TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial Comparing Mindfulness-Based Stress Reduction (MBSR) to Supportive-Expressive Therapy (SET) on Psychological and Biological Outcomes in Breast Cancer Patients
Brief Summary: This study will compare three standard treatment programs commonly offered to patients with breast cancer. The three programs being compared are 1) Mindfulness Meditation-Based Stress Reduction (MBSR), 2)Supportive- Expressive Group Therapy (SET), and 3) A one day stress-management seminar. The purpose of this study is to determine if these three treatments have different effects on psychological well-being, the immune system, and the amount of stress hormones in the bloodstream.


Options:
A: Change in quality of life (T0: before chemotherapy (week 0); T1: in the middle of chemotherapy (i.e. week 4 to 10); T2: three weeks after last cycle of chemotherapy (i.e. week 13 to 20).)
B: Self image and communication(using standardized instruments)
C: Psychological:mood, stress, post-traumatic growth, social support, quality of life, spirituality; Physical:cortisol levels (stress hormone)
D: To evaluate the efficacy of the MBSR(BC) program in improving psychological and physical symptoms, quality of life and measures of immune function and a stress hormone (cortisol) (Baseline, 6 weeks and 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The primary objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are to determine whether DAC HYP is effective in reducing the number of new gadolinium (Gd)-enhancing lesions, reducing the number of new or newly-enlarging T2 hyperintense lesions, reducing the proportion of participants with relapses, and improving quality of life.


Options:
A: Adjusted Annualized Relapse Rate Between Baseline and Week 52 (Baseline through Week 52)
B: Annualized Relapse Rate (ARR) (Baseline up to 2.5 years)
C: ARR - PDEs (Baseline to Month 36)
D: Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24 (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The primary objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are to determine whether DAC HYP is effective in reducing the number of new gadolinium (Gd)-enhancing lesions, reducing the number of new or newly-enlarging T2 hyperintense lesions, reducing the proportion of participants with relapses, and improving quality of life.


Options:
A: Annualized Relapse Rate (2 years)
B: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))
C: Adjusted Annualized Relapse Rate Between Baseline and Week 52 (Baseline through Week 52)
D: Number of new or enlarged gadolinium contrast enhancing lesions (Gd-CELs) on monthly brain MRIs collected between Weeks 8 to 24 in daclizumab- vs. placebo-treated patients

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary: The primary objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are to determine whether DAC HYP is effective in reducing the number of new gadolinium (Gd)-enhancing lesions, reducing the number of new or newly-enlarging T2 hyperintense lesions, reducing the proportion of participants with relapses, and improving quality of life.


Options:
A: Core Treatment Period: Time to Conversion to Clinically Deﬁnite Multiple Sclerosis (CDMS) (Up to a maximum of 108 weeks depending on time of enrollment)
B: Efficacy parameters
C: Number of Participants With Treatment-emergent Adverse Events (AEs) (Up to 72 weeks); Number of Participants With Abnormalities in Vital Signs (Up to Week 72); Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities (Up to 72 Weeks); Number of Participants With Abnormalities in Blood Chemistry Laboratory Data (Up to 72 Weeks); Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline (Up to 72 weeks)
D: Adjusted Annualized Relapse Rate Between Baseline and Week 52 (Baseline through Week 52)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study of Paclitaxel/Carboplatin With or Without Sorafenib in the First-Line Treatment of Patients With Stage III/IV Epithelial Ovarian Cancer
Brief Summary: This trial will compare the efficacy and toxicity of standard first-line chemotherapy alone vs. standard chemotherapy plus sorafenib in patients with stage III/IV ovarian cancer following cytoreductive surgery. Patients with residual large volume disease and/or bowel involvement will be excluded, to minimize the risk of bowel perforation.


