TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Zyban as an Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome: The ZESCA Trial
Brief Summary: Patients who continue to smoke after a heart attack have a 35% increased risk of a recurrent event or death compared with those who quit. Many patients attempt to stop smoking after a heart attack, but relapse rates approach 66%. A variety of smoking cessation aids have been shown to be effective for the general population. However, bupropion is the only non-nicotine replacement therapy shown to improve abstinence rates in healthy young smokers. Furthermore, nicotine replacement therapies (NRTs) are contraindicated in the immediate period following a heart attack because of the undesirable effects of nicotine. Although bupropion has been successfully used to reduce smoking rates in healthy young populations, its efficacy and safety in the setting of patients recovering from an ACS is unknown. These patients, if they continue to smoke, are at exceptionally high risk for recurrent cardiac events. If bupropion is effective in this population, it will have a major impact on secondary prevention of recurrent clinical events in patients who suffer a heart attack.


Options:
A: Negative Affect (1-week Post-Intervention Smoking Context); Negative Affect/Withdrawal (1-week Post-Intervention Smoking Context); N-Back Task (1-week Post-Intervention Smoking Context); Spatial Span (1-week Post-Intervention Smoking Context); Digit Span (1-week Post-Intervention Smoking Context); Anxiety Sensitivity (1-week Post-Intervention Smoking Context); Mirror-Tracing Persistence Task (1-week Post-Intervention Smoking Context); Negative Affect (1week+2days Post-Intervention Deprivation Context); Negative Affect/Withdrawal (1week+2days Post-Intervention Deprivation Context); N-Back Task (1week+2days Post-Intervention Deprivation Contex); Spatial Span (1week+2days Post-Intervention Deprivation Contex); Digit Span (1week+2days Post-Intervention Deprivation Context); Anxiety Sensitivity (1week+2days Post-Intervention Deprivation Contex); Mirror-Tracing Persistence Task (1week+2days Post-Intervention Deprivation Context)
B: 30-day Point Prevalence Abstinence, Complete-case (12 months post randomization)
C: Smoking Abstinence (12 months)
D: Number of Participants With Smoking Abstinence (4 weeks post quit day (one week following the end of treatment)); Smoking Abstinence (26 weeks post quit day); Smoking Abstinence (4 weeks post quit day (one week following the end of treatment))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Placebo-controlled, Randomised Study of the Efficacy of an HPV-16/18 VLP Vaccine in the Prevention of HPV-16 and/or HPV-18 Cervical Infection in Healthy Adolescent and Young Adult Women in North America and Brazil.
Brief Summary: The purpose of this phase IIB MedImmune-sponsored study was to evaluate the efficacy of the HPV-16/18 VLP vaccine in the prevention of infection with HPV-16 and/or HPV-18 in adolescent and young adult women. A vaccine that prevents, or even reduces, the incidence of the common types of high-risk HPVs, particularly HPV-16 and HPV-18, could result in significant reduction in the incidence of cervical cancer and cancer-related mortality, as well as a reduction in the incidence of surgical procedures following abnormal Pap smears.


Options:
A: Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Base Study (Up to 4 years); Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Long-term Follow-up (LTFU) Study (Up to 14 years since Vaccine Dose 1); Incidence of the Composite Endpoint of HPV16/18-related CIN 2 or Worse in the Long-term Follow-up (LTFU) Study (up to 22 years post Vaccination Dose 1)
B: Geometric mean titers (GMTs) to HPV types contained in the administered vaccines (4 weeks post dose 3)
C: Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. (Up to Month 48); Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). (Up to Month 48); Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. (Up to Month 84); Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). (Up to Month 84)
D: Cervical infection with HPV-16 and/or HPV-18 (Throughout the study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Open-label, 3-arm Study to Determine the Efficacy and Safety of Lenalidomide(REVLIMID) Plus Low-dose Dexamethasone When Given Until Progressive Disease or for 18 Four-week Cycles Versus the Combination of Melphalan, Prednisone, and Thalidomide Given for 12 Six-week Cycles in Patients With Previously Untreated Multiple Myeloma Who Are Either 65 Years of Age or Older or Not Candidates for Stem Cell Transplantation.
Brief Summary: The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.


