TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double-blind, Placebo-controlled Trial of the Effect of the Combination of Imipramine and Pregabalin for the Treatment of Painful Polyneuropathy
Brief Summary: Polyneuropathy of different etiologies is often associated with pain and the standard treatment for this type of pain is gabapentinoids or antidepressants. The hypothesis of this study is that the combination of the gabapentinoid pregabalin and the antidepressant imipramine will provide better pain relief than the single compounds alone.

This is a randomized, placebo-controlled, double-blind, 4-way, cross-over trial of pregabalin 300 mg/day, imipramine 75 mg/day and their combination versus placebo. The study will include 60 patients and the treatment outcome will be pain intensity as measured by numeric rating scales.


Options:
A: A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary (Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study))
B: Total pain intensity as measured by numeric rating scale 0-10 points. (Median of ratings from last week of each treatment period)
C: Number of Participants With Loss of Therapeutic Response. (13 Weeks)
D: Onset meaningful pain reduction

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Effect of Two Doses of AMR101 (Ethyl Icosapentate) on Fasting Serum Triglyceride Levels in Patients With Persistent High Triglyceride Levels (≥ 200 mg/dL and < 500 mg/dL) Despite Statin Therapy
Brief Summary: The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering high fasting triglyceride levels in patients with high risk for cardiovascular disease and fasting triglyceride levels ≥ 200 and \< 500 mg/dL.


Options:
A: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
B: Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect (baseline and 12 weeks)
C: Major coronary events (sudden cardiac death, fatal and nonfatal myocardial infarction, unstable angina pectoris including hospitalization for ischemic episodes,events of angioplasty/ stenting or coronary artery bypass grafting)
D: Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Effect of Two Doses of AMR101 (Ethyl Icosapentate) on Fasting Serum Triglyceride Levels in Patients With Persistent High Triglyceride Levels (≥ 200 mg/dL and < 500 mg/dL) Despite Statin Therapy
Brief Summary: The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering high fasting triglyceride levels in patients with high risk for cardiovascular disease and fasting triglyceride levels ≥ 200 and \< 500 mg/dL.


Options:
A: Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
B: cardiovascular deaths and hospitalization for cardiovascular causes (5 years)
C: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
D: Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect (baseline and 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence
Brief Summary: The transdermal nicotine patch is the most widely used form of tobacco dependence treatment in the US and Europe, but most smokers are unable to successfully quit with this form of treatment. Failure to respond to this treatment may, to a large extent, be due to the use of nicotine patches for only 8 weeks, the recommended treatment duration. We have found in a controlled randomized clinical trial that using the nicotine patch for 24 weeks can increase quit rates significantly. We propose here a clinical trial to replicate and extend these results to a community setting in the real-world, using the same research design utilized in clinical trials to demonstrate the effectiveness of methadone maintenance therapy for opiate dependence. Specifically, 540 smokers will receive counseling and standard (8-weeks), extended (24-weeks), or maintenance (52 weeks) therapy with transdermal nicotine patches. The main outcome is biochemically-verified smoking cessation at week 52. The cost-effectiveness, safety, and mechanism of effect (e.g., promotion of recovery following a lapse) for maintenance therapy with transdermal nicotine will also be assessed. The study results may change how we treat nicotine dependence with transdermal nicotine.


Options:
A: Duration of smoke-free status (8 weeks postpartum); Duration of breastfeeding (8 weeks postpartum)
B: Smoking cessation maintenance (12 month follow-up)
C: Point Prevalence Abstinence (52-week); Week 24 Point Prevalence Abstinence (24-week)
D: Continuous abstinence Weeks 13 -24.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence
Brief Summary: The transdermal nicotine patch is the most widely used form of tobacco dependence treatment in the US and Europe, but most smokers are unable to successfully quit with this form of treatment. Failure to respond to this treatment may, to a large extent, be due to the use of nicotine patches for only 8 weeks, the recommended treatment duration. We have found in a controlled randomized clinical trial that using the nicotine patch for 24 weeks can increase quit rates significantly. We propose here a clinical trial to replicate and extend these results to a community setting in the real-world, using the same research design utilized in clinical trials to demonstrate the effectiveness of methadone maintenance therapy for opiate dependence. Specifically, 540 smokers will receive counseling and standard (8-weeks), extended (24-weeks), or maintenance (52 weeks) therapy with transdermal nicotine patches. The main outcome is biochemically-verified smoking cessation at week 52. The cost-effectiveness, safety, and mechanism of effect (e.g., promotion of recovery following a lapse) for maintenance therapy with transdermal nicotine will also be assessed. The study results may change how we treat nicotine dependence with transdermal nicotine.


