TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Brief Summary: To evaluate the efficacy and safety of pregabalin administered twice a day compared to placebo in reducing pain in subjects with painful diabetic peripheral neuropathy.


Options:
A: Change from baseline in disease-specific functional outcome between active burst stimulation and placebo stimulation periods (12 months)
B: The difference of Visual-analogue scale (VAS) between the experimental group and the control group (13 weeks)
C: Mean VAS Back Pain (7 Day Subject VAS Pain Diary) (6 months post randomisation)
D: The primary efficacy parameter is the endpoint End of Week 12 weekly mean pain score derived from the pain diary.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Parallel Group, Double-blind, Placebo-controlled Flexible Dose Study With and Open-label Extension to Assess the Efficacy and Safety of Viagra (Sildenafil Citrate) in the Treatment of Men With Erectile Dysfunction (ED) and Concomitant Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) in the United States
Brief Summary: The purpose of this study is to determine whether Viagra is effective in treating erectile dysfunction and lower urinary tract symptoms in men affected by both conditions.


Options:
A: Change From Baseline to 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone (Baseline, Week 8)
B: Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo
C: Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks (Baseline, 12 weeks)
D: Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks (Baseline, 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
Brief Summary: The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.


Options:
A: Smoking abstinence (one year)
B: Continuous abstinence Weeks 13 -24.
C: 52-Week Point-Prevalence Abstinence (Assessed 52 weeks after quit date)
D: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale (24 hours and 7 days after quit date (week 4))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
Brief Summary: The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.


Options:
A: evaluate the abstinence of tobacco consumption (12 months)
B: Continuous abstinence Weeks 13 -24.
C: Participant smoking status. (6 and 12 month follow-up)
D: Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group (76 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
Brief Summary: The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.


Options:
A: verified abstinence 6 months (6 months)
B: Continuous abstinence Weeks 13 -24.
C: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
D: Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 (7-day point prevalence)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
Brief Summary: The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.


Options:
A: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))
B: Percent Compliance With Chantix (Months 1, 2, 3)
C: Continuous abstinence Weeks 13 -24.
D: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
Brief Summary: The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.


Options:
A: Change in Smoking Behavior (Change in cigarettes per day from Week 2 to Week 5)
B: Continuous abstinence Weeks 13 -24.
C: 7-day Point Prevalence All Tobacco Abstinence (12 weeks - end of treatment)
D: Long term abstinence (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
Brief Summary: The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.


Options:
A: Continuous abstinence Weeks 13 -24.
B: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)
C: Cigarette use (8 weeks)
D: Tobacco use abstinence (26 week)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
Brief Summary: The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.


Options:
A: 7-Day Point Prevalence Smoking Abstinence (24 weeks); Continuous Smoking Abstinence (24 weeks)
B: Continuous abstinence Weeks 13 -24.
C: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
D: 4-week continuous quit rate (CQR) for Weeks 9-12

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
Brief Summary: The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.


Options:
A: Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group (76 weeks)
B: Participant smoking status. (6 and 12 month follow-up)
C: Continuous abstinence Weeks 13 -24.
D: Percentage of Participants With 30-day Abstinence (6-months post enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
Brief Summary: The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.


Options:
A: Continuous abstinence Weeks 13 -24.
B: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))
C: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
D: Biochemically verified 7 day point prevalence abstinence from smoking.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
Brief Summary: The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.


Options:
A: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
B: Continuous abstinence Weeks 13 -24.
C: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)
D: Summarization of safety data in smokers treated with either varenicline or placebo.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
Brief Summary: The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.


Options:
A: Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement (6 months)
B: 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)
C: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)
D: Continuous abstinence Weeks 13 -24.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
Brief Summary: The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.


Options:
A: Biochemically verified 7 day point prevalence abstinence from smoking.
B: Number of smokers referred to tobacco cessation website (12 months)
C: Continuous abstinence Weeks 13 -24.
D: To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
Brief Summary: The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.


