TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis
Brief Summary: The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS.

Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression.

Other secondary objectives were:

* To assess the effect of the two doses of teriflunomide in comparison to placebo on:

  * Fatigue;
  * Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.
* To evaluate the safety and tolerability of teriflunomide.


Options:
A: Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint (up to 36 months after the last patient was randomized)
B: Confirmed Annualized Relapse Rate (up to 12 months)
C: Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate (Core treatment period between 48 - 152 weeks depending on time of enrollment)
D: Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months) (Baseline to Month 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis
Brief Summary: The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS.

Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression.

Other secondary objectives were:

* To assess the effect of the two doses of teriflunomide in comparison to placebo on:

  * Fatigue;
  * Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.
* To evaluate the safety and tolerability of teriflunomide.


Options:
A: Core Treatment Period: Overview of Failures (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled); Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled)
B: Core Treatment Period: Time to Conversion to Clinically Deﬁnite Multiple Sclerosis (CDMS) (Up to a maximum of 108 weeks depending on time of enrollment)
C: Number of patients with adverse events (Up to a maximum of 532 weeks (4 weeks after last treatment intake) or until teriflunomide is commercially available in the country where patient lives)
D: Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate (Core treatment period between 48 - 152 weeks depending on time of enrollment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis
Brief Summary: The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS.

Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression.

Other secondary objectives were:

* To assess the effect of the two doses of teriflunomide in comparison to placebo on:

  * Fatigue;
  * Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.
* To evaluate the safety and tolerability of teriflunomide.


Options:
A: Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate (Core treatment period between 48 - 152 weeks depending on time of enrollment)
B: Annualized Relapse Rate (2 years)
C: Percentage of Participants With Sustained Accumulation of Disability (SAD) (Up to 2 years); Annualized Relapse Rate (Up to 2 years)
D: Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan (Weeks 12 to 36)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis
Brief Summary: The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS.

Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression.

Other secondary objectives were:

* To assess the effect of the two doses of teriflunomide in comparison to placebo on:

  * Fatigue;
  * Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.
* To evaluate the safety and tolerability of teriflunomide.


Options:
A: Delay to disability deterioration as assessed by the Expanded Disability Status Scale (EDSS: 0.5 or 1 point increase, depending on baseline score) (every 4 weeks for one year, then every 8 weeks for one year)
B: Overview of Adverse Events (AE] (from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)); Overview of AE With Potential Risk of Occurrence (from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)); Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) (from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max))
C: Proportion of Subjects Relapsed (2 years)
D: Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate (Core treatment period between 48 - 152 weeks depending on time of enrollment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death. The primary endpoint is survival at 180 days which is defined as alive on the originally implanted HeartWare® LVAD or transplanted or explanted for recovery. Patient must survive 60 days post-explant for recovery to be considered successful. Secondary endpoints include:

* Overall survival
* Incidence of all serious adverse events, neurocognitive status and unanticipated adverse device effects.
* Incidence of all device failures and device malfunctions
* Quality of Life improvement, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQoL EQ-5D
* Functional status improvement, as measured by the New York Heart Association (NYHA) and 6-minute walk

The HeartWare® LVAD System was approved by the US FDA on November 20, 2012 as a bridge to cardiac transplantation (reference PMA P100047). Patients enrolled into this study will be followed to an outcome at six months, and then patients will receive continued follow-up in a separate study.


Options:
A: To reduce risk factors related to metabolic syndrome
B: The Primary Endpoint is Success at 180 Days Which is Defined as Alive on the Originally Implanted HeartWare® LVAD or Transplanted or Explanted for Recovery. Patient Must Survive 60 Days Post-explant for Recovery to be Considered Successful. (180 days)
C: 24 hour blood pressure (12 weeks)
D: Resting systolic blood pressure (3 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Web-based Ultra-brief Intervention for Heavy Drinkers - a Randomized Controlled Trial Comparing Personalized Normative Feedback With Self-help Material
Brief Summary: The purpose of the study is to determine whether a web-based ultra-brief intervention, consisting of personalized normative feedback or standardized self-help material, is effective in lowering self reported alcohol use in heavy drinkers.


