in a supine position and for three minutes to adjust to the room environment and relax, the ultrasound measurements were taken. Subsequently, a tape will be placed and the perceived pain, pressure pain and vascular parameters will be measured again. conditions module condition list condition Low Back Pain keyword list keyword magnetic tape Pressure Pain Vascular Ultrasound design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 22 enrollment type Actual arms interventions module arm group list arm group arm group label Experimental group arm group type Experimental arm group description Application of Magnetic Tape transversely over the vertebral levels of L4 and L5 arm group intervention list arm group intervention name Diagnostic Test: Tape application arm group label Placebo group arm group type Placebo Comparator arm group description Application of kinesiology tape transversely over the vertebral levels of L4 and L5 arm group intervention list arm group intervention name Diagnostic Test: Tape application intervention list intervention intervention type Diagnostic Test intervention name Tape application intervention description Magnetic Tape or Kinesiology tape will be applied randomly with both the examiner and the subjects blinded. intervention arm group label list intervention arm group label Experimental group Placebo group outcomes module primary outcome list primary outcome primary outcome measure peak systolic velocity (PSV) primary outcome description maximum systolic velocity of the femoral artery in (cm / s) primary outcome time frame 1 minute primary outcome measure peak diastolic velocity (PDV) primary outcome description femoral artery peak diastolic velocity in (cm / s) primary outcome time frame 1 minute primary outcome measure difference between systolic and diastolic (S / D) primary outcome description difference between systolic and diastolic in the femoral artery primary outcome time frame 1 minute primary outcome measure pulsatility index (PI) primary outcome description assesses the peripheral resistance of blood vessels primary outcome time frame 1 minute primary outcome measure resistance index (RI) primary outcome description reflects resistance to arterial flow primary outcome time frame 1 minute primary outcome measure diameter primary outcome description diameter of each artery primary outcome time frame 1 minute secondary outcome list secondary outcome secondary outcome measure Algometria secondary outcome description referred pain when pressing on the lumbar vertebral processes secondary outcome time frame 2 minutes eligibility module eligibility criteria Inclusion Criteria: The inclusion criteria will be subjects with low back pain aged 18-65 years residing in Valencia who wish to participate in the study. Exclusion Criteria: not meeting the age requirement, having conditions that would be a contraindication to placing an adhesive bandage on the skin such as allergies, also being pregnant, having a pacemaker or people who have any contraindication of electromagnetic fields, neurological diseases or taking any medication that may interact with magnetic fields. healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module location list location location facility Clinica Francisco Selva location city Valencia location zip 46008 location country Spain i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001416 condition mesh term Back Pain condition mesh id D000017116 condition mesh term Low Back Pain condition ancestor list condition ancestor condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M18585 condition browse leaf name Low Back Pain condition browse leaf as found Low Back Pain condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M3866 condition browse leaf name Back Pain condition browse leaf as found Back Pain condition browse leaf relevance high condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases
NCT04836468
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full study rank 61877 study protocol section identification module n c t id NCT04830761 org study id info org study id 2021-00164 organization org full name University of Bern org class OTHER brief title Behavior Change in Context to Contain the Spread of COVID-19 official title Behaviour Change in Context to Contain the Spread of COVID-19 status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 26, 2021 start date type Actual primary completion date struct primary completion date December 31, 2022 primary completion date type Anticipated completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date March 25, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 17, 2022 last update post date struct last update post date May 18, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Bern lead sponsor class OTHER collaborator list collaborator collaborator name Ursula Wirz Stiftung collaborator class UNKNOWN oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Project BECCCS (=Behavior Change in Context to Contain the Spread of COVID-19) aims to optimise and test a behaviour change intervention to promote correct hand hygiene at key times in the short and long term. The study's specific aims are: Optimisation phase: Identify the most effective combination and sequence of three different intervention modules (habit, motivation, social norms), and to assess usability and fidelity measures in order to optimise the intervention Evaluation phase: Test the final intervention against an active control group (basic app content including "Federal Office of Public Health" advice) detailed description Study design: In this study, the MOST methodology (multiphase optimization strategy; Collins et al., 2014) will be applied. First, the most effective intervention components for specific target groups will be determined, which is called the optimisation phase. To this end, we run a parallel randomized trial that investigates all combinations of three interventions modules (= 9 combinations) in terms of its usability and its effectiveness. To collect in-depth information about usability and feasibility, we will additionally run a qualitative survey with a small subsample of the trial. After this optimisation phase, the intervention's effectiveness will be tested against an active control group in a randomized controlled trial, which is called the evaluation phase. For the optimisation phase, participants will be randomly assigned to one of nine conditions. All participants are randomized into one of nine intervention group in a 1:1:1:1:1:1:1:1 ratio. For the randomization, an even randomization procedure is applied using Qualtrics. Because the randomization is even, the probability is fixed if the number of the participants can be divided by 9, it means that at the end we will have exactly even number of participants in each group. In the evaluation phase, the optimised intervention from the optimisation phase will be tested in an RCT. To this end, participants will be randomly assigned to one of two conditions: final intervention vs. active control group. The active control group has access to the app, receives the basic module to test the effect of the final intervention, will answer the three questionnaires (pre-test, post-test, follow-up), and the short questionnaires (diary days). Recruitment and informed consent procedure: The sample will be recruited via Facebook and Instagram. Those who click on the link of the campaign will lead to a landing page with the relevant study information. Here, participants read the study info and enter their e-mail address. When they click on "send", an info box explains that an email has been sent including the link to the actual study. In the mail, the participants can access via link to an eligibility and consent survey with detailed information about the nature of the study (=optimization and evaluation phase), its purpose, the procedures involved, the expected duration, the potential risks and benefits, any discomfort it may entail and finally an e-consent form to give consent to the study electronically. If people meet all inclusion criteria, the participants can directly sign with the mouse (on computer) or finger (on mobile device) the consent form. After the participants agree to participate in the study, they receive a registration code via e-Mail to participate in the study as well as a signed copy of the consent form (at the latest of one week after giving consent electronically). In the mail, the participants are guided to download the app "soapp" from their app store with the registration code. After downloading the app, they have to register and tip in the registration code. After that, they start with the first questionnaire T1 (optimization phase) or pre-test (evaluation phase). Study procedure: The duration of the study is 5 weeks (optimisation phase) plus a 6-month follow-up in the evaluation phase. Each participant receives two different intervention modules which each last 2 weeks. After downloading the study app, the participants receive the first baseline questionnaire (T1 or pre-test). Optimization phase: The day after T1, people attend a diary day. The diary day includes five 1-minute-questionnaires during one day. People will be informed that the intervention starts on the subsequent day after the diary day. The intervention will take four weeks and includes two modules. During the first module, people will attend another diary day at the end of each week (2 in total during one module). On the subsequent day of the last dairy day of the first module, people will receive the second questionnaire (T2). After T2, the second intervention module follows in the same structure: The participants follow the instructions of the intervention and their hand hygiene behaviour is surveyed on the last day of each week using the short questionnaire within the diary day. A day after the participants completed the last diary day and with that the second module, they receive the last questionnaire (T3). Additionally, to the normal questionnaire, the participants can indicate at T3, whether they are willing to take part in a qualitative survey. Here, people will be interviewed via telephone by a study member. This interview will take around 30 minutes for the participants, where they will be asked questions about the usability of the app and their experience with the intervention modules. This information will be used to improve the study app before starting with the evaluation phase. By the end of the study, the participants will have completed three questionnaires (T1-T3) and five short-questionnaires. Evaluation phase: The day after the pre-test questionnaire, people attend a diary day to assess their previous hand hygiene behaviour. People will be informed that the intervention starts on the subsequent day after the diary day. The intervention will run for four weeks. During these four weeks, people will attend another diary day at the end of each week (4 in total during the total intervention). A day after the last diary day of the intervention, participants are asked to fill in the second questionnaire (post-test). In the evaluation phase, the participants will receive a six-month follow-up. They will first attend a diary day after 6 months after the intervention started and will then receive the follow-up questionnaire the subsequent day. By the end of the study, the participants will have completed three questionnaires (pre-test, post-test, follow-up) and six short-questionnaires. Hypotheses: Optimisation: Hyp.1: The intervention groups show a significant increase in correct hand hygiene behaviour at key times (T3). Hyp.2: The intervention groups significantly differ in their effects on correct hand hygiene behaviour at key times (T1-T3). Hyp.3. The intervention groups show a significant increase in (not correct) hand hygiene behaviour at key times (T3). Hyp.4. The groups attending a motivation module show a significant increase in a) intention, b) self-efficacy, c) outcome expectancies and d) attitude from T1 to the post measures. Hyp.5. The groups attending a habit module show a significant increase in a) habit strength, b) action control, and c) planning from T1 to the post measures. Hyp.6. The groups attending a social norms module show a significant increase in a) injunctive norms and b) descriptive norms from T1 to the post measures. Evaluation: Hyp. 7. The intervention group show a greater increase in correct hand hygiene behaviour at key times at the post measure (H7a) and at 6-month follow-up (H7b) compared to the control group. Hyp. 8 The intervention group show a significant increase in the targeted behavioural determinants that are included compared to the control group at the post-intervention measure (H8a) and at 6-month follow-up (H8b). [the exact behavioural determinants depend on the results of the optimisation phase]. Statistics: In the optimisation phase, 387 subjects are to be randomized. This sample size was determined with an a priori power analysis with g*power (Faul et al., 2009). The aim is that a statistical analysis using repeated-measures ANOVA with a within-between-interaction with a power of 0.80 and α = 0.05, a small effect of f =0.1 should be detectable. Accounting for 20% attrition, this leads to N = 465 for the enrolment in the parallel control trial. In the evaluation phase, 204 new subjects are to be randomized. The aim is that that a statistical analysis using an independent samples t-test adopting an error probability and statistical power of α = 0.05 and β = 0.80, at least a small intermediate intervention effect of Cohen's d = 0.35 should be detectable (Faul et al., 2007). Accounting for 20% attrition, this leads to N = 245 for the enrolment in the RCT. There is no statistical criterion of termination of trial. If more participate are included in the study than 387 people in the optimisation phase and 204 people in the evaluation phase, the results can be examined in more detail and more complex contexts in terms of differential indication can be examined thereby helping to improve the intervention. Planned Analyses: The analysed sample includes all randomized participants. The analyses are carried out on the basis of the intention-to-treat approach. In the optimisation phase, the primary analyses will be conducted (T1-T3) to test the hypotheses using R and SPSS after 387 participants have completed the study. To address the primary research question, the main effect of a univariate analysis of variance with repeated measures will be analysed. After, post-hoc comparison analyses with independent t-test will be conducted between all groups. Last, multiple linear regression analyses will be conducted to test the effect of the targeted behavioural determinants on the outcome. In the evaluation phase, the primary analyses will be conducted (pre-test, post-test, follow-up) to test the hypotheses using R and SPSS after 204 participants have completed the study. Secondary follow-up analyses will be conducted six months later. Multiple linear regression analyses will be conducted to test the effect of the targeted behavioural determinants on the outcome and to test mediation hypotheses. The qualitative data in the optimisation phase are analysed by using thematic analysis (Braun & Clarke, 2006). No interim analyses or safety analyses are planned. Deviations from the planned analyses will be reported in the final report. Handling of missing data and drop-outs: The main analysis will be performed according to the intention-to-treat (ITT) principle. The ITT analysis includes every subject who is randomized according to randomized study group. It ignores noncompliance, protocol deviations as not adhering to the intervention modules, and anything that happens after randomization. Participants who withdrew consent are excluded from ITT analysis. ITT analysis avoids overoptimistic estimates of the efficacy of an intervention resulting from the removal of non-compliers by accepting that noncompliance and protocol deviations are likely to occur in practice. To analyse our hypotheses and research questions, we follow-the ITT analysis strategy. This includes: 1) Attempt to follow up all randomized individuals, even if they withdraw from allocated group. 2) Perform a main analysis that is valid under a plausible assumption about the missing data and that uses all observed data 3) Perform sensitivity analyses to explore the impact of departures from the assumption made in the main analysis 4) Account for all randomized individuals, at least in the sensitivity analyses. conditions module condition list condition Hand Hygiene keyword list keyword Behavioral intervention Hand hygiene behavior MOST Health behavior change design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description In this study, the MOST methodology (multiphase optimization strategy; Collins et al., 2007) will be applied. First, the most effective intervention components for specific target groups will be determined, which is called the optimisation phase. To this end, the investigators run a parallel randomized trial with nine intervention groups that investigates three interventions modules in different order. After this optimisation phase, the final intervention will be tested against an active control group (basic app content) in a randomized controlled trial, which is called the evaluation phase. design primary purpose Prevention design masking info design masking Triple design who masked list design who masked Participant Care Provider Investigator enrollment info enrollment count 710 enrollment type Anticipated arms interventions module arm group list arm group arm group label Habit - Motivation group arm group type Experimental arm group description First: 2 weeks habit intervention; Second: 2 weeks motivation intervention arm group intervention list arm group intervention name Behavioral: Motivation Behavioral: Habit arm group label Habit - Social group arm group type Experimental arm group description First: 2 weeks habit intervention; Second: 2 weeks social intervention arm group intervention list arm group intervention name Behavioral: Habit Behavioral: Social arm group label Habit - Habit group arm group type Experimental arm group description 4 weeks habit intervention arm group intervention list arm group intervention name Behavioral: Habit arm group label Motivation - Habit group arm group type Experimental arm group description First: 2 weeks motivation intervention; Second: 2 weeks habit intervention arm group intervention list arm group intervention name Behavioral: Motivation Behavioral: Habit arm group label Motivation - Social group arm group type Experimental arm group description First: 2 weeks motivation intervention; Second: 2 weeks social intervention arm group intervention list arm group intervention name Behavioral: Motivation Behavioral: Social arm group label Motivation - Motivation group arm group type Experimental arm group description 4 weeks motivation intervention arm group intervention list arm group intervention name Behavioral: Motivation arm group label Social - Habit group arm group type Experimental arm group description First: 2 weeks social intervention; Second: 2 weeks habit intervention arm group intervention list arm group intervention name Behavioral: Habit Behavioral: Social arm group label Social - Motivation group arm group type Experimental arm group description First: 2 weeks social intervention; Second: 2 weeks motivation intervention arm group intervention list arm group intervention name Behavioral: Motivation Behavioral: Social arm group label Social - Social group arm group type Experimental arm group description 4 weeks social intervention arm group intervention list arm group intervention name Behavioral: Social intervention list intervention intervention type Behavioral intervention name Motivation intervention description The key constructs targeted by the motivational module are attitudes towards the target behavior, risk perception, outcome expectancies and self-efficacy. The intervention includes the following techniques: information about health consequences, salience of consequences, goal setting (behavior), problem solving, verbal persuasion about capabilities, focus on past success (Michie et al., 2013) intervention arm group label list intervention arm group label Habit - Motivation group Motivation - Habit group Motivation - Motivation group Motivation - Social group Social - Motivation group intervention type Behavioral intervention name Habit intervention description The goal of the habit module is to guide participants to perform correct hand hygiene at self-selected key times repeatedly. The aim is that the behavior will be translated into a habit. The intervention includes the following techniques: Information about antecedents, self-monitoring of behavior, action planning, prompts/cues, habit formation, behavioral practice/ rehearsal, prompts/cues (physical cue) (Michie et al., 2013). intervention arm group label list intervention arm group label Habit - Habit group Habit - Motivation group Habit - Social group Motivation - Habit group Social - Habit group intervention type Behavioral intervention name Social intervention description The key constructs targeted by the social module are perceived norms including descriptive norms and injunctive norm. The intervention includes the following techniques: Monitoring of behavior by others, social incentive, social comparison, social reward, restructuring the physical environment, information about others approval, credible source, information about health consequences, feedback on behavior (Michie et al., 2013). intervention arm group label list intervention arm group label Habit - Social group Motivation - Social group Social - Habit group Social - Motivation group Social - Social group outcomes module primary outcome list primary outcome primary outcome measure Average frequency of correct hand hygiene behaviour at key times primary outcome description First, participants indicate, whether they experienced key times, e.g. arriving home, after using the toilet, which require to wash or disinfect hands since the last questionnaire. Participants will then be asked how many times they correctly washed or disinfected hands at the indicated key times. The response options are 0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always. Participants receive 5 questionnaires during a diary day. People attend a diary day after module 1 and after module 2. The frequencies across the 5-times daily diaries will be averaged to indicate the average frequency by which participants correctly performed hand hygiene at key times that day (scale ranging from 0 to 4). primary outcome time frame Day 16 (after module 1) primary outcome measure Average frequency of correct hand hygiene behaviour at key times primary outcome description First, participants indicate, whether they experienced key times, e.g. arriving home, after using the toilet, which require to wash or disinfect hands since the last questionnaire. Participants will then be asked how many times they correctly washed or disinfected hands at the indicated key times. The response options are 0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always. Participants receive 5 questionnaires during a diary day. People attend a diary day after module 1 and after module 2. The frequencies across the 5-times daily diaries will be averaged to indicate the average frequency by which participants correctly performed hand hygiene at key times that day (scale ranging from 0 to 4). primary outcome time frame Day 33 (after module 2) secondary outcome list secondary outcome secondary outcome measure Frequency of hand hygiene behaviour at key times, but not correctly secondary outcome description How many times they wash or disinfect their hands, but not correctly? The responses are: 0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always. Participants receive 5 questionnaires during a diary day. People attend a diary day after module 1 and after module 2. The frequencies across the 5-times daily diaries will be averaged to indicate the average frequency by which participants not-correctly performed hand hygiene at key times that day (scale ranging from 0 to 4). secondary outcome time frame Day 16 (after module 1) and day 33 (after module 2) secondary outcome measure Self-reported behavioural intention secondary outcome description One item: "To what extent do you intend to correctly perform your hand hygiene behavior at key times?" The response options ranged from 1 "not at all" to 6 "very strongly." Higher scores indicate stronger intention. secondary outcome time frame Day 17 (main survey T2) and day 34 (main survey T3) secondary outcome measure Mean score of self-reported fife risk perception items secondary outcome description Fife items such as "To what extent do you think that the probability is high that I will have serious health problems, if I do not perform correct hand hygiene behavior at key times?" The response options ranged from 1 "not at all" to 6 "very strongly." Higher scores indicate higher risk perception. secondary outcome time frame Day 17 (main survey T2) and day 34 (main survey T3) secondary outcome measure Mean score of eight self-reported outcome-expectancies items secondary outcome description Eight items such as "If I do not perform correct hand hygiene behavior at key times, then I stay rather healthy" The response options ranged from 1 "not at all" to 6 "very strongly." Higher scores indicate higher outcome-expectancies. secondary outcome time frame Day 17 (main survey T2) and day 34 (main survey T3) secondary outcome measure Mean score of four self-reported coping planning items secondary outcome description Four items such as: "I have made a detailed plan about how I can perform correct hand hygiene behavior at key times, when soap and water are not available' The response options ranged from 1 "not at all" to 6 "very strongly." Higher scores indicate higher coping planning. secondary outcome time frame Day 17 (main survey T2) and day 34 (main survey T3) secondary outcome measure Mean score of three self-reported action planning items secondary outcome description Three items such as: "I have made a detailed plan about when I am going to wash and disinfect may hands." The response options ranged from 1 "not at all" to 6 "very strongly." Higher scores indicate higher action planning. secondary outcome time frame Day 17 (main survey T2) and day 34 (main survey T3) secondary outcome measure Habit strength assessed with the self-report habit index (SRHI) secondary outcome description Self-Report Habit Index (SRHI) with four times such as: "Correct hand hygiene behavior at key times is something that I do automatically." The response options ranged from 1 "strongly disagree" to 6 "strongly agree" secondary outcome time frame Day 17 (main survey T2) and day 34 (main survey T3) secondary outcome measure Mean score of three self-reported injunctive norm items secondary outcome description Three items such as "To what extent do you think that most people who are important to me approve correct hand hygiene behavior at key times? The response options ranged from 1 "not at all" to 6 "very strongly." Higher scores indicate higher injunctive norms. secondary outcome time frame Day 17 (main survey T2) and day 34 (main survey T3) secondary outcome measure Mean score of two self-reported descriptive norm items secondary outcome description Two times such as "To what extent do you think that most people who are important to me perform correct hand hygiene behavior at key times? The response options ranged from 1 "not at all" to 6 "very strongly." Higher scores indicate higher descriptive norms. secondary outcome time frame Day 17 (main survey T2) and day 34 (main survey T3) secondary outcome measure Mean score of six self-reported attitude items secondary outcome description Six items such as "Correct hand hygiene behavior at key times is…" response range from pleasant to unpleasant. Higher scores indicate higher attitude. secondary outcome time frame Day 17 (main survey T2) and day 34 (main survey T3) secondary outcome measure Mean score of three self-reported action control items secondary outcome description Three items such as "During the last two weeks I have constantly monitored myself whether I washed or disinfected my hands according to my plans" The response options ranged from 1 "not at all" to 6 "very strongly." With the additional item option "During the last two weeks, I did not intend to perform correct hand hygiene behavior at key times". Higher scores indicate higher action control. secondary outcome time frame Day 17 (main survey T2) and day 34 (main survey T3) secondary outcome measure User engagement assessed with the DBCI Engagement Scale secondary outcome description Eight items such as "How strongly did you experience interest?" Response ranged from "not at all" to "moderately" to "extremely" secondary outcome time frame Day 17 (main survey T2) and day 34 (main survey T3) secondary outcome measure Intervention usability using the System Usability Scale (SUS) secondary outcome description Ten items such as "I think that I would like to use this product frequently". Response range from 1 "strongly disagree" to 6 "strongly agree" secondary outcome time frame Day 17 (main survey T2) and day 34 (main survey T3) secondary outcome measure Satisfaction using the ZUF-8 (Original Englische Version CSQ-8) secondary outcome description Eight items such as "Would you recommend this app to a friend" responses are 1 definitely not / 2 not really / 3 rather yes / 4 definitely yes secondary outcome time frame Day 17 (main survey T2) and day 34 (main survey T3) secondary outcome measure Mean score of intervention fidelity items secondary outcome description Items generated to evaluate the interventions. Fifteen items such as "The description in the soapp app was clear to me" or "The tasks with the pro and contra list was fun" The response options ranged from 1 "not at all" to 6 "very strongly." secondary outcome time frame Day 17 (main survey T2) and day 34 (main survey T3) secondary outcome measure Self-reported flu-like infection symptoms secondary outcome description In the last two weeks, did you have flu-like infection symptoms? secondary outcome time frame Day 17 (main survey T2) and day 34 (main survey T3) secondary outcome measure Self-reported statement of the occurrences of Covid-19. secondary outcome description In the last two weeks, did you have a positive corona test? secondary outcome time frame Day 17 (main survey T2) and day 34 (main survey T3) secondary outcome measure Mean score of eight self-reported self-efficacy items secondary outcome description Eight items such as "How confident are you that you correctly wash/disinfect your hands at key times, when you are on the way" The response options ranged from 1 "not at all" to 6 "very strongly." Higher scores indicate higher self-efficacy. secondary outcome time frame Day 17 (main survey T2) and day 34 (main survey T3) eligibility module eligibility criteria Inclusion Criteria: Be at least 18 years old Have signed an electronically written informed consent (online) form to participate in the study Own a smartphone with mobile access to the internet Be proficient in the German language to the degree that they understand the contents and instructions of the study. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Melanie Dr. Amrein central contact role Contact central contact phone +41316313641 central contact e mail melanie.amrein@psy.unibe.ch overall official list overall official overall official name Melanie Dr. Amrein overall official affiliation University of Bern overall official role Study Chair location list location location facility University of Bern location status Recruiting location city Bern location zip 3012 location country Switzerland location contact list location contact location contact name Melanie Amrein location contact role Contact location contact e mail melanie.amrein@psy.unibe.ch references module reference list reference reference p m i d 23512568 reference type background reference citation Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6. reference p m i d 17466815 reference type background reference citation Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. doi: 10.1016/j.amepre.2007.01.022. reference p m i d 27049339 reference type background reference citation Reyes Fernandez B, Knoll N, Hamilton K, Schwarzer R. Social-cognitive antecedents of hand washing: Action control bridges the planning-behaviour gap. Psychol Health. 2016 Aug;31(8):993-1004. doi: 10.1080/08870446.2016.1174236. Epub 2016 Apr 26. reference p m i d 23456214 reference type background reference citation Allan JL, Sniehotta FF, Johnston M. The best laid plans: planning skill determines the effectiveness of action plans and implementation intentions. Ann Behav Med. 2013 Aug;46(1):114-20. doi: 10.1007/s12160-013-9483-9. reference p m i d 29024515 reference type background reference citation Bierbauer W, Inauen J, Schaefer S, Kleemeyer MM, Luscher J, Konig C, Tobias R, Kliegel M, Ihle A, Zimmerli L, Holzer BM, Siebenhuener K, Battegay E, Schmied C, Scholz U. Health Behavior Change in Older Adults: Testing the Health Action Process Approach at the Inter- and Intraindividual Level. Appl Psychol Health Well Being. 2017 Nov;9(3):324-348. doi: 10.1111/aphw.12094. Epub 2017 Oct 12. reference p m i d 20658824 reference type background reference citation Orbell S, Verplanken B. The automatic component of habit in health behavior: habit as cue-contingent automaticity. Health Psychol. 2010 Jul;29(4):374-83. doi: 10.1037/a0019596. reference p m i d 21929476 reference type background reference citation Ajzen I. The theory of planned behaviour: reactions and reflections. Psychol Health. 2011 Sep;26(9):1113-27. doi: 10.1080/08870446.2011.613995. reference p m i d 16480553 reference type background reference citation Sniehotta FF, Scholz U, Schwarzer R. Action plans and coping plans for physical exercise: A longitudinal intervention study in cardiac rehabilitation. Br J Health Psychol. 2006 Feb;11(Pt 1):23-37. doi: 10.1348/135910705X43804. reference p m i d 30927357 reference type background reference citation Perski O, Blandford A, Garnett C, Crane D, West R, Michie S. A self-report measure of engagement with digital behavior change interventions (DBCIs): development and psychometric evaluation of the "DBCI Engagement Scale". Transl Behav Med. 2020 Feb 3;10(1):267-277. doi: 10.1093/tbm/ibz039. reference p m i d 2762479 reference type background reference citation Schmidt J, Lamprecht F, Wittmann WW. [Satisfaction with inpatient management. Development of a questionnaire and initial validity studies]. Psychother Psychosom Med Psychol. 1989 Jul;39(7):248-55. German. reference p m i d 17447868 reference type background reference citation Schwarzer R, Schuz B, Ziegelmann JP, Lippke S, Luszczynska A, Scholz U. Adoption and maintenance of four health behaviors: theory-guided longitudinal studies on dental flossing, seat belt use, dietary behavior, and physical activity. Ann Behav Med. 2007 Apr;33(2):156-66. doi: 10.1007/BF02879897. reference type background reference citation Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative research in psychology, 3(2), 77-101. reference p m i d 17695343 reference type background reference citation Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146. reference p m i d 35351716 reference type derived reference citation Amrein MA, Ruschetti GG, Baeder C, Bamert M, Inauen J. Mobile intervention to promote correct hand hygiene at key times to prevent COVID-19 in the Swiss adult general population: study protocol of a multiphase optimisation strategy. BMJ Open. 2022 Mar 28;12(3):e055971. doi: 10.1136/bmjopen-2021-055971. i p d sharing statement module i p d sharing Yes derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04830761
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full study rank 61400 study protocol section identification module n c t id NCT04836962 org study id info org study id 4-2021-0149 organization org full name Yonsei University org class OTHER brief title Does the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery? official title Does the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery? status module status verified date August 2022 overall status Completed expanded access info has expanded access No start date struct start date May 7, 2021 start date type Actual primary completion date struct primary completion date January 31, 2022 primary completion date type Actual completion date struct completion date January 31, 2022 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date August 18, 2022 last update post date struct last update post date August 23, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Yonsei University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Hypospadias is a congenital malformation that occurs in an embryological process, and occurs with an incidence of about 1/300 in male children. The caudal block was the most commonly performed method for pain control after hypospadias surgery, and showed very good analgesic effect in the immediate postoperative stage. However, the caudal block is a neuraxial block that has a limitation in its duration with single shot and shows complications and adverse effects. In recent studies, the pudendal nerve block has been suggested as an alternative method. In children undergoing hypospadias surgery, the pudendal nerve block showed a longer duration compared to the caudal block, decreased the use of analgesics within 24 hours after surgery, and showed higher parental satisfaction. On the other hand, there have been many studies to prolong the duration of the relatively short duration of caudal block. Among them, dexamethasone administered intravenously is known to improve the duration of various regional blocks and reduce the administration of additional analgesics. The aim of this study is to verify whether a single administration of dexamethasone can enhance the effect of the pudendal nerve block in children 0.5-3 years of age undergoing hypospadias surgery. conditions module condition list condition Pediatric Patients Undergoing Hypospadias Surgery design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Triple design who masked list design who masked Participant Care Provider Outcomes Assessor enrollment info enrollment count 46 enrollment type Actual arms interventions module arm group list arm group arm group label control arm group type Placebo Comparator arm group description normal saline is administrated to patients. arm group intervention list arm group intervention name Drug: normal saline arm group label dexamethasone arm group type Experimental arm group description 0.5mg/kg dexamethasone is administered to patients. arm group intervention list arm group intervention name Drug: dexamethasone intervention list intervention intervention type Drug intervention name normal saline intervention description 2cc of normal saline is administered to patient instead of dexamethasone. intervention arm group label list intervention arm group label control intervention type Drug intervention name dexamethasone intervention description dexamethasone is administered 0.5mg/kg (up to 10mg) which is diluted with normal saline to make a total of 2cc. intervention arm group label list intervention arm group label dexamethasone outcomes module primary outcome list primary outcome primary outcome measure the duration from surgery to first PCA(patient-controlled analgesia) administration primary outcome description the very first time of PCA usage after surgery, which is automatically recorded in PCA. primary outcome time frame during 48 hours after surgery secondary outcome list secondary outcome secondary outcome measure the amount of additional analgesia required for postoperative 48hrs. secondary outcome description the amount of PCA usage for 48 hrs after surgery, which is automatically recorded in PCA. secondary outcome time frame during 48 hours after surgery secondary outcome measure the number of additional analgesia required for postoperative 48hrs. secondary outcome description the number of PCA usage for 48 hrs after surgery, which is automatically recorded in PCA. secondary outcome time frame during 48 hours after surgery secondary outcome measure pain score for each time period secondary outcome description ask parents about their children's pain score at each time point secondary outcome time frame during 48 hours after surgery secondary outcome measure overall parents' satisfaction questionnaire secondary outcome description at 48 hours after surgery, parents are asked about satisfaction of their children's pain control secondary outcome time frame 48 hours after surgery eligibility module eligibility criteria Inclusion Criteria: pediatric patients aged 6 months to 3 years who are planning to undergo hypospadias surgery American Society of Anesthesiologists (ASA) classification 1~2 Exclusion Criteria: patients who are having uncorrected heart deformity patients who are having vertebrae deformity in which the pudendal nerve block cannot be performed patients with blood coagulopathy patients with diagnosed diabetes patients with diagnosed adrenal disease patients with fever above 37.5 degrees before surgery patients currently taking steroids patients contraindicated for dexamethasone administration healthy volunteers No gender Male gender based Yes minimum age 6 Months maximum age 3 Years std age list std age Child contacts locations module overall official list overall official overall official name Jeong-Rim Lee overall official affiliation Department of Anesthesiology and Pain Medicine overall official role Principal Investigator location list location location facility Yonsei University Health System, Severance Hospital location city Seoul location country Korea, Republic of i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007021 condition mesh term Hypospadias condition ancestor list condition ancestor condition ancestor id D000010409 condition ancestor term Penile Diseases condition ancestor id D000014564 condition ancestor term Urogenital Abnormalities condition ancestor id D000000013 condition ancestor term Congenital Abnormalities condition browse leaf list condition browse leaf condition browse leaf id M9223 condition browse leaf name Hypospadias condition browse leaf as found Hypospadias condition browse leaf relevance high condition browse leaf id M12472 condition browse leaf name Penile Diseases condition browse leaf relevance low condition browse leaf id M12 condition browse leaf name Congenital Abnormalities condition browse leaf relevance low condition browse leaf id M16466 condition browse leaf name Urogenital Abnormalities condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000003907 intervention mesh term Dexamethasone intervention ancestor list intervention ancestor intervention ancestor id D000000893 intervention ancestor term Anti-Inflammatory Agents intervention ancestor id D000000932 intervention ancestor term Antiemetics intervention ancestor id D000001337 intervention ancestor term Autonomic Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000005765 intervention ancestor term Gastrointestinal Agents intervention ancestor id D000005938 intervention ancestor term Glucocorticoids intervention ancestor id D000006728 intervention ancestor term Hormones intervention ancestor id D000006730 intervention ancestor term Hormones, Hormone Substitutes, and Hormone Antagonists intervention ancestor id D000018931 intervention ancestor term Antineoplastic Agents, Hormonal intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M6254 intervention browse leaf name Dexamethasone intervention browse leaf as found Blood intervention browse leaf relevance high intervention browse leaf id M3184 intervention browse leaf name Analgesics intervention browse leaf relevance low intervention browse leaf id M235540 intervention browse leaf name Dexamethasone acetate intervention browse leaf relevance low intervention browse leaf id M3369 intervention browse leaf name Anti-Inflammatory Agents intervention browse leaf relevance low intervention browse leaf id M3403 intervention browse leaf name Antiemetics intervention browse leaf relevance low intervention browse leaf id M8033 intervention browse leaf name Gastrointestinal Agents intervention browse leaf relevance low intervention browse leaf id M8199 intervention browse leaf name Glucocorticoids intervention browse leaf relevance low intervention browse leaf id M8941 intervention browse leaf name Hormones intervention browse leaf relevance low intervention browse leaf id M8940 intervention browse leaf name Hormone Antagonists intervention browse leaf relevance low intervention browse leaf id M20119 intervention browse leaf name Antineoplastic Agents, Hormonal intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infl intervention browse branch name Anti-Inflammatory Agents intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev AnEm intervention browse branch name Antiemetics intervention browse branch abbrev Gast intervention browse branch name Gastrointestinal Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Analg intervention browse branch name Analgesics
NCT04836962
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full study rank 61592 study protocol section identification module n c t id NCT04834466 org study id info org study id AlfonsoXElSabioU organization org full name Alfonso X El Sabio University org class OTHER brief title Factors Associated With Pain Level Experience in Orthodontic Treatment official title Factors Associated With Pain Level Experience in Orthodontic Treatment status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date February 4, 2021 start date type Actual primary completion date struct primary completion date February 1, 2022 primary completion date type Anticipated completion date struct completion date March 1, 2022 completion date type Anticipated study first submit date March 19, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 4, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Chia Jung Lee responsible party investigator title Principal investigator responsible party investigator affiliation Alfonso X El Sabio University lead sponsor lead sponsor name Chia Jung Lee lead sponsor class OTHER collaborator list collaborator collaborator name Shen Gaang Jong Shiaw Hospital collaborator class UNKNOWN oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Orthodontic pain has been the primary concern from all patients who requires orthodontic treatment. The design of the study will help us comprehend how patient experienced and managed pain during their orthodontic treatment, average pain level in different orthodontic appliances and factors that could affect pain level experience during treatment, including gender, age, brackets types, hygiene level and habitude. detailed description To interpret the average pain level experience in orthodontic treatment and find correlations of different pain level within each individual from the clinical reports and questionnaires collected from each patient. conditions module condition list condition Orthodontic Pain Pain Orthodontic Appliance Complication design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Cross-Sectional enrollment info enrollment count 150 enrollment type Anticipated arms interventions module intervention list intervention intervention type Behavioral intervention name Pain Level experience during orthodontic treatment intervention description A questionnaire was given to patients who have started their orthodontic treatment to assess their pain level experience outcomes module primary outcome list primary outcome primary outcome measure Pain level difference within different orthodontic appliances primary outcome description Orthodontic appliances such as Invisalign, conventional braces and self-ligated braces are included to compare. Pain assessed through visual analogue scale (VAS) rating 0(No pain) to 10(extreme pain) were given individually to participant with different orthodontic appliances to gather information. The lower the score, the lesser the pain and vise versa. primary outcome time frame From date of randomisation until the date of a 150 participation. Through study completion, an average of 1 year secondary outcome list secondary outcome secondary outcome measure Pain level difference within different factors secondary outcome description Factors such as gender, age, hygiene level, tooth discrepancies, habitude and mental state could affect the pain level experience during orthodontic treatment. Survey given with respective questions and pain assessed through visual analogue scale (VAS) rating 0(no pain) to 10(extreme pain) were given individually to participant to gather information. The lower the score, the lesser the pain and vise versa. secondary outcome time frame Through study completion, an average of 1 year. eligibility module eligibility criteria Inclusion Criteria: Patient with orthodontic treatment over 2 months and less than 12 months Patient with braces or Invisalign Patient who goes to orthodontic visits routinely Exclusion Criteria: Patient undergoing orthopaedic treatment (Functional appliances, 2x4 braces placement, maxillary expansion) Patient who do not understand Spanish Patient with cognitive impairment Patient who do not want to participate in the study Patient who have complete their orthodontic treatment healthy volunteers Accepts Healthy Volunteers gender All std age list std age Child Adult Older Adult study population Patients from Clinic Centro Odontologo Innovaccion y especialidad avanzadas who are undergoing orthodontic treatment were selected. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Chia Jung Lee central contact role Contact central contact phone +34603745177 central contact e mail jody929lee2012@gmail.com overall official list overall official overall official name Chia Jung Lee overall official affiliation University Alfonso X El Sabio overall official role Principal Investigator location list location location facility Centro Odonologico Innovacion y Especilidades Avanzadas location status Recruiting location city Madrid location zip 28037 location country Spain location contact list location contact location contact name Patricia CINTORA LOPEZ location contact role Contact location contact phone +34914402330 location contact e mail info@UAX.es references module reference list reference reference p m i d 8921656 reference type background reference citation Scheurer PA, Firestone AR, Burgin WB. Perception of pain as a result of orthodontic treatment with fixed appliances. Eur J Orthod. 1996 Aug;18(4):349-57. doi: 10.1093/ejo/18.4.349. reference p m i d 31956934 reference type background reference citation Cardoso PC, Espinosa DG, Mecenas P, Flores-Mir C, Normando D. Pain level between clear aligners and fixed appliances: a systematic review. Prog Orthod. 2020 Jan 20;21(1):3. doi: 10.1186/s40510-019-0303-z. reference p m i d 19852612 reference type background reference citation Krukemeyer AM, Arruda AO, Inglehart MR. Pain and orthodontic treatment. Angle Orthod. 2009 Nov;79(6):1175-81. doi: 10.2319/121308-632R.1. reference p m i d 29442079 reference type background reference citation Banerjee S, Banerjee R, Shenoy U, Agarkar S, Bhattacharya S. Effect of orthodontic pain on quality of life of patients undergoing orthodontic treatment. Indian J Dent Res. 2018 Jan-Feb;29(1):4-9. doi: 10.4103/ijdr.IJDR_113_16. reference p m i d 23132480 reference type background reference citation Kafle D, Rajbhandari A. Anticipated pain and pain experience among orthodontic patients: is there any difference? Kathmandu Univ Med J (KUMJ). 2012 Apr-Jun;10(38):71-3. reference p m i d 32143365 reference type background reference citation Nicotra C, Polizzi A, Zappalà G, Leonida A, Indelicato F, Caccianiga G. A Comparative Assessment of Pain Caused by the Placement of Banded Orthodontic Appliances with and without Low-Level Laser Therapy: A Randomized Controlled Prospective Study. Dent J (Basel). 2020 Mar 4;8(1). pii: E24. doi: 10.3390/dj8010024. see also link list see also link see also link label The Visual analogue Scale (VAS) for pain assessment see also link u r l https://www.physio-pedia.com/Visual_Analogue_Scale see also link label Online consent form for the survey see also link u r l https://eu.jotform.com/myforms/? see also link label Questionnaire designed and distributed through this website see also link u r l https://www.surveyhero.com i p d sharing statement module i p d sharing Undecided i p d sharing description Individual participant data could be shared for further analysis or comparison to other researchers document section large document module large doc list large doc large doc type abbrev Prot large doc has protocol Yes large doc has s a p No large doc has i c f No large doc label Study Protocol large doc date February 4, 2021 large doc upload date 03/31/2021 07:32 large doc filename Prot_000.pdf large doc type abbrev ICF large doc has protocol No large doc has s a p No large doc has i c f Yes large doc label Informed Consent Form large doc date February 4, 2021 large doc upload date 04/04/2021 14:41 large doc filename ICF_001.pdf derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions
NCT04834466
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full study rank 61866 study protocol section identification module n c t id NCT04830904 org study id info org study id 760 organization org full name IRCCS Eugenio Medea org class OTHER brief title Efficacy of Lycra Garments in Ataxic Subjects official title Efficacy of Lycra Garments in Ataxic Subjects status module status verified date August 2021 overall status Recruiting expanded access info has expanded access No start date struct start date August 3, 2020 start date type Actual primary completion date struct primary completion date December 31, 2022 primary completion date type Anticipated completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date March 11, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date August 24, 2021 last update post date struct last update post date August 25, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name IRCCS Eugenio Medea lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The aim of this study iss to analyze the effect of Lycra garments in the axial stabilization in subjects affected by ataxia, both in acquired cerebellar injuries and malformative etiology. Improvement are expected for what concerns: greater stability during stance smoother walking pattern reduction of risk of fall. The two groups (acquired and malformative) will be compared. conditions module condition list condition Ataxia, Cerebellar design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Sequential Assignment design primary purpose Supportive Care design masking info design masking None (Open Label) enrollment info enrollment count 30 enrollment type Anticipated arms interventions module arm group list arm group arm group label Use of lycra garments arm group type Experimental arm group description the subjects are assessed with and without wearing the device arm group intervention list arm group intervention name Device: personalized Lycra garments intervention list intervention intervention type Device intervention name personalized Lycra garments intervention description the subjects wear lycra garments during the assessment time and for some days after the assessment intervention arm group label list intervention arm group label Use of lycra garments outcomes module primary outcome list primary outcome primary outcome measure Movement of the center of mass over GRAIL/no device primary outcome description Balance in static conditions and Walking assessment over GRAIL. GRAIL will be used to track the movement of the Center Of Mass of the patient during 4 repetitions lasting 1 minute primary outcome time frame immediately before wearing the lycra garment primary outcome measure Movement of the center of mass over GRAIL/ with lycra garments primary outcome description Balance in static conditions and Walking assessment over GRAIL. GRAIL will be used to track the movement of the Center Of Mass of the patient during 4 repetition lasting 1 minute primary outcome time frame immediately after wearing the lycra garment primary outcome measure Berg Balance Scale/no device primary outcome description Berg Balance Scale is a scale to assess the risk of fall and balance failure. It ranges from 0 (worse outcome) to 56 (best outcome) primary outcome time frame immediately before wearing the lycra garment primary outcome measure Berg Balance Scale/ with lycra garments primary outcome description Berg Balance Scale is a scale to assess the risk of fall and balance failure. It ranges from 0 (worse outcome) to 56 (best outcome) primary outcome time frame immediately after wearing the lycra garment primary outcome measure 6 Minute Walking Test/no device primary outcome description a test to assess the walking resistance primary outcome time frame immediately before wearing the lycra garment primary outcome measure 6 Minute Walking Test/ with lycra garments primary outcome description a test to assess the walking resistance primary outcome time frame immediately after wearing the lycra garment primary outcome measure Goal Attainment Scaling/no device primary outcome description Goal Attainment Scaling is a subjective scale that can be defined between clinicians and subjects (or their parents) to identify changes in specific activities. It should be articulated up to 3 goals, and each of them should be scored with values ranging from -2 (worse score) to +2 (better) primary outcome time frame immediately before wearing the device primary outcome measure Goal Attainment Scaling/ with lycra garments primary outcome description Goal Attainment Scaling is a subjective scale that can be defined between clinicians and subjects (or their parents) to identify changes in specific activities. It should be articulated up to 3 goals, and each of them should be scored with values ranging from -2 (worse score) to +2 (better) primary outcome time frame immediately after wearing the lycra garment secondary outcome list secondary outcome secondary outcome measure Likert tolerability questionaire secondary outcome description a likert tool designed to evaluate the tolerability of the lycra garments secondary outcome time frame 14 days after wearing the lycra garment eligibility module eligibility criteria Inclusion Criteria: subjects recruited must show a framework of ataxia consequent to acquired brain injury or malformative etiology. subjects must be able to walk autonomously without any device Exclusion Criteria: presence of spasticity or muscular contractures subjects who already used lycra garments healthy volunteers No gender All minimum age 4 Years maximum age 14 Years std age list std age Child contacts locations module central contact list central contact central contact name Daniele Panzeri central contact role Contact central contact phone 031877878 central contact e mail daniele.panzeri@lanostrafamiglia.it location list location location facility IRCCS E. Medea location status Recruiting location city Bosisio Parini location state Lecco location zip 23842 location country Italy location contact list location contact location contact name Daniele Panzeri location contact role Contact location contact phone 031877878 location contact e mail daniele.panzeri@lanostrafamiglia.it i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001259 condition mesh term Ataxia condition mesh id D000002524 condition mesh term Cerebellar Ataxia condition ancestor list condition ancestor condition ancestor id D000020820 condition ancestor term Dyskinesias condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000002526 condition ancestor term Cerebellar Diseases condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M3717 condition browse leaf name Ataxia condition browse leaf as found Ataxia, Cerebellar condition browse leaf relevance high condition browse leaf id M4925 condition browse leaf name Cerebellar Ataxia condition browse leaf as found Ataxia, Cerebellar condition browse leaf relevance high condition browse leaf id M21727 condition browse leaf name Dyskinesias condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id M4927 condition browse leaf name Cerebellar Diseases condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions
NCT04830904
