TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Middle-School Based Primary Prevention Trial (HEALTHY)
Brief Summary: HEALTHY was a primary prevention trial conducted in 42 middle schools at 7 locations across the US to impact risk factors for type 2 diabetes in adolescents. Students were recruited at start of 6th grade (fall 2006) and followed to end of 8th grade (spring 2009). Half of the schools were randomized to receive an intervention that integrated four components: the school nutrition environment, physical education class activities, behavior change initiatives, and educational and promotional communications activities.


Options:
A: MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET) (Post-2 year intervention); MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET) (Post-3 year intervention)
B: Body mass index (BMI) >= 85th percentile, adjusted for gender and age (baseline, end of 7th grade, end of study); Fasting glucose (mg/dL) (baseline, end of study); Fasting insulin (mU/mL) (baseline, end of study)
C: Changes in the composite ICH score of adolescents from baseline to year 2 and 4 (2 and 4 years)
D: Students' BMI change immediately after the intervention completion (at end of the 8-month intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Middle-School Based Primary Prevention Trial (HEALTHY)
Brief Summary: HEALTHY was a primary prevention trial conducted in 42 middle schools at 7 locations across the US to impact risk factors for type 2 diabetes in adolescents. Students were recruited at start of 6th grade (fall 2006) and followed to end of 8th grade (spring 2009). Half of the schools were randomized to receive an intervention that integrated four components: the school nutrition environment, physical education class activities, behavior change initiatives, and educational and promotional communications activities.


Options:
A: Body fat (At the end of the intervention and at a six month follow-up)
B: Overweight (one school year)
C: Body mass index (BMI) >= 85th percentile, adjusted for gender and age (baseline, end of 7th grade, end of study); Fasting glucose (mg/dL) (baseline, end of study); Fasting insulin (mU/mL) (baseline, end of study)
D: Sales ($) of kids' menu items (weekly throughout study period (4 wk baseline, 8 wk Ix phase, 4 week post-ix))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Middle-School Based Primary Prevention Trial (HEALTHY)
Brief Summary: HEALTHY was a primary prevention trial conducted in 42 middle schools at 7 locations across the US to impact risk factors for type 2 diabetes in adolescents. Students were recruited at start of 6th grade (fall 2006) and followed to end of 8th grade (spring 2009). Half of the schools were randomized to receive an intervention that integrated four components: the school nutrition environment, physical education class activities, behavior change initiatives, and educational and promotional communications activities.


Options:
A: Body mass index (BMI) >= 85th percentile, adjusted for gender and age (baseline, end of 7th grade, end of study); Fasting glucose (mg/dL) (baseline, end of study); Fasting insulin (mU/mL) (baseline, end of study)
B: Intake of nutrients; Serum lipid and lipoprotein concentrations; Growth and development; Smoking; Physical activity level and fitness; Intima-media thickness of arteries and rate of NO-induced vasodilatation
C: To test the role of European genetic admixture on measures of insulin action and response in a multiethnic group of prepubertal children. (5 years); To investigate whether the impact of energy intake, energy expenditure and socioeconomic status on proxy measures of insulin sensitivity and/or action differ as a function of European ADM in prepubertal children (5 years); To test phenotype-genotype associations between each one of the AIMs and measures of FI, SI and AIRg after adjusting for body composition in a sample of AA, HA and EA prepubertal children. (5 years)
D: changes in body mass index throughout the intervention

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Middle-School Based Primary Prevention Trial (HEALTHY)
Brief Summary: HEALTHY was a primary prevention trial conducted in 42 middle schools at 7 locations across the US to impact risk factors for type 2 diabetes in adolescents. Students were recruited at start of 6th grade (fall 2006) and followed to end of 8th grade (spring 2009). Half of the schools were randomized to receive an intervention that integrated four components: the school nutrition environment, physical education class activities, behavior change initiatives, and educational and promotional communications activities.


Options:
A: standardized body mass index (zbmi)
B: Body mass index (BMI) >= 85th percentile, adjusted for gender and age (baseline, end of 7th grade, end of study); Fasting glucose (mg/dL) (baseline, end of study); Fasting insulin (mU/mL) (baseline, end of study)
C: Improvement of maximal oxygen uptake
D: BMI and aerobic fitness (1 schoolyear)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Middle-School Based Primary Prevention Trial (HEALTHY)
Brief Summary: HEALTHY was a primary prevention trial conducted in 42 middle schools at 7 locations across the US to impact risk factors for type 2 diabetes in adolescents. Students were recruited at start of 6th grade (fall 2006) and followed to end of 8th grade (spring 2009). Half of the schools were randomized to receive an intervention that integrated four components: the school nutrition environment, physical education class activities, behavior change initiatives, and educational and promotional communications activities.


