TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The HERMES Study
Brief Summary: The aim of the study is to compare the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will be up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).


Options:
A: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 52 weeks of treatment); COPD Exacerbation Rate (Moderate or Severe) (52 weeks treatment period)
B: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year. (Baseline to Week 52)
C: Number of participants with adverse events (AEs) and serious adverse events (SAEs) (Up to follow up (approximately 56 days)); Change from Baseline (Day 0 [pre-bronchodilator]) in 12-lead electrocardiogram (ECG) findings (Baseline (Day 0 [pre-bronchodilator]) and up to Day 28 (Visit 6b)); Change from Baseline (Day 0 [pre-bronchodilator]) in 12-lead electrocardiogram (ECG) findings-ventricular rate (Baseline (Day 0 [pre-bronchodilator]) and up to Day 28 (Visit 6b)); Number of participants with abnormal (potential clinical importance [PCI]) systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) (Up to Day 27 (Visit 6a)); Number of participants with abnormal (PCI) clinical chemistry (Up to Day 42 (follow up visit)); Number of participants with abnormal (PCI) hematology (Up to Day 42 (follow up visit)); Number of participants with abnormal urinalysis (Up to Day 56 (Visit follow up)); Change from Baseline (Day 0) in lung function parameters: forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) (Baseline (Day 0) and up to Day 27 (Visit 6a)); Number of participants with abnormal Holter interpretations (Up to Day 27 (Visit 6a)); Number of participants who withdrawn for exacerbations of chronic obstructive pulmonary disease (COPD) (Up to Day 27 (Visit 6a))
D: Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The HERMES Study
Brief Summary: The aim of the study is to compare the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will be up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).


Options:
A: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year (52 weeks)
B: Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Baseline to Week 24)
C: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 52 weeks of treatment); COPD Exacerbation Rate (Moderate or Severe) (52 weeks treatment period)
D: change in FEV1 from baseline during the treatment period; number of COPD exacerbations.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Two-Treatment, Crossover Study to Evaluate the Safety and Efficacy of Eurand Pancreatic Enzyme Product (PEP) in Patients With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
Brief Summary: The primary efficacy objective of this study is to compare the coefficient of fat absorption (CFA) following oral administration of Aptalis Pharma's (formerly Eurand Pharmaceuticals) pancreatic enzyme product (PEP) capsules and placebo in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).


Options:
A: 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)
B: Coefficient of Fat Absorption (%) (5 days)
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: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Two-Treatment, Crossover Study to Evaluate the Safety and Efficacy of Eurand Pancreatic Enzyme Product (PEP) in Patients With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
Brief Summary: The primary efficacy objective of this study is to compare the coefficient of fat absorption (CFA) following oral administration of Aptalis Pharma's (formerly Eurand Pharmaceuticals) pancreatic enzyme product (PEP) capsules and placebo in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).


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: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: Treatment Difference in Coefficient of Fat Absorption (CFA) Change From Baseline (Baseline, 7 weeks)
D: Change from open label baseline to end of 6 day double blind treatment period in Coefficient of Fat Absorption (CFA) (Open label baseline, end of 6 day double blind treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Two-Treatment, Crossover Study to Evaluate the Safety and Efficacy of Eurand Pancreatic Enzyme Product (PEP) in Patients With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
Brief Summary: The primary efficacy objective of this study is to compare the coefficient of fat absorption (CFA) following oral administration of Aptalis Pharma's (formerly Eurand Pharmaceuticals) pancreatic enzyme product (PEP) capsules and placebo in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).


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: 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: Coefficient of Fat Absorption (%) (5 days)
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: Autologous Stem Cell Transplantation for Crohn's Disease: ASTIC
Brief Summary: Transplant study for patients with relapsing Crohn's disease demonstrating clear intolerance or toxicity to conventional treatment.

The purpose of this study is to determine whether there is a potential clinical benefit of hematopoietic stem cell mobilisation followed by high dose immuno-ablation and autologous stem cell transplantation versus hematopoietic stem cell mobilisation only followed by best clinical practice.


Options:
A: Proportion patients in sustained disease remission (1 year)
B: Survival (6 months, then yearly x 5 years after transplant)
C: Treatment related adverse events (Month 6)
D: Safety and efficacy (fistula closure) (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-wk Prospective, Randomized, Double-blind, Multicenter Study of Relapse Following Transition From Oral Antipsychotic Medication to 2 Different Doses (25 or 50 mg Every 2 Wks) of Risperidone Long-acting Microspheres (Risperdal� CONSTA�) in Adults With Schizophrenia or Schizoaffective Disorder
Brief Summary: The purpose of this study is to assess the time for patients to relapse when switched from an oral antipsychotic to one of two doses of long-acting risperidone injection (shots). Risperidone has been used successfully to treat schizophrenia and schizoaffective disorder.


