TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Subjects With Low CA125 Platinum-Sensitive Ovarian Cancer
Brief Summary: MORAb-003-011 is a global, multicenter, double-blind, randomized placebo-controlled study to assess the safety and efficacy of farletuzumab in combination with standard chemotherapy in subjects with low cancer antigen 125 (CA125) platinum-sensitive ovarian cancer in first relapse.


Options:
A: Progression Free Survival (PFS) (From the date of randomization to the date of first documentation of PD, or date of death, whichever occurs first up to approximately 5 years 5 months)
B: Investigator-assessed Progression-free Survival (PFS) (From the date of randomization until the date of progression or death due to any cause (median time of follow-up was 17.9 months for pazopanib and 12.3 months for placebo))
C: objective response rate by RECIST 1.1 (6 months after treatment initiation)
D: progression free survival (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy in South Korea and Taiwan
Brief Summary: Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular risk participants with hypercholesterolemia in South Korea and Taiwan.

Secondary Objectives:

* To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks of treatment.
* To evaluate the effect of alirocumab on other lipid parameters: apolipoprotein B (Apo B), non high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein (a) (Lp \[a\]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), and apolipoprotein A-1 (Apo A-1).
* To evaluate the safety and tolerability of alirocumab.
* To evaluate the development of anti-alirocumab antibodies (ADA).


Options:
A: the change in fibrous cap thickness (9 month)
B: Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)
C: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis (From Baseline to Week 24)
D: Change From Baseline in Percent Atheroma Volume at Week 78 (Baseline and week 78)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Determination of the Role of Oxygen on Mechanisms Involved in Ischemia-reperfusion Injury in Suspected Acute Myocardial Infarction by Biomarkers. A Sub Study to the DETO2X-AMI Trial.
Brief Summary: Oxygen treatment is widely used in acutely ill patients, both pre-hospital and in hospital. The indication for oxygen is sometimes unquestionable, such as in many hypoxic patients, but in other situations its use is more of a practise and much less based on scientific evidence. In particular, oxygen treatment is routinely used in patients with a suspected heart attack and variably recommended in guidelines, despite very limited data supporting a beneficial effect. Indeed, a few studies even indicate that oxygen treatment might be harmful.

Immediate re-opening of the acutely blocked artery to the heart muscle is the treatment of choice to limit permanent injury. However, the sudden re-initiation of blood flow achieved with primary percutaneous coronary intervention (PCI), the reopening and stenting of the blocked vessel, can give rise to further endothelial and myocardial damage, so-called reperfusion injury. Ischemia and reperfusion associated myocardial injury (IR-injury) involves a wide range of pathological processes. Vascular leakage, activation of cell death programs, thrombocytes and white blood cells leading to extended inflammation and formation of clots are examples of those effects.

The role of oxygen treatment on these pathological processes, on the extent of IR-injury and the final infarct size in patients with acute myocardial infarctions (AMI) has not previously been studied.

In an ongoing national multicentre, randomized, registry based clinical trial, the DETO2X-AMI trial (NCT01787110), the effect of oxygen on morbidity and mortality in ACS patients is being investigated.

The present DETO2X-biomarkers study is a substudy of the DETO2X-AMI trial, evaluating the effect of oxygen treatment on biological systems involved in the pathogenesis of reversible and irreversible myocardial damage and cell death in ACS.


Options:
A: Quality of Life as Measured by SF-36 (Baseline, 6 months)
B: Oxygen Desaturation Index 4% (ODI4%) (Overnight, up to 8 hrs on nights 1 and 2)
C: Plasma concentration levels over time of biomarkers of oxidative stress, apoptosis, inflammation and platelet aggregation (Within 8hours from baseline)
D: Time to First Hospitalization (From enrolment up to 9 months); Final Utility Index of EQ-5D Questionnaire (9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilipino Americans Go4Health Weight Loss Program to Prevent Heart Disease
Brief Summary: This is a pilot randomized controlled trial intervention to improve lifestyle behaviors (physical activity and health diet) for Filipino Americans with type 2 diabetes on metformin. If the PilAm Go4Health intervention demonstrates potential efficacy, it may identify effective intervention strategies to significantly reduce risks for heart disease risks (i.e., metabolic syndrome) in Filipino Americans.


Options:
A: Body mass index (6 month change)
B: Visual Analogue Scale (Four hours)
C: Body Weight (kg) (Six months); MR spectroscopy (Six months); Magnetic resonance imaging (Six months); Dual-energy X-ray absorptiometry (DEXA) scan (Six months)
D: Feasibility for Participant Enrollment and Retention (Baseline to 6-months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: SheppheartCABG. A Randomised Clinical Trial of a Comprehensive Physical and Psycho-educative Rehabilitation Programme Plus Usual Care Versus Usual Care in Phase 1 Rehabilitation After Coronary Artery Bypass Grafting
Brief Summary: Background: Patients undergoing coronary artery bypass graft surgery often experience a range of problems and symptoms related to the procedure and the underlying heart disease.These problems include anxiety and depressive symptoms, immobility issues, complications such as wound seeping, neck and shoulder pains, interrupted and insufficient sleep. No studies have tested a combined intervention on phase 1 rehabilitation in coronary artery bypass graft surgery patients. However, randomised trials with either a physical or a mental part have been conducted with positive result, but evidence is lacking for a combined intervention. Before a large randomised trial was set up a pilot trial was conducted to evaluate the feasibility of patient recruitment and intervention: to test the safety and tolerability of the intervention by patients and to provide outcome data for sample size calculations. The SheppHeartCABG pilot showed trial feasibility, safety and sufficient inclusion rate and high compliance with most elements. Outcome data from the pilot trial has been used to sample size and power calculation in this randomised clinical trial.