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full study rank 61253 study protocol section identification module n c t id NCT04838873 org study id info org study id SO1901-31004 organization org full name Cairo University org class OTHER brief title Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center official title Randomised Controlled Trial of Open Versus Laparoscopic Radical Cystectomy at a Laparoscopic Naive Center status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date January 24, 2019 start date type Actual primary completion date struct primary completion date July 1, 2019 primary completion date type Actual completion date struct completion date December 30, 2020 completion date type Actual study first submit date March 30, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 8, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ahmed Abdelbary Ali responsible party investigator title Lecturer of Surgical Oncology responsible party investigator affiliation Cairo University lead sponsor lead sponsor name Cairo University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This study is a prospective randomised controlled study of urinary bladder cancer patients presented to urology unit at National Cancer Institute; Cairo University. detailed description The study will randomise 60 patients to one of two arms; laparoscopic-assisted radical cystectomy and open radical cystectomy. The focus of the study will be a comparison of both approaches on the patients' peri-operative outcome. conditions module condition list condition Bladder Cancer Laparoscopy design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 60 enrollment type Actual arms interventions module arm group list arm group arm group label Open Radical Cystectomy arm group type Active Comparator arm group description Standard open radical cystectomy. arm group intervention list arm group intervention name Procedure: Open radical cystectomy arm group label Laparoscopic-assisted radical cystectomy. arm group type Experimental arm group description Laparoscopic-assisted radical cystectomy. arm group intervention list arm group intervention name Procedure: Laparoscopic-assisted radical cystectomy intervention list intervention intervention type Procedure intervention name Open radical cystectomy intervention description Standard open radical cystectomy and urinary diversion intervention arm group label list intervention arm group label Open Radical Cystectomy intervention type Procedure intervention name Laparoscopic-assisted radical cystectomy intervention description Laparoscopic-assisted radical cystectomy and extracorporeal urinary diversion intervention arm group label list intervention arm group label Laparoscopic-assisted radical cystectomy. outcomes module primary outcome list primary outcome primary outcome measure Operative time primary outcome description OR time as measured in minutes, divided into time required to perform the cystectomy, lymph node dissection, and urinary diversion. primary outcome time frame During surgery primary outcome measure Blood loss primary outcome description EBL as measured in millilitres, including the effluent from the suction canister as well as estimates of the gauze swabs. primary outcome time frame During surgery primary outcome measure Length of hospital stay primary outcome description LOS as measured in days primary outcome time frame Immediate post-operative period. primary outcome measure Time to oral intake primary outcome description Measured in days primary outcome time frame Immediate post-operative period primary outcome measure Conversion rate primary outcome description Rate of conversion from laparoscopy to open surgery primary outcome time frame During surgery primary outcome measure Re-admission rate. primary outcome description Re-hospitalization requirement. primary outcome time frame Intra-operative to sixth months. primary outcome measure Opioid requirements. primary outcome description Requirement, dose and duration of narcotic analgesia. primary outcome time frame During surgery through first post-operative week. primary outcome measure Visceral injury primary outcome description Any organ injury encountered during the operation. primary outcome time frame During surgery primary outcome measure Urine leak primary outcome description Leakage of urine from urinary enteric anastomosis primary outcome time frame Up to 4 weeks primary outcome measure Wound dehiscence, infection. primary outcome description Wound gaping, evisceration or infection. primary outcome time frame Up to 4 weeks primary outcome measure Enteric fistula primary outcome description Leakage of intestinal contents due to failure of entero-enteric anastomosis primary outcome time frame Up to 4 weeks primary outcome measure Sepsis primary outcome description Infection triggering a systematic immune response primary outcome time frame Up to 4 weeks primary outcome measure Venous thromboembolism primary outcome description DVT or pulmonary embolism primary outcome time frame Up to 2 months secondary outcome list secondary outcome secondary outcome measure pT stage secondary outcome description Pathologic tumor stage (Stage 1, stage 2, stage 3 or stage 4) secondary outcome time frame Within 10 days post surgery. secondary outcome measure Lymph node retrieval secondary outcome description Number of lymph nodes retrieved by open versus laparoscopic approaches. secondary outcome time frame Within 10 days post surgery. secondary outcome measure pN stage secondary outcome description Lymph node metastasis (positive or negative), and number of positive nodes if present. secondary outcome time frame Within 10 days post surgery. secondary outcome measure Surgical margins secondary outcome description Positive margins or negative margins. Location of positive margins (Urethral, ureteric) secondary outcome time frame Within 10 days post surgery secondary outcome measure Histological grade secondary outcome description Low grade, intermediate grade or high grade secondary outcome time frame Within 10 days post surgery eligibility module eligibility criteria Inclusion Criteria: Patients with transitional cell carcinoma, squamous cell carcinoma and urinary bladder adenocarcinoma. Patients fit for surgery (ECOG Performance Status 0,1). Exclusion Criteria: Patients with medical comorbidities that preclude surgical management or minimally invasive techniques. Patients with advanced hydronephrosis or renal failure. Patients refusing surgery. Patients with urinary bladder cancer invading bladder neck or prostatic urethra. Patients with metastatic urinary bladder cancer. Patients who received prior pelvic radiotherapy. Patients refusing randomization and/or participation in the trial. healthy volunteers No gender All minimum age 30 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Hatem Aboulkassem, M.D., Ph.D. overall official affiliation National Cancer Institute, Cairo University overall official role Principal Investigator location list location location facility National Cancer Institute location city Cairo location zip 11796 location country Egypt i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001749 condition mesh term Urinary Bladder Neoplasms condition ancestor list condition ancestor condition ancestor id D000014571 condition ancestor term Urologic Neoplasms condition ancestor id D000014565 condition ancestor term Urogenital Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000001745 condition ancestor term Urinary Bladder Diseases condition ancestor id D000014570 condition ancestor term Urologic Diseases condition browse leaf list condition browse leaf condition browse leaf id M4182 condition browse leaf name Urinary Bladder Neoplasms condition browse leaf as found Bladder Cancer condition browse leaf relevance high condition browse leaf id M16472 condition browse leaf name Urologic Neoplasms condition browse leaf relevance low condition browse leaf id M16467 condition browse leaf name Urogenital Neoplasms condition browse leaf relevance low condition browse leaf id M4178 condition browse leaf name Urinary Bladder Diseases condition browse leaf relevance low condition browse leaf id M16471 condition browse leaf name Urologic Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions
NCT04838873
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full study rank 61720 study protocol section identification module n c t id NCT04832802 org study id info org study id D3349-R organization org full name VA Office of Research and Development org class FED brief title Customized Employment for Veterans With Spinal Cord Injury official title Achieving Competitive Customized Employment Through Specialized Services - Veterans: ACCESS-VETS acronym ACCESS-Vets status module status verified date February 2022 overall status Recruiting expanded access info has expanded access No start date struct start date February 14, 2022 start date type Actual primary completion date struct primary completion date September 1, 2024 primary completion date type Anticipated completion date struct completion date June 1, 2025 completion date type Anticipated study first submit date March 26, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date February 15, 2022 last update post date struct last update post date March 2, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name VA Office of Research and Development lead sponsor class FED oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary The reason for conducting this study is to learn about the best ways to help Veterans with spinal cord injury (SCI) gain meaningful employment. Spinal cord injury is a medically complex disability that poses unique barriers to employment for Veterans. Returning to work after SCI improves health and quality of life, which in turn can lower risk for suicide in this high-risk population. Hence, the Department of Veterans Affairs (VA) supports interventions that help Veterans with SCI return to work and may prevent suicide. Customized employment (CE) is an innovative strategy for tailoring vocational services to meet the needs of people with complex disabilities. To address barriers to employment faced by Veterans with SCI, this study will evaluate whether a customized employment intervention used in non-VA settings can be adapted for use by the VA as a part of SCI medical rehabilitation. The research goal is to evaluate how a CE intervention for Veterans with SCI (ACCESS-Vets) can help them discover their strengths to find and maintain competitive integrated employment in their communities. This study will compare ACCESS-Vets with the usual evidence-based supported employment program, known as Individual Placement and Support (IPS). Veterans with SCI who chose to participate in this study will be randomly selected (i.e. by chance) to work with a vocational rehabilitation specialist as part of the ACCESS-Vets intervention or the usual IPS employment program for about 8 months. Study participants will complete study questionnaires before, during, and after their participation in the employment interventions. Some Veterans and their medical rehabilitation providers will be interviewed about their experiences with the employment interventions. The study expects to find that Veterans who participate in ACCESS-Vets will have better employment and quality of life outcomes then those who participate in IPS. The study will provide information about the strategies used in the ACCESS-Vets and IPS interventions for addressing barriers to employment. Ultimately, this study may provide a model for making VA vocational services for Veterans with SCI more effective and sustainable. detailed description This randomized clinical trial (RCT) will test the effectiveness of a customized employment (CE) intervention, Achieving Competitive Customized Employment through Specialized Services (ACCESS-Vets), to complement clinical services for Veterans with spinal cord injury (SCI) and improve their employment outcomes. Background: Restoring employment is an important rehabilitation goal for Veterans with SCI because employment impacts both quality of life (QOL) and longevity. Due to the medical complexity of SCI, however, these Veterans face unique employment barriers that are not adequately addressed by current Department of Veterans Affairs (VA) vocational services. Vocational services for Veterans with SCI need to address these employment barriers, which relate to physical health, finances, time for job search, and caregiver issues. Customized employment, an innovative strategy for tailoring vocational services to meet individual needs of people with complex disabilities, could be adapted for use in SCI rehabilitation. This research will evaluate a CE intervention to help Veterans with SCI discover their strengths, customize employment plans, and find competitive integrated employment in their communities. The proposed intervention, ACCESS, is a user-driven, standardized CE program delivered by a trained employment specialist and is effective for a non-clinical, community-based population of adults with disabilities. This research is needed to test ACCESS as a complement to clinical services for a clinically defined population and to assess the potential of CE for subsequent implementation in the VA. Research Plan: The effectiveness of ACCESS-Vets will be tested with an RCT of 100 Veterans with SCI. The study will have a rolling enrollment period with an intervention period of 26 months. ACCESS-Vets is typically completed in 8 months and includes the following elements: discovery, CE planning, job development, CE negotiation, and accommodations and job retention supports. Individual Placement and Support (IPS), otherwise known as evidence-based supported employment, will serve as an active control group consistent with treatment as usual. ACCESS-Vets and IPS will be compared on changes in employment attainment. The investigators predict Veterans who participate in ACCESS-Vets will have a higher employment rate than Veterans who receiving IPS. Among Veterans who attain employment, the investigators predict those who received ACCESS-Vets will report higher job satisfaction, wages, and retention. The investigators predict, Veterans who attain employment will demonstrate statistically significant improvements in self-sufficiency, QOL, and participation in life roles compared with those who do not attain employment. Finally, qualitative interviews with Veterans and their providers will identify strategies used in IPS and ACCESS-Vets for addressing barriers to employment and how practitioners adapt the ACCESS-Vets intervention for use in a VA clinical setting. Significance: This study is responsive to Veterans' reported desire for individualized vocational rehabilitation services and to the Modernization Plan and the MISSION Act, which emphasize Veteran-centered, community-based approaches to care. The proposal goals align with the Transformation Plan of the Office of Mental Health and Suicide Prevention, which prioritizes evidence-informed, community-based employment services. Recognizing the rapid adoption of CE in state and federal agencies, VA is partnering with the Office of Disability and Employment Policy (U.S. Department of Labor) to introduce and train VA vocational staff on CE as a promising practice; however, integration of CE into standard VA clinical services has not yet been implemented. In support of VA efforts to assist Veterans to achieve competitive employment and reintegration into civilian life, this proposal will evaluate CE within the context of existing VA vocational services. conditions module condition list condition Spinal Cord Injury keyword list keyword Spinal Cord Injury Rehabilitation Randomized Clinical Trial Disability Vocational Rehabilitation Employment Clinical Intervention Veterans design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description The investigators will use a 4-year, 2-armed, multi-site randomized controlled study design with concurrent mixed methods data collection at two VAMCs (Tampa and Richmond), to compare ACCESS-Vets intervention to treatment-as-usual (TAU), which is IPS. design primary purpose Health Services Research design masking info design masking None (Open Label) enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label ACCESS-Vets Intervention Group arm group type Experimental arm group description This group will receive ACCESS-Vets, a customized employment intervention adapted for use in VA healthcare. arm group intervention list arm group intervention name Behavioral: ACCESS arm group label IPS (Usual Care) Group arm group type Active Comparator arm group description This group will receive IPS (Individual Placement and Support), the usual evidence-based supported employment program in VA. arm group intervention list arm group intervention name Behavioral: IPS intervention list intervention intervention type Behavioral intervention name ACCESS intervention description ACCESS-Vets is a customized employment intervention adapted for use in VA healthcare to help Veterans with SCI achieve competitive integrated employment. ACCESS-Vets includes the following elements: discovery, customized employment planning, job development, customized employment negotiation, and accommodations and job retention supports. intervention arm group label list intervention arm group label ACCESS-Vets Intervention Group intervention type Behavioral intervention name IPS intervention description IPS is an evidenced-based practice of supported employment that helps persons with disabilities find and maintain integrated competitive employment. IPS follows eight standardized principles: zero exclusion, integrated services, rapid job search, competitive employment, worker preferences, systematic job development, benefits planning, and time-unlimited supports. intervention arm group label list intervention arm group label IPS (Usual Care) Group outcomes module primary outcome list primary outcome primary outcome measure Change in Employment Status primary outcome description This questionnaire is administered by study staff and documents whether Competitive Integrated Employment is achieved. primary outcome time frame 6, 9 12 months secondary outcome list secondary outcome secondary outcome measure Change in Employment Satisfaction, Wages, Retention secondary outcome description Employee satisfaction survey and Employment questionnaire are administered by study staff to document job satisfaction, wages, and retention. The investigators will continue to collect data for the employed group until the investigators will have 3 post-employment time points or until the data collection period ends secondary outcome time frame 6, 9, 12 months secondary outcome measure Change in Quality of Life- Ability to Participate in Social Roles and Activities (SRA) secondary outcome description SCI-QOL Scale subset assesses participation in social roles and activities (Short Form-10 items). Item responses range from 1 (Never) to 5 (always) with a min score of 10 and a max score of 50. Higher score indicated higher QOL for Ability to Participate in SRA. secondary outcome time frame Baseline, 6, 9 12 months secondary outcome measure Change in Quality of Life- Satisfaction with SRA secondary outcome description SCI-QOL Scale subset assesses satisfaction with social roles and activities (SRA). (SF -10 items) Item responses range from 1 (Not at All) to 5 (Very Much) with a min score of 10 and a max score of 50. Higher score indicated higher QOL for satisfaction with SRA. secondary outcome time frame Baseline, 6, 9, 12 months secondary outcome measure Changes in Quality of Life- Independence secondary outcome description SCI-QOL Scale subset assesses independence (SF - 8 items). Item responses range from 1 (Never) to 5 (Always) with a min score of 8 and a max score of 40. Higher score indicates higher QOL in regards to independence. secondary outcome time frame Baseline, 6, 9, 12, months secondary outcome measure Change in Quality of Life- Positive Affect and Well-being secondary outcome description SCI-QOL Scale subset integrates constructs of positive affect and emotional well-being into SCI research and clinical practice (SF- 10 items). Item responses range from 1 (Never) to 5 (Always) with a min score of 10 and a max score of 50. Higher score indicates higher QOL for positive affect and well-being. secondary outcome time frame Baseline, 6, 9, 12 months secondary outcome measure Change in Quality of Life- Self Esteem secondary outcome description SCI-QOL Scale subset assesses cognitive, emotional, and evaluative perceptions of the self (SF- 8 items). Item responses range from 1 (Never) to 5 (Always) with a min score of 8 and a max score of 40. Higher score indicates higher QOL in regards to Self esteem. secondary outcome time frame Baseline, 6, 9, 12 months secondary outcome measure Change in Self-sufficiency - Employment Hope Scale (EHS) SF-14 secondary outcome description EHS is a 14-item measures psychological empowerment (4 items), futuristic self-motivation (2 items), utilization of skills and resources (4 items), and goal orientation (4 items) for career attainment. Items are ranked from 0 (strongly disagree) to 10 (strongly agree). Min score is 0 and maximum score of 140. Higher score indicates increased hope for employment. secondary outcome time frame Baseline, 6, 9, 12 months secondary outcome measure Change in Self-Sufficiency- Perceived Barrier Scale (PEBS) secondary outcome description PEBS is a 27-item Likert-type scale assessing extent to which job seekers perceive various barriers as limiting the ability to find a job. Items are scored from 1 (Not a Barrier) to 5 (Strong Barrier) with a minimum score of 27 and a maximum score of 135. A higher score indicated increased perception of barriers limiting ability to find a job. secondary outcome time frame Baseline, 6, 9, 12 months secondary outcome measure Change in Impact on Quality of Life and Participation- Qualitative Interviews Veteran participants secondary outcome description Qualitative interviews will contain open-ended questions about the perceived value of intervention in addressing QOL and participation. secondary outcome time frame baseline, 6-months, & 12 months secondary outcome measure Change in Employment Barriers- Employment Questionnaire secondary outcome description Open-ended questions from the Employment Questionnaire on on accommodations, supports, transportation, and barriers at work. secondary outcome time frame 6, 9, 12 months secondary outcome measure Change in Employment Barriers- Qualitative Interview -Veteran participants secondary outcome description Qualitative interviews contain open-ended questions about the perceived value of intervention in addressing employment barriers. secondary outcome time frame baseline, 6-months, & 12 months secondary outcome measure Adaption of Intervention- Benchmarks of Quality Checklist (BQC) secondary outcome description Benchmarks of Quality Checklist (BQC) is a structured CE provider form to document ACCESS omissions, modifications, and adaptations. Each item of the employment process is rated as completed, not completed, or partially completed. This form contains sections for staff to describe adaptions to the intervention. At study months 12. 18, 24, & 30, the qualitative researchers will review the BQCs that are completed on each study participant to identify how the intervention was adapted for use in the VA. secondary outcome time frame Study Months 12, 18, 24 & 30. secondary outcome measure Change in Impact on Quality of Life and Participation- Qualitative Interviews Provider participants secondary outcome description Qualitative interviews with providers will contain open-ended questions about the perceived value of intervention in addressing QOL and participation. secondary outcome time frame After the intervention begins, interviews will occur during the following 3 time periods 0- 9 months, 10-21 months, and 22-33 months secondary outcome measure Change in Employment Barriers- Qualitative Interview -Provider participants secondary outcome description Qualitative interviews with providers contain open-ended questions about the perceived value of intervention in addressing employment barriers. secondary outcome time frame After the intervention begins, interviews will occur during the following 3 time periods 0- 9 months, 10-21 months, and 22-33 months eligibility module eligibility criteria Inclusion Criteria: Veteran inclusion criteria Community-dwelling, English-Speaking Veterans 18-65 years old Want to find work in their community Have received or are currently receiving IPS VA provider inclusion criteria CE providers and other clinical providers on the SCI interdisciplinary team and other stakeholders. Exclusion Criteria: Veteran exclusion criteria Living more than an hour's drive from the VAMC Progressive spinal cord disorder or terminal diagnosis, e.g., multiple sclerosis Moderate to severe traumatic brain injury or Rancho Level of 6 or less on discharge from acute rehabilitation, Diagnosis of or documented treatment for psychosis in previous 6 months Untreated substance use disorder Visual, hearing, or cognitive impairment preventing consent or ability to participate in essential elements of the intervention VA provider exclusion criteria Providers who do not meet inclusion criteria healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Lisa Ottomanelli, PhD central contact role Contact central contact phone (813) 558-3917 central contact e mail Lisa.Ottomanelli@va.gov central contact name Areana Cruz, MSEd central contact role Contact central contact phone (813) 797-8969 central contact e mail areana.cruz@va.gov overall official list overall official overall official name Lisa Ottomanelli, PhD overall official affiliation James A. Haley Veterans' Hospital, Tampa, FL overall official role Principal Investigator location list location location facility James A. Haley Veterans' Hospital, Tampa, FL location status Recruiting location city Tampa location state Florida location zip 33612 location country United States location contact list location contact location contact name Lisa Ottomanelli, PhD location contact role Contact location contact phone 813-558-3917 location contact e mail Lisa.Ottomanelli@va.gov location contact name Areana Cruz, MSEd location contact role Contact location contact phone (813) 797-8969 location contact e mail areana.cruz@va.gov location contact name Lisa Ottomanelli, PhD location contact role Principal Investigator location facility Hunter Holmes McGuire VA Medical Center, Richmond, VA location status Not yet recruiting location city Richmond location state Virginia location zip 23249 location country United States location contact list location contact location contact name Scott McDonald, PhD location contact role Contact location contact phone 804-675-5000 location contact phone ext 3633 location contact e mail scott.mcdonald@va.gov location contact name Lance Goetz, MD location contact role Contact location contact phone 8046755000 location contact phone ext 2475 location contact e mail lance.goetz@va.gov i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000013119 condition mesh term Spinal Cord Injuries condition ancestor list condition ancestor condition ancestor id D000014947 condition ancestor term Wounds and Injuries condition ancestor id D000013118 condition ancestor term Spinal Cord Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000020196 condition ancestor term Trauma, Nervous System condition browse leaf list condition browse leaf condition browse leaf id M15068 condition browse leaf name Spinal Cord Injuries condition browse leaf as found Spinal Cord Injury condition browse leaf relevance high condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse leaf id M15067 condition browse leaf name Spinal Cord Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M21176 condition browse leaf name Trauma, Nervous System condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M4006 intervention browse leaf name Benzocaine intervention browse leaf relevance low intervention browse leaf id T433 intervention browse leaf name Tannic Acid intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Ot intervention browse branch name Other Dietary Supplements
NCT04832802
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full study rank 61499 study protocol section identification module n c t id NCT04835675 org study id info org study id ZJYY-2020006 organization org full name Zhujiang Hospital org class OTHER brief title AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Hepatobiliary Cancer Malignancies official title Development and Validation of the Performance of a cfDNA Methylation-based Model Combined With Serum Tumor Markers for Early Hepatobiliary Malignancies Detection acronym ASCEND-Hep status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 12, 2021 start date type Actual primary completion date struct primary completion date March 31, 2022 primary completion date type Anticipated completion date struct completion date June 30, 2022 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Zhujiang Hospital lead sponsor class OTHER collaborator list collaborator collaborator name Guangzhou BR collaborator class UNKNOWN oversight module is f d a regulated drug No is f d a regulated device No description module brief summary This study is a prospective, multicenter study aimed to develop and validate the performance of combined assays for cfDNA methylation markers and serum tumor markers in early hepatobiliary malignancies detection. Circulating tumor DNA (ctDNA) mutation, blood RNA markers and tissue will also be evaluated. The study will enroll approximately 496 participants, including participants with malignant or benign diseases of the hepatobiliary system. conditions module condition list condition Hepatobiliary Malignancies keyword list keyword Hepatobiliary malignancies Liquid biopsy Cell-free DNA Early detection design module study type Observational patient registry No design info design observational model list design observational model Case-Control design time perspective list design time perspective Prospective enrollment info enrollment count 496 enrollment type Anticipated arms interventions module arm group list arm group arm group label Cancer Arm arm group description Participants with new diagnosis of hepatobiliary malignancies, from whom blood samples will be collected arm group intervention list arm group intervention name Device: Multi-cancer early detection test arm group label Benign Diseases Arm arm group description Participants with benign diseases of the hepatobiliary system, from whom blood samples will be collected arm group intervention list arm group intervention name Device: Multi-cancer early detection test intervention list intervention intervention type Device intervention name Multi-cancer early detection test intervention description Blood collection and multi-cancer early detection testing intervention arm group label list intervention arm group label Benign Diseases Arm Cancer Arm outcomes module primary outcome list primary outcome primary outcome measure Sensitivity of early hepatobiliary malignancies detection and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model combined with serum tumor markers when specificity was 90%, 95% or 98% primary outcome time frame 16 months primary outcome measure Sensitivity and specificity of early hepatobiliary malignancies detection and TOO accuracy of a cfDNA methylation-based model combined with serum tumor markers primary outcome time frame 16 months secondary outcome list secondary outcome secondary outcome measure Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in early detection of hepatobiliary malignancies in different stages secondary outcome time frame 16 months secondary outcome measure Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers, clinical characteristics and other biomarkers secondary outcome time frame 16 months secondary outcome measure Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in participants with malignant or benign diseases of the hepatobiliary system secondary outcome time frame 16 months secondary outcome measure Sensitivity and specificity of a cfDNA methylation-based model or serum tumor markers in participants with hepatobiliary malignancies secondary outcome time frame 16 months eligibility module eligibility criteria Inclusion Criteria for All the Participants: 40-75 years old Ability to comply with study procedures Ability to provide a written informed consent Exclusion Criteria for All the Participants: Pregnancy or lactating women Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant Recipients of blood transfusion within 7 days prior to study blood draw Recipients of anti-microbial therapy within 14 days prior to study blood draw Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer Inclusion Criteria for Cancer Arm Participants: Confirmed diagnosis or highly suspicious cases of hepatobiliary malignancies No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw Exclusion Criteria for Cancer Arm Participants: Current diagnosis of other malignancies or multiple primary tumors Diagnosis of benign diseases by histopathological assessments Inability to characterize whether the lesion is malignant or benign Prior or ongoing treatment of cancer Inclusion Criteria for Benign Diseases Arm Participants: Confirmed diagnosis of benign diseases of the hepatobiliary system No prior radical treatment of the benign diseases prior to study blood draw Exclusion Criteria for Benign Diseases Arm Participants: Current or history of malignancies or precancerous lesions No confirmed diagnosis or inability to characterize a benign disease healthy volunteers No gender All minimum age 40 Years maximum age 75 Years std age list std age Adult Older Adult study population Eligible participants will be recruited from medical centers and assigned into two arms, including participants with new diagnosis of hepatobiliary malignancies and benign diseases of the hepatobiliary system. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Mingxin Pan, M.D. central contact role Contact central contact phone +86-020-62782562 central contact e mail pmxwxy@sohu.com overall official list overall official overall official name Mingxin Pan overall official affiliation Zhujiang Hospital overall official role Principal Investigator location list location location facility Zhujiang Hospital location status Recruiting location city Guangzhou location state Guangdong location zip 510280 location country China location contact list location contact location contact name Mingxin Pan, M.D. location contact role Contact location contact phone +86-020-62782562 location contact e mail pmxwxy@sohu.com i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009369 condition mesh term Neoplasms
NCT04835675
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full study rank 61483 study protocol section identification module n c t id NCT04835883 org study id info org study id CS20AT04-SLE101 organization org full name Hanyang University Seoul Hospital org class OTHER brief title Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients official title Open-label, Single-arm, 24-week Investigator Study to Evaluate the Efficacy and Safety of CS20AT04 (HLA-haplo Matched Allogenic Bone Marrow-Derived Stem Cells) Administered in Patients With Lupus Nephritis or Lupus Cytopenia status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date September 26, 2019 start date type Actual primary completion date struct primary completion date November 5, 2021 primary completion date type Anticipated completion date struct completion date January 20, 2026 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Chan-Bum Choi responsible party investigator title Principal Investigator responsible party investigator affiliation Hanyang University Seoul Hospital lead sponsor lead sponsor name Hanyang University Seoul Hospital lead sponsor class OTHER collaborator list collaborator collaborator name Corestem, Inc. collaborator class INDUSTRY collaborator name Ministry of Health & Welfare, Korea collaborator class OTHER_GOV oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This is an open-label, one-arm single-center phase Ⅱa study exploring the efficacy and safety of CS20AT04 (HLA-haplo Matched Allogenic Bone Marrow-Derived Stem Cells) in two subpopulation group of systemic lupus erythematosus patients - lupus nephritis and lupus cytopenia. detailed description Systemic lupus erythematosus (SLE) is a chronic inflammatory disease of unknown cause that can affect virtually every organ. A subset of SLE patients continues to suffer significant morbidity and mortality from active disease, with visceral organ involvement. Therefore, it is urgent to develop a more effective therapy for SLE disorder, especially for treatment-refractory patients. Bone marrow-derived mesenchymal stem cells are known to be effective in modulating immune cells such as T lymphocytes, B lymphocytes, dendritic cells, and Neutral Killer (NK) cells and treating acute Graft-Versus-Host Disease (GVHD). Also, based on the anti-inflammatory and immunomodulatory properties, bone marrow-derived mesenchymal stem cells have been widely studied as a candidate for the treatment of refractory immune- and inflammation-mediated disease, and have extensive experience of use. Half-matched allogeneic bone marrow-derived mesenchymal stem cells, the active ingredient of CS20AT04 Injection, not only have the potential to differentiate into various mesenchymal cells but also have various immunomodulatory and anti-inflammatory effects, and thus are expected to induce and maintain remission of lupus nephritis and lupus cytopenia. This study is designed to investigate the following. Subjects enrolled into the CS20AT04 with corticosteroid taper regimen arm will receive two infusions of CS20AT04(2.0×10^6cell/kg), on 0 day and on 12 weeks post-enrollment. Subjects will return for efficacy and safety assessments on 3 days, 1 week, and every 4 weeks each post-infusion until Week 24. Safety monitoring will be continued at 1 year, 3 years, and 5 years post-infusion. conditions module condition list condition Systemic Lupus Erythematosus keyword list keyword Systemic lupus erythematosus Allogenic bone marrow-derived mesenchymal stem cell Lupus Nephritis Lupus Cytopenia Cell Therapy Phase IIa Clinical Trial design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 10 enrollment type Anticipated arms interventions module arm group list arm group arm group label Assigned interventions arm group type Experimental arm group description Subjects enrolled into the CS20AT04 with corticosteroid taper regimen arm will receive two infusions of CS20AT04 (2.0×10^6cell/kg), on 0 day and on 12 weeks post-enrollment. arm group intervention list arm group intervention name Biological: CS20AT04 (allogenic bone marrow derived mesenchymal stem cell) intervention list intervention intervention type Biological intervention name CS20AT04 (allogenic bone marrow derived mesenchymal stem cell) intervention description Two intravenous infusions of CS20AT04 (2.0×10^6cell/kg), on 0 day and on 12 weeks The target population of this study is subjects in South Korea with a diagnosis of either lupus nephritis or lupus cytopenia. intervention arm group label list intervention arm group label Assigned interventions outcomes module primary outcome list primary outcome primary outcome measure Reduction of corticosteroid dose to ≤ 7.5 mg/day of prednisone or equivalent primary outcome description The primary efficacy objective of this study is to assess the efficacy of CS20AT04, in combination with a 24-week corticosteroid taper regimen, as measured by: Reduction of corticosteroid dose to ≤ 7.5 mg/day of prednisone or equivalent at Week 4 , and continued through Week 12 primary outcome time frame 24 weeks primary outcome measure Hematologic improvement without ongoing SLE treatment primary outcome description As Lupus cytopenia sub-group specific endpoint, Hgb increase of ≥ 1.5 g/dL, or Neutrophil count increase of ≥ 100% from pre-treatment level and an absolute increase of 500/mm3 x 10^9/L, or For pre-treatment platelet count > 20 X 10^9/L, a platelet absolute increase of ≥ 30 X 10^9/L For pre-treatment platelet count ≤ 20 X 10^9/L, a platelet absolute increase ≥ 20 X 10^9/L and ≥ 100% increase from pre-treatment level primary outcome time frame 24 weeks primary outcome measure Renal response improvement primary outcome description As Lupus nephritis (LN) sub-group specific endpoint, a renal response at 24 weeks adjudicated based on the following parameters: Urine Protein to Creatinine Ratio (UPCR) of ≤0.5mg/mg, and Estimated Glomerular Filtration Rate (eGFR)≥60mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of > 20%, and Did not receive any rescue medication for LN, and Did not receive over than 7.5mg prednisone for ≥7 consecutive days in total during week 12 through 24, just prior to the renal response assessment primary outcome time frame 24 weeks secondary outcome list secondary outcome secondary outcome measure Proportion of subjects who achieve a prednisone dose of ≤ 7.5mg/day or equivalent secondary outcome description Proportion of subjects who achieve a prednisone dose of ≤ 7.5mg/day or equivalent by Week 12 and maintain this dose ≤ 7.5mg/day prednisone or equivalent from Week 12 to 24 secondary outcome time frame 12 weeks, 24 weeks secondary outcome measure Proportion of subjects achieving Low Level Disease Activity State secondary outcome description Proportion of subjects achieving Low Level Disease Activity State (LLDAS) at Week 24 secondary outcome time frame 24 weeks secondary outcome measure Proportion of subjects with ≥ 4 point reduction from baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score secondary outcome description Proportion of subjects with ≥ 4 point reduction from baseline in SLEDAI-2K score at 24 weeks secondary outcome time frame 24 weeks secondary outcome measure Proportion of subjects with baseline Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) ≥ 4 having SLE responder index 4 (SRI5) secondary outcome description Proportion of subjects with baseline SLEDAI-2K ≥ 4 having SLE responder index 5 (SRI5) response at 24 weeks, defined by (i) a ≥ 4 point reduction from baseline in SLEDAI-2K score, (ii) no worsening (increase of < 0.30 points from baseline) in Physician's Global Assessment (PGA), and (iii) no new British Isles Lupus Assessment Group of SLE Clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment (i.e. at 24 weeks) secondary outcome time frame 24 weeks secondary outcome measure Proportion of subjects with baseline Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) ≥ 5 having SLE responder index 5 (SRI5) secondary outcome description Proportion of subjects with baseline SLEDAI-2K ≥ 5 having SLE responder index 5 (SRI5) response at 24 weeks, defined by (i) a ≥ 5 point reduction from baseline in SLEDAI-2K score, (ii) no worsening (increase of < 0.30 points from baseline) in Physician's Global Assessment (PGA), and (iii) no new British Isles Lupus Assessment Group of SLE Clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment (i.e. at 24 weeks) secondary outcome time frame 24 weeks secondary outcome measure Proportion of subjects with baseline Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) ≥ 6 having SLE responder index 6 (SRI6) secondary outcome description Proportion of subjects with baseline SLEDAI-2K ≥ 6 having SRI6 response at 24 weeks, defined by (i) a ≥ 6 point reduction from baseline in SLEDAI-2K score, (ii) no worsening (increase of < 0.30 points from baseline) in Physician's Global Assessment (PGA), and (iii) no new British Isles Lupus Assessment Group of SLE Clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment (i.e. at 24weeks) secondary outcome time frame 24 weeks secondary outcome measure Time to first severe modified SLE Flare Index (SFI) flare secondary outcome description Time to first severe modified SLE Flare Index (SFI) flare over 24 weeks secondary outcome time frame 24 weeks secondary outcome measure Change from baseline of hematologic parameters secondary outcome description For the lupus cytopenia sub-group only: Change from baseline of hematologic parameters (white blood cell counts, platelet counts, and hemoglobin) at 3 days, 1 week, 4 weeks, 12 weeks, and 24 weeks secondary outcome time frame 3 days, 1 week, 4 weeks, 12 weeks , and 24 weeks secondary outcome measure Time to first hematologic flare secondary outcome description For the lupus cytopenia sub-group only: Time to first hematologic flare over 24 weeks secondary outcome time frame 24 weeks secondary outcome measure Change in baseline of renal function parameters secondary outcome description For the lupus nephritis sub-group only: Time to event for each of the individual components of treatment failure (death, ESRD, sustained doubling of serum creatinine, renal flare, extrarenal flare, or rescue therapy) secondary outcome time frame 24 weeks secondary outcome measure Time to event for each of the individual components of treatment failure secondary outcome description For the lupus nephritis sub-group only: Time to event for each of the individual components of treatment failure (death, End-Stage Renal Disease (ESRD), sustained doubling of serum creatinine, renal flare, extrarenal flare, or rescue therapy) secondary outcome time frame 24 weeks secondary outcome measure Time to complete remission secondary outcome description For the lupus nephritis sub-group only: Time to complete remission over 24 weeks, as defined by return to normal values of serum creatinine (< 106 μmol/L), proteinuria (< 0.3 g/24 h), and urine sediment. secondary outcome time frame 24 weeks secondary outcome measure Time to first renal flare secondary outcome description For the lupus nephritis sub-group only: Time to first renal flare over 24 weeks secondary outcome time frame 24 weeks other outcome list other outcome other outcome measure Change in SLE parameters compare to baseline other outcome description Change in the following SLE parameters compared to baseline at 3 days, 1 week, 4 weeks, 12 weeks, and 24 weeks: Total Systemic Lupus Erythematosus Disease Activity Index- 2000 (SLEDAI-2K) score Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR-DI) score British Isles Lupus Assessment Group (BILAG) scale (at 4 weeks, 12 weeks, and 24 weeks) other outcome time frame 3 days, 1 week, 4 weeks, 12 weeks, and 24 weeks other outcome measure Change from baseline of Treg CD4+CD25+Foxp3+) and Th17 (CD3+CD8-IL-17A+) cell counts other outcome description Change from baseline of Treg (CD4+CD25+Foxp3+) and Th17 (CD3+CD8-IL-17A+) cell counts at 3 days, 1 week, 4 weeks, 12 weeks, 24 weeks and 0.5 years, 1 year, 1.5 years, 2 years, 3 years after the first injection, as measured by flow cytometry (FACS) analysis * CD=Cluster of Differentiation, Foxp=forkhead box P, IL=Interleukin other outcome time frame 3 days, 1 week, 4 weeks, 12 weeks, 24 weeks and 0.5 years, 1 year, 1.5 years, 2 years, 3 years eligibility module eligibility criteria Inclusion Criteria: Patients with HLA-haplo-matched bone marrow donor less than 70 years old Patients meeting: -at least 4 of the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria, including at least 1 clinical criterion and 1 immunology criterion; or -at least 4 of the 11 Revised American College of Rheumatology (ACR) Criteria for Classification of Systemic Lupus Erythematosus, according to the 1997 Update of the 1982 ACR Patients having a positive test result for antinuclear antibody (ANA; titer at least 1:80) and/or anti-double stranded DNA antibody (anti-dsDNA Ab) at screening Patients (non-responder or partial responder), defined as : -unresponsive to treatment with standard care(such as monthly i.v. pulse cyclophosphamide (CYC) 500-1000 mg/m2, mycophenolate (MMF) ≥ 2 gm/day, azathioprine (AZA) ≥ 200 mg/day, leflunomide (LEF) 20 mg/day, oral CYC, cyclosporine, mizoribine ≥ 150 mg/day, mycophenolic acid ≥ 1.44 g/day, tacrolimus (TAC) ≥ 1.5 mg twice a day alone or in combination for at least 6 months) or -with continued daily dosage of ≥15mg of prednisone or its equivalent for maintenance treatment 5-1. For the lupus cytopenia sub-group only: Patients with refractory cytopenia (at least one of anemia, leukopenia, or thrombocytopenia) in absence of any other identifiable cause, defined as: [Red blood cell associated] -Hemolytic anemia (Hgb ≤ 10g/dL) with reticulocytosis, or [White cell associated] -Neutrophil count < 1,000/mm3 (in the absence of other known cause such as corticosteroids, drugs, and infection), and/or Lymphocyte count < 1,500/mm3 [Platelet associated] Platelet count < 100,000/mm3 (in the absence of other known cause such as drugs, portal hypertension, and thrombotic thrombocytopenic purpura (TTP)) 5-2. For the lupus nephritis sub-group only: •Patients with clinical disease activity of lupus nephritis, defined by: laboratory tests documented active lupus nephritis three consecutive times: (i) decrease in renal function (serum creatinine > 106 μmol/L) (ii) increase in proteinuria (defined as urine protein/creatinine ratio (UPC) > 1), and (iii) deterioration in microscopic hematuria (defined as > 10 red cells per high power field) in the absence of menstrual hematuria or urinary tract infection at the time of screening or the presence of cellular casts renal biopsy documenting lupus nephritis according to the International Society of Nephrology/Renal Pathology Society classification of active or active/chronic lupus nephritis in renal biopsy class III, class IV-S or IV-G, class V, class III + V, or class IV + V (within 1 year) Exclusion Criteria: 1. Patients unable or unwilling to provide written informed consent 2. Patients with any history of cancer, allergy, alcohol or substance abuse, active peptic ulcer disease, heart failure, liver disease, and coagulation disorder 3. Patients who have active severe central nervous system (CNS) lupus 4. Patients who have received biologic investigational agents in the past year 5. Patients undergoing intravenous immunoglobulin or plasma exchange therapy 6. Patients who are pregnant or are lactating 7. Patients with any evidence of a major infection 8. For the lupus nephritis sub-group only: Patients with serum creatinine > 250 μmol/L healthy volunteers No gender All minimum age 18 Years maximum age 70 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Chan-Bum Choi, M.D.,Ph.D central contact role Contact central contact phone +82222909208 central contact e mail cbchoi@hanyang.ac.kr central contact name Kwijoo Kim central contact role Contact central contact phone +821027568321 central contact e mail kwjkim@corestem.com overall official list overall official overall official name Chan-Bum Choi, M.D.,Ph.D. overall official affiliation Department of Rhumatology in Hanyang University Medical Center overall official role Principal Investigator location list location location facility Hanyang University Medical Center location status Recruiting location city Seoul location zip KS013 location country Korea, Republic of location contact list location contact location contact name Chan-Bum Choi, M.D.,PhD. location contact role Contact location contact phone +82222909208 location contact e mail cbchoi@hanyang.ac.kr location contact name Kwijoo Kim location contact role Contact location contact phone +821027568321 location contact e mail kwjkim@corestem.com location contact name Chan-Bum Choi, MD, PhD location contact role Principal Investigator location contact name Sang-Cheol Bae, MD, PhD location contact role Sub-Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000008180 condition mesh term Lupus Erythematosus, Systemic condition ancestor list condition ancestor condition ancestor id D000003240 condition ancestor term Connective Tissue Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M10329 condition browse leaf name Lupus Erythematosus, Systemic condition browse leaf as found Systemic Lupus Erythematosus condition browse leaf relevance high condition browse leaf id M11490 condition browse leaf name Nephritis condition browse leaf relevance low condition browse leaf id M10330 condition browse leaf name Lupus Nephritis condition browse leaf relevance low condition browse leaf id M5616 condition browse leaf name Connective Tissue Diseases condition browse leaf relevance low condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id T3523 condition browse leaf name Lupus Nephritis condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04835883
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full study rank 61450 study protocol section identification module n c t id NCT04836312 org study id info org study id 844153 organization org full name University of Pennsylvania org class OTHER brief title Intermittent Fasting Adherence and Self Tracking official title A Soft Commitment Device to Encourage Intermittent Fasting in Patients With the Metabolic Syndrome acronym iFAST status module status verified date October 2022 overall status Completed expanded access info has expanded access No start date struct start date July 12, 2021 start date type Actual primary completion date struct primary completion date August 28, 2022 primary completion date type Actual completion date struct completion date August 28, 2022 completion date type Actual study first submit date March 22, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 12, 2022 last update post date struct last update post date October 14, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Pennsylvania lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This pilot study will randomize 34 patients with hypertension and obesity to either time-restricted feeding alone or a commitment device to encourage time-restricted feeding, including a commitment pledge, involvement of a supportive partner, setting of implementation intentions, and multiple daily reminder text messages. The intervention will last 12 weeks, followed by a 6-week follow-up period. The primary outcome is adherence to the IF regimen, captured via daily text message, over 18 weeks detailed description 1.1. Non-Pharmacologic Interventions to Improve Blood Pressure Control: Despite the wide availability of multiple classes of antihypertensive agents, compelling data that blood pressure (BP) lowering reduces mortality and cardiovascular events, and decades of public health campaigns, half of American adults with hypertension do not achieve adequate BP control. Randomized controlled trials of interventions to improve BP control in patients with hypertension have largely focused on home blood pressure monitoring, nurse- or pharmacist-lead education and medication titration, and/or financial incentives. Though many of these interventions improve short-term blood pressure control, they are cost-additive to health systems, post-intervention data is mixed, and none have been widely implemented. Though consensus guidelines recommend dietary changes to improve hypertension control, with a particular recommendation in favor of the DASH (Dietary Approaches to Stop Hypertension) diet, very few U.S. patients adhere to this complex dietary pattern. The DASH diet reduced systolic BP (SBP) by 11 mmHg in randomized controlled trials in which participants were provided with food, and 4 mmHg in a study testing a 6-month, 18-visit intensive lifestyle intervention intended to promote the DASH diet; however, BP control was not sustained 12 months after the end of the intensive intervention. 1.2. Effect of Intermittent Fasting on Metabolic Parameters: In contrast to the DASH diet, intermittent fasting (IF) is a dietary pattern that emphasizes temporal restriction of caloric intake rather than restricting the number of calories and/or changing the types of foods eaten. The simplest and most popular variation of IF involves restricting caloric intake to an 8-hour period each day, and consuming no calories for the other 16 hours (so-called 16:8 time-restricted feeding). In animal studies, IF has been shown to activate cellular pathways with potential disease-modifying benefits in a number of conditions. In small human studies, IF is associated with a reduction in SBP by 5-10 mmHg, LDL cholesterol by ~8 mg/dl, and weight by ~ 3 kg, though none of the studies of a time-restricted feeding regimen included concurrent controls. Some patients report that IF is easier to initiate and maintain than other dietary patterns, though this has not been tested empirically. 1.3. Commitment Devices to Promote Healthy Behaviors: Commitment devices are centered in theoretical research that posits a planner-doer framework, wherein an individual can be conceptualized as dual sub-selves: The planner, who cares about long-term well-being; and the doer, who cares only for the present and prioritizes immediate payoffs. Conflict between the motivations and priorities of the planner and the doer sub-selves results in failure to follow-through with a plan when the moment to act arrives. Commitment devices are mechanisms by which the planner sub-self constrains the actions of their future doer sub-self by making certain choices more costly. Hard commitments impose a financial penalty for failing to follow through on the commitment, and soft commitments impose a psychological penalty. Hard commitments have been shown to change health behaviors, as in a study where smokers forfeited money deposited in a savings account if they failed to quit smoking after 6 months. However, monetary losses may not be attractive to many people, and effective soft commitment devices may be more appealing. Pre-clinical research suggests that both intra- and interpersonal commitments might be useful components of a soft commitment device. Intrapersonal commitments have also been framed as implementation intentions, or specific plans as to where, how, and/or when an action will be taken. In small experiments, smokers who set a quit date were more likely to quit, and college students who set a date and time to visit a vaccination clinic were more likely to receive their vaccination. Interpersonal commitments leverage social networks, so that the penalty involves letting down a support partner. Involvement of social networks has been used to increase physical activity and improve control of weight and blood glucose in patients with obesity and diabetes. Social networks have been used explicitly within the context of commitment devices to encourage deposits in a savings account in a study of Chilean micro-entrepreneurs who either attended or did not attend a weekly peer support group meeting. Weight loss studies encouraging participants to exercise and change their eating behavior have employed commitment devices, including some that leveraged the involvement of family members or friends of the participant, with mixed results. 1.4 Rationale for the IFAST Study: The IF dietary pattern, though not inspired by behavioral economic concepts, is structured to take advantage of them and thus may be particularly amenable to a robust commitment device intervention. Changing one's eating patterns to a complex new diet is a cognitively intense process that requires active consideration of complex information multiple times per day, leading to cognitive overload and impaired decision-making. By contrast, IF, especially time-restricted feeding, is cognitively very simple. This simplicity may help participants avoid cognitive overload, initiate the dietary pattern and adhere over the long term. This study seeks to test how a robust soft commitment device, incorporating both intra- and interpersonal commitments, affects uptake and adherence to an intermittent fasting dietary pattern, as compared with control, in patients with obesity and hypertension conditions module condition list condition Hypertension Obesity design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Health Services Research design masking info design masking Double design who masked list design who masked Investigator Outcomes Assessor enrollment info enrollment count 34 enrollment type Actual arms interventions module arm group list arm group arm group label Attention Control arm group type No Intervention arm group description Patients will be instructed via text message and email to fast at least 16 hours per day every day. For the next 18 weeks, they will receive a daily text message via the Way to Health platform asking if they fasted for at least 16 hours over the past 24 hours. If they fail to respond, reminder text messages will be sent. Once per week, they will receive a text message asking them to weigh themselves and check their blood pressure, and reply with the results via text message arm group label Soft Commitment Device arm group type Experimental arm group description Patients randomized to the commitment device arm will be asked to visit the Way to Health platform. There, they will identify a support person, a family or friend who they speak to frequently and who is invested in their health. They will then complete a series of questions intended to create implementation intentions. Specifically, they will pick a time for their fast to begin each 24-hour period and a time for their fast to end. They will also develop strategies to deal with hunger arising during a fast period. After this process, they will sign a contract pledging to adhere to the 16:8 time-restricted feeding dietary pattern, and acknowledging that their support person will receive a copy of the contract and weekly updates about their adherence to the regimen. arm group intervention list arm group intervention name Behavioral: Soft Commitment Device intervention list intervention intervention type Behavioral intervention name Soft Commitment Device intervention description Patients randomized to the commitment device arm will be asked to visit the Way to Health platform. There, they will identify a support person, a family or friend who they speak to frequently and who is invested in their health. They will then complete a series of questions intended to create implementation intentions. Specifically, they will pick a time for their fast to begin each 24-hour period and a time for their fast to end. They will also develop strategies to deal with hunger arising during a fast period. After this process, they will sign a contract pledging to adhere to the 16:8 time-restricted feeding dietary pattern, and acknowledging that their support person will receive a copy of the contract and weekly updates about their adherence to the regimen. intervention arm group label list intervention arm group label Soft Commitment Device outcomes module primary outcome list primary outcome primary outcome measure Adherence to the Intermittent Fasting regimen, captured via daily text message, over 18 weeks, expressed in days per week primary outcome description Adherence to the IF regimen, captured via daily text message, over 18 weeks, expressed in days per week. This will measure adherence to the IF regimen throughout the 12 week intervention period and the 6 week follow-up period. primary outcome time frame Weeks 1-18 secondary outcome list secondary outcome secondary outcome measure Adherence to the IF regimen, captured via daily text message, over 12 weeks, expressed in days per week secondary outcome description Adherence to the IF regimen, captured via daily text message, over 12 weeks, expressed in days per week. This will measure adherence to the IF regimen for the 12 week intervention period only. secondary outcome time frame Weeks 1-12 secondary outcome measure Change in systolic blood pressure from baseline to 12 weeks and 18 weeks secondary outcome description Change in systolic blood pressure from baseline to 12 weeks and 18 weeks. This will be measured using a wrist-worn blood pressure cuff and captured via text messages. secondary outcome time frame Weeks 1-12 and Weeks 1-18 secondary outcome measure Change in weight from baseline to 12 weeks and 18 weeks secondary outcome description Change in weight from baseline to 12 weeks and 18 weeks. This will be measured using a digital scale and captured via text messages. secondary outcome time frame Weeks 1-12 and Weeks 1-18 other outcome list other outcome other outcome measure Exploratory analyses will compare change in blood pressure in patients that were adherent to IF ≥ 4 days per week vs. < 4 days per week other outcome description Exploratory analyses will compare change in blood pressure in patients that were adherent to IF ≥ 4 days per week vs. < 4 days per week. This will be captured using wrist-worn blood pressure cuffs. The values will be reported via text messages. other outcome time frame Weeks 1-18 other outcome measure Exploratory analyses will compare change in weight in patients that were adherent to IF ≥ 4 days per week vs. < 4 days per week other outcome description Exploratory analyses will compare change in weight in patients that were adherent to IF ≥ 4 days per week vs. < 4 days per week. This will be captured using digital scales. The values will be reported via text messages. other outcome time frame Weeks 1-18 eligibility module eligibility criteria Inclusion Criteria: Age 18 or older Body mass index > 30 kg/m2 Systolic blood pressure > 150 mmHg Owns a smartphone or tablet operating the iOS or Android operating system Exclusion Criteria: Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (reading or comprehension) Type 1 diabetes Use of insulin or insulin secretagogues (sulfonylureas, metaglinides) Use of medications that require food intake Ongoing use of pharmacologic therapy for weight loss Self-reported eating disorder Other medical condition that could be harmed by intermittent fasting as judged by study physician Anticipated life expectancy less than 6 months Any other reason why it is not feasible to complete the entire 6-month study healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Mitesh Patel, MD, MBA, MS overall official affiliation University of Pennsylvania overall official role Principal Investigator overall official name Alex Fanaroff, MD, MHS overall official affiliation University of Pennsylvania overall official role Principal Investigator location list location location facility University of Pennsylvania location city Philadelphia location state Pennsylvania location zip 19104 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006973 condition mesh term Hypertension condition ancestor list condition ancestor condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M11853 condition browse leaf name Obesity condition browse leaf relevance low condition browse leaf id M22158 condition browse leaf name Metabolic Syndrome condition browse leaf relevance low condition browse leaf id M9176 condition browse leaf name Hypertension condition browse leaf as found Hypertension condition browse leaf relevance high condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases
NCT04836312
