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Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Immunization of preterm infants with 10-valent pneumococcal conjugate vaccine. The safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in preterm infants were assessed in this study. Three parallel groups of infants received 3-dose primary immunization with PHiD-CV at 2, 4, and 6 months of age and a booster dose at 16 to 18 months: preterm I (gestation period ≥ 27 and <31 weeks, N = 50); preterm II (≥31 and <37 weeks, N = 87); and term (≥37 weeks, N = 149). Solicited symptoms and adverse events were recorded. Immune responses to PHiD-CV and coadministered vaccine antigens were measured. The incidence of solicited general symptoms was similar across groups, and the frequency of grade 3 general symptoms was low. Incidences of redness and swelling were generally lower in preterm infants. PHiD-CV was immunogenic for each of the 10 vaccine pneumococcal serotypes (postprimary, ≥92.7% of infants reached enzyme-linked immunosorbent assay antibody concentrations ≥ 0.2 μg/mL and postbooster, ≥97.6%) and for protein D, with a trend for lower postprimary geometric mean antibody concentrations and opsonophagocytic activity (OPA) titers in preterm infants for some pneumococcal serotypes. Postbooster, ≥91.9% of subjects in each group had an OPA titer ≥ 8 for each of the vaccine serotypes. Pneumococcal antibody concentrations and OPA titers after priming and booster vaccination were comparable between the 2 preterm groups. PHiD-CV was well tolerated and immunogenic in preterm infants when given as a 3-dose primary vaccination, with robust enzyme-linked immunosorbent assay antibody and OPA booster responses in the second year of life. Output: | {'conditions': 'Pneumococcal Disease', 'interventions': 'Biological: Pneumococcal conjugate vaccine GSK1024850A|Biological: Infanrix hexa'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Yoga respiratory training improves respiratory function and cardiac sympathovagal balance in elderly subjects: a randomised controlled trial. Since ageing is associated with a decline in pulmonary function, heart rate variability and spontaneous baroreflex, and recent studies suggest that yoga respiratory exercises may improve respiratory and cardiovascular function, we hypothesised that yoga respiratory training may improve respiratory function and cardiac autonomic modulation in healthy elderly subjects. 76 healthy elderly subjects were enrolled in a randomised control trial in Brazil and 29 completed the study (age 68 ± 6 years, 34% males, body mass index 25 ± 3 kg/m²). Subjects were randomised into a 4-month training program (2 classes/week plus home exercises) of either stretching (control, n=14) or respiratory exercises (yoga, n=15). Yoga respiratory exercises (Bhastrika) consisted of rapid forced expirations followed by inspiration through the right nostril, inspiratory apnoea with generation of intrathoracic negative pressure, and expiration through the left nostril. Pulmonary function, maximum expiratory and inspiratory pressures (PE(max) and PI(max), respectively), heart rate variability and blood pressure variability for spontaneous baroreflex determination were determined at baseline and after 4 months. Subjects in both groups had similar demographic parameters. Physiological variables did not change after 4 months in the control group. However, in the yoga group, there were significant increases in PE(max) (34%, p<0.0001) and PI(max) (26%, p<0.0001) and a significant decrease in the low frequency component (a marker of cardiac sympathetic modulation) and low frequency/high frequency ratio (marker of sympathovagal balance) of heart rate variability (40%, p<0.001). Spontaneous baroreflex did not change, and quality of life only marginally increased in the yoga group. Respiratory yoga training may be beneficial for the elderly healthy population by improving respiratory function and sympathovagal balance. Trial Registration CinicalTrials.gov identifier: NCT00969345; trial registry name: Effects of respiratory yoga training (Bhastrika) on heart rate variability and baroreflex, and quality of life of healthy elderly subjects. Output: | {'conditions': 'Elderly Subjects|Respiration Exercises', 'interventions': 'Other: Stretching Exercises|Other: Respiratory Exercises conducted twice a day for 10 minutes'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Novel method for measurement of fatigue in multiple sclerosis: Real-Time Digital Fatigue Score. The study's objective was to develop a real-time measurement for fatigue and to evaluate whether it is an effective clinical trial outcome measure compared with the Fatigue Severity Scale (FSS) and the Modified Fatigue Impact Scale (MFIS). Forty-nine subjects with MS and an FSS >4 recorded Real-Time Digital Fatigue Scores (RDFSs) on a wrist-worn device four times a day over 3 weeks. Scores were scaled 0-10, with 10 representing the worst possible fatigue. FSS and MFIS were evaluated and compared with RDFSs. Mean RDFSs significantly correlated with FSS (r = 0.55, p < 0.001) and MFIS (r = 0.55, p < 0.001). RDFS captured circadian variations in fatigue, with scores increasing from mean 3.4 at 9 a.m., to 4.0 at 1 p.m., 4.5 at 5 p.m., and 5.0 at 9 p.m. When all scores over all days were included in a mixed-model analysis of circadian variation, the differences in RDFS between times were more significant than in an analysis that included only single scores of data isolated from the first day of monitoring. RDFS is a promising measure. RDFS significantly correlated with FSS and MFIS, captured real-time daily and circadian variations in fatigue, and provided multiple measurements of fatigue that provided statistical advantages over FSS and MFIS. Output: | {'conditions': 'Multiple Sclerosis', 'interventions': 'Drug: American ginseng extract HT-1001|Drug: placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Impact of pitavastatin on high-sensitivity C-reactive protein and adiponectin in hypercholesterolemic patients with the metabolic syndrome: the PREMIUM Study. Inflammatory reactions and oxidative stress, which are important in progression of atherosclerosis, are reported to be increased in individuals with metabolic syndrome (MetS). On the other hand, adiponectin levels are lowered. Since effects of pitavastatin on these parameters have not been reported in hypercholesterolemic patients with MetS, the present study was conducted. To evaluate the effects of pitavastatin on inflammatory reaction, oxidative stress, and plasma adiponectin levels in hypercholesterolemic MetS patients in a multicenter trial. This open-label, single group study was performed at 7 hospitals in Japan. Pitavastatin (2mg/day) was administered to 103 consecutive patients with hypercholesterolemia, subdivided into MetS and non-MetS for 12 weeks. Blood samples were collected after overnight fasting at the start of treatment (baseline) and after 12 weeks. In the patients with MetS (n=69), mean values of plasma high-sensitivity C-reactive protein (hs-CRP) were significantly higher and mean values of plasma high-molecular-weight (HMW)-adiponectin significantly lower than in their counterparts without MetS (n=34). The baseline HMW-adiponectin and high-density lipoprotein cholesterol (HDL-C) values significantly correlated only in the MetS patients (r=0.318; p=0.01). In an effectiveness analysis including 94 patients (62 with MetS, 32 without MetS), the level of hs-CRP was significantly decreased in patients with MetS during the drug treatment, whereas HMW-adiponectin did not change. When patients with MetS were divided into two subgroups according to the percent changes in HDL-C, significantly greater increase in HMW-adiponectin by pitavastatin treatment was observed in the HDL-C ≥10% increase subgroup than in the HDL-C <10% increase subgroup (p=0.009). Twelve weeks administration of pitavastatin, in addition to the antihyperlipidemic effects, may be beneficial as an anti-atherosclerotic therapy in hypercholesterolemic patients with MetS, taking changes in hs-CRP and HMW-adiponectin into consideration. ClinicalTrials.gov identifier: NCT00444717. Output: | {'conditions': 'Metabolic Syndrome|Oxidative Stress|Inflammation', 'interventions': 'Drug: pitavastatin'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Insulin injections in relation to meals in the hospital medicine ward: comparison of 2 protocols. To investigate whether changing the prandial regular insulin to rapid-acting insulin analogue in hospital medicine wards improves the timing of insulin delivery in relation to meals and improves patient safety and glucose control. This open-label randomized controlled trial in type 2 diabetic patients compared insulin lispro with meals and basal insulin glargine (intervention) vs regular insulin before meals and basal neutral protamine Hagedorn insulin twice daily (control). The primary endpoint was the rate of targeted timing of insulin to meals (target time). In the intervention group, target time was defined as insulin administered from 15 minutes before to 15 minutes after the patient started a meal. For the control group, target time was defined as insulin administered from 30 minutes before to 30 minutes after the patient started a meal. Hypoglycemic, hyperglycemic, and severe hyperglycemic patient-days were compared between groups. Twenty-seven patients in the intervention group and thirty-three patients in the control group were studied. The percentage of times that the insulin was given within target time was significantly higher in the intervention group as a whole (88.9% vs 70.1%, P<.001) and was higher for lunch and the evening meal (90% vs 66.7% and 94.7% vs 70.1%, P<.001). The rate of hypoglycemia was lower in the intervention group (1.85% vs 15%, P<.001). The rate of hyperglycemia was similar in both groups (68.2% vs 59.8%, P = .224), but the intervention group had a higher rate of severe hyperglycemia (28.9% vs 12.9%, P = .003). The use of prandial insulin analogues in medicine wards allows better timing with meals than regular insulin and results in better hypoglycemic outcomes. Higher rates of hyperglycemia with prandial analogues may need adjustment in insulin doses. Output: | {'conditions': 'Diabetes Mellitus, Type 2', 'interventions': 'Drug: Glargine insulin|Drug: NPH insulin and regular insulin|Drug: lispro insulin'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Safety and immunogenicity of RTS,S/AS02D malaria vaccine in infants. The RTS,S/AS malaria vaccine is being developed for delivery through the World Health Organization's Expanded Program on Immunization (EPI). We assessed the feasibility of integrating RTS,S/AS02D into a standard EPI schedule for infants. In this phase 2B, single-center, double-blind, controlled trial involving 340 infants in Bagamoyo, Tanzania, we randomly assigned 340 infants to receive three doses of either the RTS,S/AS02D vaccine or the hepatitis B vaccine at 8, 12, and 16 weeks of age. All infants also received a vaccine containing diphtheria and tetanus toxoids, whole-cell pertussis vaccine, and conjugated Haemophilus influenzae type b vaccine (DTPw/Hib). The primary objectives were the occurrence of serious adverse events during a 9-month surveillance period and a demonstration of noninferiority of the responses to the EPI vaccines (DTPw/Hib and hepatitis B surface antigen) with coadministration of the RTS,S/AS02D vaccine, as compared with the hepatitis B vaccine. The detection of antibodies against Plasmodium falciparum circumsporozoite and efficacy against malaria infection were secondary objectives. At least one serious adverse event was reported in 31 of 170 infants who received the RTS,S/AS02D vaccine (18.2%; 95% confidence interval [CI], 12.7 to 24.9) and in 42 of 170 infants who received the hepatitis B vaccine (24.7%; 95% CI, 18.4 to 31.9). The results showed the noninferiority of the RTS,S/AS02D vaccine in terms of antibody responses to EPI antigens. One month after vaccination, 98.6% of infants receiving the RTS,S/AS02D vaccine had seropositive titers for anticircumsporozoite antibodies on enzyme-linked immunosorbent assay (ELISA). During the 6-month period after the third dose of vaccine, the efficacy of the RTS,S/AS02D vaccine against first infection with P. falciparum malaria was 65.2% (95% CI, 20.7 to 84.7; P=0.01). The use of the RTS,S/AS02D vaccine in infants had a promising safety profile, did not interfere with the immunologic responses to coadministered EPI antigens, and reduced the incidence of malaria infection. (ClinicalTrials.gov number, NCT00289185.) Output: | {'conditions': 'Plasmodium Falciparum|Malaria', 'interventions': 'Biological: Engerix-B|Biological: TETRActHib|Biological: GSK Malaria vaccine 257049 vaccine'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Fall prevention in acute care hospitals: a randomized trial. Falls cause injury and death for persons of all ages, but risk of falls increases markedly with age. Hospitalization further increases risk, yet no evidence exists to support short-stay hospital-based fall prevention strategies to reduce patient falls. To investigate whether a fall prevention tool kit (FPTK) using health information technology (HIT) decreases patient falls in hospitals. Cluster randomized study conducted January 1, 2009, through June 30, 2009, comparing patient fall rates in 4 urban US hospitals in units that received usual care (4 units and 5104 patients) or the intervention (4 units and 5160 patients). The FPTK integrated existing communication and workflow patterns into the HIT application. Based on a valid fall risk assessment scale completed by a nurse, the FPTK software tailored fall prevention interventions to address patients' specific determinants of fall risk. The FPTK produced bed posters composed of brief text with an accompanying icon, patient education handouts, and plans of care, all communicating patient-specific alerts to key stakeholders. The primary outcome was patient falls per 1000 patient-days adjusted for site and patient care unit. A secondary outcome was fall-related injuries. During the 6-month intervention period, the number of patients with falls differed between control (n = 87) and intervention (n = 67) units (P=.02). Site-adjusted fall rates were significantly higher in control units (4.18 [95% confidence interval {CI}, 3.45-5.06] per 1000 patient-days) than in intervention units (3.15 [95% CI, 2.54-3.90] per 1000 patient-days; P = .04). The FPTK was found to be particularly effective with patients aged 65 years or older (adjusted rate difference, 2.08 [95% CI, 0.61-3.56] per 1000 patient-days; P = .003). No significant effect was noted in fall-related injuries. The use of a fall prevention tool kit in hospital units compared with usual care significantly reduced rate of falls. clinicaltrials.gov Identifier: NCT00675935. Output: | {'conditions': 'Patient Falls', 'interventions': 'Other: Fall Prevention Tool Kit prototype using a randomized design'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:A pilot study assessing adherence to auto-bilevel following a poor initial encounter with CPAP. We hypothesized that early intervention with an auto bilevel device would improve treatment adherence compared to CPAP among OSA patients with a poor initial experience with lab-based CPAP titration. Patients with a poor initial CPAP experience were recruited for this parallel group, randomized, double-blind, controlled pilot study. After an in-lab titration, patients were randomized with either an auto-bilevel device or CPAP. Treatment adherence and functioning were assessed at 90 days. We enrolled 51 subjects, with 47 completing the protocol. Groups were equally matched for gender, age, education, and OSA severity. There was no significant difference in the proportion of compliant subjects (≥ 4 h/night) between the auto bilevel and CPAP groups (62% vs. 54%; p = 0.624) after 90 days of use. Functional outcomes significantly improved in both groups during treatment use (p < 0.001) but did not differ between groups. There was no statistically significant difference in adherence between the auto bilevel and CPAP groups in this study. Patients with a poor initial CPAP exposure may still achieve an acceptable long-term clinical outcome. Both groups demonstrated comparably significant improvements in functional outcomes, sleepiness, and fatigue complaints over the treatment period. CLINICAL TRIALS INFORMATION: NCT00635206 ClinicalTrials.gov Output: | {'conditions': 'Obstructive Sleep Apnea', 'interventions': 'Device: BiPap auto with Fi Flex|Device: Standard CPAP'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Routine administration of quadrivalent meningococcal conjugate vaccine to adolescents and certain high risk groups is recommended in the United States and Canada. We compared the immunogenicity and safety of an investigational quadrivalent meningococcal vaccine conjugated to CRM-197 (MenACWY-CRM) with a licensed quadrivalent vaccine conjugated to diphtheria toxoid (MCV4) in children aged 2-10 years. Eligible 2-5-year-olds were randomized 1:2:2 to receive either 2 doses of MenACWY-CRM, or 1 dose of MenACWY-CRM or MCV4; 6-10-year-olds were randomized 1:1 to receive a single dose of MenACWY-CRM or MCV4. The primary immunogenicity assessment was seroresponse separately for the two age cohorts 28 days following a single dose of MenACWY-CRM or MCV4. Noninferiority and superiority criteria were predefined. Solicited injection-site and systemic reactions were collected for the 7 days postvaccination. A total of 2907 children were randomized to receive study vaccine. MenACWY-CRM met statistical superiority criteria vs. MCV4 for groups W and Y and was noninferior for group C in both age strata. For group A, noninferiority criteria were not met; the group A seroresponse rates for MenACWY-CRM and MCV4, respectively were 72% (95% confidence interval 68-75%) and 77% (73-80%) in 2-5-year-olds and 77% (73-80%) and 83% (79-86%) in 6-10-year-olds. When the two age strata were combined (2-10-year-old children), MenACWY-CRM was noninferior to MCV4 for all four groups, and statistically superior for groups C, W, and Y. Safety parameters were similar across age cohorts and vaccines groups. MenACWY-CRM and MCV4 were immunogenic and well tolerated in children aged 2-10 years. Seroresponse to MenACWY-CRM was statistically noninferior to MCV4 for all groups, and statistically superior for groups C, W, and Y. Clinicaltrials.gov identifier: NCT00616421. Output: | {'conditions': 'Meningococcal Infections', 'interventions': 'Biological: MenACWY-CRM|Biological: MenACWY-CRM|Biological: Licensed meningococcal ACWY vaccine'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Verteporfin plus ranibizumab for choroidal neovascularization in age-related macular degeneration: twelve-month results of the DENALI study. To demonstrate noninferiority of ranibizumab in combination with verteporfin photodynamic therapy (PDT) versus ranibizumab monotherapy in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD). Prospective, multicenter, double-masked, randomized, phase IIIb clinical trial. Three hundred twenty-one patients randomized to receive either ranibizumab 0.5 mg monotherapy (n = 112), standard fluence (SF) verteporfin PDT combination therapy (n = 104), or reduced fluence (RF) verteporfin PDT combination therapy (n = 105). Ranibizumab was administered monthly in the monotherapy group. In both combination therapy groups, ranibizumab was initiated with 3 consecutive monthly injections, followed by retreatment as needed (pro re nata) with monthly monitoring. All patients were evaluated monthly for 12 months. Mean change in best-corrected visual acuity (BCVA) from baseline at month 12 and proportion of patients randomized to either combination therapy with a ranibizumab treatment-free interval of 3 months or longer. Two hundred eighty-six patients (89.1%) completed the 12-month study. Mean BCVA change at month 12 was +5.3 and +4.4 letters with verteporfin SF (n = 103) or verteporfin RF (n = 105) plus ranibizumab, respectively, compared with +8.1 letters with ranibizumab monotherapy (n = 110; adjusted 97.5% confidence interval [CI], (-7.90 to infinity); P = 0.0666; and 97.5% CI, (-8.51 to infinity); P = 0.1178; for combination regimens vs. monotherapy, respectively). Noninferiority of either combination regimen to monthly ranibizumab monotherapy was not demonstrated (primary end point). A ranibizumab treatment-free interval of 3 months or longer was achieved in 92.6% and 83.5% of the patients randomized to verteporfin SF or verteporfin RF groups, respectively, with a mean of 5.1 and 5.7 ranibizumab injections, respectively, and patients in the ranibizumab monotherapy arm received 10.5 injections. At month 12, mean central retinal thickness decreased by 151.7 μm and 140.9 μm for the verteporfin SF and RF groups, respectively, and by 172.2 μm with ranibizumab monotherapy. Safety and tolerability of all 3 regimens were similar to and consistent with previous studies in neovascular AMD. The number of ocular serious adverse events was low and occurred largely as single cases. Ranibizumab monotherapy or combined with verteporfin PDT improved BCVA at month 12; however, noninferiority (7-letter margin) of combination regimens to ranibizumab monotherapy was not demonstrated. Verteporfin RF did not confer clinical benefits over verteporfin SF. All treatments were well tolerated. Output: | {'conditions': 'Macular Degeneration|Choroidal Neovascularization', 'interventions': 'Drug: Verteporfin Photodynamic Therapy|Drug: Ranibizumab|Drug: Verteporfin Placebo|Drug: Ranibizumab Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Antioxidant supplementation in pregnant women with low antioxidant status. The aim of this study was to investigate the benefit of antioxidant supplementation in a cohort of women with low antioxidant status and determine the changes in cell-free mRNA. This study was a randomized, placebo-controlled trial of 8-12 weeks' pregnant women who had low antioxidant status treated with either antioxidants or control diets daily until 2 weeks' postpartum. The primary end-point was the risk of pre-eclampsia and the secondary end-point was the changes of angiogenic and anti-oxidant mRNA markers related to the outcome (ClinicalTrial.gov, number NCT01232205). There were 110 women enrolled in the study, randomly assigned to the supplementation (n = 52) and control group (n = 58). The overall rate of pre-eclampsia was 8.7% (nine subjects). There were significant differences (P = 0.034) between the supplementation and control group in the incidence of pre-eclampsia (2.0% [one case] and 14.5% [eight cases], respectively) and mRNA level of superoxide-dismutase, heme oxygenase-1, vascular endothelial growth factor receptor-1, endoglin and placental growth factor after supplementation. Supplementation of women with low antioxidant status with micronutrients containing antioxidants during early gestation might reduce the risk of pre-eclampsia. Output: | {'conditions': 'Pregnant Women|Preeclampsia', 'interventions': 'Dietary Supplement: micronutrient antioxidant|Dietary Supplement: Control'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Growth and nutrient intakes of human milk-fed preterm infants provided with extra energy and nutrients after hospital discharge. The purpose of this pilot study was to determine whether mixing a multinutrient fortifier to approximately one half of the human milk fed each day for a finite period after discharge improves the nutrient intake and growth of predominantly human milk-fed low birth weight infants. We also assessed the impact of this intervention on the exclusivity of human milk feeding. Human milk-fed (> or = 80% feeding per day) low birth weight (750-1800 g) infants (n = 39) were randomly assigned at hospital discharge to either a control or an intervention group. Infants in the control group were discharged from the hospital on unfortified human milk. Nutrient enrichment of human milk in the intervention group was achieved by mixing approximately one half of the human milk provided each day with a powdered multinutrient human milk fortifier for 12 weeks after discharge. Milk with added nutrients was estimated to contain approximately 80 kcal (336 kJ) and 2.2 g protein/100 mL plus other nutrients. Intensive lactation support was provided to both groups. Infants in the intervention group were longer during the study period, and those born < or = 1250 g had larger head circumferences than infants in the control group. There was a trend toward infants in the intervention group to be heavier at the end of the intervention compared with those in the control group. Mean protein, zinc, calcium, phosphorus, and vitamins A and D intakes were higher in the intervention group. Results from this study suggest that adding a multinutrient fortifier to approximately one half of the milk provided to predominantly human milk-fed infants for 12 weeks after hospital discharge may be an effective strategy in addressing early discharge nutrient deficits and poor growth without unduly influencing human milk feeding when intensive lactation support is provided. Output: | {'conditions': 'Infant, Low Birth Weight', 'interventions': 'Drug: Nutrient-enriched human milk'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Using vertebral bone densitometry to determine aortic calcification in patients with chronic kidney disease. Vascular calcification (VC) is a major contributor to increased cardiovascular (CV) disease in chronic kidney disease (CKD) and an independent predictor of mortality. VC is inversely correlated with bone mineral density (BMD). Screening for VC may be useful to determine those at greater CV risk and dual-energy X-ray absorptiometry (DXA) may have a dual role in providing VC measurement as well as BMD. We report cross-sectional data