Options:
A: The daily number of intakes during the first three weeks recorded with an electronic device fixed on the spray unit (microswitch-actuated metered-dose inhaler chronology, MDILog™, model MDC-511, Medtrac, Denver, Colorado). (first 3 weeks)
B: Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events (During all the study)
C: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
D: Point Prevalence Abstinence (52-week); Week 24 Point Prevalence Abstinence (24-week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence
Brief Summary: The transdermal nicotine patch is the most widely used form of tobacco dependence treatment in the US and Europe, but most smokers are unable to successfully quit with this form of treatment. Failure to respond to this treatment may, to a large extent, be due to the use of nicotine patches for only 8 weeks, the recommended treatment duration. We have found in a controlled randomized clinical trial that using the nicotine patch for 24 weeks can increase quit rates significantly. We propose here a clinical trial to replicate and extend these results to a community setting in the real-world, using the same research design utilized in clinical trials to demonstrate the effectiveness of methadone maintenance therapy for opiate dependence. Specifically, 540 smokers will receive counseling and standard (8-weeks), extended (24-weeks), or maintenance (52 weeks) therapy with transdermal nicotine patches. The main outcome is biochemically-verified smoking cessation at week 52. The cost-effectiveness, safety, and mechanism of effect (e.g., promotion of recovery following a lapse) for maintenance therapy with transdermal nicotine will also be assessed. The study results may change how we treat nicotine dependence with transdermal nicotine.


Options:
A: Quitting success rates at the end of the 1st, 3rd and 6th month (6 months)
B: The primary endpoint will be 6M of abstinence measured 18M after enrollment. (18M)
C: Point Prevalence Abstinence (52-week); Week 24 Point Prevalence Abstinence (24-week)
D: Self Reported Relapse Rate at 2 Months (2 months after joining the groups for the social networking services.); Self Reported Relapse Rate at 6 Months (6-months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence
Brief Summary: The transdermal nicotine patch is the most widely used form of tobacco dependence treatment in the US and Europe, but most smokers are unable to successfully quit with this form of treatment. Failure to respond to this treatment may, to a large extent, be due to the use of nicotine patches for only 8 weeks, the recommended treatment duration. We have found in a controlled randomized clinical trial that using the nicotine patch for 24 weeks can increase quit rates significantly. We propose here a clinical trial to replicate and extend these results to a community setting in the real-world, using the same research design utilized in clinical trials to demonstrate the effectiveness of methadone maintenance therapy for opiate dependence. Specifically, 540 smokers will receive counseling and standard (8-weeks), extended (24-weeks), or maintenance (52 weeks) therapy with transdermal nicotine patches. The main outcome is biochemically-verified smoking cessation at week 52. The cost-effectiveness, safety, and mechanism of effect (e.g., promotion of recovery following a lapse) for maintenance therapy with transdermal nicotine will also be assessed. The study results may change how we treat nicotine dependence with transdermal nicotine.