Options:
A: 2-year Progression-free Survival (2 years)
B: Event Free Survival (The duration of time from study entry to time to progression or death,or begining a subsequent therapy, whichever occurs first, assessed up to 32 weeks)
C: Progression free survival (30 months)
D: Overall Survival (Up to five years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study of Paclitaxel/Carboplatin With or Without Sorafenib in the First-Line Treatment of Patients With Stage III/IV Epithelial Ovarian Cancer
Brief Summary: This trial will compare the efficacy and toxicity of standard first-line chemotherapy alone vs. standard chemotherapy plus sorafenib in patients with stage III/IV ovarian cancer following cytoreductive surgery. Patients with residual large volume disease and/or bowel involvement will be excluded, to minimize the risk of bowel perforation.


Options:
A: 2-year Progression-free Survival (2 years)
B: Overall Survival (Up to five years)
C: Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.); Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.)
D: Progression-free Survival(PFS) (up to 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet, Obesity and Genes
Brief Summary: Study Title: Diogenes, A randomised controlled trial comparing the effect of reduced-fat diets varying in glycaemic index (high vs. low) and protein content (high vs. normal) on bodyweight in overweight and obese subjects after an initial weight loss.


Options:
A: weight loss at 12 weeks; Fat loss at 12 weeks; Lean mass change at 12 weeks
B: For adults: body weight loss maintenance (6 Month)
C: Change in insulin sensitivity between the two dietary arms (at 3-, 12- and 24 months); Change in BMI z-score between the two dietary groups (3-, 12-, and 24 months)
D: change in adiposity as measured by dual energy x-ray absorptiometry (DEXA).

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet, Obesity and Genes
Brief Summary: Study Title: Diogenes, A randomised controlled trial comparing the effect of reduced-fat diets varying in glycaemic index (high vs. low) and protein content (high vs. normal) on bodyweight in overweight and obese subjects after an initial weight loss.


Options:
A: Number of at risk participants developing GDM during pregnancy
B: Weight loss (6 months)
C: For adults: body weight loss maintenance (6 Month)
D: Carotid Intima Media Thickness (baseline and 12 months); Waist Circumference (baseline and 12 months); High Density Lipoprotein (HDL) (baseline and 12 months); Glucose (baseline and 12 months); Systolic Blood Pressure (baseline and 12 months); Coronary Artery Calcium Score (baseline and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet, Obesity and Genes
Brief Summary: Study Title: Diogenes, A randomised controlled trial comparing the effect of reduced-fat diets varying in glycaemic index (high vs. low) and protein content (high vs. normal) on bodyweight in overweight and obese subjects after an initial weight loss.


Options:
A: Blood pressure (4 months)
B: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)
C: For adults: body weight loss maintenance (6 Month)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet, Obesity and Genes
Brief Summary: Study Title: Diogenes, A randomised controlled trial comparing the effect of reduced-fat diets varying in glycaemic index (high vs. low) and protein content (high vs. normal) on bodyweight in overweight and obese subjects after an initial weight loss.


Options:
A: Body Weight (4 months); Body Weight (7 Months)
B: The primary endpoints of the study will be a set of inter-related biomarkers for hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk. (two 4-week feeding periods (56 days total))
C: weight loss at 12 weeks; Fat loss at 12 weeks; Lean mass change at 12 weeks
D: For adults: body weight loss maintenance (6 Month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet, Obesity and Genes
Brief Summary: Study Title: Diogenes, A randomised controlled trial comparing the effect of reduced-fat diets varying in glycaemic index (high vs. low) and protein content (high vs. normal) on bodyweight in overweight and obese subjects after an initial weight loss.


Options:
A: Parent and child health behaviors (Baseline, 6 months); TV Viewing Time (Baseline, 6 months)
B: Frequency of exclusive and total breastfeeding (First year)
C: For adults: body weight loss maintenance (6 Month)
D: Preventing childhood obesity (Offspring age until six years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet, Obesity and Genes
Brief Summary: Study Title: Diogenes, A randomised controlled trial comparing the effect of reduced-fat diets varying in glycaemic index (high vs. low) and protein content (high vs. normal) on bodyweight in overweight and obese subjects after an initial weight loss.