Options:
A: Response Rate; Progression Free Survival; Event Free Survival
B: Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC) (From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months.); Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis (From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months)
C: Overall survival
D: The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: San Diego Bleeding Esophageal Varices Study
Brief Summary: In unselected cirrhotic patients with bleeding esophageal varices to compare the influence on mortality rate, duration of life, quality of life, and economic costs of treatment of:

* Emergency portacaval shunt, and
* Emergency and long-term endoscopic sclerotherapy.


Options:
A: Combined: bleeding + absence of severe adverse events + survival (15 days)
B: Number of sessions to complete variceal obliteration (1 year)
C: Survival (10 years)
D: Treatment failure (5 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: San Diego Bleeding Esophageal Varices Study
Brief Summary: In unselected cirrhotic patients with bleeding esophageal varices to compare the influence on mortality rate, duration of life, quality of life, and economic costs of treatment of:

* Emergency portacaval shunt, and
* Emergency and long-term endoscopic sclerotherapy.


Options:
A: Recurrence of variceal bleeding and patient survival (12 months)
B: Number of participants with variceal rebleeding (4 years)
C: recurrence rate of variceal hemorrhage (Participants will be followed for up to 6 months starting from the date of randomization.)
D: Survival (10 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: San Diego Bleeding Esophageal Varices Study
Brief Summary: In unselected cirrhotic patients with bleeding esophageal varices to compare the influence on mortality rate, duration of life, quality of life, and economic costs of treatment of:

* Emergency portacaval shunt, and
* Emergency and long-term endoscopic sclerotherapy.


Options:
A: Survival (One Year)
B: Number of participants with variceal rebleeding (4 years)
C: Survival (10 years)
D: Survival (10 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: San Diego Bleeding Esophageal Varices Study
Brief Summary: In unselected cirrhotic patients with bleeding esophageal varices to compare the influence on mortality rate, duration of life, quality of life, and economic costs of treatment of:

* Emergency portacaval shunt, and
* Emergency and long-term endoscopic sclerotherapy.


Options:
A: Varices (6 years)
B: Rebleed, death (At least 3 months after last enrollment)
C: Survival (10 years)
D: Survival (10 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix
Brief Summary: The purpose of this study is to compare between single balloon catheter and double balloon catheter for ripening the cervix among pregnant with unfavorable cervix.


Options:
A: Attainment of vaginal delivery within 24 hours. (24 hours)
B: feasibility of randomised Induction of Labour Trial in Out-patient setting (12 months)
C: Average Time in Hours From Insertion of the Catheter Until Delivery (At the end of the study)
D: induction time to delivery (Time from induction to delivery, average 12-28 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix
Brief Summary: The purpose of this study is to compare between single balloon catheter and double balloon catheter for ripening the cervix among pregnant with unfavorable cervix.


Options:
A: Time Of Start Of Induction Of Labor To Delivery (Hours)
B: Delivery rate (proportion) (Within 24 hours)
C: Average Time in Hours From Insertion of the Catheter Until Delivery (At the end of the study)
D: Delivery Rate (Within 24 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV for Diabetic Tractional Retinal Detachment (IBETRA Study)
Brief Summary: The purpose of this study is to compare the amount of intraoperative intraocular bleeding during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD) with and without preoperative intravitreal bevacizumab treatment.


Options:
A: N/A
B: amount of intraoperative intra-ocular bleeding (three weeks)
C: The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR (3 months after last surgery)
D: E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) (24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV for Diabetic Tractional Retinal Detachment (IBETRA Study)
Brief Summary: The purpose of this study is to compare the amount of intraoperative intraocular bleeding during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD) with and without preoperative intravitreal bevacizumab treatment.