Options:
A: Body mass index (BMI) >= 85th percentile, adjusted for gender and age (baseline, end of 7th grade, end of study); Fasting glucose (mg/dL) (baseline, end of study); Fasting insulin (mU/mL) (baseline, end of study)
B: Event-related brain potentials (Change from baseline, 36-40 weeks); Task Performance (Change from baseline, 36-40 weeks); Academic Achievement (Change from baseline, 36-40 weeks)
C: Change in BMI Percentile (baseline and 12 months)
D: Body Mass Index (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Middle-School Based Primary Prevention Trial (HEALTHY)
Brief Summary: HEALTHY was a primary prevention trial conducted in 42 middle schools at 7 locations across the US to impact risk factors for type 2 diabetes in adolescents. Students were recruited at start of 6th grade (fall 2006) and followed to end of 8th grade (spring 2009). Half of the schools were randomized to receive an intervention that integrated four components: the school nutrition environment, physical education class activities, behavior change initiatives, and educational and promotional communications activities.


Options:
A: Intake of nutrients; Serum lipid and lipoprotein concentrations; Growth and development; Smoking; Physical activity level and fitness; Intima-media thickness of arteries and rate of NO-induced vasodilatation
B: Body mass index (BMI) >= 85th percentile, adjusted for gender and age (baseline, end of 7th grade, end of study); Fasting glucose (mg/dL) (baseline, end of study); Fasting insulin (mU/mL) (baseline, end of study)
C: changes in body mass index throughout the intervention
D: To test the role of European genetic admixture on measures of insulin action and response in a multiethnic group of prepubertal children. (5 years); To investigate whether the impact of energy intake, energy expenditure and socioeconomic status on proxy measures of insulin sensitivity and/or action differ as a function of European ADM in prepubertal children (5 years); To test phenotype-genotype associations between each one of the AIMs and measures of FI, SI and AIRg after adjusting for body composition in a sample of AA, HA and EA prepubertal children. (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Middle-School Based Primary Prevention Trial (HEALTHY)
Brief Summary: HEALTHY was a primary prevention trial conducted in 42 middle schools at 7 locations across the US to impact risk factors for type 2 diabetes in adolescents. Students were recruited at start of 6th grade (fall 2006) and followed to end of 8th grade (spring 2009). Half of the schools were randomized to receive an intervention that integrated four components: the school nutrition environment, physical education class activities, behavior change initiatives, and educational and promotional communications activities.


Options:
A: Our outcome measure was reduction of screen time (4 waves of data)
B: % Body Fat (Boys) (Baseline and 3 years); BMI Z-score (Boys) (Baseline and three years); % Body Fat (Girls) (Baseline and 3 years); BMI Z-score (Girls) (Baseline and three years)
C: Body mass index (BMI) >= 85th percentile, adjusted for gender and age (baseline, end of 7th grade, end of study); Fasting glucose (mg/dL) (baseline, end of study); Fasting insulin (mU/mL) (baseline, end of study)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of Tezosentan in Patients With Pre-operative Pulmonary Hypertension, Due to Left Heart Disease, Undergoing Cardiac Surgery
Brief Summary: Endothelin-1 is a powerful substance that may be involved in causing hemodynamic instability (problems related to unstable blood pressure) during and after open heart surgery. Tezosentan is an investigational intravenous drug that blocks the endothelin receptors. This clinical trial will assess the potential benefit of tezosentan compared with placebo in the treatment of patients undergoing open heart surgery with cardiopulmonary bypass (CPB). Treatment time is from the start of surgery up to 24 hours.


Options:
A: The primary objective of this trial is to demonstrate that tezosentan, a dual ERA, reduces the incidence of clinically relevant right ventricular failure in patients with pre-operative pulmonary hypertension, due to left heart disease, undergoing CPB. (During weaning from CPB)
B: Change from Baseline to Week 16 in 6-Minute Walk Test distance (Week 16); Change from Baseline to Week 16 in Pulmonary Vascular Resistance at rest (Week 16)
C: Improvement in six minute walk distance (16 weeks)
D: Change From Baseline to Week 16 in Exercise Capacity, as Measured by 6-minute Walk Distance (6MWD) (From baseline to Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis
Brief Summary: In some participants with cystic fibrosis (CF), the disease is caused by a nonsense mutation (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator (CFTR) protein. Ataluren has been shown to partially restore CFTR production in animals with CF due to a nonsense mutation. The main purpose of this study is to understand whether ataluren can safely increase functional CFTR protein in the cells of participants with CF due to a nonsense mutation.