Options:
A: alcohol intake (six months and one year); injury recidivism (six months and one year)
B: Reduction of 15% in alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the PFI group . In the self-help material group we expect that 5 - 10% will reduce their consumption equivalent. (12 months)
C: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)
D: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Web-based Ultra-brief Intervention for Heavy Drinkers - a Randomized Controlled Trial Comparing Personalized Normative Feedback With Self-help Material
Brief Summary: The purpose of the study is to determine whether a web-based ultra-brief intervention, consisting of personalized normative feedback or standardized self-help material, is effective in lowering self reported alcohol use in heavy drinkers.


Options:
A: Reduction of 15% in alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the PFI group . In the self-help material group we expect that 5 - 10% will reduce their consumption equivalent. (12 months)
B: Change in estimated Blood Alcohol Concentration (eBAC) (6, 12 and 18 weeks); Alcohol Use Disorders Identification Test (AUDIT) (6, 12 and 18 weeks)
C: Number of screening tests carried out in primary health care settings to detect excessive alcohol consumption care (5 months); Number of brief interventions for excessive alcohol consumption delivered in primary health care settings (5 months)
D: Alcohol Use Disorders Identification Test - Consumption scale (AUDIT-C scale) (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: VITA-D: Cholecalciferol Substitution in Vitamin D Deficient Kidney Transplant Recipients: A Randomized, Placebo-controlled Study to Evaluate the Posttransplant Outcome
Brief Summary: The purpose of the study is to evaluate the effects of Cholecalciferol (Vitamin D3) substitution on the posttransplant outcome (glomerular filtration rate as well as serum creatinine levels, number of acute rejection episodes, number of infections and C-reactive protein levels within the first year after transplantation) in vitamin D deficient kidney transplant recipients.


Options:
A: Correction of metabolic acidosis (12 months)
B: N/A
C: Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks
D: The immunologic effects of Vitamin D3 substitution in vitamin D deficient kidney transplant recipients will be evaluated by means of: Glomerular filtration rate (one year after kidney transplantation); Number of acute rejection episodes (one year after kidney transplantation); Number of infections (one year after kidney transplantation); CRP levels (one year after kidney transplantation); Courses of calcium levels (within the first year after kidney transplantation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Home Automated Telemanagement in COPD
Brief Summary: All chronic obstructive pulmonary diseases (COPDs) block air flow to the lungs, and the two most common forms, emphysema and chronic bronchitis, are the most common causes of respiratory failure. Previous research shows that if COPD patients know more about their disease and how to manage it themselves, they will improve their quality of life and reduce their need for urgent care. However, traditional methods of teaching COPD patients about their disease and self-management skills are expensive and require intensive work. A new, less expensive way of reaching a large group of people with this information is needed to help patients stay healthier and happier with their treatment. This study will create a computer program that can help people learn about their disease and how to manage it themselves. This study will then determine whether the computer program, called Home Automated Telemanagement (HAT), helps patients with COPD in managing their disease and following their treatment plans.


Options:
A: Change from baseline in Shuttle Walk test at 6 weeks (6 weeks)
B: Measure of physical activity (Change from Baseline to Week 12)
C: Daily number of steps (changes from baseline to 3 months)
D: Clinical health, including lung function and respiratory symptoms (Measured at baseline and every 3 months for 18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Home Automated Telemanagement in COPD
Brief Summary: All chronic obstructive pulmonary diseases (COPDs) block air flow to the lungs, and the two most common forms, emphysema and chronic bronchitis, are the most common causes of respiratory failure. Previous research shows that if COPD patients know more about their disease and how to manage it themselves, they will improve their quality of life and reduce their need for urgent care. However, traditional methods of teaching COPD patients about their disease and self-management skills are expensive and require intensive work. A new, less expensive way of reaching a large group of people with this information is needed to help patients stay healthier and happier with their treatment. This study will create a computer program that can help people learn about their disease and how to manage it themselves. This study will then determine whether the computer program, called Home Automated Telemanagement (HAT), helps patients with COPD in managing their disease and following their treatment plans.


