TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twelve-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 MG BID 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 for smoking cessation.


Options:
A: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
B: Anamnestic and biochemical* validated smoking cessation (12 months after inclusion)
C: Body Mass Index (24 months after randomization)
D: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twelve-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 MG BID 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 for smoking cessation.


Options:
A: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
B: Smoking Abstinence (week 7, week 11 and week 24 after scheduled quit day)
C: Primary efficacy and Safety endpoint: (within 12 month from enrollment)
D: Biochemically/pharmacologically-confirmed 12-month continuous abstinence as evidenced by self-reports of nonsmoking status in all interviews (i.e., at 3, 6, and 12 months) (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twelve-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 MG BID 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 for smoking cessation.


Options:
A: Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day) (12 weeks); Sustained Abstinence at the 12-week Follow up (12 weeks); Number of Days of Varenicline Use (12 weeks); Number of Active Smoking Cessation Activities Used (12 weeks)
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: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twelve-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 MG BID 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 for smoking cessation.


Options:
A: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
B: biologically verified smoking cessation or reduction (8 weeks and delivery)
C: Proportion of Cocaine Positive Urine Tests Per Week (Weekly Measures over 12 weeks)
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, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 MG BID 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 for smoking cessation.


Options:
A: Smoking Cessation at 7 days (7-day point prevalence abstinence); Continuous Smoking Abstinence at 6 weeks (6 weeks)
B: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
C: Biochemically/pharmacologically-confirmed 12-month continuous abstinence as evidenced by self-reports of nonsmoking status in all interviews (i.e., at 3, 6, and 12 months) (12 months)
D: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twelve-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 MG BID 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 for smoking cessation.


Options:
A: To assess the continuous abstinence from tobacco smoking at every visit during the last 4 weeks of treatment period, i.e. from week 4 to week 7, through direct inquiry of patients, exhaled carbon monoxide (CO) testing, and plasma cotinine measurements
B: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
C: Smoking Abstinence (3 months); Smoking Abstinence (6 months); Smoking Abstinence (12 months)
D: 7 day point prevalence of cigarette abstinence (End of trial (week 10))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Protocol For a Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Celecoxib (SC-58635) In The Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
Brief Summary: This study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial to compare the efficacy and safety of celecoxib 400mg QD versus placebo in reducing the occurrence of new colorectal adenomas post-polypectomy at Month 13 (Year 1) and Month 37 (Year 3) of study drug administration.


Options:
A: To evaluate the effects of celecoxib in reducing the proportion of subjects with new colorectal adenomas post baseline polypectomy after Month 13 (Year 1) and Month 37 (Year 3) of study drug administration. (3 years)
B: Score on the Cognitive subscale of the Alzheimer's Disease Assessment Scale at 12 months.
C: N/A
D: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time since randomization; follow-up period is 1.5 to 4.4 years); Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) (time since randomization; follow-up period is 1.5 to 4.4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Protocol For a Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Celecoxib (SC-58635) In The Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
Brief Summary: This study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial to compare the efficacy and safety of celecoxib 400mg QD versus placebo in reducing the occurrence of new colorectal adenomas post-polypectomy at Month 13 (Year 1) and Month 37 (Year 3) of study drug administration.


Options:
A: Percentage of subjects with newly detected adenomas, and will be estimated using the life table method for each treatment group (Year 3 (cumulative for year one and year three)); Percentage of patients with adenomas, aspirin use at baseline, and covariates (Year 5)
B: Histologic Regression (Post treatment evaluation was done 14 to 18 weeks after treatment randomization); Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 (Assessed every cycle while on treatment, 30 days after the last cycle of treatment)
C: To evaluate the effects of celecoxib in reducing the proportion of subjects with new colorectal adenomas post baseline polypectomy after Month 13 (Year 1) and Month 37 (Year 3) of study drug administration. (3 years)
D: Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline) (Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3); Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline) (at Month 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: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
B: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)
C: The primary outcome will be measured at 5, 10, 22, and 52 weeks after the target quit date and include: CO confirmed continuous abstinence from 5-10 weeks, 5-22 weeks and 5-52 weeks. (5-10 weeks, 5-22 weeks, and 5-52 weeks post target quit date)
D: Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment (7 days at end of treatment); Number of Participants Experiencing Treatment-emergent Adverse Events (26 weeks (12 weeks of treatment plus full post-treatment follow-up))

Answer: A
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 smoking cessation (middle and late pregnancy)
B: Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) (number of cigarettes/day as assessed at week 24)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
D: Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days (32-34 weeks gestation (Visit 6))

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: Self-Reported 7-Day Point-Prevalence Abstinence (Assessed at 52 weeks after target quit day)
B: Point Prevalence Abstinence (5 month follow-up)
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: smoking cessation (52 weeks)
B: To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. (8 weeks)
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: 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: Smoking Abstinence (3 months); Smoking Abstinence (6 months); Smoking Abstinence (12 months)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
C: Success rates and safety at week 24 in the varenicline vs placebo. Success rates will be defined as the Continuous Quit Rate since last visit. Maintain abstinence during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. (week 24)
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: 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: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
C: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)
D: Number of Participants With Smoking Cessation (12 WEEK)

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: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
B: Smoking Abstinence (12 months)
C: 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)
D: Smoking behavior (after 5 hrs abstinence)

Answer: A
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: Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12 (Week 9 - Week 12)
B: Treatment Satisfaction (End of treatment (seven weeks after baseline))
C: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
D: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.); Estimated NPS AE Rate (%), by Cohort (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.)

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: 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)
B: Number of Participants Who Self-report 7-day Point Prevalence Smoking Abstinence at 6-month Follow-up. (6-month follow-up); Number of Participants Who Self-reported 7-day Point Prevalence Smoking Abstinence as Bioverified by Breath Carbon Monoxide < 4 Parts Per Million. (6-month follow-up)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
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: 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: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
B: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
C: Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. (Mean EEG power [microvolts squared] from at baseline, 3, 24, 45, and 66 days post-quit); Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence (Changes in log withdrawal symptoms from baseline through 66 days of abstinence)
D: Smoking Abstinence (3 months); Smoking Abstinence (6 months); Smoking Abstinence (12 months)

Answer: A
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: Hamilton Depression Rating Scale (Ham-D) (Week 8); Memory Saccadic Positional Error, Degrees (Week 8); Predictive Pursuit Gain (Week 8); Maintenance Pursuit Gain (Week 8); Digit Symbol Test (Week 0, Week 2 and Week 8); Conner's Continuous Performance Test (CPT) Detectability Score (Week 0, Week 2 and Week 8); Antisaccade Error Rates (Week 0, Week 2 and Week 8); P50 (Week 0, Week 2 and Week 8)
B: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
C: Long term abstinence (one year)
D: Biochemically verified 7 day point prevalence abstinence from smoking.

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: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
B: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
C: Biochemically Verified 7-day Point Prevalence Abstinence (End of Treatment (week 24))
D: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)

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: 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: 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 abstinence from all tobacco (3 months and 6 months)
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: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)

Answer: C