Options:
A: The change in the total score of the Positive and Negative Syndrome Scale (PANSS) from the beginning to the end of the double-blind treatment period or to the last post-randomization assessment.
B: Likelihood of accepting a recommendation of long-acting atypical antipsychotic medication; Compare the time until the first episode of antipsychotic nonadherence as defined by 2 or more weeks of continuous and intentional cessation of all prescribed antipsychotic medication; Compare the total amount of outpatient days spent adherent to antipsychotic medication as a proportion of outpatient days in the study; Compare patient and family attitudes and satisfaction with antipsychotic medication given by long-acting route vs. oral route of drug delivery; 5. Modify and adapt psychoeducational material designed for multiple episode patients to better fit the needs of recently diagnosed patients with schizophrenia.
C: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia (Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks))
D: Risperidone effectiveness is measured by time to relapse within the 52 week period.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-wk Prospective, Randomized, Double-blind, Multicenter Study of Relapse Following Transition From Oral Antipsychotic Medication to 2 Different Doses (25 or 50 mg Every 2 Wks) of Risperidone Long-acting Microspheres (Risperdal� CONSTA�) in Adults With Schizophrenia or Schizoaffective Disorder
Brief Summary: The purpose of this study is to assess the time for patients to relapse when switched from an oral antipsychotic to one of two doses of long-acting risperidone injection (shots). Risperidone has been used successfully to treat schizophrenia and schizoaffective disorder.


Options:
A: The primary efficacy criteria for this study is the time from randomization to the first recurrence event during the double-blind recurrence prevention period (After 68 relapse events)
B: Time to Exacerbation of Psychotic Symptoms/Impending Relapse (Baseline of the depot maintenance phase to the end of the study (Week 52))
C: Risperidone effectiveness is measured by time to relapse within the 52 week period.
D: The difference in change from baseline to the 12-week time point between bifeprunox and placebo using the Positive and Negative Syndrome Scale (PANSS). (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-wk Prospective, Randomized, Double-blind, Multicenter Study of Relapse Following Transition From Oral Antipsychotic Medication to 2 Different Doses (25 or 50 mg Every 2 Wks) of Risperidone Long-acting Microspheres (Risperdal� CONSTA�) in Adults With Schizophrenia or Schizoaffective Disorder
Brief Summary: The purpose of this study is to assess the time for patients to relapse when switched from an oral antipsychotic to one of two doses of long-acting risperidone injection (shots). Risperidone has been used successfully to treat schizophrenia and schizoaffective disorder.


Options:
A: Risperidone effectiveness is measured by time to relapse within the 52 week period.
B: Number Who Discontinued Medication Within First 6 Study Months (Measured at Six Months)
C: change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores (The PANSS was rated at baseline, and again at weeks 1, 2, 3, 4, and 6 (or on early termination).)
D: Brief Psychiatric Rating Scale (BPRS) (intermittent); Clinical Global Impression Scale (intermittent)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategies to Help Adult ED Patients Quit Smoking
Brief Summary: The purpose of this study is to determine whether a brief, focused intervention in the hospital emergency department is effective in helping adults quit smoking.


Options:
A: 3-month cessation rate
B: 7-day Point Prevalence Abstinence From Cigarettes (24 months)
C: Results in Abstinence Rates (1 Year)
D: smoking cessation (6-months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Group Therapy for Nicotine Dependence
Brief Summary: The goal of this behavioral research study is to create and study a Mindfulness-Based Addiction Treatment (MBAT) for nicotine dependence. Mindfulness is a method to help focus attention on being in the "here and now." It can be learned through training in how to control one's attention. It is usually taught through meditation. The overarching goals of the study are to evaluate the efficacy of MBAT for nicotine dependence and the mechanisms and effects posited to mediate MBAT's impact on abstinence.


Options:
A: Change from Baseline CORE-OM measure at post-intervention and 4-month follow-up. (It is measured three weeks before the intervention starts, immediately after the 8-week intervention is finished, and 4-month after the intervention is finished.)
B: smoking cessation: 7-day point prevalence abstinence (6 months)
C: 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))
D: 30-day Point Prevalence Abstinence, Complete-case (12 months post randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Group Therapy for Nicotine Dependence
Brief Summary: The goal of this behavioral research study is to create and study a Mindfulness-Based Addiction Treatment (MBAT) for nicotine dependence. Mindfulness is a method to help focus attention on being in the "here and now." It can be learned through training in how to control one's attention. It is usually taught through meditation. The overarching goals of the study are to evaluate the efficacy of MBAT for nicotine dependence and the mechanisms and effects posited to mediate MBAT's impact on abstinence.