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full study rank 61205 study protocol section identification module n c t id NCT04839497 org study id info org study id W81XWH1820055 organization org full name Major Extremity Trauma Research Consortium org class OTHER brief title Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees. official title A Phase 2 Multicenter Randomized Single Arm Crossover Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees status module status verified date March 2022 overall status Not yet recruiting expanded access info has expanded access No start date struct start date August 1, 2022 start date type Anticipated primary completion date struct primary completion date August 1, 2025 primary completion date type Anticipated completion date struct completion date January 1, 2026 completion date type Anticipated study first submit date March 23, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date March 21, 2022 last update post date struct last update post date April 1, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Major Extremity Trauma Research Consortium lead sponsor class OTHER collaborator list collaborator collaborator name United States Department of Defense collaborator class FED oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary The study will enroll 20 adults ages 18-75 with a transtibial amputation with mature residual limbs who are ambulatory prosthesis users. Participants will be randomized to either treatment with low dose volar fibroblast injections (n=10) or to vehicle control (n=10). Participants will undergo a biopsy to harvest volar skin for fibroblast expansion and tattooing to identify injection sites on the residual limb. Fibroblasts will be processed at the Hopkins Cellular Therapy Core Lab and volar cells primed for injection will be sent to participating centers for administration. Participants randomized to the treatment group will be treated with low-dose cells. Injections will be administered on at least 1 and up to three separate days over the course of one week. Participants randomized to the vehicle control group will receive injection of cryoprotectant. All participants will be followed at 2 weeks, 1, 2, and 3 months after the last injection. These visits will include a clinical evaluation for complications, non-invasive assessments of skin firmness and thickness, skin appearance, and patient-reported outcomes. After the final monitoring visit, individuals randomized to the vehicle control group will have the opportunity to receive the volar fibroblast injections and will be followed for an additional 3 months. The investigators hypothesize that (1) There will be no difference in the rate of serious adverse events among patients treated with volar fibroblast injections compared with patients treated with vehicle control, and (2) Patients treated with volar fibroblast injections will have firmer skin on the residual limb compared with patients tread with vehicle alone. conditions module condition list condition Amputation design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Crossover Assignment design intervention model description Cross over design design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 20 enrollment type Anticipated arms interventions module arm group list arm group arm group label Volar Fibroblast Treatment arm group type Experimental arm group description Volar fibroblasts are injected into the residual limb of transtibial amputees arm group intervention list arm group intervention name Combination Product: Autologous Volar Fibroblast Injection into the Terminal Limb of Amputees arm group label Cryoprotectant arm group type No Intervention arm group description Vehicle Control. Interdermal injection of cryoprotectant intervention list intervention intervention type Combination Product intervention name Autologous Volar Fibroblast Injection into the Terminal Limb of Amputees intervention description Autologous Volar Fibroblasts Treatment- harvested from patient's biopsied volar skin. Intradermal injection of Volar fibroblasts in the residual limb of transtibial amputees. intervention arm group label list intervention arm group label Volar Fibroblast Treatment intervention other name list intervention other name Autologous Volar Fibroblast Treatment outcomes module primary outcome list primary outcome primary outcome measure Safety assessment of complications and adverse events associated with Volar Fibroblast injections primary outcome description Safety will be evaluated by routinely assessing all complications at each study visit. Minor and expected complications may include local injection reactions like bruising and erythema, swelling and pain. Minor complications that are not expected include local small hemorrhage (x<1mL), edema, nodules, papules, irritation, dermatitis, pruritus, and cellulitis. Serious Adverse Events are defined as unexpected AND serious AND related or possibly related to the study treatment. These may include but are not limited to osteomyelitis. primary outcome time frame 3 months from the injection visit primary outcome measure Efficacy of autologous volar fibroblasts for increasing skin firmness in individuals with a transtibial amputation. primary outcome description Efficacy will be determined by treatment group difference in the pre- post-change in skin firmness at three months post injection. Skin firmness is the level of resistance as measured by a non-invasive hand-held durometer primary outcome time frame Baseline through 3 months from the injection visit other outcome list other outcome other outcome measure Skin thickness other outcome description thickness of epidermal layer as measured by non-invasive OCT images other outcome time frame Baseline through 3 months from the injection visit other outcome measure Skin appearance other outcome description A photo of the treated area by trained research staff to monitor for changes in skin characteristics such as erythema and wound recurrence. Skin disturbances around the treated area will be measured by taking a photo of the area with ruler in view. other outcome time frame 3 months from the injection visit other outcome measure Participant reported health care utilization other outcome description Participants will be asked how often they stayed overnight in a hospital for treatment of a residual limb issue, and how often they saw a physical therapist, physical medicine and rehabilitation clinician, orthotist/prosthetist and wound care specialist, including at-home nurses for treatment related to the amputation. other outcome time frame 3 months from the injection visit other outcome measure Participant reported prosthesis use other outcome description Participants will be asked how often a prosthesis was worn during a typical week/day. other outcome time frame 3 months from the injection visit other outcome measure Participant reported use of support devices other outcome description participants will be asked about their use of ambulatory devices and how often a wheelchair was used. other outcome time frame 3 months from the injection visit other outcome measure Participant reported medication and treatment other outcome description Participants will be asked how often they use mediations and other treatment modalities to treat skin problems on the residual limb. other outcome time frame 3 months from the injection visit other outcome measure Participant reported physical function and activity other outcome description Participants will complete the 12-item short form of the Prosthetic Limb Users Survey of Mobility (PLUS-M), a validated self-reported instrument for measuring mobility in adults with lower limb amputation. PLUS-M questions assess respondents perceived ability to carry out actions that require use of both lower limbs, ranging from household ambulation to outdoor recreational activities. other outcome time frame 3 months from the injection visit other outcome measure Participant reported quality of life, mood and pain other outcome description Participants will complete the Patient Reported Outcomes Measurement Information System (PROMIS) 29 item short form Health related quality of life measure (HRQoL), PROMIS-29. This validated measure includes seven HRQoL domains: physical function, anxiety, depression, fatigue, sleep disturbance, social functioning and pain, and the pain domain has two subdomains (interference and intensity) other outcome time frame 3 months from the injection visit other outcome measure Participant reported skin irritation other outcome description Participants will be asked about the impact of skin irritation on the residual limb, drawing on questions from the Prosthetic Evaluation Questionnaire (PEQ), and the Dermatology Life Quality Index (DLQI). other outcome time frame 3 months from the injection visit eligibility module eligibility criteria Inclusion criteria: Ages 18 to 75, inclusive Must have a transtibial amputation Must be using a prosthesis within the vicinity of 3 months or have had osteo-integration of a prosthetic in place for 1 month In the opinion of the investigator, must be medically able to undergo the administration of study material determined by laboratory tests obtained up to 14 days before baseline for which the investigator identified no clinically significant abnormality. Able to provide written informed consent Females of childbearing potential must: have a negative pregnancy test at screening agree to not become pregnant or breastfeed for the period of the study through 1 month after completion of the study be willing to use a reliable form of contraception during the study. Has healthy skin on the residual limb and is free of severe and active skin disease (excluding those on the residual limb) such as extreme and active eczema or psoriasis, active non-healing wounds, lichen planus, a history of keloid scare formation or lupus as determined by the investigator or study nurse. Willing and able to comply with the scheduled visits, biopsy/injection procedures, wound care instructions treatment plan, and other study procedures for the duration of the study. Exclusion criteria: A skin erosion deeper than the skin dermis. Ulcers exceeding 4cm in diameter or 2cm in radius Non circular ulcers that cannot tolerate a 1cm margin at all sides Having received any investigational drug within 30 days prior to study entry An allergy history to any study materials including local anesthetic, dimethyl sulfoxide, human albumin, or bovine constituents, hetastarch, or EMLA (lidocaine 2.5% and prilocaine 2.5%). Pregnant, lactating, or trying to become pregnant A history of keloid formation Having a significant medical history that the investigator feels is not safe for study participation (for example, some forms of autoimmune conditions, metastatic cancer, infectious diseases such as HIV, HTLV I/II, Hepatitis B, Hepatitis C). Autoimmune diseases affecting the skin such as lupus. Presence of necrotic ischemic tissue on any stump ulcers, and/or capillary refill on stump skin of greater than 3 seconds Active infection of the residual limb (e.g. osteomyelitis, wound or skin condition with surrounding swelling, erythema, drainage, pain, gangrenous tissue or fever). Active smoker during the study (this includes e cigarettes and any type of tobacco use) We will also exclude those who are on chronic immunosuppressive therapies such as oral steroids, but also those on chronic topical steroids in the area of investigation. Amputees with symptomatic neuromas of the terminal limb within the last 3 months. Known bleeding disorder. Have a history of congenital or idiopathic methemoglobinemia, glucose-6-phosphate deficiencies, or use of medications associated with drug-induced methemoglobinemia. (specifically: Sulfonamides, Acetaminophen, Acetanilid, Aniline dyes, Benzocaine, Chloroquine, Dapsone, Naphthalene, Nitrates and Nitrites, Nitrofurantoin, Nitroglycerin, Nitroprusside, Pamaquine, Paraaminosalicylic acid, Phenacetin, Phenobarbital, Phenytoin, Primaquine, or Quinine.) Quadriplegics healthy volunteers No gender All minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult i p d sharing statement module i p d sharing No i p d sharing description Study results will be published and disseminated in accordance with the METRC publication and data sharing policy guide derived section misc info module version holder December 02, 2022
NCT04839497
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full study rank 61784 study protocol section identification module n c t id NCT04831970 org study id info org study id POPART organization org full name University of Milano Bicocca org class OTHER brief title POst-Prostatectomy Ablative Radiation Therapy official title POst-Prostatectomy Ablative Radiation Therapy acronym POPART status module status verified date October 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 15, 2021 start date type Actual primary completion date struct primary completion date April 30, 2026 primary completion date type Anticipated completion date struct completion date December 31, 2026 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date October 24, 2022 last update post date struct last update post date October 25, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Stefano Arcangeli responsible party investigator title Associate Professor responsible party investigator affiliation University of Milano Bicocca lead sponsor lead sponsor name University of Milano Bicocca lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The use of hypofractionated radiotherapy for prostate cancer has matured to a point that in current guidelines extremely hypofractionated image-guided IMRT regimens (6 Gy per fraction or greater) can be considered an alternative to conventionally fractionated regimens at clinics with appropriate technology, physics and clinical expertise. The delivery of fewer and larger fractions with hypofractionation compared to conventional radiotherapy might effectively improve the therapeutic ratio while maintaining isoeffective tumour doses, thus, shortening overall treatment time. In the present study, patients will undergo postoperative image-guided SBRT by means of volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) with state-of-the-art treatment-planning and quality assurance procedures. Normal tissue sparing and delivery accuracy are accomplished by the use of devices that ensure stability and beam location reproducibility. The primary endpoint is to evaluate the cumulative incidence of treatment related toxicities and adverse events in the acute (< 90 days from the end of treatment) and late (> 90 days) setting. detailed description In this observational prospective trial eligible patients are those with adverse pathological features or rising PSA after radical prostatectomy proposed for receiving 31 Gy in 5 sessions each of 6.2 Gy to the prostatic bed delivered in one week, and up to 32.5 Gy in 5 sessions each of 6.5 Gy delivered in one week, respectively, in case of clinical relapse. Patients will be treated by means of image guided volumetric modulated radiotherapy (IGRT-VMAT). A real time non-ionizing target monitoring might be used to account for intra-fractional errors, if deemed appropriate. Whether the dose constraints to the normal tissues are at risk, these will be prioritised over the prescription dose to the target. The primary endpoint of the trial is to assess the treatment related toxicity measured by the CTCAE v5.0. Secondary endpoints are quality of life in different domains (sexual, rectal , urinary) and biochemical outcome. Patients will be followed at approximately one month, then every 3 months for the first 12 months and every 6 months thereafter. Quality of Life will be prospectively evaluated through validated tools (ECOG, EPIC, IIEF-5, ICIQ-SF) at various timepoints. Percentage or total mean score will be reported according to the questionnaires, whether they grade values in a scale or use descriptive statistics. Kaplan-Meier curve analysis of biochemical relapse free survival (b-RFS) at 2 and 5-year bRFS for all patients will be estimated. conditions module condition list condition Radiation Toxicity keyword list keyword SBRT adjuvant RT salvage RT prostatectomy prostatic bed design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 30 enrollment type Anticipated outcomes module primary outcome list primary outcome primary outcome measure Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0 primary outcome description To assess treatment related acute (< 90 days from the end of treatment) and late (> 90 days) gastrointestinal (GI) and genitourinary (GU) toxicity in patients who undergo postoperative SBRT using CTCAE v.5.0 primary outcome time frame 60 months secondary outcome list secondary outcome secondary outcome measure QUALITY OF LIFE (QOL) assessed by Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire. For each domain minimum symptom score (=0) means best QOL and maximum symptom score (=12) means worst QOL secondary outcome description To measure symptom scores for each QOL domain (urinary incontinence, urinary irritative/obstructive, bowel, sexual) after SDRT by EPIC-26 Questionnaire secondary outcome time frame 60 months secondary outcome measure Number of participants with urinary incontinence assessed by International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), ranging from 0 (best) to 21 (worst) secondary outcome description To assess urinary continence after postoperative SBRT using ICIQ-SF secondary outcome time frame 60 months secondary outcome measure Number of participants with erectile dysfunction assessed by International Index of Erectile Function Questionnaire ranging from 5 (worst ) to 25 (best) secondary outcome description To assess erectile function after postoperative SBRT using IIEF 5 secondary outcome time frame 60 months secondary outcome measure Number of participants with biochemical relapse assessed by PSA (cut off 0.20 ng/mL) secondary outcome description To assess biochemical outcome after postoperative SBRT using serum PSA levels secondary outcome time frame 60 months eligibility module eligibility criteria INCLUSION CRITERIA Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy). Pathologic T3N0/Nx disease or pathologic T2N0/Nx disease, with or without a positive prostatectomy surgical margin Post-radical prostatectomy PSA of ≥ 0.1 - < 2.0 ng/mL. Clinical local relapse assessed by Magnetic Resonance Imaging (MRI) of the pelvis ECOG performance status of 0-1 No distant metastases at restaging (in case of biochemical failure), within 60 days prior to registration Patients can be on androgen deprivation therapy Ability to understand and willingness to sign a study-specific informed consent prior to study entry EXCLUSION CRITERIA N1 and or M1 patients Prior radiation of any kind to the prostate gland or pelvis Prior brachytherapy is not allowed History of inflammatory colitis or other active severe comorbidities Patients who are on immunosuppressant medication healthy volunteers No gender Male minimum age 18 Years maximum age 90 Years std age list std age Adult Older Adult study population Patients with adverse pathological features or biochemical and clinical relapse following radical prostatectomy sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Stefano Arcangeli, MD central contact role Contact central contact phone +39-0392333663 central contact e mail stefano.arcangeli@unimib.it overall official list overall official overall official name Stefano Arcangeli, MD overall official affiliation University of Milan Bicocca overall official role Principal Investigator location list location location facility Radiation Oncology, Humanitas Cancer Center (Humanitas University) location status Active, not recruiting location city Rozzano location state MI location zip 20089 location country Italy location facility Radiation Oncology, ASST Monza (University of Milan Bicocca) location status Recruiting location city Monza location zip 20900 location country Italy location contact list location contact location contact name Stefano Arcangeli, MD location contact role Contact location contact phone +39 0 39 2333663 location contact e mail stefano.arcangeli@unimib.it references module reference list reference reference p m i d 30307776 reference type result reference citation Morgan SC, Hoffman K, Loblaw DA, Buyyounouski MK, Patton C, Barocas D, Bentzen S, Chang M, Efstathiou J, Greany P, Halvorsen P, Koontz BF, Lawton C, Leyrer CM, Lin D, Ray M, Sandler H. Hypofractionated Radiation Therapy for Localized Prostate Cancer: An ASTRO, ASCO, and AUA Evidence-Based Guideline. J Clin Oncol. 2018 Oct 11:JCO1801097. doi: 10.1200/JCO.18.01097. [Epub ahead of print] reference p m i d 21656740 reference type result reference citation Kruser TJ, Jarrard DF, Graf AK, Hedican SP, Paolone DR, Wegenke JD, Liu G, Geye HM, Ritter MA. Early hypofractionated salvage radiotherapy for postprostatectomy biochemical recurrence. Cancer. 2011 Jun 15;117(12):2629-36. doi: 10.1002/cncr.25824. Epub 2010 Dec 14. reference p m i d 33482863 reference type result reference citation Bell LJ, Eade T, Hruby G, Bromley R, Kneebone A. Intra-fraction displacement of the prostate bed during post-prostatectomy radiotherapy. Radiat Oncol. 2021 Jan 22;16(1):20. doi: 10.1186/s13014-020-01743-9. reference p m i d 17869014 reference type result reference citation Wong GW, Palazzi-Churas KL, Jarrard DF, Paolone DR, Graf AK, Hedican SP, Wegenke JD, Ritter MA. Salvage hypofractionated radiotherapy for biochemically recurrent prostate cancer after radical prostatectomy. Int J Radiat Oncol Biol Phys. 2008 Feb 1;70(2):449-55. Epub 2007 Sep 14. reference p m i d 33227441 reference type result reference citation Wages NA, Sanders JC, Smith A, Wood S, Anscher MS, Varhegyi N, Krupski TL, Harris TJ, Showalter TN. Hypofractionated Postprostatectomy Radiation Therapy for Prostate Cancer to Reduce Toxicity and Improve Patient Convenience: A Phase 1/2 Trial. Int J Radiat Oncol Biol Phys. 2021 Apr 1;109(5):1254-1262. doi: 10.1016/j.ijrobp.2020.11.009. Epub 2020 Nov 21. reference p m i d 30605751 reference type result reference citation Ballas LK, Luo C, Chung E, Kishan AU, Shuryak I, Quinn DI, Dorff T, Jhimlee S, Chiu R, Abreu A, Jennelle R, Aron M, Groshen S. Phase 1 Trial of SBRT to the Prostate Fossa After Prostatectomy. Int J Radiat Oncol Biol Phys. 2019 May 1;104(1):50-60. doi: 10.1016/j.ijrobp.2018.12.047. Epub 2018 Dec 31. reference p m i d 30464605 reference type result reference citation Cuccia F, Mortellaro G, Serretta V, Valenti V, Tripoli A, Gueci M, Luca N, Lo Casto A, Ferrera G. Hypofractionated postoperative helical tomotherapy in prostate cancer: a mono-institutional report of toxicity and clinical outcomes. Cancer Manag Res. 2018 Oct 29;10:5053-5060. doi: 10.2147/CMAR.S182016. eCollection 2018. reference p m i d 26867889 reference type result reference citation Lewis SL, Patel P, Song H, Freedland SJ, Bynum S, Oh D, Palta M, Yoo D, Oleson J, Salama JK. Image Guided Hypofractionated Postprostatectomy Intensity Modulated Radiation Therapy for Prostate Cancer. Int J Radiat Oncol Biol Phys. 2016 Mar 1;94(3):605-11. doi: 10.1016/j.ijrobp.2015.11.025. Epub 2015 Dec 2. reference p m i d 31291969 reference type result reference citation Koerber SA, Katayama S, Sander A, Jaekel C, Haefner MF, Debus J, Herfarth K. Prostate bed irradiation with alternative radio-oncological approaches (PAROS) - a prospective, multicenter and randomized phase III trial. Radiat Oncol. 2019 Jul 10;14(1):122. doi: 10.1186/s13014-019-1325-x. i p d sharing statement module i p d sharing Yes i p d sharing description outcomes of individual participant data sets will be shared with other investigators involved in the study i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code i p d sharing time frame 5 years derived section misc info module version holder December 02, 2022
NCT04831970
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full study rank 61394 study protocol section identification module n c t id NCT04837040 org study id info org study id CRN00808-09 secondary id info list secondary id info secondary id 2020-005431-70 secondary id type EudraCT Number organization org full name Crinetics Pharmaceuticals Inc. org class INDUSTRY brief title A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly official title A Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Acromegaly Treated With Long-acting Somatostatin Receptor Ligands (PATHFNDR-1) acronym PATHFNDR-1 status module status verified date November 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date May 12, 2021 start date type Actual primary completion date struct primary completion date July 2023 primary completion date type Anticipated completion date struct completion date June 2025 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date November 8, 2022 last update post date struct last update post date November 14, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Crinetics Pharmaceuticals Inc. lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens. conditions module condition list condition Acromegaly keyword list keyword Acromegaly PATHFNDR Paltusotine CRN00808 design module study type Interventional phase list phase Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Investigator enrollment info enrollment count 58 enrollment type Actual arms interventions module arm group list arm group arm group label Paltusotine arm group type Experimental arm group intervention list arm group intervention name Drug: Paltusotine arm group label Placebo arm group type Placebo Comparator arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Drug intervention name Paltusotine intervention description Paltusotine, tablets, once daily by mouth intervention arm group label list intervention arm group label Paltusotine intervention other name list intervention other name CRN00808 intervention type Drug intervention name Placebo intervention description Placebo, tablets, once daily by mouth intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Proportion of subjects who maintain biochemical response in IGF-1 (≤1.0× the upper limit of normal [ULN]) at the End of the Randomized Control Phase (EOR) primary outcome time frame 36 Weeks secondary outcome list secondary outcome secondary outcome measure Change from baseline in IGF-1, in units of ULN, to EOR secondary outcome time frame 36 Weeks secondary outcome measure Proportion of subjects with GH <1.0 ng/mL at Week 34, out of those who had GH <1.0 ng/mL at baseline secondary outcome time frame 34 Weeks secondary outcome measure Change from baseline in Total Acromegaly Symptoms Diary (ASD) score to EOR secondary outcome time frame 36 Weeks eligibility module eligibility criteria Inclusion Criteria: Male and female subjects ≥18 years of age Confirmed diagnosis of acromegaly and controlled (as measured by IGF-1 ≤1.0×ULN) via stable dose of protocol defined somatostatin receptor ligand therapy Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control Willing to provide signed informed consent Exclusion Criteria: Treatment naïve or treatment-withdrawn acromegaly subjects Prior treatment with paltusotine Pituitary surgery within 24 weeks prior to Screening or history of pituitary radiation therapy History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer Known history of HIV, hepatitis B, or active hepatitis C History of alcohol or substance abuse in the past 12 months Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities Subjects with symptomatic cholelithiasis Subjects with clinically significant abnormal findings during the Screening Period, or any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study Subjects currently taking pasireotide LAR (within 24 weeks prior to Screening) or pegvisomant, dopamine agonists (within 12 weeks prior to Screening), or short acting somatostatin analogs (within 12 weeks prior to first dose of study drug) healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility Crinetics Study Site location city Phoenix location state Arizona location zip 85013 location country United States location facility Crinetics Study Site location city Los Angeles location state California location zip 90048 location country United States location facility Crinetics Study Site location city Torrance location state California location zip 90502 location country United States location facility Crinetics Study Site location city Aurora location state Colorado location zip 80045 location country United States location facility Crinetics Study Site location city Miami location state Florida location zip 33136 location country United States location facility Crinetics Study Site location city Baltimore location state Maryland location zip 21205 location country United States location facility Crinetics Study Site location city Boston location state Massachusetts location zip 02114 location country United States location facility Crinetics Study Site location city Philadelphia location state Pennsylvania location zip 19104 location country United States location facility Crinetics Study Site location city Pittsburgh location state Pennsylvania location zip 15212 location country United States location facility Crinetics Study Site location city Nashville location state Tennessee location zip 37203 location country United States location facility Crinetics Study Site location city Caba location state Buenos Aires location zip C1012AAR location country Argentina location facility Crinetics Study Site location city Ciudad Autonoma de Buenos Aire location state Buenos Aires location zip C1405BCH location country Argentina location facility Crinetics Study Site location city Córdoba location zip X5000 location country Argentina location facility Crinetics Study Site location city Gent location zip 9000 location country Belgium location facility Crinetics Study Site location city Fortaleza location state Ceará location zip 60430-275 location country Brazil location facility Crinetics Study Site location city Curitiba location state Paraná location zip 80030-110 location country Brazil location facility Crinetics Study Site location city Porto Alegre location state Rio Grande Do Sul location zip 90410-000 location country Brazil location facility Crinetics Study Site location city Ribeirão Preto location state São Paulo location zip 14051-140 location country Brazil location facility Crinetics Study Site location city Rio De Janeiro location zip 21941-913 location country Brazil location facility Crinetics Study Site location city São Paulo location zip 01228000 location country Brazil location facility Crinetics Study Site location city São Paulo location zip 05453-000 location country Brazil location facility Crinetics Study Site location city Sofia location zip 1431 location country Bulgaria location facility Crinetics Study Site location city Bron location zip 69677 location country France location facility Crinetics Study Site location city Pessac location zip 33604 location country France location facility Crinetics Study Site location city Budapest location zip 1083 location country Hungary location facility Crinetics Study Site location city Pécs location zip 7624 location country Hungary location facility Crinetics Study Site location city Be'er Sheva location zip 8410101 location country Israel location facility Crinetics Study Site location city Petach Tikva location zip 4941480 location country Israel location facility Crinetics Study Site location city Tel Aviv location zip 6423906 location country Israel location facility Crinetics Study Site location city Pisa location zip 56124 location country Italy location facility Crinetics Study Site location city Roma location zip 00168 location country Italy location facility Crinetics Study Site location city San Isidro location state Lima location zip 15023 location country Peru location facility Crinetics Study Site location city Bydgoszcz location zip 85-605 location country Poland location facility Crinetics Study Site location city Poznań location zip 60-355 location country Poland location facility Crinetics Study Site location city Wrocław location zip 50-367 location country Poland location facility Crinetics Study Site location city Kemerovo location state Kemerovo Oblast location zip 650066 location country Russian Federation location facility Crinetics Study Site location city Novosibirsk location state Novosibirsk Oblast location zip 630005 location country Russian Federation location facility Crinetics Study Site location city Novosibirsk location state Novosibirsk Oblast location zip 630087 location country Russian Federation location facility Crinetics Study Site location city Kazan location state Republic Of Tatarstan location zip 420097 location country Russian Federation location facility Crinetics Study Site location city Samara location state Samara Oblast location zip 443041 location country Russian Federation location facility Crinetics Study Site location city Moscow location zip 117186 location country Russian Federation location facility Crinetics Study Site location city Moscow location zip 125008 location country Russian Federation location facility Crinetics Study Site location city Belgrade location zip 11000 location country Serbia location facility Crinetics Study Site location city Sheffield location state South Yorkshire location zip S102JF location country United Kingdom location facility Crinetics Study Site location city Coventry location state West Midlands location zip CV2 2DX location country United Kingdom location facility Crinetics Study Site location city London location zip W12 0HS location country United Kingdom references module see also link list see also link see also link label To obtain contact information for a study center near you, click here. see also link u r l https://studykik.com/4016363-acromegaly?utm=ctgov i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 removed country list removed country Austria Germany Spain condition browse module condition mesh list condition mesh condition mesh id D000000172 condition mesh term Acromegaly condition ancestor list condition ancestor condition ancestor id D000001849 condition ancestor term Bone Diseases, Endocrine condition ancestor id D000001847 condition ancestor term Bone Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000006964 condition ancestor term Hyperpituitarism condition ancestor id D000010900 condition ancestor term Pituitary Diseases condition ancestor id D000007027 condition ancestor term Hypothalamic Diseases condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition browse leaf list condition browse leaf condition browse leaf id M2683 condition browse leaf name Acromegaly condition browse leaf as found Acromegaly condition browse leaf relevance high condition browse leaf id M4278 condition browse leaf name Bone Diseases condition browse leaf relevance low condition browse leaf id M4280 condition browse leaf name Bone Diseases, Endocrine condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M12943 condition browse leaf name Pituitary Diseases condition browse leaf relevance low condition browse leaf id M9229 condition browse leaf name Hypothalamic Diseases condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id T139 condition browse leaf name Acromegaly condition browse leaf as found Acromegaly condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M14958 intervention browse leaf name Somatostatin intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04837040
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full study rank 61775 study protocol section identification module n c t id NCT04832087 org study id info org study id P00033923 organization org full name Boston Children's Hospital org class OTHER brief title Pediatric Teduglutide Registry official title Pediatric Teduglutide Registry: Clinical Use of Teduglutide in Children With Intestinal Failure, a Multicenter Post-marketing Evaluation acronym PTR status module status verified date February 2022 overall status Recruiting expanded access info has expanded access No start date struct start date May 18, 2021 start date type Actual primary completion date struct primary completion date February 5, 2024 primary completion date type Anticipated completion date struct completion date August 5, 2024 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date February 4, 2022 last update post date struct last update post date February 22, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Lissette Jimenez responsible party investigator title Co-Director Congenital Enteropathy Program; Attending Physician, Division of Gastroenterology, Hepatology and Nutrition responsible party investigator affiliation Boston Children's Hospital lead sponsor lead sponsor name Boston Children's Hospital lead sponsor class OTHER collaborator list collaborator collaborator name Takeda collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No is u s export No description module brief summary Pediatric specific post-marketing registry to evaluate the long-term safety and efficacy of teduglutide. detailed description This will be a multi-center post-marketing pediatric registry study evaluating the efficacy and safety of teduglutide. This is an observational longitudinal registry of pediatric SBS patients who are using FDA approved teduglutide as per standard of care. conditions module condition list condition Short Bowel Syndrome design module study type Observational patient registry Yes target duration 3 Years design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 160 enrollment type Anticipated arms interventions module arm group list arm group arm group label Cohort A arm group description Participants with SBS who started Teduglutide after FDA approval (May 2019) arm group intervention list arm group intervention name Drug: Teduglutide arm group label Cohort B arm group description Subjects who participated in any of the teduglutide pediatric clinical trial studies (TED-C13-003, TED-C14-006, SHP633-303, or SHP633-304) and subsequently started therapy with teduglutide arm group intervention list arm group intervention name Drug: Teduglutide intervention list intervention intervention type Drug intervention name Teduglutide intervention description Standard of care Teduglutide dosing intervention arm group label list intervention arm group label Cohort A Cohort B intervention other name list intervention other name Gattex outcomes module primary outcome list primary outcome primary outcome measure Percent change in calories from parenteral support (PS) (Kcal/kg/day) primary outcome description Maximum percent change in calories (energy intake in kcal/kg/day) from parenteral support relative to pre- treatment (baseline) assessment up to 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A. primary outcome time frame Up to 3 years secondary outcome list secondary outcome secondary outcome measure Percent change of (PS) volume (liters/week) secondary outcome description Percent change of PS volume (liters/week) relative to pre-treatment (baseline) assessment up to 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A secondary outcome time frame Up to 3 years secondary outcome measure Percent change of PS infusions (number of days/week ) secondary outcome description Percent change of PS infusions (number of days/week relative to pre-treatment (baseline) assessment up to 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A secondary outcome time frame Up to 3 years secondary outcome measure Proportion of subjects completely weaned from PS secondary outcome description Number (proportion) of children who wean completely from PS within 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A. secondary outcome time frame Up to 3 years secondary outcome measure Adverse Events secondary outcome description Number (proportion) of subjects with adverse events among Cohort A. Number (proportion) of subjects with adverse events among Cohort B. secondary outcome time frame Up to 3 years secondary outcome measure Weight-for-age Z-score (WAZ) secondary outcome description Mean change in Weight-for-age Z-score (WAZ), relative to pre-treatment (baseline) assessment up to 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A. secondary outcome time frame Up to 3 years secondary outcome measure Height-for-age-Z-score (HAZ) secondary outcome description Mean change in Height-for-age-Z-score (HAZ), relative to pre-treatment (baseline) assessment up to 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A. secondary outcome time frame Up to 3 years secondary outcome measure Body-Mass-Index Z-score (BMIZ) secondary outcome description Mean change in Body-Mass-Index Z-score (BMIZ), relative to pre-treatment (baseline) assessment up to 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A. secondary outcome time frame Up to 3 years eligibility module eligibility criteria Cohort A: Inclusion Criteria: Diagnosis of SBS defined as intestinal resection for congenital or acquired intestinal disease leading to dependence on PS for 90 days Received teduglutide after FDA approval Age ≥ 1 years and ≤ 18 years at start of teduglutide initiation Weight ≥ 10 kg at start of teduglutide initiation Dependent on PS at the time of teduglutide initiation Subject data for primary outcome (PS energy intake in cal/kg/day) is available for medical chart abstraction at baseline (pretreatment) visit. The subject or guardian signs and dates a written informed consent form and any required privacy authorization and minor provides any assent required prior to enrolment into the registry. Exclusion Criteria: Participation in the pediatric clinical trial studies of teduglutide (TED-C13-003, TED-C14-006 or SHP633-303, SHP633-304). In the opinion of the investigator, the subject or guardian is at high risk for non-compliance. Cohort B: Inclusion Criteria: Diagnosis of SBS defined as intestinal resection for congenital or acquired intestinal disease leading to dependence on PS for 90 days Participated in clinical trial study (TED-C13-003, TED-C14-006) and/or extension study (SHP633-303, SHP633-304) Currently receiving teduglutide The subject or guardian signs and dates a written informed consent form and any required privacy authorization and minor provides any assent required prior to enrolment into the registry. Exclusion Criteria: 1. In the opinion of the investigator, the subject or guardian is at high risk for non-compliance. healthy volunteers No gender All minimum age 1 Year std age list std age Child Adult Older Adult study population Children with SBS on Teduglutide sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Lissette Jimenez, MD central contact role Contact central contact phone 6173554806 central contact e mail lissette.jimenez@childrens.harvard.edu overall official list overall official overall official name Lissette Jimenez overall official affiliation Boston Children's Hospital overall official role Principal Investigator location list location location facility Boston Children's Hospital location status Recruiting location city Boston location state Massachusetts location zip 02115 location country United States location contact list location contact location contact name Lissette Jimenez, MD,MPH location contact role Contact location contact phone 617-355-4806 location contact e mail lissette.jimenez@childrens.harvard.edu location contact name Daniel Elman, MS, MPH location contact role Contact location contact e mail Daniel.Elman@Childrens.Harvard.edu references module reference list reference reference p m i d 31495952 reference type result reference citation Kocoshis SA, Merritt RJ, Hill S, Protheroe S, Carter BA, Horslen S, Hu S, Kaufman SS, Mercer DF, Pakarinen MP, Venick RS, Wales PW, Grimm AA. Safety and Efficacy of Teduglutide in Pediatric Patients With Intestinal Failure due to Short Bowel Syndrome: A 24-Week, Phase III Study. JPEN J Parenter Enteral Nutr. 2020 May;44(4):621-631. doi: 10.1002/jpen.1690. Epub 2019 Sep 8. reference p m i d 27855998 reference type result reference citation Carter BA, Cohran VC, Cole CR, Corkins MR, Dimmitt RA, Duggan C, Hill S, Horslen S, Lim JD, Mercer DF, Merritt RJ, Nichol PF, Sigurdsson L, Teitelbaum DH, Thompson J, Vanderpool C, Vaughan JF, Li B, Youssef NN, Venick RS, Kocoshis SA. Outcomes from a 12-Week, Open-Label, Multicenter Clinical Trial of Teduglutide in Pediatric Short Bowel Syndrome. J Pediatr. 2017 Feb;181:102-111.e5. doi: 10.1016/j.jpeds.2016.10.027. Epub 2016 Nov 15. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000012778 condition mesh term Short Bowel Syndrome condition ancestor list condition ancestor condition ancestor id D000008286 condition ancestor term Malabsorption Syndromes condition ancestor id D000007410 condition ancestor term Intestinal Diseases condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000011183 condition ancestor term Postoperative Complications condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M14738 condition browse leaf name Short Bowel Syndrome condition browse leaf as found Short Bowel Syndrome condition browse leaf relevance high condition browse leaf id M10430 condition browse leaf name Malabsorption Syndromes condition browse leaf relevance low condition browse leaf id M9596 condition browse leaf name Intestinal Diseases condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M13217 condition browse leaf name Postoperative Complications condition browse leaf relevance low condition browse leaf id T5206 condition browse leaf name Short Bowel Syndrome condition browse leaf as found Short Bowel Syndrome condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id C000494910 intervention mesh term Teduglutide intervention ancestor list intervention ancestor intervention ancestor id D000005765 intervention ancestor term Gastrointestinal Agents intervention ancestor id D000011837 intervention ancestor term Radiation-Protective Agents intervention ancestor id D000020011 intervention ancestor term Protective Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M255670 intervention browse leaf name Teduglutide intervention browse leaf as found Lid intervention browse leaf relevance high intervention browse leaf id M8033 intervention browse leaf name Gastrointestinal Agents intervention browse leaf relevance low intervention browse leaf id M21022 intervention browse leaf name Protective Agents intervention browse leaf relevance low intervention browse leaf id M13836 intervention browse leaf name Radiation-Protective Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Gast intervention browse branch name Gastrointestinal Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04832087
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full study rank 61352 study protocol section identification module n c t id NCT04837586 org study id info org study id PEDS-2021-29697 organization org full name University of Minnesota org class OTHER brief title Self-Weighing for Adolescents Seeking Obesity Treatment official title Self-weighing for Weight Management in Adolescents Seeking Obesity Treatment: A Randomized Pilot status module status verified date July 2022 overall status Not yet recruiting expanded access info has expanded access No start date struct start date February 1, 2023 start date type Anticipated primary completion date struct primary completion date January 1, 2024 primary completion date type Anticipated completion date struct completion date December 31, 2024 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 15, 2022 last update post date struct last update post date July 18, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Minnesota lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary 99 patients age 12 to <18 years old with obesity (BMI >/=95th percentile), will be randomized to one of three treatment interventions: Usual Care Usual Care plus advice to weigh daily on simple scale Usual Care plus advice to weigh-daily on an EHR-connected scale Survey data collected at baseline, 2, 4, 6, and 12-weeks, and qualitative interviews at 12 weeks, will assess acceptability, safety, self-efficacy, and BMI. Recruitment will also be assessed (% eligible patients who consent). In order to understand real-world feasibility of this intervention, the clinic staff will work with patients to connect the scales to Epic. detailed description Obesity is a major public health issue because of its high prevalence and many health consequences. Obesity is driven by a dysregulation of the body's energy regulatory systems and is life-shortening. Obesity during the critical adolescent period increases risk of diabetes, cardiometabolic disease, all-cause mortality, and adulthood obesity. Rates of obesity-related cancers are increasing in younger populations. In addition to poorer health, individuals with obesity during adolescence are at risk for lower productivity, income, and likelihood of employment in adulthood, making obesity treatment and prevention important for reducing disparities. Despite consensus on the need for multi-component interventions for obesity, rates continue to climb for adolescents, youth of low-income backgrounds, and youth of racial/ethnic minority backgrounds. Clinicians cite lack of time and tools to help patients lose weight as barriers to weight counseling, and thus need practical, effective interventions they can feasibly disseminate from a busy clinical setting. Self-weighing, grounded in behavior change theory, is effective for weight loss in adults. Self-monitoring is grounded in Social Cognitive Theory (SCT), which describes behavior change as happening with reciprocal interactions with one's environment, creating external and internal self-reinforcement. Self-monitoring is one such interaction that improves self-awareness through proximate self-measurement, and improves self-efficacy, self-control, and self-reinforcement. Self-weighing (SW) is a form of self-monitoring for weight loss that is grounded in SCT. Daily SW in adults has been associated with increased exercise and cognitive restraint, and reduced snacking, television watching, and consumption of sweets. The investigator found no data on patient and parent perspectives on connecting scales to the EHR for daily weights in adolescents with obesity seeking obesity treatment. 99 patients age 12 to <18 years old with obesity (BMI >/=95th percentile), to be randomized to one of three treatment interventions: Usual Care Usual Care plus advice to weigh daily on simple scale Usual Care plus advice to weigh-daily on an EHR-connected scale Survey data collected at baseline, 2, 4, 6, and 12-weeks, and qualitative interviews at 12 weeks, will assess acceptability, safety, self-efficacy, and BMI. Recruitment will also be assessed (% eligible patients who consent). In order to understand real-world feasibility of this intervention, the clinic staff will work with patients to connect the scales to Epic. conditions module condition list condition Adolescent Obesity keyword list keyword Obesity design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 99 enrollment type Anticipated arms interventions module arm group list arm group arm group label Standard Care arm group type Active Comparator arm group description Individuals in this arm will receive standard care for their obesity in the Pediatric Weight Management Clinic arm group intervention list arm group intervention name Other: Standard Care arm group label Simple Scale arm group type Active Comparator arm group description Individuals in this arm will receive standard care for their obesity in the Pediatric Weight Management Clinic and will be encouraged to self-weigh daily utilizing a simple scale. arm group intervention list arm group intervention name Device: Simple Scale arm group label EHR-Connected Scale arm group type Active Comparator arm group description Individuals in this arm will receive standard care for their obesity in the Pediatric Weight Management Clinic and will be encouraged to self-weigh daily utilizing a Smart scale that is connected to the Electronic Health Record (EHR). arm group intervention list arm group intervention name Device: EHR-Connected Scale intervention list intervention intervention type Other intervention name Standard Care intervention description Individuals will receive standard care for their obesity through the Pediatric Weight Management Clinic. intervention arm group label list intervention arm group label Standard Care intervention type Device intervention name Simple Scale intervention description Individuals will be encouraged to perform daily weighing at home on a simple scale. intervention arm group label list intervention arm group label Simple Scale intervention type Device intervention name EHR-Connected Scale intervention description Individuals will be encouraged to perform daily weighing at home on a Smart scale that connects to the EHR. Clinic staff will review weight entries in the EHR and provide feedback. intervention arm group label list intervention arm group label EHR-Connected Scale outcomes module primary outcome list primary outcome primary outcome measure Feasibility of connecting the Smart scales to the EHR and access home weights through the EHR primary outcome description Feasibility will be measured by determining if the clinic staff can successfully connect scales to the EHR and access home weights through the EHR. Staff will record time required to connect the scale, answer questions and trouble-shoot problems that arise with the scale between visits to understand the time burden of this intervention. primary outcome time frame 12 weeks primary outcome measure Feasibility of collecting daily weights. primary outcome description Participants who are randomized to the simple scale and the EHR-connected scale will be asked to weigh themselves daily (which we anticipate will be 5-7 days per week). Participants who were randomized to the EHR-connected device will have their adherence measured by looking at the EHR to see how many daily weights were completed. Participants randomized to the simple scale will be self-reporting how many times per week they weighed themselves at home with the simple scale primary outcome time frame 12 weeks primary outcome measure Perceptions of daily weight tracking. primary outcome description Participants who are randomized to perform daily weighing on a simple scale and on an EHR-connected scale will be asked about their perceptions of having to perform this task on a daily basis via a questionnaire. The questionnaire will be a Likert scale from 0 (not helpful, not motivated, not interesting, not satisfying) to 8 (extremely helpful, extremely motivated, extremely interesting, extremely satisfying). primary outcome time frame 12 weeks eligibility module eligibility criteria Inclusion Criteria for Adolescent: Ages 12 to < 18 years Body mass index (BMI) >/= 95th percentile Exclusion Criteria for Adolescent: Score over 20 on the Eating Attitudes Test (EAT-26) Any unhealthy weight control behaviors Severe anxiety or depression Participation in another Pediatric Weight Management Clinic study Developmental delay Significant co-morbidity that might cause weight fluctuations in weight Current participation in a weight loss research study Inclusion Criteria for Parent: Parent or legal guardian of the child participant Parent aged > 18 years healthy volunteers No gender All minimum age 12 Years maximum age 17 Years std age list std age Child contacts locations module central contact list central contact central contact name Carolyn Bramante, MD central contact role Contact central contact phone 6126245624 central contact e mail bramante@umn.edu overall official list overall official overall official name Carolyn Bramante, MD overall official affiliation University of Minnesota overall official role Principal Investigator location list location location facility M Health - Pediatric Weight Management Clinic location city Minneapolis location state Minnesota location zip 55454 location country United States location contact list location contact location contact name Carolyn Bramante, MD location contact role Contact location contact phone 612-624-5624 location contact e mail bramante@umn.edu i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009765 condition mesh term Obesity condition mesh id D000063766 condition mesh term Pediatric Obesity condition ancestor list condition ancestor condition ancestor id D000044343 condition ancestor term Overnutrition condition ancestor id D000009748 condition ancestor term Nutrition Disorders condition ancestor id D000050177 condition ancestor term Overweight condition ancestor id D000001835 condition ancestor term Body Weight condition browse leaf list condition browse leaf condition browse leaf id M4266 condition browse leaf name Body Weight condition browse leaf relevance low condition browse leaf id M11853 condition browse leaf name Obesity condition browse leaf as found Obesity condition browse leaf relevance high condition browse leaf id M29308 condition browse leaf name Pediatric Obesity condition browse leaf as found Adolescent Obesity condition browse leaf relevance high condition browse leaf id M24460 condition browse leaf name Overnutrition condition browse leaf relevance low condition browse leaf id M11836 condition browse leaf name Nutrition Disorders condition browse leaf relevance low condition browse leaf id M25339 condition browse leaf name Overweight condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases
NCT04837586
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full study rank 61791 study protocol section identification module n c t id NCT04831879 org study id info org study id UKK - AMBITION organization org full name Gondola Medical Technologies SA org class INDUSTRY brief title Automated Mechanical Peripheral Stimulation to Treat Freezing of Gait in Patients With Parkinson's Disease and STN-DBS official title Automated Mechanical Peripheral Stimulation to Treat Freezing of Gait in Patients With Parkinson's Disease and Subthalamic Nucleus Deep Brain Stimulation (STN-DBS) - a Randomized Double-blind, Sham Controlled, Cross-over Trial acronym AMBITION status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 25, 2021 start date type Actual primary completion date struct primary completion date April 27, 2022 primary completion date type Anticipated completion date struct completion date June 30, 2022 completion date type Anticipated study first submit date March 25, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 14, 2021 last update post date struct last update post date April 15, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Gondola Medical Technologies SA lead sponsor class INDUSTRY collaborator list collaborator collaborator name University of Cologne collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The objective is to investigate whether AMPS (Automated Mechanical Peripheral Stimulation) is effective in reduction of FOG measured via the FOG-AC (Freezing Of Gait Assessment Course) in people with Parkinson Disease and STN-DBS (Subthalamic Nucleus Deep Brain Stimulation) in a randomized, double-blind, sham-controlled, cross-over trial detailed description The effects of AMPS treatment (effective vs sham) will be measured using the FOG-AC assessment. Patients will be randomized to receive either AMPS treatment and then sham or sham and then AMPS. Each treatment phase will be 4 weeks of treatment, separated by a 6-week washout period. conditions module condition list condition Parkinson Disease Gait Disorders, Neurologic keyword list keyword Freezing Of Gait FOG Deep Brain Stimulation Parkinson Disease design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Crossover Assignment design intervention model description Randomized sham-controlled cross-over trial design primary purpose Treatment design masking info design masking Triple design who masked list design who masked Participant Investigator Outcomes Assessor enrollment info enrollment count 40 enrollment type Anticipated arms interventions module arm group list arm group arm group label Group A AMPS - sham arm group type Experimental arm group description Treatment phase 1: AMPS Treatment phase 2: sham arm group intervention list arm group intervention name Device: GONDOLA AMPS arm group label Group B sham - AMPS arm group type Experimental arm group description Treatment phase 1: sham Treatment phase 2: AMPS arm group intervention list arm group intervention name Device: GONDOLA AMPS intervention list intervention intervention type Device intervention name GONDOLA AMPS intervention description The Gondola device is composed of two units, one per foot, each having two motors that activate rounded stimulation tips that interact with the target points. It delivers mechanical, pressure-based stimulations, sequentially in each of the four points, for the duration of 6 seconds per point. This treatment cycle is repeated 4 times, for an overall treatment duration of less than 2 minutes intervention arm group label list intervention arm group label Group A AMPS - sham Group B sham - AMPS outcomes module primary outcome list primary outcome primary outcome measure Freezing of gait assessment course primary outcome description The primary outcome is the change in FOG severity measured by the freezing of gait assessment course (FOG-AC) and evaluated by a blinded observer using video recordings (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment). Min: 0 Max: 36 Higher score indicates worse symptoms. primary outcome time frame 4 weeks secondary outcome list secondary outcome secondary outcome measure Freezing of Gait Questionnaire secondary outcome description FOG-Q (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment). Min: 0 Max: 24 Higher score indicates worse symptoms. secondary outcome time frame 4 weeks secondary outcome measure Timed up and go test secondary outcome description TUG (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment). Min: 16 Max: 64 Higher score indicates worse symptoms. secondary outcome time frame 4 weeks secondary outcome measure Movement Disorder Society - Unified Parkinson's Disease Rating Scale part I-IV secondary outcome description MDS-UPDRS I-IV (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment). Minimum score for all sections is 0, with higher scores indicating worse symptoms. Maximum value per section: I: 44 II: 52 III: 108 IV: 24 secondary outcome time frame 4 weeks secondary outcome measure Parkinson's Disease Questionnaire secondary outcome description PDQ-39 (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment) Min: 0 Max: 100 Higher score indicates worse symptoms. secondary outcome time frame 4 weeks secondary outcome measure Clinical Global Impression Severity and Improvement Scores secondary outcome description CGI-S and CGI-I (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment). Min per scale: 1 Max per scale: 7 With higher score indicating worse symptoms. secondary outcome time frame 4 weeks secondary outcome measure Falls Efficacy Scale - International secondary outcome description FES-I (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment) secondary outcome time frame 4 weeks secondary outcome measure Fast 360° turns secondary outcome description Detection of freezing of gait in patients with Parkinson's disease (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment) secondary outcome time frame 4 weeks secondary outcome measure 30-meter walk secondary outcome description Assessment to measure walking speed, functional mobility, gait, and vestibular function. (difference between the change after 4 weeks of effective AMPS treatment and after 4 weeks of sham-treatment) secondary outcome time frame 4 weeks other outcome list other outcome other outcome measure Parkinson Neuropsychometric Dementia Assessment other outcome description PANDA Minimum value is 0, and the maximal raw scores of the subtests are associate learning immediate: 12, fluency: no maximum, working memory: 6, spatial imagery: 3, associate learning delayed: 4. Higher score indicate lesser symptoms. other outcome time frame Duration of study, from screening to last follow-up visit, approximately 26 weeks other outcome measure Beck's Depression Inventory other outcome description BDI Min per scale: 0 Max per scale: 63 With higher score indicating worse symptoms. other outcome time frame Duration of study, from screening to last follow-up visit, approximately 26 weeks other outcome measure Levodopa equivalent daily dose other outcome description LEDD other outcome time frame Throughout the duration of study, approximately 26 weeks other outcome measure Deep Brain Stimulation - Total Electrical Energy Delivered other outcome description DBS TEED other outcome time frame Throughout the duration of study, approximately 26 weeks eligibility module eligibility criteria Inclusion Criteria: Informed Consent as documented by signature (Appendix Informed Consent Form) ≥18 years old Diagnosis of Parkinson's Disease according to the United Kingdom Brain Bank Criteria Bilateral STN-DBS for at least 6 months Moderate to severe FOG i.e. FOG-AC ≥8 pts. Exclusion Criteria: Known or suspected non-compliance, drug or alcohol abuse, Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc. of the participant, Participation in another study with investigational drug within the 30 days preceding and during the present study, Previous enrolment into the current study, Pregnancy Enrolment of the investigator, his/her family members, employees and other dependent persons, L-Dopa induced-freezing (defined by medical history), DBS-induced freezing (defined by medical history), Clinically relevant depression Clinically relevant cognitive impairments Shoe size greater than 46 healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Michael Barbe, MD central contact role Contact central contact phone 0221 478 7494 central contact e mail michael.barbe@uk-koeln.de overall official list overall official overall official name Michael Barbe, MD overall official affiliation Department of Neurology, University Hospital Cologne overall official role Principal Investigator location list location location facility Uniklinik Köln location status Recruiting location city Köln location state North Rhine-Westphalia location zip 50937 location country Germany location contact list location contact location contact name Elfriede Stubbs location contact role Contact location contact phone +49 221 478 98842 location contact e mail elfriede.stubbs@uk-koeln.de location contact name Michael Barbe, Dr location contact role Principal Investigator references module reference list reference reference p m i d 26164797 reference type background reference citation Stocchi F, Sale P, Kleiner AF, Casali M, Cimolin V, de Pandis F, Albertini G, Galli M. Long-term effects of automated mechanical peripheral stimulation on gait patterns of patients with Parkinson's disease. Int J Rehabil Res. 2015 Sep;38(3):238-45. doi: 10.1097/MRR.0000000000000120. reference p m i d 26469868 reference type background reference citation Quattrocchi CC, de Pandis MF, Piervincenzi C, Galli M, Melgari JM, Salomone G, Sale P, Mallio CA, Carducci F, Stocchi F. Acute Modulation of Brain Connectivity in Parkinson Disease after Automatic Mechanical Peripheral Stimulation: A Pilot Study. PLoS One. 2015 Oct 15;10(10):e0137977. doi: 10.1371/journal.pone.0137977. eCollection 2015. reference p m i d 30663967 reference type background reference citation Prusch JS, Kleiner AFR, Salazar AP, Pinto C, Marchese RR, Galli M, Pagnussat AS. Automated mechanical peripheral stimulation and postural control in subjects with Parkinson's disease and freezing of gait: a randomized controlled trial. Funct Neurol. 2018 Oct/Dec;33(4):206-212. reference p m i d 29309313 reference type background reference citation Pinto C, Pagnussat AS, Rozin Kleiner AF, Marchese RR, Salazar AP, Rieder CRM, Galli M. Automated Mechanical Peripheral Stimulation Improves Gait Parameters in Subjects With Parkinson Disease and Freezing of Gait: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2018 Jun;97(6):383-389. doi: 10.1097/PHM.0000000000000890. reference p m i d 32299120 reference type background reference citation Pagnussat AS, Salazar AP, Pinto C, Redivo Marchese R, Rieder CRM, Alves Filho JO, Franco AR, Kleiner AFR. Plantar stimulation alters brain connectivity in idiopathic Parkinson's disease. Acta Neurol Scand. 2020 Sep;142(3):229-238. doi: 10.1111/ane.13253. Epub 2020 May 5. reference p m i d 29526852 reference type background reference citation Pagnussat AS, Kleiner AFR, Rieder CRM, Frantz A, Ehlers J, Pinto C, Dorneles G, Netto CA, Peres A, Galli M. Plantar stimulation in parkinsonians: From biomarkers to mobility - randomized-controlled trial. Restor Neurol Neurosci. 2018;36(2):195-205. doi: 10.3233/RNN-170744. reference p m i d 29902470 reference type background reference citation Kleiner AFR, Souza Pagnussat A, Pinto C, Redivo Marchese R, Salazar AP, Galli M. Automated Mechanical Peripheral Stimulation Effects on Gait Variability in Individuals With Parkinson Disease and Freezing of Gait: A Double-Blind, Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Dec;99(12):2420-2429. doi: 10.1016/j.apmr.2018.05.009. Epub 2018 Jun 11. reference p m i d 26495152 reference type background reference citation Kleiner A, Galli M, Gaglione M, Hildebrand D, Sale P, Albertini G, Stocchi F, De Pandis MF. The Parkinsonian Gait Spatiotemporal Parameters Quantified by a Single Inertial Sensor before and after Automated Mechanical Peripheral Stimulation Treatment. Parkinsons Dis. 2015;2015:390512. doi: 10.1155/2015/390512. Epub 2015 Oct 1. reference p m i d 29457707 reference type background reference citation Galli M, Vicidomini C, Rozin Kleiner AF, Vacca L, Cimolin V, Condoluci C, Stocchi F, De Pandis MF. Peripheral neurostimulation breaks the shuffling steps patterns in Parkinsonian gait: a double blind randomized longitudinal study with automated mechanical peripheral stimulation. Eur J Phys Rehabil Med. 2018 Dec;54(6):860-865. doi: 10.23736/S1973-9087.18.05037-2. Epub 2018 Feb 19. reference p m i d 24436294 reference type background reference citation Barbic F, Galli M, Dalla Vecchia L, Canesi M, Cimolin V, Porta A, Bari V, Cerri G, Dipaola F, Bassani T, Cozzolino D, Pezzoli G, Furlan R. Effects of mechanical stimulation of the feet on gait and cardiovascular autonomic control in Parkinson's disease. J Appl Physiol (1985). 2014 Mar 1;116(5):495-503. doi: 10.1152/japplphysiol.01160.2013. Epub 2014 Jan 16. reference p m i d 31107357 reference type background reference citation Zamunér AR, Shiffer D, Barbic F, Minonzio M, Andrade CP, Corato M, Lalli S, Dipaola F, Cairo B, Albanese A, Porta A, Furlan R. Mechanical somatosensory stimulation decreases blood pressure in patients with Parkinson's disease. J Hypertens. 2019 Aug;37(8):1714-1721. doi: 10.1097/HJH.0000000000002084. see also link list see also link see also link label Sponsor website see also link u r l https://www.gondola-medical.com/ i p d sharing statement module i p d sharing No i p d sharing description No plan derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010300 condition mesh term Parkinson Disease condition mesh id D000009422 condition mesh term Nervous System Diseases condition mesh id D000020233 condition mesh term Gait Disorders, Neurologic condition ancestor list condition ancestor condition ancestor id D000020734 condition ancestor term Parkinsonian Disorders condition ancestor id D000001480 condition ancestor term Basal Ganglia Diseases condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009069 condition ancestor term Movement Disorders condition ancestor id D000080874 condition ancestor term Synucleinopathies condition ancestor id D000019636 condition ancestor term Neurodegenerative Diseases condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M12365 condition browse leaf name Parkinson Disease condition browse leaf as found Parkinson's Disease condition browse leaf relevance high condition browse leaf id M21211 condition browse leaf name Gait Disorders, Neurologic condition browse leaf as found Gait Disorders, Neurologic condition browse leaf relevance high condition browse leaf id M21647 condition browse leaf name Parkinsonian Disorders condition browse leaf relevance low condition browse leaf id M24756 condition browse leaf name Ganglion Cysts condition browse leaf relevance low condition browse leaf id M15510 condition browse leaf name Synovial Cyst condition browse leaf relevance low condition browse leaf id M3926 condition browse leaf name Basal Ganglia Diseases condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M11181 condition browse leaf name Movement Disorders condition browse leaf relevance low condition browse leaf id M2217 condition browse leaf name Synucleinopathies condition browse leaf relevance low condition browse leaf id M20711 condition browse leaf name Neurodegenerative Diseases condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id T4202 condition browse leaf name Oculocerebral Syndrome With Hypopigmentation condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04831879
