domenicrosati/clinical_trial_texts · Datasets at Hugging Face

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full study rank 61796 study protocol section identification module n c t id NCT04831814 org study id info org study id 61355143 organization org full name Prince of Songkla University org class OTHER brief title Narrow Band Imaging in Diagnosis of Colorectal Polyps official title Near-focus Versus Normal-focus Narrow Band Imaging Colonoscopy in Diagnosis of Colorectal Polyps Based on Combined NICE and WASP Classification: a Randomized Controlled Trial status module status verified date March 2021 overall status Completed expanded access info has expanded access No start date struct start date April 4, 2019 start date type Actual primary completion date struct primary completion date July 2, 2020 primary completion date type Actual completion date struct completion date January 14, 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 May 11, 2021 last update post date struct last update post date May 12, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Nisa Netinatsunton responsible party investigator title Principal Investigation responsible party investigator affiliation Prince of Songkla University lead sponsor lead sponsor name Prince of Songkla 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 Optical diagnosis of colorectal polyps is a promising tool to avoid risks of unnecessary polypectomies and to save costs of tissue pathology. NICE (NBI International Colorectal Endoscopic) and WASP (Workgroup on Serrated Polyps and Polyposis) classification were developed for diagnosis of adenomatous and sessile serrated polyps, respectively. detailed description Near-focus (NF) narrow-band imaging (NBI) is an image-magnifying technology which enables optical magnification of up to 65x in near focus (NF) compared with 52x in normal standard focus (SF) with the simple push of a button of the endoscope to be interchangeable between NF and SF. There were few studies comparing diagnostic accuracy between NF and SF in the diagnosis of colorectal polyps. So, our aim of the current study is to compare accuracy of NF NBI compared with SF NBI in the optical diagnosis of neoplastic and non-neoplastic polyp and the accuracy of NF NBI versus SF NBI in distinguishing serrated adenoma from hyperplastic polyp in sessile lesions using histologic evaluation as the gold standard. conditions module condition list condition Colorectal Polyp Colorectal Neoplasms 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 118 enrollment type Actual arms interventions module arm group list arm group arm group label Near Focus NBI arm group type Experimental arm group description Use of the Near Focus NBI to make optical diagnosis arm group intervention list arm group intervention name Diagnostic Test: Near Focus NBI arm group label Standard Focus NBI arm group type Active Comparator arm group description Use of the Standard Focus NBI to make optical diagnosis arm group intervention list arm group intervention name Diagnostic Test: Standard Focus NBI intervention list intervention intervention type Diagnostic Test intervention name Near Focus NBI intervention description Colonoscopy with near focus narrowing band imaging technology . Optical specifications include a 2 mm near field focal depth. Optical diagnosis of polyps were according to NICE and WASP, respectively. intervention arm group label list intervention arm group label Near Focus NBI intervention type Diagnostic Test intervention name Standard Focus NBI intervention description Colonoscopy with narrow band imaging technology.Optical diagnosis of polyps were according to NICE and WASP, respectively. intervention arm group label list intervention arm group label Standard Focus NBI outcomes module primary outcome list primary outcome primary outcome measure Rate of accurate polyp histology predictions by the Endoscopists in the two groups. primary outcome description Measure of the percentage of accurate predictions by the endoscopists in the differentiation of neoplastic from non neoplastic colorectal lesions, using the high definition NBI colonoscopy with and without near focus features primary outcome time frame At the time of procedure primary outcome measure Rate of accurate diagnosis of sessile serrated polyps/adenoma by the Endoscopists in the two groups. primary outcome description Measure of the percentage od accurate predictions by the endoscopists in the differentiation of sessile serrated polyps/adenoma from hyperplastic polyps, using the high definition NBI colonoscopy with and without near focus features. primary outcome time frame At the time of procedure secondary outcome list secondary outcome secondary outcome measure The polyp detection rate secondary outcome description The prevalence of patients with at least one polyp was detected secondary outcome time frame At the time of procedure secondary outcome measure The adenoma detection rate secondary outcome description The prevalence of patients with at least one adenoma was detected secondary outcome time frame At the time of procedure secondary outcome measure Diagnostic Characteristics secondary outcome description Compare the diagnostic characteristic (sensitivity, specificity, positive predictive value and negative predictive value) using the high definition narrow band imaging colonoscopy with and without near focus features. secondary outcome time frame At the time of procedure eligibility module eligibility criteria Inclusion Criteria: Patients who were scheduled for colonoscopy at NKC institute Exclusion Criteria: Inflammatory bowel disease Polyposis syndrome Colorectal cancer Active gastrointestinal bleeding Pregnant woman Inadequate bowel preparation Contraindication for polyps removal healthy volunteers No gender All minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name NISA NETINATSUNTON, MD. overall official affiliation NKC Institute of Gastroenterology and Hepatology, Prince of Songkla University overall official role Principal Investigator location list location location facility Prince Songkla University location city Hat Yai location state Songkhla location zip 90110 location country Thailand derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000015179 condition mesh term Colorectal Neoplasms condition mesh id D000011127 condition mesh term Polyps condition ancestor list condition ancestor condition ancestor id D000020763 condition ancestor term Pathological Conditions, Anatomical condition ancestor id D000007414 condition ancestor term Intestinal Neoplasms condition ancestor id D000005770 condition ancestor term Gastrointestinal Neoplasms 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 D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000003108 condition ancestor term Colonic Diseases condition ancestor id D000007410 condition ancestor term Intestinal Diseases condition ancestor id D000012002 condition ancestor term Rectal Diseases condition browse leaf list condition browse leaf condition browse leaf id M17042 condition browse leaf name Colorectal Neoplasms condition browse leaf as found Colorectal Neoplasms condition browse leaf relevance high condition browse leaf id M13163 condition browse leaf name Polyps condition browse leaf as found Polyps 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 M9600 condition browse leaf name Intestinal Neoplasms condition browse leaf relevance low 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 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 M5488 condition browse leaf name Colonic Diseases 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 M13996 condition browse leaf name Rectal 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 BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and 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full study rank 61660 study protocol section identification module n c t id NCT04833582 org study id info org study id ZN-c3-003 organization org full name K-Group Beta org class INDUSTRY brief title A Study of ZN-c3 in Combination With Gemcitabine in Subjects With Osteosarcoma official title A Phase 1/2 Dose Escalation and Dose Expansion Study of ZN-c3 in Combination With Gemcitabine in Adult and Pediatric Subjects With Relapsed or Refractory Osteosarcoma 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 August 30, 2023 primary completion date type Anticipated completion date struct completion date December 30, 2023 completion date type Anticipated study first submit date March 25, 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 August 9, 2022 last update post date struct last update post date August 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name K-Group Beta 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 1/2 study of ZN-c3 in combination with gemcitabine in adult and pediatric subjects with relapsed or refractory osteosarcoma. detailed description This is a phase 1/2 dose escalation and dose expansion study, evaluating the clinical activity and safety, pharmacodynamics, and pharmacokinetics of ZN-c3 in combination with gemcitabine in relapsed or refractory osteosarcoma. conditions module condition list condition Osteosarcoma design module study type Interventional phase list phase Phase 1 Phase 2 design info design allocation N/A design intervention model Sequential Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 84 enrollment type Anticipated arms interventions module arm group list arm group arm group label Combination ZN-c3 with Gemcitabine arm group type Experimental arm group intervention list arm group intervention name Drug: ZN-c3 Drug: Gemcitabine intervention list intervention intervention type Drug intervention name ZN-c3 intervention description ZN-c3 is an investigational drug. intervention arm group label list intervention arm group label Combination ZN-c3 with Gemcitabine intervention type Drug intervention name Gemcitabine intervention description Gemcitabine is an approved drug intervention arm group label list intervention arm group label Combination ZN-c3 with Gemcitabine intervention other name list intervention other name Gemzar outcomes module primary outcome list primary outcome primary outcome measure Incidence of dose-limiting toxicities (DLT) in DLT evaluable subjects and the incidence and severity of adverse events. primary outcome time frame Through Cycle 1 (21 days) Phase 1 primary outcome measure Event-free survival (EFS) at 18 weeks per RECIST (Response Evaluation Criteria in Solid Tumors) Guideline version 1.1. primary outcome description EFS at 18 weeks is defined as time from study enrollment until date of disease progression, or detection of disease at a previously uninvolved site, or date of death of the subjects at 18 weeks. primary outcome time frame During phase 2, at 18 weeks secondary outcome list secondary outcome secondary outcome measure Event-free survival (EFS) per RECIST Guideline version 1.1. secondary outcome description EFS is defined as time from study enrollment until date of last contact, date of disease progression, or detection of disease at a previously uninvolved site, or date of death. secondary outcome time frame At 12 months secondary outcome measure Median overall survival (OS) and OS at 12 months per RECIST Guideline version 1.1. secondary outcome description OS is defined as the time from date of first dosing until the date of death. secondary outcome time frame At 12 months secondary outcome measure The frequency and severity of adverse events (AEs) and laboratory abnormalities per the National Cancer Institute Common Terminology (NCI CTCAE) version 5.0.lities. secondary outcome time frame Through completion, approximately 42 months secondary outcome measure Plasma pharmacokinetics (PK) maximum concentration (Cmax). secondary outcome time frame Through completion, approximately 42 months secondary outcome measure Plasma PK time to maximum concentration (Tmax). secondary outcome time frame Through completion, approximately 42 months secondary outcome measure Area under the plasma concentration versus timepoint curve (AUC last). secondary outcome time frame Through completion, approximately 42 months secondary outcome measure Terminal half-life of the plasma PK concentration. secondary outcome time frame Through completion, approximately 42 months eligibility module eligibility criteria Inclusion Criteria: Age ≥ 12 years at the time of informed consent Bodyweight ≥ 40 kg Histologically documented relapsed or metastatic osteosarcoma. Must have measurable disease according to RECIST Guideline version 1.1 criteria. Adequate hematologic and organ function. Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception per institutional standard prior to the first dose and for 6 months after study treatment discontinuation. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: Unresolved toxicity of Grade >1 attributed to prior therapies (excluding: Grade ≤2 neuropathy, alopecia, or skin pigmentation) Prior therapy with a WEE1 inhibitor A serious illness or medical condition(s). Pregnant or lactating females. Females of childbearing potential with a positive serum pregnancy test <14 days to Day 1. Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy. 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of >470 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid. History or current evidence of congenital or family history of long QT syndrome or Torsades de Pointes (TdP). Taking medications with a known risk of TdP. Administration of strong and moderate CYP3A4 inhibitors/inducers and strong and moderate P-gp inhibitors. healthy volunteers No gender All minimum age 12 Years std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Project Director central contact role Contact central contact phone (858) 263-4333 central contact e mail info@zenopharma.com location list location location facility Site 0106 location status Recruiting location city Los Angeles location state California location zip 90095 location country United States location facility Site 0124 location status Not yet recruiting location city Oakland location state California location zip 94609 location country United States location facility Site 0195 location status Recruiting location city Santa Monica location state California location zip 90403 location country United States location facility Site 0105 location status Recruiting location city New York location state New York location zip 10065 location country United States location facility Site 0107 location status Recruiting location city Cincinnati location state Ohio location zip 45229 location country United States location facility Site 0123 location status Not yet recruiting location city Portland location state Oregon location zip 97239 location country United States location facility Site 0193 location status Not yet recruiting location city Memphis location state Tennessee location zip 38105 location country United States location facility Site 0197 location status Not yet recruiting location city Nashville location state Tennessee location zip 37332 location country United States location facility Site 0103 location status Recruiting location city Houston location state Texas location zip 77030 location country United States location facility Site 0188 location status Recruiting location city Richmond location state Virginia location zip 23298 location country United States location facility Site 0122 location status Recruiting location city Seattle location state Washington location zip 98195 location country United States location facility Site 3604 location status Recruiting location city Bordeaux location zip 33000 location country France location facility Site 3601 location status Not yet recruiting location city Lyon location zip 69008 location country France location facility Site 3602 location status Not yet recruiting location city Marseille location zip 13385 location country France location facility Site 3606 location status Not yet recruiting location city Paris location zip 75248 location country France location facility Site 3605 location status Recruiting location city Toulouse location zip 31100 location country France derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000012516 condition mesh term Osteosarcoma condition ancestor list condition ancestor condition ancestor id D000018213 condition ancestor term Neoplasms, Bone Tissue condition ancestor id D000009372 condition ancestor term Neoplasms, Connective Tissue condition ancestor id D000018204 condition ancestor term Neoplasms, Connective and Soft Tissue condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000012509 condition ancestor term Sarcoma condition browse leaf list condition browse leaf condition browse leaf id M14486 condition browse leaf name Osteosarcoma condition browse leaf as found Osteosarcoma condition browse leaf relevance high condition browse leaf id M19511 condition browse leaf name Neoplasms, Bone Tissue condition browse leaf relevance low condition browse leaf id M11469 condition browse leaf name Neoplasms, Connective Tissue condition browse leaf relevance low condition browse leaf id M19502 condition browse leaf name Neoplasms, Connective and Soft 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 M14479 condition browse leaf name Sarcoma condition browse leaf relevance low condition browse leaf id T4340 condition browse leaf name Osteosarcoma condition browse leaf as found Osteosarcoma condition browse leaf relevance high condition browse leaf id T5284 condition browse leaf name Soft Tissue Sarcoma 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 BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id C000056507 intervention mesh term Gemcitabine intervention ancestor list intervention ancestor intervention ancestor id D000000964 intervention ancestor term Antimetabolites, Antineoplastic intervention ancestor id D000000963 intervention ancestor term Antimetabolites intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000000998 intervention ancestor term Antiviral Agents intervention ancestor id D000000890 intervention ancestor term Anti-Infective Agents intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors 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 browse leaf list intervention browse leaf intervention browse leaf id M113169 intervention browse leaf name Gemcitabine intervention browse leaf as found Open- intervention browse leaf relevance high intervention browse leaf id M3433 intervention browse leaf name Antimetabolites intervention browse leaf relevance low intervention browse leaf id M3466 intervention browse leaf name Antiviral Agents intervention browse leaf relevance low intervention browse leaf id M3366 intervention browse leaf name Anti-Infective Agents 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 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	NCT04833582	[ 101, 1554, 2025, 3997, 5391, 1545, 16480, 2025, 11309, 2237, 9117, 13196, 183, 172, 189, 25021, 14056, 1942, 1568, 19203, 23493, 1571, 1604, 1477, 8916, 2025, 25021, 23992, 8916, 2025, 25021, 163, 2249, 118, 172, 1495, 118, 3135, 1495, 2369, 8916, 1554, 1271, 148, 118, 1990, 13470, 8916, 1705, 15969, 2137, 13329, 23313, 3663, 4094, 1641, 138, 8690, 1104, 163, 2249, 118, 172, 1495, 1107, 3291, 12913, 9400, 1556, 144, 5521, 6617, 1777, 16405, 1107, 12859, 26394, 1556, 152, 13894, 9275, 19878, 7903, 2078, 1641, 138, 12278, 122, 120, 123, 2091, 2217, 142, 26996, 6840, 1105, 2091, 2217, 16409, 10224, 8427, 8690, 1104, 163, 2249, 118, 172, 1495, 1107, 3291, 12913, 9400, 1556, 144, 5521, 6617, 1777, 16405, 1107, 11635, 1105, 153, 24795, 12859, 26394, 1556, 11336, 16046, 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full study rank 61910 study protocol section identification module n c t id NCT04830319 org study id info org study id HTLVIDA organization org full name Pedreira, Érika, M.D. org class INDIV brief title Pilates Method in People With HAM/TSP official title Therapeutic Effect of the Pilates Method in People With HAM/TSP: a Randomized Crossover Study status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date February 20, 2018 start date type Actual primary completion date struct primary completion date August 20, 2018 primary completion date type Actual completion date struct completion date March 15, 2020 completion date type Actual study first submit date May 23, 2018 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 Sponsor lead sponsor lead sponsor name Pedreira, Érika, M.D. lead sponsor class INDIV 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 Individuals with HTLV-1 secondary myelopathy (HAM/TSP) may have motor and sensory alterations, which may result in reduced functional performance and consequent risk of falls. The aim of the study is to verify the therapeutic effect of a Pilates exercise program on functional performance and risk of falls, when compared to task-oriented training, of people with HAM / TSP. This is a randomized, crossover clinical trial performed with individuals with HAM / TSP who are attended at a referral center who is able to perform gait whether or not to use a walking aid. Amputees, with psychiatric disorders, rheumatic or orthopedic diseases and other associated neurological disorders, which could influence the balance and functional mobility, as well as pregnant women, were excluded. Participants will be submitted to the initial evaluation of functional mobility, balance, gait balance, fatigue, gait endurance, sphincter changes and questioned about the occurrence of falls in the last three months and will answer a semi-structured questionnaire about their conjugality. They will be allocated randomly to two groups. One will perform the Pilates Method protocol and the other task-oriented training. The first group, called test-control group (GTC), will initiate the protocol with exercises of the Pilates method; the control-test group (GCT) will initiate the task-oriented training protocol. A p <0.05 will be considered a statistically significant difference. conditions module condition list condition HAM/TSP HTLV-1 Secondary Myelopathy Balance Gait Balance Functional Mobility design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Crossover Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Investigator enrollment info enrollment count 22 enrollment type Actual arms interventions module arm group list arm group arm group label Test-control group (TCG) arm group type Experimental arm group description The test-control group (TCG) will initiate the protocol with exercises of the Pilates method, which includes exercises in soil, that associate the correct respiratory movement with muscular strengthening and control, stretching from the eccentric movement, selective upper and lower trunk movements. There will be used accessories described by the method for their realization. Participants will perform the first week of awareness and body alignment exercises for 10 minutes, 10 minute breath perception, 10 minute proximal muscle accuracy and control, and 10 minute stretches; from the second week will be included selective trunk movements, with muscle strengthening of lower limbs. Rest intervals will be performed between exercises.After 20 sessions, the patients will be reassessed and will remain for a period of one month without any intervention, and at the end of this period will be reevaluated again. The TCG group will then conduct 20 task-oriented training sessions arm group intervention list arm group intervention name Other: Pilates Method Other: task-oriented training protocol arm group label Control-test group (CTG) arm group type Active Comparator arm group description The control-test group (CTG) will initiate the task-oriented training protocol. The task-oriented training protocol will include functional exercise drills, such as sit-up and workout, obstacle course workout, speed-and-direction workout, balance workout, work-up and downhill workout, each tasks performed for eight minutes, with two minutes of rest between them. The difficulty in carrying out the tasks will be progressively adjusted. At all times, individuals will be instructed to contract the pelvic floor musculature. After 20 sessions, the patients will be reassessed and will remain for a period of one month without any intervention, and at the end of this period will be reevaluated again. Next, the CTG group will perform 20 sessions of Pilates exercises. arm group intervention list arm group intervention name Other: Pilates Method Other: task-oriented training protocol intervention list intervention intervention type Other intervention name Pilates Method intervention description includes exercises in soil, that associate the correct respiratory movement with muscular strengthening and control, stretching from the eccentric movement, selective upper and lower trunk movements. There will be used accessories described by the method for their realization. Participants will perform the first week of awareness and body alignment exercises for 10 minutes, 10 minute breath perception, 10 minute proximal muscle accuracy and control, and 10 minute stretches; from the second week will be included selective trunk movements, with muscle strengthening of lower limbs. Rest intervals will be performed between exercises. intervention arm group label