on 44 patients with CKD stages 3-4 and aim to determine and validate measurement of VC using DXA. Patients had computed tomography (CT) of abdominal aorta and DXA of lateral lumbar spine, to determine both aortic VC and BMD. Semi-quantitative measurement of VC from DXA was determined (blinded) using previously validated 8- and 24-point scales, and compared with VC from CT. BMD determination from L2 to L4 vertebrae on CT was compared with DXA-reported BMD. Patients 66% male, 57% diabetic, had mean age 63.4 years and mean estimated glomerular filtration rate 31.4 +/- 12 mL/min. Aortic VC was present in 95% on CT, mean 564.9 +/- 304 Hounsfield units (HU). Aortic VC was seen in 68% on lateral DXA, mean scores 5.1 +/- 5.9 and 1.9 +/- 1.9 using 24- and 8-point scales, respectively. Strong correlation of VC measurement was present between CT and DXA (r 0.52, P < 0.001). For DXA VC 24-point score, intraclass correlations for intra-rater and inter-rater agreement were 0.91 and 0.64, respectively (8-point scale, intraclass correlations 0.90 and 0.69). Vertebral BMD measured by CT (mean 469.3 HU L2-4) also significantly correlated with lateral DXA-reported BMD (mean spine T-score -0.67 +/- 1.6) (r 0.56, P < 0.001). Despite limitations in CKD, DXA may be useful as lateral DXA images provide concurrent assessment of aortic calcification as well as lumbar spine BMD, both correlating significantly with CT measurements. Lateral DXA may provide VC screening to determine patients at greater CV risk although more studies are needed to evaluate their potential role. Output: | {'conditions': 'Vascular Calcification|Arteriosclerosis', 'interventions': 'Drug: Alendronate|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Phase II trial of pazopanib (GW786034), an oral multi-targeted angiogenesis inhibitor, for adults with recurrent glioblastoma (North American Brain Tumor Consortium Study 06-02). The objective of this phase II single-arm study was to evaluate the efficacy and safety of pazopanib, a multi-targeted tyrosine kinase inhibitor, against vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3, platelet-derived growth factor receptor-alpha and -beta, and c-Kit, in recurrent glioblastoma. Patients with < or =2 relapses and no prior anti-VEGF/VEGFR therapy were treated with pazopanib 800 mg daily on 4-week cycles without planned interruptions. Brain magnetic resonance imaging and clinical reassessment were made every 8 weeks. The primary endpoint was efficacy as measured by 6-month progression-free survival (PFS6). Thirty-five GBM patients with a median age of 53 years and median Karnofsky performance scale of 90 were accrued. Grade 3/4 toxicities included leukopenia (n = 1), lymphopenia (n = 2), thrombocytopenia (n = 1), ALT elevation (n = 3), AST elevation (n = 1), CNS hemorrhage (n = 1), fatigue (n = 1), and thrombotic/embolic events (n = 3); 8 patients required dose reduction. Two patients had a partial radiographic response by standard bidimensional measurements, whereas 9 patients (6 at the 8-week point and 3 only within the first month of treatment) had decreased contrast enhancement, vasogenic edema, and mass effect but <50% reduction in tumor. The median PFS was 12 weeks (95% confidence interval [CI]: 8-14 weeks) and only 1 patient had a PFS time > or =6 months (PFS6 = 3%). Thirty patients (86%) had died and median survival was 35 weeks (95% CI: 24-47 weeks). Pazopanib was reasonably well tolerated with a spectrum of toxicities similar to other anti-VEGF/VEGFR agents. Single-agent pazopanib did not prolong PFS in this patient population but showed in situ biological activity as demonstrated by radiographic responses. ClinicalTrials.gov identifier: NCT00459381. Output: | {'conditions': 'Brain and Central Nervous System Tumors', 'interventions': 'Drug: pazopanib hydrochloride'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Randomized controlled study of the histamine H3 inverse agonist MK-0249 in adult attention-deficit/hyperactivity disorder. It has been suggested that the histamine subtype 3 receptor inverse agonists such as MK-0249 might be effective in treating attention-deficit/hyperactivity disorder (ADHD). We evaluated the effects of MK-0249 in adults with ADHD. A randomized, double-blind, placebo-controlled, incomplete block, 2-period crossover study of MK-0249 5-10 mg/d and osmotic-release oral system (OROS) methylphenidate 54-72 mg/d (active comparator) was performed in 72 men and women aged ≥ 18 to ≤ 55 years who met DSM-IV criteria for ADHD of either inattentive or combined subtype and who had a chronic course of behavior disorder. The study was conducted from August 2007 through April 2008 at 6 US sites. Primary efficacy was assessed by the mean change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score after 4 weeks of treatment. Change from baseline in AISRS at week 4 for MK-0249 was not different from placebo (P = .341), whereas a significant benefit was seen for OROS methylphenidate versus placebo (P < .001). Analysis of secondary end points, including the Conners Adult ADHD Rating Scales, showed results consistent with the AISRS. A similar percentage of patients reported adverse events for MK-0249 compared with placebo (73% versus 69%, respectively). However, a greater percentage of patients reported insomnia as an adverse event with MK-0249 treatment compared with placebo (32% versus 11%, respectively). MK-0249 10 mg/d is not effective for the treatment of adult ADHD. ClinicalTrials.gov identifier: NCT00475735. Output: | {'conditions': 'Attention-Deficit/Hyperactivity Disorder (ADHD)', 'interventions': 'Drug: MK0249|Drug: Concerta (methylphenidate)|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Modulation of innate and adaptive immune responses by tofacitinib (CP-690,550). Inhibitors of the JAK family of nonreceptor tyrosine kinases have demonstrated clinical efficacy in rheumatoid arthritis and other inflammatory disorders; however, the precise mechanisms by which JAK inhibition improves inflammatory immune responses remain unclear. In this study, we examined the mode of action of tofacitinib (CP-690,550) on JAK/STAT signaling pathways involved in adaptive and innate immune responses. To determine the extent of inhibition of specific JAK/STAT-dependent pathways, we analyzed cytokine stimulation of mouse and human T cells in vitro. We also investigated the consequences of CP-690,550 treatment on Th cell differentiation of naive murine CD4(+) T cells. CP-690,550 inhibited IL-4-dependent Th2 cell differentiation and interestingly also interfered with Th17 cell differentiation. Expression of IL-23 receptor and the Th17 cytokines IL-17A, IL-17F, and IL-22 were blocked when naive Th cells were stimulated with IL-6 and IL-23. In contrast, IL-17A production was enhanced when Th17 cells were differentiated in the presence of TGF-β. Moreover, CP-690,550 also prevented the activation of STAT1, induction of T-bet, and subsequent generation of Th1 cells. In a model of established arthritis, CP-690,550 rapidly improved disease by inhibiting the production of inflammatory mediators and suppressing STAT1-dependent genes in joint tissue. Furthermore, efficacy in this disease model correlated with the inhibition of both JAK1 and JAK3 signaling pathways. CP-690,550 also modulated innate responses to LPS in vivo through a mechanism likely involving the inhibition of STAT1 signaling. Thus, CP-690,550 may improve autoimmune diseases and prevent transplant rejection by suppressing the differentiation of pathogenic Th1 and Th17 cells as well as innate immune cell signaling. Output: | {'conditions': "Crohn's Disease", 'interventions': 'Drug: CP-690,550|Drug: CP-690,550|Drug: CP-690,550'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Detection of pulmonary emboli with 99mTc-labeled anti-D-dimer (DI-80B3)Fab' fragments (ThromboView). We report a new method to diagnose acute pulmonary embolism (PE) by single photon emission computerized tomography (SPECT) after administration of (99m)Tc-labeled anti-D-dimer (DI-80B3) monoclonal antibody Fab' fragments. This novel technique provides an additional approach to diagnosing PE in patients for whom other methods are nondiagnostic or contraindicated. We performed a prospective, multicenter study to investigate the sensitivity and specificity of (99m)Tc-DI-80B3/SPECT in patients with suspected acute PE. Subjects with a moderate to high clinical probability of PE or a positive D-dimer test underwent a PE-protocol contrast-enhanced multidetector thoracic computed tomography (CT) scan as well as (99m)Tc-DI-80B3/SPECT (0.5 mg (99m)Tc-DI-80B3 intravenously followed by a thoracic SPECT 2.5 h later). Separate and independent adjudication committees, blinded to clinical data and other test results, interpreted the (99m)Tc-DI-80B3/SPECT scans (PE detected as foci of abnormally increased (99m)Tc uptake) and the thoracic CT scans using Prospective Investigation of Pulmonary Embolism Diagnosis II criteria. Of the 52 patients who were enrolled and completed both tests, 42 had both evaluable SPECT scans and thoracic CT scans. Using the criterion standard (thoracic CT scan) there were 21 patients with PE and 21 without. (99m)Tc-DI-80B3/SPECT had a sensitivity of 76.2% (95% confidence interval, 52.8-91.8%) and a specificity of 90.5% (95% confidence interval, 69.8-98.8%). Treatment-related serious adverse events did not occur. (99m)Tc-DI-80B3/SPECT was sensitive and specific for acute PE in subjects with moderate to high clinical probability of PE or a positive D-dimer test. (99m)Tc-DI-80B3/SPECT demonstrated an acceptable safety profile and avoids exposure to contrast. Output: | {'conditions': 'Acute Pulmonary Embolism', 'interventions': 'Other: ThromboView'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial. Smoking cessation is a key component of secondary cardiovascular disease prevention. Varenicline, a partial alpha4beta2 nicotinic acetylcholine receptor agonist, is effective for smoking cessation in healthy smokers, but its efficacy and safety in smokers with cardiovascular disease are unknown. A multicenter, randomized, double-blind, placebo-controlled trial compared the efficacy and safety of varenicline with placebo for smoking cessation in 714 smokers with stable cardiovascular disease. Participants received varenicline (1 mg twice daily) or placebo, along with smoking-cessation counseling, for 12 weeks. Follow-up lasted 52 weeks. The primary end point was carbon monoxide-confirmed continuous abstinence rate for weeks 9 through 12 (last 4 weeks of treatment). The continuous abstinence rate was higher for varenicline than placebo during weeks 9 through 12 (47.0% versus 13.9%; odds ratio, 6.11; 95% confidence interval [CI], 4.18 to 8.93) and weeks 9 through 52 (19.2% versus 7.2%; odds ratio, 3.14; 95% CI, 1.93 to 5.11). The varenicline and placebo groups did not differ significantly in cardiovascular mortality (0.3% versus 0.6%; difference, -0.3%; 95% CI, -1.3 to 0.7), all-cause mortality (0.6% versus 1.4%; difference, -0.8%; 95% CI, -2.3 to 0.6), cardiovascular events (7.1% versus 5.7%; difference, 1.4%; 95% CI, -2.3 to 5.0), or serious adverse events (6.5% and 6.0%; difference, 0.5%; 95% CI, -3.1 to 4.1). As a result of adverse events, 9.6% of varenicline and 4.3% of placebo participants discontinued study drug. Varenicline is effective for smoking cessation in smokers with cardiovascular disease. It was well tolerated and did not increase cardiovascular events or mortality; however, trial size and duration limit definitive conclusions about safety. Clinical Trial Registration Information- URL: http://www.clinicaltrials.gov/ct2/show/NCT00282984. Unique identifier: NCT00282984. Output: | {'conditions': 'Smoking Cessation', 'interventions': 'Drug: placebo|Drug: Varenicline'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Efficacy of tramadol versus fentanyl for postoperative analgesia in neonates. To assess, in newborn infants submitted to surgical procedures, the efficacy of two opioids-fentanyl and tramadol-regarding time to extubate, time to achieve 100 ml/kg of enteral feeding and pain in the first 72 h after surgery. Controlled, blind, randomised clinical trial. Neonatal intensive care unit. 160 newborn infants up to 28 days of life requiring major or minor surgeries. Patients were randomised to receive analgesia with fentanyl (1-2 μg/kg/h intravenously) or tramadol (0.1-0.2 mg/kg/h intravenously) in the first 72 h of the postoperative period, stratified by surgical size and by patient's gender. Pain assessed by validated neonatal scales (Crying, Requires oxygen, Increased vital signs, Expression and Sleepless Scale and the Neonatal Facial Coding System), time until extubation and time to reach 100 ml/kg enteral feeding. Statistical analysis included repeated measures analysis of variance adjusted for confounding variables and Kaplan-Meier curve adjusted by a Cox model of proportional risks. Neonatal characteristics were (mean±SD) birth weight of 2924±702 g, gestational age of 37.6±2.2 weeks and age at surgery of 199±63 h. The main indication of surgery was gastrointestinal malformation (85 newborns; 53%). Neonates who received fentanyl or tramadol were similar regarding time until extubation, time to reach 100 ml/kg of enteral feeding and pain scores in the first 72 h after surgery. Tramadol was as effective as fentanyl for postoperative pain relief in neonates but does not appear to offer advantages over fentanyl regarding the duration of mechanical ventilation and time to reach full enteral feeding. Trial registration NCT00713726. Output: | {'conditions': 'Pain|Neonatal Infections|Analgesia', 'interventions': 'Drug: FentanyL|Drug: Tramadol'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Efficacy and safety of adjunctive oral ziprasidone for acute treatment of depression in patients with bipolar I disorder: a randomized, double-blind, placebo-controlled trial. To assess efficacy and safety of adjunctive ziprasidone in subjects with bipolar depression treated with lithium, lamotrigine, or valproate. 298 adult outpatients with bipolar I disorder (DSM-IV criteria) were randomized to receive ziprasidone, 20-80 mg twice a day, or placebo twice a day for 6 weeks plus their preexisting mood stabilizer. The primary efficacy variable was change in Montgomery-Asberg Depression Rating Scale (MADRS) total scores from baseline to 6 weeks. The key secondary efficacy endpoint was change from baseline to week 6 in Clinical Global Impressions-Severity (CGI-S) scores. Computer-administered assessments for diagnostic confidence were included for quality control and to evaluate study performance. The study was conducted between October 2007 and December 2008. The mean ± SD daily dose of ziprasidone was 89.8 ± 29.1 mg. Least squares mean ± standard error changes from baseline to week 6 on MADRS total score for ziprasidone and placebo treatment groups were -13.2 ± 1.2 and -12.9 ± 1.1, respectively, with a 2-sided P value of .792. There was no significant difference on the key secondary variable (CGI-S). Adjunctive ziprasidone was well tolerated. Poor quality ratings at baseline were associated with a trend for better improvement on placebo than ziprasidone. Among 43 placebo-treated subjects with poor baseline quality ratings, 29 (67.4%) had baseline MADRS scores > 10 points higher on the computer-administered assessment than the MADRS administered by the site-based rater. The response favoring placebo over ziprasidone observed in this subgroup suggests that poor signal detection in some clinical trials can be a consequence of "subject inflation" as well as "rater inflation." Adjunctive ziprasidone treatment failed to separate from mood stabilizer alone on primary and secondary endpoints. Possible contributions to this result include enrollment of a substantial number of subjects with low diagnostic confidence, low quality ratings on the MADRS, and overzealous reporting of symptoms by subjects. clinical trials.gov Identifier: NCT00483548. Output: | {'conditions': 'Bipolar Disorder|Depression, Bipolar', 'interventions': 'Drug: Ziprasidone|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Less weight gain and hypoglycaemia with once-daily insulin detemir than NPH insulin in intensification of insulin therapy in overweight Type 2 diabetes patients: the PREDICTIVE BMI clinical trial. To assess weight change when once-daily insulin detemir (detemir) or neutral protamine Hagedorn insulin (NPH) are used in already overweight Type 2 diabetes patients requiring intensified insulin therapy. This 26-week randomized, controlled trial included adults with Type 2 diabetes [glycated haemoglobin (HbA(1c)) 7.5-11.0%, body mass index (BMI) 25-40 kg/m(2)] who had received two daily doses of insulin (at least one a premix) for > or = 3 months. Subjects received either detemir (n = 125) or NPH (n = 146) once daily in the evening and insulin aspart at main meals. Concomitant treatment with metformin was allowed. Basal insulin was titrated to a pre-breakfast plasma glucose target of 6.1 mmol/l without unacceptable hypoglycaemia. Insulin aspart was also titrated (target, postprandial glucose < or = 10.0 mmol/l without unacceptable hypoglycaemia). At 26 weeks, weight had increased significantly less with detemir (0.4 kg) than with NPH (1.9 kg; difference 1.5 kg, P < 0.0001). BMI increase was also less with detemir than with NPH (difference 0.6 kg/m(2), P < 0.0001). HbA(1c) decreased from 8.9 to 7.8% (detemir) and from 8.8 to 7.8% (NPH; not significant for between-treatment difference). Incidence of hypoglycaemia was lower with detemir [relative risks 0.62 (all events) and 0.43 (nocturnal); P < 0.0001 for both]. PREDICTIVE BMI was the first study to examine the effect of once-daily detemir with weight as the primary endpoint in a large population of overweight Type 2 diabetes patients. Use of once-daily detemir for intensification of insulin therapy resulted in less weight gain, less hypoglycaemia and equivalent glycaemic control compared with NPH. Output: | {'conditions': 'Diabetes|Diabetes Mellitus, Type 2', 'interventions': 'Drug: insulin detemir|Drug: insulin NPH|Drug: insulin aspart'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Evaluation of a low-dose oral contraceptive pill for primary dysmenorrhea: a placebo-controlled, double-blind, randomized trial. To evaluate the efficacy and safety of low-dose oral contraceptives (IKH-01; 0.035 mg ethinyl estradiol and 1 mg norethisterone) for patients with primary dysmenorrhea. Placebo-controlled, double-blind, randomized trial. Clinical trial sites in Japan. One hundred fifteen patients with primary dysmenorrhea. Patients randomly assigned to receive IKH-01 or placebo for four cycles. Total dysmenorrhea score, verbal rating scale defining pain according to limited ability to work and need for analgesics, and visual analog scale (VAS). Reduction in total dysmenorrhea score and VAS before and after treatment was significantly higher in the IKH-01 group than in the placebo group. Total dysmenorrhea score and VAS in the IKH-01 group significantly decreased from cycles 2 to 5. Overall incidence of adverse events was significantly higher in the IKH-01 group. Incidence decreased over time in the IKH-01 group; it was invariable in the placebo group. No serious adverse events occurred. IKH-01 could be used as a single agent or in combination with analgesics for treatment of primary dysmenorrhea. Output: | {'conditions': 'Dysmenorrhea', 'interventions': 'Drug: Norethindrone,Ethinyl Estrsdiol'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Light-activated tissue bonding for excisional wound closure: a split-lesion clinical trial. Apposition of wound edges by sutures provides a temporary scaffold and tension support for healing. We have developed a novel tissue-sealing technology, photoactivated tissue bonding (PTB), which immediately crosslinks proteins between tissue planes, thereby sealing on a molecular scale. To determine the effectiveness of PTB for superficial closure of skin excisions and to compare the results with standard epidermal suturing. A split-lesion, paired comparison study of 31 skin excisions was performed. Following deep closure with absorbable sutures, one-half of each wound was superficially closed with nonabsorbable nylon sutures while the other half was stained with Rose Bengal dye and treated with green light. Overall appearance and scar characteristics were rated at 2weeks and 6months in a blinded manner by three dermatologists viewing photographs, by two onsite physicians and by patients. At 2weeks, neither sutured nor PTB-treated segments showed dehiscence; however, PTB-sealed segments showed less erythema than sutured segments as determined by photographic (P=0·001) and onsite evaluations (P=0·005). Overall appearance after PTB was judged better than after sutures (P=0·002). At 6months, scars produced by PTB were deemed superior to scars resulting from sutures in terms of appearance (P<0·001), width (P=0·002) and healing (P=0·003). Patients were more satisfied with the appearance of the PTB-sealed wound half after 2weeks and 6months (P=0·013 and P=0·003, respectively). A novel molecular suturing technique produces effective wound sealing and less scarring than closure with nylon interrupted epidermal sutures. Comparisons with better suturing techniques are warranted. Output: | {'conditions': 'Basal Cell Carcinoma|Squamous Cell Carcinoma|Atypical Nevus', 'interventions': 'Procedure: tissue bonding|Procedure: sutures'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Characterization of the metabolic and physiologic response to chromium supplementation in subjects with type 2 diabetes mellitus. The objective of the study was to provide a comprehensive evaluation of chromium (Cr) supplementation on metabolic parameters in a cohort of type 2 diabetes mellitus subjects representing a wide phenotype range and to evaluate changes in "responders" and "nonresponders." After preintervention testing to assess glycemia, insulin sensitivity (assessed by euglycemic clamps), Cr status, and body composition, subjects were randomized in a double-blind fashion to placebo or 1000 microg Cr. A substudy was performed to evaluate 24-hour energy balance/substrate oxidation and myocellular/intrahepatic lipid content. There was not a consistent effect of Cr supplementation to improve insulin action across all phenotypes. Insulin sensitivity was negatively correlated to soleus and tibialis muscle intramyocellular lipids and intrahepatic lipid content. Myocellular lipids were significantly lower in subjects randomized to Cr. At preintervention, responders, defined as insulin sensitivity change from baseline of at least 10% or greater, had significantly lower insulin sensitivity and higher fasting glucose and A(1c) when compared with placebo and nonresponders, that is, insulin sensitivity change from baseline of less than 10%. Clinical response was significantly correlated (P < .001) to the baseline insulin sensitivity, fasting glucose, and A(1c). There was no difference in Cr status between responder and nonresponders. Clinical response to Cr is more likely in insulin-resistant subjects who have more elevated fasting glucose and A(1c) levels. Chromium may reduce myocellular lipids and enhance insulin sensitivity in subjects with type 2 diabetes mellitus who do respond clinically independent of effects on weight or hepatic glucose production. Thus, modulation of lipid metabolism by Cr in peripheral tissues may represent a novel mechanism of action. Output: | {'conditions': 'Type 2 Diabetes', 'interventions': 'Dietary Supplement: chromium picolinate 1000 mcg daily vs placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Feasibility and effectiveness of an aerobic exercise program in children with fibromyalgia: results of a randomized controlled pilot trial. To determine the feasibility of conducting a randomized controlled trial of a 12-week exercise intervention in children with fibromyalgia (FM) and to explore the effectiveness of aerobic exercise on physical fitness, function, pain, FM symptoms, and quality of life (QOL). FM patients ages 8-18 years were randomized to a 12-week exercise intervention of either aerobics or qigong. Both groups participated in 3 weekly training sessions. Program adherence and safety were monitored at each session. Data were collected at 3 testing sessions, 2 prior to and 1 after the intervention, and included FM symptoms, function, pain, QOL, and fitness measures. Thirty patients participated in the trial. Twenty-four patients completed the program; 4 patients dropped out prior to training and 2 dropped out of the aerobics program. Better adherence was reported in the aerobics group than in the qigong group (67% versus 61%). Significant improvements in physical function, functional capacity, QOL, and fatigue were observed in the aerobics group. Anaerobic function, tender point count, pain, and symptom severity improved similarly in both groups. It is feasible to conduct an exercise intervention trial in children with FM. Children with FM tolerate moderate-intensity exercise without exacerbation of their disease. Significant improvements in physical function, FM symptoms, QOL, and pain were demonstrated in both exercise groups; the aerobics group performed better in several measures compared with the qigong group. Future studies may need larger sample sizes to confirm clinical improvement and to detect differences in fitness in childhood FM. Output: | {'conditions': 'Muscular Disease|Fibromyalgia', 'interventions': 'Behavioral: Aerobic exercise|Behavioral: Qigong exercise'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Eicosapentaenoic acid reduces rectal polyp number and size in familial adenomatous polyposis. The omega-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA) has anticolorectal cancer activity in vitro and in preclinical models. The present study tested whether a novel, enteric-coated formulation of EPA, as the free fatty acid (EPA-FFA), has chemopreventative efficacy in patients with familial adenomatous polyposis (FAP), in a randomised, double-blind, placebo-controlled trial. Patients undergoing endoscopic surveillance of their retained rectum postcolectomy were randomised to EPA-FFA (SLA Pharma) 2 g daily or placebo for 6 months. The number and size of polyps in an area of mucosa defined by a tattoo were determined before and after intervention. Global rectal polyp burden was scored (-1, 0, +1) by examination of video endoscopy records. Mucosal fatty acid content was measured by gas chromatography-mass spectrometry. 