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full study rank 61514 study protocol section identification module n c t id NCT04835480 org study id info org study id US-China-HY1001 organization org full name Healthgen Biotechnology Corp. org class INDUSTRY brief title A Phase II Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites official title A Phase II, Multicenter, Randomized, Positive-Controlled, and Multi-Cohort Study of OsrHSA in Patients With Decompensated Cirrhotic Ascites status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 22, 2021 start date type Actual primary completion date struct primary completion date June 30, 2022 primary completion date type Anticipated completion date struct completion date June 30, 2022 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date November 11, 2021 last update post date struct last update post date November 19, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Healthgen Biotechnology Corp. lead sponsor class INDUSTRY oversight module is f d a regulated drug Yes is f d a regulated device No description module brief summary The study is designed to study the efficacy of IV OsrHSA or positive control HSA (10 g and 20 g IV everyday) for 14 days. After a screening period of up to 14 days, the eligible subjects will be randomized in a 4:1 ratio to OsrHSA and positive control HSA, respectively, in each cohort. Each enrolled subject will receive multiple assigned doses of OsrHSA. The Investigator and subjects will be blind to treatment assignment (OsrHSA or positive control HSA) in each cohort. During the study, subjects will be evaluated for efficacy, safety, tolerability, and immunogenicity. In each cohort, subjects will be stratified by baseline serum albumin level. If serum albumin reaches 35 g/L or more, the study drug or control drug administration may be terminated early. Subjects will have 3 follow-up visits in 2 weeks. conditions module condition list condition Cirrhotic Ascites design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Investigator enrollment info enrollment count 220 enrollment type Anticipated arms interventions module arm group list arm group arm group label OsrHSA Group arm group type Experimental arm group description OsrHSA (10g or 20g), IV, qd arm group intervention list arm group intervention name Drug: OrsHSA arm group label HSA Group1 arm group type Active Comparator arm group description HSA (10g or 20g), IV, qd arm group intervention list arm group intervention name Drug: HSA intervention list intervention intervention type Drug intervention name OrsHSA intervention description OsrHSA a recombinant HSA, which was expressed and purified from the plant Oryza sativa intervention arm group label list intervention arm group label OsrHSA Group intervention type Drug intervention name HSA intervention description Albutein® 20% (ALBUMIN HUMAN INFUSION 20% 50ML) intervention arm group label list intervention arm group label HSA Group1 outcomes module primary outcome list primary outcome primary outcome measure OrsHSA exhibits good efficacy by rescue serum albumin levels. primary outcome description A relatively high percentage of subjects whose serum albumin reaches 35 g/L or more at any time up to 14 days by using OsrHSA. primary outcome time frame 14 days eligibility module eligibility criteria Inclusion Criteria: Able to understand and willing to sign the ICF; Decompensated cirrhosis with ascites by clinical, laboratory, or imaging evidence. Male or female eligible; Age ≥18 years and ≤80 years; Serum albumin ≤30 g/L; Has adequate venous access; Be a female of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal and has a follicle stimulating hormone > 40mIU/mL, or surgically sterile [defined as having a bilateral oophorectomy, hysterectomy or tubal ligation]) or a woman of childbearing potential who agrees to one of the following to prevent pregnancy and has a negative serum pregnancy test at screening: Practicing abstinence; If a sexually active woman of childbearing potential (sexually active with a non-sterile male partner) agrees to prevent pregnancy by using double methods of contraception as follow until at least 90 days after the administration of the investigational product: simultaneous use of the intrauterine contraceptive device, placed at least 4 weeks prior to study drug administration, and condom for the male partner; simultaneous use of hormonal contraceptives, starting at least 4 weeks prior to study drug administration and must agree to use the same hormonal contraceptive throughout the study, and condom for the male partner; simultaneous use of a diaphragm with intravaginally applied spermicide and male condoms for the male partner, starting at least 21 days prior to study drug administration. Male subjects who are not vasectomized for at least 6 months and who are sexually active with a non-sterile female partner must agree to use double methods of contraception below from the first dose of randomized study drug until 90 days after their dose and must not donate sperm during their study participation period: simultaneous use of a male condom and, for the female partner, hormonal contraceptives (used since at least 4 weeks) or intrauterine contraceptive device (placed since at least 4 weeks); simultaneous use of a male condom and, for the female partner, a diaphragm with intravaginally applied spermicide. Exclusion Criteria: Previous known allergic/adverse reaction to cereal or any food containing cereal, including rice; A history of a severe allergic reaction to any HpHSA component or any food; Positive IgE and IgG against rice at the screening, i.e. anti-rice Ig E ≥ 0.35 kU/L and anti-rice Ig G ≥ 25.0 mgA/L; Subjects who have medical conditions except for hepatic cirrhosis, currently requiring the use of albumin such as paracentesis-induced circulatory dysfunction, large- volume paracentesis (>5 L each time); Nephrotic syndrome, hepatorenal syndrome or Creatinine >2 × upper limit of normal (ULN), significant cardiopulmonary or structural heart disease, hemodialysis, active upper gastrointestinal bleeding, subjects with hepatic encephalopathy Grade III or IV (see Appendix 5 for hepatic encephalopathy stages); Malignant ascites or ascites caused by cancer embolus; Subjects with Grade C or D liver cancer according to the Barcelona-Clinic Liver Cancer staging (See Appendix 6); Pregnancy; HIV positive; Active obstructive disease in the biliary tract defined by ultrasound or other imaging modalities; With the following abnormal laboratory test values: Absolute neutrophil count (NE#) <1.0 × 109/L, platelets <30 × 109/L, white blood cells<2.0 × 109/L, hemoglobin <75 g/L; ALT and (or) AST >5 × ULN, total bilirubin > 5.0 ×ULN; PT INR > 2.0; Urine protein > 2+; Subjects with Stage C or D heart failure according to ACCF/AHA Stage (See Appendix 7); Previous transplant; The mental state that prevents the subject from understanding the nature, extent, and consequences of the study; Any clinical condition that the Investigator considers would make the subject unsuitable for the trial. healthy volunteers No gender All minimum age 18 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Healthgen Wuhan central contact role Contact central contact phone +86 27 59403931 central contact e mail info@oryzogen.com location list location location facility First Hospital of Jilin University location status Recruiting location city Changchun location state Jilin location country China location contact list location contact location contact name Xinrui Wang, MD location contact role Contact location contact phone +86 431 85612437 derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001201 condition mesh term Ascites condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M3661 condition browse leaf name Ascites condition browse leaf as found Ascites condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M8814 intervention browse leaf name Altretamine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04835480
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full study rank 61262 study protocol section identification module n c t id NCT04838756 org study id info org study id 2020-04936 organization org full name Region Skane org class OTHER brief title Mammography Screening With Artificial Intelligence (MASAI) official title A Randomized, Single-blinded, Controlled Trial on the Efficacy of Mammography Screening With Artificial Intelligence - the MASAI Study acronym MASAI status module status verified date April 2022 overall status Enrolling by invitation expanded access info has expanded access No start date struct start date April 12, 2021 start date type Actual primary completion date struct primary completion date November 12, 2024 primary completion date type Anticipated completion date struct completion date April 12, 2025 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 26, 2022 last update post date struct last update post date April 27, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Region Skane lead sponsor class OTHER collaborator list collaborator collaborator name Unilabs collaborator class UNKNOWN collaborator name Cancer Registry of Norway collaborator class OTHER_GOV oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this randomized controlled trial is to assess whether AI can improve the efficacy of mammography screening, by adapting single and double reading based on AI derived cancer-risk scores and to use AI as a decision support in the screen reading, compared with conventional mammography screening (double reading without AI). detailed description European guidelines recommend that mammography exams in breast cancer screening are read by two breast radiologists to ensure a high sensitivity. Double reading is, however, resource demanding and still results in missed cancers. Computer-aided detection based on AI has been shown to have similar accuracy as an average breast radiologist. AI can be used as decision support by highlighting suspicious findings in the image as well as a means to triage screen exams according to risk of malignancy. Eligible women will be randomized (1:1) to the intervention (AI-integrated mammography screening) or control arm (conventional mammography screening). In the intervention arm, exams will be analysed with AI and triaged into two groups based on risk of malignancy. Low risk exams will be single read and high risk exams will be double read. The high risk group will contain appx. 10% of the screening population. Within the high-risk group, exams with the highest 1% risk will by default be recalled by the readers with the exception of obvious false positives. AI risk scores and Computer-Aided Detection (CAD)-marks of suspicious calcifications and masses are provided to the reader(s). In the control arm, screen exams are double read without AI (standard of care). Considering the interplay of number of interval cancers and workload, the study will be considered successful if the interval-cancer rate in the intervention arm is not more than 20% larger than in the control arm. If the interval-cancer rate is statistically and clinically significantly lower in the intervention arm than in the control arm, AI-integrated mammography screening will be considered superior to conventional mammography screening. conditions module condition list condition Breast Cancer keyword list keyword Mammography Screening Artificial Intelligence design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Screening design masking info design masking Single design masking description Participants have the possibility to opt-out. If they do not opt-out, neither the participant nor the nurse performing the screen exam will know to what study arm the participant was allocated. The radiologist reading the screen exam will however not be blinded to allocation information. design who masked list design who masked Participant enrollment info enrollment count 100000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Intervention arm arm group type Experimental arm group description AI-integrated mammography screening arm group intervention list arm group intervention name Other: AI screening modality arm group label Control arm arm group type Experimental arm group description Conventional mammography screening (standard of care) arm group intervention list arm group intervention name Other: Conventional screening modality intervention list intervention intervention type Other intervention name AI screening modality intervention description Screen exam will be analysed with an AI system (Transpara, ScreenPoint, Nijmegen, The Netherlands) that assigns exams with a cancer-risk score from 1 to 10, as well as presenting CAD-marks at suspicious findings. Exams with risk score 1-9 will be single read and exam with score 10 will be double read. Risk scores and CAD-marks are provided to the reader(s). The reader(s) will decide whether to recall the woman for work-up or not (as per standard of care). In addition, exams with the highest 1% risk will by default be recalled with the exception of obvious false positives. intervention arm group label list intervention arm group label Intervention arm intervention type Other intervention name Conventional screening modality intervention description Screen exams will be read by two radiologists without the support of AI. intervention arm group label list intervention arm group label Control arm outcomes module primary outcome list primary outcome primary outcome measure Interval-cancer rate primary outcome description Women with interval cancer per 1000 screens primary outcome time frame 43 months secondary outcome list secondary outcome secondary outcome measure Cancer-detection rate secondary outcome description Women with screen-detected cancer per 1000 screens secondary outcome time frame 15 months secondary outcome measure Recall rate secondary outcome description Number of recalls per 1000 screens secondary outcome time frame 15 months secondary outcome measure False-positive rate secondary outcome description Women with false positive per 1000 screens secondary outcome time frame 15 months secondary outcome measure Positive Predictive Value-1 secondary outcome description Women with cancer for all recalls secondary outcome time frame 15 months secondary outcome measure Sensitivity and specificity secondary outcome description True and false-positive rate secondary outcome time frame 43 months secondary outcome measure Cancer detection per cancer type secondary outcome description Screen detection of cancer in relation to cancer type, size and stage secondary outcome time frame 19 months secondary outcome measure Tumour biology of interval cancers secondary outcome description Characterization of interval cancers per type, size and stage secondary outcome time frame 43 months secondary outcome measure Screen-reading workload secondary outcome description Number of screen-readings and number of consensus meetings secondary outcome time frame 19 months secondary outcome measure Incremental cost-effectiveness ratio secondary outcome description The incremental cost-effectiveness ratio for AI-integrated mammography screening versus standard of care secondary outcome time frame 43 months eligibility module eligibility criteria Inclusion Criteria: Women eligible for population-based mammography screening. Exclusion Criteria: None. healthy volunteers Accepts Healthy Volunteers gender Female minimum age 40 Years maximum age 74 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Kristina Lång, MD PhD overall official affiliation Region Skåne overall official role Principal Investigator location list location location facility Mammography Unit, Unilabs/Skane University Hospital location city Malmö location state Skane location zip 20550 location country Sweden i p d sharing statement module i p d sharing No i p d sharing description IPD could be considered to be shared in future collaborations. derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M4372 condition browse leaf name Breast Neoplasms condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04838756
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full study rank 61578 study protocol section identification module n c t id NCT04834648 org study id info org study id LEI/IRC/09/019/20 organization org full name Seva Foundation org class OTHER brief title Improve Timely Referral Flow and Compliance of Diabetic Retinopathy Patients official title Operations Research to Improve Timely Referral Flow and Compliance of Diabetic Retinopathy Patients From Peripheral Eye Care Centers to Tertiary Center in Nepal: Cluster Randomised Control Trial status module status verified date March 2022 overall status Completed expanded access info has expanded access No start date struct start date March 15, 2021 start date type Actual primary completion date struct primary completion date August 30, 2021 primary completion date type Actual completion date struct completion date December 30, 2021 completion date type Actual study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date March 9, 2022 last update post date struct last update post date March 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Seva Foundation lead sponsor class OTHER collaborator list collaborator collaborator name Lumbini Eye Institute and Hospital collaborator class OTHER collaborator name Indian Institute of Public Health, India collaborator class OTHER collaborator name Seva Canada Society collaborator class OTHER collaborator name Queen's University, Belfast collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary An effective referral system helps to ensure a close relationship between all levels of the health system and ensures clients receive optimum care at the appropriate level and at affordable cost, and hospital facilities are used optimally and cost-effectively. A referral system requires consideration of all its important components that can be then adjusted to the local situation. Being a system, the important components of a referral system are Health system issues (Service providers, Referral protocols, Communication & transportation provide), Referring facility& Referral practicalities (Client & their condition, Protocols of care, Care provider & documents, Referral decision, Outward referral form, Communicate with referral facility, Client information, Referral register), Referral facility& Referral practicalities (Client with referral form, Treat the client with the document, Rehabilitation plan, Back referral form, Feedback to referring facility, Referral register) and Supervision and capacity building (Referral monitoring, Ensure back referral, Feedback and training to facility staff and Feedback to central level) ((USAID), 2012). There are mainly two limitations on referring Diabetic Retinopathy patients. Patient-related reasons: lack of awareness, belief, cost, distance from screening/ treatment centers, discomfort from dilating drops, efforts to attend yet another center, fear of laser treatment, fear of its impact on quality of life and jobs, lack of family support and guilt surrounding the failure to control blood sugar. Provider-related reasons are poor counseling and advisory services about ocular complications for patients with diabetes, inefficient call and recall system, long waiting times for screening or treatment, and complicated referral mechanism. Lumbini eye institute is a comprehensive tertiary eye care center in western Nepal. In spite of 19 peripheral referral centers under it, there is a poor inflow of Diabetic retinopathy patients as against the estimated disease burden in the catchment area. The objective of our study is to improve timely referral flow from referring centers and compliance with referral cases after the intervention. In order to meet our objective, the investigators tend to implement patient counseling at referral centers, a referral tracking system, and a fast-track mechanism for patients at base hospitals. detailed description Background: Changes in lifestyle and a growing number of aging populations have increased the prevalence of diabetes worldwide. Diabetes imposes a heavy disease burden in both developed and developing countries (1). Diabetic retinopathy is the commonest microvascular complication of diabetes and the leading cause of blindness in adults. There are no symptoms initially; visual impairment is seen in the proliferative stage and in macular involvement. Vision once lost will never be regained (2). The prevalence of diabetic retinopathy was 10%-50% for Type 1 and 25.2% for Type2. The worldwide prevalence of diabetic retinopathy was found to be 34.6%. WHO estimates Diabetic retinopathy is responsible for 4.8% of 37 million cases of blindness throughout the world. Several studies in Nepal showed the prevalence of 9% to 78%. A study at LEIRC showed PDR and ADED to 34%; this suggests a major blockage of cases at the tertiary and primary level (2013-2014). Early diagnosis and treatment are the key components to reduce Diabetic blindness. A comprehensive set of guidelines (CARE 2019) recommends initial dilatation and comprehensive eye examination by an optometrist or ophthalmologist. Patient with Mild, Moderate and Severe Diabetic retinopathy requires a referral and they need reexamination or follow up within time limit of 3-6 months, less than 3 months and less than 1 month respectively. Incidence of visual loss secondary to proliferative Diabetic Retinopathy can be reduced by referral to an ophthalmologist. Multiple studies show laser photocoagulation of new vessels reduces the incidence of Diabetic Blindness by 60% to 80%. Lumbini eye institute is a comprehensive tertiary eye care center in western Nepal. In spite of 19 peripheral referral centers under it, there is a poor inflow of Diabetic retinopathy patients as against the estimated disease burden in the catchment area. There are mainly two limitations on referring Diabetic Retinopathy patients. Patient-related reasons: lack of awareness, belief, cost, distance from screening/ treatment centers, discomfort from dilating drops, efforts to attend yet another center, fear of laser treatment, fear of its impact on quality of life and jobs, lack of family support and guilt surrounding the failure to control blood sugar. Provider-related reasons are poor counseling and advisory services about ocular complications for patients of diabetes, inefficient call and recall system, long waiting times for screening or treatment, and complicated referral mechanism (2). Considering these reasons and problem tree analysis effective interventions designed. Counseling and telephonic follow-up at referring facility; fast track system at the base hospital. The objective of our study is to improve timely referral flow from referring centers and compliance with referral cases after the intervention. Methods: Study Design: Two arm parallel, cluster Randomised control trial with allocation ratio 1:1 will be used. Study Setting : All diabetic retinopathy patients attending peripheral eye care centers will be the study population. Lumbini Eye Institute and Research Center (LEIRC) - a comprehensive tertiary referral eye care center located in the Western part of Nepal has nineteen referring centers: five secondary eye hospitals (SEC), three district eye care centers (DECC), and eleven primary eye care centers (PECC). The referral center (LEIRC) has several sub-specialty services; the Retina department is well equipped with two consultants, one retina fellow, and one separate counselor. A secondary eye hospital has a general ophthalmologist, ophthalmic paramedical personnel (optometrist/ophthalmic assistant), and a counselor with limited diagnostic tools for diabetic retinopathy (DR). A primary/district eye care center has ophthalmic paramedical personnel (optometrist/ophthalmic assistant) and an optician with a direct ophthalmoscope for retina examination. Masking: At LEI the staff will be blinded about the intervention/ control referring centers. Data collection plan: An experienced team member will be responsible for data collection and telephonic follow-up. the project coordinator will be trained thoroughly trained on the completion of the data collection form Data Management Plan: The demographic information and other variables of the patient who are referred from peripheral eye care centers will be collected and entered in an excel sheet. One of the team members will be responsible for data management. Data Analytic plan: Data will be analyzed using IBM SPSS. Differences indifference in compliance and referral rates will be computed. Study period: Approximately 19 months (March 2020 to December 2021) Ethical consideration: Ethical approval is taken from the Institutional review committee, LEIRC. Data confidentiality will be maintained. Ethical considerations: Written Consent form including the title of the study and their support during the study period was sent to all 10 centers included in the study. These consent forms were signed by the head of centers on 12th June 2020 and sent to LEIRC. Ethical Approval from the Institutional Review Committee (IRC) of LEIRC was taken on 8th August 2020. Data confidentiality will be maintained. No personal information will be used in analysis, reports, and publications. Discussion: Diabetic Retinopathy is a global epidemic in both developed and developing countries with significant morbidity and mortality. In a study done by Mishra SK et al, they found people were less aware of the microvascular complications of diabetes. They didn't meet the physician regularly for diabetes control and didn't know about regular eye examinations with ophthalmologists. Even though the incidence of blindness secondary to diabetes mellitus can be significantly reduced; there is still a large number of diabetes patient with vision loss due to retinal complications of the disease In a study done by Tien Y. Wang et al, they came with a broad-based system-level approach to prevent vision loss resulting from Diabetic Retinopathy: 1: Targeted health care education to improve public knowledge. 2: well-implemented community or national level screening programs for all patients with diabetes. 3: Timely referral for severe level of Diabetic Retinopathy. 4: Appropriate treatment for advanced Diabetic Retinopathy (PDR and DME). In our study the investigators wanted to make the patient aware of the changes diabetes can bring to the eye, the investigators implemented Structured Counseling where the patient is explained in detail about the changes diabetes makes in the eye. It also includes the impact on vision and different treatment options available and the rate. They are also explained to go to a base hospital where they will be evaluated by a retina specialist thus decreasing a load of visual impairment due to diabetes. World Health Organization (WHO) has identified adherence to follow-up services as a key component in effective management of Diabetic Retinopathy9. In this study, they found improving the clarity of the referral process by explaining the treatment costs, the reason for referral, and likely health benefits to the patient helped by increasing follow-up rates9. Keeping this in the investigators explained the treatment cost and about the base hospital in detain as our structured counseling. A study done by Mishra SK et al found major facilitator was the existence of referral slips to expedite treatment upon reaching the health facility and the major barrier was a failure to receive preferential treatment at the facility, despite the presence of the slip. In addition to this, they found lack of feedback as a barrier to functional referral system 3. Similarly, during our problem tree analysis, the investigators found a longer waiting time and no preferential treatment as a factor in the referral system. The investigators tried implementing a referral slip and planned to decrease the waiting time by allowing them to visit the ophthalmologist directly at our center. This point will also be explained by the counselor during counseling. conditions module condition list condition Diabetes Diabetic Retinopathy keyword list keyword referral rate diabetic retinopathy counselling design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Health Services Research design masking info design masking Single design masking description At LEI the staff will be blinded about the intervention/ control referring centers design who masked list design who masked Care Provider enrollment info enrollment count 150 enrollment type Actual arms interventions module arm group list arm group arm group label Structured Counseling arm group type Experimental arm group description Structured Counseling, which includes A. Counseling is done by a trained counselor B. Telephonic Follow up: C. Development of Fast Track system at the Base Hospital. D. Provide Health Education Material to all Diabetic Patients. E. Referral communication and feedback between referring and referral facility. arm group intervention list arm group intervention name Behavioral: Structured Counseling arm group label Control Arm arm group type No Intervention arm group description General Counseling, which included saying you need to visit the hospital and you have involvement in the eyes due to diabetes, providing a health education leaflet. intervention list intervention intervention type Behavioral intervention name Structured Counseling intervention description Structured Counseling, which includes A. Counseling is done by a trained counselor B. Telephonic Follow up: C. Development of Fast Track system at the Base Hospital. D. Provide Health Education Material to all Diabetic Patients. E. Referral communication and feedback between referring and referral facility. intervention arm group label list intervention arm group label Structured Counseling outcomes module primary outcome list primary outcome primary outcome measure Primary Outcome primary outcome description Percentage of referral compliance before and after intervention primary outcome time frame 8 months eligibility module eligibility criteria Inclusion Criteria: All Diabetic Retinopathy patients attending the peripheral eye centers linked with LEIRC. Exclusion Criteria: All referred Diabetic patients who not is willing to be part of the study. healthy volunteers No gender All minimum age 16 Years maximum age 100 Years std age list std age Child Adult Older Adult contacts locations module location list location location facility Lumbini Eye Institute and Research Center location city Butwal location country Nepal i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000012164 condition mesh term Retinal Diseases condition mesh id D000003930 condition mesh term Diabetic Retinopathy condition ancestor list condition ancestor condition ancestor id D000005128 condition ancestor term Eye Diseases condition ancestor id D000003925 condition ancestor term Diabetic Angiopathies condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000048909 condition ancestor term Diabetes Complications condition ancestor id D000003920 condition ancestor term Diabetes Mellitus condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition browse leaf list condition browse leaf condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf relevance low condition browse leaf id M14151 condition browse leaf name Retinal Diseases condition browse leaf as found Retinopathy condition browse leaf relevance high condition browse leaf id M6277 condition browse leaf name Diabetic Retinopathy condition browse leaf as found Diabetic Retinopathy condition browse leaf relevance high condition browse leaf id M7423 condition browse leaf name Eye Diseases condition browse leaf relevance low condition browse leaf id M6272 condition browse leaf name Diabetic Angiopathies condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M25157 condition browse leaf name Diabetes Complications condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC11 condition browse branch name Eye Diseases condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases
NCT04834648
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full study rank 61312 study protocol section identification module n c t id NCT04838106 org study id info org study id PID15456 secondary id info list secondary id info secondary id 21/SC/0021 secondary id type Other Identifier secondary id domain South Central - Hampshire B Research Ethics Committee secondary id 21/CAG/0017 secondary id type Other Identifier secondary id domain Confidentiality Advisory Group organization org full name University of Oxford org class OTHER brief title Outcomes of Patients Who Survived Treatment on an Intensive Care Unit for COVID-19 in England and Wales official title Outcomes of Patients Who Survived Treatment on an Intensive Care Unit for COVID-19 in England and Wales: a Comparative Retrospective Cohort Study (OPTIC-19) acronym OPTIC-19 status module status verified date June 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date August 1, 2020 start date type Actual primary completion date struct primary completion date July 31, 2023 primary completion date type Anticipated completion date struct completion date July 31, 2023 completion date type Anticipated study first submit date April 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date August 19, 2022 last update post date struct last update post date August 24, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Oxford lead sponsor class OTHER collaborator list collaborator collaborator name Intensive Care National Audit & Research Centre collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This retrospective cohort study aims to characterise outcomes for patients treated on an intensive care unit (ICU) with COVID-19 in England and Wales, one year after discharge from hospital. Outcomes will be compared with patients admitted as an emergency to an ICU for other conditions. The study will use existing national audit data linked to routine healthcare datasets. detailed description Across England and Wales, over 10,000 patients have been treated for severe coronavirus disease 2019 (COVID-19) on an intensive care unit. Around 60% survived to leave hospital. It is unknown how survivors' severe COVID-19 infection, or the treatment they received on the intensive care unit, will affect their long-term health. Understanding what happens to these patients can help ensure they receive suitable care from their General Practitioner (GP) and other National Health Service (NHS) services after they leave hospital. This study will follow up survivors for 1 year after discharge from hospital. The investigators will use data collected by the Intensive Care National Audit and Research Centre (ICNARC) to identify patients who were treated on an ICU for COVID-19. The investigators will then use NHS data to see whether these patients were readmitted to hospital and why. Information from the Office of National Statistics will identify whether patients died. By linking different sources of patient data, the investigators will estimate the health risks faced by survivors of severe COVID-19. These risks will be compared to those in patients treated on an ICU for other conditions. conditions module condition list condition Covid19 Myocardial Infarction Stroke Critical Illness Heart Failure Deep Vein Thrombosis Pulmonary Embolism Renal Failure design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Retrospective enrollment info enrollment count 319600 enrollment type Anticipated arms interventions module arm group list arm group arm group label Covid19 arm group description Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency with confirmed COVID-19 between 1st January to 1st July 2020. arm group intervention list arm group intervention name Other: Not applicable as observational study arm group label Non Covid19 arm group description Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency without confirmed COVID-19 between 1st July 2016 and 1st July 2020. arm group intervention list arm group intervention name Other: Not applicable as observational study intervention list intervention intervention type Other intervention name Not applicable as observational study intervention description Not applicable as observational study. intervention arm group label list intervention arm group label Covid19 Non Covid19 outcomes module primary outcome list primary outcome primary outcome measure Mortality Rate primary outcome description Mortality after discharge from hospital primary outcome time frame One year secondary outcome list secondary outcome secondary outcome measure Rate of emergency hospital admission secondary outcome description Emergency hospital admission secondary outcome time frame one year secondary outcome measure Rate of emergency hospital admission for respiratory infection secondary outcome description Emergency hospital admission for respiratory infection secondary outcome time frame one year secondary outcome measure Rate of emergency hospital admission for a major adverse cardiac event secondary outcome description Emergency hospital admission for a major adverse cardiac event (myocardial infarction, stroke, heart failure) secondary outcome time frame one year secondary outcome measure Rate of emergency hospital admission for a venous thrombotic event secondary outcome description Emergency hospital admission for a venous thrombotic event (deep vein thrombosis or pulmonary embolism) secondary outcome time frame one year secondary outcome measure Rate of development of end stage renal failure secondary outcome description Development of end stage renal failure treated by renal replacement therapy secondary outcome time frame one year eligibility module eligibility criteria Inclusion Criteria: Age 16 years or over Admitted to an adult, general ICU in England or Wales as an emergency (unplanned) Admitted to ICU for either: a) confirmed COVID-19 between 1st January to 1st July 2020 or b) without confirmed COVID-19 between 1st July 2016 and 1st July 2020- Exclusion Criteria: Patients who died in hospital after treatment on an ICU healthy volunteers No gender All minimum age 16 Years std age list std age Child Adult Older Adult study population Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency between 1st July 2016 and 1st July 2020 who survived to hospital discharge. sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Peter Watkinson, MD overall official affiliation University of Oxford overall official role Principal Investigator location list location location facility Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford location city Oxford location state Oxfordshire location zip OX3 9DU location country United Kingdom i p d sharing statement module i p d sharing No i p d sharing description Individual participant data will not be made publicly available due to privacy and legal implications. document section large document module large doc list large doc large doc type abbrev Prot large doc has protocol Yes large doc has s a p No large doc has i c f No large doc label Study Protocol large doc date June 17, 2022 large doc upload date 08/09/2022 09:02 large doc filename Prot_000.pdf derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition mesh id D000011655 condition mesh term Pulmonary Embolism condition mesh id D000009203 condition mesh term Myocardial Infarction condition mesh id D000013927 condition mesh term Thrombosis condition mesh id D000004617 condition mesh term Embolism condition mesh id D000020246 condition mesh term Venous Thrombosis condition mesh id D000007238 condition mesh term Infarction condition mesh id D000016638 condition mesh term Critical Illness condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition ancestor id D000006331 condition ancestor term Heart Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000007511 condition ancestor term Ischemia condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000009336 condition ancestor term Necrosis condition ancestor id D000017202 condition ancestor term Myocardial Ischemia condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000016769 condition ancestor term Embolism and Thrombosis condition ancestor id D000020969 condition ancestor term Disease Attributes condition browse leaf list condition browse leaf condition browse leaf id M18162 condition browse leaf name Critical Illness condition browse leaf as found Critical Illness condition browse leaf relevance high condition browse leaf id M21459 condition browse leaf name Stroke condition browse leaf relevance low condition browse 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leaf id M13661 condition browse leaf name Pulmonary Embolism condition browse leaf as found Pulmonary Embolism condition browse leaf relevance high condition browse leaf id M6936 condition browse leaf name Embolism condition browse leaf as found Embolism condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 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NCT04838106
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full study rank 61827 study protocol section identification module n c t id NCT04831411 org study id info org study id WBV-PRE training after TKA organization org full name Pamukkale University org class OTHER brief title Comparison of Early Whole Body Vibration and Progressive Resistance Training in Fast-Track Total Knee Arthroplasty. official title Comparison of Early Whole Body Vibration and Progressive Resistance Training to Enhance Recovery After Fast-Track Total Knee Arthroplasty: A Randomized Comparative Study. status module status verified date September 2022 overall status Completed expanded access info has expanded access No start date struct start date July 28, 2020 start date type Actual primary completion date struct primary completion date June 23, 2022 primary completion date type Actual completion date struct completion date July 8, 2022 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date September 27, 2022 last update post date struct last update post date September 28, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Gökhan Bayrak responsible party investigator title Director responsible party investigator affiliation Pamukkale University lead sponsor lead sponsor name Pamukkale University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Patients who have undergone total knee arthroplasty (TKA) with Fast-Track recovery protocol at the Department of Orthopedics and Traumatology at the Local University Hospital and meet the inclusion and exclusion criteria will constitute the study sample. The patients will be divided into 2 groups using the computerized randomization method in the post-operative 4th week; Whole Body Vibration Group and Progressive Resistance Exercise Group. The first evaluation of the participants will be made at the end of the post-operative 4th week. Final evaluations will be made at the end of the post-operative 10th week, following the 6-week training. detailed description Patients who have undergone total knee arthroplasty (TKA) with Fast-Track recovery protocol at the Department of Orthopedics and Traumatology at the Local University Hospital and meet the inclusion and exclusion criteria will constitute the study sample. The patients will be divided into 2 groups using the computerized randomization method in the post-operative 4th week; Whole Body Vibration Group and Progressive Resistance Exercise Group. The first evaluation of the participants will be made at the end of the post-operative 4th week. After 2 days and 6 weeks of training a week, final evaluations will be made at the end of the 10th postoperative week. Evaluations will include measures of impairment in body functions and structures, activity limitation measures, balance assessment, and quality of life assessments. Evaluations will be made by a blind researcher. The study will be started with a total of 28 patients, including 14 participants in both groups. The sample size was determined by performing a power analysis. The purpose of the study will be explained to the patients by the researcher and the patients who agree to participate in the planned study will be included in the study. conditions module condition list condition Knee Arthropathy keyword list keyword fast-track surgery whole body vibration progressive resistance training total knee arthroplasty rehabilitation design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Outcomes Assessor enrollment info enrollment count 34 enrollment type Actual arms interventions module arm group list arm group arm group label Whole Body Vibration arm group type Active Comparator arm group description The training program will last 2 days a week and 6 weeks in total. Each session includes a warm-up, progressive whole-body vibration training and a cooling exercise. On the remaining days of the week, all patients will apply the standard exercise program, which includes simple home exercises, at home. arm group intervention list arm group intervention name Procedure: Total Knee Arthroplasty Other: Whole Body Vibration arm group label Progressive Resistance Training arm group type Active Comparator arm group description The training program will last 2 days a week and 6 weeks in total. Each session includes a warm-up, progressive resistance training and a cooling exercise. On the remaining days of the week, all patients will apply the standard exercise program, which includes simple home exercises, at home. arm group intervention list arm group intervention name Procedure: Total Knee Arthroplasty Other: Progressive Resistance Training intervention list intervention intervention type Procedure intervention name Total Knee Arthroplasty intervention description The extremities of patients admitted to the operating room to be applied TKA will be determined using a safe surgical Fast-Track recovery protocol. Patients will be operated by the same surgical team using the same technique. Spinal anaesthesia or general anaesthesia will be applied to the patients according to the evaluations of the anesthesiologists. intervention arm group label list intervention arm group label Progressive Resistance Training Whole Body Vibration intervention type Other intervention name Whole Body Vibration intervention description Whole Body Vibration intervention arm group label list intervention arm group label Whole Body Vibration intervention type Other intervention name Progressive Resistance Training intervention description Progressive Resistance Training intervention arm group label list intervention arm group label Progressive Resistance Training outcomes module primary outcome list primary outcome primary outcome measure Balance primary outcome description Kinesthetic Ability Trainer® (KAT Model TS 650) will be used to evaluate balance. Patients will use the lines on the platform to place their feet in the same place for each measurement. Patients will be informed that the cursor on the system interface indicating the location of the pressure centre should be moved as little as possible and kept close to the centre. The rates of pressure centre change will be recorded as a result of the balance score obtained after 30 seconds of measurements on bipedal feet. Measurements will be applied in 3 repetitions and their average will be recorded and recorded in the study. primary outcome time frame 6 weeks primary outcome measure Quadriceps muscle strength primary outcome description A handheld dynamometer (Commander Muscle Tester, JTech, USA) will be used for quadriceps muscle strength measurement. Patients will be seated on the treatment table with their hips and knees in 90 ° flexion with their feet hanging down. In this position, the hands will be on crossed shoulders and the use of bodyweight will be prevented. During the measurements, verbal guidance will be given to the patients in order to achieve maximum effort. Measurements will be made from the distal anterior face of the tibia with 3 consecutive maximum isometric contractions. The average of the measurement values will be recorded as a score. primary outcome time frame 6 weeks secondary outcome list secondary outcome secondary outcome measure Pain assesment secondary outcome description Pain will be assessed by the Visual Pain Scale (pain perceived during rest, sleep and walking). secondary outcome time frame 6 weeks secondary outcome measure Western Ontario and McMaster Universities Osteoarthritis Index score secondary outcome description Western Ontario and McMaster Universities Osteoarthritis Index score is a patient-reported questionnaire that evaluates pain, stiffness, and physical function in patients with hip and knee OA. The index consists of 24 questions and the scores of the questions range from 0 (none) to 4 (very severe) and the results are evaluated over 100 points (minimum score:0 and the maximum score:100). Higher scores indicate worst knee functions. secondary outcome time frame 6 weeks secondary outcome measure Quality of life measure secondary outcome description Short form-36 will be used for quality of life assessment. SF-36 is a patient-reported questionnaire developed and made available to determine health-related quality of life. SF-36 consists of 36 items that measure eight dimensions of physical function, social function, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy/vitality, pain and general health perception. The subscales assess health between 0 and 100, with 0 showing bad health and 100 showing better health. Higher scores indicate better quality of life. secondary outcome time frame 6 weeks secondary outcome measure 40 m fast-paced walk test secondary outcome description Patients will be asked to walk along the 10-meter track as fast as possible, turn around the cone at the finish, and complete the 40-meter total distance. After the patient passed the baseline in the last stage, the time will be stopped and the total time will be recorded. Lower walking distance indicates better walking capacity. secondary outcome time frame 6 weeks secondary outcome measure Sit-to-stand test secondary outcome description The patient will be seated in the middle of a chair with a height of standard 44 cm, with his back straight, arms crossed in front of his chest, and feet on the ground. The patient will be asked to get up from the chair and sit down as much as the patient could for 30 seconds. The exact number of starts will be made formed from the patient's score. Higher scores indicate better overall strength. secondary outcome time frame 6 weeks secondary outcome measure Stair climbing test secondary outcome description The patient will be asked to climb and descend the 9-step 16-20 centimetre ladder as quickly but safely as possible. The patient will be allowed to use a handrail or a walking aid, and the method used was recorded. The test will start with the start command and the time stopped when the patient returned to the starting place. The patient will be allowed to stop and rest when requested, but the duration will be continued. The total time was recorded as a score. Lower scores indicate better knee functions. secondary outcome time frame 6 weeks secondary outcome measure Timed up and go test secondary outcome description Timed up and go test (TUG) is a measurement that evaluates functional mobility, dynamic balance, fall risk and postural stability, which can be applied for different purposes in different age and patient groups. The activities that make up the test evaluate the transition from sitting to standing position, walking, turning, and sitting again, which are necessary for functional mobility and dynamic balance. The TUG test measures the time it takes an individual to get up from a standard chair with armrests and walk a distance of 3 meters, return from a designated or marked place, return to the chair, and sit down again. Lower scores indicate better mobility and balance. secondary outcome time frame 6 weeks eligibility module eligibility criteria Inclusion Criteria: Undergoing unilateral TKA surgery due to knee OA, Being between the ages of 50-75, To be able to understand the verbal and written information given. Exclusion Criteria: To undergo revision TKA surgery. Participating in any exercise or strengthening training within the last 3 months. Having undergone major surgery on the extremity to be operated on. Having a comorbid disease such as rheumatoid arthritis, cancer. Having a neurological disease that causes functional insufficiency. Having a diagnosed psychiatric disorder. Having received anaesthesia for any reason in the last 1 month. Regularly using hypnotics or anxiolytics. Having dementia. Having a hearing or vision impairment that cannot be corrected with a hearing aid or glasses. Being morbidly obese (Body mass index> 40 kg/m2). Having implanted pacemakers or defibrillators. Having dermatological problems affecting the thigh. Having a score above 3 in the American Society of Anesthesiologists classification score. healthy volunteers No gender All minimum age 50 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Gökhan Bayrak overall official affiliation Pamukkale University overall official role Principal Investigator location list location location facility Gökhan Bayrak location city Denizli location country Turkey references module reference list reference reference p m i d 20397856 reference type background reference citation Johnson AW, Myrer JW, Hunter I, Feland JB, Hopkins JT, Draper DO, Eggett D. Whole-body vibration strengthening compared to traditional strengthening during physical therapy in individuals with total knee arthroplasty. Physiother Theory Pract. 2010 May;26(4):215-25. doi: 10.3109/09593980902967196. reference p m i d 31703305 reference type background reference citation Hsiao YH, Chien SH, Tu HP, Fu JC, Tsai ST, Chen YS, Chen YJ, Chen CH. Early Post-Operative Intervention of Whole-Body Vibration in Patients After Total Knee Arthroplasty: A Pilot Study. J Clin Med. 2019 Nov 7;8(11). pii: E1902. doi: 10.3390/jcm8111902. reference p m i d 26763947 reference type background reference citation Bily W, Franz C, Trimmel L, Loefler S, Cvecka J, Zampieri S, Kasche W, Sarabon N, Zenz P, Kern H. Effects of Leg-Press Training With Moderate Vibration on Muscle Strength, Pain, and Function After Total Knee Arthroplasty: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Jun;97(6):857-65. doi: 10.1016/j.apmr.2015.12.015. Epub 2016 Jan 4. reference p m i d 25525066 reference type background reference citation Wang P, Yang X, Yang Y, Yang L, Zhou Y, Liu C, Reinhardt JD, He C. Effects of whole body vibration on pain, stiffness and physical functions in patients with knee osteoarthritis: a systematic review and meta-analysis. Clin Rehabil. 2015 Oct;29(10):939-51. doi: 10.1177/0269215514564895. Epub 2014 Dec 18. Review. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007592 condition mesh term Joint Diseases condition ancestor list condition ancestor condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition browse leaf list condition browse leaf condition browse leaf id M9773 condition browse leaf name Joint Diseases condition browse leaf as found Arthropathy condition browse leaf relevance high condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04831411
