TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Who Have Chronic HCV-1/HIV-1 Co-Infection and Are Treatment-Naïve for Hepatitis C
Brief Summary: The purpose of this study is to determine whether the combination of telaprevir, peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus (HCV) infection in subjects who are infected with both HCV and human immunodeficiency virus (HIV).


Options:
A: Percentage of Participants Achieving Sustained Virologic Response (SVR)12 (Posttreatment Week 12); Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug (Baseline to Week 12)
B: Proportion of Subjects Achieving Undetectable HCV RNA at Week 12 (12 weeks after first dose of study drug)
C: HCV RNA (At each clinic visit, throughout study); Adverse events, laboratory parameters, vital signs (At each clinic visit, throughout study)
D: Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 (A Weeks 4 and 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Web-based Support for Caregivers of Veterans Undergoing Chemotherapy
Brief Summary: Given the growing strain on the Veterans Administration resulting from increasing caseloads of cancer patients, interventions are badly needed that assist patients in managing their illness, improve quality of life and avoid acute episodes that result in urgent care use and increased mortality. Previous studies have found that cancer patients undergoing chemotherapy can effectively manage their own symptoms when monitored using automated telephone calls. Such technology, however, may challenge the number of Veterans who lack social support and/or independence. The goal was to develop and test a technology that not only monitors patients automatically by telephone, but also gives them self management advice and engages a friend or family member to serve as a CarePartner willing to play a limited role in identifying patient symptoms and psychosocial needs to reinforce self management and provide social support. The investigators found that this technology indeed helped patients better control their symptoms, especially when a caregiver participated in the program along with them.


Options:
A: Mammography Adherence (12 months)
B: Summed Symptom Severity (3 months)
C: Failure to persist with medication regimen (6 months)
D: Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis Relapses
Brief Summary: The efficacy of oral corticosteroids for the treatment of relapses of multiple sclerosis has not been proved. French neurologists treat such patients with intravenous corticosteroids. The aim of the study is to check if the efficacy of high dose oral methylprednisolone is similar to the efficacy intravenous (IV) prednisolone. The main criteria of efficacy is symptom recovery within 28 days after inclusion.


Options:
A: Estimated Annualized Aggregate Relapse Rate (ARR) (Baseline to end of study (Month 24))
B: Annualized Relapse Rate (2 years)
C: Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6 (Month 3 and Month 6)
D: At least 1 point-reduction on Kurtzke functional scale (28 days after beginning of corticotherapy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis Relapses
Brief Summary: The efficacy of oral corticosteroids for the treatment of relapses of multiple sclerosis has not been proved. French neurologists treat such patients with intravenous corticosteroids. The aim of the study is to check if the efficacy of high dose oral methylprednisolone is similar to the efficacy intravenous (IV) prednisolone. The main criteria of efficacy is symptom recovery within 28 days after inclusion.


Options:
A: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))
B: Percentage of Participants With 3-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS) (Baseline, every 3 month up to the maximum of approximately 3 years)
C: Number of Participants With Anti-DAC HYP Binding Antibodies (ADAbs): Electrochemiluminescent (ECL) Anti-Drug Antibody (ADA) Assay (Up to 44 weeks); Number of Participants With Anti-DAC HYP Neutralizing Antibodies (NAbs): ECL ADA Assay (Up to 44 weeks); TP-DI Sub-study: Area-Under-the-Curve From Zero to Infinity (AUCinf) of Each Probe Drug (Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and at 0.5 and 1, 2, 3, 4, 6, 8, 10 , 24, 48, 72 and 96 hours post-probe drug cocktail administration); TP-DI Sub-study: Dextromethorphan to Dextrorphan Urine Concentration Ratio (Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and for 12 hours after probe-drug cocktail administration)
D: At least 1 point-reduction on Kurtzke functional scale (28 days after beginning of corticotherapy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Enteral Glutamine Supplementation on Mortality and Infectious Morbidity in Severely Burned Patients: a Multi-center Pilot Trial
Brief Summary: The purpose of this study is to test the following hypotheses:

1. Enteral glutamine administration decreases in-hospital mortality in adult patients with severe thermal burn injuries.
2. Enteral glutamine administration decreases hospital-acquired blood stream infections from Gram negative organisms and length of stay in ICU and hospital for adult patients with severe thermal burn injuries.
3. Enteral glutamine administration will improve the physical function of surviving burn injured patients and reduce their cost of care.

The objectives of this trial are to determine the overall treatment effect and safety of glutamine in burn patients. Specifically, the investigators want to assess the following outcomes in a sample of 1200 patients in 80 sites:

1. In patients with severe, life-threatening burn injury, what is the effect of enteral glutamine on time to discharge alive from hospital
2. In patients with severe, life-threatening burn injury, what is the effect of enteral glutamine on 6 month mortality, hospital-acquired blood stream infections from Gram negative organisms, hospital mortality, duration of stay in ICU and hospital, health-related quality of life, and health care resources?


