TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate ( CP-526,555) in Comparison to Zyban for Smoking Cessation
Brief Summary: The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.


Options:
A: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
B: Smoking Abstinence (3 months); Smoking Abstinence (6 months); Smoking Abstinence (12 months)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
D: Biochemically-validated smoking cessation (middle and late pregnancy)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate ( CP-526,555) in Comparison to Zyban for Smoking Cessation
Brief Summary: The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.


Options:
A: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
D: Prolonged abstinence from all tobacco (3 months and 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate ( CP-526,555) in Comparison to Zyban for Smoking Cessation
Brief Summary: The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.


Options:
A: Quit Rate (4 months)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: Smoking Behavior (2)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate ( CP-526,555) in Comparison to Zyban for Smoking Cessation
Brief Summary: The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.


Options:
A: Treatment Satisfaction (End of treatment (seven weeks after baseline))
B: N/A
C: Rating of urges to smoke 1-week after the target quit (1 week)
D: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate ( CP-526,555) in Comparison to Zyban for Smoking Cessation
Brief Summary: The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.


Options:
A: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
B: Participants Abstinent From Cigarettes (Two years)
C: The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.
D: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate ( CP-526,555) in Comparison to Zyban for Smoking Cessation
Brief Summary: The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.


Options:
A: The Fagerstrom Test for Nicotine Dependence, expired CO level, and urine cotinine will be used to determine if bupropion SR, when used as an adjunct to antipsychotic medication, is superior to placebo for helping patients with schizophrenia improve their (Expired CO weekly, Fagerstrom baseline and end of study, Urine cotinine baseline, week 2 and week 8); Neuropsychological testing will be used to determine the effects of smoking cessation on patient's attention and memory function. (Beginning and end of study)
B: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
D: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Global Phase IV, Double-Blind, Placebo-Controlled, Randomized Trial To Evaluate The Effectiveness Of Detrusitol Sr 4mg On Patient's Perception Of Bladder Condition (PPBC).
Brief Summary: The purpose of this study is to evaluate the effectiveness of Detrusitol (tolterodine tartrate) SR, 4 mg once daily, on patient's perception of the symptoms of overactive bladder and which of these bothersome symptoms are improved with treatment.


Options:
A: Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 (Baseline, Week 12)
B: Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants (Baseline (BL); Week 12); CFB at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants (Baseline; Week 12)
C: Change From Baseline to Week 12 in Bladder Wall Thickness (Baseline and Week 12); Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12 (Week 12)
D: Patient Perception of Bladder Condition at 12 weeks of treatment compared to placebo.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Double-Phase, Randomized, Double-Blind, Placebo Controlled (12-Week Double-Blind Followed by 12-Week Open-Label) Study Evaluating the Effect of Tolterodine ER on Urgency Urinary Incontinence (UUI), Urgency, Frequency, Sexual Quality of Life and Sexual Function in Women With Overactive Bladder
Brief Summary: The purpose of the study is to assess the impact of treatment with tolterodine ER versus placebo on Urgency Urinary Incontinence in sexually active women with OAB symptoms.


Options:
A: Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition (Baseline and Week 12)
B: Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline.
C: Change from baseline in maximum cystometric capacity (4 Weeks)
D: Change in Urge Urinary Incontinence (UUI) Episodes (Baseline through 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Ivabradine on Cardiovascular Events in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction. A Three-year Randomised Double-blind Placebo-controlled International Multicentre Study.
Brief Summary: The aim of this study is to test whether ivabradine is able to reduce cardiovascular events when given to patients with coronary artery disease and impaired heart function.


Options:
A: N/A
B: Change in VO2max measured by CPEX (After 2 weeks of intervention)
C: Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date (Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)); Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated) (Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011))
D: Primary Composite Endpoint (From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome After Symptomatic Proximal Deep Venous Thrombosis
Brief Summary: The purpose of this study is to determine whether elastic compression stockings used for 2 years are effective in preventing the post-thrombotic syndrome in patients with symptomatic proximal deep venous thrombosis.