Options:
A: Change in the prevalence of overweight and obesity (Baseline, Month 9)
B: Change in Body Mass Index (Baseline, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24 months)
C: For adults: body weight loss maintenance (6 Month)
D: Changes in the composite ICH score of adolescents from baseline to year 2 and 4 (2 and 4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Bone/Muscle Changes Following Hip Fracture in Older White Women
Brief Summary: The major goals of this study are:

1. To conduct an intervention development study to evaluate the feasibility of implementing an exercise intervention for reduction losses in bone mineral density, muscle mass, and strength, and clinically relevant aspects of functioning following a hip fracture, and to obtain preliminary tests of the effective ness of these interventions.
2. To evaluate the effect of home-based exercise intervention on bone metabolism.
3. To evaluate the effects of hip fracture on bone metabolism.
4. To evaluate the effects of exercise and hip fracture on hormonal regulators.
5. To evaluate the association between markers of bone metabolism hormone regulators, and BMD.
6. To separate out the effects of hip fracture on bone turnover from those of aging in persons with low bone mineral density.


Options:
A: Knee-extension strength in the fractured limb in comparison with the non-fractured limb. (At inclusion, at postoperative day 10 and/or at discharge.)
B: Change in the performance-based Short physical performance battery (SPPB) (Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery)
C: Lower extremity function (Short Physical Performance Battery (SPPB) (Change from baseline will be assessed at 6 and 12 months)
D: Self-efficacy (2, 6, and 12 months post hip fracture); Exercise behavior and activity (2, 6, and 12 months post hip fracture); Subjective reporting of exercise (2, 6, and 12 months post hip fracture)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Safety, Dose Escalating Study of MultiGeneAngio in Patients With Peripheral Arterial Disease
Brief Summary: The purpose of this study is to evaluate the safety and activity of increasing doses of MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential treatment for patients with peripheral arterial disease.


Options:
A: side effects (3months)
B: Ankle brachial index (6 months); Healing (1 year); Amputation rate (1 year)
C: The safety of MultiGeneAngio will be assessed by monitoring adverse events (Up to 15 years after treatment)
D: Major amputation

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Erythropoietin in Patients With ST-Segment-Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention (REVIVAL-3)
Brief Summary: The purpose of this study is to determine whether erythropoietin is superior to placebo with respect to left ventricular ejection fraction in patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention.


Options:
A: incidence of acute kidney injury (change of renal function including SCr, cystatin C, creatinine clearance from 24 h before operation to postoperative day (POD) 5)
B: Left ventricular ejection fraction measured by magnetic resonance imaging (4-6 months)
C: Combined proportion of unfavourable neurological outcomes at 6 months: severe disability (defined as GOSE scores 2-4) or death (GOSE score 1). (6 months)
D: Neurological/functional outcome as measured by the Barthel Index (BI) (day 90)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Testing a Full Substitution Therapy Approach As Treatment of Tobacco Dependence
Brief Summary: This study will test a new medication strategy designed to help smokers quit. It will combine selegiline, a drug currently approved and available for the treatment of Parkinson's disease, with a nicotine skin patch. Forty nicotine-dependent smokers will enrolled in this study. Twenty will receive placebo (inactive pill) plus nicotine patch, and twenty will receive selegiline plus nicotine patch. Once enrolled in the study, subjects will visit the Nicotine Dependence Clinic at CAMH on a weekly basis for assessment of smoking behavior, a brief health check, collection of breath and urine samples (necessary to drug levels and nicotine levels), and receive brief individual counseling designed to help them stop smoking. The medication phase of this study lasts 9 weeks. A follow-up visit will be conducted six months after trial completion. At that point, health and behavioral measures will be re-assessed.