Options:
A: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months (6 months)
B: Point prevalence of smoking cessation (those who have quitted smoking and have not smoked in the past week prior to the assessment date). (52 weeks after starting the treatment)
C: Continuous abstinence Weeks 13 -24.
D: Long term abstinence (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety of Varenicline Tartrate ( CP-526,555) for Smoking Cessation
Brief Summary: The primary purpose of this study is to obtain safety information on cigarette smokers treated with 52 weeks of varenicline regardless of smoking status.


Options:
A: Summarization of safety data in smokers treated with either varenicline or placebo.
B: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)
C: Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26 (Change from Baseline to Week 26)
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: A 52-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety of Varenicline Tartrate ( CP-526,555) for Smoking Cessation
Brief Summary: The primary purpose of this study is to obtain safety information on cigarette smokers treated with 52 weeks of varenicline regardless of smoking status.


Options:
A: Summarization of safety data in smokers treated with either varenicline or placebo.
B: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety of Varenicline Tartrate ( CP-526,555) for Smoking Cessation
Brief Summary: The primary purpose of this study is to obtain safety information on cigarette smokers treated with 52 weeks of varenicline regardless of smoking status.


Options:
A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Baseline up to 30 days after last dose of study treatment or up to Week 16); Number of Participants With Psychiatric Adverse Events (Baseline up to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS) (Baseline to Week 12); Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS) (Baseline to Week 24); Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase (Week 1 to Week 12 (Treatment phase)); Number of Participants With Suicidal Behavior or Suicical Ideation ("Yes" Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase (Week 13 to Week 24 (Post treatment phase)); Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline (Bsl) to Week 12); Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline to Week 24); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1 (Baseline, Week 1); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12 (Baseline, Week 12); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24 (Baseline, Week 24)
B: Summarization of safety data in smokers treated with either varenicline or placebo.
C: Continuous abstinence Weeks 13 -24.
D: Determine the efficacy of combined therapy (VRN+nicotine patches) versus monotherapy (VRN+placebo patches) in smoking cessation assessed as continuous abstinence rate (CAR) from week 2 to week 12. (Participants will be followed for the duration of treatment, 12 weeks.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety of Varenicline Tartrate ( CP-526,555) for Smoking Cessation
Brief Summary: The primary purpose of this study is to obtain safety information on cigarette smokers treated with 52 weeks of varenicline regardless of smoking status.


Options:
A: Summarization of safety data in smokers treated with either varenicline or placebo.
B: Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events (During all the study)
C: Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events (During all the study)
D: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Multicenter Study With Follow-Up Evaluating the Safety and Efficacy of Varenicline Tartrate in Comparison to Transdermal Nicotine Patch for Smoking Cessation
Brief Summary: Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation.


Options:
A: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
B: Change in smoking status over time (At 12, 26, and 52 weeks following start of treatment)
C: Change From Baseline Smoking Abstinence Rates at 12 Weeks (12 weeks)
D: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Baseline up to 30 days after last dose of study treatment or up to Week 16); Number of Participants With Psychiatric Adverse Events (Baseline up to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS) (Baseline to Week 12); Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS) (Baseline to Week 24); Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase (Week 1 to Week 12 (Treatment phase)); Number of Participants With Suicidal Behavior or Suicical Ideation ("Yes" Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase (Week 13 to Week 24 (Post treatment phase)); Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline (Bsl) to Week 12); Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline to Week 24); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1 (Baseline, Week 1); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12 (Baseline, Week 12); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24 (Baseline, Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Multicenter Study With Follow-Up Evaluating the Safety and Efficacy of Varenicline Tartrate in Comparison to Transdermal Nicotine Patch for Smoking Cessation
Brief Summary: Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation.


Options:
A: Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)
B: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
C: Continuous Nicotine Abstinence (8 weeks)
D: effectiveness (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Multicenter Study With Follow-Up Evaluating the Safety and Efficacy of Varenicline Tartrate in Comparison to Transdermal Nicotine Patch for Smoking Cessation
Brief Summary: Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch 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: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
C: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (12 weeks)
D: N/A

Answer: B