Options:
A: Clinical health, including lung function and respiratory symptoms (Measured at baseline and every 3 months for 18 months)
B: Physical activity (Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)); Physical activity (Change between T1 and T2: 3 months follow up)
C: Chronic Respiratory Disease Questionnaire (6, 12, and 18 months); 6-minute walk (6, 12, and 18 months)
D: COPD hospitalization rates (1 year (study inclusion - 12 months of follow-up))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma
Brief Summary: This clinical trial will compare the efficacy and safety of the combination of AMG 386 and FOLFIRI with FOLFIRI alone in second line treatment of metastatic colorectal cancer.


Options:
A: Progression free survival (every course for first three courses, then every other course)
B: To estimate the treatment effect as measured by progression free survival (PFS) in subjects treated with AMG 386 + FOLFIRI relative to subjects treated with FOLFIRI + placebo. (The time frame will be event driven and will occur when 100 subjects have experienced a PFS event (radiographic disease progression or death).)
C: Overall Survival (Every 8 weeks, up to 12 months after the last participant was randomized or until the target number of events (deaths) was met, whichever was later. (Overall survival data was collected till 24 Jan 2014 which was date of observation of the 571st death))
D: Overall Survival: Time From Randomization to Death From Any Cause (within 6.5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Resistance Training in Radically Treated Respiratory Cancer Patients: a Prospective Randomized Multicenter Study
Brief Summary: The first part of the study is an observational part. In eligible patients with early stage respiratory cancer, the primary and secondary endpoints will be evaluated before and after their scheduled radical cancer therapy. The measured variables, include a blood sample, pulmonary function tests, level of dyspnea, exercise tests, measurement of body composition, respiratory and peripheral muscle force, health related quality of life and psychological status. Only registered participants having completed a radical treatment and having either less than 70% of the predicted normal value of the quadriceps force (QF) or a decrease of more than 10% predicted value of the QF between pre-and post radical treatment, will be allowed to participate to the second part of the study. These patients will then be randomized in three groups. Group A, the control group, will have the usual care and follow up according to clinical symptoms. Group B will be offered a conventional resistance training program (CRT), and group C, will be offered a whole body vibration resistance training (WBV) on the FITVIBE-platform. All previous variables will be measured after 6 and 12 weeks of training.


Options:
A: Systemic inflammation measured by c-reactive protein. (12 weeks)
B: QoL: Physical Well-Being (FACT-L) (assessed after 12 weeks of enrolement); General Fatigue (MFI) (assessed after 12 weeks of enrolement)
C: VO2peak (baseline and after 12 weeks)
D: The change of 6MWD observed between pre-and post radical treatment (12 weeks); between post radical treatment and after a 12 week resistance training (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Resistance Training in Radically Treated Respiratory Cancer Patients: a Prospective Randomized Multicenter Study
Brief Summary: The first part of the study is an observational part. In eligible patients with early stage respiratory cancer, the primary and secondary endpoints will be evaluated before and after their scheduled radical cancer therapy. The measured variables, include a blood sample, pulmonary function tests, level of dyspnea, exercise tests, measurement of body composition, respiratory and peripheral muscle force, health related quality of life and psychological status. Only registered participants having completed a radical treatment and having either less than 70% of the predicted normal value of the quadriceps force (QF) or a decrease of more than 10% predicted value of the QF between pre-and post radical treatment, will be allowed to participate to the second part of the study. These patients will then be randomized in three groups. Group A, the control group, will have the usual care and follow up according to clinical symptoms. Group B will be offered a conventional resistance training program (CRT), and group C, will be offered a whole body vibration resistance training (WBV) on the FITVIBE-platform. All previous variables will be measured after 6 and 12 weeks of training.


