TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed Dose Study on the Efficacy of [Vortioxetine] Lu AA21004 on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder (MDD)
Brief Summary: Major Depressive Disorder (MDD) is a severe and common psychiatric disorder. Although MDD primarily involves mood disturbances, patients also usually present alterations in cognitive function (attention, memory, executive functioning and psychomotor speed). Even though antidepressants are suggested in the literature to potentially improve cognitive dysfunction in patients with MDD to some degree, there is a lack of adequate and well-controlled studies to investigate this effect. This study will evaluate the efficacy, safety and tolerability of a new antidepressant Vortioxetine versus placebo on cognitive dysfunction in adult patients with MDD.


Options:
A: Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8 (Baseline to Week 8)
B: Change From Baseline to Week 8 in DSST (Number of Correct Symbols) and RAVLT (Acquisition and Delayed Recall) Using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scores (Baseline and Week 8)
C: Change From Baseline in MADRS Total Score After 6 Weeks of Treatment (Baseline and Week 6)
D: Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment (Baseline and Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An International Randomised Controlled Trial to Establish the Effects of Low-dose rtPA and the Effects of Early Intensive Blood Pressure Lowering in Patients With Acute Ischaemic Stroke
Brief Summary: ENCHANTED is an independent, investigator initiated, international collaborative, quasi-factorial randomised controlled trial involving a package of 2 linked comparative randomised treatment arms, which aims to address 4 key questions in patients eligible for thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP) lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)?

The rtPA dose arm of the study addressing questions (1) and (3) concluded with a publication of the results in May 2016. The BP intensity arm of the study addressing questions (2) and (4) concluded with a publication of the results in February 2019.


Options:
A: Favourable outcome (day 90)
B: Rate of patients with intracranial hemorrhagic complications (Scan performed between 24 and 36 hours after thrombectomy)
C: Assessment of modified Rankin Scale shift analysis at 90 days after onset (90 days)
D: Combined death and disability (90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease
Brief Summary: Pulmonary rehabilitation is an effective treatment for people with chronic obstructive pulmonary disease (COPD) which improves symptoms, reduces hospitalisation and lowers healthcare costs. However less than 1% of Australians with COPD receive pulmonary rehabilitation each year, due to poor access to programs and high levels of disability. This randomised controlled trial will examine the benefits and costs of a novel, entirely home-based pulmonary rehabilitation program for COPD. We hypothesise that home-based pulmonary rehabilitation can deliver equivalent clinical outcomes at lower cost than the centre-based program.

We will randomly allocate 144 people with COPD to undertake either standard pulmonary rehabilitation in a hospital setting, or a low-cost home-based program. Those who undertake pulmonary rehabilitation in the hospital setting will attend the hospital twice each week for eight weeks for supervised exercise training and education. People in the home pulmonary rehabilitation group will receive one home visit and weekly telephone calls for eight weeks, for supervision and mentoring of exercise and provision of education. We will compare the number of people who complete the program in each setting. We will also test whether the groups have similar results for the standard pulmonary rehabilitation outcomes of breathlessness, quality of life and exercise capacity, at the end of the program and 12 months later. We will compare health care costs and personal costs between groups after 12 months.

If home-based pulmonary rehabilitation can improve uptake of this important treatment, deliver good clinical outcomes and reduce costs this will have significant and long-lasting benefits for patients, the community and the health system


Options:
A: Chronic Respiratory Disease Questionnaire (6, 12, and 18 months); 6-minute walk (6, 12, and 18 months)
B: Change in 6-minute walk test (Baseline, 8 weeks and 12 months)
C: To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . (12 months); To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group. (12 months)
D: 6-Minute Walking Distance (Baseline and 8 weeks follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease
Brief Summary: Pulmonary rehabilitation is an effective treatment for people with chronic obstructive pulmonary disease (COPD) which improves symptoms, reduces hospitalisation and lowers healthcare costs. However less than 1% of Australians with COPD receive pulmonary rehabilitation each year, due to poor access to programs and high levels of disability. This randomised controlled trial will examine the benefits and costs of a novel, entirely home-based pulmonary rehabilitation program for COPD. We hypothesise that home-based pulmonary rehabilitation can deliver equivalent clinical outcomes at lower cost than the centre-based program.

We will randomly allocate 144 people with COPD to undertake either standard pulmonary rehabilitation in a hospital setting, or a low-cost home-based program. Those who undertake pulmonary rehabilitation in the hospital setting will attend the hospital twice each week for eight weeks for supervised exercise training and education. People in the home pulmonary rehabilitation group will receive one home visit and weekly telephone calls for eight weeks, for supervision and mentoring of exercise and provision of education. We will compare the number of people who complete the program in each setting. We will also test whether the groups have similar results for the standard pulmonary rehabilitation outcomes of breathlessness, quality of life and exercise capacity, at the end of the program and 12 months later. We will compare health care costs and personal costs between groups after 12 months.