Options:
A: -Expression of TLR2 and TLR4 in peripheral blood monocytes was determined by flow cytometry
B: Time to Discharge Alive (3 months)
C: 28-day Mortality (Day 28)
D: The change in daily total Sequential Organ Failure Assessment Score (SOFA)each day over 10 days. (daily until discharge from intensive care unit, death or maximum duration of 10 days.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of Macrolide Maintenance Therapy and Bacterial Colonisation on Exacerbation Frequency and Progression of COPD, a Randomized Double-blind Placebo-controlled Trial
Brief Summary: To assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in the year of treatment.


Options:
A: myeloperoxidase in induced sputum (3 weeks)
B: Inflammatory markers (outcome will be assessed up to two months post initial bronchoscopy)
C: reduction of number of exacerbations; reduction of number of hospitalisations
D: Reduction in number of exacerbations (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of Macrolide Maintenance Therapy and Bacterial Colonisation on Exacerbation Frequency and Progression of COPD, a Randomized Double-blind Placebo-controlled Trial
Brief Summary: To assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in the year of treatment.


Options:
A: Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (Measured monthly through 13 months)
B: reduction of number of exacerbations; reduction of number of hospitalisations
C: Proportion of Participants With Severe Asthma Exacerbations (from baseline to week 26)
D: Reduction in number of exacerbations (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of Macrolide Maintenance Therapy and Bacterial Colonisation on Exacerbation Frequency and Progression of COPD, a Randomized Double-blind Placebo-controlled Trial
Brief Summary: To assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in the year of treatment.


Options:
A: Reduction in number of exacerbations (1 year)
B: 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)
C: Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery) (Up to 6 weeks after delivery)
D: Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (Measured monthly through 13 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The primary purpose of this study is to determine the safety, tolerability and pharmacokinetics of ABT-308 in healthy volunteers and patients with mild to moderate controlled asthma.


Options:
A: Safety and tolerability will be determined by evaluation of adverse events, vital sign monitoring, physical examination, electrocardiograms, lung function and laboratory assessments. (12 weeks after last dose)
B: The primary endpoint in this study is the number of patients (responder) with a reduction of 75% or more in eosinophils per HPF (distal or proximal esophagus) from baseline to week 13. (13 weeks)
C: Number of Participants With Histologic Response at the Final Treatment Period Evaluation (Week 16) (Week 16); Number of Participants With Dysphagia Symptom Response at the Final Treatment Period Evaluation (Week 16) (Week 16)
D: Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups (16 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Segment Elevation Myocardial Infarction The Eindhoven Reperfusion Study
Brief Summary: The DEBATER study is designed to determine the superiority of abciximab over no abciximab and to determine the superiority of drug eluting stents over bare metal stents in patients with acute myocardial infarction who undergo percutaneous coronary intervention.


Options:
A: Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events (30 Days); Stent Arm - Ischemic Target Lesion Revascularization (1 year); Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis (1 year)
B: Composite of target vessel failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vesselpost-procedure. (1 and 6 months and at 1, 3, 4, and 5 years post-procedure.)
C: target vessel failure (30 days and one year)
D: The incidence of complete ST segment resolution (defined as ≥70% ST 1. The incidence of complete ST segment resolution (60 to 90 minutes after the last angiogram)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).
Brief Summary: Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.


Options:
A: Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism) (20 days)
B: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event (12 months)
C: incidence of VTE (up to 30 days after operation)
D: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).
Brief Summary: Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.


Options:
A: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6-, or 12-month study treatment period)
B: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)
C: Percentage of Patients With Venous Thromboembolisms (12 weeks); Percentage of Patients Who Experienced Clinically Significant Bleeding Events. (13 weeks)
D: Incidence of NCI CTC Toxicity III°/IV° and severe bleedings (minimum of 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).
Brief Summary: Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.


Options:
A: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)
B: Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation (Day 1 up to 12 Months); Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation (Day 1 up to 12 months)
C: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)
D: Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment (Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).
Brief Summary: Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.


Options:
A: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
B: Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism) (20 days)
C: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)
D: Composite end-point represented by the time in days from randomisation to the first occurrence of VTE (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).
Brief Summary: Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.


Options:
A: Incidence of NCI CTC Toxicity III°/IV° and severe bleedings (minimum of 3 months)
B: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)
C: symptomatic objectively confirmed VTE, asymptomatic ultrasonography-confirmed DVT or VTE-related death (30 days)
D: Composite of Recurrent VTE or VTE Death at 36 Months (36 months); Composite of Recurrent VTE or VTE Death at 18 Months (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).
Brief Summary: Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.


Options:
A: Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period (Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy))
B: Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up)
C: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)
D: Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period (Baseline to Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).
Brief Summary: Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.


Options:
A: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)
B: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE (For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180))
C: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (6- or 12-month study treatment period)
D: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6- or 12-month study treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).
Brief Summary: Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.


Options:
A: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6-, or 12-month study treatment period)
B: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
C: Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death (From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first)
D: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)

Answer: D