Options:
A: Number of days alive and out of hospital or emergency department (In 30 days)
B: Incidence of Post-thrombotic Syndrome (PTS) (During 2-year follow up)
C: Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) Through Day 35 (Up to Day 35); Number of Participants With AEs Resulting in Study Intervention Discontinuation Through Day 35 (Up to Day 35); Number of Participants With Serious Adverse Events Through Day 35 (Up to Day 35); Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale Through Day 28 (Up to Day 28)
D: Improvement of Total EKOS Thrombus Score, a specifically developed venographic scoring system (After 15 hours of CDT)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome After Symptomatic Proximal Deep Venous Thrombosis
Brief Summary: The purpose of this study is to determine whether elastic compression stockings used for 2 years are effective in preventing the post-thrombotic syndrome in patients with symptomatic proximal deep venous thrombosis.


Options:
A: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (Between 6 and 24 months after randomization)
B: Patency after 6 months (6 months); Post-thrombotic syndrome after 2 years (yrs) (2 years)
C: Incidence of Post-thrombotic Syndrome (PTS) (During 2-year follow up)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome After Symptomatic Proximal Deep Venous Thrombosis
Brief Summary: The purpose of this study is to determine whether elastic compression stockings used for 2 years are effective in preventing the post-thrombotic syndrome in patients with symptomatic proximal deep venous thrombosis.


Options:
A: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (6- or 12-month study treatment period)
B: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE (For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180))
C: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
D: Incidence of Post-thrombotic Syndrome (PTS) (During 2-year follow up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Safety and Efficacy of Low and High Carbohydrate Diets
Brief Summary: This study will compare the safety and effectiveness of a low carbohydrate diet (Atkins Diet) with a high carbohydrate diet (conventional USDA diet).


Options:
A: Primary Outcome Measures Described Below (December 2011)
B: N/A
C: Weight loss (2 years)
D: Change in Hemoglobin A1C (A1C) (Baseline, 12 weeks and 24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Safety and Efficacy of Low and High Carbohydrate Diets
Brief Summary: This study will compare the safety and effectiveness of a low carbohydrate diet (Atkins Diet) with a high carbohydrate diet (conventional USDA diet).


Options:
A: Weight loss (2 years)
B: Breast Cancer Recurrence (Lifetime)
C: N/A
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Safety and Efficacy of Low and High Carbohydrate Diets
Brief Summary: This study will compare the safety and effectiveness of a low carbohydrate diet (Atkins Diet) with a high carbohydrate diet (conventional USDA diet).


Options:
A: To assess the prevalence and 6-year progression rate of subclinical atherosclerotic disease in a population aged 40-54 years using basic and advanced cardiovascular imaging techniques. (20 years)
B: Change in body weight (measured at Year 2)
C: Triglyceride level, glycated hemoglobin level, fasting plasma glucose (baseline and every 3 months during year 1, every 6 months therafter)
D: Weight loss (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Renin Angiotensin System Blockage-DN (RASS)
Brief Summary: To determine if renin angiotensin medications can prevent or delay the onset of diabetic kidney disease.


Options:
A: To recruit 285 type 1 DM Pts without HTN, diabetic nephropathy, or microalbuminuria into a 5-year study to determine the effect of inhibition RAS with either losartan or enalapril. (5 year); To obtain two percutaneous renal biopsies from each patient, five years apart. (5 year)
B: Basement membrane thickness; Mesangial expansion
C: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
D: Time to the first occurrence of microalbuminuria defined as excretion of greater than 35 mg albumin/g urine creatinine for women and greater than 25 mg albumin/g urine creatinine for men in morning spot urine (Time to the first occurrence)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Renin Angiotensin System Blockage-DN (RASS)
Brief Summary: To determine if renin angiotensin medications can prevent or delay the onset of diabetic kidney disease.