55 patients with FAP were evaluated by an intention-to-treat analysis (EPA-FFA 28, placebo 27). Treatment with EPA-FFA for 6 months was associated with a mean 22.4% (95% CI 5.1% to 39.6%) reduction in polyp number (p=0.012) and a 29.8% (3.6% to 56.1%) decrease in the sum of polyp diameters (p=0.027). Global polyp burden worsened over 6 months in the placebo group (-0.34) unlike the EPA-FFA group (+0.09, difference 0.42 (0.10-0.75), p=0.011). EPA-FFA treatment led to a mean 2.6-fold increase in mucosal EPA levels (p=0.018 compared with placebo). EPA-FFA was well tolerated with an incidence of adverse events similar to placebo. EPA-FFA has chemopreventative efficacy in FAP, to a degree similar to that previously observed with selective cyclo-oxygenase-2 inhibitors. EPA holds promise as a colorectal cancer chemoprevention agent with a favourable safety profile. Output: | {'conditions': 'Familial Adenomatous Polyposis Coli|FAP', 'interventions': 'Drug: Eicosapentanoic Acid (EPA)|Procedure: Endoscopy|Procedure: Biopsies taken|Procedure: Clinical Chemistry|Procedure: Haematology|Procedure: Physical examination|Procedure: Vital signs|Procedure: Urine pregnancy test|Procedure: Completion of patient diary card|Procedure: Peripheral blood sample'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Randomized trial: immunogenicity and safety of coadministered human papillomavirus-16/18 AS04-adjuvanted vaccine and combined hepatitis A and B vaccine in girls. This randomized, open, controlled, multicenter study (110886/NCT00578227) evaluated human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (HPV-16/18 vaccine) coadministered with inactivated hepatitis A and B (HAB) vaccine. Coprimary objectives were to demonstrate noninferiority of hepatitis A, hepatitis B, and HPV-16/18 immune responses at month 7 when vaccines were coadministered, compared with the same vaccines administered alone. Healthy girls (9-15 years) were age-stratified (9, 10-12, and 13-15 years) and randomized to receive HPV (n = 270), HAB (n = 271), or HPV + HAB (n = 272). Vaccines were administered at months 0, 1, and 6. Immunogenicity was evaluated at months 0 and 7. The hepatitis A immune response was noninferior for HPV + HAB, versus HAB, for seroconversion rates (100% in each group) and geometric mean antibody titers (GMTs) (95% CI) (4,504.2 [3,993.0-5,080.8] and 5,288.4 [4,713.3-5,933.7] mIU/mL, respectively). The hepatitis B immune response was noninferior for HPV + HAB, versus HAB, for anti-HBs seroprotection rates (98.3% and 100%); GMTs were 3,136.5 [2,436.0-4,038.4] and 5,646.5 [4,481.3-7,114.6] mIU/mL, respectively. The HPV-16/18 immune response was noninferior for HPV + HAB, versus HPV, for seroconversion rates (99.6% and 100% for both antigens) and GMTs (22,993.5 [20,093.4-26,312.0] and 26,981.9 [23,909.5-30,449.1] EL.U/mL for HPV-16; 8,671.2 [7,651.7-9,826.6] and 11,182.7 [9,924.8-12,600.1] EL.U/mL for HPV-18, respectively). No subject withdrew because of adverse events. No vaccine-related serious adverse events were reported. Immune responses and reactogenicity were similar in girls aged 9 years compared with the entire study population. Results support coadministration of HPV-16/18 vaccine with HAB vaccine in girls aged 9-15 years. The HPV-16/18 vaccine was immunogenic and generally well tolerated in 9-year-old girls. Output: | {'conditions': 'Human Papillomavirus (HPV) Infection', 'interventions': 'Biological: Twinrix â„¢ Paediatric|Biological: Cervarixâ„¢'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Ameliorating hypertension and insulin resistance in subjects at increased cardiovascular risk: effects of acetyl-L-carnitine therapy. Insulin resistance, a key component of the metabolic syndrome, is a risk factor for diabetes mellitus and cardiovascular disease. Acetyl-L-carnitine infusion acutely ameliorated insulin sensitivity in type 2 diabetics with insulin resistance. In this sequential off-on-off pilot study, we prospectively evaluated the effects of 24-week oral acetyl-L-carnitine (1 g twice daily) therapy on the glucose disposal rate (GDR), assessed by hyperinsulinemic euglycemic clamps, and components of the metabolic syndrome in nondiabetic subjects at increased cardiovascular risk a priori segregated into 2 groups with GDR < or =7.9 (n=16) or >7.9 (n=16) mg/kg per minute, respectively. Baseline GDR and systolic blood pressure were negatively correlated (n=32; P=0.001; r=-0.545), and patients with GDR < or =7.9 mg/kg per minute had higher systolic/diastolic blood pressure than those with higher GDR. Acetyl-L-carnitine increased GDR from 4.89+/-1.47 to 6.72+/-3.12 mg/kg per minute (P=0.003, Bonferroni-adjusted) and improved glucose tolerance in patients with GDR < or =7.9 mg/kg per minute, whereas it had no effects in those with higher GDRs. Changes in GDR were significantly different between groups (P=0.017, ANCOVA). Systolic blood pressure decreased from 144.0+/-13.6 to 135.1+/-8.4 mm Hg and from 130.8+/-12.4 to 123.8+/-10.8 mm Hg in the lower and higher GDR groups, respectively (P<0.05 for both; P<0.001 overall) and progressively recovered toward baseline over 8 weeks posttreatment. Total and high molecular weight adiponectin levels followed specular trends. Diastolic blood pressure significantly decreased only in those with higher GDRs. Treatment was well tolerated in all of the patients. Acetyl-L-carnitine safely ameliorated arterial hypertension, insulin resistance, impaired glucose tolerance, and hypoadiponectinemia in subjects at increased cardiovascular risk. Whether these effects may translate into long-term cardioprotection is worth investigating. Output: | {'conditions': 'Type 2 Diabetes Mellitus', 'interventions': 'Drug: L-acetylcarnitine'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Evaluation of the total face mask for noninvasive ventilation to treat acute respiratory failure. We hypothesized that the total face mask (TFM) would be perceived as more comfortable than a standard oronasal mask (ONM) by patients receiving noninvasive mechanical ventilation (NIV) therapy for acute respiratory failure (ARF) and would be quicker to apply by respiratory therapists. Sixty patients presenting with ARF were randomized to receive NIV via either an ONM or a TFM. Mask comfort and dyspnea were assessed using visual analog scores. Other outcomes included time required to apply, vital signs and gas exchange at set time points, and early NIV discontinuation rates (ie, stoppage while still requiring ventilatory assistance). Mask comfort and dyspnea scores were similar for both groups through 3 h of use. The time required to apply the mask (5 min [interquartile range (IQR), 2-8] vs 3.5 min [IQR, 1.9-5]), and duration of use (15.7 h [IQR, 4.0-49.8]) vs 6.05 h [IQR, 0.9-56.7]) were not significantly different between the ONM and the TFM group, respectively. Except for heart rate, which was higher at baseline in the TFM group, no differences in vital signs or gas exchange were detected between the groups during the first 3 h (P > .05). Early NIV discontinuation rates were similar for both the ONM group and TFM group (40% vs 57.1%); however, eight patients in the TFM group were switched to an ONM within 3 h, and none from the ONM group was switched to a TFM (P < .05). Among patients with ARF requiring NIV, the ONM and TFM were perceived to be equally comfortable and had similar application times. Early NIV discontinuation rates, improvements in vital signs and gas exchange, and intubation and mortality rates were also similar. ClinicalTrials.gov; No.: NCT00686257; URL: www.clinicaltrials.gov. Output: | {'conditions': 'Acute Respiratory Insufficiency', 'interventions': 'Device: Total face mask (interface for NPPV)|Device: Comfort full or RT040 oronasal mask (interface for NPPV)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Fentanyl pectin nasal spray in breakthrough cancer pain. Abstract Fentanyl pectin nasal spray (FPNS) is being developed to improve analgesic onset, treatment efficacy, and satisfaction/acceptability in treating breakthrough cancer pain (BTCP). Patients (n = 114) were entered into a randomized, placebo-controlled, double-blind, multicenter study. Patients who successfully titrated (n = 83) entered a double-blind phase; 10 episodes of BTCP were treated with the effective dose (7) or placebo (3). Pain intensity (11-point scale) and pain relief (5-point scale) were assessed between 5 and 60 minutes. Use of rescue medications was recorded, and acceptability assessments were conducted 30 and 60 minutes post dose. Only 6% of patients failed to titrate to an effective dose of FPNS due to lack of efficacy and 5% due to adverse events. A total of 91% of randomized patients completed the study. Episode analysis (FPNS, n = 459; placebo, n = 200) revealed that compared with placebo, 33% of FPNS episodes showed an onset of improvement in pain intensity at 5 minutes (P < 0.05); 33% of episodes by 10 minutes had clinically meaningful pain relief (> or = 2 point decrease in pain intensity; P < 0.0001). Satisfaction with the convenience and ease of use of FPNS was reported by 70% and 68% of patients, respectively; 87% of patients elected to continue treatment post study. FPNS provided rapid analgesia in BTCP and was well accepted by patients. Output: | {'conditions': 'Cancer Pain', 'interventions': 'Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Bronchodilator effect on ventilatory, pulmonary gas exchange, and heart rate kinetics during high-intensity exercise in COPD. Respiratory mechanical abnormalities in patients with chronic obstructive pulmonary disease (COPD) may impair cardiodynamic responses and convective oxygen delivery during exercise, resulting in slower ventilatory, pulmonary gas exchange (PGE), and heart rate (HR) kinetics compared with normal. We reasoned that bronchodilators and the attendant reduction of operating lung volumes should accelerate ventilatory, PGE, and HR kinetics in the transition from rest to high-intensity exercise. Twelve clinically stable COPD patients undertook constant-work rate cycle testing at 75% of each individual's maximum work capacity after receiving either combined nebulized bronchodilators (BD) or placebo (PL), randomly. Mean response time (MRT) and amplitude of slow component for oxygen uptake (V'O(2)), carbon dioxide production (V'CO(2)), ventilation (V'(E)), and HR together with operating dynamic end-expiratory lung volume (EELV) were measured. Resting and exercise EELV decreased significantly by 0.38 L after BD compared with PL. After BD, V'O(2), V'CO(2), V'(E), and HR MRT accelerated (p < 0.05) by an average of 12, 22, 27, and 22 s, respectively (i.e., 15, 18, 22 and 27%, respectively). The slow component for V'O(2) declined by an average of 55 ml/min compared with PL. Speeded MRT for V'O(2) correlated with indices of reduced lung hyperinflation, such as resting EELV (r = -0.64, p = 0.025) and EELV at isotime (r = -0.77, p = 0.0032). The results confirm an important interaction between abnormal dynamic respiratory mechanics and indices of cardio-circulatory function in the rest-to-exercise transition in COPD patients. Output: | {'conditions': 'Chronic Obstructive Pulmonary Disease', 'interventions': 'Drug: Combivent'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:The performance of MelaFind: a prospective multicenter study. To demonstrate the safety and effectiveness of MelaFind, a noninvasive and objective computer-vision system designed to aid in detection of early pigmented cutaneous melanoma. A prospective, multicenter, blinded study. The diagnostic performance of MelaFind and of study clinicians was evaluated using the histologic reference standard. Standard images and patient information for a subset of 50 randomly selected lesions (25 melanomas) were used in a reader study of 39 independent dermatologists to estimate clinicians' biopsy sensitivity to melanoma. Three academic and 4 community practices in the United States with expertise in management of pigmented skin lesions. A total of 1383 patients with 1831 lesions enrolled from January 2007 to July 2008; 1632 lesions (including 127 melanomas-45% in situ-with median Breslow thickness of invasive lesions, 0.36 mm) were eligible and evaluable for the study end points. Sensitivity of MelaFind; specificities and biopsy ratios for MelaFind and the study investigators; and biopsy sensitivities of independent dermatologists in the reader study. The measured sensitivity of MelaFind was 98.4% (125 of 127 melanomas) with a 95% lower confidence bound at 95.6% and a biopsy ratio of 10.8:1; the average biopsy sensitivity of dermatologists was 78% in the reader study. Including borderline lesions (high-grade dysplastic nevi, atypical melanocytic proliferations, or hyperplasias), MelaFind's sensitivity was 98.3% (172 of 175), with a biopsy ratio of 7.6:1. On lesions biopsied mostly to rule out melanoma, MelaFind's average specificity (9.9%) was superior to that of clinicians (3.7%) (P=.02). MelaFind is a safe and effective tool to assist in the evaluation of pigmented skin lesions. clinicaltrials.gov Identifier: NCT00434057. Output: | {'conditions': 'Melanoma', 'interventions': 'Device: MelaFind(R)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Efficacy and safety of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. To examine lisdexamfetamine dimesylate (LDX) efficacy and safety versus placebo in adolescents with attention-deficit/hyperactivity disorder (ADHD). Adolescents (13 through 17) with at least moderately symptomatic ADHD (ADHD Rating Scale IV: Clinician Version [ADHD-RS-IV] score ≥28) were randomized to placebo or LDX (30, 50, or 70 mg/d) in a 4-week, forced-dose titration, double-blind study. Primary and secondary efficacy measures were the ADHD-RS-IV, Clinical Global Impressions-Improvement (CGI-I), and Youth QOL-Research Version (YQOL-R). Safety assessments included treatment-emergent adverse events (TEAEs), vital signs, laboratory findings, physical examinations, and ECG. Overall, 314 participants were randomized; 309 were in efficacy analyses and 49 withdrew (11 due to TEAEs). Least squares mean (SE) change from baseline at endpoint in ADHD-RS-IV total scores were -18.3 (1.25), -21.1 (1.28), -20.7 (1.25) for 30, 50, and 70 mg/d LDX, respectively; -12.8 (1.25) for placebo (p ≤ .0056 versus placebo for each). Differences in ADHD-RS-IV total scores favored all LDX doses versus placebo at all weeks (p ≤ .0076). On the CGI-I, 69.1% of participants were rated very much/much improved at endpoint with LDX all doses versus placebo (39.5%) (p < .0001). YQOL-R changes at endpoint scores for LDX groups versus placebo were not significant. Commonly reported LDX (all doses combined) TEAEs (≥5%) were decreased appetite, headache, insomnia, decreased weight, and irritability. Small mean increases in pulse and blood pressure and no clinically meaningful trends in ECG changes were noted with LDX. LDX at all doses was effective versus placebo in treating adolescent ADHD and demonstrated a safety profile consistent with previous LDX studies. CLINICAL TRIALS REGISTRY INFORMATION: Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD); http://www.clinicaltrials.gov; NCT00735371. Output: | {'conditions': 'ADHD', 'interventions': 'Drug: LDX 30 mg|Drug: LDX 50 mg|Drug: LDX 70 mg|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Rituximab serum concentrations during immuno-chemotherapy of follicular lymphoma correlate with patient gender, bone marrow infiltration and clinical response. Treatment of follicular lymphoma with rituximab is currently recommended at a dose of 375 mg/m(2). We aimed to provide a rationale for optimal dosing and scheduling of this anti-CD20 antibody based on pharmacokinetics. Clinical efficacy of immunochemotherapy with rituximab, fludarabine and mitoxantrone followed by 2-monthly rituximab maintenance was evaluated in 29 patients with previously untreated follicular lymphoma in a prospective phase II trial (AGMT-NHL9). Pharmacokinetic analysis was assessed in 17 patients. Induction treatment resulted in high clinical response rates (complete remission 66%; ORR 100%). Significantly higher complete remission rates were observed in female patients (86 vs. 47%; Odds Ratio 6.8, 95% CI: 1.12; 41.82; P=0.05). Rituximab pharmacokinetic analysis showed a high variability ranging over almost 1 order of magnitude at maintenance cycle 1 (area under the curve 1,540-12,025 g/L*days). Median area under the curve was lower in men (81%) and in patients with initial bone marrow infiltration (76%). Higher rituximab serum concentrations before next therapy (C(trough)) were associated with female sex (P=0.04) as well as with absence of initial bone marrow infiltration (P=0.001). C(trough) correlated with remission quality (complete vs. partial remission; P=0.005) and progression-free survival (P=0.03). A decline in rituximab C(trough) below 25,000 ng/mL was observed 9.5 to 62 months before clinical relapse (P=0.008). The results of this pilot trial suggest that more differentiated dosing schedules based on gender and bone marrow infiltration should be explored for rituximab therapy for lymphoma. This study was registered in ClinicalTrials.gov (Identifier: NCT01560117). Output: | {'conditions': 'Follicular T-NHL Lymphoma|Rituximab Maintenance', 'interventions': 'Drug: Rituximab'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Improving continuous wound infusion effectiveness for postoperative analgesia after cesarean delivery: a randomized controlled trial. To evaluate in which anatomical layer (above the fascia or below the fascia) continuous wound infusion of local anesthetic, combined with nonsteroidal antiinflammatory drugs, through a multiorifice catheter has the best effectiveness during the first 48 hours on postoperative pain intensity after elective cesarean delivery. Fifty-six women undergoing elective cesarean delivery under spinal anesthesia were randomly allocated to receive 48-hour continuous wound infusion either above the fascia or below the fascia using ropivacaine and ketoprofene through a multiholed wound catheter. No other systemic analgesics were used, except for rescue patient-controlled intravenous morphine. Evaluation by a blinded investigator included visual analog scale scores at rest and at movement, morphine consumption, patient satisfaction, residual pain at 1 and 6 months, and undesirable side effects. Continuous wound infusion below the fascia resulted in significantly reduced pain at rest and total postoperative morphine consumption (15.7 mg, 95% confidence interval 9.7-20.7 mg) compared with wound administration above the fascia (26.4 mg, 95% confidence interval 18.1-34.7). No undesirable side effects or residual pain requiring treatment were recorded in both groups, whereas analgesia and satisfaction were excellent. After cesarean delivery, continuous wound infusion over 48 hours with ropivacaine and ketoprofene through a multiholed wound catheter inserted below the fascia results in better analgesia when compared with administration above the fascia. ClinicalTrials.gov, www.clinicaltrials.gov, NCT01160913. I. Output: | {'conditions': 'Cesarean Section', 'interventions': 'Procedure: Continuous wound infusion|Procedure: Continuous wound'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Reversal of profound neuromuscular block by sugammadex administered three minutes after rocuronium: a comparison with spontaneous recovery from succinylcholine. Rocuronium in intubation doses provides similar intubation conditions as succinylcholine, but has a longer duration of action. This study compared time to sugammadex reversal of profound rocuronium-induced neuromuscular block with time to spontaneous recovery from succinylcholine. One hundred and fifteen adult American Society of Anesthesiologists Class I-II surgical patients were randomized to this multicenter, safety-assessor-blinded, parallel group, active-controlled, Phase IIIa trial. Anesthesia was induced and maintained with propofol and an opioid. Neuromuscular transmission was blocked and tracheal intubation facilitated with 1.2 mg/kg rocuronium or 1 mg/kg succinylcholine. Sugammadex (16 mg/kg) was administered 3 min after rocuronium administration. Neuromuscular function was monitored by acceleromyography. The primary efficacy endpoint was the time from the start of relaxant administration to recovery of the first train-of-four twitch (T(1)) to 10%. One hundred and ten patients received study treatment. Mean times to recovery of (T(1)) to 10% and (T(1)) to 90% were significantly faster in the rocuronium-sugammadex group (4.4 and 6.2 min, respectively), as compared with the succinylcholine group (7.1 and 10.9 min, respectively; all P < 0.001). Timed from sugammadex administration, the mean time to recovery of (T(1)) to 10%, (T(1)) to 90%, and the train-of-four (T(4)/T(1)) ratio to 0.9 was 1.2, 2.9, and 2.2 min, respectively. Reoccurrence of the block was not observed. There were no serious adverse events related to study treatments. Reversal of profound high-dose rocuronium-induced neuromuscular block (1.2 mg/kg) with 16 mg/kg sugammadex was significantly faster than spontaneous recovery from 1 mg/kg succinylcholine. Output: | {'conditions': 'Anesthesia, General', 'interventions': 'Drug: Sugammadex|Drug: succinylcholine'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Peginterferon alfa-2a plus ribavirin for HIV-HCV genotype 1 coinfected patients: a randomized international trial. The safety and efficacy of weight-based ribavirin (RBV) dosing regimens in patients with HIV-HCV coinfection has not been demonstrated in randomized clinical trials. This randomized, double-blind, international, parallel-group study in specialist outpatient clinics in the United States, Spain, and Portugal compares the efficacy and safety of 2 RBV dose regimens (800 mg/day and 1000/1200 mg/day) combined with peginterferon alfa-2a (40KD) in patients with HIV-HCV (genotype 1) coinfection. Patients with HIV-HCV coinfection, quantifiable HCV RNA in serum, HCV genotype-1 infection, compensated liver disease, and stable HIV disease (CD4+ count ≥100 cells/µL) with or without ongoing antiretroviral therapy were randomized to 48 weeks' treatment with RBV at standard dose (800 mg/day) or weight-based dose (1000 mg/day for patients weighing <75 kg; 1200 mg/day for patients weighing ≥75 kg) in combination with peginterferon alfa-2a (40KD) 180 µg once a week. Planned enrollment was 400 patients with ≥100 non-Latino African Americans. The primary endpoint was sustained virological response (SVR) (undetectable HCV RNA [<20 IU/mL] at the end of a 24-week untreated follow-up period [week 72]). SVR rates were 19% (26/135) and 22% (60/275) in patients randomized to RBV 800 mg/day and 1000/1200 mg/day, respectively (odds ratio, 1.15; 95% CI, 0.68-1.93; P = .6119). In the 1000/1200 mg/day RBV dose group, the incidence of hemoglobin reductions <100 g/L and anaemia reported as an adverse event were higher versus the standard 800 mg/day RBV dose group. Compared with the standard RBV dose (800 mg/day), weight-based RBV dosing (1000/1200 mg/day) did not significantly increase SVR rates, but did increase the incidence of anemia in HIV-HCV (genotype 1) coinfected patients. Output: | {'conditions': 'Hepatitis C, Chronic', 'interventions': 'Drug: Peginterferon alfa-2a|Drug: Ribavirin|Drug: Ribavirin'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Immunization of preterm infants with 10-valent pneumococcal conjugate vaccine. The safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in preterm infants were assessed in this study. Three parallel groups of infants received 3-dose primary immunization with PHiD-CV at 2, 4, and 6 months of age and a booster dose at 16 to 18 months: preterm I (gestation period ≥ 27 and <31 weeks, N = 50); preterm II (≥31 and <37 weeks, N = 87); and term (≥37 weeks, N = 149). Solicited symptoms and adverse events were recorded. Immune responses to PHiD-CV and coadministered vaccine antigens were measured. The incidence of solicited general symptoms was similar across groups, and the frequency of grade 3 general symptoms was low. Incidences of redness and swelling were generally lower in preterm infants. PHiD-CV was immunogenic for each of the 10 vaccine pneumococcal serotypes (postprimary, ≥92.7% of infants reached enzyme-linked immunosorbent assay antibody concentrations ≥ 0.2 μg/mL and postbooster, ≥97.6%) and for protein D, with a trend for lower postprimary geometric mean antibody concentrations and opsonophagocytic activity (OPA) titers in preterm infants for some pneumococcal serotypes. Postbooster, ≥91.9% of subjects in each group had an OPA titer ≥ 8 for each of the vaccine serotypes. Pneumococcal antibody concentrations and OPA titers after priming and booster vaccination were comparable between the 2 preterm groups. PHiD-CV was well tolerated and immunogenic in preterm infants when given as a 3-dose primary vaccination, with robust enzyme-linked immunosorbent assay antibody and OPA booster responses in the second year of life. Output: | {'conditions': 'Pneumococcal Disease|Streptococcus Pneumoniae Vaccines', 'interventions': 'Biological: GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)|Biological: Infanrixâ„¢-IPV/Hib'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Evaluation