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full study rank 61665 study protocol section identification module n c t id NCT04833517 org study id info org study id RNT-Prostate organization org full name Universität des Saarlandes org class OTHER brief title Prospective REgistry of Targeted RadionucLide TherapY in Patients With mCRPC (REALITY Study) official title REALITY Study: Analysis of a Prospective REgistry to Assess Outcome and Toxicity of Targeted RadionucLide TherapY in Patients With mCRPC in Clinical Routine. status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date January 1, 2016 start date type Actual primary completion date struct primary completion date December 31, 2024 primary completion date type Anticipated completion date struct completion date December 31, 2025 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date November 27, 2022 last update post date struct last update post date November 30, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Samer Ezziddin, MD responsible party investigator title Director, Dept. of Nuclear Medicine responsible party investigator affiliation Universität des Saarlandes lead sponsor lead sponsor name Universität des Saarlandes lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This prospective registry aims to assess outcome and toxicity of targeted radionuclide therapies in patients with advanced prostate cancer in clinical routine. While the major investigated treatment modality is prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, also other radionuclide therapies such as Ra223 and liver-directed radioembolization are included. The investigators believe that prospectively assessed long-term outcome data on implementation of radionuclide therapy, especially in the palliative setting of advanced mCRPC, help to better define the real benefits and risks of the respective treatment modalities for patients regarding survival and quality-of-life. detailed description Targeted radionuclide therapy is comprised of different modalities that may be applied in advanced prostate cancer, either targeting bone metastases (mainly using Radium-223), any site of metastases with PSMA-expression (ß- / alpha-emitter labelled radioligands) or loco-regionally applying internal radiation (Yttrium-90 microspheres) to metastatic liver disease. While in Germany, each form of treatment is used in clinical routine, data is sparse regarding the real benefits and risks of respective modalities, also when used in a sequential order. As an example, patients receiving Ra223 treatment may later undergo PSMA targeted radioligand therapy, with little data available on dependent response relationships or cumulative risks. Prospective assessment of outcomes and toxicities in a radionuclide therapy registry is apparently superior over retrospective analyses of selected patient populations. The goal of the REALITY study is to gain a better understanding of the real-life clinical application of radionuclide therapies, with a focus on PSMA-targeted radioligand therapy in a high-volume treatment centre, and the impact of each treatment for patient outcome. Based on primary and secondary outcome measures the potential prediction of treatment benefit by baseline patient and tumor characteristics, and early changes of biomarkers will be of interest. conditions module condition list condition Prostate Cancer Metastatic Castration Resistant Prostatic Cancer Advanced Prostate Carcinoma keyword list keyword mCRPC Radioligand Therapy PSMA PSMA-targeted Therapy Radionuclide Therapy Ra-223 Bone-targeted Radionuclide Therapy Radioembolization SIRT design module study type Observational patient registry Yes target duration 5 Years design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 500 enrollment type Anticipated arms interventions module arm group list arm group arm group label Lu177 PSMA RLT arm group description Lutetium-177 prostate-specific membrane antigen (Lu177 PSMA) radioligand therapy (RLT) according to standard local protocol arm group label Ac225 PSMA RLT arm group description Actinium-225 prostate-specific membrane antigen (Ac225 PSMA) radioligand therapy (RLT) according to standard local protocol arm group label Tandem Lu177 / Ac225 PSMA RLT arm group description Combined Lu177 / Ac225 PSMA radioligand therapy according to standard local protocol arm group label Ra223 chloride arm group description Bone-targeted Radium-223 (Ra223) radionuclide therapy in standard application arm group label Sm153 EDTMP arm group description Bone-targeted Samarium-153 (Sm153) EDTMP radionuclide therapy in standard application arm group label Y90 microshperes arm group description Radioembolization with yttrium-90 (Y90) microspheres, standard methodology arm group label Tb161 PSMA RLT arm group description Terbium-161 prostate-specific membrane antigen (Tb161 PSMA) radioligand therapy (RLT) according to standard local protocol outcomes module primary outcome list primary outcome primary outcome measure PSA response primary outcome description Best PSA response and PSA response after 3 months from start of radionuclide therapy primary outcome time frame up to 10 years primary outcome measure PSA-PFS primary outcome description PSA-based progression-free survival (PFS) according to PCWG3 criteria. From date of start of radionuclide therapy until documented and confirmed PSA-progression primary outcome time frame up to 10 years primary outcome measure OS primary outcome description Overall survival. From date of start of radionuclide therapy until the date of death from any cause assessed primary outcome time frame up to 10 years primary outcome measure Toxicity (adverse events) primary outcome description All toxicity occurring after start of radionuclide treatment will be registered according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.03). primary outcome time frame up to 10 years primary outcome measure Toxicity-related discontinuation of radionuclide treatment primary outcome description Rate of toxicity-related discontinuation of radionuclide therapy primary outcome time frame up to 10 years secondary outcome list secondary outcome secondary outcome measure Conventional imaging response secondary outcome description Response to radionuclide therapy based on conventional imaging according to RECIST 1.1 secondary outcome time frame up to10 years secondary outcome measure Molecular imaging response secondary outcome description Response to radionuclide therapy based on molecular imaging secondary outcome time frame up to 10 years secondary outcome measure Quality-of-life in patients receiving radionuclide therapy secondary outcome description Quality-of-life assessed from start of radionuclide treatment by EORTC QLQ-C30 questionaires secondary outcome time frame up to 10 years secondary outcome measure Pain control achieved by radionuclide therapy secondary outcome description Based on VAS-BPI patient questionaires from start of radionuclide treatment secondary outcome time frame up to 10 years secondary outcome measure Absorbed doses achieved by radionuclide therapy secondary outcome description Absorbed doses in Gy/GBq based on intra- / posttherapeutic dosimetry when available secondary outcome time frame up to 10 years eligibility module eligibility criteria Inclusion Criteria: Signed informed consent form (Registry Study Inclusion Form) Inclusion Criteria for PSMA RLT: sufficient humoral expression defined as tracer uptake markedly higher than (physiologic) uptake in healthy liver tissue. sufficient bone marrow reserve: leukocytes ≥ 2 G/L, platelets > 75 × 109/L sufficient overall patient condition: Eastern Oncology Cooperative Group (ECOG) performance status ≤ 3 Exclusion Criteria: Inability or unwillingness to provide informed consent healthy volunteers No gender Male minimum age 18 Years std age list std age Adult Older Adult study population Patients with advanced castration-resistant prostate cancer, who receive radionuclide treatment including PSMA-targeted radioligand therapy, Radium-223 or other bone-targeted radionuclide therapy and liver-directed radioembolization. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Samer Ezziddin, MSc, MD, PhD central contact role Contact central contact phone +49 6841 16 22201 central contact e mail PSMA@uks.eu central contact name Katja Threm central contact role Contact central contact phone +49 6841 16 24667 central contact e mail nuklearmedizin@uks.eu overall official list overall official overall official name Samer Ezziddin, MSc, MD, PhD overall official affiliation Universität des Saarlandes overall official role Principal Investigator location list location location facility Dept. of Nuclear Medicine, Saarland University location status Recruiting location city Homburg location state Saarland location zip 66421 location country Germany derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000011471 condition mesh term Prostatic Neoplasms condition mesh id D000064129 condition mesh term Prostatic Neoplasms, Castration-Resistant condition ancestor list condition ancestor condition ancestor id D000005834 condition ancestor term Genital Neoplasms, Male condition ancestor id D000014565 condition ancestor term Urogenital Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000011469 condition ancestor term Prostatic Diseases condition browse leaf list condition browse leaf condition browse leaf id M4686 condition browse leaf name Carcinoma condition browse leaf relevance low condition browse leaf id M13487 condition browse leaf name Prostatic Neoplasms condition browse leaf as found Prostatic Cancer condition browse leaf relevance high condition browse leaf id M29368 condition browse leaf name Prostatic Neoplasms, Castration-Resistant condition browse leaf as found Castration-Resistant Prostatic Cancer condition browse leaf relevance high condition browse leaf id M8098 condition browse leaf name Genital Neoplasms, Male condition browse leaf relevance low condition browse leaf id M16467 condition browse leaf name Urogenital Neoplasms condition browse leaf relevance low condition browse leaf id M13485 condition browse leaf name Prostatic Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M250090 intervention browse leaf name Samarium Sm-153 lexidronam intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04833517
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full study rank 61549 study protocol section identification module n c t id NCT04835025 org study id info org study id TJ-IRB20210338 organization org full name Tongji Hospital org class OTHER brief title Radiotherapy Combined With Immunotherapy for Brain Metastases of Non-small Cell Lung Cancer official title A Retrospective, Multicenter Case-control Study of Radiotherapy Combined With Immunotherapy for Brain Metastases of Non-small Cell Lung Cancer status module status verified date April 2021 overall status Suspended why stopped because of COVID-19 expanded access info has expanded access No start date struct start date January 1, 2018 start date type Actual primary completion date struct primary completion date December 31, 2019 primary completion date type Actual completion date struct completion date July 31, 2021 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Tongji Hospital lead sponsor class OTHER collaborator list collaborator collaborator name Wuhan Union Hospital, China collaborator class OTHER collaborator name Wuhan University collaborator class OTHER collaborator name Sun Yat-sen University collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary This is a Retrospective, Multicenter, Controlled Study to Evaluate Immunotherapy and Radiotherpay for Brain Lesions as a Potential Treatment for Patients with Brain Metastasis in non-small cell lung cancer conditions module condition list condition Non Small Cell Lung Cancer design module study type Observational patient registry Yes target duration 2 Years design info design observational model list design observational model Cohort design time perspective list design time perspective Other enrollment info enrollment count 200 enrollment type Anticipated arms interventions module arm group list arm group arm group label Control group (radiotherapy group) arm group description In non-small cell lung cancer, patients with brain metastases received radiotherapy for brain lesion (without limitation of dose and treatment method for radiotherapy) , but not receiving immunotherapy. Those patients would enter the control group. After patients experiencing disease progression(PD) in this group, follow-up treatment does not include immunotherapy until tumor progression again or death. arm group intervention list arm group intervention name Drug: PD-1/PD-L1 inhibitor intervention list intervention intervention type Drug intervention name PD-1/PD-L1 inhibitor intervention description In non-small cell lung cancer, patients with brain metastases received radiotherapy for brain lesions and immunotherapy (including sequential and concurrent model). Those patients would enter the trial group; After patients experiencing PD in this group, follow-up treatment until tumor progression again or death intervention arm group label list intervention arm group label Control group (radiotherapy group) outcomes module primary outcome list primary outcome primary outcome measure progression-free surival primary outcome description Progression-free survival: From the first treatment to the date of first documentation of disease progression, or death due to any cause primary outcome time frame 3 years secondary outcome list secondary outcome secondary outcome measure overall survival secondary outcome description Overall survival: From the first administration to death from any cause secondary outcome time frame 3 years eligibility module eligibility criteria Inclusion Criteria: Experimental group: 18 years old ≤ age ≤ 75 years old, no gender limitation; NSCLC who have received radiotherapy for brain lesions + PD-1/PD-L1 immunotherapy; Histologically confirmed as NSCLC; Imaging confirmed brain metastasis (CT or MRI); The presence of imaging-evaluable lesions can be evaluated in accordance with RECIST 1.1 Control group: 1 18 years old ≤ age ≤ 75 years old, no gender limitation; 2 NSCLC who has received radiotherapy for brain lesions; 3 Histologically confirmed as non-small cell lung cancer; 4 Imaging confirmed brain metastasis (CT or MRI); 5 The presence of imaging-evaluable lesions can be evaluated in accordance with RECIST 1.1 - Exclusion Criteria: 1 The age is less than 18 years old, regardless of gender; 2 Histologically confirmed as NSCLC 3 Imaging confirmed the absence of brain metastases 4 NSCLC with brain metastasis only received chemotherapy or targeted therapy, and did not receive radiotherapy or immunotherapy - healthy volunteers No gender All minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult study population 18 years old ≤ age ≤ 75 years old, no gender limitation; NSCLC who have received radiotherapy for brain lesions ±PD-1/PD-L1 immunotherapy; Histologically confirmed as non-small cell lung cancer; Imaging confirmed brain metastasis (CT or MRI) sampling method Non-Probability Sample contacts locations module location list location location facility Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, Hubei, P. R. China location city Wuhan location state Hubei location zip 430030 location country China references module reference list reference reference p m i d 32008623 reference type result reference citation Bade BC, Dela Cruz CS. Lung Cancer 2020: Epidemiology, Etiology, and Prevention. Clin Chest Med. 2020 Mar;41(1):1-24. doi: 10.1016/j.ccm.2019.10.001. reference p m i d 30955514 reference type result reference citation Nasim F, Sabath BF, Eapen GA. Lung Cancer. Med Clin North Am. 2019 May;103(3):463-473. doi: 10.1016/j.mcna.2018.12.006. reference p m i d 27535388 reference type result reference citation Rodriguez-Canales J, Parra-Cuentas E, Wistuba II. Diagnosis and Molecular Classification of Lung Cancer. Cancer Treat Res. 2016;170:25-46. doi: 10.1007/978-3-319-40389-2_2. reference p m i d 32158220 reference type result reference citation Wang S, Hu C, Xie F, Liu Y. Use of Programmed Death Receptor-1 and/or Programmed Death Ligand 1 Inhibitors for the Treatment of Brain Metastasis of Lung Cancer. Onco Targets Ther. 2020 Jan 23;13:667-683. doi: 10.2147/OTT.S235714. eCollection 2020. reference p m i d 31813004 reference type result reference citation Li W, Yu H. Separating or combining immune checkpoint inhibitors (ICIs) and radiotherapy in the treatment of NSCLC brain metastases. J Cancer Res Clin Oncol. 2020 Jan;146(1):137-152. doi: 10.1007/s00432-019-03094-9. Epub 2019 Dec 7. reference p m i d 29700092 reference type result reference citation Jones GS, Baldwin DR. Recent advances in the management of lung cancer. Clin Med (Lond). 2018 Apr 1;18(Suppl 2):s41-s46. doi: 10.7861/clinmedicine.18-2-s41. reference p m i d 32723363 reference type result reference citation Chen Y, Gao M, Huang Z, Yu J, Meng X. SBRT combined with PD-1/PD-L1 inhibitors in NSCLC treatment: a focus on the mechanisms, advances, and future challenges. J Hematol Oncol. 2020 Jul 28;13(1):105. doi: 10.1186/s13045-020-00940-z. reference p m i d 32926760 reference type result reference citation Qian JM, Martin AM, Martin K, Hammoudeh L, Catalano PJ, Hodi FS, Cagney DN, Haas-Kogan DA, Schoenfeld JD, Aizer AA. Response rate and local recurrence after concurrent immune checkpoint therapy and radiotherapy for non-small cell lung cancer and melanoma brain metastases. Cancer. 2020 Dec 15;126(24):5274-5282. doi: 10.1002/cncr.33196. Epub 2020 Sep 14. reference p m i d 32354698 reference type result reference citation Eguren-Santamaria I, Sanmamed MF, Goldberg SB, Kluger HM, Idoate MA, Lu BY, Corral J, Schalper KA, Herbst RS, Gil-Bazo I. PD-1/PD-L1 Blockers in NSCLC Brain Metastases: Challenging Paradigms and Clinical Practice. Clin Cancer Res. 2020 Aug 15;26(16):4186-4197. doi: 10.1158/1078-0432.CCR-20-0798. Epub 2020 Apr 30. reference p m i d 30853981 reference type result reference citation Protopapa M, Kouloulias V, Nikoloudi S, Papadimitriou C, Gogalis G, Zygogianni A. From Whole-Brain Radiotherapy to Immunotherapy: A Multidisciplinary Approach for Patients with Brain Metastases from NSCLC. J Oncol. 2019 Feb 3;2019:3267409. doi: 10.1155/2019/3267409. eCollection 2019. reference p m i d 30452687 reference type result reference citation Miyamoto S, Nomura R, Sato K, Awano N, Kuse N, Inomata M, Izumo T, Terada Y, Furuhata Y, Bae Y, Kunitoh H. Nivolumab and stereotactic radiation therapy for the treatment of patients with Stage IV non-small-cell lung cancer. Jpn J Clin Oncol. 2019 Feb 1;49(2):160-164. doi: 10.1093/jjco/hyy171. reference p m i d 32682248 reference type result reference citation Vilarino N, Bruna J, Bosch-Barrera J, Valiente M, Nadal E. Immunotherapy in NSCLC patients with brain metastases. Understanding brain tumor microenvironment and dissecting outcomes from immune checkpoint blockade in the clinic. Cancer Treat Rev. 2020 Sep;89:102067. doi: 10.1016/j.ctrv.2020.102067. Epub 2020 Jul 7. reference p m i d 33109224 reference type result reference citation Kowalski ES, Remick JS, Sun K, Alexander GS, Khairnar R, Morse E, Cherng HR, Berg LJ, Poirier Y, Lamichhane N, Becker S, Chen S, Molitoris JK, Kwok Y, Regine WF, Mishra MV. Immune checkpoint inhibition in patients treated with stereotactic radiation for brain metastases. Radiat Oncol. 2020 Oct 27;15(1):245. doi: 10.1186/s13014-020-01644-x. i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000008175 condition mesh term Lung Neoplasms condition mesh id D000002289 condition mesh term Carcinoma, Non-Small-Cell Lung condition mesh id D000001932 condition mesh term Brain Neoplasms condition ancestor list condition ancestor condition ancestor id D000012142 condition ancestor term Respiratory Tract Neoplasms condition ancestor id D000013899 condition ancestor term Thoracic Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition ancestor id D000002283 condition ancestor term Carcinoma, Bronchogenic condition ancestor id D000001984 condition ancestor term Bronchial Neoplasms condition ancestor id D000016543 condition ancestor term Central Nervous System Neoplasms condition ancestor id D000009423 condition ancestor term Nervous System Neoplasms condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M10324 condition browse leaf name Lung Neoplasms condition browse leaf as found Lung Cancer condition browse leaf relevance high condition browse leaf id M4698 condition browse leaf name Carcinoma, Non-Small-Cell Lung condition browse leaf as found Non-Small Cell Lung Cancer condition browse leaf relevance high condition browse leaf id M11459 condition browse leaf name Neoplasm Metastasis condition browse leaf relevance low condition browse leaf id M4686 condition browse leaf name Carcinoma condition browse leaf relevance low condition browse leaf id M4361 condition browse leaf name Brain Neoplasms condition browse leaf as found Brain Metastases condition browse leaf relevance high condition browse leaf id M14131 condition browse leaf name Respiratory Tract Neoplasms condition browse leaf relevance low condition browse leaf id M15810 condition browse leaf name Thoracic Neoplasms condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id M4692 condition browse leaf name Carcinoma, Bronchogenic condition browse leaf relevance low condition browse leaf id M4412 condition browse leaf name Bronchial Neoplasms condition browse leaf relevance low condition browse leaf id M11519 condition browse leaf name Nervous System Neoplasms condition browse leaf relevance low condition browse leaf id M18089 condition browse leaf name Central Nervous System Neoplasms condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000082082 intervention mesh term Immune Checkpoint Inhibitors intervention ancestor list intervention ancestor intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M2343 intervention browse leaf name Immune Checkpoint Inhibitors intervention browse leaf as found Provoked intervention browse leaf relevance high intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04835025
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full study rank 61169 study protocol section identification module n c t id NCT04839965 org study id info org study id AP-017 organization org full name Ampio Pharmaceuticals. Inc. org class INDUSTRY brief title Study of Intravenous Ampion in Adult COVID-19 Patients Requiring Supplemental Oxygen official title A Randomized, Double-Blinded, Placebo Controlled Phase II Study to Evaluate the Safety and Efficacy of IV Ampion in Adult COVID-19 Patients Requiring Oxygen Supplementation status module status verified date March 2022 overall status Terminated why stopped The AP-017 study was prematurely terminated by the sponsor after an interim analysis. start date struct start date July 5, 2021 start date type Actual primary completion date struct primary completion date February 7, 2022 primary completion date type Actual completion date struct completion date April 4, 2022 completion date type Actual study first submit date April 8, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual results first submit date October 17, 2022 results first submit q c date November 9, 2022 results first post date struct results first post date November 30, 2022 results first post date type Actual results first posted q c comments date struct results first posted q c comments date November 9, 2022 results first posted q c comments date type Actual last update submit date November 9, 2022 last update post date struct last update post date November 30, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Ampio Pharmaceuticals. Inc. lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary This is a Phase 2 randomized study to evaluate the safety and efficacy of IV Ampion in improving the clinical course and outcomes of adult COVID-19 patients requiring supplemental oxygen. detailed description Ampion is the low molecular weight filtrate of human serum albumin with the in vitro ability to modulate inflammatory cytokine levels. Ampion has the potential to improve clinical outcomes for COVID-19 patients by reducing inflammatory cytokines correlated with the disease. This study aims to evaluate Ampion and clinical outcomes in patients with COVID-19 requiring supplemental oxygen. conditions module condition list condition COVID-19 design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Investigator enrollment info enrollment count 36 enrollment type Actual arms interventions module arm group list arm group arm group label IV Ampion arm group type Experimental arm group description Ampion administered via intravenous infusion arm group intervention list arm group intervention name Biological: Ampion arm group label IV placebo arm group type Placebo Comparator arm group description Placebo administered via intravenous infusion arm group intervention list arm group intervention name Other: Saline intervention list intervention intervention type Biological intervention name Ampion intervention description Ampion administered via intravenous infusion intervention arm group label list intervention arm group label IV Ampion intervention type Other intervention name Saline intervention description Placebo administered via intravenous infusion intervention arm group label list intervention arm group label IV placebo outcomes module primary outcome list primary outcome primary outcome measure Number of Participants With Occurrence of Mechanical Ventilation or Death primary outcome description Assess the effect of Ampio compared to placebo on prevention of need for mechanical ventilation or death. This is measured as the occurrence of subjects on mechanical ventilation or death by day 28. primary outcome time frame Day 28 secondary outcome list secondary outcome secondary outcome measure The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo secondary outcome description Number of subjects with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of treatment of IV Ampion compared to Placebo. AEs were assessed based on symptoms as a severity rating of mild, moderate, or severe. The relationship between AE and study drug was determined as either unrelated, possibly related, or related. SAEs are defined as resulting death, life threatening, requires prolonged hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. secondary outcome time frame Baseline to Day 60 eligibility module eligibility criteria Inclusion Criteria: Male or female, ≥ 18 years old Diagnosed with COVID-19, as evaluated by laboratory diagnostic test or diagnosis based on radiological clinical findings Baseline severity categorization of severe or critical COVID-19 infection per FDA Guidance for developing drugs and biological products for COVID-19 (February 2021) Severe COVID-19 Symptoms suggestive of severe systemic illness with COVID-19, which include shortness of breath or respiratory distress Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate ≥ 30 per minute, heart rate ≥ 125 per minute, SpO2 ≤ 93% on room air at sea level (SpO2 ≤ 90% at altitude) or PaO2/FiO2 < 300 Critical COVID-19 Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced cannula at flow rates >20 l/min with fraction oxygen ≥ 0.5) or Non-invasive mechanical or endotracheal mechanical ventilation Informed consent obtained from the patient or the patient's legal representative Exclusion Criteria: As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study and/or progression to death is imminent and inevitable irrespective of the provision of treatments. Clinical diagnosis of respiratory failure (therapy not able to be administered in setting of resource limitation) Shock defined by systolic blood pressure <90 mm Hg, or diastolic blood pressure <60 mm Hg or requiring vasopressors. Multi-organ dysfunction/failure Patient has severe chronic obstructive or restrictive pulmonary disease (COPD) (as defined by prior pulmonary function tests), chronic renal failure, or significant liver abnormality (e.g., cirrhosis, transplant, etc.). Patient has chronic conditions requiring chemotherapy or immunosuppressive medication. A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or ingredients in 5% human albumin (N-acetyltryptophan, sodium caprylate). Prolonged QT interval. Patient has known pregnancy or is currently breastfeeding. Patient planning to become pregnant, or father a child, during the treatment and follow-up period and/or is not willing to remain abstinent or use contraception. Participation in another clinical trial (not including treatments for COVID-19 as approved by the FDA through expanded access, emergency, or compassionate use), or participation in a trial such that enrollment in this study would fall within the time frame of the half-life of the other investigational product(s). healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility Ampio Pharmaceuticals location city Englewood location state Colorado location zip 80112 location country United States results section participant flow module flow group list flow group flow group id FG000 flow group title IV Ampion flow group description Ampion administered via intravenous infusion Ampion: 125 mL Ampion administered via intravenous infusion twice daily (250 mL / day) for five days. flow group id FG001 flow group title IV Placebo flow group description Placebo administered via intravenous infusion Saline: 125 mL Placebo administered via intravenous infusion twice daily (250 mL / day) for five days. flow period list flow period flow period title Overall Study flow milestone list flow milestone flow milestone type STARTED flow achievement list flow achievement flow achievement group id FG000 flow achievement num subjects 21 flow achievement group id FG001 flow achievement num subjects 15 flow milestone type COMPLETED flow achievement list flow achievement flow achievement group id FG000 flow achievement num subjects 14 flow achievement group id FG001 flow achievement num subjects 9 flow milestone type NOT COMPLETED flow achievement list flow achievement flow achievement group id FG000 flow achievement num subjects 7 flow achievement group id FG001 flow achievement num subjects 6 flow drop withdraw list flow drop withdraw flow drop withdraw type Death flow reason list flow reason flow reason group id FG000 flow reason num subjects 6 flow reason group id FG001 flow reason num subjects 6 flow drop withdraw type Lost to Follow-up flow reason list flow reason flow reason group id FG000 flow reason num subjects 1 flow reason group id FG001 flow reason num subjects 0 baseline characteristics module baseline group list baseline group baseline group id BG000 baseline group title IV Ampion baseline group description Ampion administered via intravenous infusion Ampion: 125 mL Ampion administered via intravenous infusion twice daily (250 mL / day) for five days. baseline group id BG001 baseline group title IV Placebo baseline group description Placebo administered via intravenous infusion Saline: 125 mL Placebo administered via intravenous infusion twice daily (250 mL / day) for five days. baseline group id BG002 baseline group title Total baseline group description Total of all reporting groups baseline denom list baseline denom baseline denom units Participants baseline denom count list baseline denom count baseline denom count group id BG000 baseline denom count value 21 baseline denom count group id BG001 baseline denom count value 15 baseline denom count group id BG002 baseline denom count value 36 baseline measure list baseline measure baseline measure title Age, Continuous baseline measure param type Mean baseline measure dispersion type Standard Deviation baseline measure unit of measure years baseline class list baseline class baseline category list baseline category baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 56.8 baseline measurement spread 10.0 baseline measurement group id BG001 baseline measurement value 53.4 baseline measurement spread 15.0 baseline measurement group id BG002 baseline measurement value 55.4 baseline measurement spread 12.3 baseline measure title Sex: Female, Male baseline measure param type Count of Participants baseline measure unit of measure Participants baseline class list baseline class baseline category list baseline category baseline category title Female baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 7 baseline measurement group id BG001 baseline measurement value 2 baseline measurement group id BG002 baseline measurement value 9 baseline category title Male baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 14 baseline measurement group id BG001 baseline measurement value 13 baseline measurement group id BG002 baseline measurement value 27 baseline measure title Ethnicity (NIH/OMB) baseline measure param type Count of Participants baseline measure unit of measure Participants baseline class list baseline class baseline category list baseline category baseline category title Hispanic or Latino baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 1 baseline measurement group id BG001 baseline measurement value 3 baseline measurement group id BG002 baseline measurement value 4 baseline category title Not Hispanic or Latino baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 20 baseline measurement group id BG001 baseline measurement value 12 baseline measurement group id BG002 baseline measurement value 32 baseline category title Unknown or Not Reported baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 0 baseline measurement group id BG001 baseline measurement value 0 baseline measurement group id BG002 baseline measurement value 0 baseline measure title Race (NIH/OMB) baseline measure param type Count of Participants baseline measure unit of measure Participants baseline class list baseline class baseline category list baseline category baseline category title American Indian or Alaska Native baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 0 baseline measurement group id BG001 baseline measurement value 0 baseline measurement group id BG002 baseline measurement value 0 baseline category title Asian baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 0 baseline measurement group id BG001 baseline measurement value 0 baseline measurement group id BG002 baseline measurement value 0 baseline category title Native Hawaiian or Other Pacific Islander baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 0 baseline measurement group id BG001 baseline measurement value 0 baseline measurement group id BG002 baseline measurement value 0 baseline category title Black or African American baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 3 baseline measurement group id BG001 baseline measurement value 1 baseline measurement group id BG002 baseline measurement value 4 baseline category title White baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 18 baseline measurement group id BG001 baseline measurement value 14 baseline measurement group id BG002 baseline measurement value 32 baseline category title More than one race baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 0 baseline measurement group id BG001 baseline measurement value 0 baseline measurement group id BG002 baseline measurement value 0 baseline category title Unknown or Not Reported baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 0 baseline measurement group id BG001 baseline measurement value 0 baseline measurement group id BG002 baseline measurement value 0 baseline measure title Region of Enrollment baseline measure param type Number baseline measure unit of measure participants baseline class list baseline class baseline class title United States baseline category list baseline category baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 21 baseline measurement group id BG001 baseline measurement value 15 baseline measurement group id BG002 baseline measurement value 36 baseline measure title Body Mass Index (BMI) baseline measure param type Mean baseline measure dispersion type Standard Deviation baseline measure unit of measure kg/m^2 baseline class list baseline class baseline category list baseline category baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 37.3 baseline measurement spread 13.7 baseline measurement group id BG001 baseline measurement value 31.4 baseline measurement spread 6.8 baseline measurement group id BG002 baseline measurement value 34.9 baseline measurement spread 11.6 outcome measures module outcome measure list outcome measure outcome measure type Primary outcome measure title Number of Participants With Occurrence of Mechanical Ventilation or Death outcome measure description Assess the effect of Ampio compared to placebo on prevention of need for mechanical ventilation or death. This is measured as the occurrence of subjects on mechanical ventilation or death by day 28. outcome measure population description Intent to Treat (ITT) outcome measure reporting status Posted outcome measure param type Count of Participants outcome measure unit of measure Participants outcome measure time frame Day 28 outcome group list outcome group outcome group id OG000 outcome group title IV Ampion outcome group description Ampion administered via intravenous infusion Ampion: 125 mL Ampion administered via intravenous infusion twice daily (250 mL / day) for five days. outcome group id OG001 outcome group title IV Placebo outcome group description Placebo administered via intravenous infusion Saline: 125 mL Placebo administered via intravenous infusion twice daily (250 mL / day) for five days. outcome denom list outcome denom outcome denom units Participants outcome denom count list outcome denom count outcome denom count group id OG000 outcome denom count value 21 outcome denom count group id OG001 outcome denom count value 15 outcome class list outcome class outcome category list outcome category outcome measurement list outcome measurement outcome measurement group id OG000 outcome measurement value 5 outcome measurement group id OG001 outcome measurement value 5 outcome measure type Secondary outcome measure title The Number of Participants With Treatment Emergent Adverse Events of Ampion Compared to Placebo outcome measure description Number of subjects with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of treatment of IV Ampion compared to Placebo. AEs were assessed based on symptoms as a severity rating of mild, moderate, or severe. The relationship between AE and study drug was determined as either unrelated, possibly related, or related. SAEs are defined as resulting death, life threatening, requires prolonged hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. outcome measure population description Intent to Treat (ITT) outcome measure reporting status Posted outcome measure param type Count of Participants outcome measure unit of measure Participants outcome measure time frame Baseline to Day 60 outcome group list outcome group outcome group id OG000 outcome group title IV Ampion outcome group description Ampion administered via intravenous infusion Ampion: 125 mL Ampion administered via intravenous infusion twice daily (250 mL / day) for five days. outcome group id OG001 outcome group title IV Placebo outcome group description Placebo administered via intravenous infusion Saline: 125 mL Placebo administered via intravenous infusion twice daily (250 mL / day) for five days. outcome denom list outcome denom outcome denom units Participants outcome denom count list outcome denom count outcome denom count group id OG000 outcome denom count value 21 outcome denom count group id OG001 outcome denom count value 15 outcome class list outcome class outcome class title Treatment Emergent Adverse Events (TEAE's) outcome category list outcome category outcome measurement list outcome measurement outcome measurement group id OG000 outcome measurement value 15 outcome measurement group id OG001 outcome measurement value 12 outcome class title Study Drug Related TEAE's outcome category list outcome category outcome measurement list outcome measurement outcome measurement group id OG000 outcome measurement value 0 outcome measurement group id OG001 outcome measurement value 3 outcome class title Moderate or Severe TEAE's outcome category list outcome category outcome measurement list outcome measurement outcome measurement group id OG000 outcome measurement value 12 outcome measurement group id OG001 outcome measurement value 8 outcome class title Serious Adverse Events outcome category list outcome category outcome measurement list outcome measurement outcome measurement group id OG000 outcome measurement value 11 outcome measurement group id OG001 outcome measurement value 8 adverse events module events frequency threshold 0 events time frame 60 days events description Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. event group list event group event group id EG000 event group title IV Ampion event group description Ampion administered via intravenous infusion Ampion: 125 mL Ampion administered via intravenous infusion twice daily (250 mL / day) for five days. event group deaths num affected 6 event group deaths num at risk 21 event group serious num affected 11 event group serious num at risk 21 event group other num affected 15 event group other num at risk 21 event group id EG001 event group title IV Placebo event group description Placebo administered via intravenous infusion Saline: 125 mL Placebo administered via intravenous infusion twice daily (250 mL / day) for five days. event group deaths num affected 6 event group deaths num at risk 15 event group serious num affected 8 event group serious num at risk 15 event group other num affected 12 event group other num at risk 15 serious event list serious event serious event term Atrial Fibrillation serious event organ system Cardiac disorders serious event source vocabulary MedDRA (24.1) serious event assessment type Non-systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 0 serious event stats num affected 0 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 15 serious event term Cardiac Arrest serious event organ system Cardiac disorders serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 0 serious event stats num affected 0 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 4 serious event stats num affected 4 serious event stats num at risk 15 serious event term Cardio Respiratory Arrest serious event organ system Cardiac disorders serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 0 serious event stats num affected 0 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 15 serious event term Myocardial Infarction serious event organ system Cardiac disorders serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 0 serious event stats num affected 0 serious event stats num at risk 15 serious event term Ventricular Tachycardia serious event organ system Cardiac disorders serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 0 serious event stats num affected 0 serious event stats num at risk 15 serious event term Organ Failure serious event organ system General disorders serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 0 serious event stats num affected 0 serious event stats num at risk 15 serious event term Bacteraemia serious event organ system Infections and infestations serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 0 serious event stats num affected 0 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 15 serious event term COVID-19 Pneumonia serious event organ system Infections and infestations serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 0 serious event stats num affected 0 serious event stats num at risk 15 serious event term Perirectal Abscess serious event organ system Infections and infestations serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 0 serious event stats num affected 0 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 15 serious event term Pneumonia Bacterial serious event organ system Infections and infestations serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 0 serious event stats num affected 0 serious event stats num at risk 15 serious event term Septic Shock serious event organ system Infections and infestations serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 2 serious event stats num affected 2 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 3 serious event stats num affected 3 serious event stats num at risk 15 serious event term Acute Kidney Injury serious event organ system Renal and urinary disorders serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 0 serious event stats num affected 0 serious event stats num at risk 15 serious event term Renal Failure serious event organ system Renal and urinary disorders serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 0 serious event stats num affected 0 serious event stats num at risk 15 serious event term Renal Impairment serious event organ system Renal and urinary disorders serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 0 serious event stats num affected 0 serious event stats num at risk 15 serious event term Acute Respiratory Distress Syndrome serious event organ system Respiratory, thoracic and mediastinal disorders serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 0 serious event stats num affected 0 serious event stats num at risk 15 serious event term Acute Respiratory Failure serious event organ system Respiratory, thoracic and mediastinal disorders serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 6 serious event stats num affected 6 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 3 serious event stats num affected 3 serious event stats num at risk 15 serious event term Aspiration serious event organ system Respiratory, thoracic and mediastinal disorders serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 0 serious event stats num affected 0 serious event stats num at risk 15 serious event term Pneumothorax Spontaneous serious event organ system Respiratory, thoracic and mediastinal disorders serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 15 serious event term Pulmonary Embolism serious event organ system Respiratory, thoracic and mediastinal disorders serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 0 serious event stats num affected 0 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 15 serious event term Respiratory Failure serious event organ system Respiratory, thoracic and mediastinal disorders serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 3 serious event stats num affected 3 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 15 serious event term Hypotension serious event organ system Vascular disorders serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 0 serious event stats num affected 0 serious event stats num at risk 15 serious event term Shock serious event organ system Vascular disorders serious event source vocabulary MedDRA (24.1) serious event assessment type Systematic Assessment serious event stats list serious event stats serious event stats group id EG000 serious event stats num events 1 serious event stats num affected 1 serious event stats num at risk 21 serious event stats group id EG001 serious event stats num events 0 serious event stats num affected 0 serious event stats num at risk 15 other event list other event other event term Anaemia other event organ system Blood and lymphatic system disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 3 other event stats num affected 3 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Bandaemia other event organ system Blood and lymphatic system disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Leukocytosis other event organ system Blood and lymphatic system disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 5 other event stats num affected 5 other event stats num at risk 21 other event stats group id EG001 other event stats num events 2 other event stats num affected 2 other event stats num at risk 15 other event term Thrombocytopenia other event organ system Blood and lymphatic system disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Bradycardia other event organ system Cardiac disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 2 other event stats num affected 2 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Tachycardia other event organ system Cardiac disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Deafness Bilateral other event organ system Ear and labyrinth disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 0 other event stats num affected 0 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Ear Pain other event organ system Ear and labyrinth disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Dry Eye other event organ system Eye disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Abdominal Pain other event organ system Gastrointestinal disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Constipation other event organ system Gastrointestinal disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 2 other event stats num affected 2 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Diarrhoea other event organ system Gastrointestinal disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 2 other event stats num affected 2 other event stats num at risk 15 other event term Dyspepsia other event organ system Gastrointestinal disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 0 other event stats num affected 0 other event stats num at risk 21 other event stats group id EG001 other event stats num events 2 other event stats num affected 2 other event stats num at risk 15 other event term Flatulence other event organ system Gastrointestinal disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Frequent Bowel Movements other event organ system Gastrointestinal disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Gastrointestinal Haemorrhage other event organ system Gastrointestinal disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Feeling Abnormal other event organ system General disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 0 other event stats num affected 0 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Feeling Hot other event organ system General disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Hypothermia other event organ system General disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Infusion Site Coldness other event organ system General disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 0 other event stats num affected 0 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Oedema other event organ system General disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Oedema Peripheral other event organ system General disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Pyrexia other event organ system General disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 3 other event stats num affected 3 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Systemic Inflammatory Response Syndrom other event organ system General disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Oral Candidiasis other event organ system Infections and infestations other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Pneumonia other event organ system Infections and infestations other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 0 other event stats num affected 0 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Pneumonia Bacterial other event organ system Infections and infestations other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Pneumonia Serratia other event organ system Infections and infestations other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Respiratory Tract Infection Bacterial other event organ system Infections and infestations other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Urinary Tract Infection other event organ system Infections and infestations other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Infusion Related Reactions other event organ system Injury, poisoning and procedural complications other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 0 other event stats num affected 0 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Blood Creatine Increased other event organ system Investigations other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 0 other event stats num affected 0 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Cardiac Murmur other event organ system Investigations other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Fibrin D Dimer Increased other event organ system Investigations other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 0 other event stats num affected 0 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Platelet Count Decreased other event organ system Investigations other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Transaminases Increased other event organ system Investigations other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 2 other event stats num affected 2 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Weight Decreased other event organ system Investigations other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term White Blood Cell Count Decreased other event organ system Investigations other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Acidosis other event organ system Metabolism and nutrition disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Alkalosis Hypochloraemic other event organ system Metabolism and nutrition disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Hyperglycemia other event organ system Metabolism and nutrition disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 2 other event stats num affected 2 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Hyperkalaemia other event organ system Metabolism and nutrition disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 3 other event stats num affected 3 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Hypermagnesaemia other event organ system Metabolism and nutrition disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Hypernatraemia other event organ system Metabolism and nutrition disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 3 other event stats num affected 3 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Hyperphosphataemia other event organ system Metabolism and nutrition disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Hypocalcaemia other event organ system Metabolism and nutrition disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 0 other event stats num affected 0 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Hypoglycaemia other event organ system Metabolism and nutrition disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Hypokalaemia other event organ system Metabolism and nutrition disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 2 other event stats num affected 2 other event stats num at risk 21 other event stats group id EG001 other event stats num events 2 other event stats num affected 2 other event stats num at risk 15 other event term Hyponatraemia other event organ system Metabolism and nutrition disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 2 other event stats num affected 2 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Malnutrition other event organ system Metabolism and nutrition disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Type 2 Diabetes Mellitus other event organ system Metabolism and nutrition disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Back Pain other event organ system Musculoskeletal and connective tissue disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Pain in Extremity other event organ system Musculoskeletal and connective tissue disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 0 other event stats num affected 0 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Amnesia other event organ system Nervous system disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Balance Disorder other event organ system Nervous system disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Dizziness other event organ system Nervous system disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Dizziness Exertional other event organ system Nervous system disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 0 other event stats num affected 0 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Encephalopathy other event organ system Nervous system disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Headache other event organ system Nervous system disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 0 other event stats num affected 0 other event stats num at risk 21 other event stats group id EG001 other event stats num events 2 other event stats num affected 2 other event stats num at risk 15 other event term Intensive Care Unit Acquired Weakness other event organ system Nervous system disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Intercranial Pressure Increased other event organ system Nervous system disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 0 other event stats num affected 0 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Paraesthesia other event organ system Nervous system disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 0 other event stats num affected 0 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Toxic Encephalopathy other event organ system Nervous system disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Anxiety other event organ system Psychiatric disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 4 other event stats num affected 4 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Libido Decreased other event organ system Psychiatric disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Acute Renal Injury other event organ system Renal and urinary disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 2 other event stats num affected 2 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Urinary Retention other event organ system Renal and urinary disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Breast Mass other event organ system Reproductive system and breast disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Genital Lesion other event organ system Reproductive system and breast disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Nasal Congestion other event organ system Respiratory, thoracic and mediastinal disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Paranasal Sinus Hypersecretion other event organ system Respiratory, thoracic and mediastinal disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Pneumomediastinum other event organ system Respiratory, thoracic and mediastinal disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Pneumothorax other event organ system Respiratory, thoracic and mediastinal disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Pneumothorax Spontaneous other event organ system Respiratory, thoracic and mediastinal disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Productive Cough other event organ system Respiratory, thoracic and mediastinal disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Decubitus Ulcer other event organ system Skin and subcutaneous tissue disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Rash other event organ system Skin and subcutaneous tissue disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 0 other event stats num affected 0 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Deep Vein Thrombosis other event organ system Vascular disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 0 other event stats num affected 0 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Embolism Venous other event organ system Vascular disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 0 other event stats num affected 0 other event stats num at risk 21 other event stats group id EG001 other event stats num events 1 other event stats num affected 1 other event stats num at risk 15 other event term Flushing other event organ system Vascular disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 1 other event stats num affected 1 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 other event term Hypertension other event organ system Vascular disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 0 other event stats num affected 0 other event stats num at risk 21 other event stats group id EG001 other event stats num events 2 other event stats num affected 2 other event stats num at risk 15 other event term Hypotension other event organ system Vascular disorders other event source vocabulary MedDRA (24.1) other event assessment type Systematic Assessment other event stats list other event stats other event stats group id EG000 other event stats num events 2 other event stats num affected 2 other event stats num at risk 21 other event stats group id EG001 other event stats num events 0 other event stats num affected 0 other event stats num at risk 15 more info module certain agreement agreement p i sponsor employee No agreement restrictive agreement Yes point of contact point of contact title Dr. Howard Levy / Chief Medical Officer point of contact organization Ampio Pharmaceuticals point of contact e mail clinicaltrials@ampiopharma.com point of contact phone 17204376500 document section large document module large doc list large doc large doc type abbrev Prot large doc has protocol Yes large doc has s a p No large doc has i c f No large doc label Study Protocol large doc date January 21, 2022 large doc upload date 08/10/2022 10:01 large doc filename Prot_000.pdf large doc type abbrev SAP large doc has protocol No large doc has s a p Yes large doc has i c f No large doc label Statistical Analysis Plan large doc date February 11, 2022 large doc upload date 08/10/2022 11:26 large doc filename SAP_001.pdf derived section misc info module version holder December 02, 2022 submission tracking condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology
NCT04839965