Options:
A: Treatment or "Failure" Defined as Vitrectomy (within 112 days of randomization); Safety (Injected-related, Ocular Drug-related and Systemic Drug-related) (Baseline to 16 weeks)
B: The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR (3 months after last surgery)
C: amount of intraoperative intra-ocular bleeding (three weeks)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 12,000 Unit Capsules in Subjects Aged 7 - 11 With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Brief Summary: This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to Cystic Fibrosis.


Options:
A: Coefficient of Fat Absorption (%) (5 days)
B: Coefficient of Fat Absorption over 72 hours (CFA-72h) (72 hours)
C: Percent Coefficient of Fat Absorption (CFA%) (Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods)
D: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 12,000 Unit Capsules in Subjects Aged 7 - 11 With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Brief Summary: This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to Cystic Fibrosis.


Options:
A: Percent Coefficient of Fat Absorption (CFA%) (Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods)
B: Coefficient of Fat Absorption (%) (5 days)
C: Treatment Difference in Coefficient of Fat Absorption (CFA) Change From Baseline (Baseline, 7 weeks)
D: Coefficient of Fat Absorption over 72 hours (CFA-72h) (72 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 12,000 Unit Capsules in Subjects Aged 7 - 11 With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Brief Summary: This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to Cystic Fibrosis.


Options:
A: Second-phase insulin response during GPA test (5 hours)
B: To evaluate the efficacy of NM-BL compared to placebo in patients with Exocrine Pancreatic Insufficiency (EPI) due to CF, where the primary variable is coefficient of fat absorption (CFA%) (72 hrs)
C: Percent Coefficient of Fat Absorption (CFA%) (Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods)
D: Coefficient of Fat Absorption (%) (5 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date
Brief Summary: The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.


Options:
A: Percentage of Participants With 4-week Continuous Abstinence (CA) (Week 9 through Week 12)
B: Continuous abstinence Weeks 13 -24.
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: 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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date
Brief Summary: The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.


Options:
A: N/A
B: To compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation, and to evaluate continuous abstinence from smoking for 12 weeks after the treatment period.
C: Percentage of Participants With 4-week Continuous Abstinence (CA) (Week 9 through Week 12)
D: Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 (12 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 (24 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 (52 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 (64 weeks following treatment initiation); Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 (104 weeks following treatment initiation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date
Brief Summary: The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.


Options:
A: Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).
B: 4-week continuous quit rate (CQR) for Weeks 9-12
C: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))
D: Percentage of Participants With 4-week Continuous Abstinence (CA) (Week 9 through Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date
Brief Summary: The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.


Options:
A: 7-day point prevalent CO validated smoking cessation. (Three months after lung screening)
B: Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale (1 week)
C: Rating of urges to smoke 1-week after the target quit (1 week)
D: Percentage of Participants With 4-week Continuous Abstinence (CA) (Week 9 through Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date
Brief Summary: The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.


Options:
A: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)
B: 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.)
C: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
D: Percentage of Participants With 4-week Continuous Abstinence (CA) (Week 9 through Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date
Brief Summary: The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.


Options:
A: Smoking Abstinence (week 7, week 11 and week 24 after scheduled quit day)
B: Quit Rate (Study weeks 6 through 9)
C: Quit Rate (4 months)
D: Percentage of Participants With 4-week Continuous Abstinence (CA) (Week 9 through Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date
Brief Summary: The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.


Options:
A: Percentage of Participants With 4-week Continuous Abstinence (CA) (Week 9 through Week 12)
B: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)
C: Summarization of safety data in smokers treated with either varenicline or placebo.
D: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date
Brief Summary: The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.


Options:
A: 7-Day Point-Prevalence Abstinence (12 months)
B: 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)
C: Percentage of Participants With 4-week Continuous Abstinence (CA) (Week 9 through Week 12)
D: Smoking Abstinence (12 months)

Answer: C