Options:
A: Estimated Percentage of Participants in Blood Pressure Control at Baseline (Baseline); Estimated Percentage of Participants in Blood Pressure Control at 6 Months (6month); Estimated Percentage of Participants in Blood Pressure Control at 12 Months (12 month); Estimated Percentage of Participants in Blood Pressure Control at 18 Months (18 month); Blood Pressure Averages Systolic & Diastolic (Baseline); Blood Pressure Averages Systolic & Diastolic (12-month)
B: To recruit 285 type 1 DM Pts without HTN, diabetic nephropathy, or microalbuminuria into a 5-year study to determine the effect of inhibition RAS with either losartan or enalapril. (5 year); To obtain two percutaneous renal biopsies from each patient, five years apart. (5 year)
C: Cardiovascular mortality (Sept 2010); MI (non fatal) (Sept 2010); Stroke (non fatal) (Sept 2010); Revascularisation (operating procedures) (Sept 2010); Amputations, non traumatic (Sept 2010)
D: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Renin Angiotensin System Blockage-DN (RASS)
Brief Summary: To determine if renin angiotensin medications can prevent or delay the onset of diabetic kidney disease.


Options:
A: The rate of decline of glomerular filtration rate (GFR).GFR is measured at baseline,and at 6,12,18,24,30 and 36 months after randomization
B: To recruit 285 type 1 DM Pts without HTN, diabetic nephropathy, or microalbuminuria into a 5-year study to determine the effect of inhibition RAS with either losartan or enalapril. (5 year); To obtain two percutaneous renal biopsies from each patient, five years apart. (5 year)
C: Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale. (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)
D: Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale (From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week Double-blind, Randomised, Parallel-group, Multi-centre Study Evaluating the Efficacy of Tiotropium Versus Placebo in Patients With Mild COPD, According to Swedish Guidelines (SPIRIMILD)
Brief Summary: To show that treatment with tiotropium inhalation capsules (18 μg q.d.) via HandiHaler® improves lung function in patients with mild COPD according to Swedish guidelines.


Options:
A: Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date (From the date of randomization until date of death due to any cause (average of 2 study years))
B: The primary efficacy endpoint is defined as area under the curve of change in FEV1 from baseline for the time period from pre-dose to 2 hours post dose (AUC0 2hFEV1) after 12 weeks of randomised treatment. (week 12)
C: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
D: Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose (from baseline up to 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-week Double-blind, Randomised, Parallel-group, Multi-centre Study Evaluating the Efficacy of Tiotropium Versus Placebo in Patients With Mild COPD, According to Swedish Guidelines (SPIRIMILD)
Brief Summary: To show that treatment with tiotropium inhalation capsules (18 μg q.d.) via HandiHaler® improves lung function in patients with mild COPD according to Swedish guidelines.


Options:
A: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 (Baseline and Day 337); Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (During actual study treatment period (planned Day 1 to Day 337))
B: The primary efficacy endpoint is defined as area under the curve of change in FEV1 from baseline for the time period from pre-dose to 2 hours post dose (AUC0 2hFEV1) after 12 weeks of randomised treatment. (week 12)
C: Trough FEV1 after 12 weeks of treatment (12 weeks)
D: 90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase (baseline, 96 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Rate of Decline of Lung Function With Tiotropium 18 mcg Inhalation Capsule Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD).
Brief Summary: The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.


Options:
A: Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years); Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years)
B: reduction of number of exacerbations; reduction of number of hospitalisations
C: myeloperoxidase in induced sputum (3 weeks)
D: Mean change in the Leicester Cough Questionnaire (LCQ) scores. (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Rate of Decline of Lung Function With Tiotropium 18 mcg Inhalation Capsule Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD).
Brief Summary: The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.


Options:
A: All cause mortality at 3 years
B: Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years); Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years)
C: Change in trough FEV1 for tiotropium compared to placebo when added to formoterol/budesonide combination (2 weeks)
D: Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint (Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Rate of Decline of Lung Function With Tiotropium 18 mcg Inhalation Capsule Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD).
Brief Summary: The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.


Options:
A: Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years); Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (From day 30 to 4 years)
B: Forced expiratory volume in 1 second (FEV1) (Measured at baseline); Emphysema, as shown on chest CT scan (Measured at baseline); Airway wall thickness on chest CT scan (Measured at baseline); COPD status (COPD participants versus control group participants) (Measured at baseline)
C: Morbidity (Up to end of follow-up (data presented up to 15 years)); Lung Function (Up to end of follow-up (data presented up to 15 years)); Mortality (Up to end of follow-up (data presented up to 15 years))
D: all-cause mortality (one year)

Answer: A