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full study rank 61580 study protocol section identification module n c t id NCT04834622 org study id info org study id 219425/Z/19/Z-PND secondary id info list secondary id info secondary id 278445 secondary id type Other Identifier secondary id domain Health Research Authority organization org full name King's College London org class OTHER brief title Community Singing Interventions for Postnatal Depression: a Hybrid Type II Effectiveness-implementation Trial official title Community Singing Interventions for Postnatal Depression: a Hybrid Type II Effectiveness-implementation Trial acronym SHAPER-PND status module status verified date August 2020 overall status Not yet recruiting expanded access info has expanded access No start date struct start date September 2021 start date type Anticipated primary completion date struct primary completion date December 2023 primary completion date type Anticipated completion date struct completion date December 2023 completion date type Anticipated study first submit date May 26, 2020 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 15, 2021 last update post date struct last update post date July 22, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name King's College London lead sponsor class OTHER collaborator list collaborator collaborator name University College, London collaborator class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Postnatal depression (PND) affects over 13% of new mothers but there is still not an ideal treatment for all cases. Pharmaceutical and psychotherapy have offered solutions but there are challenges in treatment uptake and adherence and long waiting-lists for psychotherapy. Many mothers attend group activities with their babies, some including music and singing. Community group singing has shown improvement in mental health and singing to babies has shown improvement in mother-infant interaction and reduced infant distress. In this realm, Melodies for Mums (M4M) is a programme based in Lambeth and Southwark providing 10-week singing and music sessions for mothers with postnatal depression (PND) and their babies in community Children's Centres or online, according to government social distancing guidelines. Studies have demonstrated its effectiveness in reducing symptoms of PND faster than usual care or social groups, and preliminary process evaluations have suggested its suitability. It has also been identified as a strong way of engaging mothers from minority backgrounds who are less likely to seek professional support for their mental health. However, the programme is reliant on short-term grants and has not been implemented in clinical care. Therefore, there is a clear need to invest more research into this programme to help it achieve its potential. The investigators aim to conduct M4M in a clinical trial aimed at women experiencing symptoms of postnatal depression in the boroughs of Southwark, Lambeth and Lewisham. The investigators will collect data on the wellbeing of the women through a series of interviews and questionnaires and the investigators will also collect biological samples for stress and immunity markers from mothers and babies. In the long term the investigators intend to establish defined clinical referral pathways for patients from primary (GPs, community, among others) and secondary care (specialist doctor, hospital clinic) settings. In addition, the investigators will collect further evidence of the clinical, implementation and economic effectiveness of the intervention. detailed description Postnatal depression (PND) affects at least 12-15% of new mothers, with symptoms including fatigue, anhedonia, insomnia and irritability. However, challenges surround the fact that there is still no complete treatment solution. Although pharmacological treatment has had positive results, these are hampered by low uptake and adherence amongst mothers, while psychotherapy has produced mixed results and has similar challenges around low uptake or delayed treatment. However, many mothers engage in community group activities with their babies, such as attending mother-infant play groups. Such activities have been identified as ways of relaxing mothers, providing good sources of social interaction, decreasing the monotony of each day and also providing a sense of personal fulfillment for mothers. There is also a growing body of evidence demonstrating the effects of community group singing on mental health. Singing to new babies is practised in cultures around the world, and research has demonstrated valuable benefits such as improving mother-infant interaction and reducing distress in babies. Listening to music during pregnancy is also associated with higher levels of wellbeing and reduced symptoms of PND in the first 3 months post-birth, while daily singing to babies is associated with fewer symptoms of PND and higher levels of wellbeing, self-esteem and perceived mother-infant bond. Consequently, there is a strong theoretical background to why singing could support mothers with PND. While small studies have supported the efficacy of this intervention, the present large scale study is needed to measure effectiveness and promote the uptake within the NHS, as well as in order to fully understand the mechanisms underpinning its efficacy. Trial design and aims: These sessions/activities will be delivered for 10-weeks and the women will be followed up at 20- and 36-weeks post randomisation. On week 0 (before the start of the study), 6, 10, 20 and 36 women will either be visited by members of the KCL research team (to be assessed given questionnaires and provide samples) or will complete online questionnaires (see table of measures). The end of the trial for a participant will be after the 36-week follow up, or withdrawal. This is a multi-centre trial that will be run in locations across London (primarily in the boroughs of Lewisham, Lambeth and Southwark), specifically in children's or community venues. These venues will be thoroughly safety- and risk-assessed in light of COVID-19 and adherence to any COVID-secure measures will be closely monitored by Breathe. In the event that one or several women need to self-isolate due to confirmed or suspected exposure to COVID-19, the sessions will be delivered to her/them online via Zoom. This will allow for the sessions to still be conducted in person with the remaining women. In order to enrol a sufficiently large sample of women, there will be 12 blocks of the 10-week singing programme in total: 10 intervention blocks will be for the experimental group, and 2 blocks will be for women in the wait-list control group that wish to take part in the singing sessions. The 2 wait-list blocks will be offered singing sessions after a woman has completed the first 10 weeks of the study and no data will be collected regarding these singing sessions, apart from the control follow-up data that this group is expected to provide. In the event that one or several women need to self-isolate due to confirmed or suspected exposure to COVID-19, the sessions will be delivered to her/them online via Zoom. This will allow for the sessions to still be conducted in person with the remaining women. In the event of the artist or the Breathe officer having to self-isolate, a replacement Breathe-trained artist will be ready to step-in and deliver the sessions. The same will apply to Breathe staff; there will be another staff member available to be present at the sessions. The aims are to explore the clinical effectiveness of the intervention in a larger sample size than previous studies for scalability (to ascertain whether the initial findings can be replicated at a larger scale) and to explore the implementation effectiveness of the intervention, including its uptake, suitability, acceptability, appropriateness and feasibility (to identify not just 'if' but also 'why' the intervention works and support our understanding). It will also explore the cost effectiveness of the intervention, including the cost of delivering the interventions and the balance of benefit for the health sector, in order to be able to develop strong business plan for the intervention. Participants and Recruitment process: This study aims to recruit 400 women (and their babies) that meet criteria on the Structured Clinical Interview for DSM-IV Disorders (SCID) for major depressive disorder and score equal to or above 10 on the Edinburgh Postnatal Depression Scale (EPDS). Participants will be recruited through clinic and the community (including study advertisement on social media, patient groups and self-referral). In order to recruit a sufficient number of women for this study in the current pandemic, most of the signposting will be done through GPs, midwives, health visitors and community mental health teams that remain engaged with the population despite the pandemic. In addition, signposting via social media, especially targeted advertising in local women's groups will be another valuable route for recruitment. The women will be explained the trial, given the PIS and ICF and if consented, will be randomised (2:1) to an intervention group (M4M singing sessions) or a control group (other community-based mother and baby activities). This group will be involved in the clinical and the implementation effectiveness of the study. In addition, circa 30-50 wider stakeholders involved in the intervention will be recruited by research staff. This group includes artists, psychiatrists, GPs, health visitors, commissioners and others involved in the delivery of the intervention. The wider stakeholders and mothers involved in implementation science research will be provided with a specific ICF and a PIS. Measures collected: Measures will be collected from both the intervention and control groups. Participants will be visited at their homes (or online via Zoom if necessary) for baseline/week 0 and week 10 assessments. Week 6, 20 and 36 visits will be completed online due to the self-reporting nature of the measures to be captured. If a mother cannot access a computer/laptop to complete the online questionnaires, these will be printed and posted to them. In order to allow for flexibility in the schedule, a +/-1 week variation in the date of collection of the measures below (apart from week 10, when the window will be weeks 10-12) will be accepted. These measures will be collected from the control and the intervention groups simultaneously. The following measures will be collected: Week 0 (screening/baseline): baseline demographics, repeated demographics, Brief Life Events Scale, Child Experience of Care and Abuse (CECA-Q), Composite Abuse Scale (CAS) - Pregnancy Version, Intrusive Life Events Scale; Structured Clinical Interview for DSM-IV (SCID), Edinburgh Postnatal Depression Scale (EPDS), Hamilton Depression Rating Scale (HDRS), Beck Depression Inventory (BDI), Office for National Statistics Wellbeing Scale (ONS), State Trait Anxiety Inventory (STAI), Perceived Stress Scale (PSS); CARE-index, Maternal Postpartum Attachment Scale (MPAS), Parent Reflective Functioning Questionnaire (PRFQ), UCLA Loneliness Scale, Short General Self-Efficacy Scale (G, SE-6), Multidimensional Scale of Perceived Social Support (MSPSS); Diurnal saliva samples in mothers and babies. Week 1: Pre-post session saliva samples in mothers and babies. Week 6: Repeated demographics, EPDS, BDI, ONS, STAI, PSS, MPAS, UCLA Loneliness Scale, GSE-6, MSPSS, Pre-post session saliva samples in mothers and babies. Week 10: Repeated demographics, EPDS, HRDS, BDI, ONS, STAI, PSS, CARE-Index, MPAS, PRFQ, UCLA Loneliness Scale, GSE-6, MSPSS, Pre-post session saliva samples in mothers and babies, Diurnal saliva samples in mothers and babies, Hair cortisol sample, focus groups (qualitative research). Week 20: Repeated demographics, EPDS, BDI, ONS, STAI, PSS, MPAS, UCLA Loneliness Scale, GSE-6, MSPSS. Week 36: Repeated demographics, EPDS, BDI, ONS, STAI, PSS, CARE-Index, MPAS, PRFQ, UCLA Loneliness Scale, GSE-6, MSPSS. Collection, transportation and storage of samples: Pre-post session saliva samples collected at sessions from mothers and babies will be retrieved using passive drooling (mothers) or salivettes (babies) and transported by one of the researchers in the team and used for cortisol, oxytocin, cytokines and other stress hormones analysis. The samples will be kept on ice and brought to the Maurice Wohl Clinical Neuroscience Institute (King's College London, Denmark Hill) to be stored at -80 degree C until analysis. Six saliva samples from mothers (and two samples from their baby, providing consent) will be collected by mothers at home at awakening, +15, +30+ and +60 min after awakening, at 12 noon and 8 pm, and used for diurnal cortisol and other stress hormones. They will be kept in the fridge at home, and then posted or transported to the Maurice Wohl Clinical Neuroscience Institute (King's College London, Denmark Hill), to be stored at -20⁰C until analysis. Hair samples will be kept at room temperature for short-term storage but will be transferred to -20⁰C for longer-term storage, until analysis (cortisol and other stress hormones) is conducted. Samples will be processed, analysed and remaining material will be kept for 10 years after completion of the study. Results will be identified according to anonymised codes and stored securely. Follow-up: Follow-up will be done at weeks 20 and 36, using the questionnaires mentioned above. Participants' wellbeing will be monitored through the questionnaires and any issues will be flagged by the KCL or UCL team or by Breathe that will do onward reporting if needed. No samples will be collected at follow-up. Wider stakeholders: a series of questionnaires/interviews will be performed to collect implementation science data only. conditions module condition list condition Postnatal Depression design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Outcomes Assessor enrollment info enrollment count 400 enrollment type Anticipated arms interventions module arm group list arm group arm group label Melodies for Mums arm group type Experimental arm group description Mothers will start a block of 10-week classes and continue with their group for the duration of the course. Classes will take place in Children's Centres (or online). Mothers will attend with their babies and will sit in a socially-distanced circle on the floor surrounded by soft play cushions and mats. Classes will start with welcome songs, introducing everyone to one another, and involve a range of singing and music activities. Mothers will be required to respect social distancing guidelines. Music activities will include learning songs from around the world and will be accompanied by instruments that the mothers and babies can play together. Instruments will not be shared and will be disinfected before and after the singing sessions. Mothers will also work to write some of their own songs over the weeks. Recordings of the group singing the songs together will be made for the mothers to listen to at home. Classes will be led by professional workshop leaders trained by Breathe. arm group intervention list arm group intervention name Behavioral: Melodies for Mums arm group label Control (mother-baby community sessions) arm group type Active Comparator arm group description Our control group will be a 'active' control. During the first 10 weeks (during the study period), mothers in the control group will receive details of other non-music classes available to them in the community (or online if necessary, depending on the programs available at the time and government guidelines) and will receive the same schedule of texts and phone calls to encourage them to join these activities. They will still be seen by the researchers to collect clinical measures and biological samples (including the pre-post saliva samples) and to monitor engagement in other activities. Following the first 10 weeks, the mothers in the control group will be offered a place on the singing programme, but these data will not be part of the study, and they will not join groups with women who are in the study arm group intervention list arm group intervention name Behavioral: Control Community Sessions intervention list intervention intervention type Behavioral intervention name Melodies for Mums intervention description Melodies for Mums (M4M) is an intervention that was developed and tested as part of a collaboration between the Royal College of Music, Imperial College London and University College London from 2015-2017. The programme involved weekly singing classes for mothers and their babies delivered in groups of 8-12 in Children's Centres for 10 weeks. A trained artist delivers 1-hour long singing sessions to mothers with postnatal depression (and their babies) for a period of 10-weeks. The sessions are aimed at the mothers, with songs ranging from sound baths to folk songs and songs created by the mothers themselves. Mothers randomised to the intervention will be prompted via text message, each week before the session, to attend these singing sessions. intervention arm group label list intervention arm group label Melodies for Mums intervention type Behavioral intervention name Control Community Sessions intervention description Group mother-baby interventions in the community (i.e. baby play, baby reading sessions, baby massage, etc). A list of these activities will be collected from the activities on offer in the community. All the mothers randomised to the control group will be pointed towards these activities, prompted by text messages in line with the prompts received by the mothers in the intervention group. Mothers will be encouraged to attend these non-music based community activities once a week with their babies. intervention arm group label list intervention arm group label Control (mother-baby community sessions) outcomes module primary outcome list primary outcome primary outcome measure To assess the effectiveness of group singing interventions on symptoms of postnatal depression using the Edinburgh Postnatal Depression Scale (EPDS) primary outcome description To assess the effectiveness of group singing interventions on symptoms of postnatal depression using the Edinburgh Postnatal Depression Scale (EPDS) The EPDS was developed to assist health professionals in detecting mothers suffering from Postnatal depression. The scale consists of 10 short statements. A mother checks off one of four possible answers that is closest to how she has felt during the past week. The EPDS is measured on a scale of 0-30, where a higher score indicates more severe depression. Mothers scoring above 12 or 13 are likely to be suffering from depression. primary outcome time frame The primary outcome measure is change in EPDS total score between baseline and Week 10 (end of treatment). primary outcome measure To assess the acceptability of the intervention using the Acceptability of Intervention Measure (AIM) primary outcome description To assess the acceptability of the singing intervention, using the Acceptability of Intervention Measure (AIM). A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. primary outcome time frame The primary outcome implementation measure is acceptability collected at week 10 (end of treatment). secondary outcome list secondary outcome secondary outcome measure To assess whether singing improves (changes) further aspects of mental health, including depression using the Hamilton Depression Rating Scale (HDRS). secondary outcome description To assess whether singing improves (changes) further aspects of mental health, including depression, using: Hamilton Depression Rating Scale (HDRS): is a semi-structured clinician-administered depression assessment scale. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale. secondary outcome time frame Compare change between baseline and weeks 6, 10, 20 and 36. secondary outcome measure To assess whether singing improves (changes) further aspects of mental health, including depression using the Beck Depression Inventory (BDI). secondary outcome description To assess whether singing improves (changes) further aspects of mental health, including depression, using: Beck Depression Inventory (BDI): is a 21-item, self-rated scale that evaluates key symptoms of depression. Each item is rated 0-3, whereby a higher score indicates more severe depression. 1-10 is considered normal; 11-16 is mild mood disturbance; 17-20 is borderline clinical depression; 21-30 is moderate depression; 31-40 is severe depression; 40 and above is extreme depression. secondary outcome time frame Compare change between baseline and weeks 6, 10, 20 and 36. secondary outcome measure To assess whether singing improves (changes) further aspects of mental health, including stress using the Perceived Stress Scale (PSS) secondary outcome description To assess whether singing improves (changes) further aspects of mental health, including stress. Stress will be evaluated using the following scale: Perceived Stress Scale (PSS): is an 11-item questionnaire assessing one's perceived stress levels. Each question must be answered on a likert scale, ranging from 'never' (0) to 'very often', (5), whereby a higher score indicates greater stress. secondary outcome time frame Compare change between baseline and weeks 6, 10, 20 and 36. secondary outcome measure To assess whether singing improves (changes) further aspects of mental health, including wellbeing using the Office for National Statistics Wellbeing Scale (ONS): secondary outcome description Wellbeing will be evaluated using the following scale: Office for National Statistics Wellbeing Scale (ONS): is a four-item questionnaire assessing life satisfaction, worthwhile, happiness, and anxiety. People are asked to respond to the questions on a scale from 0 to 10 where for life satisfaction/worthwhile/happiness a higher score indicates greater wellbeing, and for anxiety a greater score indicates greater anxiety. secondary outcome time frame Compare change between baseline and weeks 6, 10, 20 and 36. secondary outcome measure To assess whether singing improves (changes) further aspects of mental health, including anxiety, using the State-Trait Anxiety Scale (STAI) secondary outcome description Anxiety will be evaluated using the following scale: State-Trait Anxiety Scale (STAI): is a self-rated questionnaire which assesses intensity or frequency of anxiety. It is divided into two sections, one measuring 'state' and the other 'trait' of anxiety. The range of possible scores for each section is 20 to 80, whereby a higher score indicates greater anxiety. A cut-off score of at least 40 has been considered to be clinically meaningful. secondary outcome time frame Compare change between baseline and weeks 6, 10, 20 and 36. secondary outcome measure To ascertain whether singing improves the observed mother-infant interaction using the Crittenden CARE-Index (CCI) secondary outcome description To assess whether the singing intervention improves upon aspects of the mother-infant relationship. The observed mother-infant interaction will be assessed using: Crittenden CARE-Index (CCI): The CCI is a validated tool to clinically assess the mother-infant interaction. Videos are filmed of a mother and her baby playing, and are rated from 0-14 for aspects of maternal behaviour, aspects of infant behaviour, and dyadic synchrony, whereby a higher score indicates greater amounts of that behaviour present. secondary outcome time frame Compare change between baseline and weeks 10 and 36. secondary outcome measure To ascertain whether singing improves the perceived mother-infant relationship using the Maternal Postpartum Attachment Scale (MPAS) secondary outcome description To assess whether the singing intervention improves upon aspects of the mother-infant relationship. The perceived mother-infant relationship will be assessed using: Maternal Postpartum Attachment Scale (MPAS): The MPAS is a 19-item questionnaire assessing maternal feelings of attachment and bonding towards her baby. Items are rated from 1 to 5, whereby a lower score indicates less bonding/attachment with her baby. secondary outcome time frame Compare change between baseline and weeks 6, 10, 20 and 36. secondary outcome measure To ascertain whether singing improves the perceived mother-infant relationship using the Parent Reflective Functioning Questionnaire (PRFQ) secondary outcome description To assess whether the singing intervention improves upon aspects of the mother-infant relationship. The perceived mother-infant relationship will be assessed using: Parent Reflective Functioning Questionnaire (PRFQ): The PRFQ is an 18-item questionnaire that asks mothers to reflect on their relationship with their infant and how attuned they perceive themselves to be. It assesses a caregiver's capability to reflect upon her own internal mental experiences as well as those of the baby. Each item is rated on a likert scale from 1 (strongly disagree) to 7 (strongly agree) with a total possible score ranging from 18-126. secondary outcome time frame Compare change between baseline and weeks 6, 10, 20 and 36. secondary outcome measure To ascertain whether singing improves social support and reduces loneliness using the UCLA Loneliness Scale secondary outcome description To assess whether the singing intervention improves aspects of loneliness and perceived support. UCLA Loneliness Scale: is a 20-item questionnaire that assesses one's perceived sense of loneliness. Questions address relationships and loneliness. Items are rated as 'often,' 'sometimes,' 'rarely,' or 'never.' Scores can range from 20-80, whereby a higher score indicates a greater sense of loneliness. secondary outcome time frame Compare change between baseline and weeks 6, 10, 20 and 36. secondary outcome measure To ascertain whether singing improves social support and reduces loneliness using the Multidimensional Scale of Perceived Social Support (MSPSS) secondary outcome description To assess whether the singing intervention improves aspects of loneliness and perceived support. Multidimensional Scale of Perceived Social Support (MSPSS): is a 12-item questionnaire that assesses perceived support (practical and emotional) from peers, family, and friends. Each item is rated from 1 (very strongly disagree) to 7 (very strongly agree) and is scored from 12-84, where a higher score indicates a greater sense of perceived social support. secondary outcome time frame Compare change between baseline and weeks 6, 10, 20 and 36. secondary outcome measure To identify whether there are biological mechanisms underpinning the psychological outcomes assessed using changes in measurements in stress hormones, including hair cortisol, diurnal cortisol and salivary cytokines secondary outcome description Stress hormones, including hair cortisol, diurnal cortisol and salivary cytokines. These measures will be analysed using an array of techniques including enzyme-linked immunosorbent assay (ELISA). Higher levels of cortisol and cytokines may indicate higher levels of stress. secondary outcome time frame Compare change between week 1 and weeks 6 and 10. secondary outcome measure To identify whether there are biological mechanisms underpinning the psychological outcomes assessed using changes in measurements in salivary oxytocin secondary outcome description Levels of salivary oxytocin measured. These measures will be analysed using an array of techniques including enzyme-linked immunosorbent assay (ELISA). Higher levels of oxytocin may indicate positive interactions between mothers and babies. secondary outcome time frame Compare change between week 1 and weeks 6 and 10. secondary outcome measure To identify how the singing sessions affect the lived experience of mothers with PND using focus groups secondary outcome description Focus groups: focus groups will take place immediately following session 10 (if logistically possible) for all mothers focusing on their lived experience of the intervention and their reported mechanisms of effect secondary outcome time frame Qualitative data collection at week 10 (end of intervention). secondary outcome measure To explore the phenomenology of PND and how singing intersects with PND among women with particular risk factors for PND (traumatic birth, adverse childhood experiences, and social isolation/loneliness) using semi-structured interviews secondary outcome description Semi structured interviews: individual or small-group interviews with three sub-groups of women self-reporting particular risk factors for PND: traumatic birth, adverse childhood experiences, and social isolation/loneliness. These interviews will focus in-depth on the phenomenology of PND and how singing intersects with the specific context of PND among the sub-groups. secondary outcome time frame Qualitative data collection at week 10 (end of intervention). secondary outcome measure To assess the acceptability of the intervention using the Intervention Measure (AIM) secondary outcome description Total score of the acceptability of Intervention Measure (AIM). A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). secondary outcome time frame Quantitative data collection at week 10 (end of intervention). secondary outcome measure To assess reasons for perceived acceptability of the intervention using semi-structured interviews secondary outcome description Semi-structured interviews secondary outcome time frame Qualitative data collection at week 10 (end of intervention). secondary outcome measure To assess uptake/reach of the intervention using recruitment rate records secondary outcome description Number of eligible women that sign up to the intervention secondary outcome time frame Quantitative data collection at week 10 (end of intervention). secondary outcome measure To assess the appropriateness of the intervention using Intervention Appropriateness Measure (IAM) secondary outcome description Total score of the Intervention Appropriateness Measure (IAM): A 4-item measure of perceived intervention appropriateness. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. secondary outcome time frame Qualitative data collection at week 10 (end of intervention). secondary outcome measure To assess the appropriateness of the intervention using semi-structured interviews secondary outcome description To assess the appropriateness of the intervention using semi-structured interviews secondary outcome time frame Qualitative data collection at week 10 (end of intervention). secondary outcome measure To assess the feasibility of the intervention using the Feasibility of Intervention Measure (FIM) secondary outcome description Total score of the Feasibility of Intervention Measure (FIM): A 4-item instrument to assess perceived intervention feasibility. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. secondary outcome time frame Quantitative data collection at week 10 (end of intervention). secondary outcome measure To assess the feasibility of the intervention using semi-structured interviews secondary outcome description To assess the feasibility of the intervention using semi-structured interviews secondary outcome time frame Quantitative data collection at week 10 (end of intervention). secondary outcome measure To assess intervention adherence and attrition rates using attendance data (rates and drop out reasons) secondary outcome description Data on the overall adherence to the intervention, number of drops-outs each week and reasons why. This data will be compiled to assess the percentage of attendance and collect the reasons why mothers did not attend sessions. secondary outcome time frame Quantitative data collection at week 10 (end of intervention). secondary outcome measure To assess the adoption of the intervention using participants and stakeholder enrollment rates secondary outcome description The number of individuals signing mothers up to the intervention, the number of individuals delivering the intervention and the number of individuals supporting the intervention (and continuing to do so) secondary outcome time frame Quantitative data collection at week 10 (end of intervention). secondary outcome measure To assess the cost effectiveness of the intervention using the 5-level EQ-5D version (EQ5D-5L) secondary outcome description EQ5D-5L (quality of life measure): The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. secondary outcome time frame Quantitative and qualitative data collection at week 10 (end of intervention). secondary outcome measure To assess the cost effectiveness of the intervention using the Adult Service Use Schedule (AD-SUS) secondary outcome description To assess the cost effectiveness of the intervention using the Adult Service Use Schedule (AD-SUS): a questionnaire that evaluates healthcare service use by adults. secondary outcome time frame Quantitative and qualitative data collection at week 10 (end of intervention). secondary outcome measure To assess the cost effectiveness of the intervention using implementation activity logs (to estimate implementation costs). secondary outcome description To assess the cost effectiveness of the intervention using implementation activity logs. secondary outcome time frame Quantitative and qualitative data collection at week 10 (end of intervention). secondary outcome measure To assess factors affecting the sustainability and scalability of the intervention using the NOMAD Scale: secondary outcome description To assess factors affecting the sustainability and scalability of the intervention using the NOMAD Scale. secondary outcome time frame Quantitative and qualitative data collection at week 10 (end of intervention). secondary outcome measure To assess factors affecting the sustainability and scalability of the intervention using semi-structured interviews secondary outcome description To assess factors affecting the sustainability and scalability of the intervention using semi-structured interviews secondary outcome time frame Quantitative and qualitative data collection at week 10 (end of intervention). eligibility module eligibility criteria Inclusion Criteria: Women aged 18 or older Satisfactory understanding of English Women who have a child between 0 and up to 9 months old Women with postnatal depression diagnosed using symptoms of PND at a minimum score of 10 on the Edinburgh Postnatal Depression Scale (EPDS) AND meeting diagnostic criteria for major depressive episode on the Structured Clinical Interview for DSM-IV Disorders (SCID) Access to an internet-connected device (mobile phone, tablet, computer or laptop) to allow completion of assessments and participation in the singing sessions. Exclusion Criteria: Child outside of the age-range specified Unable to give informed consent healthy volunteers No gender Female minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Carolina Estevao, PhD central contact role Contact central contact phone 020 7848 0531 central contact e mail shaperpnd@kcl.ac.uk central contact name Rebecca Bind, PhD central contact role Contact central contact phone 020 7848 5450 central contact e mail rebecca.bind@kcl.ac.uk overall official list overall official overall official name Carmine M Pariante overall official affiliation King's College London - IoPPN overall official role Principal Investigator references module reference list reference reference p m i d 35105591 reference type derived reference citation Soukup T, Davis RE, Baldellou Lopez M, Healey A, Estevao C, Fancourt D, Dazzan P, Pariante C, Dye H, Osborn T, Bind R, Sawyer K, Rebecchini L, Hazelgrove K, Burton A, Manoharan M, Perkins R, Podlewska A, Chaudhuri R, Derbyshire-Fox F, Hartley A, Woods A, Crane N, Bakolis I, Sevdalis N. Study protocol: randomised controlled hybrid type 2 trial evaluating the scale-up of two arts interventions for postnatal depression and Parkinson's disease. BMJ Open. 2022 Feb 1;12(2):e055691. doi: 10.1136/bmjopen-2021-055691. reference p m i d 34789494 reference type derived reference citation Estevao C, Bind R, Fancourt D, Sawyer K, Dazzan P, Sevdalis N, Woods A, Crane N, Rebecchini L, Hazelgrove K, Manoharan M, Burton A, Dye H, Osborn T, Davis RE, Soukup T, Arias de la Torre J, Bakolis I, Healey A, Perkins R, Pariante C. SHAPER-PND trial: clinical effectiveness protocol of a community singing intervention for postnatal depression. BMJ Open. 2021 Nov 17;11(11):e052133. doi: 10.1136/bmjopen-2021-052133. i p d sharing statement module i p d sharing Yes i p d sharing description Anonymised data sets will be made available on the KCL Research Data Management System. Protocol will be published on a peer-reveiwed journal. i p d sharing info type list i p d sharing info type Study Protocol i p d sharing time frame To be submitted for publication in the next 2 weeks. i p d sharing access criteria Open-access. document section large document module large doc list large doc large doc type abbrev Prot large doc has protocol Yes large doc has s a p No large doc has i c f No large doc label Study Protocol large doc date October 13, 2020 large doc upload date 03/29/2021 06:23 large doc filename Prot_000.pdf large doc type abbrev ICF large doc has protocol No large doc has s a p No large doc has i c f Yes large doc label Informed Consent Form large doc date September 29, 2020 large doc upload date 02/08/2021 06:15 large doc filename ICF_001.pdf derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000019052 condition mesh term Depression, Postpartum condition mesh id D000003863 condition mesh term Depression condition mesh id D000003866 condition mesh term Depressive Disorder condition ancestor list condition ancestor condition ancestor id D000001526 condition ancestor term Behavioral Symptoms condition ancestor id D000019964 condition ancestor term Mood Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition ancestor id D000011644 condition ancestor term Puerperal Disorders condition ancestor id D000011248 condition ancestor term Pregnancy Complications condition browse leaf list condition browse leaf condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf as found Depression condition browse leaf relevance high condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf as found Depression condition browse leaf relevance high condition browse leaf id M20229 condition browse leaf name Depression, Postpartum condition browse leaf as found Postnatal Depression condition browse leaf relevance high condition browse leaf id M3970 condition browse leaf name Behavioral Symptoms condition browse leaf relevance low condition browse leaf id M20988 condition browse leaf name Mood Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse leaf id M13651 condition browse leaf name Puerperal Disorders condition browse leaf relevance low condition browse leaf id M13279 condition browse leaf name Pregnancy Complications condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id T114 intervention browse leaf name Chrysanthemum intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev HB intervention browse branch name Herbal and Botanical intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04834622
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full study rank 61507 study protocol section identification module n c t id NCT04835571 org study id info org study id 756191 organization org full name Linkoeping University org class OTHER_GOV brief title CARotid Mri of Atherosclerosis official title CARotid Mri of Atherosclerosis acronym CARMA status module status verified date April 2021 overall status Suspended why stopped Covid-19 expanded access info has expanded access No start date struct start date January 6, 2017 start date type Actual primary completion date struct primary completion date December 12, 2018 primary completion date type Actual completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ebo De Muinck responsible party investigator title Professor Ebo de Muinck responsible party investigator affiliation Linkoeping University lead sponsor lead sponsor name Linkoeping University lead sponsor class OTHER_GOV collaborator list collaborator collaborator name Region Östergötland collaborator class OTHER collaborator name Region Jönköping County collaborator class OTHER_GOV collaborator name FORSS, Forskningsrådet i Sydöstra Sverige collaborator class UNKNOWN oversight module oversight has d m c No description module brief summary In the entire world most people die from cardiovascular disease. Death is primarily from myocardial infarction (MI) and stroke which are most often caused by rupture of atherosclerotic plaques. Patients with high-grade, i.e. ≥ 70% carotid artery stenosis are at especially high risk. Magnetic Resonance Imaging (MRI) studies show that two features inside plaques that are associated with the risk of plaque rupture and subsequent cardiovascular events are: lipid rich necrotic core (LRNC) and intraplaque hemorrhage (IPH). MRI studies on carotid artery plaques typically relies on proton-density-weighted fast-spin echo, blood-suppressed T1- and T2-weighted gradient-echo sequences. The end-result is nonquantitative measures, where plaque features are identified due to their relative signal intensity. To address these problems of non-specificity, we developed a quantitative MRI (qMRI) technique based on Dixon sequences. The study intention is to enable in-depth analysis of plaque features and their relation to clinical data. For example there is an insufficient understanding of associations between lipid biomarkers and plaque contents. Our hypothesis is that we can identify quantitative changes in both plaque and lipid biomarkers after one year of optimized cardiovascular risk management (including treatment with lipid lowering drugs), and establish if there is any associations between these features. Because there is a well-established link between systemic inflammation and the presence of atherosclerotic plaques we will also study the relationship between LRNC and IPH as measured by qMRI versus circulating markers of inflammation. Method: Patients with known carotid stenosis are invited for a baseline visit and a 1-year follow up visit. The study visits include clinical assessment, blood tests, patient interview and magnetic resonance imaging of the carotid arteries. All participants are offered optimized cardiovascular risk management through the individual assessment by the study physicians. detailed description Regarding quality assurance plans that address data validation and registry procedures, the current study is a single centre investigator-initiated study and therefore there are no plans for site monitoring and auditing. The reliability and validity of the MRI data has been previously confirmed with comparison to 3D histology data (Koppal et al. Quantitative fat and R2* mapping in vivo to measure lipid-rich necrotic core and intraplaque hemorrhage in carotid atherosclerosis. Magn Reson Med. 2017;78(1):285-96.). Concerning data checks, intraobserver reliability regarding baseline and follow-up measurements will be ascertained (Intraclass Correlation Coefficients (ICC), Bland Altman). Data is collected from patient medical records (electronic), dedicated study record forms (paper) and clinical assessments, resulting in quantitative measures. These external data sources are transferred into a study database. The current study is a clinical study, using only clinically validated laboratory parameters. The source of the lab values and their normal ranges is the electronic patient record. The normal ranges have been established by the clinical chemistry and haematology laboratories at Linköping University Hospital. Clinical diagnosis and procedures are recorded using the International Classification of Diseases (ICD) classification. The study was approved by the Swedish Ethical Review Authority (approval nr: 2016-441-31) and performed in accordance with the Declaration of Helsinki. Written informed consent has been obtained from all study participants. Patients are selected based on duplex ultrasound criteria established for the European Carotid Surgery Trial. A cut-off at doppler flow velocity has been used to identify eligible patients and after considering inclusion and exclusion criteria patients have been contacted by the study clinicians dr Elin Good or dr Ebo de Muinck for recruitment. Any registration for adverse events follows the same procedures as in routine care. Sample size assessment was based on results from previous studies in relation to our primary outcome variables. For example, one study with 24 patients and a follow-up time of three months experienced a significant reduction of lipid rich necrotic core, using magnetic resonance imaging (Alkhalil et al. T2 mapping MRI technique quantifies carotid plaque lipid, and its depletion after statin initiation, following acute myocardial infarction. Atherosclerosis. 2018;279:100-6.). Therefore, we aimed to include 50 patients who have completed both baseline and follow-up, and the follow-up time was set to 12 months. Our plan for missing data in situations where variables are missing, unavailable, non-reported, uninterpretable etc is to not exclude the study participant, in order to avoid bias. For example, in cases where the imaging data from one patient is lost, we will still use the remaining clinical data from that patient if the patient has been included in the study. Regarding Statistical analysis, SPSS Statistics 26 (International Business Machines Corporation, New York, NY, USA) is used for statistical analysis. Continuous variables are summarized as mean ± standard deviation (SD). To address the primary objectives (the strength of the association between fat fraction (FF) and R2*) Pearson correlation coefficient is used, and Paired-samples T test is used for analysing changes in quantitative values between baseline and follow-up. Intra-observer repeatability measurements were calculated using ICC. For ICC evaluation we used two-way random effect models, checking for absolute agreement, average measures presented. conditions module condition list condition Carotid Stenosis Carotid Artery Plaque Carotid Atherosclerosis keyword list keyword Carotid stenosis Cardiovascular MRI Atherosclerotic plaque design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design intervention model description Single group, repeated measures design. The treatment is design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 52 enrollment type Actual arms interventions module arm group list arm group arm group label CARMA study participants arm group type Experimental arm group description All patients in the study are in the same treatment arm: all were treated for 12 months according to routine care and international guidelines for cardiovascular disease prevention in patients with very high cardiovascular risk. Through study physicians patients received an individual assessment and optimized cardiovascular risk management, including life style advice and adjustments in their medical preventive treatment, based on drugs used in standard care (eg. lipid lowering medication, anti-hypertensive-treatment, anti-thrombotic treatment). All treatment goals were set in accordance with current guidelines at the time for study participation. arm group intervention list arm group intervention name Other: Optimization of cardiovascular risk management intervention list intervention intervention type Other intervention name Optimization of cardiovascular risk management intervention description Treatment goals were set according to current guidelines (Perk et al. Eur Guidelines on CVD prevention in clinical practice (2012). Eur heart J. 2012;33(13):1635-701): blood pressure <140/90 mmHg Tot cholesterol <5 mmol/l LDL <1,8 mmol/l Waist circumference: men <94 cm, women <80 cm BMI <25 kg/m2 HbA1c without diabetes mellitus <42 mmol/mol, HbA1c with diabetes mellitus <52 mmol/mol Antithrombotic treatment (or anticoagulants, if indicated) Physical activity 30 min/day, 5 days/week, alternatively high-intensity training at least15 min/day, 5 days/week or a combination of the two. Healthy diet, including low levels of saturated fats, high intake of vegetables, fruits, whole-grain and fish Smoking cessation Low alcohol consumption Patients were encouraged to follow the above recommendations through support of the study physicians, who made individual assessments of all patients and adjusted ongoing medical treatment to reach treatment targets. intervention arm group label list intervention arm group label CARMA study participants outcomes module primary outcome list primary outcome primary outcome measure Changes in fat fraction (FF) and R2* in relation to changes in plasma lipoproteins. primary outcome description FF, Fat Fraction. Measured by Dixon MRI sequences, quantitatively corresponding to lipid rich necrotic core. R2* (= 1/T2*) is the rate of signal loss, it can be viewed as a measure for the presence of (heme) iron. As we have shown in a previous study, it correlates to the extent of intraplaque hemorrhage. primary outcome time frame Baseline - 1-year follow up secondary outcome list secondary outcome secondary outcome measure Changes in fat fraction (FF) and R2* in relation to changes in inflammatory lymphocyte subtypes secondary outcome description For FF and R2*, see above. Inflammatory lymphocytes subtypes are measured using flow cytometry, with focus on lymphocyte T cell subtypes and Natural Killer cells. secondary outcome time frame Baseline - 1-year follow up eligibility module eligibility criteria Inclusion Criteria: - Carotid plaques with a cut-off at doppler flow velocity ≥ 1.3 m/sec at a Doppler angle of 50-60°, which corresponds to a ≥ 50% stenosis according to these criteria. Exclusion Criteria: Performed or planned carotid surgery Carotid occlusion Renal failure (GFR <45 ml/h) Inflammatory diseases, anti-inflammatory treatment or malignancies Stroke <30 days before admission Co-morbidities that disable informed consent or participation in the study investigations (e.g. contraindications for MRI) healthy volunteers No gender All minimum age 18 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Ebo de Muinck, Professor overall official affiliation Linkoeping University overall official role Principal Investigator references module reference list reference reference p m i d 27510300 reference type background reference citation Koppal S, Warntjes M, Swann J, Dyverfeldt P, Kihlberg J, Moreno R, Magee D, Roberts N, Zachrisson H, Forssell C, Länne T, Treanor D, de Muinck ED. Quantitative fat and R2* mapping in vivo to measure lipid-rich necrotic core and intraplaque hemorrhage in carotid atherosclerosis. Magn Reson Med. 2017 Jul;78(1):285-296. doi: 10.1002/mrm.26359. Epub 2016 Aug 11. reference p m i d 26879568 reference type background reference citation Good E, Länne T, Wilhelm E, Perk J, Jaarsma T, de Muinck E. High-grade carotid artery stenosis: A forgotten area in cardiovascular risk management. Eur J Prev Cardiol. 2016 Sep;23(13):1453-60. doi: 10.1177/2047487316632629. Epub 2016 Feb 15. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000016893 condition mesh term Carotid Stenosis condition mesh id D000002340 condition mesh term Carotid Artery Diseases condition mesh id D000050197 condition mesh term Atherosclerosis condition ancestor list condition ancestor condition ancestor id D000001161 condition ancestor term Arteriosclerosis condition ancestor id D000001157 condition ancestor term Arterial Occlusive Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000002561 condition ancestor term Cerebrovascular Disorders condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M25341 condition browse leaf name Atherosclerosis condition browse leaf as found Atherosclerosis condition browse leaf relevance high condition browse leaf id M5627 condition browse leaf name Constriction, Pathologic condition browse leaf relevance low condition browse leaf id M18390 condition browse leaf name Carotid Stenosis condition browse leaf as found Carotid Stenosis condition browse leaf relevance high condition browse leaf id M28156 condition browse leaf name Plaque, Atherosclerotic condition browse leaf relevance low condition browse leaf id M4746 condition browse leaf name Carotid Artery Diseases condition browse leaf as found Carotid Atherosclerosis condition browse leaf relevance high condition browse leaf id M3621 condition browse leaf name Arteriosclerosis condition browse leaf relevance low condition browse leaf id M3617 condition browse leaf name Arterial Occlusive Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M4962 condition browse leaf name Cerebrovascular Disorders condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3396 intervention browse leaf name Anticoagulants intervention browse leaf relevance low intervention browse leaf id M2929 intervention browse leaf name Ethanol intervention browse leaf relevance low intervention browse leaf id M3429 intervention browse leaf name Antihypertensive Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev AnCoag intervention browse branch name Anticoagulants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev AnAg intervention browse branch name Antihypertensive Agents
NCT04835571
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full study rank 61648 study protocol section identification module n c t id NCT04833738 org study id info org study id Yuzuncu Yil University organization org full name Yuzuncu Yıl University org class OTHER brief title Hyaluronic Acid, Corticosteroid and Electrotherapy in Subacromial Impingement Syndrome official title Subakromiyal sıkışma Sendromunda Hyaluronik Asit, Kortikosteroid ve Elektroterapi status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date September 11, 2013 start date type Actual primary completion date struct primary completion date December 10, 2013 primary completion date type Actual completion date struct completion date May 28, 2014 completion date type Actual study first submit date April 2, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Şeyhmus KAPLAN responsible party investigator title Department of Sports Medicine responsible party investigator affiliation Yuzuncu Yıl University lead sponsor lead sponsor name Şeyhmus KAPLAN lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Background: Electrotherapy, corticosteroid, and hyaluronic acid have been used to treat subacromial impingement syndrome. However, we need to compare treatment options to provide the optimal results. This study aims to compare the effect of hyaluronic acid, corticosteroid, and electrotherapy in subacromial impingement syndrome. Design: Ninety five patients were randomised into three equal groups according to treatment types. Hyaluronic acid (20 mg/2ml, three times one week apart) or corticosteroid (triamcinolone acetonide, 40 mg/ml, single dose) treatments were applied as subacromial injections. Electrotherapy consisted of 14 sessions TENS (20 min.), hotpack (20 min.) and ultrasound (1.5watt/cm2, 1 MHz, 6 min.). Patients were evaluated before treatment, one and four weeks post end of treatment. Visual Analogue Scale (VAS), range of motion (ROM), and Shoulder Disability Questionnaire (SDQ) were used as outcome measures. conditions module condition list condition Subacromial Impingement Pain, Shoulder design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Outcomes Assessor enrollment info enrollment count 90 enrollment type Actual arms interventions module arm group list arm group arm group label Electrotherapy arm group type Active Comparator arm group intervention list arm group intervention name Other: Electrotherapy arm group label corticosteroid arm group type Active Comparator arm group intervention list arm group intervention name Drug: Corticosteroids Triamcinolone Acetonide arm group label hyaluronic acid arm group type Active Comparator arm group intervention list arm group intervention name Drug: Hyaluronic acid intervention list intervention intervention type Drug intervention name Hyaluronic acid intervention arm group label list intervention arm group label hyaluronic acid intervention type Drug intervention name Corticosteroids Triamcinolone Acetonide intervention description triamcinolone acetonide, 40 mg/ml, single dose intervention arm group label list intervention arm group label corticosteroid intervention type Other intervention name Electrotherapy intervention description electrotherapy intervention arm group label list intervention arm group label Electrotherapy outcomes module primary outcome list primary outcome primary outcome measure Visual Analogue Scale primary outcome description Higher scores represent higher level of shoulder pain. primary outcome time frame 1 min. primary outcome measure range of motion primary outcome description Higher scores represent lower level of shoulder function. primary outcome time frame 5 min. primary outcome measure Shoulder Disability Questionnaire primary outcome description Higher scores represent higher level of shoulder pain. primary outcome time frame 15 min eligibility module eligibility criteria Inclusion Criteria: The diagnosis of subacromial impingement syndrome Exclusion Criteria: Patients aged <20 or >50 years or who have the following medical conditions were excluded: physical therapy or injection in the past 6 months, shoulder instability, acute trauma, adhesive capsulitis, psychiatric illness, diabetes mellitus, malignancy. healthy volunteers No gender All minimum age 20 Years maximum age 50 Years std age list std age Adult i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000019534 condition mesh term Shoulder Impingement Syndrome condition mesh id D000020069 condition mesh term Shoulder Pain condition ancestor list condition ancestor condition ancestor id D000007592 condition ancestor term Joint Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000070599 condition ancestor term Shoulder Injuries condition ancestor id D000014947 condition ancestor term Wounds and Injuries condition ancestor id D000018771 condition ancestor term Arthralgia condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M20629 condition browse leaf name Shoulder Impingement Syndrome condition browse leaf as found Subacromial Impingement condition browse leaf relevance high condition browse leaf id M21060 condition browse leaf name Shoulder Pain condition browse leaf as found Pain, Shoulder condition browse leaf relevance high condition browse leaf id M9773 condition browse leaf name Joint Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M602 condition browse leaf name Shoulder Injuries condition browse leaf relevance low condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse leaf id M19986 condition browse leaf name Arthralgia condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000014221 intervention mesh term Triamcinolone intervention mesh id D000014222 intervention mesh term Triamcinolone Acetonide intervention mesh id C000005900 intervention mesh term Triamcinolone hexacetonide intervention mesh id D000006820 intervention mesh term Hyaluronic Acid intervention mesh id C000030262 intervention mesh term Triamcinolone diacetate intervention ancestor list intervention ancestor intervention ancestor id D000000893 intervention ancestor term Anti-Inflammatory Agents intervention ancestor id D000005938 intervention ancestor term Glucocorticoids intervention ancestor id D000006728 intervention ancestor term Hormones intervention ancestor id D000006730 intervention ancestor term Hormones, Hormone Substitutes, and Hormone Antagonists intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000007166 intervention ancestor term Immunosuppressive Agents intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000276 intervention ancestor term Adjuvants, Immunologic intervention ancestor id D000055675 intervention ancestor term Viscosupplements intervention ancestor id D000020011 intervention ancestor term Protective Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M9030 intervention browse leaf name Hyaluronic Acid intervention browse leaf as found Compression intervention browse leaf relevance high intervention browse leaf id M16126 intervention browse leaf name Triamcinolone intervention browse leaf as found Manual intervention browse leaf relevance high intervention browse leaf id M16127 intervention browse leaf name Triamcinolone Acetonide intervention browse leaf as found Correlative studies intervention browse leaf relevance high intervention browse leaf id M237968 intervention browse leaf name Triamcinolone hexacetonide intervention browse leaf as found Kothala Himbutu intervention browse leaf relevance high intervention browse leaf id M209570 intervention browse leaf name Triamcinolone diacetate intervention browse leaf as found Kothala Himbutu intervention browse leaf relevance high intervention browse leaf id M3369 intervention browse leaf name Anti-Inflammatory Agents intervention browse leaf relevance low intervention browse leaf id M8199 intervention browse leaf name Glucocorticoids intervention browse leaf relevance low intervention browse leaf id M8941 intervention browse leaf name Hormones intervention browse leaf relevance low intervention browse leaf id M8940 intervention browse leaf name Hormone Antagonists intervention browse leaf relevance low intervention browse leaf id M9364 intervention browse leaf name Immunosuppressive Agents intervention browse leaf relevance low intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse leaf id M2780 intervention browse leaf name Adjuvants, Immunologic intervention browse leaf relevance low intervention browse leaf id M27448 intervention browse leaf name Viscosupplements intervention browse leaf relevance low intervention browse leaf id M21022 intervention browse leaf name Protective Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Infl intervention browse branch name Anti-Inflammatory Agents
NCT04833738
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full study rank 61428 study protocol section identification module n c t id NCT04836598 org study id info org study id 11671 organization org full name Zagazig University org class OTHER_GOV brief title Bikini Scarless Laparoscopic Cholecystectomy for Morbid Obesity as a Day Case. official title Bikini Scarless Laparoscopic Cholecystectomy for Morbid Obesity as a Day Case. status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date November 30, 2016 start date type Actual primary completion date struct primary completion date April 20, 2021 primary completion date type Anticipated completion date struct completion date April 30, 2021 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Bassem Mohamed Sieda responsible party investigator title assistant professor of general surgeryt responsible party investigator affiliation Zagazig University lead sponsor lead sponsor name Zagazig University lead sponsor class OTHER_GOV oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Background: Bikini line laparoscopic cholecystectomy is a safe method, used as a scarless cosmetic port technique for gall bladder diseases in morbid obese patients as a day case. Objectives: The aim of this study was to investigate the safety and efficacy of an elective Bikini line laparoscopic cholecystectomy in the morbid obese patients with chronic calcular cholecystitis, and review our experience with Bikini line laparoscopic cholecystectomy as minimal invasive scarless technique. We issued a modifications in order to minimize the number of ports (Brief ports) and modify port sites, using the Bikini line laparoscopic cholecystectomy as a cosmetic and hidden scar laparoscopy for obese patients concerned with aesthetic results and body image. Aiming at faster recovery, decrease pain and improve cosmoses. Bikini Line laparoscopic cholecystectomy is technically safe and effective day surgery procedure for chronic cholecystitis patients with higher patient satisfaction regarding pain and cosmoses. Obesity, intended as BMI 40, does not have any obstacle on the technical feasibility of BLLC. detailed description Thoroughly, BLLC is a novel technique aimed at solving the issue of cosmoses that is always presented as a main complaint from morbid obese patients. The main concern to use Brief ports laparoscopy or hidden scar laparoscopy to reduce incisions and change sites. The study designed to identify superiority of technique regarding success as a day case surgery, better cosmoses and lesser pain. We tried to wear off the port sites scar and kept our stabs in the suprapubic Bikin line. We kept camera port in the navel's natural scar and used the other ports in lower abdominal crease at Bikini line. Cosmosis has been and still the reason among patient population to accept the laparoscopic surgery, many synonyms can be applied here, as Cosmotic,Hidden scar, Scarless, Non-visualized or Scarless Bikini cholecystectomy. BLLC is performed under general anesthesia. Patient placed in the supine position with patient's legs apart and arms are rolled in, patient strapped to table at the mid-thigh. Surgeon stood between patient's legs, the camera man stood on the right side of patient, monitor placed near patient head to the right side. Three ports were used, 12 mm visiport (….) umbilical, with A 30 degree camera used, 5mm in Bikini line at Right mid-clavicular line and third port 5mm in Bikini line at left mid-clavicular line (Figure) Patient kept in reverse Trendlenburg position with maximum degree 20. But to lesser degree than done in classic LC, conditions module condition list condition Cholecystitis, Chronic keyword list keyword scarless cholecystectomy Breif port cholecystectomy design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Patients were randomly allocated into 2 groups (Consort Chart) and each group categorized into 3 subgroups according to BMI, into class I: Obese Class 1 30-34.9kg/m2, Class II: Obese Class II 35-39.9kg/m2 and class III: Morbidly Obese Class III >40kg/m2 design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 3 enrollment type Anticipated arms interventions module arm group list arm group arm group label Multiport laparoscopic cholecystectomy arm group type Active Comparator arm group description controlled group arm group intervention list arm group intervention name Other: laparoscopic cholecystectomy arm group label Bikini line laparoscopic cholecystectomy arm group type Active Comparator arm group description bikini line 2 ports arm group intervention list arm group intervention name Other: laparoscopic cholecystectomy intervention list intervention intervention type Other intervention name laparoscopic cholecystectomy intervention description A Prospective randomized controlled trial study was undertaken along 4 years Between November 2016 and October 2020, in two institutions. 400 patients were selected, 200 patients underwent BLLC and 200 patients underwent multiple port laparoscopic cholecystectomy (MPLC). intervention arm group label list intervention arm group label Bikini line laparoscopic cholecystectomy Multiport laparoscopic cholecystectomy intervention other name list intervention other name brief port scarless laparoscopic cholecystectomy outcomes module primary outcome list primary outcome primary outcome measure a successful and safe day case primary outcome description a successful and safe day case laparoscopic cholecystectomy with discharge on the same day with no significant pain. patient stayed more than a day was not enrolled primary outcome time frame 4 years secondary outcome list secondary outcome secondary outcome measure Measured patient satisfaction from body image and cosmoses within 6 months from surgery. secondary outcome description Postoperative pain was defined as mild, moderate sever according to visual analogue scale (VAS) Pain assessment at the tommy and at port sites were assessed at postoperative day 1 and at discharge as follow, 8 hours, at discharge time at 12 hours or 24 hours postoperative, and after discharge at 48 hours, 72 hours achieved through Telephone call with the patient. Patient satisfaction from cosmetic outcome was measured on 10 points scale. Divided into mild satisfied (1-3 points), moderate (4-7)and highly satisfied (8-10 points) at the second postoperative visit at 30 days postoperative, after 3 months and after 6 months, based on patient question to rate it, mild satisfaction: 1-3, moderate satisfaction:4-7 and highly satisfied: from 8-10 secondary outcome time frame 3 years eligibility module eligibility criteria Inclusion Criteria: Morbid obese patients with BMI ≤30 KG/M2 and ≥ 40 9kg/m2 with symptomatic uncomplicated gall stones, ASA 1-3. Exclusion Criteria: Acute calcular cholecystitis, BMI ≥45, ASA 4 or higher, length of stay more than 1 day. Patients required additional trocars for patient safety, readmission, healthy volunteers No gender All minimum age 17 Years maximum age 65 Years std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Bassem M Sieda, professor central contact role Contact central contact phone 0541900039 central contact e mail drbassemmostafa@yahoo.com central contact name Bassem M Sieda, professor central contact role Contact central contact e mail drbassemmostafa@yahoo.com overall official list overall official overall official name Bassem M Sieda, professor overall official affiliation 1975 overall official role Study Chair location list location location facility Zagazig University hospitals location status Recruiting location city Zagazig location state Outside USA location zip 12345 location country Egypt location contact list location contact location contact name Bassem M Sieda, professor location contact role Contact location contact e mail drbassemmostafa@yahoo.com location contact name Bassem M Sieda location contact role Contact location contact e mail drbassemmostafa@yahoo.com location facility Zagazig University hospitals location status Completed location city Zagazig location state Outside USA location zip 12345 location country Egypt location facility Saudi German hospital location status Recruiting location city Riyadh location state Outside USA location zip 11671 location country Saudi Arabia location contact list location contact location contact name Bassem M Sieda location contact role Contact location contact phone 0541900039 location contact e mail drbassemmostafa@yahoo.com location facility Saudi german hospital location status Recruiting location city Riyadh location zip 11671 location country Saudi Arabia location contact list location contact location contact name Bassem M Sieda location contact role Contact location contact phone 00966541900039 location contact phone ext 00966541900039 location contact e mail drbassemmostafa@yahoo.com i p d sharing statement module i p d sharing Yes i p d sharing description data can be shared through the publisher and all authers i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code i p d sharing time frame 1 year i p d sharing access criteria publisher which is international journa derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002764 condition mesh term Cholecystitis condition mesh id D000009767 condition mesh term Obesity, Morbid condition ancestor list condition ancestor condition ancestor id D000009765 condition ancestor term Obesity condition ancestor id D000044343 condition ancestor term Overnutrition condition ancestor id D000009748 condition ancestor term Nutrition Disorders condition ancestor id D000050177 condition ancestor term Overweight condition ancestor id D000001835 condition ancestor term Body Weight condition ancestor id D000005705 condition ancestor term Gallbladder Diseases condition ancestor id D000001660 condition ancestor term Biliary Tract Diseases condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition browse leaf list condition browse leaf condition browse leaf id M11853 condition browse leaf name Obesity condition browse leaf relevance low condition browse leaf id M11854 condition browse leaf name Obesity, Morbid condition browse leaf as found Morbid Obesity condition browse leaf relevance high condition browse leaf id M5157 condition browse leaf name Cholecystitis condition browse leaf as found Cholecystitis condition browse leaf relevance high condition browse leaf id M24172 condition browse leaf name Acalculous Cholecystitis condition browse leaf relevance low condition browse leaf id M24460 condition browse leaf name Overnutrition condition browse leaf relevance low condition browse leaf id M11836 condition browse leaf name Nutrition Disorders condition browse leaf relevance low condition browse leaf id M25339 condition browse leaf name Overweight condition browse leaf relevance low condition browse leaf id M4266 condition browse leaf name Body Weight condition browse leaf relevance low condition browse leaf id M7975 condition browse leaf name Gallbladder Diseases condition browse leaf relevance low condition browse leaf id M4098 condition browse leaf name Biliary Tract Diseases condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse leaf id T1150 condition browse leaf name Cholecystitis condition browse leaf as found Cholecystitis condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04836598