Options:
A: Change From Baseline in Total Chloride Transport at Day 14 of Cycles 1 and 2 (Baseline of Cycle 1 and Cycle 2, Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days)); Number of Participants With a Chloride Transport Response at Day 14 of Cycles 1 and 2 (Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days)); Number of Participants With Normalization of Chloride Transport Between Baseline and Day 14 of Cycles 1 and 2 (Overall Baseline and Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days))
B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) in Ivacaftor Arm (Day 1 up to Week 108 (Study 112))
C: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24 (Baseline, Week 24)
D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24 (baseline through 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis
Brief Summary: In some participants with cystic fibrosis (CF), the disease is caused by a nonsense mutation (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator (CFTR) protein. Ataluren has been shown to partially restore CFTR production in animals with CF due to a nonsense mutation. The main purpose of this study is to understand whether ataluren can safely increase functional CFTR protein in the cells of participants with CF due to a nonsense mutation.


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8 (Baseline, Week 4 and Week 8 of each treatment period)
C: Part A: Observed Plasma Concentration of Lumacaftor (LUM) and Ivacaftor (IVA) at Hour 4 Post-dose (C4h) on Day 1 (4 hours post-morning dose on Day 1); Part A: Observed Plasma Concentration of Lumacaftor (LUM) and Ivacaftor (IVA) at Hour 4 Post-dose (C4h) on Day 14 (4 hours post-morning dose on Day 14); Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to End of Dosing Interval (AUCtau) of Lumacaftor (LUM) and Ivacaftor (IVA) (Day 14 (pre-morning dose, 4, 6, 12, and 24 hours post-morning dose for LUM; pre-morning dose, 2, 4, 6, 12 hours post-morning dose for IVA)); Part B: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 26)
D: Change From Baseline in Total Chloride Transport at Day 14 of Cycles 1 and 2 (Baseline of Cycle 1 and Cycle 2, Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days)); Number of Participants With a Chloride Transport Response at Day 14 of Cycles 1 and 2 (Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days)); Number of Participants With Normalization of Chloride Transport Between Baseline and Day 14 of Cycles 1 and 2 (Overall Baseline and Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis
Brief Summary: In some participants with cystic fibrosis (CF), the disease is caused by a nonsense mutation (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator (CFTR) protein. Ataluren has been shown to partially restore CFTR production in animals with CF due to a nonsense mutation. The main purpose of this study is to understand whether ataluren can safely increase functional CFTR protein in the cells of participants with CF due to a nonsense mutation.


Options:
A: Change From Baseline in Total Chloride Transport at Day 14 of Cycles 1 and 2 (Baseline of Cycle 1 and Cycle 2, Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days)); Number of Participants With a Chloride Transport Response at Day 14 of Cycles 1 and 2 (Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days)); Number of Participants With Normalization of Chloride Transport Between Baseline and Day 14 of Cycles 1 and 2 (Overall Baseline and Day 14 of Cycle 1 and Cycle 2 (1 cycle=28 days))
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: Percentage of Predicted Function (Percent-Predicted) of Forced Expiratory Volume in One Second (FEV1) at Baseline (Baseline (Week 1)); Percentage Change From Baseline in Percent-Predicted of FEV1 at Week 48 (End of Treatment (EOT) (Week 48))
D: Change From Baseline to End of Treatment in Total Chloride Transport (Baseline of Cycle 1 and Cycle 2, Day 14 and Day 28 of Cycle 1 and Cycle 2 (1 cycle=28 days)); Number of Participants With a Chloride Transport Response (Baseline of Cycle 1 and Cycle 2 and Day 28 of Cycle 1 and Cycle 2 (1 cycle=28 days)); Number of Participants With a Chloride Transport Normalization Between Baseline and End of Treatment (Baseline of Cycle 1 and Cycle 2 and Day 28 of Cycle 1 and Cycle 2 (1 cycle=28 days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Chemoprophylaxis for HIV Prevention in Men
Brief Summary: The purpose of this study is to determine whether daily use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) can prevent HIV infection in men who also receive HIV counseling, condoms, and treatment for other sexually transmitted infections (STIs).