of the safety of rituximab in combination with a tumor necrosis factor inhibitor and methotrexate in patients with active rheumatoid arthritis: results from a randomized controlled trial. To assess the safety of rituximab in combination with a tumor necrosis factor (TNF) inhibitor and methotrexate (MTX) in patients with rheumatoid arthritis (RA). Adult patients with active RA (≥ 5 swollen and ≥ 5 tender joints) receiving a stable dose of MTX (10-25 mg/week) and stable dose of TNF inhibitor (etanercept or adalimumab) for ≥ 12 weeks were randomized 2:1 to receive one course of rituximab or placebo, given intravenously at a dose of 2 × 500 mg. The primary end point was the proportion of patients developing ≥ 1 serious infection through week 24. Fifty-one patients were treated with either rituximab or placebo in combination with background MTX and a TNF inhibitor. Baseline characteristics were generally balanced between groups, except for corticosteroid usage (36% in the rituximab arm versus 17% in the placebo arm). A serious infection (pneumonia) was observed in 1 patient (3%) in the rituximab group after 14.4 patient-years of exposure (6.95 events per 100 patient-years, 95% confidence interval 0.98-49.35), compared with none in the placebo group at week 24. Infections were reported in 18 patients (55%) and 11 patients (61%) in the rituximab and placebo groups, respectively. Grade 3 infections were reported in 3 patients (9%) receiving rituximab and in none of the patients receiving placebo. No grade 4 infections were observed, nor were there any opportunistic, fungal, or tuberculosis infections. Serious adverse events (SAEs) were reported in 2 rituximab-treated patients (pneumonia and coronary artery occlusion), whereas there were no SAEs reported in placebo-treated patients. At week 24, the percentage of patients achieving an American College of Rheumatology 20% (ACR20) improvement response was 30% in the rituximab group compared with 17% in the placebo group, and ACR50 responses were achieved by 12% and 6% of patients, respectively. The preliminary safety profile of rituximab in combination with a TNF inhibitor and MTX was consistent with the safety profile of rituximab in combination with MTX in other RA trials without a TNF inhibitor, with no new safety signals observed. SAEs were numerically more frequent in the rituximab group, and there was no clear evidence of an efficacy advantage in patients receiving rituximab in combination with a TNF inhibitor and MTX. Output: | {'conditions': 'Rheumatoid Arthritis', 'interventions': 'Biological: Rituximab|Other: Placebo|Drug: Methotrexate|Drug: Etanercept|Drug: Adalimumab|Drug: Methylprednisolone|Dietary Supplement: Folate|Drug: Glucocorticoid'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Adjunctive therapy with pregabalin in generalized anxiety disorder patients with partial response to SSRI or SNRI treatment. This study evaluated the efficacy of adjunctive pregabalin versus placebo for treatment of patients with generalized anxiety disorder (GAD) who had not optimally responded to previous or prospective monotherapies. This was a phase 3, randomized, double-blind, placebo-controlled study. Patients diagnosed with GAD who had a historical and current lack of response to pharmacotherapy [Hamilton Anxiety Rating Scale (HAM-A) of ≥ 22 at screening] were randomized to adjunctive treatment with either pregabalin (150-600 mg/day) or placebo. The primary outcome measure was the change in HAM-A total scores after 8 weeks of combination treatment. Adverse events were regularly monitored. Randomized patients (N=356) were treated with pregabalin (n=180) or placebo (n=176). Mean baseline HAM-A scores were 20.7 and 21.4, respectively. After treatment, the mean change in HAM-A was significantly greater for pregabalin compared with placebo (-7.6 vs. -6.4, respectively; P<0.05). HAM-A responder rates (≥ 50% reduction) were significantly higher for pregabalin (47.5%) versus placebo (35.2%; P=0.0145). The time-to-sustained response favored pregabalin over placebo (P=0.014). Adverse events were consistent with previous studies and discontinuations were infrequent for pregabalin (4.4%) and placebo (2.3%). The study was discontinued early after an interim analysis. The results indicate that adjunctive pregabalin is an efficacious therapy for patients with GAD who experience an inadequate response to established treatments. Output: | {'conditions': 'Generalized Anxiety Disorder', 'interventions': 'Drug: pregabalin|Drug: placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Follicular and endocrine profiles associated with different GnRH-antagonist regimens: a randomized controlled trial. This trial assessed the impact of early initiation of gonadotrophin-releasing hormone (GnRH) antagonist on follicular and endocrine profiles compared with the fixed GnRH-antagonist protocol. Eighty-five oocyte donors were randomized to GnRH antagonist starting in the mid-luteal phase of the prestimulation cycle (degarelix-ML group), on stimulation day 1 (early follicular phase, degarelix-EF group) or day 6 (fixed protocol) (mid-follicular phase, ganirelix-MF group). Subjects in the degarelix-EF and ganirelix-MF groups received placebo in the prestimulation cycle. At start of stimulation, serum concentrations of FSH (4.6 ± 2.3 versus 6.0 ± 1.8IU/l), LH (2.7 ± 1.4 versus 4.7 ± 1.9IU/l) and oestradiol (87 ± 35 versus 129 ± 50pmol/l) were markedly lower (P<0.001) in the degarelix-ML group than in the placebo group. The coefficients of variation of follicle size (36.7 ± 5.5% versus 39.2 ± 9.4%) were not significantly different. No differences in endometrial histology, embryo quality and pregnancy rates in recipient cycles were observed between the regimens. In conclusion, early administration of GnRH antagonist altered the endocrine profile without modifying the follicular synchrony for the majority of subjects. Whether patients with a more heterogeneous follicle size at start of stimulation may benefit from an earlier intervention remains to be proven. Output: | {'conditions': 'Infertility, Female', 'interventions': 'Drug: Degarelix mid-luteal, 2.5 mg|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Measuring flushing symptoms with extended-release niacin using the flushing symptom questionnaire: results from a randomised placebo-controlled clinical trial. Niacin is underutilised because of flushing. Lack of a quantitative tool to assess niacin-induced flushing has precluded the objective evaluation of flushing associated with extended-release (ER) niacin formulations. We developed the Flushing Symptom Questionnaire((c)) (FSQ), a quantitative tool to assess patient-reported flushing, and assessed its ability to characterise ER niacin-induced flushing. This study focused on the responses to one question in the FSQ, the Global Flushing Severity Score (GFSS), reported on a 0-10 scale (none = 0, mild = 1-3, moderate = 4-6, severe = 7-9 and extreme = 10) to assess flushing during ER niacin initiation (week 1) and maintenance (weeks 2-8). Flushing severity with ER niacin was greatest during week 1 and remained greater than placebo for the study duration. During weeks 2-8, 40% of patients on ER niacin vs. 8% of those on placebo had > 1 day/week with 'moderate or greater' GFSS. In conclusion, the GFSS component of the FSQ was a sensitive and responsive quantitative measure of ER niacin-induced flushing that will aid in the objective comparison of novel strategies intended to improve tolerability and adherence to niacin, an agent proven to reduce cardiovascular risk. Output: | {'conditions': 'Flushing', 'interventions': 'Drug: MK0524A, /Duration of Treatment : 8 Weeks|Drug: Comparator : placebo (unspecified) /Duration of Treatment : 8 Weeks'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. Therapeutic proteins/peptides can produce immunogenic responses that may increase the risk of adverse events or reduce efficacy. The objectives were to measure and characterize antibody formation to liraglutide, a glucagon-like peptide-1 receptor agonist, to investigate the impact on glycemic control and safety, and to compare it with exenatide, an agent in the same class. Antibody data were collected during six Liraglutide Effect and Action in Diabetes (LEAD) trials (26-104 wk duration). Samples for determination of antibody formation were collected at LEAD trial sites and analyzed at central laboratories. Antibodies were measured in LEAD trial participants with type 2 diabetes. Interventions included once-daily liraglutide (1.2 or 1.8 mg) or twice-daily exenatide (10 μg). The main outcome measures included the proportion of patients positive for anti-liraglutide or anti-exenatide antibodies, a glucagon-like peptide-1 cross-reacting effect, and an in vitro liraglutide- or exenatide-neutralizing effect. Change in glycosylated hemoglobin A(1c) (HbA(1c)) by antibody status and magnitude [negative, positive (high or low level)]. After 26 wk, 32 of 369 (8.7%) and 49 of 587 (8.3%) patients had low-level antibodies to liraglutide 1.2 and 1.8 mg, respectively [mean 3.3% antibody-bound radioactivity out of total radioactivity (%B/T), range 1.6-10.7%B/T], which did not attenuate glycemic efficacy (HbA(1c) reductions 1.1-1.3% in antibody-positive vs. 1.2% in antibody-negative patients). In LEAD-6, 113 of 185 extension patients (61%) had anti-exenatide antibodies at wk 26 (range 2.4-60.2%B/T). High levels of anti-exenatide antibodies were correlated with significantly smaller HbA(1c) reductions (P = 0.0022). After switching from exenatide to liraglutide, anti-exenatide antibodies did not compromise a further glycemic response to liraglutide (additional 0.4% HbA(1c) reduction). Liraglutide was less immunogenic than exenatide; the frequency and levels of anti-liraglutide antibodies were low and did not impact glycemic efficacy or safety. Output: | {'conditions': 'Diabetes|Diabetes Mellitus, Type 2', 'interventions': 'Drug: liraglutide|Drug: placebo|Drug: liraglutide|Drug: liraglutide|Drug: glimepiride|Drug: metformin|Drug: placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Switching to tenofovir/emtricitabine from abacavir/lamivudine in HIV-infected adults with raised cholesterol: effect on lipid profiles. The aim of this study was to investigate the effect on fasting lipid parameters of switching to tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC) from abacavir (ABC) plus lamivudine (3TC; both fixed-dose combinations), while maintaining ritonavir-boosted lopinavir (LPV/r). This was an open-label randomized two-arm 12-week controlled study in virologically suppressed HIV-infected patients with elevated cholesterol (≥5.2 mmol/l). Patients stable on ABC/3TC plus LPV/r either continued treatment or switched to TDF/FTC plus LPV/r for 12 weeks. Standard efficacy and safety end points (including fasting lipids) were assessed. In total, 85 subjects were treated (n=42 ABC/FTC and n=43 TDF/3TC). A statistically significant decrease in total cholesterol was observed in the TDF/FTC group: from median (IQR) 6.22 mmol/l (5.91-6.77) at baseline to 5.75 mmol/l (5.04-6.18) at week 12 (median [IQR] change from baseline -0.73 mmol/l [-1.20- -0.18]; P<0.001). No notable change was observed for the ABC/3TC group. The difference between groups at week 12 was -0.82 mmol/l (P<0.001). For TDF/FTC (but not for ABC/3TC), statistically significant reductions (P<0.05) from baseline were observed in total, low-density lipoprotein, high-density lipoprotein (HDL)- and non-HDL cholesterol (at weeks 4 and 12). Statistically significant decreases were observed in median estimated creatinine clearance (Cockcroft-Gault) from baseline to week 12 for patients who switched to TDF/FTC (-5.47 ml/min) versus the ABC/3TC group (-2.15 ml/min; P=0.016 between groups). Virological suppression was maintained in both groups. No new safety issues were identified. Switching to TDF/FTC from ABC/3TC was associated with rapid improvements in fasting lipid parameters and continued virological control in patients receiving LPV/r as the third component of antiretroviral therapy. The effect of these changes on clinical end points remains unclear and would need to be evaluated in a longer-term study. Output: | {'conditions': 'HIV-1', 'interventions': 'Drug: Truvada + Kaletra|Drug: Kivexa + Kaletra'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Paracervical block with combined ketorolac and lidocaine in first-trimester surgical abortion: a randomized controlled trial. To study the effects of a paracervical block with combined ketorolac and lidocaine on perceived pain during first-trimester surgical abortion. A double-masked, placebo-controlled, randomized clinical trial of 50 women undergoing first-trimester surgical abortions (before 11 weeks of gestation) received either oral ibuprofen with a lidocaine-alone paracervical block or an oral placebo and paracervical block with combined ketorolac and lidocaine. Women completed a series of 100-mm visual analog scales (anchors: 0=none, 100 mm=worst imaginable) to measure their perceived pain (anticipated pain, pain during and after surgical abortion, and total satisfaction). Twenty-five women received preoperative oral ibuprofen followed by paracervical block with lidocaine alone, and 25 received oral placebo followed by paracervical block with combined ketorolac and lidocaine. Groups were similar with respect to sociodemographic variables. Women who received paracervical block with combined ketorolac and lidocaine reported significantly less pain after cervical dilation (59.8 compared with 74.8 mm, P<.05). The groups did not differ in perceived procedure-related or postoperative pain. There was no difference in overall satisfaction with pain control between the two groups (63.6 compared with 62.9 mm, P=.93). Paracervical block with combined ketorolac and lidocaine significantly decreases perceived pain associated with cervical dilation during first-trimester surgical abortion. This analgesic mixture may be offered as an alternative pain regimen to women seeking first-trimester surgical abortion. It may also offer improved pain control in other gynecologic procedures necessitating cervical dilation. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00617097. I. Output: | {'conditions': 'Pain|Abortion, Induced', 'interventions': 'Drug: lidocaine|Drug: ketorolac and lidocaine'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Folic acid supplementation prevents phenytoin-induced gingival overgrowth in children. Gingival overgrowth is an important adverse effect of phenytoin (PHT) therapy, occurring in about half of the patients. This study aimed to evaluate the effect of oral folic acid supplementation (0.5 mg/day) for the prevention of PHT-induced gingival overgrowth (PIGO) in children with epilepsy aged 6-15 years on PHT monotherapy for 6 months. This was a randomized, double-blind, placebo-controlled trial conducted at a tertiary level hospital from May 2008 to June 2009. Children aged 6-15 years started on PHT monotherapy within last 1 month were eligible for inclusion. Preexisting gingival overgrowth, use of other folic acid antagonists, and macrocytic anemia were exclusion criteria. Trial subjects were randomized to receive either folic acid or placebo. The primary outcome measure was incidence of any degree of gingival overgrowth after 6 months of PHT monotherapy. The trial was registered with clinicaltrials.gov (NCT00781196). A total of 120 children were recruited, 62 and 58, respectively, in folic acid and placebo arms. The 2 arms were comparable at baseline. Twenty-one percent of patients in the folic acid arm developed PIGO, as compared with 88% receiving placebo (p < 0.001). Absolute risk reduction of PIGO by folic acid was 67% (95% confidence interval 54%-80%), and relative risk reduction was 0.76. Oral folic acid was found to decrease the incidence of PIGO in children on PHT monotherapy, in a statistically significant and clinically relevant manner. This study provides Class I evidence that folic acid supplementation, 0.5 mg/day, is associated with prevention of gingival overgrowth in children taking PHT monotherapy. Output: | {'conditions': 'Gingival Overgrowth', 'interventions': 'Drug: folic acid|Drug: placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Autologous stem cell therapy in the treatment of limb ischaemia induced chronic tissue ulcers of diabetic foot patients. Despite improvements in surgical revascularisation, limitations like anatomical factors or atherosclerosis limit the success of revascularisation in diabetic patients with critical limb ischaemia. Stem cells were shown to improve microcirculation in published studies. The aim of this study was to evaluate safety, feasibility and efficacy of transplantation of bone marrow derived cellular products regarding improvement in microcirculation and lowering of amputation rate. Bone marrow mononuclear cells (BMCs) in comparison with expanded bone marrow cells enriched in CD90+ cells ('tissue repair cells', TRCs) were used in the treatment of diabetic ulcers to induce revascularisation. Diabetic foot patients with critical limb ischaemia without option for surgical or interventional revascularisation were eligible. Parameters examined were ABI, TcPO(2) , reactive hyperaemia and angiographic imaging before and after therapy. Of 30 patients included in this trial, 24 were randomised to receive either BMCs or TRCs. The high number of drop-outs in the control group (4 of 6) led to exclusion from evaluation. A total of 22 patients entered treatment; one patient in the TRC group and two in the BMC group did not show wound healing during follow up, one patient in each treatment group died before reaching the end of the study; one after having achieved wound healing (BMC group), the other one without having achieved wound healing (TRC group). Thus, 18 patients showed wound healing after 45 weeks. The total number of applicated cells was 3.8 times lower in the TRC group, but TRC patients received significantly higher amounts of CD90+ cells. Improvement in microvascularisation was detected in some, but not all patients by angiography, TcPO(2) improved significantly compared with baseline in both therapy groups. The transplantation of BMCs as well as TRCs proved to be safe and feasible. Improvements of microcirculation and complete wound healing were observed in the transplant groups. Output: | {'conditions': 'Diabetic Foot', 'interventions': 'Biological: tissue repair cells (TRC)|Biological: bone marrow stem cells (BMC)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Efficacy of amlodipine/olmesartan medoxomil ± HCTZ in obese patients uncontrolled on antihypertensive monotherapy. BP-CRUSH (Blood Pressure Control in All Subgroups With Hypertension) was a phase IV, prospective, open-label, multicenter, single-arm, dose-titration study (N = 999). The present subgroup analysis reports the efficacy/safety of up to 20 weeks of treatment with amlodipine (AML)/olmesartan medoxomil (OM) ± hydrochlorothiazide (HCTZ) in obese and non-obese patients with hypertension uncontrolled on antihypertensive monotherapy. Eligible obese (body mass index ≥30 kg/m(2); n = 505) and non-obese (<30 kg/m(2); n = 494) patients were switched to AML/OM 5/20 mg and uptitrated at 4-week intervals to AML/OM 5/40 mg, AML/OM 10/40 mg, AML/OM 10/40 mg + HCTZ 12.5 mg, and AML/OM 10/40 mg + HCTZ 25 mg. Uptitration to higher doses of AML/OM was permitted if mean seated systolic BP (SeSBP) was ≥120 mmHg, or mean seated diastolic BP (SeDBP) was ≥70 mmHg. HCTZ was added if mean SeSBP was ≥125 mmHg, or mean SeDBP was ≥75 mmHg. ClinicalTrials.gov identifier: NCT00791258 The primary efficacy endpoint was the cumulative proportion of patients achieving SeSBP <140 mmHg (<130 mmHg for patients with diabetes mellitus) at 12 weeks. Secondary endpoints included seated cuff BP (SeBP) goal rates, ambulatory BP target rates, and mean change from baseline in SeBP and ambulatory BP at weeks 12 and 20. At 12 weeks, 71.6% of obese patients (80.2% non-obese) achieved the primary endpoint of cumulative SeSBP <140 mmHg (<130 mmHg for patients with diabetes). The cumulative SeBP goal of <140/90 mmHg (<130/80 mmHg if diabetes) was achieved by 64.8% and 81.2% of obese patients by weeks 12 and 20, respectively (vs. 77.9% and 88.5% of non-obese patients, respectively). Treatment was well-tolerated, with 26.1% of obese patients (24.9% non-obese) experiencing drug-related treatment-emergent adverse events (TEAEs). There were no serious drug-related TEAEs. An AML/OM ± HCTZ treatment regimen provided effective and safe BP control in obese patients with hypertension uncontrolled on monotherapy. Output: | {'conditions': 'Hypertension', 'interventions': 'Drug: amlodipine and olmesartan medoxomil tablets|Drug: hydrochlorothiazide tablets'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Effect of fesoterodine 4 mg on bladder diary and patient-reported outcomes during the first week of treatment in subjects with overactive bladder. To assess the onset of efficacy of fesoterodine 4 mg versus placebo in subjects with overactive bladder (OAB) symptoms. Subjects who reported OAB symptoms for ≥ 3 months and recorded ≥ 8 micturitions and ≥ 1 urgency urinary incontinence (UUI) episode per 24 hours in 3-day baseline diaries were randomized to fesoterodine 4 mg, tolterodine extended release (ER) 4 mg, or placebo. This is an analysis of first week data from a 12-week, double-blind trial. ClinicalTrials.gov unique ID: NCT00444925. Baseline to week 1 changes in 3-day bladder diary variables, Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS) scores reported by subjects receiving fesoterodine 4 mg or placebo. By week 1, fesoterodine 4 mg (n = 679) was associated with significantly greater improvements compared with placebo (n = 334) in micturitions, urgency, severe urgency and UUI episodes, frequency-urgency sum, and MVV per 24 hours and 3-day diary-dry rate (all p < 0.05), but not nocturnal micturitions per 24 hours (p = 0.273). These differences were significant as early as day 5 of treatment (i.e., day 1 of the 3-day diary) for all diary endpoints except nocturnal micturitions and MVV. Changes in PPBC scores were significantly more favorable with fesoterodine 4 mg versus placebo (p = 0.0143); changes in UPS scores were not significantly different (p = 0.077). The results provide evidence that patients receiving fesoterodine 4 mg for their OAB symptoms may expect to experience a response as early as 1 week after initiating treatment. One limitation is that, although 65% of subjects had received treatment with antimuscarinics before the study, whether subjects were dissatisfied with previous treatment and reasons for dissatisfaction were not collected. This might affect the magnitude of outcome improvements. Also, it is not known whether the UPS is sensitive enough to detect treatment differences as early as week 1. Output: | {'conditions': 'Overactive Bladder', 'interventions': 'Drug: fesoterodine fumarate|Drug: placebo|Drug: tolterodine tartrate'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Predicting short term response to anti-inflammatory therapy in young children with asthma. Currently available anti-inflammatory treatment for young children with asthma includes inhaled corticosteroids (ICS) and the leukotriene receptor antagonist (LTRA) montelukast. To evaluate potential biomarkers of predicting short-term (6-week) response to ICS and LTRAs in children with asthma. A total of 102 children aged 4 to 7 years with episodic asthma were enrolled in an open labelled single-centre study. Biomarkers and asthma characteristics were evaluated as predictors of treatment. Of 102 patients 45 became symptomatic during observation and were randomised to treatment either to montelukast or fluticasone for 6 weeks. Forced Expiratory Volume in one second (FEV1) increased with both treatments: FEV1 at randomisation was 90.2% and after therapy 106.8% with fluticasone vs. 90.8% and 103.7% for montelukast, respectively, showing that montelukast and fluticasone were equally effective in this age group (p = 0.44). Strong correlations to a favourable treatment response were pre-bronchodilatory FEV1 (p < 0.001) and airway reversibility (p = 0.04) at time of randomisation. None of the other biomarkers (methacholine testing, exhaled nitric oxide [eNO], presence of allergy, total Immunoglobulin E [IgE], cumulative specific IgE, eosinophils and parental smoking) were predictive. Despite the small sample size and the open-label design, the study suggests that the use of pre-bronchodilatory FEV1 and airway reversibility appears to be a good indicator of short-term anti-inflammatory therapy in young children with asthma. Output: | {'conditions': 'Asthma', 'interventions': 'Drug: Montelukast|Drug: Fluticasone'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:The MONET trial: darunavir/ritonavir with or without nucleoside analogues, for patients with HIV RNA below 50 copies/ml. In virologically suppressed patients, darunavir-ritonavir (DRV/r) monotherapy could maintain virological suppression similarly to DRV/r and two nucleosides. Two hundred and fifty-six patients with HIV RNA less than 50 copies/ml for over 24 weeks on current antiretrovirals [non-nucleoside reverse transcriptase inhibitor (NNRTI)-based (43%), or protease inhibitor-based (57%)], switched to DRV/r 800/100 mg once daily, either as monotherapy (n = 127) or with two nucleoside reverse transcriptase inhibitors (NRTIs) (n = 129). Treatment failure was defined as two consecutive HIV RNA levels above 50 copies/ml (TLOVR) by week 48, or switches off study treatment. The trial had 80% power to show noninferiority for the monotherapy arm (delta = -12%). Patients were 81% male and 91% Caucasian, with mean age 44 years, and CD4 cell count of 574 cells/microl. In the primary efficacy analysis, HIV RNA less than 50 copies/ml by week 48 (per protocol) was 86.2 versus 