list intervention arm group label Control-test group (CTG) Test-control group (TCG) intervention type Other intervention name task-oriented training protocol intervention description The control-test group (CTG) will initiate the task-oriented training protocol. The task-oriented training protocol will include functional exercise drills, such as sit-up and workout, obstacle course workout, speed-and-direction workout, balance workout, work-up and downhill workout, each tasks performed for eight minutes, with two minutes of rest between them. The difficulty in carrying out the tasks will be progressively adjusted. At all times, individuals will be instructed to contract the pelvic floor musculature. After 20 sessions, the patients will be reassessed and will remain for a period of one month without any intervention, and at the end of this period will be reevaluated again. Next, the CTG group will perform 20 sessions of Pilates exercises. intervention arm group label list intervention arm group label Control-test group (CTG) Test-control group (TCG) outcomes module primary outcome list primary outcome primary outcome measure Balance primary outcome description Berg's Balance Scale (BBS) primary outcome time frame 15 minutes primary outcome measure Functional Mobility primary outcome description Timed up and Go (TUG) primary outcome time frame 3 minutes primary outcome measure Gait Balance primary outcome description Dynamic Gait Index (DGI) primary outcome time frame 10 minutes primary outcome measure Balance primary outcome description Balance Evaluation Systems Test of dynamic balance (mini-BESTest) primary outcome time frame 20 minutes eligibility module eligibility criteria Inclusion Criteria: individuals with probable and/or defined diagnosis of HAM / TSP, according to WHO criteria, of both sexes, aged 18 to 64 years. Exclusion Criteria: individuals with lower limb amputation, pregnancy, psychiatric disorders, rheumatic or orthopedic diseases, other associated neurological disorders, and those who have difficulty understanding the assessment instruments. healthy volunteers No gender All minimum age 18 Years maximum age 64 Years std age list std age Adult contacts locations module location list location location facility Universidade Católica do Salvador location city Salvador location state Bahia location zip 40000-00 location country Brazil 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 D000013118 condition mesh term Spinal Cord Diseases condition ancestor list condition ancestor 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 M11459 condition browse leaf name Neoplasm Metastasis condition browse leaf relevance low condition browse leaf id M4286 condition browse leaf name Bone Marrow Diseases condition browse leaf relevance low condition browse leaf id M15067 condition browse leaf name Spinal Cord Diseases condition browse leaf as found Myelopathy condition browse leaf relevance high condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id T2845 condition browse leaf name Human T-cell Leukemia Virus Type 1 condition browse leaf relevance low condition browse leaf id T2840 condition browse leaf name HTLV-1 Associated Myelopathy/tropical Spastic Paraparesis condition browse leaf as found HAM/TSP condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name 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full study rank 61476 study protocol section identification module n c t id NCT04835974 org study id info org study id No-reflow phenomenon organization org full name Assiut University org class OTHER brief title the No-reflow in Diabetic Patients Treated With Primary Percutaneous Coronary Intervention (PCI) official title Metabolic Profile as a Predictor of No-reflow in Diabetic Patients Treated With Primary Percutaneous Coronary Intervention (PCI) 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 1, 2021 start date type Anticipated primary completion date struct primary completion date May 1, 2022 primary completion date type Anticipated completion date struct completion date May 2022 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 8, 2021 study first post date type Actual last update submit date April 13, 2021 last update post date struct last update post date April 14, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name El Zahraa Gamal responsible party investigator title Metabolic profile as a predictor of no reflow in diabetic patients treated with primary Percutaneous Coronary Intervention (PCI) . responsible party investigator affiliation Assiut University lead sponsor lead sponsor name Assiut 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 1- to find metabolic factors that correlate with the development of no reflow phenomenon that may help prevent its occurrence . detailed description Acute myocardial infarction (AMI) with its accompanying adverse sequelae is one of the most common causes of morbidity and mortality in the world . Although reperfusion techniques for ST- elevation myocardial infarction (STEMI ) are constantly improving, no-reflow can still lead to poor prognosis . At present, the exact mechanism of no-reflow remains unclear, but clinical and laboratory findings suggest that it is related to the embolism of the capillary bed, ischemic injury, vascular endothelial dysfunction, production of oxygen free radical , and other factors . The no-reflow phenomenon is one of complications of poor functional and clinical outcomes for patients with (AMI) . The no-reflow phenomenon is present in 25% to 30% of patients with (AMI) underwent successful coronary recanalization, as shown by angiography . The myocardial no-reflow phenomenon is associated with a reducution of antegrade myocardial blood flow inspite of an open infarct-related artery in patients with (STEMI ) undergoing (PCI). Importantly, no-reflow is known to be related to unfavorable clinical outcome and prognosis . The cause of this complex phenomenon is the variable combination of four pathogenetic components: distal atherothrombotic embolization, ischemic injury, reperfusion injury and susceptibility of coronary microcirculation to injury . As a consequence, appropriate strategies are expected to prevent or treat these components are expected to avoid the no-reflow. Coronary reperfusion therapy is widely performed in patients with (AMI) . However, in spite of patency of the infarct-related artery , there is no guarantee of salvage of myocardium at risk of ischemia .The no-reflow phenomenon is found in >30% of patients after thrombolysis or catheter-based (PCI) for (AMI) . It is important, therefore, to be able to predict which lesions are high risk for no reflow before beginning PCI . There are numerous recognized risk factors for the development of coronary artery disease (CAD), one of the best known is the association between blood lipids and CAD . Several prospective studies have established that the risk of cardiac morbidity and mortality is directly related to the concentration of plasma cholesterol. ' The most prevalent view is that the increased risk of myocardial infarction associated with elevated plasma cholesterol levels can be adequately explained on the basis of the increase in number and severity of coronary atherosclerotic vascular lesions . . conditions module condition list condition No-Reflow Phenomenon 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 Other design masking info design masking None (Open Label) enrollment info enrollment count 120 enrollment type Anticipated arms interventions module arm group list arm group arm group label diabetic patients with reflow phenomenon arm group type Experimental arm group description All Assiut University heart Hospital patients ,and who meet the listed inclusion and exclusion criteria will be eligible for the study. Patients' charts will be retrieved based on their intervention procedures. The charts will be reviewed and eligible patients will be filtered. The needed variables will be entered into our data base for later data analysis. arm group intervention list arm group intervention name Diagnostic Test: 1- LDL-C (low-density lipoprotein cholesterol)\| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- S intervention list intervention intervention type Diagnostic Test intervention name 1- LDL-C (low-density lipoprotein cholesterol)\| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- S intervention description Blood samples were obtained before PCI, and the following parameters will be measured: LDL-C (low-density lipoprotein cholesterol)\| and HDL-C(high-density lipoprotein cholesterol) Ratio. Glycemia will be assessed : RBS ( random blood sugar ) . Serum Uric acid : S .UA intervention arm group label list intervention arm group label diabetic patients with reflow phenomenon outcomes module primary outcome list primary outcome primary outcome measure measure serum random blood sugar primary outcome description to detect the correlation between the diabetus mellitus (serum random blood sugar) and no-reflow phenomenon and analysis of this metabolic factors in patient withSTEMI who will undergo primaru PCI and show its effects on no-reflow phenomenon that may help prevent its occurrence . primary outcome time frame baseline secondary outcome list secondary outcome secondary outcome measure measure the serum uric acid secondary outcome description to detect the correlation between the serum uric acid , lipid profile and no-reflow phenomenon and show other metabolic factors effects on no-reflow to avoid its occurance secondary outcome time frame baseline secondary outcome measure measure the lipid profile secondary outcome description to detect the correlation between lipid profile and no-reflow phenomenon secondary outcome time frame baseline eligibility module eligibility criteria Inclusion Criteria: diabetic patients with STEMI treated with primary PCI Exclusion Criteria: non diabetic . with selected PCI (1) a history of an unprotected left main artery with severe liver and kidney diseases or coronary artery bypass grafting . (2) patients who had valvular disease or cardiomyopathy . (3) severe dissection, thromboembolism in other parts, or vasospasm; and known malignancy . (4) patients with contraindications for anticoagulant therapy, such as active visceral hemorrhage, hemorrhagic stroke, or ischemic stroke within half a year (including transient ischemic attack), or aortic dissection, or patients with hematological diseases complicated with coagulation disorders . healthy volunteers Accepts Healthy Volunteers gender All std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name alzahraa gamal, master central contact role Contact central contact phone 01026181748 central contact e mail alzahraagamal@gmail.com central contact name hatem abdel elrahman central contact role Contact central contact phone 01005212162 central contact e mail Hatem19652006@yahoo.com references module reference list reference reference p m i d 6683937 reference type background reference citation Bernstein JM, Lee J, Conboy K, Ellis E, Li P. The role of IgE mediated hypersensitivity in recurrent otitis media with effusion. Am J Otol. 1983 Jul;5(1):66-9. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000054318 condition mesh term No-Reflow Phenomenon condition ancestor list condition ancestor condition ancestor id D000007511 condition ancestor term Ischemia condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M26773 condition browse leaf name No-Reflow Phenomenon condition browse leaf as found No-Reflow Phenomenon condition browse leaf relevance high condition browse leaf id M9695 condition browse leaf name Ischemia 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 intervention browse module 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full study rank 61749 study protocol section identification module n c t id NCT04832425 org study id info org study id PRAX-114-213 organization org full name Praxis Precision Medicines org class INDUSTRY brief title A Clinical Trial of PRAX-114 in Participants With Major Depressive Disorder official title A Phase 2/3 Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of PRAX-114 in Participants With Major Depressive Disorder status module status verified date July 2022 overall status Completed expanded access info has expanded access No start date struct start date March 30, 2021 start date type Actual primary completion date struct primary completion date May 5, 2022 primary completion date type Actual completion date struct completion date May 5, 2022 completion date type Actual study first submit date March 19, 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 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 Sponsor lead sponsor lead sponsor name Praxis Precision Medicines 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 This is a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of PRAX-114 in participants with moderate to severe major depressive disorder (MDD). Participants will be randomized to receive 28 days of either 40 mg PRAX-114 or placebo in a 1:1 ratio. conditions module condition list condition Major Depressive Disorder keyword list keyword Mood Disorders Depressive Disorder Depression Depressive Disorder, Unipolar Depressive Symptoms Agents, GABA Receptors, GABA-A Allosteric Regulation design module study type Interventional phase list phase Phase 2 Phase 3 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 216 enrollment type Actual arms interventions module arm group list arm group arm group label PRAX-114 arm group type Experimental arm group description 40 mg PRAX-114 once daily arm group intervention list arm group intervention name Drug: PRAX-114 arm group label Placebo arm group type Placebo Comparator arm group description Placebo once daily arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Drug intervention name PRAX-114 intervention description 40 mg once daily intervention arm group label list intervention arm group label PRAX-114 intervention type Drug intervention name Placebo intervention description Placebo once daily intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Change from baseline in 17-Item Hamilton Depression Rating Scale (HAM-D17) total score at Day 15 primary outcome description The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement. primary outcome time frame 15 days secondary outcome list secondary outcome secondary outcome measure Change from baseline in HAM-D17 total score at Day 29 secondary outcome description The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement. secondary outcome time frame 29 days secondary outcome measure Change from baseline in HAM-D17 total score at all other time points secondary outcome description The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement. secondary outcome time frame 8 days, 22 days, 36 days, and 43 days secondary outcome measure Change from baseline in Clinical Global Impression-Severity (CGI-S) score at Day 15 and all other time points secondary outcome description The CGI-S assesses the clinician's impression of the participant's current depression symptoms. The clinician should use his/her total clinical experience with this patient population and rate the current severity of the participant's mental illness on a 7-point scale from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients). secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure Clinical Global Impression-Improvement (CGI-I) score at Day 15 and all other time points secondary outcome description The CGI-I assesses the participant's improvement (or worsening). The clinician is required to assess the participant's condition relative to Baseline (Day 1) on a 7-point scale from 1 (Very much improved) to 7 (Very much worse). secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure HAM-D17 response (reduction from baseline score of ≥50%) at Day 15, Day 29, and all other time points secondary outcome description The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement. secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure HAM-D17 remission (total score of ≤7) at Day 15, Day 29, and all other time points secondary outcome description The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement. secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure Change from baseline in the Symptoms of Depression Questionnaire (SDQ) total and sub-scale scores at Day 15 and all other time points secondary outcome description The SDQ is a 44-item, self-report scale assessing the severity of symptoms across several subtypes of depression. Items are scored on a 7-point scale (ranging from 1 to 6). The SDQ total score is the sum of all 44 item scores and ranges from 44 to 264 with higher scores indicating worse symptoms. secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure Patient Global Impression-Improvement (PGI-I) score at Day 15 and all other time points secondary outcome description The PGI-I scale is a global self-assessment used to rate the response of a participant's condition to therapy or intervention. It consists of 1 question that asks the participant to rate their current condition compared to how it was prior to beginning treatment on a scale of 1 (very much better) to 7 (very much worse). secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure Change from baseline in the Work and Social Adjustment Scale (WSAS) at Day 15 and all other time points secondary outcome description The WSAS assesses the degree to which mental health problems interfere with day-to-day functioning in 5 domains: work, social leisure activities, private leisure activities, home- management, and personal relationships. The WSAS total score is the sum of the 5 item scores and ranges from 0 to 40, with higher scores indicating poorer adjustment. secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure Change from baseline in the 12-Item Short Form Survey (SF-12) at Day 15 and all other time points secondary outcome description The SF-12 is composed of 12 questions covering 8 dimensions of health: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Total scores range from 0 (worse health) to 100 (better health). secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure Incidence and severity of Adverse Events (AE) secondary outcome description An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study drug, whether or not considered related to the study drug. secondary outcome time frame 43 days secondary outcome measure Incidence of AEs by preferred term secondary outcome description The incidence of AEs will be reported by preferred term, including any terms related to clinically significant changes in body temperature, pulse rate, respiratory rate, blood pressure (systolic and diastolic), clinical laboratory measures (chemistry, hematology, urinalysis, and coagulation), and electrocardiogram parameters (heart rate, PR, QRS, QT, and corrected QT intervals). secondary outcome time frame Up to 43 days secondary outcome measure Incidence of Columbia-Suicide Severity Rating Scale (C-SSRS) measured suicidal ideation or behavior secondary outcome description The C-SSRS is composed of 5 yes/no questions addressing suicidal behavior and 5 yes/no questions addressing suicidal ideation, with sub-questions assessing the severity. Incidence is measured as the number of "yes" answers indicating the presence of suicidal ideation or behavior. secondary outcome time frame Up to 43 days eligibility module eligibility criteria Inclusion Criteria: Recurrent MDD diagnosis with a current episode duration of at least 8 weeks and no more than 24 months. HAM-D17 total score of ≥23 at Screening and Baseline. Body mass index (BMI) between 18 and 38 kg/m2 (inclusive). Exclusion Criteria: Lifetime history of seizures, including febrile seizures. Neurodegenerative disorder (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, or Huntington's disease). Lifetime history of bipolar disorder, a psychotic disorder (eg, schizophrenia or schizoaffective disorder), or obsessive compulsive disorder or a history of a psychotic mood episode in last 2 years. Any current psychiatric disorder (other than MDD). Lifetime history of treatment resistant depression. Received electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS) within the last year or transcranial magnetic stimulation (TMS) within the last 6 months prior to Screening. Daily consumption of more than 2 standard alcohol-containing beverages for males or more than 1 standard alcohol-containing beverages for females. healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name VP, Clinical Development overall official affiliation Praxis Precision Medicines overall official role Study Director location list location location facility Praxis Research Site location city Phoenix location state Arizona location zip 85012 location country United States location facility Praxis Research Site location city Garden Grove location state California location zip 92845 location country United States location facility Praxis Research Site location city Lafayette location state California location zip 94549 location country United States location facility Praxis Research Site location city Lemon Grove location state California 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Research Site location city Marlton location state New Jersey location zip 08053 location country United States location facility Praxis Research Site location city Cedarhurst location state New York location zip 11516 location country United States location facility Praxis Research Site location city Rochester location state New York location zip 14618 location country United States location facility Praxis Research Site location city Staten Island location state New York location zip 10312 location country United States location facility Praxis Research Site location city Dayton location state Ohio location zip 45417 location country United States location facility Praxis Research Site location city Allentown location state Pennsylvania location zip 18104 location country United States location facility Praxis Research Site location city Media location state Pennsylvania location zip 19063 location country United States location facility Praxis Research Site location city Memphis location state Tennessee location zip 38119 location country United States location facility Praxis Research Site location city Austin location state Texas location zip 78737 location country United States location facility Praxis Research Site location city San Antonio location state Texas location zip 78229 location country United States location facility Praxis Research Site location city Charlottesville location state Virginia location zip 22903 location country United States location facility Praxis Research Site location city Everett location state Washington location zip 98201 location country United States location facility Praxis Research Site location city Noble Park location state Victoria location zip 3174 location country Australia 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 D000004194 condition mesh term Disease condition mesh id D000003866 condition mesh term Depressive Disorder condition mesh id D000003863 condition mesh term Depression condition mesh id D000003865 condition mesh term Depressive Disorder, Major 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 ancestor id D000001526 condition ancestor term Behavioral Symptoms condition browse leaf list condition browse leaf condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf as found Depressive Disorder condition browse leaf relevance high 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 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 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 M225603 intervention browse leaf name Pramoxine intervention browse leaf relevance low intervention browse branch list 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"full study rank 61330 study protocol section identification module n c t id NCT04837872 org study i(...TRUNCATED)	NCT04837872	[101,1554,2025,3997,5391,23493,1568,2025,11309,2237,9117,13196,183,172,189,25021,14056,1942,1568,192(...TRUNCATED)	[0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0(...TRUNCATED)	[1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1(...TRUNCATED)
"full study rank 61292 study protocol section identification module n c t id NCT04838366 org study i(...TRUNCATED)	NCT04838366	[101,1554,2025,3997,5391,26752,1477,2025,11309,2237,9117,13196,183,172,189,25021,14056,1942,1568,192(...TRUNCATED)	[0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0(...TRUNCATED)	[1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1(...TRUNCATED)
"full study rank 61645 study protocol section identification module n c t id NCT04833777 org study i(...TRUNCATED)	NCT04833777	[101,1554,2025,3997,5391,22433,1571,2025,11309,2237,9117,13196,183,172,189,25021,14056,1942,1568,192(...TRUNCATED)	[0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0(...TRUNCATED)	[1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1(...TRUNCATED)
