TrialPanorama/Dataset huggingface dataset:
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: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)
C: Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions. (Last 4 weeks of treatment); Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions (First 3 weeks (pretreatment))
D: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)

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: 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)
B: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)
C: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
D: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)

Answer: C
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: Treatment Satisfaction (End of treatment (seven weeks after baseline))
B: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
C: 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)
D: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)

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: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)
B: Tobacco use (Six-month follow-up)
C: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
D: 7 day point prevalence of cigarette abstinence (End of trial (week 10))

Answer: C
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: 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)
B: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
C: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)
D: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)

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: Validated smoking cessation (6 months)
B: Percent Treatment Sessions Attended (52 weeks)
C: Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) (weeks 8-11 after quit date)
D: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period

Answer: D
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 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) (weeks 8-11 after quit date)
B: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
C: Point prevalence abstinence
D: The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.

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: Comparison of Prolonged Abstinence (up to12 weeks post-quit)
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: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
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 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: Continuous smoking abstinence rate (Weeks 9 to 12)
B: Changes in endothelial function between baseline and during medically-aided smoking cessation program. (Baseline, 1 month, 3 months, 6 months and 12 months.)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
D: Continuous abstinence from smoking from week 9 to week 48 without the use of any other smoking cessation treatments other than trials' treatment (from week 9 to week 48)

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: Biochemically validated quit rates (6 weeks after treatment, end of pregnancy)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: 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)
D: Biochemically-validated smoking cessation (middle and late pregnancy)

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: sustained smoking abstinence (during the study)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: Point Prevalence Abstinence (5 month follow-up)
D: 7-Day Point Prevalence Abstinence From Smoking by Intervention (26 weeks after the target quit smoking date); 7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group (26 weeks after the target quit smoking date)

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: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
B: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
D: Change in Carbon Monoxide Level (Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week); Change in Cancer Related Toxin, 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol or NNAL (Baseline, 4 week, 8 week, 13 week, 26 week); Change in the use of e-cigarettes (Baseline, 2 week, 4 week, 6 week, 8 week, 13 week, 26 week)

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 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: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: Treatment Satisfaction (End of treatment (seven weeks after baseline))
D: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26. (26 weeks)

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: Cotinine Level (Baseline, 4 weeks, 8 weeks); Change From Baseline in Cognitive Performance (basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks))
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: 4-week continuous quit rate (CQR) for Weeks 9-12
D: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)

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: Seven-day point prevalence and treatment or treatment strategy (At week 6); Main effects of varenicline and nicotine patch + lozenge on smokers who remain on these medications throughout the trial as documented in questionnaires (Up to 12 weeks); Probability of response at week 12 conditional on response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and treatment switching (At 12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after the initial treatment with nicotine patch + lozenge for six weeks (12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after initial treatment with varenicline for six weeks (12 weeks)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: 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)
D: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months (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: Change in lung function values in smokers without previous respiratory disease (2 years)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: 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)
D: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 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: Biochemically confirmed 7-day point-prevalence abstinence at 6-month (6-month follow-up)
B: Self-reported 7-day Point Prevalence Abstinence (3 months); Self-reported 30 Day Smoking Abstinence (3 months); Self-reported Continuous Abstinence at 3 Months (3 months); Self-reported 7-day Point Prevalence Abstinence (6 months); Self-reported 30-day Point Prevalence Abstinence (6 months); Self-reported Continuous Abstinence (6 months); Self-reported 7-day Point Prevalence Abstinence (12 months); Self-reported 30-day Point Prevalence Abstinence (12 months); Self-reported Continuous Abstinence (12 months); Objective Smoking Abstinence (12 months)
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 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: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
D: 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)

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: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: Survival abstinence rate with maintenance treatment (48 weeks after start of treatment)
D: biologically verified smoking cessation or reduction (8 weeks and delivery)

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: Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) (weeks 8-11 after quit date)
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: Diagnosis of bipolar disorder or related mental illness by direct interview (Diagnosis is established primarily at the initial study visit. Participants who consent to recontact are re-evaluated when they or family informants report events that could lead to a revised diagnosis.)

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: Summarization of safety data in smokers treated with either varenicline or placebo.
B: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
C: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)
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: B