TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-Week Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation
Brief Summary: The purpose of this study is to test whether the addition of a nicotine patch to varenicline increases smoking cessation success rate and whether the combination is safe.


Options:
A: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) (Week 9 through Week 12)
B: Change From Baseline Smoking Abstinence Rates at 12 Weeks (12 weeks)
C: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-Week Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation
Brief Summary: The purpose of this study is to test whether the addition of a nicotine patch to varenicline increases smoking cessation success rate and whether the combination is safe.


Options:
A: reducers (week-24 from baseline)
B: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
C: 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)
D: To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-Week Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation
Brief Summary: The purpose of this study is to test whether the addition of a nicotine patch to varenicline increases smoking cessation success rate and whether the combination is safe.


Options:
A: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
B: Primary efficacy and Safety endpoint: (within 12 month from enrollment)
C: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
D: Smoking Status (at week 48)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-Week Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation
Brief Summary: The purpose of this study is to test whether the addition of a nicotine patch to varenicline increases smoking cessation success rate and whether the combination is safe.


Options:
A: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
B: Number of cigarettes smoked per day (End of 6 week intervention)
C: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))
D: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-Week Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation
Brief Summary: The purpose of this study is to test whether the addition of a nicotine patch to varenicline increases smoking cessation success rate and whether the combination is safe.


Options:
A: Percent Treatment Sessions Attended (52 weeks)
B: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
C: Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12. (Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks))
D: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-Week Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation
Brief Summary: The purpose of this study is to test whether the addition of a nicotine patch to varenicline increases smoking cessation success rate and whether the combination is safe.


Options:
A: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
B: smoking cessation (12 months)
C: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
D: 6 Month Self-reported Abstinence From Smoking (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-Week Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation
Brief Summary: The purpose of this study is to test whether the addition of a nicotine patch to varenicline increases smoking cessation success rate and whether the combination is safe.


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: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
C: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
D: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-Week Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation
Brief Summary: The purpose of this study is to test whether the addition of a nicotine patch to varenicline increases smoking cessation success rate and whether the combination is safe.


Options:
A: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
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: 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)
D: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-Week Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation
Brief Summary: The purpose of this study is to test whether the addition of a nicotine patch to varenicline increases smoking cessation success rate and whether the combination is safe.


Options:
A: Will bupropion reduce relapse to smoking compared to placebo (52 weeks and 76 weeks)
B: Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco (12 weeks following start of medication)
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: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-Week Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation
Brief Summary: The purpose of this study is to test whether the addition of a nicotine patch to varenicline increases smoking cessation success rate and whether the combination is safe.


Options:
A: Pocket depth in peridontitis (Change from baseline at 12 months); Per-implant marginal bone loss (Change from baseline at 12 months); Size reduction of oral mucosal diseases (Change from baseline at 12 months)
B: Continuous abstinence: measured at end of treatment and at 6- and 12- months after cessation.
C: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-Week Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation
Brief Summary: The purpose of this study is to test whether the addition of a nicotine patch to varenicline increases smoking cessation success rate and whether the combination is safe.


Options:
A: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
B: Tobacco use abstinence (26 week)
C: Biochemically confirmed continuous 30-day abstinence from smoking (12 weeks post-Target Quit Day (TQD))
D: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26 Week, Randomized, Double-blind, Parallel-group, Active Controlled, Multicenter, Multinational Safety Study Evaluating the Risk of Serious Asthma-related Events During Treatment With Symbicort®, a Fixed Combination of Inhaled Corticosteroid (ICS) (Budesonide) and a Long Acting β2-agonist (LABA) (Formoterol) as Compared to Treatment With ICS (Budesonide) Alone in Adult and Adolescent (≥12 Years of Age) Patients With Asthma
Brief Summary: The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma


Options:
A: Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) (Up to 27 weeks); Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation (Up to 26 weeks)
B: Forced Expiratory Volume in 1 Second (FEV1) - Post Dose (60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg); Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose (Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg)
C: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Week 12)
D: Change in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy (Week 0 and 12 visits)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26 Week, Randomized, Double-blind, Parallel-group, Active Controlled, Multicenter, Multinational Safety Study Evaluating the Risk of Serious Asthma-related Events During Treatment With Symbicort®, a Fixed Combination of Inhaled Corticosteroid (ICS) (Budesonide) and a Long Acting β2-agonist (LABA) (Formoterol) as Compared to Treatment With ICS (Budesonide) Alone in Adult and Adolescent (≥12 Years of Age) Patients With Asthma
Brief Summary: The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma


Options:
A: Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24)
B: Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) (Up to 27 weeks); Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation (Up to 26 weeks)
C: Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24); Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24 (Baseline and Week 24)
D: Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours PostDose (FEV1 AUEC0-12) at Week 12 (Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hours); Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 1 (predose, baseline), Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26 Week, Randomized, Double-blind, Parallel-group, Active Controlled, Multicenter, Multinational Safety Study Evaluating the Risk of Serious Asthma-related Events During Treatment With Symbicort®, a Fixed Combination of Inhaled Corticosteroid (ICS) (Budesonide) and a Long Acting β2-agonist (LABA) (Formoterol) as Compared to Treatment With ICS (Budesonide) Alone in Adult and Adolescent (≥12 Years of Age) Patients With Asthma
Brief Summary: The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma


Options:
A: FEV1, (Forced expiratory volume in the 1st second).
B: Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) (Up to 27 weeks); Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation (Up to 26 weeks)
C: morning peak expiratory flow (PEF) daily measured by patients
D: The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hr) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) (Baseline to Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26 Week, Randomized, Double-blind, Parallel-group, Active Controlled, Multicenter, Multinational Safety Study Evaluating the Risk of Serious Asthma-related Events During Treatment With Symbicort®, a Fixed Combination of Inhaled Corticosteroid (ICS) (Budesonide) and a Long Acting β2-agonist (LABA) (Formoterol) as Compared to Treatment With ICS (Budesonide) Alone in Adult and Adolescent (≥12 Years of Age) Patients With Asthma
Brief Summary: The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma


Options:
A: Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12 (Baseline and Week 12)
B: morning peak expiratory flow (PEF) daily measured by patients
C: Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) (Up to 27 weeks); Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation (Up to 26 weeks)
D: Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24 (Baseline and Day 168/Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26 Week, Randomized, Double-blind, Parallel-group, Active Controlled, Multicenter, Multinational Safety Study Evaluating the Risk of Serious Asthma-related Events During Treatment With Symbicort®, a Fixed Combination of Inhaled Corticosteroid (ICS) (Budesonide) and a Long Acting β2-agonist (LABA) (Formoterol) as Compared to Treatment With ICS (Budesonide) Alone in Adult and Adolescent (≥12 Years of Age) Patients With Asthma
Brief Summary: The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma


Options:
A: Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) (Up to 27 weeks); Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation (Up to 26 weeks)
B: Treatment Failure (16 weeks)
C: Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial (baseline and after 16 weeks of treatment)
D: Peak FEV1 Within 3 Hours Post-dose Response (24 weeks); Trough FEV1 Response (24 weeks); The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821) (24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Oral Azithromycin (500 Mg OD) as a Supplement to Standard Care for Adult Patients With Acute Exacerbations of Asthma
Brief Summary: Acute attacks (exacerbations) of asthma are common and cause a great deal of suffering in asthmatic patients. Current treatments for asthma attacks are not completely effective and new and better treatments are needed. Viruses often cause asthma attacks and bacterial lung infections have also been associated with asthma attacks. However, the role for bacteria is uncertain. Current asthma guidelines for doctors treating asthma exacerbations do not recommend the routine use of antibiotics. The investigators would like to investigate whether or not azithromycin, which is a safe and well tolerated antibiotic (an antibacterial) that has been used for many years in the treatment of respiratory disease, might be of benefit in asthma attacks. As there is some evidence that azithromycin has anti-viral properties this may add to its benefits (antibiotics don't usually affect viruses). By looking at the effect of azithromycin on asthma attacks this will help us to show whether or not azithromycin should be recommended during an acute asthma attack in addition to the usual care that is provided to these patients as it may help them recover quicker from the exacerbation. The investigators will also be able to look at why azithromycin may be effective - if it is having an anti-bacterial and/or anti-viral effect.


Options:
A: Symptom scoring (1 to 3 years of age); Duration in days of each asthmatic episode from randomisation start (1 to 3 years of age)
B: Juniper Asthma Control Questionnaire (ACQ) Results (Measured every four weeks during the 16-week treatment period, with the change (week 16 minus baseline) as the primary outcome)
C: Progression to Clinically Significant Lower Respiratory Tract Symptoms (14 days after initiation of APRIL therapy); OCELOT: Pediatric Respiratory Assessment Measure (36-72 hours after initiation of OCELOT therapy)
D: Diary card summary symptom score (10 days after randomisation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Oral Azithromycin (500 Mg OD) as a Supplement to Standard Care for Adult Patients With Acute Exacerbations of Asthma
Brief Summary: Acute attacks (exacerbations) of asthma are common and cause a great deal of suffering in asthmatic patients. Current treatments for asthma attacks are not completely effective and new and better treatments are needed. Viruses often cause asthma attacks and bacterial lung infections have also been associated with asthma attacks. However, the role for bacteria is uncertain. Current asthma guidelines for doctors treating asthma exacerbations do not recommend the routine use of antibiotics. The investigators would like to investigate whether or not azithromycin, which is a safe and well tolerated antibiotic (an antibacterial) that has been used for many years in the treatment of respiratory disease, might be of benefit in asthma attacks. As there is some evidence that azithromycin has anti-viral properties this may add to its benefits (antibiotics don't usually affect viruses). By looking at the effect of azithromycin on asthma attacks this will help us to show whether or not azithromycin should be recommended during an acute asthma attack in addition to the usual care that is provided to these patients as it may help them recover quicker from the exacerbation. The investigators will also be able to look at why azithromycin may be effective - if it is having an anti-bacterial and/or anti-viral effect.


Options:
A: Symptom scoring (1 to 3 years of age); Duration in days of each asthmatic episode from randomisation start (1 to 3 years of age)
B: Diary card summary symptom score (10 days after randomisation)
C: Peak expiratory flow rate. (12 weeks)
D: Patient's daily diary summary symptom scores/Morning diary PEFR (During the Study Conduct)

Answer: B