Options:
A: Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm) (9 weeks)
B: 4-week continuous quit rate (CQR) for Weeks 9-12
C: tobacco abstinence (6 months)
D: biologically verified smoking cessation or reduction (8 weeks and delivery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Testing a Full Substitution Therapy Approach As Treatment of Tobacco Dependence
Brief Summary: This study will test a new medication strategy designed to help smokers quit. It will combine selegiline, a drug currently approved and available for the treatment of Parkinson's disease, with a nicotine skin patch. Forty nicotine-dependent smokers will enrolled in this study. Twenty will receive placebo (inactive pill) plus nicotine patch, and twenty will receive selegiline plus nicotine patch. Once enrolled in the study, subjects will visit the Nicotine Dependence Clinic at CAMH on a weekly basis for assessment of smoking behavior, a brief health check, collection of breath and urine samples (necessary to drug levels and nicotine levels), and receive brief individual counseling designed to help them stop smoking. The medication phase of this study lasts 9 weeks. A follow-up visit will be conducted six months after trial completion. At that point, health and behavioral measures will be re-assessed.


Options:
A: Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm) (9 weeks)
B: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
C: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)
D: Percentage of Participants With 4-week Continuous Abstinence (CA) (Week 9 through Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Testing a Full Substitution Therapy Approach As Treatment of Tobacco Dependence
Brief Summary: This study will test a new medication strategy designed to help smokers quit. It will combine selegiline, a drug currently approved and available for the treatment of Parkinson's disease, with a nicotine skin patch. Forty nicotine-dependent smokers will enrolled in this study. Twenty will receive placebo (inactive pill) plus nicotine patch, and twenty will receive selegiline plus nicotine patch. Once enrolled in the study, subjects will visit the Nicotine Dependence Clinic at CAMH on a weekly basis for assessment of smoking behavior, a brief health check, collection of breath and urine samples (necessary to drug levels and nicotine levels), and receive brief individual counseling designed to help them stop smoking. The medication phase of this study lasts 9 weeks. A follow-up visit will be conducted six months after trial completion. At that point, health and behavioral measures will be re-assessed.


Options:
A: Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm) (9 weeks)
B: 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7
C: Treatment Satisfaction (End of treatment (seven weeks after baseline))
D: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Testing a Full Substitution Therapy Approach As Treatment of Tobacco Dependence
Brief Summary: This study will test a new medication strategy designed to help smokers quit. It will combine selegiline, a drug currently approved and available for the treatment of Parkinson's disease, with a nicotine skin patch. Forty nicotine-dependent smokers will enrolled in this study. Twenty will receive placebo (inactive pill) plus nicotine patch, and twenty will receive selegiline plus nicotine patch. Once enrolled in the study, subjects will visit the Nicotine Dependence Clinic at CAMH on a weekly basis for assessment of smoking behavior, a brief health check, collection of breath and urine samples (necessary to drug levels and nicotine levels), and receive brief individual counseling designed to help them stop smoking. The medication phase of this study lasts 9 weeks. A follow-up visit will be conducted six months after trial completion. At that point, health and behavioral measures will be re-assessed.


Options:
A: Percent Treatment Sessions Attended (52 weeks)
B: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months (6 months)
C: Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm) (9 weeks)
D: Number of Participants With Smoking Abstinence at Month 6 (Month 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Testing a Full Substitution Therapy Approach As Treatment of Tobacco Dependence
Brief Summary: This study will test a new medication strategy designed to help smokers quit. It will combine selegiline, a drug currently approved and available for the treatment of Parkinson's disease, with a nicotine skin patch. Forty nicotine-dependent smokers will enrolled in this study. Twenty will receive placebo (inactive pill) plus nicotine patch, and twenty will receive selegiline plus nicotine patch. Once enrolled in the study, subjects will visit the Nicotine Dependence Clinic at CAMH on a weekly basis for assessment of smoking behavior, a brief health check, collection of breath and urine samples (necessary to drug levels and nicotine levels), and receive brief individual counseling designed to help them stop smoking. The medication phase of this study lasts 9 weeks. A follow-up visit will be conducted six months after trial completion. At that point, health and behavioral measures will be re-assessed.


Options:
A: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
B: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))
C: Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm) (9 weeks)
D: Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 (12 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 (24 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 (52 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 (64 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 (104 weeks following treatment initiation)

Answer: C