If home-based pulmonary rehabilitation can improve uptake of this important treatment, deliver good clinical outcomes and reduce costs this will have significant and long-lasting benefits for patients, the community and the health system


Options:
A: Steps per day as mean over one week from baseline until the treatment end (Every day for 6 months)
B: Change in 6-minute walk test (Baseline, 8 weeks and 12 months)
C: The dyspnea of the chronic respiratory questionnaire (CRQ) at 12 months is the primary outcome variable. (The data collection was terminated in January 2007 and publication was done December 2008)
D: Change in the distance walked at a 6MWT measured at week 12 (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease
Brief Summary: Pulmonary rehabilitation is an effective treatment for people with chronic obstructive pulmonary disease (COPD) which improves symptoms, reduces hospitalisation and lowers healthcare costs. However less than 1% of Australians with COPD receive pulmonary rehabilitation each year, due to poor access to programs and high levels of disability. This randomised controlled trial will examine the benefits and costs of a novel, entirely home-based pulmonary rehabilitation program for COPD. We hypothesise that home-based pulmonary rehabilitation can deliver equivalent clinical outcomes at lower cost than the centre-based program.

We will randomly allocate 144 people with COPD to undertake either standard pulmonary rehabilitation in a hospital setting, or a low-cost home-based program. Those who undertake pulmonary rehabilitation in the hospital setting will attend the hospital twice each week for eight weeks for supervised exercise training and education. People in the home pulmonary rehabilitation group will receive one home visit and weekly telephone calls for eight weeks, for supervision and mentoring of exercise and provision of education. We will compare the number of people who complete the program in each setting. We will also test whether the groups have similar results for the standard pulmonary rehabilitation outcomes of breathlessness, quality of life and exercise capacity, at the end of the program and 12 months later. We will compare health care costs and personal costs between groups after 12 months.

If home-based pulmonary rehabilitation can improve uptake of this important treatment, deliver good clinical outcomes and reduce costs this will have significant and long-lasting benefits for patients, the community and the health system


Options:
A: Treatment Adherence (10 months)
B: Self-Reported Respiratory-Specific Quality of Life (four months from randomization); Self-Reported Respiratory-Specific Quality of Life (twelve months from randomization)
C: Effectiveness of an Tele Respiratory Rehabiltation program (TeleRehab) in the maintenance of benefits after an intensive respiratory rehabilitation program evaluated through the 6 m Walking test and health quality questionnaires after 12 months (One Year)
D: Change in 6-minute walk test (Baseline, 8 weeks and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease
Brief Summary: Pulmonary rehabilitation is an effective treatment for people with chronic obstructive pulmonary disease (COPD) which improves symptoms, reduces hospitalisation and lowers healthcare costs. However less than 1% of Australians with COPD receive pulmonary rehabilitation each year, due to poor access to programs and high levels of disability. This randomised controlled trial will examine the benefits and costs of a novel, entirely home-based pulmonary rehabilitation program for COPD. We hypothesise that home-based pulmonary rehabilitation can deliver equivalent clinical outcomes at lower cost than the centre-based program.

We will randomly allocate 144 people with COPD to undertake either standard pulmonary rehabilitation in a hospital setting, or a low-cost home-based program. Those who undertake pulmonary rehabilitation in the hospital setting will attend the hospital twice each week for eight weeks for supervised exercise training and education. People in the home pulmonary rehabilitation group will receive one home visit and weekly telephone calls for eight weeks, for supervision and mentoring of exercise and provision of education. We will compare the number of people who complete the program in each setting. We will also test whether the groups have similar results for the standard pulmonary rehabilitation outcomes of breathlessness, quality of life and exercise capacity, at the end of the program and 12 months later. We will compare health care costs and personal costs between groups after 12 months.

If home-based pulmonary rehabilitation can improve uptake of this important treatment, deliver good clinical outcomes and reduce costs this will have significant and long-lasting benefits for patients, the community and the health system


Options:
A: Training time (3 month)
B: To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . (12 months); To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group. (12 months)
C: Measure of physical activity (Change from Baseline to Week 12)
D: Change in 6-minute walk test (Baseline, 8 weeks and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase 2 Study of Ruxolitinib Efficacy and Safety in Combination With Capecitabine for Subjects With Recurrent or Treatment Refractory Metastatic Pancreatic Cancer (The RECAP Trial)
Brief Summary: The purpose of this study was to determine whether ruxolitinib added to capecitabine is effective in improving the overall survival of patients with metastatic pancreatic cancer.


Options:
A: Overall Survival (OS) (From day of randomization to the date of death, assessed up to 60 months)
B: Progression free survival (4 years)
C: Overall Survival (Primary analysis includes study data from the start of the study (first dose for that subject) until the death of the subject (up to 8 months).)
D: Determine if the Treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in Combination With Gemcitabine Improves Overall Survival as Compared With Placebo in Combination With Gemcitabine in Subjects With Metastatic Adenocarcinoma of the Pancreas (From randomization up to 20 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion
Brief Summary: The aim of SOCCER is to evaluate the effects of treatment with supplemental O2 before and during acute balloon angioplasty (PCI) for patients with ST-elevation myocardial infarction (STEMI). One hundred STEMI patients are randomized in the ambulance to either standard O2 treatment (10 l/min) or no supplemental O2, to be given until the end of the acute PCI. Cardiac magnetic resonance imaging and echocardiography during the hospital stay is used to assess infarct size and myocardial performance. All patients are followed for 6 months. At 6 months, perceived health and NT-proBNP are recorded for all patients, and an additional echocardiography is performed. The primary endpoint is the fraction of myocardium saved with the acute PCI. The secondary endpoints include the pain difference between inclusion time and start of PCI and myocardial performance on echocardiography.