Options:
A: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
B: Point Prevalence Abstinence (52-week); Week 24 Point Prevalence Abstinence (24-week)
C: 7-day smoking abstinence (7 days); 6-month smoking abstinence (6 months); cost-effectiveness (6 months)
D: Participants Abstinent From Cigarettes (Two years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence
Brief Summary: The transdermal nicotine patch is the most widely used form of tobacco dependence treatment in the US and Europe, but most smokers are unable to successfully quit with this form of treatment. Failure to respond to this treatment may, to a large extent, be due to the use of nicotine patches for only 8 weeks, the recommended treatment duration. We have found in a controlled randomized clinical trial that using the nicotine patch for 24 weeks can increase quit rates significantly. We propose here a clinical trial to replicate and extend these results to a community setting in the real-world, using the same research design utilized in clinical trials to demonstrate the effectiveness of methadone maintenance therapy for opiate dependence. Specifically, 540 smokers will receive counseling and standard (8-weeks), extended (24-weeks), or maintenance (52 weeks) therapy with transdermal nicotine patches. The main outcome is biochemically-verified smoking cessation at week 52. The cost-effectiveness, safety, and mechanism of effect (e.g., promotion of recovery following a lapse) for maintenance therapy with transdermal nicotine will also be assessed. The study results may change how we treat nicotine dependence with transdermal nicotine.


Options:
A: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
B: Point Prevalence Abstinence (52-week); Week 24 Point Prevalence Abstinence (24-week)
C: N/A
D: sustained smoking abstinence (during the study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride Levels ≥ 500 mg/dL and ≤ 2000 mg/dL
Brief Summary: The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 2000 mg/dL.


Options:
A: Major cardiovascular events, which comprises fatal cardiovascular diseases (CVD), non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal stroke and cardiac interventions (PCI and CABG) (monitored during intervention)
B: Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect (baseline and 12 weeks)
C: Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure. (24months)
D: Survival free of atrial fibrillation (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride Levels ≥ 500 mg/dL and ≤ 2000 mg/dL
Brief Summary: The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 2000 mg/dL.


Options:
A: All-cause mortality (from enrollment to 1252 deaths in R2 arm); All cause mortality or hospitalizations for any reason (from enrollment to 1252 deaths)
B: Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect (baseline and 12 weeks)
C: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
D: Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect (baseline and 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Multicenter Phase II Study to Assess the Efficacy and Safety of Sorafenib Added to Standard Treatment With Topotecan in Patients With Platinum-resistant Recurrent Ovarian Cancer
Brief Summary: It is assumed, that the patients of the standard arm show a median progression-free survival time of 4.4 months those of the experimental arm of at least 6.9 months. Assuming a recruitment period of 18 months and follow-up for at least 12 months a total sample size of 174 patients is required (two-sided, α=0.05, 80% power). To account for 5% drop-outs 184 patients will be randomized.

A Data Monitoring and Safety Board (DMSB) will be established. This board will evaluate the safety profile of the drug combination after 6 patients and after 12 patients have received 1 cycle of treatment.


Options:
A: Median Progression-free Survival (PFS) in each study arm (average of 18 months)
B: Objective Response Rate (ORR) (RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months))
C: Progression-Free Survival (PFS) Comparison (2 Years)
D: Primary objective: Determination of the progression-free survival (PFS) of patients treated with topotecan and sorafenib versus topotecan and placebo (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Multicenter Phase II Study to Assess the Efficacy and Safety of Sorafenib Added to Standard Treatment With Topotecan in Patients With Platinum-resistant Recurrent Ovarian Cancer
Brief Summary: It is assumed, that the patients of the standard arm show a median progression-free survival time of 4.4 months those of the experimental arm of at least 6.9 months. Assuming a recruitment period of 18 months and follow-up for at least 12 months a total sample size of 174 patients is required (two-sided, α=0.05, 80% power). To account for 5% drop-outs 184 patients will be randomized.

A Data Monitoring and Safety Board (DMSB) will be established. This board will evaluate the safety profile of the drug combination after 6 patients and after 12 patients have received 1 cycle of treatment.