87.8% in the monotherapy and triple therapy arms; by intent-to-treat switch equals failure, efficacy was 84.3 versus 85.3%; by a switch-included analysis, efficacy was 93.5 versus 95.1%: all three comparisons showed noninferior efficacy for DRV/r monotherapy. CD4 cell counts remained stable during the trial in both arms. One patient per arm showed at least one protease inhibitor mutation, and one patient in the triple therapy arm showed an NRTI mutation. Nine patients per arm discontinued randomized treatment for either adverse events or other reasons. No new or unexpected safety signals were detected. In this study for patients with HIV RNA less than 50 copies/ml on other antiretrovirals at baseline, switching to DRV/r monotherapy showed noninferior efficacy versus triple antiretroviral therapy. Output: | {'conditions': 'HIV Infections|AIDS Virus|Human Immunodeficiency Virus|Acquired Immunodeficiency Syndrome Virus', 'interventions': 'Drug: darunavir (DRV, TMC114)|Drug: darunavir (DRV, TMC114)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Achievement of specified low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol apolipoprotein B, and high-sensitivity C-reactive protein levels with ezetimibe/simvastatin or atorvastatin in metabolic syndrome patients with and without atherosclerotic vascular disease (from the VYMET study). Metabolic syndrome (MetS) and atherosclerotic vascular disease (AVD) are associated with increased coronary heart disease risk. To assess percent change from baseline in lipids and high-sensitivity C-reactive protein (hs-CRP) levels and the proportion of subjects reaching specified low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (HDL-C) and apolipoprotein B (Apo B) single, dual, and triple targets and hs-CRP <2 mg/L among subjects with and without AVD treated with ezetimibe/simvastatin or atorvastatin for 6 weeks. Adults (N = 1143) with MetS and hypercholesterolemia were randomized to starting and next higher doses of ezetimibe/simvastatin (10/20 or 10/40 mg) or atorvastatin (10, 20, or 40 mg). Ezetimibe/simvastatin produced significantly greater reductions in evaluated lipids than atorvastatin for most prespecified dose comparisons. More subjects without AVD achieved LDL-C levels <100 mg/dL, non-HDL-C levels <130 mg/dL, and dual LDL-C/non-HDL targets (83%-92% vs 62%-76%) and Apo B <90 mg/dL or triple targets (65%-75% vs 41%-49%) with 40 mg of atorvastatin or 10/20-40 mg of ezetimibe/simvastatin compared with 10 or 20 mg of atorvastatin, respectively. More subjects with AVD achieved LDL-C<70 mg/dL and non-HDL-C<100 mg/dL single and dual targets (65%-80%) and Apo B <80 mg/dL (53%-63%) with 10/20-40 mg of ezetimibe/simvastatin than with 40 mg of atorvastatin (40%-49%). More subjects achieved triple lipid targets with 10/20-40 mg of ezetimibe/simvastatin versus 10-40 mg of atorvastatin (50%-63% vs 24%-40%). Achievement of hs-CRP <2 mg/L was similar across all doses regardless of AVD status. More intensive therapy was required for >80% of subjects to achieve LDL-C <100 mg/dL and non-HDL-C <130 mg/dL and for the majority of subjects to achieve lower levels of LDL-C <70 mg/dL, non-HDL-C <100 mg/dL, and/or Apo B <90 mg/dL. The effect of ezetimibe on cardiovascular risk reduction has yet to be established. (Clintrials.gov no: NCT00409773). Output: | {'conditions': 'Hypercholesterolemia|Metabolic Syndrome', 'interventions': 'Drug: ezetimibe (+) simvastatin|Drug: Comparator: atorvastatin calcium|Drug: Comparator: Placebo (unspecified)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Viusid, a nutritional supplement, increases survival and reduces disease progression in HCV-related decompensated cirrhosis: a randomised and controlled trial. Viusid is a nutritional supplement with recognised antioxidant and immunomodulatory properties which could have beneficial effects on cirrhosis-related clinical outcomes such as survival, disease progression and development of hepatocellular carcinoma (HCC). This study evaluated the efficacy and safety of viusid in patients with HCV-related decompensated cirrhosis. A randomised double-blind and placebo-controlled study was conducted in a tertiary care academic centre (National Institute of Gastroenterology, Havana, Cuba). The authors randomly assigned 100 patients with HCV-related decompensated cirrhosis to receive viusid (three oral sachets daily, n=50) or placebo (n=50) during 96 weeks. The primary outcome of the study was overall survival at 96 weeks, and the secondary outcomes included time to disease progression, time to HCC diagnosis, time to worsening of the prognostic scoring systems Child-Pugh and Model for End-Stage Liver Disease, and time to a new occurrence or relapse for each one of the main clinical complications secondary to portal hypertension at 96 weeks. Viusid led to a significant improvement in overall survival (90%) versus placebo (74%) (HR 0.27, 95% CI 0.08 to 0.92; p=0.036). A similar improvement in disease progression was seen in viusid-treated patients (28%), compared with placebo-treated patients (48%) (HR 0.47, 95% CI 0.22 to 0.89; p=0.044). However, the beneficial effects of viusid were wholly observed among patients with Child-Pugh classes B or C, but not among patients with Child-Pugh class A. The cumulative incidence of HCC was significantly reduced in patients treated with viusid (2%) as compared with placebo (12%) (HR 0.15, 95% CI 0.019 to 0.90; p=0.046). Viusid was well tolerated. The results indicate that treatment with viusid leads to a notable improvement in overall clinical outcomes such as survival, disease progression and development of HCC in patients with HCV-related decompensated cirrhosis. Trial registration number http://ClinicalTrials.gov (NCT00502086). Output: | {'conditions': 'Cirrhosis|Chronic Hepatitis C', 'interventions': 'Dietary Supplement: Viusid (nutritional supplement)|Other: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:A randomized placebo-controlled trial of varenicline for smoking cessation allowing flexible quit dates. Current smoking cessation guidelines recommend setting a quit date prior to starting pharmacotherapy. However, providing flexibility in the date of quitting may be more acceptable to some smokers. The objective of this study was to compare varenicline 1 mg twice daily (b.i.d.) with placebo in subjects using a flexible quit date paradigm after starting medication. In this double-blind, randomized, placebo-controlled international study, smokers of ≥10 cigarettes/day, aged 18-75 years, and who were motivated to quit were randomized (3:1) to receive varenicline 1 mg b.i.d. or placebo for 12 weeks. Subjects were followed up through Week 24. Subjects were instructed to quit between Days 8 and 35 after starting medication. The primary endpoint was carbon monoxide-confirmed continuous abstinence during Weeks 9-12, and a key secondary endpoint was continuous abstinence during Weeks 9-24. Overall, 493 subjects were randomized to varenicline and 166 to placebo. Continuous abstinence was higher for varenicline than for placebo subjects at the end of treatment (Weeks 9-12: 53.1% vs. 19.3%; odds ratio [OR] 5.9; 95% CI, 3.7-9.4; p < .0001) and through 24 weeks follow-up (Weeks 9-24: 34.7% vs. 12.7%; OR 4.4; 95% CI, 2.6-7.5; p < .0001). Serious adverse events occurred in 1.2% varenicline (none were psychiatric) and 0.6% placebo subjects. Fewer varenicline than placebo subjects reported depression-related adverse events (2.3% vs. 6.7%, respectively). Varenicline 1 mg b.i.d. using a flexible quit date paradigm had similar efficacy and safety compared with previous fixed quit date studies. Output: | {'conditions': 'Smoking Cessation', 'interventions': 'Drug: placebo|Drug: varenicline'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Stat3 as a therapeutic target for the treatment of psoriasis: a clinical feasibility study with STA-21, a Stat3 inhibitor. Epidermal keratinocytes in psoriatic lesions are characterized by activated Stat3, and increased levels of cytokines and growth factors that promote Stat3 activation have been found within psoriatic lesions. K5.Stat3C transgenic mice, in which keratinocytes express a constitutively active Stat3, develop psoriasis-like skin lesions. In this study, we examined whether STA-21, a small Stat3 inhibitor, could be useful in ameliorating the skin lesions not only in the model mouse but also in human psoriasis. Treatment with STA-21 markedly inhibited the cytokine-dependent nuclear translocation of Stat3 in normal human keratinocytes in vitro. Keratinocyte proliferation was inhibited by STA-21 in a dose-dependent manner through downregulation of c-Myc and cyclin D1, whereas involucrin, transglutaminase 1, and keratin 10 levels were upregulated. Topical application of STA-21 abolished the generation of skin lesions in K5.Stat3C mice. Finally, we treated psoriasis patients with STA-21-containing ointment in a nonrandomized study. Psoriatic lesions in six of the eight patients showed improvement after topical STA-21 treatment for 2 weeks. Therefore, we conclude that targeting Stat3 may lead to a therapy for psoriasis. Output: | {'conditions': 'Psoriasis', 'interventions': 'Drug: Topical application of STA-21 ointment for treatment of psoriasis'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Ocular hypotensive effect of the Rho kinase inhibitor AR-12286 in patients with glaucoma and ocular hypertension. To evaluate the ocular hypotensive efficacy of 0.05%, 0.1% and 0.25% AR-12286 Ophthalmic Solutions in patients diagnosed with ocular hypertension or glaucoma. Parallel comparison, vehicle-controlled, double-masked, 3-week randomized clinical trial. Subjects (n = 89) with elevated intraocular pressure (IOP) were assigned randomly to receive either 1 of 3 concentrations of AR-12286 or its vehicle. Dosing was once-daily in the morning for 7 days, then once-daily in the evening for 7 days, then twice daily for 7 days. Primary and secondary efficacy end points were mean IOP at each diurnal time point (8 am, 10 am, 12 pm, and 4 pm) and mean change in IOP from baseline, respectively. All 3 concentrations of AR-12286 produced statistically and clinically significant reductions in mean IOP that were dose dependent, with peak effects occurring 2 to 4 hours after dosing. Mean IOP at peak effect ranged from 17.6 to 18.7 mm Hg (-6.8 to -4.4 mm Hg) for the 3 concentrations. The largest IOP reductions were produced by 0.25% AR-12286 after twice daily dosing (up to -6.8 mm Hg; 28%). The 0.25% concentration dosed once-daily in the evening produced highly significant IOP reductions throughout the following day (-5.4 to -4.2 mm Hg). The only adverse event of note was trace (+0.5) to moderate (+2) conjunctival hyperemia that was transient, typically lasting 4 hours or less. After once-daily evening dosing, hyperemia was seen in less than 10% of patients. AR-12286 was well tolerated and provided clinically and statistically significant ocular hypotensive efficacy in patients with ocular hypertension and glaucoma. Output: | {'conditions': 'Elevated Intraocular Pressure', 'interventions': 'Drug: AR-12286|Drug: AR-12286 vehicle'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:RNAi-based treatment for neovascular age-related macular degeneration by Sirna-027. To assess the safety, tolerability, pharmacokinetics, and dose-limiting toxicity of single intravitreal injection of Sirna-027, a small interfering RNA targeting vascular endothelial growth factor receptor-1, in patients with choroidal neovascularization (CNV) resulting from neovascular age-related macular degeneration (AMD). Secondary objectives included assessment of anatomic changes in retinal thickness, size of CNV, and changes in visual acuity. Prospective, open-label, single-dose, dose-escalation phase 1 study. Twenty-six eyes of 26 patients with a median age of 82 years and CNV resulting from AMD who had previous treatments with other therapies were treated at 2 academic retinal practices. Patients received a single dose of Sirna-027 (100, 200, 400, 800, 1200, or 1600 microg/eye). Blood was sampled for pharmacokinetic analysis at 1, 4, and 24 hours after injection and on day 7. Patients underwent ophthalmic examinations including visual acuity, fluorescein angiography, and optical coherence tomography at screening and days 7, 14, 28, and 84. The main outcome measures were adverse reactions and dose-limiting toxicities. Intravitreal injection of a single dose of Sirna-027 from 100 to 1600 microg was well tolerated in patients with AMD, with no dose-limiting toxicity found. Adverse events were mild to moderate in severity. Adjusted mean foveal thickness decreased within 2 weeks after study treatment. The decrease was most pronounced in the 100- and 200-microg doses. A single intravitreal dose of Sirna-027 up to 1600 microg/eye was well tolerated in patients with CNV resulting from neovascular AMD that had been refractory to other therapies. Stabilization or improvement in visual acuity and foveal thickness was observed. No dose-response or dose-limiting effects were noted. Output: | {'conditions': 'Age-Related Macular Degeneration|Choroidal Neovascularization', 'interventions': 'Drug: AGN211745|Drug: AGN211745|Drug: AGN211745|Drug: AGN211745|Drug: AGN211745|Drug: AGN211745'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. Influenza-associated morbidity and mortality has not decreased in the last decade, despite increased receipt of vaccine. To improve the immunogenicity of influenza vaccine, a high-dose (HD) trivalent, inactivated influenza vaccine was developed. A multicenter, randomized, double-blind controlled study was conducted to compare HD vaccine (which contains 60 microg of hemagglutinin per strain) with the licensed standard-dose (SD) vaccine (which contains 15 microg of hemagglutinin per strain) in adults > or = 65 years of age. HD vaccine was administered to 2575 subjects, and SD vaccine was administered to 1262 subjects. There was a statistically significant increase in the rates of seroconversion and mean hemagglutination inhibition titers at day 28 after vaccination among those who received HD vaccine, compared with those who received SD vaccine. Mean postvaccination titers for individuals who received HD vaccine were 116 for H1N1, 609 for H3N2, and 69 for B strain; for those who received SD vaccine, mean postvaccination titers were as 67 for H1N1, 333 for H3N2, and 52 for B strain. The HD vaccine met superiority criteria for both A strains, and the responses for B strain met non-inferiority criteria. Seroprotection rates were also higher for those who received HD vaccine than for those who received SD vaccine vaccine, for all strains. Local reactions were more frequent in individuals who received HD vaccine, but the reactions were mild to moderate. There was a statistically significant increase in the level of antibody response induced by HD influenza vaccine, compared with that induced by SD vaccine, without an attendant increase in the rate or severity of clinically relevant adverse reactions. These results suggest that the high-dose vaccine may provide improved protective benefits for older adults. ClinicalTrials.gov identifier: NCT00391053 . Output: | {'conditions': 'Orthomyxoviridae Infection|Influenza|Myxovirus Infection', 'interventions': 'Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine|Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine|Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine|Biological: Inactivated, Split-Virion Influenza Vaccine'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Pediatric catheterization laboratory anticoagulation with bivalirudin. Pediatric physicians regularly face the problem of uncertain procedural anticoagulation in children, especially in neonates. We sought to evaluate the safety, plasma concentration (pharmacokinetics, PK), pharmacodynamics (PD), and dosing guidelines of bivalirudin when used as a procedural anticoagulant in pediatric percutaneous intravascular procedures. Pediatric subjects undergoing percutaneous intravascular procedures for congenital heart disease were enrolled and received the current weight-based dose used in percutaneous coronary interventions (0.75 mg/kg bolus, 1.75 mg/kg/hr infusion). Blood samples for PK/PD analyses were drawn, and safety was evaluated by monitoring bleeding and thrombosis events. A total of 110 patients (11 neonates, 33 infants, 32 young children, and 34 older children) were enrolled; 106 patients received the protocol dose. The PK/PD response of bivalirudin was predictable and behaved in a manner similar to that in adults. Weight-normalized bivalirudin clearance rates were more rapid in neonates and decreased with increasing age. Bivalirudin concentrations were slightly lower in neonates, with a trend to an increase with age. Activating clotting time response was consistent with adult studies and prolonged in all age groups, and there was reasonable correlation between activating clotting time and bivalirudin plasma concentrations across all age groups. There were few major bleeding (2 of 110, 1.8%) or thrombotic events (9 of 110, 8.2%) reported. PK/PD response of bivalirudin in the pediatric population is predictable and behaves in a manner similar to that in adults. Using adult dosing, bivalirudin safely provided the expected anticoagulant effect in the pediatric population undergoing intravascular procedures for congenital heart disease. Output: | {'conditions': 'Cardiology', 'interventions': 'Drug: bivalirudin'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Bl-1020, a new γ-aminobutyric acid-enhanced antipsychotic: results of 6-week, randomized, double-blind, controlled, efficacy and safety study. BL-1020 is a γ-aminobutyric acid (GABA)-enhanced antipsychotic that combines dopamine antagonism with GABA agonist activity. On the basis of animal models, we tested the hypotheses that BL-1020 would be effective in ameliorating both psychotic symptoms and cognitive impairments, with a favorable safety profile in acutely ill schizophrenia patients. 363 hospital-based psychiatric patients in India, Romania, and United States aged 18 to 65 years and meeting criteria for DSM-IV-TR diagnosis of chronic schizophrenia were randomized double-blind to receive BL-1020 10 mg/d, BL-1020 20-30 mg/d, placebo, or risperidone (2-8 mg/d) for 6 weeks. The main outcome measures were the positive and negative syndrome scale (PANSS), brief assessment of cognition in schizophrenia, readiness for discharge questionnaire, clinical global impressions scale (CGI) , and extrapyramidal symptom rating scale. The study ran from July 2008 to June 2009. BL-1020 20-30 mg was significantly better than placebo on PANSS (P = .02) and CGI (P < .001) measurements, with no significant differences noted between BL-1020 20-30 mg and risperidone. There were no significant differences in the maximum change on extrapyramidal symptom rating scale between risperidone and BL-1020 20-30 mg, and both were significantly worse (P < .001) than placebo. BL-1020 20-30 mg was associated with significantly greater improvements on cognitive functioning as measured by the brief assessment of cognition in schizophrenia composite score when compared to placebo (effect size = 0.50, P = .009), risperidone (effect size = 0.43, P = .019), and BL-1020 10 mg (effect size = 0.42, P = .013) after 6 weeks. BL-1020 appears to be an effective antipsychotic with possible procognitive effects that will need to be further tested for short- and long-term effects. A further randomized controlled trial using the U.S. Food and Drug Administration-recommended Measurement and Treatment Research to Improve Cognition in Schizophrenia cognitive battery is ongoing. ClinicalTrials.gov identifier: NCT00567710. Output: | {'conditions': 'Schizophrenia', 'interventions': 'Drug: BL - 1020|Drug: BL - 1020|Drug: Placebo|Drug: Risperidone'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:A randomized controlled trial demonstrates that a novel closed-loop propofol system performs better hypnosis control than manual administration. The purpose of this randomized control trial was to determine the performance of a novel rule-based adaptive closed-loop system for propofol administration using the bispectral index (BIS(R)) and to compare the system's performance with manual administration. The effectiveness of the closed-loop system to maintain BIS close to a target of 45 was determined and compared with manual administration. After Institutional Review Board approval and written consent, 40 patients undergoing major surgery in a tertiary university hospital were allocated to two groups using computer-generated block randomization. In the Closed-loop group (n = 20), closed-loop control was used to maintain anesthesia at a target BIS of 45, and in the Control group (n = 20), propofol was administered manually to maintain the same BIS target. To evaluate each technique's performance in maintaining a steady level of hypnosis, the BIS values obtained during the surgical procedure were stratified into four clinical performance categories relative to the target BIS: < or = 10%, 11-20%, 21-30%, or > 30% defined as excellent, good, poor, or inadequate control of hypnosis, respectively. The controller performance was compared using Varvel's controller performance indices. Data were compared using Fisher's exact test and the Mann-Whitney U test, P < 0.05 showing statistical significance. In the Closed-loop group, four females and 16 males (aged 54 +/- 20 yr; weight 79 +/- 7 kg) underwent anesthesia lasting 143 +/- 57 min. During 55%, 29%, 9%, and 7% of the total anesthesia time, the system showed excellent, good, poor, and inadequate control, respectively. In the Control group, five females and 15 males (aged 59 +/- 16 yr; weight 75 +/- 13 kg) underwent anesthesia lasting 157 +/- 81 min. Excellent, good, poor, and inadequate control were noted during 33%, 33%, 15%, and 19% of the total anesthesia time, respectively. In the Closed-loop group, excellent control of anesthesia occurred significantly more often (P < 0.0001), and poor and inadequate control occurred less often than in the Control group (P < 0.01). The median performance error and the median absolute performance error were significantly lower in the Closed-loop group compared with the Control group (-1.1 +/- 5.3% vs -10.7 +/- 13.1%; P = 0.004 and 9.1 +/- 1.9% vs 15.7 +/- 7.4%; P < 0.0001, respectively). The closed-loop system for propofol administration showed better clinical and control system performance than manual administration of propofol. (Clinical Trials gov. NCT 01019746). Output: | {'conditions': 'HYPNOSIS', 'interventions': 'Drug: propofol'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 oral suspension (liquid formulation) in Finnish infants. The lyophilized formulation of a human rotavirus vaccine, Rotarix™ (RIX4414) is highly immunogenic. In order to comply with the World Health Organization's (WHO) recommendation, a liquid formulation of the vaccine that does not require reconstitution was developed. The immunogenicity, reactogenicity and safety of the liquid formulation were compared with lyophilized formulation in two Finnish studies. In Study A infants aged 6-12 weeks received two doses of the lyophilized or liquid formulation of the vaccine or placebo following a 0,1 month schedule. In Study B, infants aged 10-17 weeks received two doses of either liquid or lyophilized formulation of the vaccine. In both studies, anti-rotavirus IgA antibodies were assessed pre-vaccination and one month post-Dose 2. In Study A, the anti-rotavirus seroconversion rate was 90% (95% CI: 81.2-95.6%) and 83.7% (95% CI: 74.2-90.8%) in the groups that received the liquid and the lyophilized formulation of RIX4414, respectively; the respective anti-rotavirus IgA seroconversion rates in Study B were 88.6% (95% CI: 86.1-90.8%) and 90.5% (95% CI: 86.2-93.8%). Reactogenicity and safety profiles of the two vaccine formulations were similar. Liquid formulation of the rotavirus vaccine allows greater flexibility in supply and reduces logistical costs. Output: | {'conditions': 'Gastroenteritis', 'interventions': 'Biological: 2-dose oral live attenuated G1P[8] human rotavirus vaccine'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Effects of a novel aldosterone synthase inhibitor for treatment of primary hypertension: results of a randomized, double-blind, placebo- and active-controlled phase 2 trial. LCI699, a novel inhibitor of aldosterone synthase, reduces serum aldosterone, and may have benefit in the treatment of hypertension. We performed the first double-blind, randomized trial with LCI699 in patients with primary hypertension. We randomized 524 patients to LCI699 0.25 mg once daily (n=92), 0.5 mg once daily (n=88), 1.0 mg once daily (n=86), and 0.5 mg twice daily (n=97); eplerenone 50 mg twice daily (n=84); or placebo (n=77) for 8 weeks. Adrenocorticotropic hormone (250 μg IV) stimulation testing was performed in a subset of patients to quantify the selectivity of LCI699 for aldosterone synthase compared with 11-β-hydroxylase. Reductions in clinic diastolic blood pressure were significant for LCI699 1.0 mg (-7.1 mm Hg; P=0.0012) and eplerenone 50 mg twice daily (-7.9 mm Hg; P<0.0001) compared with placebo (-2.6 mm Hg) but not other doses of LCI699. Significant reductions in clinic systolic blood pressure were observed with all doses of LCI699 (P<0.005 or better) and eplerenone (P<0.0001). All doses of LCI699 significantly reduced 24-hour ambulatory blood pressure compared with placebo (P<0.01). Adrenocorticotropic hormone stimulation of cortisol was suppressed in ≈20% of subjects receiving LCI699 at a total daily dose of 1.0 mg. Safety and tolerability were similar among LCI699, placebo, and eplerenone. Aldosterone synthase inhibition with LCI699 significantly lowered clinic and ambulatory blood pressure. A minority of subjects developed blunted adrenocorticotropic hormone-stimulated release of cortisol. These results support additional research to evaluate use of aldosterone synthase inhibition in primary hypertension and/or patients characterized by aldosterone excess. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00758524. Output: | {'conditions': 'Essential Hypertension', 'interventions': 'Drug: LCI699|Drug: Eplerenone|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Renin-angiotensin system inhibitors reduce the progression of mesangioproliferative glomerulonephritis: 10 year follow-up. Proteinuria is a common presentation of mesangioproliferative glomerulonephritis (MsPGN). No studies are available on the long-term effect of treatment by renin-angiotensin system (RAS) inhibitors on renal outcome in MsPGN patients. This study prospectively evaluates the effects of RAS inhibitors on renal outcome in patients with low risk MsPGN followed up for 10 years using historical patients with similar features at the time of presentation as untreated controls. decrease of basal proteinuria>20% and loss>20% of basal glomerular filtrate rate (GFR) at the end of first year of observation. The patients were re-evaluated bimonthly during the first year and every 6 months thereafter. Twenty-five patients fulfilled the selection criteria. After one year follow-up 19 patients reached the endpoint of proteinuria and no patient reached the endpoint of GFR. No significant change in blood pressure levels (BP) and GFR was registered, by contrast daily proteinuria decreased significantly (p<0.001), falling by 29% at sixth month and 47% at the end of the follow-up. The historical control group consisted of 15 untreated patients seen between 1987 and 1992. The two-way analysis of variance for repeated measures showed greater values of GFR (p<0.001) and lower levels of daily proteinuria (p<0.001) in treated patients as compared to untreated controls. This 10-year follow-up study indicates that the early treatment with RAS inhibitors at low doses favourably influences the long-term renal outcome in proteinuric patients with MsPGN. Limitations were the small sample size and lack of randomization. Output: | {'conditions': 'IGA Glomerulonephritis', 'interventions': 'Drug: Ramipril or losartan'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Efficacy of combined local mechanical vibrations, continuous passive motion and thermotherapy in the management of osteoarthritis of the knee. We evaluated the efficacy of combined mechanical vibrations, continuous passive motion (CPM) and heat on the severity of pain in management of osteoarthritis of the knee (OA-K). In this controlled, double crossover study, 71 OA-K patients were randomized in Phase 1 to receive 4 weeks active treatment consisting of two 20-min sessions per day (34 patients, Group AB) or treatment with a sham device (37 patients, Group BA). This was followed by a 2-week washout period (Phase 2). In Phase 3, patients crossed over so that Group AB was treated with the sham device and Group BA received active treatment for an additional 4 weeks. Patient assessments of pain (visual analog scale, VAS) and Western Ontario and McMaster Universities (WOMAC) OA index were performed at baseline and at study weeks 2, 4, 6, and 10. Net treatment effects were estimated by comparing outcomes between active and sham treatment study phases. Treatment benefits were noted for both of the trial's two pre-specified primary endpoints, VAS and WOMAC. VAS was reduced at all follow-up time points for patients receiving active treatment compared to sham treatment with a net treatment effect of 14.4+/-4.1 mm (P=0.001). Similarly, the WOMAC score was reduced significantly with active treatment at all measured points with a net effect of 8.8+/-1.9 points (P<0.001). The secondary endpoints, range of motion (ROM) and treatment satisfaction, also improved with active vs sham treatment. Four weeks treatment with combined CPM, vibration and local heating significantly decreases pain, improves ROM and the quality of life in patients with OA-K (ClinicalTrials.gov registration number: NCT00858416). Output: | {'conditions': 'Osteoarthritis|Knee Pain', 'interventions': 'Device: "Kineticure System" followed by sham|Device: sham followed by "Kineticure System"'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Conversion to tacrolimus once-daily from ciclosporin in stable kidney transplant recipients: a multicenter study. This 24-week, open, single-arm, prospective, multicenter study evaluated the effects of conversion from ciclosporin to Tacrolimus QD in adult kidney transplant patients. Stable patients receiving ciclosporin were converted to Tacrolimus QD at 0.1mg/kg/day. Relative change in renal function (primary endpoint) was assessed using estimated creatinine clearance (eCrCl) with a noninferiority margin set at -10%. A total of 346 patients were enrolled; and 301 patients were treated per protocol (PPS) in the hyperlipidemia (n=42), hypertrichosis (n=106), hypertension (n=77) and gingival hyperplasia (n=76) groups. Relative change in eCrCl was -0.6% in all PPS patients (95% CI, -2.2; 0.9) and -5.3% in the hyperlipidemia (CI, -9.59; -0.97), 0.9% in the hypertrichosis (CI, -2.59; 4.45), -0.1% in the hypertension (CI, -3.8; 3.68), and -1% in the gingival hyperplasia groups (CI, -4.63; 2.65) (PPS), meeting noninferiority criteria. There was no acute rejection. Decreases in serum lipids and blood pressure were moderate but without meaningful change in the number of treatment medications. Substantial decreases in severity of ciclosporin-related cosmetic side effects were evident from investigator and patient self-report of symptoms. Renal function remained stable after conversion to Tacrolimus QD. The effect of conversion on cardiovascular parameters was not clinically meaningful, however, marked improvement in ciclosporin-related cosmetic side effects was observed. (ClinicalTrials.gov number: NCT00481481). Output: | {'conditions': 'Transplantation', 'interventions': 'Drug: tacrolimus'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Percutaneous coronary intervention with oral sirolimus and bare metal stents has comparable safety and efficacy to treatment with drug eluting stents, but with significant cost saving: long-term follow-up results from the randomised, controlled ORAR III (Oral Rapamycin in ARgentina) study. Previous randomised studies have shown a significant reduction in restenosis when oral rapamycin (OR) is administered to patients undergoing bare metal stent (BMS) implantation. How this regimen compares to drug eluting stents (DES) is unknown. Two-hundred patients with de novo coronary lesions were randomised to treatment with OR plus BMS (100 pts) or with DES (100 pts). OR was given as a bolus of 10 mg per day before PCI followed by daily doses of 3 mg during following 13 days. Primary endpoints were to compare hospital, follow-up and overall cost at one, two, three and five years of follow-up. The secondary endpoints included death, myocardial infarction (MI) and stroke and were analysed as major adverse cardiovascular events (MACCE). Target vessel (TVR) and target lesion revascularisation (TLR) were independently analysed. Costs included procedural resources, hospitalisation, medications, repeat revascularisation procedures and professional fees. Baseline demographic, clinical and angiographic characteristics were similar. At 18.3 +/- 7 months of follow-up, the initial strategy of OR plus BMS resulted in significant cost saving when compared to DES (p=0.0001). TLR rate was 8.2% with DES and 7.0% with OR plus BMS (p=0.84), similarly no differences in TVR rate in both groups was seen (10.6% and 10.5% in OR and DES group respectively, p=0.86). Non-inferiority testing, determined that DES therapy failed to be cost saving compared to OR in all possible cost scenarios. A strategy of OR plus BMS is cost saving compared to DES in patients undergoing PCI for de novo coronary lesions. Output: | {'conditions': 'Coronary Heart Disease|Coronary Restenosis', 'interventions': 'Drug: Oral sirolimus|Device: Drug Eluting stent'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Efficacy and tolerability of atorvastatin/fenofibrate fixed-dose combination tablet compared with atorvastatin and fenofibrate monotherapies in patients with dyslipidemia: a 12-week, multicenter, double-blind, randomized, parallel-group study. Coadministration of statin and fenofibrate monotherapies is frequently used to treat patients with dyslipidemia; however, a fixed-dose combination (FDC) tablet is not currently marketed. This study evaluates a new FDC tablet of atorvastatin 40 mg and fenofibrate 100 mg. This was a 12-week, multicenter, double-blind, randomized, parallel-group Phase IIb study. Adults with dyslipidemia (non-HDL-C >130 mg/dL and triglycerides [TG] > or =150 but < or =500 mg/dL) were randomly assigned in a 1:1:1 ratio to receive the FDC, atorvastatin 40 mg, or fenofibrate 145 mg for 12 weeks. Study medication was taken once daily in the evening, without regard to meals. Patients attended follow-up visits after 4, 8, and 12 weeks of the double-blind treatment. The primary efficacy end points were the mean percentage changes from baseline to the final visit (week 12) in non-HDL-C, HDL-C, and TG. Secondary variables were LDL-C, VLDL-C particle concentration, total cholesterol, apolipoprotein B, lipoprotein (a), high-sensitivity C-reactive protein, fibrinogen, homocysteine, creatinine, myeloperoxidase, and lipoprotein-associated phospholipase A2. Tolerability was assessed by adverse events, laboratory parameters, vital signs, physical examinations, and ECGs. Patients (n = 220) were aged 26 to 87 years; 115 (52.3%) were men and 105 (47.7%) were women; 189 (85.9%) were white, 17 (7.7%) were black, and 15 (6.8%) were Hispanic or Latino; and mean (SD) weight was 200.5 (40.85) lb (range, 103.5-367.4 lb). Previous treatments were statins (25.9% [57/220]), fibrates (1.8% [4/220]), and dietary supplements (25.5% [56/220]); 57.7% (127/220) of patients were treatment naive. Use of the FDC was associated with an improvement in non-HDL-C (-44.8%) that was significantly greater than with fenofibrate monotherapy (-16.1%; P < 0.001) but was not significantly different from that with atorvastatin monotherapy (-40.2%; P = NS). HDL-C increased significantly more in the FDC group (19.7%) than with atorvastatin (6.5%; P < 0.001) but was not significantly different from fenofibrate (18.2%; P = NS). TG lowering in the FDC group (-49.1%) was significantly greater than with both atorvastatin (-28.9%; P < 0.001) and fenofibrate (-27.8%; P = 0.001). LDL-C lowering in the FDC group (-42.3%) was significantly greater than with fenofibrate (-13.9%; P < 0.001) but not significantly different from atorvastatin (-43.1%; P = NS). The FDC had either comparable or significantly greater improvements in other lipid variables and multiple secondary variables. The FDC was generally well tolerated; the tolerability profile was consistent with those of atorvastatin and fenofibrate monotherapies. Treatment-emergent adverse events (ie, those occurring after the first dose of study medication) were recorded in 43 of 73 patients (58.9%) for the FDC, 49 of 74 (66.2%) for atorvastatin, and 48 of 73 (65.8%) for fenofibrate. In this 12-week study, patients with dyslipidemia treated with the 40/100-mg atorvastatin/ fenofibrate FDC had a significantly greater reduction in TG than those treated with atorvastatin 40 mg or higher-dose fenofibrate 145 mg. Treatment with the FDC was also associated with a significantly greater reduction in non-HDL-C compared with fenofibrate alone and a greater increase in HDL-C compared with atorvastatin alone. All treatments were generally well tolerated. Output: | {'conditions': 'Dyslipidemia', 'interventions': 'Drug: LCP-AtorFen|Drug: atorvastatin|Drug: fenofibrate'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Randomised clinical trial: a novel rabeprazole extended release 50 mg formulation vs. esomeprazole 40 mg in healing of moderate-to-severe erosive oesophagitis - the results of two double-blind studies. Current PPIs may not achieve desired outcomes in some GERD patients due to limited duration of acid inhibition. To evaluate a novel rabeprazole extended release (ER), which provides longer duration of drug exposure and acid suppression, in healing and symptomatic resolution of moderate-severe erosive oesophagitis. Patients with LA grade C or D oesophagitis were randomised to rabeprazole-ER 50 mg or esomeprazole 40 mg once daily in two identical 8-week double-blind trials (N = 2130). Two primary endpoints were tested sequentially: (1) healing by 8 weeks [hypothesis: rabeprazole-ER non-inferior to esomeprazole (non-inferiority margin = 8%)], (2) healing by 4 weeks [hypothesis: rabeprazole-ER superior to esomeprazole (P < 0.05)]. The secondary endpoint was sustained heartburn resolution at 4 weeks. Rabeprazole-ER was non-inferior to esomeprazole in week-8 healing (80.0% vs. 75.0%; 77.5% vs. 78.4%). Week-4 healing (54.8% vs. 50.3%; 50.9% vs. 50.7%) and sustained heartburn resolution (48.3% vs. 48.2%; 53.2% vs. 52.5%) were not significantly different. Post hoc combined results for grade D revealed rabeprazole-ER vs. esomeprazole differences in week-8 healing = 10.4% (95% CI: -1.4%, 22.2%) and week-4 healing = 12.0% (P = 0.048). Rabeprazole-ER is as effective as esomeprazole in healing moderate-severe oesophagitis and achieves similar rates of heartburn resolution. Subgroup analysis suggests the possibility of benefit in severe oesophagitis, but this requires further evaluation (ClinicalTrials.gov: NCT00658528 and NCT00658775). Output: | {'conditions': 'Gastroesophageal Reflux Disease (GERD)', 'interventions': 'Drug: Rabeprazole sodium|Drug: Esomeprazole'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:0 Output: | {'conditions': "Hodgkin's Lymphoma", 'interventions': 'Drug: Obatoclax mesylate (GX15-070MS)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Pharmacokinetics and pharmacodynamics of aliskiren/hydrochlorothiazide single-pill combination tablets and free combination of aliskiren and hydrochlorothiazide. Single-pill combinations (SPCs) of complementary antihypertensive agents provide patients with a simple and effective treatment regimen. To ensure that the efficacy and safety of an SPC is the same as that for the individual drugs administered together (free combination), SPC and free-combination formulations must be shown to be bioequivalent. Three open-label, randomized studies compared the pharmacokinetics of SPC tablets of the direct renin inhibitor aliskiren and hydrochlorothiazide (HCT), at doses of 150/25, 300/12.5, and 300/25 mg, with the corresponding free combinations in healthy volunteers. Data from 2 randomized, double-blinded studies of patients with hypertension were used to assess inhibition of plasma renin activity (PRA) by the aliskiren/HCT 300/25 mg SPC and the free combination. At all dose combinations, aliskiren and HCT systemic drug exposure was similar when administered as an SPC or free combination, indicating bioequivalence. Aliskiren/HCT 300/25 mg SPC inhibited PRA to the same extent as the free combination. HCT alone increased PRA through activation of the renin-angiotensin system; aliskiren prevented this diuretic-induced increase to the same extent when administered as the free combination or as the SPC. In conclusion, aliskiren/HCT SPCs are pharmacokinetically and pharmacodynamically bioequivalent to aliskiren and HCT in free combination. Output: | {'conditions': 'Hypertension', 'interventions': 'Drug: Aliskiren|Drug: Hydrochlorothiazide'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:A phase II study of aflibercept in patients with advanced epithelial ovarian cancer and symptomatic malignant ascites. The recombinant fusion protein, aflibercept binds and neutralizes vascular endothelial growth factor (VEGF) A, B and placental growth factor (PlGF). Aflibercept inhibits ascites formation and reduces tumor burden in an ovarian cancer model. This open-label, single-arm, multicenter phase II study assessed the efficacy and safety of aflibercept in patients with advanced chemo-resistant epithelial ovarian cancer and symptomatic malignant ascites. Patients who required ≥3 previous paracenteses at 1-4 paracenteses per month received intravenous aflibercept 4mg/kg every 2 weeks. The primary endpoint was repeat paracentesis response rate (RPRR), with response defined as at least a two-fold increase in time to repeat paracentesis compared with the baseline interval. Ten out of 16 enrolled patients achieved a response; the RPRR was 62.5% (95% CI 35.4%-84.8%). Aflibercept was considered effective based on a hypothesis that the RPRR was ≥60%. Median time to repeat paracentesis was 76.0 (95% CI 64.0-178.0) days, which was 4.5 times longer than the baseline interval (16.8 days). Median progression-free survival was 59.5 (95% CI 41.0-83.0) days. Twelve patients experienced adverse events considered related to aflibercept treatment including hypertension (7 patients), headache, anorexia, and dysphonia (3 patients each). Two patients experienced Grade 3/4 treatment-related adverse events (Grade 3 hypertension and weight loss in one patient, Grade 3 intestinal perforation in one patient). Aflibercept 4mg/kg every 2 weeks was effective at controlling malignant ascites, reducing the interval between repeat paracenteses. The safety profile was consistent with that reported for anti-VEGF agents. Output: | {'conditions': 'Ovarian Neoplasms', 'interventions': 'Drug: AVE0005 (VEGF Trap)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Growth hormone treatment prevents loss of lean mass after bariatric surgery in morbidly obese patients: results of a pilot, open, prospective, randomized, controlled study. The loss of lean body mass (LBM) negatively influences the outcome in bariatric surgery. Impaired GH secretion is frequent in obese patients. Our objective was to investigate if GH treatment prevents LBM loss in the early postoperative period. This was an open, prospective, randomized, and controlled study. A total of 24 women (body mass index: 44.4 +/- 7.6 kg/m(2), aged 36.8 +/- 11.7 yr) undergoing laparoscopic-adjustable silicone gastric banding (LASGB) and with GH deficiency after LASGB was included in the study. Group A (n = 12) included a standardized diet regimen and exercise program plus recombinant human GH (0.5 +/- 0.13 mg every day), and group B (n = 12) included a standardized diet regimen and exercise program. The follow-up duration was 6 months. The excess of body weight loss did not differ between groups A and B after 3 and 6 months. At 3 months, LBM loss was lower (P < 0.0001) and fat mass (FM) loss was higher (P = 0.02) in group A than group B. At 3 and 6 months, appendicular skeletal muscle mass loss was lower (P = 0.000) in group A than group B. At 3 (P = 0.0003 and 0.0005, respectively) and 6 months (P < 0.0001 and 0.0002, respectively), the percent changes of FM and lean body mass were significantly higher in group A than group B. In both groups fasting and postglucose area under the plasma concentration-time curve insulin significantly reduced. The homeostasis model assessment of insulin and insulin sensitivity indexes and total to high-density lipoprotein cholesterol ratio improved only in group A. GH treatment for 6 months after LASGB reduces loss in LBM and appendicular skeletal muscle mass during a standardized program of low-calorie diet and physical exercise program, with improvement of lipid profile and without a deterioration of glucose tolerance. Output: | {'conditions': 'Obesity|GHD', 'interventions': 'Drug: Recombinant GH Saizen (Merck-Serono)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Botulinum toxin type A in post-stroke upper limb spasticity. To evaluate the efficacy and safety of one-time injections of botulinum toxin type A (BoNTA) in Japanese patients with post-stroke upper limb spasticity. In a multicentre, randomised, double-blind, parallel-group, placebo-controlled study, 109 patients with upper limb spasticity were randomised to receive a single treatment with lower-dose (120-150 U) or higher-dose (200-240 U) BoNTA or placebo into upper limb muscles. NCT00460564. The tone of the wrist flexor was assessed at baseline and at weeks 0, 1, 4, 6, 8 and 12 using the Modified Ashworth Scale (MAS) for wrist, finger, thumb and disability in activities of daily living (ADL) was rated using the 4-point Disability Assessment Scale (DAS). The primary endpoint was area under the curve (AUC) of the change from baseline in the MAS wrist score in the higher-dose groups. Subjects were randomised with 51 in the higher BoNTA group, 26 in the higher-dose placebo group, 21 in the lower BoNTA group and 11 in the lower-dose placebo group. Significant improvement in spasticity with higher-dose BoNTA was demonstrated by a mean difference in the AUC of the change from baseline in the MAS wrist score between the higher-dose BoNTA group and the higher-dose placebo group of -6.830 (p < 0.001, t-test), no significant different was demonstrated between the lower-dose BoNTA group and the lower-dose placebo group (p = 0.215, t-test). Significant improvements with higher-dose BoNTA were also observed in the DAS scores for limb position (p = 0.001-0.022) at all time points and dressing (p = 0.018-0.038, Wilcoxon test) at weeks 6, 8 and 12. No clinically relevant difference was noted in the frequency of treatment-related adverse events between BoNTA-treated and placebo-treated patients. The long-term efficacy and safety, and the effects on rehabilitation of BoNTA on upper limb will be evaluated using the data obtained in the open-label phase. Higher-dose BoNTA reduced spasticity in upper limb muscles and improved ADL performance in terms of limb position and dressing. BoNTA is safe and effective in the treatment of post-stroke upper limb spasticity. Output: | {'conditions': 'Post-Stroke Spasticity|Cerebrovascular Accident', 'interventions': 'Drug: GSK1358820|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Once-daily dosing of delayed-release oral mesalamine (400-mg tablet) is as effective as twice-daily dosing for maintenance of remission of ulcerative colitis. The practice of dosing mesalamines in divided doses for the treatment of ulcerative colitis (UC) began with sulfasalazine and was driven by sulfapyridine toxicity. This convention and the assumption that dosing multiple times a day is necessary to treat UC had not been challenged until recently. This study was conducted to determine the efficacy and safety of once-daily dosing of delayed-release mesalamine (Asacol 400-mg tablets) compared with twice-daily dosing for maintaining remission in UC patients. A multicenter, randomized, investigator-blinded, 12-month, active-control trial was conducted to assess the noninferiority of delayed-release mesalamine 1.6-2.4 g/day administered once daily compared with twice daily in patients with mild-to-moderate UC currently in clinical remission. The primary end point was maintenance of clinical remission at month 6. A total of 1023 patients were randomized and dosed. The primary objective of noninferiority was met. At month 6, 90.5% of patients receiving once-daily dosing had maintained clinical remission, compared with 91.8% of patients receiving twice-daily dosing (95% confidence interval for twice daily - once daily, -2.3 to 4.9). At month 12, 85.4% of patients receiving once-daily dosing had maintained clinical remission, compared with 85.4% of patients receiving twice-daily dosing (95% confidence interval for twice daily - once daily, -4.6 to 4.7). Both regimens had low rates of withdrawals as a result of adverse events and serious adverse events. Once-daily dosing of delayed-release mesalamine at doses of 1.6-2.4 g/day was shown to be as effective as twice-daily dosing for maintenance of clinical remission in patients with UC. Output: | {'conditions': 'Ulcerative Colitis', 'interventions': 'Drug: Mesalamine Once-Daily|Drug: Mesalamine Twice-Daily'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Phase II, randomized, double-blind, placebo-controlled, multicenter study to investigate the immunogenicity and safety of a West Nile virus vaccine in healthy adults. ChimeriVax-WN02 is a live, attenuated chimeric vaccine for protection against West Nile virus. This Phase II, randomized, double-blind, placebo-controlled, multicenter study assessed the immunogenicity, viremia, and safety of the ChimeriVax-WN02 vaccine. The 2-part study included adults in general good health. In part 1, subjects aged 18-40 years were randomized to 1 of 4 treatment groups: ChimeriVax-WN02 3.7- × -10(5) plaque-forming units (PFU), 3.7 × 10(4) PFU, 3.7 × 10(3) PFU, or placebo. In part 2, subjects aged 41-64 and ≥ 65 years were randomized to receive ChimeriVax-WN02 3.7 × 10(5) PFU or placebo. In both part 1 and part 2, seroconversion was achieved at day 28 by >96% of subjects in active treatment groups. In part 1, neutralizing antibody titers at day 28 were higher and viremia levels lower with the highest dose, whereas the adverse event profile was similar between the dose groups. In part 2, antibody titers and viremia levels were higher in subjects aged ≥ 65 years, and more subjects in the 41-64 years cohort experienced adverse events. The ChimeriVax-WN02 vaccine was highly immunogenic in younger adults and the elderly, and it was well tolerated at all dose levels and in all age groups investigated. Clinical Trials.gov identifier: NCT00442169. Output: | {'conditions': 'West Nile Fever', 'interventions': 'Biological: ChimeriVax-WN02 Low Dose|Biological: ChimeriVax-WN02 Medium Dose|Biological: ChimeriVax-WN02 High Dose|Biological: 0.9% Saline solution|Biological: ChimeriVax-WN02 High Dose|Biological: 0.9 % NaCl solution'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Pallidal versus subthalamic deep-brain stimulation for Parkinson's disease. Deep-brain stimulation is the surgical