Options:
A: Ventilator-free Days (VFDs) to Study Day 28 (28 days)
B: Chest pain measured with VAS (1 h)
C: Myocardial salvage index (Day 4-6 after the acute PCI)
D: 1-year all-cause mortality (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet Composition and Genetics: Effects on Weight, Inflammation and Biomarkers
Brief Summary: The purpose of the MENU Study is to examine whether there is a differential weight loss response to different dietary macronutrient composition (higher carbohydrate and lower fat versus lower carbohydrate and higher monounsaturated fat \[MUFA\] or lower carbohydrate and walnut-rich higher fat diets) in a weight loss intervention in healthy obese women, depending on insulin resistance status. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.


Options:
A: 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)
B: Weight loss (1 year)
C: Atrial tachycardia and atrial fibrillation burden (18 months)
D: COPD exacerbations in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year); Airflow obstruction/change in pulmonary function (pre-randomization and after 2 years follow-up); Pneumonia in the past year over the course of the study (at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet Composition and Genetics: Effects on Weight, Inflammation and Biomarkers
Brief Summary: The purpose of the MENU Study is to examine whether there is a differential weight loss response to different dietary macronutrient composition (higher carbohydrate and lower fat versus lower carbohydrate and higher monounsaturated fat \[MUFA\] or lower carbohydrate and walnut-rich higher fat diets) in a weight loss intervention in healthy obese women, depending on insulin resistance status. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.


Options:
A: Death, all-cause (Up to 7 years)
B: Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
C: Weight loss (1 year)
D: 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))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet Composition and Genetics: Effects on Weight, Inflammation and Biomarkers
Brief Summary: The purpose of the MENU Study is to examine whether there is a differential weight loss response to different dietary macronutrient composition (higher carbohydrate and lower fat versus lower carbohydrate and higher monounsaturated fat \[MUFA\] or lower carbohydrate and walnut-rich higher fat diets) in a weight loss intervention in healthy obese women, depending on insulin resistance status. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.


Options:
A: Weight loss (1 year)
B: Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies (12 months); Alanine Transaminase (ALT) Levels (3 month endpoint); Alanine Transaminase (ALT) Levels (6 months)
C: Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure. (24months)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet Composition and Genetics: Effects on Weight, Inflammation and Biomarkers
Brief Summary: The purpose of the MENU Study is to examine whether there is a differential weight loss response to different dietary macronutrient composition (higher carbohydrate and lower fat versus lower carbohydrate and higher monounsaturated fat \[MUFA\] or lower carbohydrate and walnut-rich higher fat diets) in a weight loss intervention in healthy obese women, depending on insulin resistance status. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.


Options:
A: Atrial tachycardia and atrial fibrillation burden (18 months)
B: Weight loss (1 year)
C: 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)
D: Change in body weight (measured at Year 2)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Diet Composition and Genetics: Effects on Weight, Inflammation and Biomarkers
Brief Summary: The purpose of the MENU Study is to examine whether there is a differential weight loss response to different dietary macronutrient composition (higher carbohydrate and lower fat versus lower carbohydrate and higher monounsaturated fat \[MUFA\] or lower carbohydrate and walnut-rich higher fat diets) in a weight loss intervention in healthy obese women, depending on insulin resistance status. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.


Options:
A: Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization. (Total follow-up time of up to approximately 6 years.)
B: Cumulative incidence of Major depressive Disorder (12 months)
C: Weight loss (1 year)
D: Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Baby Observational and Nutritional Study (BONUS)
Brief Summary: Cystic fibrosis (CF) is a life-shortening disease that causes breathing and digestive problems, but can now be diagnosed at the time of birth. Lung function is very hard to measure in infants, but growth is not. In this study the investigators aim to define growth in infants with CF in the first year of life with research quality precision and to understand factors that interfere with good growth.

Pancreatic enzyme replacement therapy (PERT) will be also be studied in a subgroup of infants. Two different doses of PERT will be evaluated for improving fat and nitrogen absorption in infants with CF.


Options:
A: Development and evaluation of the CFAbd-Score (initially named JenAbdomen CF-Score), a CF-specific PROM following FDA recommendations (7 years); Development and evaluation of a diary for assessment and quantification of abdominal symptoms, a CF-specific PROM following FDA recommendations (7)
B: Incremental gain in weight, length, and head circumference (one year)
C: Treatment Difference in Coefficient of Fat Absorption (CFA) Change From Baseline (Baseline, 7 weeks)
D: 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)

Answer: B