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full study rank 61796 study protocol section identification module n c t id NCT04831814 org study id info org study id 61355143 organization org full name Prince of Songkla University org class OTHER brief title Narrow Band Imaging in Diagnosis of Colorectal Polyps official title Near-focus Versus Normal-focus Narrow Band Imaging Colonoscopy in Diagnosis of Colorectal Polyps Based on Combined NICE and WASP Classification: a Randomized Controlled Trial status module status verified date March 2021 overall status Completed expanded access info has expanded access No start date struct start date April 4, 2019 start date type Actual primary completion date struct primary completion date July 2, 2020 primary completion date type Actual completion date struct completion date January 14, 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 May 11, 2021 last update post date struct last update post date May 12, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Nisa Netinatsunton responsible party investigator title Principal Investigation responsible party investigator affiliation Prince of Songkla University lead sponsor lead sponsor name Prince of Songkla 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 Optical diagnosis of colorectal polyps is a promising tool to avoid risks of unnecessary polypectomies and to save costs of tissue pathology. NICE (NBI International Colorectal Endoscopic) and WASP (Workgroup on Serrated Polyps and Polyposis) classification were developed for diagnosis of adenomatous and sessile serrated polyps, respectively. detailed description Near-focus (NF) narrow-band imaging (NBI) is an image-magnifying technology which enables optical magnification of up to 65x in near focus (NF) compared with 52x in normal standard focus (SF) with the simple push of a button of the endoscope to be interchangeable between NF and SF. There were few studies comparing diagnostic accuracy between NF and SF in the diagnosis of colorectal polyps. So, our aim of the current study is to compare accuracy of NF NBI compared with SF NBI in the optical diagnosis of neoplastic and non-neoplastic polyp and the accuracy of NF NBI versus SF NBI in distinguishing serrated adenoma from hyperplastic polyp in sessile lesions using histologic evaluation as the gold standard. conditions module condition list condition Colorectal Polyp Colorectal Neoplasms 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 118 enrollment type Actual arms interventions module arm group list arm group arm group label Near Focus NBI arm group type Experimental arm group description Use of the Near Focus NBI to make optical diagnosis arm group intervention list arm group intervention name Diagnostic Test: Near Focus NBI arm group label Standard Focus NBI arm group type Active Comparator arm group description Use of the Standard Focus NBI to make optical diagnosis arm group intervention list arm group intervention name Diagnostic Test: Standard Focus NBI intervention list intervention intervention type Diagnostic Test intervention name Near Focus NBI intervention description Colonoscopy with near focus narrowing band imaging technology . Optical specifications include a 2 mm near field focal depth. Optical diagnosis of polyps were according to NICE and WASP, respectively. intervention arm group label list intervention arm group label Near Focus NBI intervention type Diagnostic Test intervention name Standard Focus NBI intervention description Colonoscopy with narrow band imaging technology.Optical diagnosis of polyps were according to NICE and WASP, respectively. intervention arm group label list intervention arm group label Standard Focus NBI outcomes module primary outcome list primary outcome primary outcome measure Rate of accurate polyp histology predictions by the Endoscopists in the two groups. primary outcome description Measure of the percentage of accurate predictions by the endoscopists in the differentiation of neoplastic from non neoplastic colorectal lesions, using the high definition NBI colonoscopy with and without near focus features primary outcome time frame At the time of procedure primary outcome measure Rate of accurate diagnosis of sessile serrated polyps/adenoma by the Endoscopists in the two groups. primary outcome description Measure of the percentage od accurate predictions by the endoscopists in the differentiation of sessile serrated polyps/adenoma from hyperplastic polyps, using the high definition NBI colonoscopy with and without near focus features. primary outcome time frame At the time of procedure secondary outcome list secondary outcome secondary outcome measure The polyp detection rate secondary outcome description The prevalence of patients with at least one polyp was detected secondary outcome time frame At the time of procedure secondary outcome measure The adenoma detection rate secondary outcome description The prevalence of patients with at least one adenoma was detected secondary outcome time frame At the time of procedure secondary outcome measure Diagnostic Characteristics secondary outcome description Compare the diagnostic characteristic (sensitivity, specificity, positive predictive value and negative predictive value) using the high definition narrow band imaging colonoscopy with and without near focus features. secondary outcome time frame At the time of procedure eligibility module eligibility criteria Inclusion Criteria: Patients who were scheduled for colonoscopy at NKC institute Exclusion Criteria: Inflammatory bowel disease Polyposis syndrome Colorectal cancer Active gastrointestinal bleeding Pregnant woman Inadequate bowel preparation Contraindication for polyps removal healthy volunteers No gender All minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name NISA NETINATSUNTON, MD. overall official affiliation NKC Institute of Gastroenterology and Hepatology, Prince of Songkla University overall official role Principal Investigator location list location location facility Prince Songkla University location city Hat Yai location state Songkhla location zip 90110 location country Thailand derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000015179 condition mesh term Colorectal Neoplasms condition mesh id D000011127 condition mesh term Polyps condition ancestor list condition ancestor condition ancestor id D000020763 condition ancestor term Pathological Conditions, Anatomical condition ancestor id D000007414 condition ancestor term Intestinal Neoplasms condition ancestor id D000005770 condition ancestor term Gastrointestinal Neoplasms 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 D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000003108 condition ancestor term Colonic Diseases condition ancestor id D000007410 condition ancestor term Intestinal Diseases condition ancestor id D000012002 condition ancestor term Rectal Diseases condition browse leaf list condition browse leaf condition browse leaf id M17042 condition browse leaf name Colorectal Neoplasms condition browse leaf as found Colorectal Neoplasms condition browse leaf relevance high condition browse leaf id M13163 condition browse leaf name Polyps condition browse leaf as found Polyps 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 M9600 condition browse leaf name Intestinal Neoplasms condition browse leaf relevance low 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 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 M5488 condition browse leaf name Colonic Diseases 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 M13996 condition browse leaf name Rectal 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 BC06 condition browse branch name Digestive 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

NCT04831814

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full study rank 61660 study protocol section identification module n c t id NCT04833582 org study id info org study id ZN-c3-003 organization org full name K-Group Beta org class INDUSTRY brief title A Study of ZN-c3 in Combination With Gemcitabine in Subjects With Osteosarcoma official title A Phase 1/2 Dose Escalation and Dose Expansion Study of ZN-c3 in Combination With Gemcitabine in Adult and Pediatric Subjects With Relapsed or Refractory Osteosarcoma 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 August 30, 2023 primary completion date type Anticipated completion date struct completion date December 30, 2023 completion date type Anticipated study first submit date March 25, 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 August 9, 2022 last update post date struct last update post date August 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name K-Group Beta 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 1/2 study of ZN-c3 in combination with gemcitabine in adult and pediatric subjects with relapsed or refractory osteosarcoma. detailed description This is a phase 1/2 dose escalation and dose expansion study, evaluating the clinical activity and safety, pharmacodynamics, and pharmacokinetics of ZN-c3 in combination with gemcitabine in relapsed or refractory osteosarcoma. conditions module condition list condition Osteosarcoma design module study type Interventional phase list phase Phase 1 Phase 2 design info design allocation N/A design intervention model Sequential Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 84 enrollment type Anticipated arms interventions module arm group list arm group arm group label Combination ZN-c3 with Gemcitabine arm group type Experimental arm group intervention list arm group intervention name Drug: ZN-c3 Drug: Gemcitabine intervention list intervention intervention type Drug intervention name ZN-c3 intervention description ZN-c3 is an investigational drug. intervention arm group label list intervention arm group label Combination ZN-c3 with Gemcitabine intervention type Drug intervention name Gemcitabine intervention description Gemcitabine is an approved drug intervention arm group label list intervention arm group label Combination ZN-c3 with Gemcitabine intervention other name list intervention other name Gemzar outcomes module primary outcome list primary outcome primary outcome measure Incidence of dose-limiting toxicities (DLT) in DLT evaluable subjects and the incidence and severity of adverse events. primary outcome time frame Through Cycle 1 (21 days) Phase 1 primary outcome measure Event-free survival (EFS) at 18 weeks per RECIST (Response Evaluation Criteria in Solid Tumors) Guideline version 1.1. primary outcome description EFS at 18 weeks is defined as time from study enrollment until date of disease progression, or detection of disease at a previously uninvolved site, or date of death of the subjects at 18 weeks. primary outcome time frame During phase 2, at 18 weeks secondary outcome list secondary outcome secondary outcome measure Event-free survival (EFS) per RECIST Guideline version 1.1. secondary outcome description EFS is defined as time from study enrollment until date of last contact, date of disease progression, or detection of disease at a previously uninvolved site, or date of death. secondary outcome time frame At 12 months secondary outcome measure Median overall survival (OS) and OS at 12 months per RECIST Guideline version 1.1. secondary outcome description OS is defined as the time from date of first dosing until the date of death. secondary outcome time frame At 12 months secondary outcome measure The frequency and severity of adverse events (AEs) and laboratory abnormalities per the National Cancer Institute Common Terminology (NCI CTCAE) version 5.0.lities. secondary outcome time frame Through completion, approximately 42 months secondary outcome measure Plasma pharmacokinetics (PK) maximum concentration (Cmax). secondary outcome time frame Through completion, approximately 42 months secondary outcome measure Plasma PK time to maximum concentration (Tmax). secondary outcome time frame Through completion, approximately 42 months secondary outcome measure Area under the plasma concentration versus timepoint curve (AUC last). secondary outcome time frame Through completion, approximately 42 months secondary outcome measure Terminal half-life of the plasma PK concentration. secondary outcome time frame Through completion, approximately 42 months eligibility module eligibility criteria Inclusion Criteria: Age ≥ 12 years at the time of informed consent Bodyweight ≥ 40 kg Histologically documented relapsed or metastatic osteosarcoma. Must have measurable disease according to RECIST Guideline version 1.1 criteria. Adequate hematologic and organ function. Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception per institutional standard prior to the first dose and for 6 months after study treatment discontinuation. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: Unresolved toxicity of Grade >1 attributed to prior therapies (excluding: Grade ≤2 neuropathy, alopecia, or skin pigmentation) Prior therapy with a WEE1 inhibitor A serious illness or medical condition(s). Pregnant or lactating females. Females of childbearing potential with a positive serum pregnancy test <14 days to Day 1. Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy. 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of >470 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid. History or current evidence of congenital or family history of long QT syndrome or Torsades de Pointes (TdP). Taking medications with a known risk of TdP. Administration of strong and moderate CYP3A4 inhibitors/inducers and strong and moderate P-gp inhibitors. healthy volunteers No gender All minimum age 12 Years std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Project Director central contact role Contact central contact phone (858) 263-4333 central contact e mail info@zenopharma.com location list location location facility Site 0106 location status Recruiting location city Los Angeles location state California location zip 90095 location country United States location facility Site 0124 location status Not yet recruiting location city Oakland location state California location zip 94609 location country United States location facility Site 0195 location status Recruiting location city Santa Monica location state California location zip 90403 location country United States location facility Site 0105 location status Recruiting location city New York location state New York location zip 10065 location country United States location facility Site 0107 location status Recruiting location city Cincinnati location state Ohio location zip 45229 location country United States location facility Site 0123 location status Not yet recruiting location city Portland location state Oregon location zip 97239 location country United States location facility Site 0193 location status Not yet recruiting location city Memphis location state Tennessee location zip 38105 location country United States location facility Site 0197 location status Not yet recruiting location city Nashville location state Tennessee location zip 37332 location country United States location facility Site 0103 location status Recruiting location city Houston location state Texas location zip 77030 location country United States location facility Site 0188 location status Recruiting location city Richmond location state Virginia location zip 23298 location country United States location facility Site 0122 location status Recruiting location city Seattle location state Washington location zip 98195 location country United States location facility Site 3604 location status Recruiting location city Bordeaux location zip 33000 location country France location facility Site 3601 location status Not yet recruiting location city Lyon location zip 69008 location country France location facility Site 3602 location status Not yet recruiting location city Marseille location zip 13385 location country France location facility Site 3606 location status Not yet recruiting location city Paris location zip 75248 location country France location facility Site 3605 location status Recruiting location city Toulouse location zip 31100 location country France derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000012516 condition mesh term Osteosarcoma condition ancestor list condition ancestor condition ancestor id D000018213 condition ancestor term Neoplasms, Bone Tissue condition ancestor id D000009372 condition ancestor term Neoplasms, Connective Tissue condition ancestor id D000018204 condition ancestor term Neoplasms, Connective and Soft Tissue condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000012509 condition ancestor term Sarcoma condition browse leaf list condition browse leaf condition browse leaf id M14486 condition browse leaf name Osteosarcoma condition browse leaf as found Osteosarcoma condition browse leaf relevance high condition browse leaf id M19511 condition browse leaf name Neoplasms, Bone Tissue condition browse leaf relevance low condition browse leaf id M11469 condition browse leaf name Neoplasms, Connective Tissue condition browse leaf relevance low condition browse leaf id M19502 condition browse leaf name Neoplasms, Connective and Soft 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 M14479 condition browse leaf name Sarcoma condition browse leaf relevance low condition browse leaf id T4340 condition browse leaf name Osteosarcoma condition browse leaf as found Osteosarcoma condition browse leaf relevance high condition browse leaf id T5284 condition browse leaf name Soft Tissue Sarcoma 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 BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id C000056507 intervention mesh term Gemcitabine intervention ancestor list intervention ancestor intervention ancestor id D000000964 intervention ancestor term Antimetabolites, Antineoplastic intervention ancestor id D000000963 intervention ancestor term Antimetabolites intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000000998 intervention ancestor term Antiviral Agents intervention ancestor id D000000890 intervention ancestor term Anti-Infective Agents intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors 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 browse leaf list intervention browse leaf intervention browse leaf id M113169 intervention browse leaf name Gemcitabine intervention browse leaf as found Open- intervention browse leaf relevance high intervention browse leaf id M3433 intervention browse leaf name Antimetabolites intervention browse leaf relevance low intervention browse leaf id M3466 intervention browse leaf name Antiviral Agents intervention browse leaf relevance low intervention browse leaf id M3366 intervention browse leaf name Anti-Infective Agents 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 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

NCT04833582

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full study rank 61910 study protocol section identification module n c t id NCT04830319 org study id info org study id HTLVIDA organization org full name Pedreira, Érika, M.D. org class INDIV brief title Pilates Method in People With HAM/TSP official title Therapeutic Effect of the Pilates Method in People With HAM/TSP: a Randomized Crossover Study status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date February 20, 2018 start date type Actual primary completion date struct primary completion date August 20, 2018 primary completion date type Actual completion date struct completion date March 15, 2020 completion date type Actual study first submit date May 23, 2018 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 Sponsor lead sponsor lead sponsor name Pedreira, Érika, M.D. lead sponsor class INDIV 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 Individuals with HTLV-1 secondary myelopathy (HAM/TSP) may have motor and sensory alterations, which may result in reduced functional performance and consequent risk of falls. The aim of the study is to verify the therapeutic effect of a Pilates exercise program on functional performance and risk of falls, when compared to task-oriented training, of people with HAM / TSP. This is a randomized, crossover clinical trial performed with individuals with HAM / TSP who are attended at a referral center who is able to perform gait whether or not to use a walking aid. Amputees, with psychiatric disorders, rheumatic or orthopedic diseases and other associated neurological disorders, which could influence the balance and functional mobility, as well as pregnant women, were excluded. Participants will be submitted to the initial evaluation of functional mobility, balance, gait balance, fatigue, gait endurance, sphincter changes and questioned about the occurrence of falls in the last three months and will answer a semi-structured questionnaire about their conjugality. They will be allocated randomly to two groups. One will perform the Pilates Method protocol and the other task-oriented training. The first group, called test-control group (GTC), will initiate the protocol with exercises of the Pilates method; the control-test group (GCT) will initiate the task-oriented training protocol. A p <0.05 will be considered a statistically significant difference. conditions module condition list condition HAM/TSP HTLV-1 Secondary Myelopathy Balance Gait Balance Functional Mobility design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Crossover Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Investigator enrollment info enrollment count 22 enrollment type Actual arms interventions module arm group list arm group arm group label Test-control group (TCG) arm group type Experimental arm group description The test-control group (TCG) will initiate the protocol with exercises of the Pilates method, which includes exercises in soil, that associate the correct respiratory movement with muscular strengthening and control, stretching from the eccentric movement, selective upper and lower trunk movements. There will be used accessories described by the method for their realization. Participants will perform the first week of awareness and body alignment exercises for 10 minutes, 10 minute breath perception, 10 minute proximal muscle accuracy and control, and 10 minute stretches; from the second week will be included selective trunk movements, with muscle strengthening of lower limbs. Rest intervals will be performed between exercises.After 20 sessions, the patients will be reassessed and will remain for a period of one month without any intervention, and at the end of this period will be reevaluated again. The TCG group will then conduct 20 task-oriented training sessions arm group intervention list arm group intervention name Other: Pilates Method Other: task-oriented training protocol arm group label Control-test group (CTG) arm group type Active Comparator arm group description The control-test group (CTG) will initiate the task-oriented training protocol. The task-oriented training protocol will include functional exercise drills, such as sit-up and workout, obstacle course workout, speed-and-direction workout, balance workout, work-up and downhill workout, each tasks performed for eight minutes, with two minutes of rest between them. The difficulty in carrying out the tasks will be progressively adjusted. At all times, individuals will be instructed to contract the pelvic floor musculature. After 20 sessions, the patients will be reassessed and will remain for a period of one month without any intervention, and at the end of this period will be reevaluated again. Next, the CTG group will perform 20 sessions of Pilates exercises. arm group intervention list arm group intervention name Other: Pilates Method Other: task-oriented training protocol intervention list intervention intervention type Other intervention name Pilates Method intervention description includes exercises in soil, that associate the correct respiratory movement with muscular strengthening and control, stretching from the eccentric movement, selective upper and lower trunk movements. There will be used accessories described by the method for their realization. Participants will perform the first week of awareness and body alignment exercises for 10 minutes, 10 minute breath perception, 10 minute proximal muscle accuracy and control, and 10 minute stretches; from the second week will be included selective trunk movements, with muscle strengthening of lower limbs. Rest intervals will be performed between exercises. intervention arm group label list intervention arm group label Control-test group (CTG) Test-control group (TCG) intervention type Other intervention name task-oriented training protocol intervention description The control-test group (CTG) will initiate the task-oriented training protocol. The task-oriented training protocol will include functional exercise drills, such as sit-up and workout, obstacle course workout, speed-and-direction workout, balance workout, work-up and downhill workout, each tasks performed for eight minutes, with two minutes of rest between them. The difficulty in carrying out the tasks will be progressively adjusted. At all times, individuals will be instructed to contract the pelvic floor musculature. After 20 sessions, the patients will be reassessed and will remain for a period of one month without any intervention, and at the end of this period will be reevaluated again. Next, the CTG group will perform 20 sessions of Pilates exercises. intervention arm group label list intervention arm group label Control-test group (CTG) Test-control group (TCG) outcomes module primary outcome list primary outcome primary outcome measure Balance primary outcome description Berg's Balance Scale (BBS) primary outcome time frame 15 minutes primary outcome measure Functional Mobility primary outcome description Timed up and Go (TUG) primary outcome time frame 3 minutes primary outcome measure Gait Balance primary outcome description Dynamic Gait Index (DGI) primary outcome time frame 10 minutes primary outcome measure Balance primary outcome description Balance Evaluation Systems Test of dynamic balance (mini-BESTest) primary outcome time frame 20 minutes eligibility module eligibility criteria Inclusion Criteria: individuals with probable and/or defined diagnosis of HAM / TSP, according to WHO criteria, of both sexes, aged 18 to 64 years. Exclusion Criteria: individuals with lower limb amputation, pregnancy, psychiatric disorders, rheumatic or orthopedic diseases, other associated neurological disorders, and those who have difficulty understanding the assessment instruments. healthy volunteers No gender All minimum age 18 Years maximum age 64 Years std age list std age Adult contacts locations module location list location location facility Universidade Católica do Salvador location city Salvador location state Bahia location zip 40000-00 location country Brazil 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 D000013118 condition mesh term Spinal Cord Diseases condition ancestor list condition ancestor 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 M11459 condition browse leaf name Neoplasm Metastasis condition browse leaf relevance low condition browse leaf id M4286 condition browse leaf name Bone Marrow Diseases condition browse leaf relevance low condition browse leaf id M15067 condition browse leaf name Spinal Cord Diseases condition browse leaf as found Myelopathy condition browse leaf relevance high condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id T2845 condition browse leaf name Human T-cell Leukemia Virus Type 1 condition browse leaf relevance low condition browse leaf id T2840 condition browse leaf name HTLV-1 Associated Myelopathy/tropical Spastic Paraparesis condition browse leaf as found HAM/TSP condition browse leaf relevance high 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 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

NCT04830319

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full study rank 61476 study protocol section identification module n c t id NCT04835974 org study id info org study id No-reflow phenomenon organization org full name Assiut University org class OTHER brief title the No-reflow in Diabetic Patients Treated With Primary Percutaneous Coronary Intervention (PCI) official title Metabolic Profile as a Predictor of No-reflow in Diabetic Patients Treated With Primary Percutaneous Coronary Intervention (PCI) 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 1, 2021 start date type Anticipated primary completion date struct primary completion date May 1, 2022 primary completion date type Anticipated completion date struct completion date May 2022 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 8, 2021 study first post date type Actual last update submit date April 13, 2021 last update post date struct last update post date April 14, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name El Zahraa Gamal responsible party investigator title Metabolic profile as a predictor of no reflow in diabetic patients treated with primary Percutaneous Coronary Intervention (PCI) . responsible party investigator affiliation Assiut University lead sponsor lead sponsor name Assiut 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 1- to find metabolic factors that correlate with the development of no reflow phenomenon that may help prevent its occurrence . detailed description Acute myocardial infarction (AMI) with its accompanying adverse sequelae is one of the most common causes of morbidity and mortality in the world . Although reperfusion techniques for ST- elevation myocardial infarction (STEMI ) are constantly improving, no-reflow can still lead to poor prognosis . At present, the exact mechanism of no-reflow remains unclear, but clinical and laboratory findings suggest that it is related to the embolism of the capillary bed, ischemic injury, vascular endothelial dysfunction, production of oxygen free radical , and other factors . The no-reflow phenomenon is one of complications of poor functional and clinical outcomes for patients with (AMI) . The no-reflow phenomenon is present in 25% to 30% of patients with (AMI) underwent successful coronary recanalization, as shown by angiography . The myocardial no-reflow phenomenon is associated with a reducution of antegrade myocardial blood flow inspite of an open infarct-related artery in patients with (STEMI ) undergoing (PCI). Importantly, no-reflow is known to be related to unfavorable clinical outcome and prognosis . The cause of this complex phenomenon is the variable combination of four pathogenetic components: distal atherothrombotic embolization, ischemic injury, reperfusion injury and susceptibility of coronary microcirculation to injury . As a consequence, appropriate strategies are expected to prevent or treat these components are expected to avoid the no-reflow. Coronary reperfusion therapy is widely performed in patients with (AMI) . However, in spite of patency of the infarct-related artery , there is no guarantee of salvage of myocardium at risk of ischemia .The no-reflow phenomenon is found in >30% of patients after thrombolysis or catheter-based (PCI) for (AMI) . It is important, therefore, to be able to predict which lesions are high risk for no reflow before beginning PCI . There are numerous recognized risk factors for the development of coronary artery disease (CAD), one of the best known is the association between blood lipids and CAD . Several prospective studies have established that the risk of cardiac morbidity and mortality is directly related to the concentration of plasma cholesterol. ' The most prevalent view is that the increased risk of myocardial infarction associated with elevated plasma cholesterol levels can be adequately explained on the basis of the increase in number and severity of coronary atherosclerotic vascular lesions . . conditions module condition list condition No-Reflow Phenomenon 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 Other design masking info design masking None (Open Label) enrollment info enrollment count 120 enrollment type Anticipated arms interventions module arm group list arm group arm group label diabetic patients with reflow phenomenon arm group type Experimental arm group description All Assiut University heart Hospital patients ,and who meet the listed inclusion and exclusion criteria will be eligible for the study. Patients' charts will be retrieved based on their intervention procedures. The charts will be reviewed and eligible patients will be filtered. The needed variables will be entered into our data base for later data analysis. arm group intervention list arm group intervention name Diagnostic Test: 1- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- S intervention list intervention intervention type Diagnostic Test intervention name 1- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- S intervention description Blood samples were obtained before PCI, and the following parameters will be measured: LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. Glycemia will be assessed : RBS ( random blood sugar ) . Serum Uric acid : S .UA intervention arm group label list intervention arm group label diabetic patients with reflow phenomenon outcomes module primary outcome list primary outcome primary outcome measure measure serum random blood sugar primary outcome description to detect the correlation between the diabetus mellitus (serum random blood sugar) and no-reflow phenomenon and analysis of this metabolic factors in patient withSTEMI who will undergo primaru PCI and show its effects on no-reflow phenomenon that may help prevent its occurrence . primary outcome time frame baseline secondary outcome list secondary outcome secondary outcome measure measure the serum uric acid secondary outcome description to detect the correlation between the serum uric acid , lipid profile and no-reflow phenomenon and show other metabolic factors effects on no-reflow to avoid its occurance secondary outcome time frame baseline secondary outcome measure measure the lipid profile secondary outcome description to detect the correlation between lipid profile and no-reflow phenomenon secondary outcome time frame baseline eligibility module eligibility criteria Inclusion Criteria: diabetic patients with STEMI treated with primary PCI Exclusion Criteria: non diabetic . with selected PCI (1) a history of an unprotected left main artery with severe liver and kidney diseases or coronary artery bypass grafting . (2) patients who had valvular disease or cardiomyopathy . (3) severe dissection, thromboembolism in other parts, or vasospasm; and known malignancy . (4) patients with contraindications for anticoagulant therapy, such as active visceral hemorrhage, hemorrhagic stroke, or ischemic stroke within half a year (including transient ischemic attack), or aortic dissection, or patients with hematological diseases complicated with coagulation disorders . healthy volunteers Accepts Healthy Volunteers gender All std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name alzahraa gamal, master central contact role Contact central contact phone 01026181748 central contact e mail alzahraagamal@gmail.com central contact name hatem abdel elrahman central contact role Contact central contact phone 01005212162 central contact e mail Hatem19652006@yahoo.com references module reference list reference reference p m i d 6683937 reference type background reference citation Bernstein JM, Lee J, Conboy K, Ellis E, Li P. The role of IgE mediated hypersensitivity in recurrent otitis media with effusion. Am J Otol. 1983 Jul;5(1):66-9. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000054318 condition mesh term No-Reflow Phenomenon condition ancestor list condition ancestor condition ancestor id D000007511 condition ancestor term Ischemia condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M26773 condition browse leaf name No-Reflow Phenomenon condition browse leaf as found No-Reflow Phenomenon condition browse leaf relevance high condition browse leaf id M9695 condition browse leaf name Ischemia 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 intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M16429 intervention browse leaf name Uric Acid 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

NCT04835974