Options:
A: Change in physical fitness measured by CPET (ml/kg/min) (Pre neoadjuvant chemoradiotherpy(NACRT), post NACRT (week 0 of SRETP) and week 9 of SRETP)
B: The change of 6MWD observed between pre-and post radical treatment (12 weeks); between post radical treatment and after a 12 week resistance training (12 weeks)
C: What is the effect of chemotherapy on the fitness of patients prior to cancer surgery? (2 years)
D: Menopausal symptoms (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Lnug Transplantation
Brief Summary: A prospective, interventional rehabilitation program was initiated to improve exercise capacity and psychosocial functioning in patients after lung transplantation (LTx) and to evaluate long-term effects on health-related quality of life (HRQoL).

Study subjects were randomized to either intervention or to control group and were followed with regular cardiopulmonary exercise testings and HRQoL measurements (SF-36) for 36±3 months after LTx. Patient characteristics did not differ concerning age, gender, and diagnosis at study entry. IG patients received regular psychosocial support and performed a home-based supervised ergometer training program. CG patients were recommended to perform regular exercising.


Options:
A: Physical Function- Walking: Change in Average Steps Per Day at Month 3 (Baseline and 3 months); Physical Function- Walking: Change in Average Steps Per Day at Month 6 (Baseline and 6 months); Physical Function- Balance: Change in Berg Balance at Month 3 (Baseline and 3 months.); Physical Function- Balance: Change From Baseline to 6 Months (Baseline and 6 months); Physical Function-Lower Body Strength: Change From Baseline to 3 Months (Baseline and 3 months.); Physical Function-Lower Body Strength: Change From Baseline to 6 Months (Baseline and 6 months.); Physical Function- Respiratory-related Quality of Life Change From Baseline to 3 Months. (Baseline and 3 months.); Physical Function- Respiratory-related Quality of Life: Change From Baseline to 6 Months. (Baseline and 6 months); Physical Activity-Minutes of Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 3 Months. (Baseline and 3 months.); Physical Activity-Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 6 Months. (Baseline and 6 months.)
B: Change in daily physical activity (Measured for 1 week pre-transplant, measured for 1 week at randomisation (1-2 months post-transplant), 1 week following the 3 month intervention, 1 week at 6 months post randomisation and 1 week at 12 months post-randomisation.)
C: Change in peak oxygen uptake (0-20 weeks)
D: HRQoL, exercise capacity (36 mts)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of a Nurse-driven ICT-supported Disease Management Program to Improve the Treatment of Patients With Atrial Fibrillation.
Brief Summary: * Randomized controlled trial comparing specialized AF Clinic with 'care as usual'
* Hypothesis: treatment of AF patients in the AF-Clinic by a nurse, specialised in AF, using guideline-based dedicated software, under supervision of a cardiologist, is efficient, safe and not inferior to care as usual by a cardiologists.


Options:
A: Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes. (minimum of 1 year)
B: Framingham Risk Score (15 months)
C: Death (4 months); Death (8 months); Death (12 months); Death (16 months); Death (20 months); Death (24 months); Death (3 years); Death (4 years); Stroke/Systemic embolism (SE) (4 months); Stroke/Systemic embolism (SE) (8 months); Stroke/Systemic embolism (SE) (12 months); Stroke/Systemic embolism (SE) (16 months); Stroke/Systemic embolism (SE) (20 months); Stroke/Systemic embolism (SE) (24 months); Stroke/Systemic embolism (SE) (3 years); Stroke/Systemic embolism (SE) (4 years); Major bleeding (4 months); Major bleeding (8 months); Major bleeding (12 months); Major bleeding (16 months); Major bleeding (20 months); Major bleeding (24 months); Major bleeding (3 years); Major bleeding (4 years)
D: Time to First Event (Death, Stroke, Major Bleed) (Time to event)

Answer: A