Options:
A: 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))
B: Self-reported prolonged abstinence and cotinine-validated point-prevalence abstinence at 1 year follow-up (1 year)
C: Prolonged Abstinence Rates (6-month)
D: Three month point-prevalence abstinence from cigarettes (3 months post-intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Group Therapy for Nicotine Dependence
Brief Summary: The goal of this behavioral research study is to create and study a Mindfulness-Based Addiction Treatment (MBAT) for nicotine dependence. Mindfulness is a method to help focus attention on being in the "here and now." It can be learned through training in how to control one's attention. It is usually taught through meditation. The overarching goals of the study are to evaluate the efficacy of MBAT for nicotine dependence and the mechanisms and effects posited to mediate MBAT's impact on abstinence.


Options:
A: 7-day point prevalence by self report (at 6 months)
B: Smoking Abstinence (End of Treatment (8 weeks))
C: Feasibility of study recruitment into the three interventions (Baseline); Feasibility of retention of participants at 3-month follow-up (3-month follow-up); Feasibility of retention of participants at 6-month follow-up (6-month follow-up); Acceptability of the three interventions (3-month follow-up)
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Gradual vs. Abrupt Cessation Treatment for Smoking
Brief Summary: This study tests whether stopping smoking by gradually cutting down first is more or less successful than stopping abruptly. We hypothesize that stopping by gradually cutting down first will produce more abstinence than stopping abruptly.


Options:
A: Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement (6 months)
B: Blood Pressure, Health-Related Quality of Life(Medical outcome Study Short Form-36) (Baseling, 12month, 24month)
C: Depression Score (6 months); Abstinent From Smoking (6 months); Days Walk Per Week (6 months); Minutes Per Week of Moderate Physical Activity (6 months); Minutes Per Week of Vigorous Physical Activity (6 months)
D: Participant smoking status. (6 and 12 month follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Gradual vs. Abrupt Cessation Treatment for Smoking
Brief Summary: This study tests whether stopping smoking by gradually cutting down first is more or less successful than stopping abruptly. We hypothesize that stopping by gradually cutting down first will produce more abstinence than stopping abruptly.


Options:
A: 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)
B: Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement (6 months)
C: 7-Day Point Prevalence Abstinence From Smoking by Intervention (26 weeks after the target quit smoking date); 7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group (26 weeks after the target quit smoking date)
D: Biochemically Verified 7-day Point Prevalence Abstinence (End of Treatment (week 24))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Gradual vs. Abrupt Cessation Treatment for Smoking
Brief Summary: This study tests whether stopping smoking by gradually cutting down first is more or less successful than stopping abruptly. We hypothesize that stopping by gradually cutting down first will produce more abstinence than stopping abruptly.


Options:
A: Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline (week-12); Sustained smoking abstinence at week-12 (week 12)
B: self-reported 7-day point prevalence quit rate (at 12 months follow-up); prolonged abstinence quit rate (at 12 months follow-up)
C: Continuous Abstinence From Smoking at Ten Weeks Post-quit (May 2009)
D: Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Gradual vs. Abrupt Cessation Treatment for Smoking
Brief Summary: This study tests whether stopping smoking by gradually cutting down first is more or less successful than stopping abruptly. We hypothesize that stopping by gradually cutting down first will produce more abstinence than stopping abruptly.


Options:
A: To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. (8 weeks)
B: Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement (6 months)
C: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
D: Continuous abstinence: measured at end of treatment and at 6- and 12- months after cessation.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.
Brief Summary: The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.


Options:
A: In the population with CRP ≥ 10 mg/L at baseline; Clinical response at week 6; Clinical response at week 6 and week 26
B: Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.
C: Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments (Baseline, Week 10); Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments (Baseline, Week 10)
D: Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase (Baseline to Week 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.
Brief Summary: The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.


Options:
A: To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC). (6 weeks)
B: Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments (Baseline, Week 10); Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments (Baseline, Week 10)
C: Number of Subjects Without Mucosal Ulceration at Week 12 (Week 12)
D: Clinical remission (CDAI score of <150) (Week 11)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clarithromycin as Immunomodulatory Therapy for the Management of Septic Syndrome by Ventilator-Associated Pneumonia
Brief Summary: The aim of this clinical trial is to clarify the clinical efficacy of clarithromycin as immunotherapy for the management of septic syndrome by ventilator-associated pneumonia.


Options:
A: the prevalence of nasopharyngeal carriage of the newborn of any of the following bacteria: 1) Group B Streptococci (GBS) , 2) S.pneumoniae and 3) S.aureus (6 days)
B: Change in FEV1 From Baseline to End of Treatment at Day 168 (change from baseline to day 168)
C: Immediately after intubation an upper GI endoscopy will be done. The following primary endpoint will be recorded: Stomach clear from any content: yes or no (dichotomous). (10 minutes)
D: Estimation of crude mortality by any reason of each study group; Estimation of attributable mortality by VAP of each study group; 7-day mortality rate of each group; 28-mortality rate of each group; Rate of progression to multiple organ failure and septic shock (and number of failing organs) of each study group; Time to progression to multiple organ failure and septic shock of each study group; Days of resolution of VAP; Days in ICU after diagnosis of VAP

Answer: D