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full study rank 61749 study protocol section identification module n c t id NCT04832425 org study id info org study id PRAX-114-213 organization org full name Praxis Precision Medicines org class INDUSTRY brief title A Clinical Trial of PRAX-114 in Participants With Major Depressive Disorder official title A Phase 2/3 Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of PRAX-114 in Participants With Major Depressive Disorder status module status verified date July 2022 overall status Completed expanded access info has expanded access No start date struct start date March 30, 2021 start date type Actual primary completion date struct primary completion date May 5, 2022 primary completion date type Actual completion date struct completion date May 5, 2022 completion date type Actual study first submit date March 19, 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 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 Sponsor lead sponsor lead sponsor name Praxis Precision Medicines 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 This is a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of PRAX-114 in participants with moderate to severe major depressive disorder (MDD). Participants will be randomized to receive 28 days of either 40 mg PRAX-114 or placebo in a 1:1 ratio. conditions module condition list condition Major Depressive Disorder keyword list keyword Mood Disorders Depressive Disorder Depression Depressive Disorder, Unipolar Depressive Symptoms Agents, GABA Receptors, GABA-A Allosteric Regulation design module study type Interventional phase list phase Phase 2 Phase 3 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 216 enrollment type Actual arms interventions module arm group list arm group arm group label PRAX-114 arm group type Experimental arm group description 40 mg PRAX-114 once daily arm group intervention list arm group intervention name Drug: PRAX-114 arm group label Placebo arm group type Placebo Comparator arm group description Placebo once daily arm group intervention list arm group intervention name Drug: Placebo intervention list intervention intervention type Drug intervention name PRAX-114 intervention description 40 mg once daily intervention arm group label list intervention arm group label PRAX-114 intervention type Drug intervention name Placebo intervention description Placebo once daily intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Change from baseline in 17-Item Hamilton Depression Rating Scale (HAM-D17) total score at Day 15 primary outcome description The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement. primary outcome time frame 15 days secondary outcome list secondary outcome secondary outcome measure Change from baseline in HAM-D17 total score at Day 29 secondary outcome description The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement. secondary outcome time frame 29 days secondary outcome measure Change from baseline in HAM-D17 total score at all other time points secondary outcome description The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement. secondary outcome time frame 8 days, 22 days, 36 days, and 43 days secondary outcome measure Change from baseline in Clinical Global Impression-Severity (CGI-S) score at Day 15 and all other time points secondary outcome description The CGI-S assesses the clinician's impression of the participant's current depression symptoms. The clinician should use his/her total clinical experience with this patient population and rate the current severity of the participant's mental illness on a 7-point scale from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients). secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure Clinical Global Impression-Improvement (CGI-I) score at Day 15 and all other time points secondary outcome description The CGI-I assesses the participant's improvement (or worsening). The clinician is required to assess the participant's condition relative to Baseline (Day 1) on a 7-point scale from 1 (Very much improved) to 7 (Very much worse). secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure HAM-D17 response (reduction from baseline score of ≥50%) at Day 15, Day 29, and all other time points secondary outcome description The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement. secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure HAM-D17 remission (total score of ≤7) at Day 15, Day 29, and all other time points secondary outcome description The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement. secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure Change from baseline in the Symptoms of Depression Questionnaire (SDQ) total and sub-scale scores at Day 15 and all other time points secondary outcome description The SDQ is a 44-item, self-report scale assessing the severity of symptoms across several subtypes of depression. Items are scored on a 7-point scale (ranging from 1 to 6). The SDQ total score is the sum of all 44 item scores and ranges from 44 to 264 with higher scores indicating worse symptoms. secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure Patient Global Impression-Improvement (PGI-I) score at Day 15 and all other time points secondary outcome description The PGI-I scale is a global self-assessment used to rate the response of a participant's condition to therapy or intervention. It consists of 1 question that asks the participant to rate their current condition compared to how it was prior to beginning treatment on a scale of 1 (very much better) to 7 (very much worse). secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure Change from baseline in the Work and Social Adjustment Scale (WSAS) at Day 15 and all other time points secondary outcome description The WSAS assesses the degree to which mental health problems interfere with day-to-day functioning in 5 domains: work, social leisure activities, private leisure activities, home- management, and personal relationships. The WSAS total score is the sum of the 5 item scores and ranges from 0 to 40, with higher scores indicating poorer adjustment. secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure Change from baseline in the 12-Item Short Form Survey (SF-12) at Day 15 and all other time points secondary outcome description The SF-12 is composed of 12 questions covering 8 dimensions of health: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Total scores range from 0 (worse health) to 100 (better health). secondary outcome time frame 8 days, 15 days, 22 days, 29 days, 36 days, and 43 days secondary outcome measure Incidence and severity of Adverse Events (AE) secondary outcome description An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study drug, whether or not considered related to the study drug. secondary outcome time frame 43 days secondary outcome measure Incidence of AEs by preferred term secondary outcome description The incidence of AEs will be reported by preferred term, including any terms related to clinically significant changes in body temperature, pulse rate, respiratory rate, blood pressure (systolic and diastolic), clinical laboratory measures (chemistry, hematology, urinalysis, and coagulation), and electrocardiogram parameters (heart rate, PR, QRS, QT, and corrected QT intervals). secondary outcome time frame Up to 43 days secondary outcome measure Incidence of Columbia-Suicide Severity Rating Scale (C-SSRS) measured suicidal ideation or behavior secondary outcome description The C-SSRS is composed of 5 yes/no questions addressing suicidal behavior and 5 yes/no questions addressing suicidal ideation, with sub-questions assessing the severity. Incidence is measured as the number of "yes" answers indicating the presence of suicidal ideation or behavior. secondary outcome time frame Up to 43 days eligibility module eligibility criteria Inclusion Criteria: Recurrent MDD diagnosis with a current episode duration of at least 8 weeks and no more than 24 months. HAM-D17 total score of ≥23 at Screening and Baseline. Body mass index (BMI) between 18 and 38 kg/m2 (inclusive). Exclusion Criteria: Lifetime history of seizures, including febrile seizures. Neurodegenerative disorder (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, or Huntington's disease). Lifetime history of bipolar disorder, a psychotic disorder (eg, schizophrenia or schizoaffective disorder), or obsessive compulsive disorder or a history of a psychotic mood episode in last 2 years. Any current psychiatric disorder (other than MDD). Lifetime history of treatment resistant depression. Received electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS) within the last year or transcranial magnetic stimulation (TMS) within the last 6 months prior to Screening. Daily consumption of more than 2 standard alcohol-containing beverages for males or more than 1 standard alcohol-containing beverages for females. healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name VP, Clinical Development overall official affiliation Praxis Precision Medicines overall official role Study Director location list location location facility Praxis Research Site location city Phoenix location state Arizona location zip 85012 location country United States location facility Praxis Research Site location city Garden Grove location state California location zip 92845 location country United States location facility Praxis Research Site location city Lafayette location state California location zip 94549 location country United States location facility Praxis Research Site location city Lemon Grove location state California location zip 91945 location country United States location facility Praxis Research Site location city Oceanside location state California location zip 92056 location country United States location facility Praxis Research Site location city Pico Rivera location state California location zip 90660 location country United States location facility Praxis Research Site location city Redlands location state California location zip 92374 location country United States location facility Praxis Research Site location city Jacksonville location state Florida location zip 32256 location country United States location facility Praxis Research Site location city Orange City location state Florida location zip 32763 location country United States location facility Praxis Research Site location city Orlando location state Florida location zip 32801 location country United States location facility Praxis Research Site location city Atlanta location state Georgia location zip 30331 location country United States location facility Praxis Research Site location city Decatur location state Georgia location zip 30030 location country United States location facility Praxis Research Site location city Chicago location state Illinois location zip 60076 location country United States location facility Praxis Research Site location city Gaithersburg location state Maryland location zip 20877 location country United States location facility Praxis Research Site location city Worcester location state Massachusetts location zip 01655 location country United States location facility Praxis Research Site location city O'Fallon location state Missouri location zip 63368 location country United States location facility Praxis Research Site location city Las Vegas location state Nevada location zip 89102 location country United States location facility Praxis Research Site location city Berlin location state New Jersey location zip 08009 location country United States location facility Praxis Research Site location city Marlton location state New Jersey location zip 08053 location country United States location facility Praxis Research Site location city Cedarhurst location state New York location zip 11516 location country United States location facility Praxis Research Site location city Rochester location state New York location zip 14618 location country United States location facility Praxis Research Site location city Staten Island location state New York location zip 10312 location country United States location facility Praxis Research Site location city Dayton location state Ohio location zip 45417 location country United States location facility Praxis Research Site location city Allentown location state Pennsylvania location zip 18104 location country United States location facility Praxis Research Site location city Media location state Pennsylvania location zip 19063 location country United States location facility Praxis Research Site location city Memphis location state Tennessee location zip 38119 location country United States location facility Praxis Research Site location city Austin location state Texas location zip 78737 location country United States location facility Praxis Research Site location city San Antonio location state Texas location zip 78229 location country United States location facility Praxis Research Site location city Charlottesville location state Virginia location zip 22903 location country United States location facility Praxis Research Site location city Everett location state Washington location zip 98201 location country United States location facility Praxis Research Site location city Noble Park location state Victoria location zip 3174 location country Australia 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 D000004194 condition mesh term Disease condition mesh id D000003866 condition mesh term Depressive Disorder condition mesh id D000003863 condition mesh term Depression condition mesh id D000003865 condition mesh term Depressive Disorder, Major 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 ancestor id D000001526 condition ancestor term Behavioral Symptoms condition browse leaf list condition browse leaf condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf as found Depressive Disorder condition browse leaf relevance high 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 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 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 M225603 intervention browse leaf name Pramoxine 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

NCT04832425

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"full study rank 61330 study protocol section identification module n c t id NCT04837872 org study i(...TRUNCATED)

NCT04837872

[101,1554,2025,3997,5391,23493,1568,2025,11309,2237,9117,13196,183,172,189,25021,14056,1942,1568,192(...TRUNCATED)

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