TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A 16-week Randomised, Placebo-controlled, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler (2 Actuations of 2.5 Mcg Once Daily) With That of Salmeterol From the Hydrofluoroalkane Metered Dose Inhaler (2 Actuations of 25 Mcg Twice Daily) in Moderate Persistent Asthma Patients With the B16-Arg/Arg Genotype
Brief Summary: This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks.

The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.


Options:
A: Forced Expiratory Volume in One Second (FEV1) Peak Within 0-3 Hours Post-dose Response (10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration)
B: Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial (baseline and after 16 weeks of treatment)
C: Number of Patients With Drug-related Adverse Events (after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409)
D: Model Predicted Change From Baseline Trough Force Expiratory Volume in 1 Second (FEV1) (Baseline (Day 1) and Day 15 of each treatment period); Percentage of Chance That FF 100 mcg Alone Corrected Change From Baseline FEV1 Response Would Exceed a Target Response by Dose of UMEC Combined With FF 100 mcg (Baseline (Day 1) and Day 15 of each treatment period); Mean Change From Baseline in Trough FEV1 on Day 15 of Each of the 3 Treatment Periods (Baseline (Day 1) and Day 15 of each treatment period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 16-week Randomised, Placebo-controlled, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler (2 Actuations of 2.5 Mcg Once Daily) With That of Salmeterol From the Hydrofluoroalkane Metered Dose Inhaler (2 Actuations of 25 Mcg Twice Daily) in Moderate Persistent Asthma Patients With the B16-Arg/Arg Genotype
Brief Summary: This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks.

The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.


Options:
A: Time to All-Cause Mortality (Up to 3 years); Time to First COPD Exacerbation (Up to 3 years)
B: Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial (baseline and after 16 weeks of treatment)
C: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Trough FEV1 Response Determined After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984). (48 weeks)
D: Change Between Week 14 and Week 0 in the Morning (AM) Peak Expiratory Flow (PEF) (AM PEF was measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 16-week Randomised, Placebo-controlled, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler (2 Actuations of 2.5 Mcg Once Daily) With That of Salmeterol From the Hydrofluoroalkane Metered Dose Inhaler (2 Actuations of 25 Mcg Twice Daily) in Moderate Persistent Asthma Patients With the B16-Arg/Arg Genotype
Brief Summary: This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks.

The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.


Options:
A: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Trough FEV1 Response Determined After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984). (48 weeks)
B: Time to All-Cause Mortality (Up to 3 years); Time to First COPD Exacerbation (Up to 3 years)
C: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Trough FEV1 Response Determined After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984). (48 weeks)
D: Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial (baseline and after 16 weeks of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 16-week Randomised, Placebo-controlled, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler (2 Actuations of 2.5 Mcg Once Daily) With That of Salmeterol From the Hydrofluoroalkane Metered Dose Inhaler (2 Actuations of 25 Mcg Twice Daily) in Moderate Persistent Asthma Patients With the B16-Arg/Arg Genotype
Brief Summary: This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks.

The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.


Options:
A: Number of Patients With Drug-related Adverse Events (after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409)
B: Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial (baseline and after 16 weeks of treatment)
C: 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)
D: morning peak expiratory flow (PEF) daily measured by patients

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 16-week Randomised, Placebo-controlled, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler (2 Actuations of 2.5 Mcg Once Daily) With That of Salmeterol From the Hydrofluoroalkane Metered Dose Inhaler (2 Actuations of 25 Mcg Twice Daily) in Moderate Persistent Asthma Patients With the B16-Arg/Arg Genotype
Brief Summary: This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks.

The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.


Options:
A: Mean Change From Baseline in Clinic Visit Trough 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: 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)
C: Peak FEV1 (L) Defined as the Highest Bronchodilatory Effect on FEV1 During a Period of 5 Min to 4 h After the Last Evening Dose of Each Treatment Period (3 weeks)
D: Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial (baseline and after 16 weeks of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 16-week Randomised, Placebo-controlled, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler (2 Actuations of 2.5 Mcg Once Daily) With That of Salmeterol From the Hydrofluoroalkane Metered Dose Inhaler (2 Actuations of 25 Mcg Twice Daily) in Moderate Persistent Asthma Patients With the B16-Arg/Arg Genotype
Brief Summary: This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks.