Options:
A: HIV Seroconversion (Monthly follow-up through a median of 1.2 years); Grade 1 or Higher Creatinine Toxicity (Duration of follow-up, median 1.2 years); Grade 3 or Higher Phosphorous Toxicity (The entire follow-up period, median 1.2 years); Grade 2, 3, or 4 Laboratory Adverse Events (Entire follow-up, median 1.2 years); Grade 2, 3, or 4 Clinical Adverse Events (Entire follow-up, median 1.2 years)
B: Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants (Up to 36 months); Number of Participants With Serious Adverse Events (SAEs) (Up to 36 months)
C: Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study); All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study)
D: HIV Infection (Cumulative HIV infection between enrollment and 52 weeks); Confirmed Grade 2 or Higher Serum Creatinine Toxicity (cumulative toxicity through 52 weeks of product use and 4 weeks post product); Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration (10-26 months per site); Confirmed Grade 3 or Higher Reduction in Phosphorus (Through 52 weeks on product and 4 weeks post-product); Confirmed Grade 3 or Higher ALT Elevation (Through 52 weeks on product and 4 weeks post-product); Confirmed Grade 3 or Higher AST Elevation (Through 52 weeks on product and 4 weeks post-product)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Country, Double-Blind, Randomized, 2-Arm, Parallel-Group Study, Evaluating Efficacy and Safety of Rimonabant 20 mg OD, With/Without Association of Nicotine Patch, as Aid to Smoking Cessation During 9-Week Period
Brief Summary: The primary objective is to compare the efficacy of rimonabant 20 mg OD fixed dose plus nicotine patch 21 mg OD with the combination rimonabant 20 mg OD fixed dose plus placebo patch on abstinence from smoking in cigarette smokers motivated to quit.

Secondary objectives are to evaluate the clinical and biological safety of rimonabant associated with nicotine replacement therapy during a 9-week treatment period and to evaluate the effect of the combination on weight and craving.


Options:
A: Continuous and complete smoking abstinence of the pregnant women from the first administration of nicotine/placebo patch until delivery. (from the first administration of nicotine/placebo patch until delivery)
B: Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) measurements
C: Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events (During all the study)
D: The daily number of intakes during the first three weeks recorded with an electronic device fixed on the spray unit (microswitch-actuated metered-dose inhaler chronology, MDILog™, model MDC-511, Medtrac, Denver, Colorado). (first 3 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Red Cell Storage Duration and Outcomes in Cardiac Surgery
Brief Summary: The purpose of this study is to determine whether length of storage of RBC is related to postoperative morbid outcomes in patients undergoing cardiac surgery.


Options:
A: Mortality at Day 90 (90 Day)
B: Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery. (30 days post surgery.); Effect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure Events (30 days post surgery); Effect of RBC Age on Occurrence of Neurologic Events (30 days post surgery.); Effect of RBC Age on Occurrence of Pulmonary Events. (30 days post surgery.); Effect of RBC Age on Occurrence of Renal Failure (30 days post surgery.); Effect of RBC Age on Occurrence of Infection Events (30 days post surgery.); Effect of RBC Age on Occurrence of Atrial Fibrillation (30 days post surgery.); Effect of RBC Age on Occurrence of Asystole (30 days post surgery.); Effect of RBC Age on Occurrence of Gastrointestinal Events (30 days post surgery.); Effect of RBC Age on Occurrence of Any Reoperation (30 days post surgery.); Effect of RBC Age on Occurrence of Vascular Events (30 days post surgery.)
C: 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality (2 weeks, 4 weeks, 12 weeks, 90 days)
D: Microcirculatory Flow Index (MFI) before and after blood transfusion. (One hour after the end of blood transfusion compared with before blood transfusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: PEARL Intervention to Reduce Depression Among Adults With Epilepsy
Brief Summary: The purpose of this study is to test the effectiveness of a home-based depression treatment intervention called "Program to Encourage Active, Rewarding Lives (PEARL)". We hypothesize that over a 12-month period, compared to usual care, those receiving the PEARL intervention will show more improvement with their depression, have higher quality of life and function, and use fewer medical services.


Options:
A: The primary outcome is defined by the number of patients free from clinically relevant adverse treatment events and/or drug interactions in each treatment arm at end of study. (6 months)
B: Severity of depressive symptoms, measured by Patient Health Questionnaire - 9 items (PHQ-9) (Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline))
C: Mean SCL-20 depression scores (6 & 12 months post-baseline); Depression treatment response, defined as greater than 50% decrease in SCL-20 score from baseline (6 & 12 months post-baseline); Complete depression remission defined as SCL-20 score less than 0.5. (6 & 12 months post-baseline)
D: Severity of depressive symptoms (7 Days)

Answer: C