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full study rank 61528 study protocol section identification module n c t id NCT04835298 org study id info org study id PO20065* organization org full name CHU de Reims org class OTHER brief title Breathlessness Assessment in Adult Patients With Myotonic Dystrophy Type 1 official title Characters) Dyspnea Assessment in Adult Patients With Myotonic Dystrophy Type 1: a Monocentric Pilot Study status module status verified date June 2022 overall status Completed expanded access info has expanded access No start date struct start date July 3, 2020 start date type Actual primary completion date struct primary completion date July 20, 2021 primary completion date type Actual completion date struct completion date June 14, 2022 completion date type Actual study first submit date March 31, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date June 14, 2022 last update post date struct last update post date June 15, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name CHU de Reims lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Myotonic dystrophy type 1 (DM1) is one of the most common neuromuscular diseases in adults. As respiratory dysfunction is the most common cause of death in patients with DM1, a respiratory disease progression must be monitored combining symptom screening and respiratory function testing, in order to identify the appropriate time to initiate non invasive ventilation (NIV). Dyspnea, one of the main respiratory symptoms, has been little studied in patients with DM1. The main objective of this study is to provide the first multidimensional description of dyspnea in patients with DM1. The secondary objectives are: To compare respiratory symptoms according to the presence or not of criteria from respiratory function testing to initiate NIV To assess associations between dyspnea and respiratory function testing To assess associations between dyspnea and number of Cytosine Thymine Guanine (CTG) repeats To assess associations between dyspnea and muscular strength To assess associations between dyspnea and BMI To assess associations between dyspnea and anxiety or depression To assess associations between dyspnea and cognitive impairment To assess associations between dyspnea and quality of life. conditions module condition list condition Myotonic Dystrophy Type 1 (DM1) design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Prospective enrollment info enrollment count 34 enrollment type Actual arms interventions module arm group list arm group arm group label Myotonic dystrophy type 1 arm group description adult patients with myotonic dystrophy type 1 arm group intervention list arm group intervention name Other: Dyspnea intervention list intervention intervention type Other intervention name Dyspnea intervention description questionnaires intervention arm group label list intervention arm group label Myotonic dystrophy type 1 outcomes module primary outcome list primary outcome primary outcome measure Dyspnea primary outcome description Borg scale at rest and after 6 minute walking test primary outcome time frame Month 6 eligibility module eligibility criteria Inclusion Criteria: patient with myotonic dystrophy type 1 confirmed by genetic analysis with an age older than 18 years Exclusion Criteria: an ongoing or recent (i.e. within the last 4 weeks prior to study recruitment) medical condition, including pulmonary exacerbations patient already under non-invasive mechanical ventilation healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population adult patients with myotonic dystrophy type 1 sampling method Non-Probability Sample contacts locations module location list location location facility Chu Reims location city Reims location zip 51092 location country France i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009223 condition mesh term Myotonic Dystrophy condition ancestor list condition ancestor condition ancestor id D000009136 condition ancestor term Muscular Dystrophies condition ancestor id D000020966 condition ancestor term Muscular Disorders, Atrophic condition ancestor id D000009135 condition ancestor term Muscular Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000020967 condition ancestor term Myotonic Disorders condition ancestor id D000020271 condition ancestor term Heredodegenerative Disorders, Nervous System condition ancestor id D000019636 condition ancestor term Neurodegenerative Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000009468 condition ancestor term Neuromuscular Diseases condition ancestor id D000030342 condition ancestor term Genetic Diseases, Inborn condition browse leaf list condition browse leaf condition browse leaf id M6743 condition browse leaf name Dyspnea condition browse leaf relevance low condition browse leaf id M11327 condition browse leaf name Myotonic Dystrophy condition browse leaf as found Myotonic Dystrophy condition browse leaf relevance high condition browse leaf id M11245 condition browse leaf name Muscular Dystrophies condition browse leaf relevance low condition browse leaf id M3741 condition browse leaf name Atrophy condition browse leaf relevance low condition browse leaf id M21850 condition browse leaf name Muscular Disorders, Atrophic condition browse leaf relevance low condition browse leaf id M11244 condition browse leaf name Muscular Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M21851 condition browse leaf name Myotonic Disorders condition browse leaf relevance low condition browse leaf id M21245 condition browse leaf name Heredodegenerative Disorders, Nervous System condition browse leaf relevance low condition browse leaf id M20711 condition browse leaf name Neurodegenerative Diseases condition browse leaf relevance low condition browse leaf id M11563 condition browse leaf name Neuromuscular Diseases condition browse leaf relevance low condition browse leaf id M22839 condition browse leaf name Genetic Diseases, Inborn condition browse leaf relevance low condition browse leaf id T4024 condition browse leaf name Myotonic Dystrophy condition browse leaf as found Myotonic Dystrophy condition browse leaf relevance high condition browse leaf id T4025 condition browse leaf name Myotonic Dystrophy Type 1 condition browse leaf as found Myotonic Dystrophy Type 1 condition browse leaf relevance high condition browse leaf id T3963 condition browse leaf name Muscular Dystrophy condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04835298
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full study rank 61624 study protocol section identification module n c t id NCT04834050 org study id info org study id 26022019 organization org full name Hatay Dortyol State Hospital org class OTHER_GOV brief title Can 4 Weeks of Exercise Program Change Quadriceps Architecture in Patients With Rheumatoid Arthritis official title Can 4 Weeks of Exercise Program Change Quadriceps Architecture in Patients With Rheumatoid Arthritis status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date October 1, 2018 start date type Actual primary completion date struct primary completion date June 12, 2019 primary completion date type Actual completion date struct completion date February 20, 2020 completion date type Actual study first submit date March 31, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Ovgu Bickici responsible party investigator title OB responsible party investigator affiliation Hatay Dortyol State Hospital lead sponsor lead sponsor name Ovgu Bickici lead sponsor class OTHER_GOV oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Quadriceps femoris (QF) atrophy is seen in rheumatoid arthritis and knee osteoarthritis (OA) patients. Exercise therapy is mile stone in knee OA patients also it can help thicken QF muscle of RA patients. We primarily aimed to demonstrate the influence of 4 weeks of knee isometric home-based training on QF muscle parts thickness and pennation angle measurements of RA patients with ultrasonography (USG). This study included 12 patients with RA, 12 patients with knee OA as positive control group and 13 volunteers as healthy control group. All participants were given 4 weeks of quadriceps-hamstring isometric home-based training. At baseline and at the end of the program, WOMAC and Lequesne algofunctional index scores of knee OA patients and DAS28-CRP scores of RA patients were recorded. Dominant knee thickness and pennation angle measurements of QF muscle parts were evaluated by ultrasonography. conditions module condition list condition Arthritis, Rheumatoid Knee Osteoarthritis Quadriceps Muscle Atrophy Ultrasonography Exercise design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 37 enrollment type Actual arms interventions module arm group list arm group arm group label Rheumatoid arthritis patients arm group type Experimental arm group intervention list arm group intervention name Procedure: Quadriceps femoris isometric home-based exercise arm group label Knee Osteoarthritis patients arm group type Experimental arm group intervention list arm group intervention name Procedure: Quadriceps femoris isometric home-based exercise arm group label Healthy patients arm group type Experimental arm group intervention list arm group intervention name Procedure: Quadriceps femoris isometric home-based exercise intervention list intervention intervention type Procedure intervention name Quadriceps femoris isometric home-based exercise intervention description All 3 groups of participants were given 4-week (5 days/week) quadriceps-hamstring isometric home-based exercise training for their both knees. Exercises were performed (with maximal effort for 10 seconds) at a rate of 20 repetitions per day. Training was performed at outpatient clinic for 30 minutes. intervention arm group label list intervention arm group label Healthy patients Knee Osteoarthritis patients Rheumatoid arthritis patients outcomes module primary outcome list primary outcome primary outcome measure Change of quadriceps femoris parts thickness measures primary outcome description Dominant knee vastus lateralis, medialis, intermedius and rectus femoris thicknesses of 3 groups were calculated at baseline and at the end of intervention. primary outcome time frame At baseline and after 4 weeks of intervention primary outcome measure Change of quadriceps femoris parts pennation angles primary outcome description Pennation angles of vastus lateralis, medialis and intermedius were calculated at baseline and at the end of exercise program. primary outcome time frame At baseline and after 4 weeks of intervention secondary outcome list secondary outcome secondary outcome measure Change of The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score of knee OA secondary outcome description The Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores of knee OA patients were calculated at baseline and at the end of exercise program. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is divided into 3 subscales: Pain, stiffness, physical function. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of scores of 3 subscales were multipled with 100 and divided by 96 and resulted in WOMAC score of the patients. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. secondary outcome time frame At baseline and after 4 weeks of intervention secondary outcome measure Change of Disease activity score 28-C reactive protein (DAS28-CRP) secondary outcome description Disease activity score 28-C reactive protein (DAS28-CRP) scores of RA patients were calculated at baseline and at the end of program. A score lower than 2.6 means remission, score between 2.6 and 3.2 means low disease activity, score between 3.2 and 5.1 means moderate disease activity and score higher than 5.1 means high disease activity. secondary outcome time frame At baseline and after 4 weeks of intervention secondary outcome measure Change of Lequesne scores of knee OA patients secondary outcome description Lequesne algofunctional index scores of knee OA patients were calculated at baseline and at the end of the intervention. The Lequesne OA index is scored as the sum of questions ranging from 0 to 24, higher scores meaning worse outcome. secondary outcome time frame At baseline and after 4 weeks of intervention eligibility module eligibility criteria The inclusion criteria for all participants were being between 18-65 yy. The inclusion criteria for RA patients were: confirmed diagnosis of RA according to 2010 ACR/EULAR classification criteria and lack of any other inflammatory articular diseases. The inclusion criteria for knee OA patients were: diagnosis according to ACR classification criteria of knee OA with grade 2-3 according to the Kellgren-Lawrence grading system and lack of any other inflammatory articular diseases. Volunteers who did not have any knee pain, no clinical degenerative or inflammatory signs were included in the healthy control group. - Exclusion criteria for all participants were: being out of age range, history of knee joint trauma, surgery or knee joint injection in the previous 6 months, presence of any other disease that can affect thigh muscles (radiculopathy, myopathy, hip problems). Patients with secondary knee OA were not included. - healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module location list location location facility Gazi University Faculty of Medicine location city Ankara location country Turkey i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 submission tracking submission info list submission info submission release date August 30, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001168 condition mesh term Arthritis condition mesh id D000001172 condition mesh term Arthritis, Rheumatoid condition mesh id D000020370 condition mesh term Osteoarthritis, Knee condition mesh id D000009133 condition mesh term Muscular Atrophy condition ancestor list condition ancestor condition ancestor id D000007592 condition ancestor term Joint Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000010003 condition ancestor term Osteoarthritis condition ancestor id D000012216 condition ancestor term Rheumatic Diseases condition ancestor id D000003240 condition ancestor term Connective Tissue Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition ancestor id D000001284 condition ancestor term Atrophy condition ancestor id D000020763 condition ancestor term Pathological Conditions, Anatomical condition ancestor id D000020879 condition ancestor term Neuromuscular Manifestations condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M12078 condition browse leaf name Osteoarthritis condition browse leaf relevance low condition browse leaf id M3628 condition browse leaf name Arthritis condition browse leaf as found Arthritis condition browse leaf relevance high condition browse leaf id M21321 condition browse leaf name Osteoarthritis, Knee condition browse leaf as found Knee Osteoarthritis condition browse leaf relevance high condition browse leaf id M11242 condition browse leaf name Muscular Atrophy condition browse leaf as found Muscle Atrophy condition browse leaf relevance high condition browse leaf id M3741 condition browse leaf name Atrophy condition browse leaf relevance low condition browse leaf id M3632 condition browse leaf name Arthritis, Rheumatoid condition browse leaf as found Arthritis, Rheumatoid condition browse leaf relevance high condition browse leaf id M9773 condition browse leaf name Joint Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M14197 condition browse leaf name Rheumatic Diseases condition browse leaf relevance low condition browse leaf id M5475 condition browse leaf name Collagen Diseases condition browse leaf relevance low condition browse leaf id M5616 condition browse leaf name Connective Tissue Diseases condition browse leaf relevance low condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id M21672 condition browse leaf name Pathological Conditions, Anatomical condition browse leaf relevance low condition browse leaf id M21772 condition browse leaf name Neuromuscular Manifestations condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC20 condition browse branch name Immune System Diseases
NCT04834050
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full study rank 61462 study protocol section identification module n c t id NCT04836156 org study id info org study id PekingUPH10B004 organization org full name Peking University People's Hospital org class OTHER brief title Neoadjuvant Therapy Study Guided by Drug Screening in Vitro for Human Epidermal Growth Factor Receptor 2 (HER2) Negative Early Breast Cancer Patients official title Neoadjuvant Therapy Study Guided by Drug Screening in Vitro Patient-derived Tumor-like Cell Clusters for Human Epidermal Growth Factor Receptor 2 (HER2) Negative Early Breast Cancer Patients status module status verified date March 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 2, 2021 start date type Actual primary completion date struct primary completion date June 30, 2022 primary completion date type Anticipated completion date struct completion date December 31, 2026 completion date type Anticipated study first submit date March 28, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date March 27, 2022 last update post date struct last update post date April 6, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Peking University People's Hospital lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Neoadjuvant treatment is an important treatment for early breast cancer patients. Patients with triple negative subtype who achieved pCR after neoadjuvant treatment would have longer survival. The neoadjuvant treatment for her2 negative patient was chemotherapy with combined drugs. However, not all patients benefit from chemotherapy but suffer from chemotherapy-related side effects. It was unknown for a patient who could benefit from which drug before chemotherapy. Drug sensitivity screening in vitro was a promising method for choosing chemotherapy. But there was no method could select effective drugs accurately for breast cancer patients until now. Previously, investigators developed a patient-derived tumor-like cell clusters in vitro culture technology. Feasibility for guiding clinical treatment by drug sensitivity screening based on this technology have been explored by preliminary exploration with a well corresponding. And the results have been published. This study will explore whether drug screening in vitro patient-derived tumor-like cell clusters from breast cancer tissue could be a method for selection of chemotherapy for her2 negative participants. detailed description Neoadjuvant chemotherapy for breast cancer could make unresectable breast cancer be resectable and improve breast conservation rate. Patients with triple negative subtype who achieved pCR after neoadjuvant treatment would have longer survival. The neoadjuvant treatment for her2 negative patient was chemotherapy with combined drugs. However, not all patients benefit from chemotherapy but suffer from chemotherapy-related side effects. It was unknown for a patient who could benefit from which drug before chemotherapy. Drug sensitivity screening in vitro was a promising method for choosing chemotherapy. But there was no method could select effective drugs accurately for breast cancer participants until now. Previously, investigators developed a patient-derived tumor-like cell clusters (PTC) in vitro culture technology. It is a cell cluster including tumor cells, mesenchymal cells and lymphocytes, which simulates the tumor microenvironment in vitro. In the preliminary exploration, investigators included 35 early breast cancer participants, the corresponding between in vitro drug sensitivity screening based on this technology and clinical treatment results was well. The results have been published. This study will focus on her2 negative early breast cancer participants. 46 participants will be included. All of them will received in vitro drug sensitivity screening upon PTC before neoadjuvant therapy. The choice of chemotherapy drugs is determined based on the PTC drug sensitivity results. If single-agent chemotherapy is effective in vitro, this drug will be the chemotherapy regimen for the corresponding participants. conditions module condition list condition HER2-negative Early Breast Cancer design module study type Interventional phase list phase Phase 1 Phase 2 design info design allocation Non-Randomized design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 46 enrollment type Anticipated arms interventions module arm group list arm group arm group label Neoadjuvant therapy base on PTC drug screening for triple negative early breast cancer arm group type Experimental arm group description Patients with triple negative subtype will receive neoadjuvant chemotherapy based on PTC drug screening. arm group intervention list arm group intervention name Drug: neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for triple negative breast cancer arm group label Neoadjuvant therapy base on PTC drug screening for luminal like early breast cancer arm group type Experimental arm group description Patients with luminal like subtype will receive neoadjuvant chemotherapy based on PTC drug screening. arm group intervention list arm group intervention name Drug: neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for luminal like breast cancer intervention list intervention intervention type Drug intervention name neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for triple negative breast cancer intervention description The choice of chemotherapy is based on the PTC drug sensitivity results. intervention arm group label list intervention arm group label Neoadjuvant therapy base on PTC drug screening for triple negative early breast cancer intervention other name list intervention other name docetaxel and carboplatin docetaxel and epirubicin intervention type Drug intervention name neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for luminal like breast cancer intervention description The choice of chemotherapy is based on the PTC drug sensitivity results. intervention arm group label list intervention arm group label Neoadjuvant therapy base on PTC drug screening for luminal like early breast cancer intervention other name list intervention other name docetaxel and cyclophosphamide epirubicin and cyclophosphamide docetaxel and epirubicin outcomes module primary outcome list primary outcome primary outcome measure pathological complete response(pCR) primary outcome description ypT0/is, ypN0 primary outcome time frame up to 24 weeks secondary outcome list secondary outcome secondary outcome measure event-free survival (EFS) secondary outcome description The time from random assignment to disease progression, including local progression before surgery; disease recurrence-local, regional, distant, ipsilateral noninvasive, or contralateral (invasive or noninvasive)-or death from any cause secondary outcome time frame 5 years secondary outcome measure invasive disease-free survival (IDFS) secondary outcome description The time from surgery to the first documented occurrence of an event defined as ipsilateral invasive local recurrence, ipsilateral locoregional invasive recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause secondary outcome time frame 5 years secondary outcome measure objective response rate secondary outcome description complete response and partial response secondary outcome time frame up to 24 weeks eligibility module eligibility criteria Inclusion Criteria: invasive breast cancer HER2 negative T2 or node positive Eastern Cooperative Oncology Group(ECOG) 0-1 Exclusion Criteria: stage IV inflammatory breast cancer Severe chronic disease healthy volunteers No gender Female minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Chaobin Wang, doctor central contact role Contact central contact phone +86-10-8832-4010 central contact e mail hzwcb1990@163.com overall official list overall official overall official name Shu Wang, doctor overall official affiliation Peking University People's Hospital overall official role Principal Investigator location list location location facility Peking University People's Hospital location status Recruiting location city Beijing location country China location contact list location contact location contact name Chaobin Wang, doctor location contact role Contact location contact phone +86-10-88324010 location contact e mail hzwcb1990@163.com derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001943 condition mesh term Breast Neoplasms condition ancestor list condition ancestor condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000001941 condition ancestor term Breast Diseases condition ancestor id D000012871 condition ancestor term Skin Diseases condition browse leaf list condition browse leaf condition browse leaf id M4372 condition browse leaf name Breast Neoplasms condition browse leaf as found Breast Cancer condition browse leaf relevance high condition browse leaf id M4370 condition browse leaf name Breast Diseases condition browse leaf relevance low condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000003520 intervention mesh term Cyclophosphamide intervention mesh id D000016190 intervention mesh term Carboplatin intervention mesh id D000077143 intervention mesh term Docetaxel intervention mesh id D000015251 intervention mesh term Epirubicin intervention mesh id D000010634 intervention mesh term Phenobarbital intervention ancestor list intervention ancestor intervention ancestor id D000007166 intervention ancestor term Immunosuppressive Agents intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000018501 intervention ancestor term Antirheumatic Agents intervention ancestor id D000018906 intervention ancestor term Antineoplastic Agents, Alkylating intervention ancestor id D000000477 intervention ancestor term Alkylating Agents intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000019653 intervention ancestor term Myeloablative Agonists intervention ancestor id D000050257 intervention ancestor term Tubulin Modulators intervention ancestor id D000050256 intervention ancestor term Antimitotic Agents intervention ancestor id D000050258 intervention ancestor term Mitosis Modulators intervention ancestor id D000000903 intervention ancestor term Antibiotics, Antineoplastic intervention ancestor id D000059005 intervention ancestor term Topoisomerase II Inhibitors intervention ancestor id D000059003 intervention ancestor term Topoisomerase Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000000927 intervention ancestor term Anticonvulsants intervention ancestor id D000006993 intervention ancestor term Hypnotics and Sedatives intervention ancestor id D000002492 intervention ancestor term Central Nervous System Depressants intervention ancestor id D000018691 intervention ancestor term Excitatory Amino Acid Antagonists intervention ancestor id D000018683 intervention ancestor term Excitatory Amino Acid Agents intervention ancestor id D000018377 intervention ancestor term Neurotransmitter Agents intervention ancestor id D000018757 intervention ancestor term GABA Modulators intervention ancestor id D000018682 intervention ancestor term GABA Agents intervention ancestor id D000065695 intervention ancestor term Cytochrome P-450 CYP2B6 Inducers intervention ancestor id D000065693 intervention ancestor term Cytochrome P-450 Enzyme Inducers intervention ancestor id D000065701 intervention ancestor term Cytochrome P-450 CYP3A Inducers intervention browse leaf list intervention browse leaf intervention browse leaf id M17802 intervention browse leaf name Carboplatin intervention browse leaf as found Program intervention browse leaf relevance high intervention browse leaf id M5879 intervention browse leaf name Cyclophosphamide intervention browse leaf as found Based intervention browse leaf relevance high intervention browse leaf id M1668 intervention browse leaf name Docetaxel intervention browse leaf as found Three intervention browse leaf relevance high intervention browse leaf id M11052 intervention browse leaf name Mitogens intervention browse leaf relevance low intervention browse leaf id M17106 intervention browse leaf name Epirubicin intervention browse leaf as found Primary care intervention browse leaf relevance high intervention browse leaf id M12692 intervention browse leaf name Phenobarbital intervention browse leaf as found Glecaprevir/Pibrentasvir intervention browse leaf relevance high intervention browse leaf id M9364 intervention browse leaf name Immunosuppressive Agents intervention browse leaf relevance low intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse leaf id M19757 intervention browse leaf name Antirheumatic Agents intervention browse leaf relevance low intervention browse leaf id M20095 intervention browse leaf name Antineoplastic Agents, Alkylating intervention browse leaf relevance low intervention browse leaf id M2972 intervention browse leaf name Alkylating Agents intervention browse leaf relevance low intervention browse leaf id M25350 intervention browse leaf name Tubulin Modulators intervention browse leaf relevance low intervention browse leaf id M25349 intervention browse leaf name Antimitotic Agents intervention browse leaf relevance low intervention browse leaf id M3374 intervention browse leaf name Anti-Bacterial Agents intervention browse leaf relevance low intervention browse leaf id M3376 intervention browse leaf name Antibiotics, Antitubercular intervention browse leaf relevance low intervention browse leaf id M3398 intervention browse leaf name Anticonvulsants intervention browse leaf relevance low intervention browse leaf id M9195 intervention browse leaf name Hypnotics and Sedatives intervention browse leaf relevance low intervention browse leaf id M19924 intervention browse leaf name Excitatory Amino Acid Antagonists intervention browse leaf relevance low intervention browse leaf id M19657 intervention browse leaf name Neurotransmitter Agents intervention browse leaf relevance low intervention browse leaf id M19980 intervention browse leaf name GABA Modulators intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev ARhu intervention browse branch name Antirheumatic Agents intervention browse branch abbrev AntiConv intervention browse branch name Anticonvulsants intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents
NCT04836156
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full study rank 61443 study protocol section identification module n c t id NCT04836403 org study id info org study id CMUH105-REC1-138(AR-1) organization org full name China Medical University Hospital org class OTHER brief title Validation of the Chinese Version of the Sinus and Nasal Quality of Life Survey (SN-5) official title Validation of the Chinese Version of the Sinus and Nasal Quality of Life Survey (SN-5) and Correlation With Pediatric Obstructive Sleep Apnea and Asthma status module status verified date August 2021 overall status Completed expanded access info has expanded access No start date struct start date December 1, 2016 start date type Actual primary completion date struct primary completion date December 31, 2017 primary completion date type Actual completion date struct completion date December 31, 2017 completion date type Actual study first submit date March 29, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date August 3, 2021 last update post date struct last update post date August 5, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name China Medical University Hospital lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of our study was to validate the Chinese version of the Sinus and Nasal Quality of Life Survey (SN-5)and correlation with the incidence of pediatric obstructive sleep apnea and asthma. The study will enroll pediatric patients of rhino-sinusitis and their parents to finish Questionnaire 1, including Chinese version of SN-5, visual analogue scale (VAS), Pediatric allergy disease Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ), OSA-18 quality of Life Survey, and asthma-diagnostic questionnaire . Some patients re-tested SN-5 in 1 week later. After four weeks, participants finish these questionnaire 2, including SN-5, VAS, and PADQLQ. In addition, the author will invite health children without rhino-sinusitis disease and their parents to fill in Questionnaire 1. The Chinese version of SN-5 will be validated to establish its reliability and validity. detailed description The purpose of the study was to validate the Chinese version of the Sinus and Nasal Quality of Life Survey (SN-5)and correlation with the incidence of pediatric obstructive sleep apnea and asthma. The study will enroll pediatric patients of rhino-sinusitis and parents to finish Questionnaire 1, including Chinese version of SN-5, visual analogue scale (VAS), Pediatric allergy disease Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ), OSA-18 quality of Life Survey, and asthma-diagnostic questionnaire . Some patients re-tested SN-5 in 1 week later. After four weeks, they finish these questionnaire 2, including SN-5, VAS, and PADQLQ. In addition, the author will invite health children without rhino-sinusitis disease and their parents to fill in Questionnaire 1. The Chinese version of SN-5 will be validated to establish its reliability and validity. From December 2016 to December 2017, healthy volunteers and children with persistent sinonasal symptoms were enrolled. Guardians of the participants completed the SN-5, a visual analog scale (VAS) of nasal symptoms, and the Obstructive Sleep Apnea-18 (OSA-18) ; the responses were used to assess internal consistency, discriminant validity, and treatment responsiveness. A nontreatment group was administered the SN-5 1 week later to assess test-retest reliability. conditions module condition list condition Chronic Rhinosinusitis keyword list keyword SN-5 Quality of life children design module study type Observational patient registry No design info design observational model list design observational model Case-Control design time perspective list design time perspective Prospective enrollment info enrollment count 116 enrollment type Actual arms interventions module arm group list arm group arm group label Rhinosinusitis without treatment group arm group description children aged 2 and 12 years with rhinosinusitis not receiving treatment arm group intervention list arm group intervention name Other: Sinus and nasal quality of life survey questionnaire (SN-5) arm group label Rhinosinusitis with treatment group arm group description children aged 2 and 12 years with rhinosinusitis receiving treatment arm group intervention list arm group intervention name Other: Sinus and nasal quality of life survey questionnaire (SN-5) arm group label healthy volunteers arm group description children aged 2 and 12 years without rhinosinusitis arm group intervention list arm group intervention name Other: Sinus and nasal quality of life survey questionnaire (SN-5) intervention list intervention intervention type Other intervention name Sinus and nasal quality of life survey questionnaire (SN-5) intervention description The SN-5 consists of five questions on a 7-point scale that assesses the frequency of the following symptoms: (1) nasal obstruction, (2) sinus infection, (3) allergies, (4) emotional distress, and (5) activity limitations. The scoring system is as follows: 1 indicates "none of the time," 2 indicating "hardly any time at all," 3 indicates "a small part of the time," 4 indicates "some of the time," 5 indicates "a good part of the time," 6 indicates "most of the time," and 7 indicates "all of the time." Higher scores indicate more severe sinonasal symptoms. One item from a global faces scale scored from 0 to 10 is used to evaluate overall QoL related to nasal or sinus disease. Higher scores on this scale indicate a less severe impact of nasal or sinus disease. The scores from the first five items (1-7 each) intervention arm group label list intervention arm group label Rhinosinusitis with treatment group Rhinosinusitis without treatment group healthy volunteers outcomes module primary outcome list primary outcome primary outcome measure Test-retest reliability primary outcome description A nontreatment group was administered the SN-5 1 week later to assess test-retest reliability. primary outcome time frame 1 week primary outcome measure Concurrent validity primary outcome description The correlation between SN-5 and VAS scores was used to analyze the concurrent validity of the SN-5. primary outcome time frame baseline primary outcome measure Discriminant validity primary outcome description Discriminant validity was assessed by calculating the difference between the SN-5 scores for participants with rhinosinusitis and for the healthy participants. These differences were analyzed with the Mann-Whitney U test. primary outcome time frame baseline secondary outcome list secondary outcome secondary outcome measure the mean scores of SN-5 secondary outcome description To evaluate the responsiveness of the treatment , the author compare the mean score of treatment group after 4-week-treatment compared to baseline mean score of SN-5 before treatment.Data analyzed with the Wilcoxon signed-rank test. Effects were evaluated through intention-to-treat analysis. secondary outcome time frame 4 week secondary outcome measure correlation with score of SN-5 and score of OSA-18 quality of life questionnaire (OSA-18) secondary outcome description To evaluate the correlation of SN-5 and OSA-18, Spearman correlation coefficients between the SN-5 and OSA-18 scores were analyzed. secondary outcome time frame baseline and 4 week eligibility module eligibility criteria Inclusion Criteria: Children with one or more of the following symptoms, purulent nasal discharge, nasal congestion, cough, or postnasal drip for at least 1 month. Exclusion Criteria: craniofacial anomalies cognitive deficits illiteracy in traditional Chinese. healthy volunteers Accepts Healthy Volunteers gender All minimum age 2 Years maximum age 12 Years std age list std age Child study population Rhinosinusitis patients were recruited from pediatric clinics practicing Western or Chinese medicine sampling method Probability Sample references module reference list reference reference p m i d 35595617 reference type derived reference citation Lai WY, Kay DJ, Wei CC, Huang FW, Liang KL, Yen HR. Validation of the traditional Chinese version of the Sinus and Nasal Quality of Life Survey (SN-5) for children. Pediatr Neonatol. 2022 Jul;63(4):410-417. doi: 10.1016/j.pedneo.2022.01.008. Epub 2022 May 2. i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M3513 condition browse leaf name Apnea condition browse leaf relevance low condition browse leaf id M14846 condition browse leaf name Sleep Apnea Syndromes condition browse leaf relevance low condition browse leaf id M21163 condition browse leaf name Sleep Apnea, Obstructive condition browse leaf relevance low condition browse leaf id M3708 condition browse leaf name Asthma condition browse leaf relevance low condition browse leaf id T6034 condition browse leaf name Quality of Life condition browse leaf as found Quality of Life condition browse leaf relevance high condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04836403
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full study rank 61639 study protocol section identification module n c t id NCT04833855 org study id info org study id 20190194 organization org full name Amgen org class INDUSTRY brief title Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria official title A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging, Phase 2b Study to Evaluate Efficacy and Safety of Tezepelumab for the Treatment of Chronic Spontaneous Urticaria acronym INCEPTION status module status verified date November 2022 overall status Active, not recruiting start date struct start date April 15, 2021 start date type Actual primary completion date struct primary completion date December 21, 2022 primary completion date type Anticipated completion date struct completion date April 13, 2023 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date November 9, 2022 last update post date struct last update post date November 14, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Amgen lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No description module brief summary The primary objective of this study is to evaluate the effect of tezepelumab on improvement in the Urticaria Activity Score over 7 days (UAS7). conditions module condition list condition Chronic Spontaneous Urticaria keyword list keyword CSU design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Triple design who masked list design who masked Participant Care Provider Investigator enrollment info enrollment count 183 enrollment type Actual arms interventions module arm group list arm group arm group label Group 1: Omalizumab arm group type Active Comparator arm group description Participants naive to anti-IgE therapies will receive omalizumab. arm group intervention list arm group intervention name Biological: Omalizumab arm group label Group 2: Placebo arm group type Placebo Comparator arm group description Participants naive to anti-IgE therapies will receive a placebo. arm group intervention list arm group intervention name Biological: Placebo arm group label Group 3: Tezepelumab Dose 1 arm group type Experimental arm group description Participants naive to anti-IgE therapies will receive tezepelumab. arm group intervention list arm group intervention name Biological: Tezepelumab Dose 1 arm group label Group 4: Tezepelumab Dose 2 arm group type Experimental arm group description Participants naive to anti-IgE therapies will receive tezepelumab. arm group intervention list arm group intervention name Biological: Tezepelumab Dose 2 arm group label Group 5: Placebo arm group type Placebo Comparator arm group description Participants previously treated with anti-IgE therapies will receive a placebo. arm group intervention list arm group intervention name Biological: Placebo arm group label Group 6: Tezepelumab Dose 1 arm group type Experimental arm group description Participants previously treated with anti-IgE therapies will receive tezepelumab. arm group intervention list arm group intervention name Biological: Tezepelumab Dose 1 arm group label Group 7: Tezepelumab Dose 2 arm group type Experimental arm group description Participants previously treated with anti-IgE therapies will receive tezepelumab. arm group intervention list arm group intervention name Biological: Tezepelumab Dose 2 intervention list intervention intervention type Biological intervention name Tezepelumab Dose 1 intervention description Subcutaneous injection. intervention arm group label list intervention arm group label Group 3: Tezepelumab Dose 1 Group 6: Tezepelumab Dose 1 intervention type Biological intervention name Tezepelumab Dose 2 intervention description Subcutaneous injection. intervention arm group label list intervention arm group label Group 4: Tezepelumab Dose 2 Group 7: Tezepelumab Dose 2 intervention type Biological intervention name Omalizumab intervention description Subcutaneous injection. intervention arm group label list intervention arm group label Group 1: Omalizumab intervention other name list intervention other name Xolair intervention type Biological intervention name Placebo intervention description Subcutaneous injection. intervention arm group label list intervention arm group label Group 2: Placebo Group 5: Placebo outcomes module primary outcome list primary outcome primary outcome measure Change from Baseline in Urticaria Activity Score over 7 days (UAS7) primary outcome time frame Baseline to Week 16 secondary outcome list secondary outcome secondary outcome measure Number of Participants with a Complete Response in Urticaria Activity Score over 7 Days (UAS7) secondary outcome description Complete response is defined as having a UAS7 score of 0 at week 16. secondary outcome time frame Week 16 secondary outcome measure Change from Baseline in Itch Severity Score over 7 Days (ISS7) secondary outcome time frame Baseline to Week 16 secondary outcome measure Change from Baseline in Hives Severity Score over 7 Days (HSS7) secondary outcome time frame Baseline to Week 16 secondary outcome measure Number of Participants with a Urticaria Activity Score over 7 days (UAS7) Score of 6 or Below secondary outcome time frame Week 16 secondary outcome measure Number of Participants with a Change from Baseline in Urticaria Activity Score over 7 days (UAS7) of ≤ -10 secondary outcome time frame Baseline to Week 16 secondary outcome measure Number of Participants with a Complete Resolution of Itch using the Itch Severity Score over 7 Days (ISS7) secondary outcome description Complete resolution of itch is defined as having a ISS7 score of 0 at week 16. secondary outcome time frame Week 16 secondary outcome measure Number of Participants with a Change from Baseline in Itch Severity Score over 7 days (ISS7) of ≤ -5 secondary outcome time frame Baseline to Week 16 secondary outcome measure Number of Participants with a Complete Resolution of Hives using the Hives Severity Score over 7 Days (HSS7) secondary outcome description Complete resolution of hives is defined as a HSS7 score of 0 at week 16. secondary outcome time frame Week 16 secondary outcome measure Number of Participants with a Change from Baseline in Hives Severity Score over 7 Days (HSS7) of ≤ -5.5 secondary outcome time frame Baseline to Week 16 secondary outcome measure Change from Baseline in Sleep Interference Score secondary outcome time frame Baseline to Week 16 secondary outcome measure Change from Baseline in Sleep Quality Diary Items secondary outcome time frame Baseline to Week 16 secondary outcome measure Change from Baseline in Urticaria Control Test (UCT) Score secondary outcome time frame Baseline to Week 16 secondary outcome measure Change from Baseline in Angioedema Activity Score over 7 Days (AAS7) secondary outcome time frame Baseline to Week 16 secondary outcome measure Number of Cumulative Weeks that Participants are Angioedema Occurrence-free using the Angioedema Activity Score over 7 Days (AAS7) secondary outcome time frame Baseline to Week 16 secondary outcome measure Change from Baseline in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) Score secondary outcome time frame Baseline to Week 16 secondary outcome measure Change from Baseline in Dermatology Life Quality Index (DLQI) Score secondary outcome time frame Baseline to Week 16 secondary outcome measure Change from Baseline in Angioedema Quality of Life Questionnaire (AE-QoL) Score secondary outcome time frame Baseline to Week 16 secondary outcome measure Change from Baseline in Angioedema Control Test (AECT) Score secondary outcome time frame Baseline to Week 16 secondary outcome measure Number of Participants with Complete Control in Angioedema Control Test (AECT) secondary outcome description Complete control is defined as having an AECT score of 16 at week 16. secondary outcome time frame Week 16 secondary outcome measure Change from Baseline in Work Productivity and Activity Impairment Questionnaire: Chronic Urticaria (WPAI-CU) Score secondary outcome time frame Baseline to Week 16 secondary outcome measure Total Number of H1-antihistamine Rescue Medication Uses secondary outcome time frame Baseline to Week 16 secondary outcome measure Maximum Observed Concentration of Tezepelumab in Serum (Cmax) secondary outcome time frame Baseline to Week 16 secondary outcome measure Number of Participants who Experience an Adverse Event (AE) secondary outcome time frame Baseline to Week 32 secondary outcome measure Number of Participants who Experience a Serious Adverse Event (SAE) secondary outcome time frame Baseline to Week 32 eligibility module eligibility criteria Inclusion Criteria: Signed informed consent must be obtained prior to participation in the study. Male and female participants ≥ 18 years and ≤ 80 years of age at the time of screening. Chronic spontaneous urticaria (CSU) diagnosis for ≥ 6 months at the time of screening. CSU inadequately controlled by second generation H1-antihistamines (sgAH) at enrollment, as defined by all of the following: The presence of itch and hives for >= 6 consecutive weeks at any time prior to screening visit 2 Failure to respond to an sgAH (up to 4 times the approved dose) Urticaria Activity Score over 7 days (UAS7) (range 0-42) >= 16 and Hives Severity Score over 7 days (HSS7) (range 0-21) >= 8 during the 7 days prior to enrollment Participant with CSU who discontinued, is intolerant to, or was an inadequate responder to anti-IgE therapies despite being treated with omalizumab 300 mg every 4 weeks (Q4W) for 6 months or higher doses of omalizumab > 2 months or another anti-IgE therapy. Note: This criterion is only applicable for anti-IgE-experienced participants. Participant willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules. Subject must have been on a sgAH at approved or increased doses (up to 4x the approved dose) for treatment of CSU for at least 3 consecutive days immediately prior to the day -14 screening visit (screening visit 2) and must have documented current use on the day of screening visit 1 Exclusion Criteria: Disease related, including but not limited to: Urticaria is solely due to inducible urticaria Active dermatologic diseases (or conditions) other than chronic urticaria, with urticaria wheals or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency) Any other active skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (eg, atopic dermatitis, dermatitis herpetiformis, senile pruritus, etc.) History of a clinically significant infection within 28 days prior to day 1 that, in the opinion of the investigator or medical monitor, might compromise the safety of the participant in the study, interfere with evaluation of the investigational product, or reduce the participants ability to participate in the study. Evidence of active tuberculosis (TB) (in the opinion of the investigator), either treated or untreated, or a positive purified protein derivative (PPD) or QuantiFERON-TB Gold Plus (QFT-Plus) test for TB during screening. History of malignancy, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ 12 months prior to screening or other malignancies treated with apparent success with curative therapy ≥ 5 years prior to screening visit 1. Subject is unable to complete an electronic patient diary or complete questionnaires, or does not meet the required level of compliance with the eDiary during the 14 days sgAH stabilization period Other medical conditions History or evidence of severe depression, schizophrenia, previous suicide attempts, or suicidal ideation. Prior/concomitant therapy, including but not limited to: Treatment with any biologic products (eg, omalizumab, ligelizumab) within 4 months or 5 half-lives (whichever is longer) prior to screening visit 1 Routine (daily or every other day for 5 or more consecutive days) use of systemic corticosteroids, systemic hydroxychloroquine, methotrexate, cyclosporine A, cyclophosphamide, tacrolimus, azathioprine, and mycophenolate mofetil within 30 days prior to screening visit 1. Major surgery within 8 weeks prior to screening visit 1 or planned inpatient surgery or hospitalization during the study period. Receipt of Ig or blood products within 30 days prior to screening visit 1. Vaccination with a live or attenuated vaccine within 30 days prior to screening visit 1. Receipt of COVID-19 vaccines and inactive/killed vaccinations (eg, inactive influenza) are allowed, provided the vaccinations are not administered within 7 days before or after any study dosing visit. Known hypersensitivity, including severe hypersensitivity reactions and/or history of anaphylactic shock, to any of the products or components to be administered during dosing or to products of similar chemical classes (ie, to murine, chimeric, or human antibodies. healthy volunteers No gender All minimum age 18 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name MD overall official affiliation Amgen overall official role Study Director location list location location facility Clinical Research Center of Alabama location city Birmingham location state Alabama location zip 35209 location country United States location facility First OC Dermatology location city Fountain Valley location state California location zip 92708 location country United States location facility Avance Clinical Trials location city Laguna Niguel location state California location zip 92677 location country United States location facility Jonathan Corren MD Inc location city Los Angeles location state California location zip 90025 location country United States location facility Dermatology Research Associates location city Los Angeles location state California location zip 90045 location country United States location facility Clinical Science Institute location city Santa Monica location state California location zip 90404 location country United States location facility Asthma and Allergy Associates PC location city Colorado Springs location state Colorado location zip 80907 location country United States location facility The Community Research of South Florida location city Miami Lakes location state Florida location zip 33016 location country United States location facility Advanced Medical Research PC location city Sandy Springs location state Georgia location zip 30328 location country United States location facility Dawes Fretzin Clinical Research Group, LLC location city Indianapolis location state Indiana location zip 46250 location country United States location facility Epiphany Dermatology of Kansas, LLC location city Overland Park location state Kansas location zip 66210 location country United States location facility Bluegrass Allergy Care location city Lexington location state Kentucky location zip 40509 location country United States location facility Family Allergy and Asthma Research Institute location city Louisville location state Kentucky location zip 40215 location country United States location facility Johns Hopkins Asthma and Allergy Center location city Baltimore location state Maryland location zip 21224 location country United States location facility David Fivenson MD Professional Liability Company location city Ann Arbor location state Michigan location zip 48103 location country United States location facility Clarkston Skin Research location city Clarkston location state Michigan location zip 48346 location country United States location facility Henry Ford Medical Center - New Center One location city Detroit location state Michigan location zip 48202 location country United States location facility Washington University School of Medicine location city Saint Louis location state Missouri location zip 63110 location country United States location facility Icahn School of Medicine at Mount Sinai location city New York location state New York location zip 10029 location country United States location facility Bernstein Clinical Research Center LLC location city Cincinnati location state Ohio location zip 45236 location country United States location facility Aventiv Research Inc location city Dublin location state Ohio location zip 43016 location country United States location facility Clinical Partners LLC location city Johnston location state Rhode Island location zip 02919 location country United States location facility The Allergy Asthma and Sinus Center, East Tennessee Center for Clinical Research location city Knoxville location state Tennessee location zip 37909 location country United States location facility Suzanne Bruce and Associates location city Houston location state Texas location zip 77056 location country United States location facility Cutis Wellness Dermatology and Dermatopathology, PLLC location city Laredo location state Texas location zip 78041 location country United States location facility Dermatology Research Institute Incorporated location city Calgary location state Alberta location zip T2J 7E1 location country Canada location facility Brunswick Dermatology Centre location city Fredericton location state New Brunswick location zip E3B 1G9 location country Canada location facility LEADER Research location city Hamilton location state Ontario location zip L8L 3C3 location country Canada location facility Lynderm Research Inc location city Markham location state Ontario location zip L3P 1X3 location country Canada location facility Cheema Research Incorporated location city Mississauga location state Ontario location zip L5A 3V4 location country Canada location facility Dr. S. K. Siddha Medicine Professional Corporation location city Newmarket location state Ontario location zip L3Y 5G8 location country Canada location facility Allergy Research Canada Incorporated location city Niagara Falls location state Ontario location zip L2H 1H5 location country Canada location facility Gordon Sussman Clinical Research Incorporated location city North York location state Ontario location zip M3B 3S6 location country Canada location facility Clinique Spécialisée en Allergie de la Capitale location city Quebec location zip G1V 4W2 location country Canada location facility Centre Hospitalier Universitaire de Brest - Hôpital Morvan location city Brest location zip 29200 location country France location facility Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon location city Grenoble Cedex 9 location zip 38043 location country France location facility Hôpital Saint Eloi location city Montpellier cedex 5 location zip 34295 location country France location facility Centre Hospitalier Universitaire Archet 2 location city Nice location zip 06202 location country France location facility Centre Hospitalier Lyon Sud location city Pierre Benite Cedex location zip 69495 location country France location facility *Charité* location city Berlin location zip 12203 location country Germany location facility Universitaetsklinikum Dresden location city Dresden location zip 01307 location country Germany location facility Johannes Gutenberg Universitaet Mainz location city Mainz location zip 55101 location country Germany location facility Laiko General Hospital of Athens location city Athens location zip 11527 location country Greece location facility Sotiria General Hospital location city Athens location zip 11527 location country Greece location facility Attikon University General Hospital of Athens location city Athens location zip 12462 location country Greece location facility Andreas Syggros Hospital location city Athens location zip 16121 location country Greece location facility George Papageorgiou General Hospital of Thessaloniki location city Thessaloniki location zip 56403 location country Greece location facility Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico location city Milano location zip 20122 location country Italy location facility Azienda Ospedaliero Universitaria di Modena location city Modena location zip 41124 location country Italy location facility Fondazione Policlinico Tor Vergata location city Roma location zip 00133 location country Italy location facility Policlinico Universitario Agostino Gemelli location city Roma location zip 00168 location country Italy location facility IRCCS Istituto Clinico Humanitas location city Rozzano MI location zip 20089 location country Italy location facility Azienda Ospedaliera Citta della Salute e della Scienza di Torino location city Torino location zip 10126 location country Italy location facility Fujita Health University Bantane Hospital location city Nagoya-shi location state Aichi location zip 454-8509 location country Japan location facility Hiroshima University Hospital location city Hiroshima-shi location state Hiroshima location zip 734-8551 location country Japan location facility Takagi Dermatological Clinic location city Obihiro-shi location state Hokkaido location zip 080-0013 location country Japan location facility Kosugi Dermatology Clinic location city Kawasaki-shi location state Kanagawa location zip 211-0063 location country Japan location facility Nomura Dermatology Clinic location city Yokohama-shi location state Kanagawa location zip 221-0825 location country Japan location facility Osaka Habikino Medical Center location city Habikino-shi location state Osaka location zip 583-8588 location country Japan location facility Dermatology and Ophthalmology Kume Clinic location city Sakai-shi location state Osaka location zip 593-8324 location country Japan location facility Nihon University Itabashi Hospital location city Itabashi-ku location state Tokyo location zip 173-8610 location country Japan location facility NTT Medical Center Tokyo location city Shinagawa-ku location state Tokyo location zip 141-8625 location country Japan location facility Hallym University Dongtan Sacred Heart Hospital location city Hwaseong-si, Gyeonggi-do location zip 18450 location country Korea, Republic of location facility Seoul National University Bundang Hospital location city Seongnam-si, Gyeonggi-do location zip 13620 location country Korea, Republic of location facility Severance Hospital, Yonsei University Health System location city Seoul location zip 03722 location country Korea, Republic of location facility Asan Medical Center location city Seoul location zip 05505 location country Korea, Republic of location facility Hallym University Kangnam Sacred Heart Hospital location city Seoul location zip 07441 location country Korea, Republic of location facility Ajou University Hospital location city Suwon-si, Gyeonggi-do location zip 16499 location country Korea, Republic of location facility Uniwersyteckie Centrum Kliniczne location city Gdansk location zip 80-214 location country Poland location facility AMICARE z ograniczona odpowiedzialnoscia spolka komandytowa location city Lodz location zip 91-495 location country Poland location facility SPZOZ Centralny Szpital Kliniczny location city Lodz location zip 92-213 location country Poland location facility Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie location city Lublin location zip 20-081 location country Poland location facility Clinical Research Center Spzoo Medic-R Spolka Komandytowa location city Poznan location zip 61-731 location country Poland location facility Kliniczny Szpital Wojewodzki nr 1 im Fryderyka Chopina location city Rzeszow location zip 35-055 location country Poland location facility Klinika Osipowicz and Turkowski Spzoo Opieka Wielospecjalistyczna Osipowicz and Turkowski location city Warszawa location zip 02-473 location country Poland location facility Wojskowy Instytut Medyczny location city Warszawa location zip 04-141 location country Poland location facility Hospital del Mar location city Barcelona location state Cataluña location zip 08003 location country Spain location facility Hospital de la Santa Creu i Sant Pau location city Barcelona location state Cataluña location zip 08041 location country Spain location facility Hospital Universitari de Bellvitge location city Hospitalet de LLobregat location state Cataluña location zip 08907 location country Spain location facility Hospital General Universitario de Valencia location city Valencia location state Comunidad Valenciana location zip 46014 location country Spain location facility Hospital Arnau de Vilanova de Valencia location city Valencia location state Comunidad Valenciana location zip 46015 location country Spain references module see also link list see also link see also link label AmgenTrials clinical trials website see also link u r l http://www.amgentrials.com i p d sharing statement module i p d sharing Yes i p d sharing description De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) i p d sharing time frame Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study. i p d sharing access criteria Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below. i p d sharing u r l https://www.amgen.com/datasharing derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000014581 condition mesh term Urticaria condition mesh id D000080223 condition mesh term Chronic Urticaria condition ancestor list condition ancestor condition ancestor id D000017445 condition ancestor term Skin Diseases, Vascular condition ancestor id D000012871 condition ancestor term Skin Diseases condition ancestor id D000006969 condition ancestor term Hypersensitivity, Immediate condition ancestor id D000006967 condition ancestor term Hypersensitivity condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M16482 condition browse leaf name Urticaria condition browse leaf as found Urticaria condition browse leaf relevance high condition browse leaf id M2129 condition browse leaf name Chronic Urticaria condition browse leaf as found Chronic Spontaneous Urticaria condition browse leaf relevance high condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse leaf id M18866 condition browse leaf name Skin Diseases, Vascular condition browse leaf relevance low condition browse leaf id M9170 condition browse leaf name Hypersensitivity condition browse leaf relevance low condition browse leaf id M9172 condition browse leaf name Hypersensitivity, Immediate condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000069444 intervention mesh term Omalizumab intervention mesh id D000000911 intervention mesh term Antibodies, Monoclonal intervention ancestor list intervention ancestor intervention ancestor id D000018926 intervention ancestor term Anti-Allergic Agents intervention ancestor id D000018927 intervention ancestor term Anti-Asthmatic Agents intervention ancestor id D000019141 intervention ancestor term Respiratory System Agents intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M413 intervention browse leaf name Omalizumab intervention browse leaf as found Healthy Participants intervention browse leaf relevance high intervention browse leaf id M9336 intervention browse leaf name Immunoglobulins intervention browse leaf relevance low intervention browse leaf id M3377 intervention browse leaf name Antibodies intervention browse leaf relevance low intervention browse leaf id M3382 intervention browse leaf name Antibodies, Monoclonal intervention browse leaf as found Stromal Vascular Fraction intervention browse leaf relevance high intervention browse leaf id M20115 intervention browse leaf name Anti-Allergic Agents intervention browse leaf relevance low intervention browse leaf id M20116 intervention browse leaf name Anti-Asthmatic Agents intervention browse leaf relevance low intervention browse leaf id M20290 intervention browse leaf name Respiratory System Agents intervention browse leaf relevance low intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev AAll intervention browse branch name Anti-Allergic Agents intervention browse branch abbrev Resp intervention browse branch name Respiratory System Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04833855