The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.


Options:
A: Total Number of Asthma Exacerbations Reported During the Treatment Period (From Baseline (Week 1) until the end of treatment (up to Week 16))
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: Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period (Day 1 to Week 26 of the Treatment Period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 16-week Randomised, Placebo-controlled, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler (2 Actuations of 2.5 Mcg Once Daily) With That of Salmeterol From the Hydrofluoroalkane Metered Dose Inhaler (2 Actuations of 25 Mcg Twice Daily) in Moderate Persistent Asthma Patients With the B16-Arg/Arg Genotype
Brief Summary: This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks.

The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.


Options:
A: Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial (baseline and after 16 weeks of treatment)
B: 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)
C: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Trough FEV1 Response Determined After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984). (48 weeks)
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 205.419 (NCT01172821) and the Present 205.418 (NCT01172808) (24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the Clinical Effectiveness of a Human Monoclonal Antibody to Clostridium Difficile Toxin A (GS-CDA1) and a Human Monoclonal Antibody to Clostridium Difficile Toxin B (MDX-1388) in Patients Being Treated for Clostridium Difficile Associated Disease
Brief Summary: Patients with Clostridium difficile associated disease who fulfill the eligibility criteria will be approached to participate. All study patients must receive standard of care treatment for Clostridium difficile associated disease. Enrolled patients will be randomized to receive a single intravenous solution of a human monoclonal antibody (huMab) to C. difficile toxin A (GS-CDA1) combined with a human monoclonal antibody to C. difficile toxin B (MDX-1388) or 0.9% sodium chloride as placebo in a 1:1 treatment allocation. Patients will be evaluated for safety and clinical outcomes through day 84 +/- 10 days. Occurrence of adverse events, use of concomitant medications, and stool output will be assessed at scheduled phone contacts and study visits. Some patients enrolled will have a subsequent visit on day 168 ± 14 days.


Options:
A: Number of Participants With Recurrence of Clostridium Difficile Associated Disease (CDAD) (Day 0 to Day 84)
B: Resolution of diarrhea
C: The evaluation of the safety of HBT (13 Weeks post HBT); To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT. (13 Weeks post HBT)
D: Number of Participants With a Clinical Response Outcome of Clostridium Difficile Infection Cure at the End of Study Treatment (Baseline (Day 0) through Study Day 19); Number of Participants With a Clinical Response Outcome of Failure or Unable to Evaluate at the End of Study Treatment (Baseline (Day 0) through Study Day 19)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-Based Training in Cognitive Behavior Therapy
Brief Summary: The computer-based training program (CBT for CBT) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving substance abuse treatment.


Options:
A: Longest Duaration of Achieved Abstinance (12 weeks of treatment); Percentage Samples Submitted Negative for Crack Cocaine Use (12 weeks); Number of Participants Completing 4, 8 and 12 Weeks of Treatment (Number of participant retained in treatment at weeks 4, 8 and 12.); Treatment Attendance (12 weeks)
B: abused drug abstinence measured by observed urine specimen testing weeks 1-52, and bimonthly months 13-18
C: reduction in drug use (8 weeks)
D: Change in Cocaine Use by Self Report (12 weeks); Change in Cocaine Use by Urine Toxicology Results (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Computer-Based Training in Cognitive Behavior Therapy
Brief Summary: The computer-based training program (CBT for CBT) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving substance abuse treatment.


Options:
A: longest continuous period of cocaine abstinence (Week 8)
B: N/A
C: Percentage of Monthly Urine Samples That Are Negative for Cocaine (1 year)
D: reduction in drug use (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-Center, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Daily Dosing With Oxybutynin Topical Gel to Treat the Symptoms of Overactive Bladder With a 14-Week Open-Label Safety Extension
Brief Summary: A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.


Options:
A: Change from baseline in the mean number of micturitions per 24 hours (Within a 12-week treatment period)
B: Baseline Average Number of Daily Incontinence Episodes (Baseline); Change From Baseline in Average Daily Number of Incontinence Episodes (Baseline to Week 12)
C: Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline.
D: Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 (Study Baseline, Week 12); Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1 (Study Baseline, Week 12)

Answer: B