procedure of choice for patients with advanced Parkinson's disease. The globus pallidus interna and the subthalamic nucleus are accepted targets for this procedure. We compared 24-month outcomes for patients who had undergone bilateral stimulation of the globus pallidus interna (pallidal stimulation) or subthalamic nucleus (subthalamic stimulation). At seven Veterans Affairs and six university hospitals, we randomly assigned 299 patients with idiopathic Parkinson's disease to undergo either pallidal stimulation (152 patients) or subthalamic stimulation (147 patients). The primary outcome was the change in motor function, as blindly assessed on the Unified Parkinson's Disease Rating Scale, part III (UPDRS-III), while patients were receiving stimulation but not receiving antiparkinsonian medication. Secondary outcomes included self-reported function, quality of life, neurocognitive function, and adverse events. Mean changes in the primary outcome did not differ significantly between the two study groups (P=0.50). There was also no significant difference in self-reported function. Patients undergoing subthalamic stimulation required a lower dose of dopaminergic agents than did those undergoing pallidal stimulation (P=0.02). One component of processing speed (visuomotor) declined more after subthalamic stimulation than after pallidal stimulation (P=0.03). The level of depression worsened after subthalamic stimulation and improved after pallidal stimulation (P=0.02). Serious adverse events occurred in 51% of patients undergoing pallidal stimulation and in 56% of those undergoing subthalamic stimulation, with no significant between-group differences at 24 months. Patients with Parkinson's disease had similar improvement in motor function after either pallidal or subthalamic stimulation. Nonmotor factors may reasonably be included in the selection of surgical target for deep-brain stimulation. (ClinicalTrials.gov numbers, NCT00056563 and NCT01076452.) Output: | {'conditions': "Parkinson's Disease", 'interventions': 'Procedure: Bilateral Deep Brain Stimulation'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:A randomized, controlled trial of raltegravir intensification in antiretroviral-treated, HIV-infected patients with a suboptimal CD4+ T cell response. Some human immunodeficiency virus (HIV)-infected individuals are not able to achieve a normal CD4(+) T cell count despite prolonged, treatment-mediated viral suppression. We conducted an intensification study to assess whether residual viral replication contributes to replenishment of the latent reservoir and whether mucosal HIV-specific T cell responses limit the reservoir size. Thirty treated subjects with CD4(+) T cell counts of <350 cells/mm(3) despite viral suppression for ≥ 1 year were randomized to add raltegravir (400 mg twice daily) or matching placebo for 24 weeks. The primary end points were the proportion of subjects with undetectable plasma viremia (determined using an ultrasensitive assay with a lower limit of detection of <.3 copy/mL) and a change in the percentage of CD38(+)HLA-DR(+)CD8(+) T cells in peripheral blood mononuclear cells (PBMCs). The proportion of subjects with undetectable plasma viremia did not differ between the 2 groups (P = .42). Raltegravir intensification did not have a significant effect on immune activation or HIV-specific responses in PBMCs or gut-associated lymphoid tissue. Low-level viremia is not likely to be a significant cause of suboptimal CD4(+) T cell gains during HIV treatment. NCT00631449. Output: | {'conditions': 'HIV Infections', 'interventions': 'Drug: Raltegravir|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. Biologic agents offer a range of new therapeutic options for patients with psoriasis; however, the relative benefit-risk profiles of such therapies are not well known. We compared two biologic agents, ustekinumab (an interleukin-12 and interleukin-23 blocker) and etanercept (an inhibitor of tumor necrosis factor alpha), for the treatment of psoriasis. We randomly assigned 903 patients with moderate-to-severe psoriasis to receive subcutaneous injections of either 45 or 90 mg of ustekinumab (at weeks 0 and 4) or high-dose etanercept (50 mg twice weekly for 12 weeks). The primary end point was the proportion of patients with at least 75% improvement in the psoriasis area-and-severity index (PASI) at week 12; a secondary end point was the proportion with cleared or minimal disease on the basis of the physician's global assessment. Assessors were unaware of the treatment assignments. The efficacy and safety of a crossover from etanercept to ustekinumab were evaluated after week 12. There was at least 75% improvement in the PASI at week 12 in 67.5% of patients who received 45 mg of ustekinumab and 73.8% of patients who received 90 mg, as compared with 56.8% of those who received etanercept (P=0.01 and P<0.001, respectively). Similarly, 65.1% of patients who received 45 mg of ustekinumab and 70.6% of patients who received 90 mg of ustekinumab had cleared or minimal disease according to the physician's global assessment, as compared with 49.0% of those who received etanercept (P<0.001 for both comparisons). Among patients who did not have a response to etanercept, 48.9% had at least 75% improvement in the PASI within 12 weeks after crossover to ustekinumab. One or more adverse events occurred through week 12 in 66.0% of patients who received 45 mg of ustekinumab and 69.2% of patients who received 90 mg of ustekinumab and in 70.0% who received etanercept; 1.9%, 1.2%, and 1.2%, respectively, had serious adverse events. Safety patterns were similar before and after crossover from etanercept to ustekinumab. The efficacy of ustekinumab at a dose of 45 or 90 mg was superior to that of high-dose etanercept over a 12-week period in patients with psoriasis. (ClinicalTrials.gov number, NCT00454584.) Output: | {'conditions': 'Psoriasis', 'interventions': 'Drug: CNTO 1275 45 mg|Drug: CNTO 1275 90 mg|Drug: Etanercept 50 mg'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Effect of adding the novel fiber, PGX®, to commonly consumed foods on glycemic response, glycemic index and GRIP: a simple and effective strategy for reducing post prandial blood glucose levels--a randomized, controlled trial. Reductions in postprandial glycemia have been demonstrated previously with the addition of the novel viscous polysaccharide (NVP), PolyGlycopleX® (PGX®), to an OGTT or white bread. This study explores whether these reductions are sustained when NVP is added to a range of commonly consumed foods or incorporated into a breakfast cereal. Ten healthy subjects (4M, 6F; age 37.3 ± 3.6 y; BMI 23.8 ± 1.3 kg/m2), participated in an acute, randomized controlled trial. The glycemic response to cornflakes, rice, yogurt, and a frozen dinner with and without 5 g of NVP sprinkled onto the food was determined. In addition, 3 granolas with different levels of NVP and 3 control white breads and one white bread and milk were also consumed. All meals contained 50 g of available carbohydrate. Capillary blood samples were taken fasting and at 15, 30, 45, 60, 90 and 120 min after the start of the meal. The glycemic index (GI) and the glycemic reduction index potential (GRIP) were calculated. The blood glucose concentrations at each time and the iAUC values were subjected to repeated-measures analysis of variance (ANOVA) examining for the effect of test meal. After demonstration of significant heterogeneity, differences between individual means was assessed using GLM ANOVA with Tukey test to adjust for multiple comparisons. Addition of NVP reduced blood glucose response irrespective of food or dose (p < 0.01). The GI of cornflakes, cornflakes+NVP, rice, rice+NVP, yogurt, yogurt+NVP, turkey dinner, and turkey dinner+NVP were 83 ± 8, 58 ± 7, 82 ± 8, 45 ± 4, 44 ± 4, 38 ± 3, 55 ± 5 and 41 ± 4, respectively. The GI of the control granola, and granolas with 2.5 and 5 g of NVP were 64 ± 6, 33 ± 5, and 22 ± 3 respectively. GRIP was 6.8 ± 0.9 units per/g of NVP. Sprinkling or incorporation of NVP into a variety of different foods is highly effective in reducing postprandial glycemia and lowering the GI of a food. NCT00935350. Output: | {'conditions': 'Blood Glucose, Postprandial', 'interventions': 'Dietary Supplement: PolyGlycopleX (PGX)|Dietary Supplement: PolyGlycopleX (PGX)|Dietary Supplement: PolyGlycopleX (PGX)'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Effect of supplementation with cholecalciferol and calcium on 2-y bone mass accrual in HIV-infected children and adolescents: a randomized clinical trial. Skeletal abnormalities have been reported in HIV-infected children and adolescents. Although the etiology is not well understood, vitamin D deficiency may be involved. The study objective was to evaluate the effect of vitamin D and calcium supplementation on bone mass accrual in HIV-infected youth. Perinatally HIV-infected children were randomly assigned to receive vitamin D (100,000 IU cholecalciferol given every 2 mo) and calcium (1 g/d) (supplemented group) or double placebo (placebo group) for 2 y. The total-body bone mineral content (TBBMC), total-body bone mineral density (TBBMD), spine bone mineral content (SBMC), and spine bone mineral density (SBMD) were assessed by using dual-energy X-ray absorptiometry at baseline and at 2 annual follow-up visits. Fifty-nine participants, aged 6-16 y, were randomly assigned to either the supplemented (n = 30) or the placebo (n = 29) group. At enrollment, supplemented and placebo groups did not differ with respect to age, sex, dietary intakes of vitamin D and calcium, mean baseline serum 25-hydroxyvitamin D [25(OH)D] concentration, TBBMC, TBBMD, SBMC, or SBMD. Significant increases in serum 25(OH)D were observed in the supplemented group but not in the placebo group. TBBMC, TBBMD, SBMC, and SBMD increased significantly at 1 and 2 y in both groups. No between-group differences were observed at any time before or after adjustment for stage of sexual maturation by mixed linear model analysis. One gram of calcium per day and oral cholecalciferol at a dosage of 100,000 IU every 2 mo administered to HIV-infected children and adolescents did not affect bone mass accrual despite significant increases in serum 25(OH)D concentrations. This trial was registered at clinicaltrials.gov as NCT00724178. Output: | {'conditions': 'HIV Infection|Bone Mass', 'interventions': 'Dietary Supplement: cholecalciferol plus calcium carbonate'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Stereoacuity in children with anisometropic amblyopia. To determine factors associated with pretreatment and posttreatment stereoacuity in subjects with moderate anisometropic amblyopia. Data for subjects enrolled in seven studies conducted by the Pediatric Eye Disease Investigator Group were pooled. The sample included 633 subjects aged 3 to <18 years with anisometropic amblyopia, no heterotropia observed by cover test, and baseline amblyopic eye acuity of 20/100 or better. A subset included 248 subjects who were treated with patching or Bangerter filters and had stereoacuity testing at both the baseline and outcome examinations. Multivariate regression models identified factors associated with baseline stereoacuity and with outcome stereoacuity as measured by the Randot Preschool Stereoacuity test. Better baseline stereoacuity was associated with better baseline amblyopic eye acuity (P < 0.001), less anisometropia (P = 0.03), and anisometropia due to astigmatism alone (P < 0.001). Better outcome stereoacuity was associated with better baseline stereoacuity (P < 0.001) and better amblyopic eye acuity at outcome (P < 0.001). Among 48 subjects whose amblyopic eye visual acuity at outcome was 20/25 or better and within one line of the fellow eye, stereoacuity was worse than that of children with normal vision of the same age. In children with anisometropic amblyopia of 20/40 to 20/100 inclusive, better posttreatment stereoacuity is associated with better baseline stereoacuity and better posttreatment amblyopic eye acuity. Even if their visual acuity deficit resolves, many children with anisometropic amblyopia have stereoacuity worse than that of nonamblyopic children of the same age. Output: | {'conditions': 'Amblyopia', 'interventions': 'Device: Bangerter filters|Device: Patching|Procedure: Near activities'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Selective vitamin D receptor activation with paricalcitol for reduction of albuminuria in patients with type 2 diabetes (VITAL study): a randomised controlled trial. Despite treatment with renin–angiotensin–aldosterone system (RAAS) inhibitors, patients with diabetes have increased risk of progressive renal failure that correlates with albuminuria. We aimed to assess whether paricalcitol could be used to reduce albuminuria in patients with diabetic nephropathy. In this multinational, placebo-controlled, double-blind trial, we enrolled patients with type 2 diabetes and albuminuria who were receiving angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. Patients were assigned (1:1:1) by computer-generated randomisation sequence to receive 24 weeks’ treatment with placebo,1 μg/day paricalcitol, or 2 μg/day paricalcitol. The primary endpoint was the percentage change in geometric mean urinary albumin-to-creatinine ratio (UACR) from baseline to last measurement during treatment for the combined paricalcitol groups versus the placebo group. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00421733. Between February, 2007, and October, 2008, 281 patients were enrolled and assigned to receive placebo(n=93), 1 μg paricalcitol (n=93), or 2 μg paricalcitol (n=95); 88 patients on placebo, 92 on 1 μg paricalcitol, and 92 on2 μg paricalcitol received at least one dose of study drug, and had UACR data at baseline and at least one timepoint during treatment, and so were included in the primary analysis. Change in UACR was: –3% (from 61 to 60 mg/mmol;95% CI –16 to 13) in the placebo group; –16% (from 62 to 51 mg/mmol; –24 to –9) in the combined paricalcitol groups, with a between-group difference versus placebo of –15% (95% CI –28 to 1; p=0.071); –14% (from 63 to 54 mg/mmol; –24 to –1) in the 1 μg paricalcitol group, with a between-group difference versus placebo of –11%(95% CI –27 to 8; p=0.23); and –20% (from 61 to 49 mg/mmol; –30 to –8) in the 2 μg paricalcitol group, with a between-group difference versus placebo of –18% (95% CI –32 to 0; p=0.053). Patients on 2 μg paricalcitol showed a nearly, sustained reduction in UACR, ranging from –18% to –28% (p=0.014 vs placebo). Incidence of hypercalcaemia,adverse events, and serious adverse events was similar between groups receiving paricalcitol versus placebo. Addition of 2 μg/day paricalcitol to RAAS inhibition safely lowers residual albuminuria in patients with diabetic nephropathy, and could be a novel approach to lower residual renal risk in diabetes. Abbott. Output: | {'conditions': 'Diabetic Nephropathy|Chronic Kidney Disease', 'interventions': 'Drug: Zemplar (paricalcitol ) capsules|Drug: Zemplar (paricalcitol) capsules|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Comparing etoricoxib and celecoxib for preemptive analgesia for acute postoperative pain in patients undergoing arthroscopic anterior cruciate ligament reconstruction: a randomized controlled trial. The efficacy of selective cox-2 inhibitors in postoperative pain reduction were usually compared with conventional non-selective conventional NSAIDs or other types of medicine. Previous studies also used selective cox-2 inhibitors as single postoperative dose, in continued mode, or in combination with other modalities. The purpose of this study was to compare analgesic efficacy of single preoperative administration of etoricoxib versus celecoxib for post-operative pain relief after arthroscopic anterior cruciate ligament reconstruction. One hundred and two patients diagnosed as anterior cruciate ligament injury were randomized into 3 groups using opaque envelope. Both patients and surgeon were blinded to the allocation. All of the patients were operated by one orthopaedic surgeon under regional anesthesia. Each group was given either etoricoxib 120 mg., celecoxib 400 mg., or placebo 1 hour prior to operative incision. Post-operative pain intensity, time to first dose of analgesic requirement and numbers of analgesic used for pain control and adverse events were recorded periodically to 48 hours after surgery. We analyzed the data according to intention to treat principle. Among 102 patients, 35 were in etoricoxib, 35 in celecoxib and 32 in placebo group. The mean age of the patients was 30 years and most of the injury came from sports injury. There were no significant differences in all demographic characteristics among groups. The etoricoxib group had significantly less pain intensity than the other two groups at recovery room and up to 8 hours period but no significance difference in all other evaluation point, while celecoxib showed no significantly difference from placebo at any time points. The time to first dose of analgesic medication, amount of analgesic used, patient's satisfaction with pain control and incidence of adverse events were also no significantly difference among three groups. Etoricoxib is more effective than celecoxib and placebo for using as preemptive analgesia for acute postoperative pain control in patients underwent arthroscopic anterior cruciate ligament reconstruction. NCT01017380. Output: | {'conditions': 'Anterior Cruciate Ligament Injury', 'interventions': 'Drug: Celecoxib|Drug: etoricoxib'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Intramyocardial plasmid-encoding human vascular endothelial growth factor A165/basic fibroblast growth factor therapy using percutaneous transcatheter approach in patients with refractory coronary artery disease (VIF-CAD). VIF-CAD randomized, placebo-controlled, double-blind trial was an attempt to induce therapeutic angiogenesis by percutaneous intramyocardial transfer of bicistronic (vascular endothelial growth factor/fibroblast growth factor [VEGF/FGF]) plasmid (pVIF) in patients with refractory heart ischemia. Myocardial perfusion, clinical symptoms, exercise tolerance, left ventricular function, and safety were assessed. Fifty-two patients with refractory coronary artery disease were randomized to receive VEGF/FGF plasmid (n = 33) or placebo plasmid (n = 19) into myocardial region showing stress-induced perfusion defects. Repeat stress and rest technetium Tc 99m sestamibi single-photon emission computed tomography at 5 months was the primary efficacy measure. Secondary assessment included Canadian Cardiovascular Society class and exercise tolerance at 5 and 12 months. Rest- and stress-induced perfusion defects did not differ between groups. Canadian Cardiovascular Society functional class improved after 5 (P = .0210) and 12 months (P = .0607) in the treatment group. The exercise tolerance of treated patients improved: total exercise time increased marginally (P = .0541); maximum workload (P = .0419) and total test distance (P = .0473) increased significantly, compared to placebo. Bicistronic VEGF/FGF plasmid therapy did not improve myocardial perfusion measured by single-photon emission computed tomography. However, treated patients experienced improvement with respect to exercise tolerance and clinical symptoms. Intramyocardial VEGF/FGF bicistronic plasmid transfer seemed safe throughout the follow-up period of 1 year. Output: | {'conditions': 'Coronary Artery Disease', 'interventions': 'Genetic: intramyocardial injection of VEGF-A165/bFGF:placebo plasmid'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Effects of the angiotensin receptor blocker azilsartan medoxomil versus olmesartan and valsartan on ambulatory and clinic blood pressure in patients with stages 1 and 2 hypertension. Azilsartan medoxomil is an angiotensin receptor blocker (ARB) being developed for hypertension treatment. To compare this ARB with others in the class, we studied the effects of 2 doses of azilsartan medoxomil, with valsartan 320 mg and olmesartan medoxomil (olmesartan) 40 mg, in a randomized, double-blind, placebo-controlled trial using ambulatory blood pressure (BP) monitoring and clinic BP measurements. The primary efficacy end point was the change from baseline in 24-hour mean systolic BP. Hierarchical analysis testing for superiority over placebo was followed by noninferiority analysis and then superiority testing of azilsartan medoxomil (80 mg and then 40 mg) versus the comparator ARBs. For 1291 randomized patients, mean age was 56 years, 54% were men, and baseline 24-hour mean systolic BP was 145 mm Hg. Azilsartan medoxomil at 80 mg had superior efficacy to both valsartan at 320 mg and olmesartan at 40 mg: placebo-adjusted 24-hour systolic BP was lowered (-14.3 mm Hg) more than 320 mg of valsartan (-10.0 mm Hg; P<0.001) and 40 mg of olmesartan (-11.7 mm Hg; P=0.009). Azilsartan medoxomil at 40 mg was noninferior to 40 mg of olmesartan (difference: -1.4 mm Hg [95% CI: -3.3 to 0.5]). For clinic systolic BP, both doses of azilsartan medoxomil were superior to the comparator ARBs. Safety and tolerability were similar among the placebo and 4 active treatments. These data demonstrate that azilsartan medoxomil at its maximal dose has superior efficacy to both olmesartan and valsartan at their maximal, approved doses without increasing adverse events. Azilsartan medoxomil could provide higher rates of hypertension control within the ARB class. Output: | {'conditions': 'Hypertension', 'interventions': 'Drug: Azilsartan medoxomil|Drug: Azilsartan medoxomil|Drug: Valsartan|Drug: Olmesartan|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Thermotherapy. An alternative for the treatment of American cutaneous leishmaniasis. Pentavalent antimonials (Sb5) and miltefosine are the first-line drugs for treating cutaneous leishmaniasis in Colombia; however, toxicity and treatment duration negatively impact compliance and cost, justifying an active search for better therapeutic options. We compared the efficacy and safety of thermotherapy and meglumine antimoniate for the treatment of cutaneous leishmaniasis in Colombia. An open randomized Phase III clinical trial was performed in five military health centres. located in northwestern, central and southern Colombia. Volunteers with parasitological positive diagnosis (Giemsa-stained smears) of cutaneous leishmaniasis were included. A single thermotherapy session involving the application of 50°C at the center and active edge of each lesion. Meglumine antimoniate was administered intramuscularly at a dose of 20 mg Sb5/kg weight/day for 20 days. Both groups were comparable. The efficacy of thermotherapy was 64% (86/134 patients) by protocol and 58% (86/149) by intention-to-treat. For the meglumine antimoniate group, efficacy by protocol was 85% (103/121 patients) and 72% (103/143) by intention-to-treat, The efficacy between the treatments was statistically significant (p 0.01 and < 0.001) for analysis by intention to treat and by protocol, respectively. There was no difference between the therapeutic response with either treatment regardless of the Leishmania species responsible for infection. The side effects of meglumine antimoniate included myalgia, arthralgia, headache and fever. Regarding thermotherapy, the only side effect was pain at the lesion area four days after the initiation of treatment. Although the efficacy rate of meglumine antimoniate was greater than that of thermotherapy for the treatment of cutaneous leishmaniasis, the side effects were also greater. Those factors, added to the increased costs, the treatment adherence problems and the progressive lack of therapeutic response, make us consider thermotherapy as a first line treatment for cutaneous leishmaniasis. Output: | {'conditions': 'Cutaneous Leishmaniasis', 'interventions': 'Drug: Miltefosine|Device: Thermotherapy|Drug: Glucantime®'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Long-term treatment with pitavastatin is effective and well tolerated by patients with primary hypercholesterolemia or combined dyslipidemia. The primary objective was to assess the safety and tolerability of pitavastatin 4mg once daily during 52 weeks treatment. The secondary objectives were to assess the effect on lipid and lipoprotein fractions and ratios, and LDL-C target attainment. Patients with primary hypercholesterolemia or combined dyslipidemia who had previously received pitavastatin, atorvastatin or simvastatin for 12 weeks during double-blind phase III studies received open-label pitavastatin 4mg once daily for up to 52 weeks. Investigators at 72 sites enrolled 1353 patients who received at least one dose of pitavastatin 4mg; 155 (11.5%) patients discontinued treatment during the 52-week follow up. The proportion of patients achieving NCEP and EAS LDL-C targets at week 52 was 74.0% and 73.5% respectively. The reduction in LDL-C levels seen during the double-blind studies was sustained, while HDL-C levels rose continually during follow up, ultimately increasing by 14.3% over the initial baseline. Changes in other efficacy parameters (triglycerides, total cholesterol, non-HDL-C, Apo-A1 and Apo-B, high sensitivity C-reactive protein, oxidised LDL) and ratios (total cholesterol: HDL-C, non-HDL-C:HDL-C and Apo-B:Apo-A1) were sustained during 52-weeks treatment compared with the end of the double-blind studies. Pitavastatin was well tolerated: 4.1% of patients withdrew from the study due to treatment emergent adverse events (TEAEs) and none of the serious adverse events were considered treatment-related. No clinically significant abnormalities were associated with pitavastatin in routine laboratory variables, urinalysis, vital signs or 12-lead ECG. There were no reports of myopathy, myositis or rhabdomyolysis. The most common TEAEs were: increased creatine phosphokinase (5.8%), nasopharyngitis (5.4%) and myalgia (4.1%). Pitavastatin 4mg once daily was effective and well tolerated during 52-weeks treatment in patients with primary hypercholesterolemia or combined dyslipidemia. Around three-quarters of patients achieved NCEP and EAS LDL-C targets at week 52, HDL-C levels rose continually during follow up, while changes in other efficacy parameters were sustained over the year-long study. Output: | {'conditions': 'Hypercholesterolemia|Dyslipidemia', 'interventions': 'Drug: Pitavastatin'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Insulin pump therapy with automated insulin suspension in response to hypoglycemia: reduction in nocturnal hypoglycemia in those at greatest risk. To evaluate a sensor-augmented insulin pump with a low glucose suspend (LGS) feature that automatically suspends basal insulin delivery for up to 2 h in response to sensor-detected hypoglycemia. The LGS feature of the Paradigm Veo insulin pump (Medtronic, Inc., Northridge, CA) was tested for 3 weeks in 31 adults with type 1 diabetes. There were 166 episodes of LGS: 66% of daytime LGS episodes were terminated within 10 min, and 20 episodes lasted the maximum 2 h. LGS use was associated with reduced nocturnal duration ≤2.2 mmol/L in those in the highest quartile of nocturnal hypoglycemia at baseline (median 46.2 vs. 1.8 min/day, P = 0.02 [LGS-OFF vs. LGS-ON]). Median sensor glucose was 3.9 mmol/L after 2-h LGS and 8.2 mmol/L at 2 h after basal restart. Use of an insulin pump with LGS was associated with reduced nocturnal hypoglycemia in those at greatest risk and was well accepted by patients. Output: | {'conditions': 'Diabetes Mellitus, Type 1', 'interventions': 'Device: X54 insulin pump with low suspend feature'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Radiographic progression of ankylosing spondylitis after up to two years of treatment with etanercept. To investigate the effect of etanercept therapy on radiographic progression in patients with ankylosing spondylitis (AS). Patients with AS who had previously participated in a 24-week randomized, double-blind, placebo-controlled trial of etanercept therapy were enrolled in a 72-week open-label extension. Radiographs of the cervical and lumbar spine from patients who received etanercept (25 mg twice weekly) for up to 96 weeks were compared with radiographs from patients in a large prevalence cohort (Outcome Assessments in Ankylosing Spondylitis International Study [OASIS]) who had not been treated with anti-tumor necrosis factor alpha (anti-TNFalpha) agents. Radiographs obtained at 2 time points up to 96 weeks apart from patients in both study populations were digitized and read by 2 independent readers who were blinded with regard to patient group and sequence. The primary end point was the 96-week change in the modified Stoke AS Spine Score (mSASSS). A total of 257 patients treated with etanercept were compared with 175 unselected patients from the OASIS study. There was no significant difference in the change in the mSASSS from baseline among patients who received etanercept (mean +/- SD 0.91 +/- 2.45) versus those from the OASIS group (0.95 +/- 3.18). Unlike other inflammatory rheumatic diseases such as rheumatoid arthritis and psoriatic arthritis, structural progression in AS seems to be independent of TNF, despite the fact that TNF is responsible for the signs and symptoms due to inflammation in this disease. Output: | {'conditions': 'Ankylosing Spondylitis', 'interventions': 'Drug: Etanercept'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. The long-term efficacy and safety of aclidinium bromide, a novel, long-acting muscarinic antagonist, were investigated in patients with moderate to severe chronic obstructive pulmonary disease (COPD). In two double-blind, 52-week studies, ACCLAIM/COPD I (n=843) and II (n=804), patients were randomised to inhaled aclidinium 200 μg or placebo once-daily. Patients were required to have a post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity ratio of ≤70% and FEV1<80% of the predicted value. The primary endpoint was trough FEV1 at 12 and 28 weeks. Secondary endpoints were health status measured by St George's Respiratory Questionnaire (SGRQ) and time to first moderate or severe COPD exacerbation. At 12 and 28 weeks, aclidinium improved trough FEV1 versus placebo in ACCLAIM/COPD I (by 61 and 67 mL; both p<0.001) and ACCLAIM/COPD II (by 63 and 59 mL; both p<0.001). More patients had a SGRQ improvement≥4 units at 52 weeks with aclidinium versus placebo in ACCLAIM/COPD I (48.1% versus 39.5%; p=0.025) and ACCLAIM/COPD II (39.0% versus 32.8%; p=0.074). The time to first exacerbation was significantly delayed by aclidinium in ACCLAIM/COPD II (hazard ratio [HR] 0.7; 95% confidence interval [CI] 0.55 to 0.92; p=0.01), but not ACCLAIM/COPD I (HR 1.0; 95% CI 0.72 to 1.33; p=0.9). Adverse events were minor in both studies. Aclidinium is effective and well tolerated in patients with moderate to severe COPD. ClinicalTrials.gov: NCT00363896 (ACCLAIM/COPD I) and NCT00358436 (ACCLAIM/COPD II). Output: | {'conditions': 'Chronic Obstructive Pulmonary Disease', 'interventions': 'Drug: Aclidinium bromide|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:A multicenter phase II study to evaluate the efficacy and safety of gefitinib as first-line treatment for Korean patients with advanced pulmonary adenocarcinoma harboring EGFR mutations. This study was designed to prospectively evaluate the efficacy and safety of first-line gefitinib treatment in patients with advanced pulmonary adenocarcinoma harboring epidermal growth factor receptor (EGFR) mutations and to explore the molecular factors affecting the efficacy of gefitinib. Tumor tissue, derived from either the original tumor or the metastatic or recurrent site was taken from chemo-naïve pts with advanced (stage IIIB, IV, and recurrent) pulmonary adenocarcinoma. Tumor genomic DNA underwent direct sequencing for EGFR exons 18, 19, 20, and 21. Patients with EGFR mutations received 250 mg of gefitinib daily until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR). Secondary endpoints were progression free survival (PFS), overall survival (OS) and tolerability. Out of 147 screened patients, 45 pts (31%) had EGFR mutations and received gefitinib. The most common EGFR mutations were in-frame exon 19 deletions (29 pts, 64%) and L858R point mutation in exon 21 (15 pts, 33%). One patient had atypical mutation of L861Q in exon 21. The ORR was 53.3% (95% CI, 38.6-67.9) and disease control rate (DCR) including stable disease was 86.7%. The median progression free survival (PFS) was 398 days and the median overall survival (OS) was 819 days. Treatment was well tolerated. Grade 3/4 adverse events (AEs) were reported by 6 patients and treatment-related Grade 3 AEs by 3 patients. There were no treatment-related Grade 4 AEs. Exploratory subgroup analysis according to the EGFR mutation subtypes was carried out. The ORR and DCR were higher in patients with exon 19 deletions than those with L858R (62.1% vs 33.3%; P=0.0705 and 96.6% vs 66.7%; P=0.0062, respectively). All 4 patients with progressive disease had a L858R mutation. No secondary resistant mutations such as T790M mutation or insertions in exon 20 were found in those patients. In addition, OS was significantly better in patients with exon 19 deletions than those with L858R (24-month OS rate was 72.1% vs 32.0%, P=0.0148). Gefitinib as the first-line treatment for Korean patients with advanced pulmonary adenocarcinoma harboring EGFR mutations was effective and well tolerated. Subgroup analysis suggests that the benefit from gefitinib treatment was more prominent in patients with the exon 19 deletion mutations (ClinicalTrials.gov number, NCT00344773). Output: | {'conditions': 'Pulmonary Cancer', 'interventions': 'Drug: Gefitinib'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Safety and efficacy of ABT-089 in pediatric attention-deficit/hyperactivity disorder: results from two randomized placebo-controlled clinical trials. To assess the safety and efficacy of ABT-089, a novel α(4)β(2) neuronal nicotinic receptor partial agonist, vs. placebo in children with attention-deficit/hyperactivity disorder (ADHD). Two multicenter, randomized, double-blind, placebo-controlled, parallel-group studies of children 6 through 12 years of age were conducted. Study 1 (n = 274) assessed six treatment groups over 8 weeks: 4 once-daily (QD) ABT-089 doses (0.085-0.700 mg/kg), QD atomoxetine, and placebo. Study 2 (n = 119) assessed three treatment groups over 6 weeks: 2 QD ABT-089 doses (0.7 mg/kg, 1.4 mg/kg) and placebo. The primary efficacy variable was the investigator-administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV: Home Version (ADHD-RS-IV [HV]) Total Score. Safety was assessed by adverse event (AE) monitoring, laboratory tests, vital signs, physical examinations, and electrocardiogram measures. There was no statistically significant difference between ABT-089 and placebo in mean change from baseline to final evaluation of ADHD-RS-IV (HV) Total Score or other outcome measures at any dose in either study. In Study 1, atomoxetine showed statistically significant improvement for the primary and most secondary endpoints. ABT-089 was generally safe and well tolerated, with no statistically significant difference between any ABT-089 dose and placebo in the overall incidence of any specific AE, and no clinically significant changes in other safety measures. ABT-089 did not show efficacy on the primary efficacy variable, the ADHD-RS-IV (HV) Total Score, or other measures of ADHD symptomatology in children with ADHD, and had a safety profile similar to placebo. These results contrast with published reports of efficacy of nicotinic modulators in adults with ADHD. Output: | {'conditions': 'Attention-Deficit/Hyperactivity Disorder', 'interventions': 'Drug: ABT-089|Drug: atomoxetine|Drug: placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Rapid virological response and treatment duration for chronic hepatitis C genotype 1 patients: a randomized trial. Recommended treatment for hepatitis C virus genotype 1 (HCV-1) patients is peginterferon plus ribavirin for 48 weeks. We assessed whether treatment duration of 24 weeks is as effective as standard treatment in HCV-1 patients with a rapid virological response (RVR; seronegative for hepatitis C virus [HCV] RNA at 4 weeks). Two hundred HCV-1 patients were randomized (1:1) to either 24 or 48 weeks of peginterferon-alpha-2a (180 microg/week) and ribavirin (1000-1200 mg/day) with a 24-week follow-up. The primary endpoint was a sustained virological response (SVR; seronegative for HCV RNA at 24-week follow-up). Overall, the 48-week arm had a significantly higher SVR rate (79%) than the 24-week arm (59%, P = 0.002). For 87 (43.5%) patients with an RVR, the 24-week arm had a lower SVR rate [88.9%; 95% confidence interval (CI): 80%-98%] than the 48-week arm (100%, P = 0.056). For 52 patients with low baseline viremia (<400,000 IU/mL) and an RVR, the 24-week arm had rates (CI) of relapse and SVR of 3.6% (-3%-11%) and 96.4% (89%-103%), respectively, which were comparable to those of the 48-week arm (0% and 100%) with difference (CI) of 3.6% (-7.2%-6.6%) and -3.6% (-14.3% to -0.6%), respectively. Multivariate analysis in all patients showed that RVR was the strongest independent factor associated with an SVR, followed by treatment duration, mean weight-based exposure of ribavirin, and baseline viral load. HCV-1 patients derive a significantly better SVR from 48 weeks versus 24 weeks of peginterferon/ribavirin even if they attain an RVR. Both 24 and 48 weeks of therapy can achieve high SVR rates (>96%) in HCV-1 patients with low viral loads and an RVR. Output: | {'conditions': 'Chronic Hepatitis C|Genotype', 'interventions': 'Drug: pegylated interferon alpha 2a and ribavirin|Drug: Pegylated interferon alfa-2a and ribavirin'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Plasma cytokine and angiogenic factor profiling identifies markers associated with tumor shrinkage in early-stage non-small cell lung cancer patients treated with pazopanib. There is an unmet need for pharmacodynamic and predictive biomarkers for antiangiogenic agents. Recent studies have shown that soluble vascular endothelial growth factor receptor 2 (sVEGFR2), VEGF, and several other soluble factors may be modulated by VEGF pathway inhibitors. We conducted a broad profiling of cytokine and angiogenic factors (CAF) to investigate the relationship between baseline CAF levels, CAF changes during treatment, and tumor shrinkage in early-stage non-small cell lung cancer (NSCLC) patients treated with pazopanib, an oral angiogenesis inhibitor targeting VEGFR, platelet-derived growth factor receptor, and c-kit. Plasma samples were collected before treatment and on the last day of therapy from 33 patients with early-stage NSCLC participating in a single-arm phase II trial. Levels of 31 CAFs were measured by suspension bead multiplex assays or ELISA and correlated with change in tumor volume. Pazopanib therapy was associated with significant changes of eight CAFs; sVEGFR2 showed the largest decrease, whereas placental growth factor underwent the largest increase. Increases were also observed in stromal cell-derived factor-1alpha, IP-10, cutaneous T-cell-attracting chemokine, monokine induced by IFN-gamma, tumor necrosis factor-related apoptosis-inducing ligand, and IFN-alpha. Posttreatment changes in plasma sVEGFR2 and interleukin (IL)-4 significantly correlated with tumor shrinkage. Baseline levels of 11 CAFs significantly correlated with tumor shrinkage, with IL-12 showing the strongest association. Using multivariate classification, a baseline CAF signature consisting of hepatocyte growth factor and IL-12 was associated with tumor response to pazopanib and identified responding patients with 81% accuracy. These data suggest that CAF profiling may be useful for identifying patients likely to benefit from pazopanib, and merit further investigation in clinical trials. Output: | {'conditions': 'Non-Small Cell Lung Cancer|Lung Cancer, Non-Small Cell', 'interventions': 'Drug: Pazopanib'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Effects of 20 mg rosuvastatin on VLDL1-, VLDL2-, IDL- and LDL-ApoB kinetics in type 2 diabetes. In addition to its efficacy in reducing LDL-cholesterol, rosuvastatin has been shown to significantly decrease plasma triacylglycerol. The use of rosuvastatin may be beneficial in patients with type 2 diabetes, who usually have increased triacylglycerol levels. However, its effects on the metabolism of triacylglycerol-rich lipoproteins in type 2 diabetic patients remains unknown. We performed a randomised double-blind crossover trial of 6-week treatment with placebo or rosuvastatin 20 mg in eight patients with type 2 diabetes who were being treated with oral glucose-lowering agents. In each patient, an in vivo kinetic study of apolipoprotein B (ApoB)-containing lipoproteins with [13C]leucine was performed at the end of each treatment period. A central randomisation centre used computer-generated tables to allocate treatments. Participants, caregivers and those assessing the outcomes were blinded to group assignment. Rosuvastatin 20 mg significantly reduced plasma LDL-cholesterol, triacylglycerol and total ApoB. It also significantly reduced ApoB pool sizes of larger triacylglycerol-rich VLDL particles (VLDL1; p = 0.011), smaller VLDL particles (VLDL2; p = 0.011), intermediate density lipoprotein (IDL; p = 0.011) and LDL (p = 0.011). This reduction was associated with a significant increase in the total fractional catabolic rate of VLDL1-ApoB (6.70 +/- 3.24 vs 4.52 +/- 2.34 pool/day, p = 0.049), VLDL2-ApoB (8.72 +/- 3.37 vs 5.36 +/- 2.64, p = 0.011), IDL-ApoB (7.06 +/- 1.68 vs 4.21 +/- 1.51, p = 0.011) and LDL-ApoB (1.02 +/- 0.27 vs 0.59 +/- 0.13, p = 0.011). Rosuvastatin did not change the production rates of VLDL2-, IDL- or LDL-, but did reduce VLDL1-ApoB production rate (12.4 +/- 4.5 vs 19.5 +/- 8.4 mg kg(-1) day(-1), p = 0.035). No side effects of rosuvastatin were observed during the study. In type 2 diabetic patients rosuvastatin 20 mg not only induces a significant increase of LDL-ApoB catabolism (73%), but also has favourable effects on the catabolism of triacylglycerol-rich lipoproteins, e.g. a significant increase in the catabolism of VLDL1-ApoB (48%), VLDL2-ApoB (63%) and IDL-ApoB (68%), and a reduction in the production rate of VLDL1-ApoB (-36%). The effects of rosuvastatin on the metabolism of triacylglycerol-rich lipoproteins may be beneficial for prevention of atherosclerosis in type 2 diabetic patients. Output: | {'conditions': 'Diabetes', 'interventions': 'Drug: Rosuvastatin|Drug: Placebo'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Propofol and remifentanil versus midazolam and fentanyl for sedation during therapeutic hypothermia after cardiac arrest: a randomised trial. To compare two protocols for sedation and analgesia during therapeutic hypothermia: midazolam and fentanyl versus propofol and remifentanil. The primary outcome was the time from discontinuation of infusions to extubation or decision not to extubate (offset time). Secondary outcomes were blood pressure, heart rate, use of vasopressors and inotropic drugs, pneumonia and neurological outcome. This was an open, randomised, controlled trial on 59 patients treated with therapeutic hypothermia (33-34 °C for 24 h) after cardiac arrest in two Norwegian university hospitals between April 2008 and May 2009. The intervention was random allocation to sedation and analgesia with propofol/remifentanil or midazolam/fentanyl. Twenty-nine patients received propofol and remifentanil, and 30 midazolam and fentanyl. Baseline characteristics were similar. Sedation and analgesia were stopped in 35 patients, and extubation was performed in 17 of these. Sedation had to be continued for 24 patients. Time to offset was significantly lower in patients given propofol and remifentanil [mean (95 % confidence intervals) 13.2 (2.3-24) vs. 36.8 (28.5-45.1) h, respectively, p < 0.001]. Patients given propofol and remifentanil needed norepinephrine infusions twice as often (23 vs. 12 patients, p = 0.003). Incidence of pneumonia and 3-month neurological outcome were similar in the two groups. Time to offset was significantly shorter in patients treated with propofol and remifentanil. However, the clinical course in 40 % of patients prevented discontinuation of sedation and potential benefits from a faster recovery. The propofol and remifentanil group required norepinephrine twice as often, but both protocols were tolerated in most patients. Output: | {'conditions': 'Hypothermia', 'interventions': 'Drug: remifentanil and propofol|Drug: fentanyl and midazolam'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Expectations about and experiences with insulin therapy contribute to diabetes treatment satisfaction in insulin-naïve patients with type 2 diabetes. The aim of this study was to investigate how patients' expectations about and experiences with insulin therapy contribute to diabetes treatment satisfaction. The Expectations about Insulin Therapy (EAITQ) and the Experience with Insulin Therapy Questionnaires (EWITQ) were administered at baseline and end-point, respectively to insulin-naïve patients with type 2 diabetes in a randomised trial comparing treatment algorithms for inhaled insulin. Pearson correlation coefficients were calculated between EAITQ and EWITQ scores, patient characteristics and patient-reported outcomes measures. Wilcoxon Signed Rank test compared EAITQ and EWITQ item score distributions. Differences between EAITQ and EWITQ scores were calculated to categorize patients according to the extent to which their expectations were met by experiences (i.e. unmet, met, exceeded). EAITQ and EWITQ data were available for 240 patients (61% male, mean age 58 years, mean diabetes duration 10 years, mean baseline HbA(1c) 8.4%). Increasingly positive expectations were significantly associated with greater self-efficacy; greater levels of positive experiences were significantly associated with greater positive expectations, shorter diabetes duration, less symptom distress, greater well-being, self-efficacy and diabetes treatment satisfaction. Overall, patients' experiences with inhaled insulin therapy were significantly more positive than their expectations: 58% patients' experiences exceeded expectations, 29% patients' experiences met expectations and 13% patients' experiences did not meet expectations. Post hoc tests indicated that treatment satisfaction scores differed among these groups (all p < 0.01). Expectations may not independently impact treatment satisfaction, but the relationship with experiences significantly contributes to it. The EAITQ and EWITQ may be useful tools for clinicians to better understand patients' expectations about and experiences with insulin therapy. Output: | {'conditions': 'Diabetes Mellitus, Type 2', 'interventions': 'Drug: simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder|Drug: intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Intraoperative bleeding during vitrectomy for diabetic tractional retinal detachment with versus without preoperative intravitreal bevacizumab (IBeTra study). To compare the amount of intraoperative intraocular bleeding in patients with diabetes with macula-involving tractional retinal detachment (TRD) undergoing pars plana vitrectomy (PPV) with and without preoperative intravitreal bevacizumab (IVB) injection. An institutional study was carried out with consecutive patients with diabetic retinopathy and macula-involving TRD of recent (3 months) onset who were randomly assigned to PPV only (PPV group) or PPV combined with one IVB (1.5 mg/0.06 ml) injection 2 weeks prior to surgery (bevacizumab (BEV)/PPV group). All patients underwent 23-gauge PPV 3 weeks after baseline. The main outcome measure was erythrocyte count in the fluid retrieved from the vitrectomy cassette using a Neubauer counting chamber. The study included 20 patients. The mean erythrocyte count was 14,865x10(3) (SD 19,332x10(3); median 4,500x10(3)) cells in the BEV/PPV group, and 176,240x10(3) (SD 108,375x10(3); median 166,600x10(3)) cells in the PPV group. The mean erythrocyte count was significantly lower in the BEV/PPV group than in the PPV group (p<0.0001). No major adverse events were identified. Preoperative IVB injection was associated with reduced intraocular bleeding during 23-gauge PPV for diabetic macula-involving TRD. Further studies are needed to confirm our preliminary findings. NCT00690768. Output: | {'conditions': 'Diabetic Retinopathy|Retinal Detachment', 'interventions': 'Drug: Bevacizumab|Procedure: pars plana vitrectomy'} |
Your goal is to extract structured information from the user's input that matches the form described below. When extracting information please make sure it matches the type information exactly. Do not add any attributes that do not appear in the schema shown below.
```TypeScript
{ // Information on the clinical trial characteristics from the abstract
conditions: string // The condition or disease being treated in the clinical trial
drug_or_intervention: string // The drug or intervention used in the clinical trial
}
```
Please output the extracted information in JSON format. Do not output anything except for the extracted information. Do not add any clarifying information. Do not add any fields that are not in the schema. If the text contains attributes that do not appear in the schema, please ignore them. All output must be in JSON format and follow the schema specified above. Wrap the JSON in <json> tags.
Input:Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. The frequency of obesity has risen dramatically in recent years but only few safe and effective drugs are currently available. We assessed the effect of liraglutide on bodyweight and tolerability in obese individuals without type 2 diabetes. We did a double-blind, placebo-controlled 20-week trial, with open-label orlistat comparator in 19 sites in Europe. 564 individuals (18-65 years of age, body-mass index 30-40 kg/m2) were randomly assigned, with a telephone or web-based system, to one of four liraglutide doses (1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg, n=90-95) or to placebo (n=98) administered once a day subcutaneously, or orlistat (120 mg, n=95) three times a day orally. All individuals had a 500 kcal per day energy-deficit diet and increased their physical activity throughout the trial, including the 2-week run-in. Weight change analysed by intention to treat was the primary endpoint. An 84-week open-label extension followed. This study is registered with ClinicalTrials.gov, number NCT00422058. Participants on liraglutide lost significantly more weight than did those on placebo (p=0.003 for liraglutide 1.2 mg and p<0.0001 for liraglutide 1.8-3.0 mg) and orlistat (p=0.003 for liraglutide 2.4 mg and p<0.0001 for liraglutide 3.0 mg). Mean weight loss with liraglutide 1.2-3.0 mg was 4.8 kg, 5.5 kg, 6.3 kg, and 7.2 kg compared with 2.8 kg with placebo and 4.1 kg with orlistat, and was 2.1 kg (95% CI 0.6-3.6) to 4.4 kg (2.9-6.0) greater than that with placebo. More individuals (76%, n=70) lost more than 5% weight with liraglutide 3.0 mg that with placebo (30%, n=29) or orlistat (44%, n=42). Liraglutide reduced blood pressure at all doses, and reduced the prevalence of prediabetes (84-96% reduction) with 1.8-3.0 mg per day. Nausea and vomiting occurred more often in individuals on liraglutide than in those on placebo, but adverse events were mainly transient and rarely led to discontinuation of treatment. Liraglutide treatment over 20 weeks is well tolerated, induces weight loss, improves certain obesity-related risk factors, and reduces prediabetes. Novo Nordisk A/S, Bagsvaerd, Denmark. Output: | {'conditions': 'Metabolism and Nutrition Disorder|Obesity', 'interventions': 'Drug: liraglutide|Drug: orlistat|Drug: placebo'} |