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full study rank 61589 study protocol section identification module n c t id NCT04834505 org study id info org study id EUS-AIP-PC-1 organization org full name Peking Union Medical College Hospital org class OTHER brief title To Differentiate Focal Autoimmune Pancreatitis From Pancreatic Cancer by Endoscopic Ultrasound official title Construction and Validation of a Diagnosis Model Based on Endoscopic Ultrasound Characteristics for Differentiating Between Focal Autoimmune Pancreatitis and Pancreatic Cancer status module status verified date September 2022 overall status Recruiting expanded access info has expanded access No start date struct start date May 11, 2021 start date type Actual primary completion date struct primary completion date September 2023 primary completion date type Anticipated completion date struct completion date March 2024 completion date type Anticipated study first submit date April 4, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date September 27, 2022 last update post date struct last update post date September 28, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Tao Guo responsible party investigator title Associated professor in Department of Gastroenterolgy responsible party investigator affiliation Peking Union Medical College Hospital lead sponsor lead sponsor name Peking Union Medical College Hospital lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Autoimmune pancreatitis (AIP) is a special type of chronic pancreatitis mediated by autoimmunity. The classic manifestation of AIP is diffuse pancreatic enlargement, some of which are characterized by focal enlargement. Clinically, it is divided into diffuse AIP (DAIP) and focal AIP (FAIP) according to morphology. FAIP can be clinically manifested as obstructive jaundice, peripancreatic lymphadenopathy and vascular involvement, which may mimic pancreatic cancer (PC). CT/MRI is the important imaging tool for diagnosing pancreatic diseases. However, due to the overlap of the imaging features of FAIP and PC, it is challenging to differentiate the two by CT/MRI. Endoscopic ultrasound (EUS) can clearly display the pancreatic parenchyma and pancreatic duct system and has become a routine modality for the evaluation of pancreatic diseases. The aim of this study is to construct a diagnosis model for distinguishing between FAIP and PC by comparing the EUS characteristics of the two, and further validate its diagnostic efficacy. detailed description A derivation sample is established by retrospectively collecting the EUS images of about 100 FAIP patients and about 200 PC patients who were diagnosed for the first time in Peking Union Medical College Hospital in the past 6 years and underwent EUS at the same time. The parenchymal and ductal changes of pancreas were defined according to the Rosemont criteria. The parenchymal characteristics included hyperechoic foci/strands and lobularity, and the ductal changes included main pancreatic duct (MPD) dilation. Other EUS characteristics not included in the conventional criteria were described based on the literatures, including pancreatic diffuse hypoechogenicity, focal hypoechogenicity, pancreatic diffuse enlargement, focal enlargement, peripancreatic hypoechoic margin, common bile duct (CBD) dilation, bile duct wall thickening, lymphadenopathy and vessel involvement. The EUS characteristics of the two groups of patients are included in the multivariate stepwise logistic regression and receiver operating characteristics (ROC) analyses to construct a differential diagnosis model in derivation sample. Further, the differential diagnosis model will be prospectively validated by calculating the sensitivity and specificity in about 90 patients who are going to undergo EUS due to the difficulty in distinguishing between FAIP and PC. Diagnosis of AIP meets the revised Mayo clinic criteria (revised HISORt criteria) including features of histology, imaging, serology, other organs involvement and response to steroid therapy. Diagnosis of pancreatic duct adenocarcinoma is confirmed by surgical pathology or by cytology/histology after EUS-guided fine needle aspiration or biopsy. conditions module condition list condition Autoimmune Pancreatitis Pancreatic Cancer design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Other enrollment info enrollment count 390 enrollment type Anticipated arms interventions module arm group list arm group arm group label Derivation sample arm group description The patients conclusively diagnosed as FAIP or PC are retrospectively collected. arm group intervention list arm group intervention name Other: EUS for derivation sample arm group label Validation sample arm group description The patients with difficulty in distinguishing between FAIP and PC are prospectively enrolled. arm group intervention list arm group intervention name Other: Diagnostic imaging modalities for validation sample intervention list intervention intervention type Other intervention name Diagnostic imaging modalities for validation sample intervention description Endoscopic ultrasound and other imaging modalities such as CT, MRI, or PET-CT are performed. intervention arm group label list intervention arm group label Validation sample intervention type Other intervention name EUS for derivation sample intervention description Endoscopic ultrasound was performed. intervention arm group label list intervention arm group label Derivation sample outcomes module primary outcome list primary outcome primary outcome measure To construct a diagnosis model for distinguishing FAIP from PC and further validate its efficacy primary outcome description Score is assigned to each predictor based on the odd ratio (OR) value, individual risk is estimated based on the sum of weighted score for each predictor and optimal cut-off point is obtained based on receiver operating characteristic (ROC) analysis. Sensitivity and specificity were used to assess the diagnostic efficacy. primary outcome time frame 1 week after the diagnosis is conclusive secondary outcome list secondary outcome secondary outcome measure Compare the efficacy of EUS based on the model with that of CT/MRI/PET-CT in differentiating between FAIP and PC secondary outcome description Sensitivity and specificity were used to assess the diagnostic efficacy secondary outcome time frame 1 week after the diagnosis is conclusive eligibility module eligibility criteria Inclusion Criteria: Patients with difficulty in distinguishing between FAIP and PC Exclusion Criteria: Referred patients with a history of having being conclusively diagnosed as AIP or PC; Patients with DAIP; Patients with alcoholic pancreatitis, hypertriglyceridemia pancreatitis or pancreatitis due to gallstones; Patients with pancreatic cystic tumors, pancreatic neuroendocrine tumors or solid pseudopapillary tumors of pancreas; Patients who cannot undergo EUS due to unsuitable conditions. healthy volunteers No gender All maximum age 75 Years std age list std age Child Adult Older Adult study population In derivation sample, the patients conclusively diagnosed as FAIP or PC are retrospectively collected. In validation sample, the patients with difficulty in distinguishing between FAIP and PC are prospectively enrolled. In the end, the patient with a diagnosis that is neither FAIP nor PC and the patient without conclusive diagnosis are withdrawn from the study. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Tao Guo, MD central contact role Contact central contact phone 8610-69155017 central contact e mail guoqiong990@126.com overall official list overall official overall official name Tao Guo, MD overall official affiliation Peking Union Medical College Hospital overall official role Principal Investigator location list location location facility Peking Union Medical College Hospital location status Recruiting location city Beijing location state Beijing location zip 100730 location country China location contact list location contact location contact name Tao Guo, MD location contact role Contact location contact phone 8610-69155017 location contact e mail guoqiong990@126.com location contact name Tao Guo, MD location contact role Principal Investigator references module reference list reference reference p m i d 25770706 reference type background reference citation Hart PA, Zen Y, Chari ST. Recent Advances in Autoimmune Pancreatitis. Gastroenterology. 2015 Jul;149(1):39-51. doi: 10.1053/j.gastro.2015.03.010. Epub 2015 Mar 12. reference p m i d 16932997 reference type background reference citation Kamisawa T, Okamoto A. Autoimmune pancreatitis: proposal of IgG4-related sclerosing disease. J Gastroenterol. 2006 Jul;41(7):613-25. doi: 10.1007/s00535-006-1862-6. reference p m i d 30012334 reference type background reference citation Miyabe K, Zen Y, Cornell LD, Rajagopalan G, Chowdhary VR, Roberts LR, Chari ST. Gastrointestinal and Extra-Intestinal Manifestations of IgG4-Related Disease. Gastroenterology. 2018 Oct;155(4):990-1003.e1. doi: 10.1053/j.gastro.2018.06.082. Epub 2018 Sep 12. reference p m i d 22069025 reference type background reference citation Muhi A, Ichikawa T, Motosugi U, Sou H, Sano K, Tsukamoto T, Fatima Z, Araki T. Mass-forming autoimmune pancreatitis and pancreatic carcinoma: differential diagnosis on the basis of computed tomography and magnetic resonance cholangiopancreatography, and diffusion-weighted imaging findings. J Magn Reson Imaging. 2012 Apr;35(4):827-36. doi: 10.1002/jmri.22881. Epub 2011 Nov 8. reference p m i d 20598255 reference type background reference citation Gardner TB, Levy MJ. EUS diagnosis of chronic pancreatitis. Gastrointest Endosc. 2010 Jun;71(7):1280-9. doi: 10.1016/j.gie.2010.02.038. No abstract available. reference p m i d 19214678 reference type background reference citation Hoki N, Mizuno N, Sawaki A, Tajika M, Takayama R, Shimizu Y, Bhatia V, Yamao K. Diagnosis of autoimmune pancreatitis using endoscopic ultrasonography. J Gastroenterol. 2009;44(2):154-9. doi: 10.1007/s00535-008-2294-2. Epub 2009 Feb 13. reference p m i d 19410017 reference type background reference citation Chari ST, Takahashi N, Levy MJ, Smyrk TC, Clain JE, Pearson RK, Petersen BT, Topazian MA, Vege SS. A diagnostic strategy to distinguish autoimmune pancreatitis from pancreatic cancer. Clin Gastroenterol Hepatol. 2009 Oct;7(10):1097-103. doi: 10.1016/j.cgh.2009.04.020. Epub 2009 May 4. i p d sharing statement module i p d sharing No i p d sharing description The protocol of the study is private. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010190 condition mesh term Pancreatic Neoplasms condition mesh id D000010195 condition mesh term Pancreatitis condition mesh id D000081012 condition mesh term Autoimmune Pancreatitis condition ancestor list condition ancestor condition ancestor id D000004067 condition ancestor term Digestive System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000004701 condition ancestor term Endocrine Gland Neoplasms condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000010182 condition ancestor term Pancreatic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000050500 condition ancestor term Pancreatitis, Chronic condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M12262 condition browse leaf name Pancreatic Neoplasms condition browse leaf as found Pancreatic Cancer condition browse leaf relevance high condition browse leaf id M12267 condition browse leaf name Pancreatitis condition browse leaf as found Pancreatitis condition browse leaf relevance high condition browse leaf id M2253 condition browse leaf name Autoimmune Pancreatitis condition browse leaf as found Autoimmune Pancreatitis condition browse leaf relevance high condition browse leaf id M8038 condition browse leaf name Gastrointestinal Neoplasms condition browse leaf relevance low condition browse leaf id M6408 condition browse leaf name Digestive System Neoplasms condition browse leaf relevance low condition browse leaf id M7015 condition browse leaf name Endocrine Gland Neoplasms condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M12254 condition browse leaf name Pancreatic Diseases condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id M25413 condition browse leaf name Pancreatitis, Chronic condition browse leaf relevance low condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id T4387 condition browse leaf name Pancreatic Cancer condition browse leaf as found Pancreatic Cancer condition browse leaf relevance high condition browse leaf id T564 condition browse leaf name Autoimmune Pancreatitis condition browse leaf as found Autoimmune Pancreatitis condition browse leaf relevance high condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases
NCT04834505
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full study rank 61194 study protocol section identification module n c t id NCT04839640 org study id info org study id 123456789 organization org full name Cairo University org class OTHER brief title Study of Wear in Composite Resin and Reinforced Acrylic Denture Teeth Used in Complete Denture Construction for Completely Edentulous Patients official title Study of Wear in Composite Resin and Reinforced Acrylic Denture Teeth Used in Complete Denture Construction for Completely Edentulous Patients (Randomized Controlled Trial) status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date May 1, 2018 start date type Actual primary completion date struct primary completion date May 1, 2019 primary completion date type Actual completion date struct completion date May 1, 2019 completion date type Actual study first submit date April 17, 2018 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name shereen ismail responsible party investigator title principle investigator responsible party investigator affiliation Cairo University lead sponsor lead sponsor name Cairo University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Visit 1: Clinical examination and investigations will be carried out for the eligible patients including TMJ examination and intraoral examination for oral mucosa. Diagnostic charts will be prepared with full medical and dental history as well as radiographic records. Primary impression will be performed with irreversible hydro-colloid impression material (alginate), The impressions will be poured with type IV dental stone to obtain diagnostic casts, special tray will be constructed. Visit 2: Maxillary Face-bow will be recorded to mount the upper cast. The diagnostic casts will be mounted on semi adjustable articulator in centric occluding relation to evaluate the inter-arch distance. Visit 3: Secondary impression will be performed in special trays by elastomeric impression material. The impression will be poured into typeIV dental stone in order to obtain master cast. Visit 4: Trial denture base will be constructed and tried in patient's mouth for obtaining maxilla-mandibular relation using face bow record and centric relation record, then mounting of the casts on semi adjustable articulator will be done. The teeth will be set according to the randomization group. Visit 5: The denture bases will be tried in with acrylic teeth in patient's mouth. Visit 6: The denture will be delivered to the patient and occlusal adjustments will be done. Visit 7: Recall visit after one week, further adjustments will be done. The denture will be sent to the scanning center and given to the patient again. Visit 8: At 3 months follow up, the denture will be inspected for calculus and will be immersed in ultrasonic cleaner for 15 seconds to remove calculus and then scanned. Visit 9: At 6 months follow up, the denture will be inspected for calculus and will be immersed in ultrasonic cleaner for 15 seconds to remove calculus and then scanned. Visit 10: At 9 months follow up, the denture will be inspected for calculus and will be immersed in ultrasonic cleaner for 15 seconds to remove calculus and then scanned. The optical methods tend to fulfill the need for quantitative characterization of surface topography. Specimens will be photographed using USB Digital microscope with a built-in camera (Scope Capture Digital Microscope, Guangdong, China) connected with an IBM compatible personal computer using a fixed magnification of 120X.The images will be recorded with a resolution of 1280 × 1024 pixels per image. Digital microscope images will be cropped using Microsoft office picture manager to specify/standardize area of roughness measurement. The cropped images will be analyzed using WSxM software. Specimens will be photographed using USB Digital microscope with a built-in camera (Scope Capture Digital Microscope, Guangdong, China) connected with an IBM compatible personal computer using a fixed magnification of 120X. The images will be recorded with a resolution of 1280 × 1024 pixels per image. Digital microscope images will be cropped to 350 x 400 pixels using Microsoft office picture manager to specify/standardize area of roughness measurement. The cropped images will be analyzed using WSxM software. conditions module condition list condition Wear, Occlusal design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description split mouth technique design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 6 enrollment type Actual arms interventions module arm group list arm group arm group label reinforced acrylic resin denture teeth arm group type Active Comparator arm group description Shufo acrylic denture teeth arm group intervention list arm group intervention name Other: Bredent denture teeth arm group label Composite resin denture teeth arm group type Experimental arm group description Bredent denture teeth arm group intervention list arm group intervention name Other: Bredent denture teeth intervention list intervention intervention type Other intervention name Bredent denture teeth intervention description composite resin denture teeth intervention arm group label list intervention arm group label Composite resin denture teeth reinforced acrylic resin denture teeth outcomes module primary outcome list primary outcome primary outcome measure Optical scanning to detect difference in wear at baseline and 3 months follow up visits primary outcome description Specimens will be photographed using USB Digital microscope with a built-in camera (Scope Capture Digital Microscope, Guangdong, China) connected with an IBM compatible personal computer using a fixed magnification of 120X. The images will be recorded with a resolution of 1280 × 1024 pixels per image. Digital microscope images will be cropped to 350 x 400 pixels using Microsoft office picture manager to specify/standardize area of roughness measurement. The cropped images will be analyzed using WSxM software. primary outcome time frame 3 months primary outcome measure Optical scanning to detect difference in wear at baseline and 6 months follow up visits primary outcome description Specimens will be photographed using USB Digital microscope with a built-in camera (Scope Capture Digital Microscope, Guangdong, China) connected with an IBM compatible personal computer using a fixed magnification of 120X. The images will be recorded with a resolution of 1280 × 1024 pixels per image. Digital microscope images will be cropped to 350 x 400 pixels using Microsoft office picture manager to specify/standardize area of roughness measurement. The cropped images will be analyzed using WSxM software. primary outcome time frame 6 months primary outcome measure Optical scanning to detect difference in wear at baseline and 9 months follow up visits primary outcome description Specimens will be photographed using USB Digital microscope with a built-in camera (Scope Capture Digital Microscope, Guangdong, China) connected with an IBM compatible personal computer using a fixed magnification of 120X. The images will be recorded with a resolution of 1280 × 1024 pixels per image. Digital microscope images will be cropped to 350 x 400 pixels using Microsoft office picture manager to specify/standardize area of roughness measurement. The cropped images will be analyzed using WSxM software. primary outcome time frame 9 months eligibility module eligibility criteria Inclusion Criteria: Edentulous subjects with indication for full dentures Skeletal class I maxillomandibular relationship Exclusion Criteria: Uncooperative patients. Subjects that wear dentures for less than 6 hours per day Subjects from which no compliance can be expected healthy volunteers Accepts Healthy Volunteers gender All std age list std age Child Adult Older Adult contacts locations module location list location location facility Cairo University location city Cairo location country Egypt i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000019217 condition mesh term Tooth Attrition condition mesh id D000057085 condition mesh term Tooth Wear condition ancestor list condition ancestor condition ancestor id D000009057 condition ancestor term Stomatognathic Diseases condition ancestor id D000014076 condition ancestor term Tooth Diseases condition browse leaf list condition browse leaf condition browse leaf id M11178 condition browse leaf name Mouth, Edentulous condition browse leaf relevance low condition browse leaf id M27858 condition browse leaf name Tooth Wear condition browse leaf as found Wear, Occlusal condition browse leaf relevance high condition browse leaf id M20358 condition browse leaf name Tooth Attrition condition browse leaf as found Wear, Occlusal condition browse leaf relevance high condition browse leaf id M11169 condition browse leaf name Stomatognathic Diseases condition browse leaf relevance low condition browse leaf id M15983 condition browse leaf name Tooth Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC07 condition browse branch name Mouth and Tooth Diseases condition browse branch abbrev All condition browse branch name All Conditions
NCT04839640
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full study rank 61582 study protocol section identification module n c t id NCT04834596 org study id info org study id 2021 OOPS organization org full name University Hospital, Angers org class OTHER_GOV brief title Detection and Automatic Segmentation of Liver Nodules in Patients With Colorectal Adenocarcinoma official title Detection and Automatic Segmentation of Liver Nodules in Patients With Colorectal acronym OOPS status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date May 2, 2021 start date type Anticipated primary completion date struct primary completion date December 1, 2021 primary completion date type Anticipated completion date struct completion date May 2, 2022 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University Hospital, Angers lead sponsor class OTHER_GOV oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Evaluation of the diagnostic performance of artificial intelligence-based software for the detection of liver nodules on scanner in patients at risk of liver metastases of colorectal cancer detailed description The aim of this study is to evaluate the performance of a software for liver nodule detection in patients with colorectal cancer compared to the consensus of two radiologists analysis. 300 hepatic scanners will be analysed. conditions module condition list condition Detection of Liver Metastases design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Retrospective enrollment info enrollment count 300 enrollment type Anticipated arms interventions module arm group list arm group arm group label patients without hepatic metastases arm group description hepatic scanner of 100 patients with colorectal cancer without hepatic metastases will be analysed arm group intervention list arm group intervention name Other: retrospectives analysis on hepatic scanner arm group label patients with synchronous hepatic metastases arm group description hepatic scanner of 100 patients with colorectal cancer with synchronous hepatic metastases will be analysed arm group intervention list arm group intervention name Other: retrospectives analysis on hepatic scanner arm group label patients with metachronous hepatic metastases arm group description hepatic scanner of 100 patients with colorectal cancer with metachronous hepatic metastases will be analysed arm group intervention list arm group intervention name Other: retrospectives analysis on hepatic scanner intervention list intervention intervention type Other intervention name retrospectives analysis on hepatic scanner intervention description hepatic scanner will be analysed by two radiologist and by the software intervention arm group label list intervention arm group label patients with metachronous hepatic metastases patients with synchronous hepatic metastases patients without hepatic metastases outcomes module primary outcome list primary outcome primary outcome measure To evaluate the performance of the software for detection of hepatic nodules on CT scan of patients with colorectal cancer compared to a reference constituted by the evaluation established by two radiologists in consensus. primary outcome description Number of nodules detected by the software compared to the reference method primary outcome time frame 1 month eligibility module eligibility criteria Inclusion Criteria: Patients consecutively treated for colorectal cancer a Availability of imaging by injected abdominal scanner including at least one portal phase Age over 18 Exclusion Criteria: Patients with treatment of the hepatic nodule by ablation or previous hepatic surgery Imaging follow-up <12 months Non-interpretable scanner (artefact, injection quality, etc.) Patients with more than 10 liver metastases healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population patients with colorectal cancer sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Marie Bost central contact role Contact central contact e mail mabost@chu-angers.fr location list location location facility UHAngers location city Angers location zip 49933 location country France location contact list location contact location contact name marie bost location contact role Contact location contact e mail mabost@chu-angers.fr location contact name Anita Paisant location contact role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009362 condition mesh term Neoplasm Metastasis condition ancestor list condition ancestor condition ancestor id D000009385 condition ancestor term Neoplastic Processes condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M2737 condition browse leaf name Adenocarcinoma condition browse leaf relevance low condition browse leaf id M11459 condition browse leaf name Neoplasm Metastasis condition browse leaf as found Metastases condition browse leaf relevance high condition browse leaf id M11482 condition browse leaf name Neoplastic Processes condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M10262 intervention browse leaf name Liver Extracts intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Hemat intervention browse branch name Hematinics intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04834596
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full study rank 61802 study protocol section identification module n c t id NCT04831736 org study id info org study id 21-00072 organization org full name NYU Langone Health org class OTHER brief title Effect of Postoperative Single Dose of Ketamine on Pain After Mastectomy official title Randomized, Single-blind, Placebo-controlled Study on the Effect of Postoperative Administration of Single Dose Ketamine After Mastectomy on Pain status module status verified date September 2022 overall status Completed expanded access info has expanded access No start date struct start date April 26, 2021 start date type Actual primary completion date struct primary completion date March 29, 2022 primary completion date type Actual completion date struct completion date March 29, 2022 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date September 20, 2022 last update post date struct last update post date September 22, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name NYU Langone Health lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No is u s export Yes description module brief summary This is a randomized, single blinded, placebo-controlled trial to study the effectiveness of a subanesthetic dose (0.6mg/kg) of ketamine versus placebo (saline) on postoperative pain on adult women undergoing mastectomy. The objective of the study is to examine the effect of a subanesthetic dose (0.6mg/kg) of ketamine vs. saline control on postoperative pain in subjects who have undergone mastectomy. conditions module condition list condition Postoperative Pain keyword list keyword Mastectomy design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 31 enrollment type Actual arms interventions module arm group list arm group arm group label Treatment arm group type Experimental arm group intervention list arm group intervention name Drug: Ketamine arm group label Control arm group type Placebo Comparator arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Drug intervention name Ketamine intervention description Ketamine at a dose of 0.6 mg/kg will be administered intravenously (IV) while the participant is recovering in the PACU. The study drug will be administered over at least 30 minutes at one time point and will be administered after subject has been deemed to be stable (hemodynamically stable, awake) by the study team on POD 0. intervention arm group label list intervention arm group label Treatment intervention type Drug intervention name Placebo intervention description Matching equal dose of saline placebo will be administered intravenously while the participant is recovering in the PACU. intervention arm group label list intervention arm group label Control outcomes module primary outcome list primary outcome primary outcome measure Brief Pain Inventory-short form (BPI) Pain Severity Subscale Score primary outcome description BPI Pain Severity Subscale consists of 4 questions (asking to rate pain). Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain. primary outcome time frame 24 Hours Post-Op (Day 2) primary outcome measure Brief Pain Inventory-short form (BPI) Pain Severity Subscale Score primary outcome description BPI Pain Severity Subscale consists of 4 questions (asking to rate pain). Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain. primary outcome time frame 48 Hours Post-Op (Day 3) secondary outcome list secondary outcome secondary outcome measure Brief Pain Inventory-short form (BPI) Pain Severity Subscale Score secondary outcome description BPI Pain Severity Subscale is a 4-item questionnaire asking participants to rate pain. Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain. secondary outcome time frame Baseline (Day 0) secondary outcome measure Brief Pain Inventory-short form (BPI) Pain Severity Subscale Score secondary outcome description BPI Pain Severity Subscale is a 4-item questionnaire asking participants to rate pain. Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain. secondary outcome time frame Day 7 Post-Op (Day 8) secondary outcome measure Brief Pain Inventory-short form (BPI) Pain Interference Subscale Score secondary outcome description BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference. secondary outcome time frame Baseline (Day 0) secondary outcome measure Brief Pain Inventory-short form (BPI) Pain Interference Subscale Score secondary outcome description BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference. secondary outcome time frame Day 1 Post-Op (Day 2) secondary outcome measure Brief Pain Inventory-short form (BPI) Pain Interference Subscale Score secondary outcome description BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference. secondary outcome time frame Day 2 Post-Op (Day 3) secondary outcome measure Brief Pain Inventory-short form (BPI) Pain Interference Subscale Score secondary outcome description BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference. secondary outcome time frame Day 7 Post-Op (Day 8) secondary outcome measure Total Dosage of Opioid Use secondary outcome description Use and dosage will be assessed through medical records and subject reports. secondary outcome time frame Day of Surgery (Day 1) secondary outcome measure Total Dosage of Opioid Use secondary outcome description Use and dosage will be assessed through medical records and subject reports. secondary outcome time frame Day 1 Post-Op (Day 2) secondary outcome measure Total Dosage of Opioid Use secondary outcome description Use and dosage will be assess through medical records and subject reports. secondary outcome time frame Day 2 Post-Op (Day 3) secondary outcome measure Total Dosage of Opioid Use secondary outcome description Use and dosage will be assess through medical records and subject reports. secondary outcome time frame Day 7 Post-Op (Day 8) secondary outcome measure Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score secondary outcome description The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The total range of score is 1-35; the higher the score, the higher the frequency of fatigue. secondary outcome time frame Baseline (Day 0) secondary outcome measure Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score secondary outcome description The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The total range of score is 1-35; the higher the score, the higher the frequency of fatigue. secondary outcome time frame Day 1 Post-Op (Day 2) secondary outcome measure Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score secondary outcome description The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The total range of score is 1-35; the higher the score, the higher the frequency of fatigue. secondary outcome time frame Day 2 Post-Op (Day 3) secondary outcome measure Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score secondary outcome description The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The total range of score is 1-35; the higher the score, the higher the frequency of fatigue. secondary outcome time frame Day 7 Post-Op (Day 8) secondary outcome measure Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score secondary outcome description The PROMIS Sleep Disturbance Short Form consists of 6 items assessing sleep disturbance. Each question is answered with a score of 1-5 (varies). The total range of score is 1-30; the lower the score, the better the quality of sleep. secondary outcome time frame Baseline (Day 0) secondary outcome measure Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score secondary outcome description The PROMIS Sleep Disturbance Short Form consists of 6 items assessing sleep disturbance. Each question is answered with a score of 1-5 (varies). The total range of score is 1-30; the lower the score, the better the quality of sleep. secondary outcome time frame Day 7 Post-Op (Day 8) secondary outcome measure Generalized Anxiety Disorder (GAD-2) Score secondary outcome description GAD-2 consists of 2 items and measures how often one has been bothered by anxiety-related problems. Each is answered with a score of 0 (not at all) to 3 (nearly every day). The total range of score is 0-6; the higher the score, the more frequent one is bothered by anxiety. secondary outcome time frame Baseline (Day 0) secondary outcome measure Generalized Anxiety Disorder (GAD-2) Score secondary outcome description GAD-2 consists of 2 items and measures how often one has been bothered by anxiety-related problems. Each is answered with a score of 0 (not at all) to 3 (nearly every day). The total range of score is 0-6; the higher the score, the more frequent one is bothered by anxiety. secondary outcome time frame Day 7 Post-Op (Day 8) secondary outcome measure Breast Cancer Pain Questionnaire (BCPQ) - Pain Score secondary outcome description If the patient reports pain in the area of the breast, armpit, side of the body, or arm on the side of operation, dependent on the location, the patient will be asked to report level of pain (0 is no pain and 10 is the worst pain imaginable). For each location, the total score is 0-10; the higher the score, the worse the pain. secondary outcome time frame Day 7 Post-Op (Day 8) secondary outcome measure Quality of Recovery (QoR-15) Survey Score secondary outcome description Part A of QoR-15 consists of 10 conditions. Based on how the patient has been feeling in the last 24 hours, they will respond to each condition using an 11-point Likert scale ranging from 0 to 10, where 0 is none of the time [poor] and 10 is all of the time [excellent]). The total range of score for Part A is 0-100; the higher the score, the better the participant has been feeling. Part B consists of 5 symptoms. The patient will indicate whether they have experienced each symptom over the last 24 hours using an 11-point Likert scale ranging from 10 to 0, where 10 is none of the time [excellent] and 0 is all of the time [poor]). The total range of score for Part B is 0-50; the higher the score, the better the participant has been feeling. The total score is the sum of of scores from Parts A and B. Scores range from 0-150; the higher the score, the better the participant has been feeling. secondary outcome time frame Day 2 Post-Op (Day 3) secondary outcome measure Quality of Recovery (QoR-15) Survey Score secondary outcome description Part A of QoR-15 consists of 10 conditions. Based on how the patient has been feeling in the last 24 hours, they will respond to each condition using an 11-point Likert scale ranging from 0 to 10, where 0 is none of the time [poor] and 10 is all of the time [excellent]). The total range of score for Part A is 0-100; the higher the score, the better the participant has been feeling. Part B consists of 5 symptoms. The patient will indicate whether they have experienced each symptom over the last 24 hours using an 11-point Likert scale ranging from 10 to 0, where 10 is none of the time [excellent] and 0 is all of the time [poor]). The total range of score for Part B is 0-50; the higher the score, the better the participant has been feeling. The total score is the sum of of scores from Parts A and B. Scores range from 0-150; the higher the score, the better the participant has been feeling. secondary outcome time frame Day 7 Post-Op (Day 8) secondary outcome measure Occurrence of Side-Effects secondary outcome description Side effects are calculated using a 7-item psycho-behavioral questionnaire. Participants indicate whether they have experienced any of the listed side effects. secondary outcome time frame Day of Surgery (Day 1) secondary outcome measure Occurrence of Side-Effects secondary outcome description Side effects are calculated using a 7-item psycho-behavioral questionnaire. Participants indicate whether they have experienced any of the listed side effects. secondary outcome time frame Day 1 Post-Op (Day 2) eligibility module eligibility criteria Inclusion Criteria: Adult women, aged 18 to 80 years old, who will undergo mastectomy. Willing to comply with all study procedures and be available for the duration of the study. Will be scheduled for elective breast surgery for oncologic indication as follows: mastectomy +/- lymph node dissection, prophylactic mastectomy, unilateral or bilateral, with immediate reconstruction No distant metastases. Subject is American Society of Anesthesiologists (ASA) physical status 1, 2, or 3. Subject is medically stable. Exclusion Criteria: Cognitive impairment (by history) or clinical signs of altered mental status such as confusion, amnesia, disorientation, fluctuating levels of alertness, etc. that may interference with adherence to study procedures and/or participant safety. Past ketamine or phencyclidine misuse or abuse. Schizophrenia or history of psychosis. Known sensitivity or allergy to ketamine. Liver or renal insufficiency. History of uncontrolled hypertension, chest pain, cardiac arrythmia, stroke, head trauma, intracranial mass or hemorrhage or pressure, glaucoma, acute globe injury, uncontrolled thyroid disease, porphyria, or any other contraindication to ketamine. Use of lamotrigine, alfentanil, physostigmine, and 4-aminopyridine are contraindicated Pregnancy or nursing women BMI>35. Currently participating in another pain interventional trial. Unwillingness to give informed consent. Non-English speaking patients as QoR-15 and BCPQ have not been validated in all other languages healthy volunteers No gender Female gender based Yes minimum age 18 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Lisa Doan, MD overall official affiliation NYU Langone Health overall official role Principal Investigator location list location location facility NYU Langone Health location city New York location state New York location zip 10016 location country United States i p d sharing statement module i p d sharing Yes i p d sharing description Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request. i p d sharing info type list i p d sharing info type Study Protocol i p d sharing time frame Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research. i p d sharing access criteria The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to lisa.doan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010149 condition mesh term Pain, Postoperative condition ancestor list condition ancestor condition ancestor id D000011183 condition ancestor term Postoperative Complications condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M12221 condition browse leaf name Pain, Postoperative condition browse leaf as found Postoperative Pain condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M13217 condition browse leaf name Postoperative Complications condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000007649 intervention mesh term Ketamine intervention ancestor list intervention ancestor intervention ancestor id D000000700 intervention ancestor term Analgesics intervention ancestor id D000018689 intervention ancestor term Sensory System Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000000778 intervention ancestor term Anesthetics, Dissociative intervention ancestor id D000018686 intervention ancestor term Anesthetics, Intravenous intervention ancestor id D000018681 intervention ancestor term Anesthetics, General intervention ancestor id D000000777 intervention ancestor term Anesthetics intervention ancestor id D000002492 intervention ancestor term Central Nervous System Depressants intervention ancestor id D000018691 intervention ancestor term Excitatory Amino Acid Antagonists intervention ancestor id D000018683 intervention ancestor term Excitatory Amino Acid Agents intervention ancestor id D000018377 intervention ancestor term Neurotransmitter Agents intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention browse leaf list intervention browse leaf intervention browse leaf id M9826 intervention browse leaf name Ketamine intervention browse leaf as found Hospital intervention browse leaf relevance high intervention browse leaf id M3184 intervention browse leaf name Analgesics intervention browse leaf relevance low intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse leaf id M3260 intervention browse leaf name Anesthetics, Dissociative intervention browse leaf relevance low intervention browse leaf id M19919 intervention browse leaf name Anesthetics, Intravenous intervention browse leaf relevance low intervention browse leaf id M19914 intervention browse leaf name Anesthetics, General intervention browse leaf relevance low intervention browse leaf id M19924 intervention browse leaf name Excitatory Amino Acid Antagonists intervention browse leaf relevance low intervention browse leaf id M19657 intervention browse leaf name Neurotransmitter Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04831736
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full study rank 61230 study protocol section identification module n c t id NCT04839172 org study id info org study id CMOTC organization org full name Cardenal Herrera University org class OTHER brief title Effect of Football on the Musculoskeletal System and Hormonal System official title Study of the Effect of Football Practice on Bone Remodeling. status module status verified date March 2022 overall status Completed expanded access info has expanded access No start date struct start date July 1, 2021 start date type Actual primary completion date struct primary completion date July 10, 2021 primary completion date type Actual completion date struct completion date December 30, 2021 completion date type Actual study first submit date April 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date March 8, 2022 last update post date struct last update post date March 9, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Isabel Almodóvar Fernández responsible party investigator title PhD responsible party investigator affiliation Cardenal Herrera University lead sponsor lead sponsor name Cardenal Herrera University lead sponsor class OTHER collaborator list collaborator collaborator name Villarreal CF collaborator class UNKNOWN oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Several studies have shown that football practice regulates bone remodeling, producing an increase of bone mineral density and reducing the risk of fractures. Thus, the aim of this study is to evaluate the effect of football practice on the regulation of bone turnover in Spanish adult football players. Thanks to the collaboration agreement "Aula Endavant" the Villarreal CF participates as a collaborator in this Project. This agreement allows us to use their facilities and to analyze several football players' data. detailed description Several studies have shown that football practice regulates bone remodeling, producing an increase of bone mineral density and reducing the risk of fractures. These studies are mainly performed in adolescents and there are few results obtained from European adults subjects. Thus, the aim of this study is to evaluate the effect of football practice on the regulation of bone turnover in Spanish adult football players. Secondary objectives include: describing bone mineral density values, evaluating percentage of total lean mass and body fat, describing dietary and physical habits and analyzing blood tests of professional football players. As well as, they include updating the current state of knowledge of the influence of sports on bone. Thanks to the collaboration agreement "Aula Endavant" the Villarreal CF participates as a collaborator in this Project. This agreement allows us to use their facilities and to analyze several football players' data. In addition, different members of the club will directly participate as researchers during the development of this study. One of the strengths of this study is that the data were obtained from two consecutive seasons of an elite soccer team. One of the potential limitations that we have faced in this study is that in order to obtain a large sample, it is necessary to analyse the soccers from two consecutive seasons, which makes the study temporarily longer than desired. conditions module condition list condition Regional Body Composition Cortisol and Testosterone Levels keyword list keyword Regional body composition Testosterone Cortisol design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Retrospective enrollment info enrollment count 30 enrollment type Actual arms interventions module intervention list intervention intervention type Diagnostic Test intervention name Dual-energy X-ray Absorptiometry (DXA) scan intervention description Longitudinal changes in body composition are examined over four consecutive seasons (2017-2018, 2018-2019, 2019-2020, 2020-2021), four times per season in the following stages: start-preseason, start-season, mid-season and end-season. intervention other name list intervention other name Fasting blood samples outcomes module primary outcome list primary outcome primary outcome measure to examine the evolution of total and regional body composition and cortisol and testosterone levels of Spanish elite soccer players during a soccer season primary outcome description to examine the evolution of total and regional body composition and cortisol and testosterone levels of Spanish elite soccer players during a soccer season primary outcome time frame 3 years eligibility module eligibility criteria Inclusion Criteria: male gender aged between 18 and 40 years who practice soccer for more than 6 hours / week from the age of 10 to the present. Exclusion Criteria: play other elite sports than soccer play 6 or more hours of recreational sports per week smokers individuals with chronic cardiovascular diseases, hypo and hyperthyroidism, hypertension, rheumatoid arthritis and osteoarthritis gender Male minimum age 18 Years maximum age 40 Years std age list std age Adult study population male professional soccer players playing in the top soccer championship in Spain sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Adolfo Muñoz Macho, MD overall official affiliation Medical Services of Villarreal CF SAD overall official role Study Chair location list location location facility Villarreal CF location city Villarreal location state Castellón location zip 12540 location country Spain i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M9064 intervention browse leaf name Hydrocortisone intervention browse leaf relevance low intervention browse leaf id M15661 intervention browse leaf name Testosterone intervention browse leaf relevance low intervention browse leaf id M155022 intervention browse leaf name Hydrocortisone 17-butyrate 21-propionate intervention browse leaf relevance low intervention browse leaf id M228602 intervention browse leaf name Hydrocortisone acetate intervention browse leaf relevance low intervention browse leaf id M263157 intervention browse leaf name Hydrocortisone hemisuccinate intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infl intervention browse branch name Anti-Inflammatory Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals
NCT04839172
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full study rank 61219 study protocol section identification module n c t id NCT04839315 org study id info org study id 21-000501 organization org full name Mayo Clinic org class OTHER brief title COVID-19 Vaccination in Rheumatic Disease Patients official title Immunological Consequences of COVID-19 Vaccination in Patients With Rheumatic Diseases status module status verified date May 2022 overall status Terminated why stopped Difficulty with enrollment expanded access info has expanded access No start date struct start date February 15, 2021 start date type Actual primary completion date struct primary completion date February 9, 2022 primary completion date type Actual completion date struct completion date February 9, 2022 completion date type Actual study first submit date April 5, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date May 31, 2022 last update post date struct last update post date June 3, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Hu Zeng responsible party investigator title Principal Investigator responsible party investigator affiliation Mayo Clinic lead sponsor lead sponsor name Mayo Clinic lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No description module brief summary The research is being done to study the immune responses to COVID-19 vaccination in patients with rheumatic diseases. detailed description Because patients treated with immunosuppressive agents have been excluded from initial clinical trials, and most patients with rheumatic diseases are taking immunosuppressants, the immune responses towards the mRNA COVID19 vaccines in these patients remains unknown. The goal is to study the immune response to COVID-19 vaccination in patients with rheumatic diseases. Blood samples collected before and longitudinally after mRNA-based COVID-19 vaccination (i.e., Pfizer and Moderna vaccines) will enable detailed immunological investigation of the interaction between COVID-19 vaccination and rheumatic diseases. These efforts will provide novel insights into the COVID-19 vaccine response in patients with rheumatic diseases, and eventually would inform clinical management to improve patient care. conditions module condition list condition Systemic Lupus Erythematosus Sjogren's Syndrome Inflammatory Myositis Psoriatic Arthritis Gout Ankylosing Spondylitis Arthritis of Multiple Sites Associated With Inflammatory Bowel Disease (Diagnosis) Osteoarthritis design module study type Interventional phase list phase Early Phase 1 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Health Services Research design masking info design masking None (Open Label) enrollment info enrollment count 58 enrollment type Actual arms interventions module arm group list arm group arm group label mRNA COVID19 vaccines arm group type Other arm group description mRNA-based COVID19 vaccines arm group intervention list arm group intervention name Biological: mRNA COVD19 vaccine intervention list intervention intervention type Biological intervention name mRNA COVD19 vaccine intervention description Subjects will receive two doses of mRNA based COVID19 vaccines. intervention arm group label list intervention arm group label mRNA COVID19 vaccines outcomes module primary outcome list primary outcome primary outcome measure Humoral responses towards mRNA COVID-19 vaccines primary outcome description We aim to examine SARS-Cov2 specific antibody, and autoantibody generation primary outcome time frame 2 weeks to 6 months after second dose of vaccine secondary outcome list secondary outcome secondary outcome measure Cellular immune responses towards mRNA COVID-19 vaccines secondary outcome description measurement of immune cell distributions, type I interferon activity, and SARS-Cov2 specific T cell responses secondary outcome time frame 2 weeks to 6 months after second dose of vaccine eligibility module eligibility criteria Inclusion Criteria: Rheumatologist confirmed diagnosis of one of the following diagnoses: Systemic lupus erythematosus; Sjogren syndrome; Inflammatory myositis; Psoriatic arthritis; Osteoarthritis; Gout; Ankylosing spondylitis; IBD-related arthritis. Exclusion Criteria: Active infection or untreated malignancy (other than skin cancer) at enrollment. Pregnancy healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Hu Zeng, PhD overall official affiliation Mayo Clinic overall official role Principal Investigator location list location location facility Mayo Clinic in Rochester location city Rochester location state Minnesota location zip 55905 location country United States references module see also link list see also link see also link label Mayo Clinic Clinical Trials see also link u r l https://www.mayo.edu/research/clinical-trials derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000013166 condition mesh term Spondylitis condition mesh id D000001168 condition mesh term Arthritis condition mesh id D000015535 condition mesh term Arthritis, Psoriatic condition mesh id D000013167 condition mesh term Spondylitis, Ankylosing condition mesh id D000012216 condition mesh term Rheumatic Diseases condition mesh id D000012859 condition mesh term Sjogren's Syndrome condition mesh id D000009220 condition mesh term Myositis condition mesh id D000015212 condition mesh term Inflammatory Bowel Diseases condition mesh id D000008180 condition mesh term Lupus Erythematosus, Systemic condition mesh id D000003095 condition mesh term Collagen Diseases condition ancestor list condition ancestor condition ancestor id D000007592 condition ancestor term Joint Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000007410 condition ancestor term Intestinal Diseases condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000005759 condition ancestor term Gastroenteritis condition ancestor id D000003240 condition ancestor term Connective Tissue Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition ancestor id D000025242 condition ancestor term Spondylarthropathies condition ancestor id D000025241 condition ancestor term Spondylarthritis condition ancestor id D000013122 condition ancestor term Spinal Diseases condition ancestor id D000001847 condition ancestor term Bone Diseases condition ancestor id D000011565 condition ancestor term Psoriasis condition ancestor id D000017444 condition ancestor term Skin Diseases, Papulosquamous condition ancestor id D000012871 condition ancestor term Skin Diseases condition ancestor id D000001850 condition ancestor term Bone Diseases, Infectious condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000000844 condition ancestor term Ankylosis condition ancestor id D000001172 condition ancestor term Arthritis, Rheumatoid condition ancestor id D000014987 condition ancestor term Xerostomia condition ancestor id D000012466 condition ancestor term Salivary Gland Diseases condition ancestor id D000009059 condition ancestor term Mouth Diseases condition ancestor id D000009057 condition ancestor term Stomatognathic Diseases condition ancestor id D000015352 condition ancestor term Dry Eye Syndromes condition ancestor id D000007766 condition ancestor term Lacrimal Apparatus Diseases condition ancestor id D000005128 condition ancestor term Eye Diseases condition ancestor id D000009135 condition ancestor term Muscular Diseases condition ancestor id D000009468 condition ancestor term Neuromuscular Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf relevance low condition browse leaf id M15113 condition browse leaf name Spondylitis condition browse leaf as found Spondylitis condition browse leaf relevance high condition browse leaf id M15114 condition browse leaf name Spondylitis, Ankylosing condition browse leaf as found Ankylosing Spondylitis condition browse leaf relevance high condition browse leaf id M12078 condition browse leaf name Osteoarthritis condition browse leaf relevance low condition browse leaf id M3628 condition browse leaf name Arthritis condition browse leaf as found Arthritis condition browse leaf relevance high condition browse leaf id M9596 condition browse leaf name Intestinal Diseases condition browse leaf relevance low condition browse leaf id M17069 condition browse leaf name Inflammatory Bowel Diseases condition browse leaf as found Inflammatory Bowel Disease condition browse leaf relevance high condition browse leaf id M14816 condition browse leaf name Sjogren's Syndrome condition browse leaf as found Sjogren's Syndrome condition browse leaf relevance high condition browse leaf id M10329 condition browse leaf name Lupus Erythematosus, Systemic condition browse leaf as found Systemic Lupus Erythematosus condition browse leaf relevance high condition browse leaf id M17330 condition browse leaf name Arthritis, Psoriatic condition browse leaf as found Psoriatic Arthritis condition browse leaf relevance high condition browse leaf id M11324 condition browse leaf name Myositis condition browse leaf as found Myositis condition browse leaf relevance high condition browse leaf id M22188 condition browse leaf name Spondylarthritis condition browse leaf relevance low condition browse leaf id M14197 condition browse leaf name Rheumatic Diseases condition browse leaf as found Rheumatic Diseases condition browse leaf relevance high condition browse leaf id M5475 condition browse leaf name Collagen Diseases condition browse leaf as found Rheumatic Diseases condition browse leaf 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NCT04839315
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