Options:
A: Primary objective: Determination of the progression-free survival (PFS) of patients treated with topotecan and sorafenib versus topotecan and placebo (18 months)
B: Progression-free Survival(PFS) (up to 2 years)
C: Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS) (Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years.)
D: Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) (From randomization through September 17, 2010 (up to 3 years, 5 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Multicenter Phase II Study to Assess the Efficacy and Safety of Sorafenib Added to Standard Treatment With Topotecan in Patients With Platinum-resistant Recurrent Ovarian Cancer
Brief Summary: It is assumed, that the patients of the standard arm show a median progression-free survival time of 4.4 months those of the experimental arm of at least 6.9 months. Assuming a recruitment period of 18 months and follow-up for at least 12 months a total sample size of 174 patients is required (two-sided, α=0.05, 80% power). To account for 5% drop-outs 184 patients will be randomized.

A Data Monitoring and Safety Board (DMSB) will be established. This board will evaluate the safety profile of the drug combination after 6 patients and after 12 patients have received 1 cycle of treatment.


Options:
A: Recommended Phase 2 Dose (RP2D) - Part 1 (Phase 1b) (Cycle 1 (21-days)); Objective Response Rates (ORR) - Part 2 (Phase 2a) (12 months); Measure the Progression Free Survival (PFS)- Part 3 ( Phase 3) (12 Months)
B: Median Progression-free Survival (PFS) in each study arm (average of 18 months)
C: Overall survival (OS) (This outcome measure will be assess approximately 4.5-5 years after the last patient enrolled)
D: Primary objective: Determination of the progression-free survival (PFS) of patients treated with topotecan and sorafenib versus topotecan and placebo (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Myo-inositol May Prevent Gestational Diabetes in Obese Women
Brief Summary: Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. This is a prospective, randomized, double center, placebo-controlled study. Two hundred and twenty obese pregnant women will be included in the trial and, after an informed consent, will assume randomly 2 g of myo-inositol twice a day or placebo from 12-13th weeks gestation until delivery. Then,they will perform an Oral Glucose Tolerance Test (OGTT) at 24-28th weeks gestation. Records about delivery (gestational age, neonatal weight...) will be registered.


Options:
A: number of gestational diabetes cases diagnosed with OGTT (24-28th weeks gestation); difference in HOMA values (from first trimester to OGTT)
B: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
C: Mean Fetal Weight at Birth (Immediately after delivery of fetus)
D: Need of insulin treatment for GDM (Day of delivery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Myo-inositol May Prevent Gestational Diabetes in Obese Women
Brief Summary: Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. This is a prospective, randomized, double center, placebo-controlled study. Two hundred and twenty obese pregnant women will be included in the trial and, after an informed consent, will assume randomly 2 g of myo-inositol twice a day or placebo from 12-13th weeks gestation until delivery. Then,they will perform an Oral Glucose Tolerance Test (OGTT) at 24-28th weeks gestation. Records about delivery (gestational age, neonatal weight...) will be registered.


Options:
A: OGTT
B: Maternal Weight Change (baseline to 2 weeks post partum)
C: The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups. (3 - 6 months)
D: number of gestational diabetes cases diagnosed with OGTT (24-28th weeks gestation); difference in HOMA values (from first trimester to OGTT)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Non-Inferiority Bladder Scan Study to Investigate Residual Urine After Use of Intermittent Catheters in Male Subjects
Brief Summary: Male intermittent catheters (ICs) range from 340-500 mm long, with the European standard minimum length being 360 mm for a catheter without a balloon and 275 mm for one with a balloon. This length is defined by hospital standards although it is known that the male urethra has an approximate maximum length of 29 cmA new intermittent catheter developed by Coloplast A/S is a 30-cm-long sterile, ready-to-use, hydrophilic-coated male catheter. There is a lack of clinical data documenting that male ICs that are shorter and more or less flexible than standard catheters can sufficiently empty the bladder of male subjects. This will be tested using ultrasound to measure residual urine in the bladder following catheterisation with new product and standard length catheter.


Options:
A: Mean Residual Urine Volume (3 catheterisations on 1 day)
B: Quality of Life (0-100 Point) (6 weeks)
C: Percentage of Participants (1 week)
D: UTIs (Urine cultures were done at day 0, 7, 14, 28, 42, and 56 (8 weeks).)

Answer: A