Objective: The objective of this trial is to investigate the benefits and harms of a phase 1 comprehensive cardiac rehabilitation programme consisting of an exercise-training and a psycho-educative component, including plus treatment as usual in patients who undergo coronary artery bypass grafting.


Options:
A: Change in Mean Daily Steps (Baseline and end of Maintenance Period at Week 16)
B: Autonomic Function (Change from Baseline in Autonomic Function at 8 weeks of Cardiac Rehabilitation Program)
C: 6-minute walk test (4 week)
D: Peripheral blood gene expression (baseline); Peripheral blood gene expression (6wks after starting 12week exercise training (or conventional care)); peripheral blood gene expression (12 weeks after exercise training (or conventional care)); Peripheral blood gene expression (24 weeks after starting 12 weeks exercise training programme)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) A Randomized, Controlled, Double-blind, Parallel Group, Proof-of-concept Trial EDITA
Brief Summary: Trial Design Patients with borderline PAH indicated by borderline mPAP values will be included in this single centre study. This clinical investigation is performed as a Proof-of-Concept (PoC) investigator initiated trial (IIT) using a prospective, randomized, double-blind, parallel group, placebo-controlled, phase IIA clinical study design. On their first visit their medical history will be obtained and physical examination will be conducted. Moreover, an electrocardiogram (ECG), laboratory testing (NT-proBNP, uric acid and other laboratory tests), echocardiography at rest and right heart catheterization will be carried out. If patients have been identified within the last 6 months before screening investigations by right heart catheterization, the measurements are considered valid as baseline investigations and will not be repeated. If patients fulfill the inclusion criteria and still suffer from borderline mPAP values they will be invited to join the study. The clinical investigations will begin within 28 days. The prospective study will comprise a 6 months study period (180 ±2 weeks) plus the screening phase up to 28 days and a follow-up phase of 30 ±7 days.


Options:
A: Frequently Reported (15% or More Overall) Adverse Events by Severity (Baseline to Week 295); Serum Aminotransferases Relative to the Upper Limit of the Normal Range (ULN) (Baseline to Week 295)
B: Time to Death or Disease (IPF) Progression. (Up to 48 months)
C: Improvement in six minute walk distance (16 weeks)
D: Mean Pulmonary Arterial Pressure Change From Baseline (baseline, 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: LA Sprouts: The Impact of Gardening and Nutrition Education on Childhood Obesity in Latino Youth
Brief Summary: The overall goal of this project is to conduct a randomized controlled 12-week after school, gardening, nutrition and cooking program (called "LA Sprouts") to improve dietary intake and reduce obesity in 3rd, 4th and 5th grade students (ages 8-12 years) in Los Angeles. Approximately 400 3rd - 5th grade students participating in the LA's Best after school program will participate. Four elementary schools in Los Angeles will be selected to participate in the study. Schools will be randomized by region to either receive the intervention (LA Sprouts; 2 schools, n=200 students) or serve as controls (received a delayed intervention program one school semester later; 2 schools, n=200 students). The LA Sprouts intervention will take place at the elementary schools, with gardens on campus specially designed and built for this project. The program will be held once a week for 12 weeks and will consist of a 45-minute gardening lesson, taught by Master Gardeners from the University of California Cooperative Extension (supervised by Nicole Gatto, MPH, PhD), and a 45-minute nutrition education and cooking lesson, taught by USC a Nutrition Educator (supervised by Jaimie Davis, PhD, RD). Measures of childhood obesity (i.e., body mass index (BMI) and body fat percentages), blood pressure, metabolic function (fasting blood glucose, insulin and lipids), dietary intake and related behaviors, and school performance will be measured before and after the implementation of the program in both intervention and control participants. Approximately 10 additional students of the same age will be asked to participate in a focus group to evaluate the questionnaire developed for this study. In addition, approximately 20 additonal students of the same age will be asked to participate in a test-retest session to validate the reliability of the questionnaire.


Options:
A: % Body Fat (Boys) (Baseline and 3 years); BMI Z-score (Boys) (Baseline and three years); % Body Fat (Girls) (Baseline and 3 years); BMI Z-score (Girls) (Baseline and three years)
B: change in adiposity (baseline and 12 weeks); change in blood pressure (baseline and 12 weeks); change in metabolic function (baseline and 12 weeks)
C: Smoking prevalence of adolescents in each group (six years)
D: Change in body mass index (BMI) (Baseline, Month 3)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Importance of Surgical Approach for Hysterectomies on Metabolic Effects Regarding Development of Insulin Resistance and Subsequent Recovery. A Randomized Controlled Study.
Brief Summary: Insulin resistance is a key reaction to surgery and trauma and reflects the degree of metabolic stress. With greater degree of insulin resistance the development of complications increase, in particular infectious complications. The aim of this study is to determine if robotic assisted total laparoscopic hysterectomy induces less insulin resistance compared to abdominal hysterectomy. Insulin resistance is measured by the hyperinsulinemic normoglycemic clamp method. In addition inflammatory factors and clinical recovery will be measured.


Options:
A: Operative Time (Intra operative)
B: Duration of Surgery (after surgey)
C: Operative time of the procedure (Range from 90 minutes to 210 minutes)
D: Insulin resistance (3 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Importance of Surgical Approach for Hysterectomies on Metabolic Effects Regarding Development of Insulin Resistance and Subsequent Recovery. A Randomized Controlled Study.
Brief Summary: Insulin resistance is a key reaction to surgery and trauma and reflects the degree of metabolic stress. With greater degree of insulin resistance the development of complications increase, in particular infectious complications. The aim of this study is to determine if robotic assisted total laparoscopic hysterectomy induces less insulin resistance compared to abdominal hysterectomy. Insulin resistance is measured by the hyperinsulinemic normoglycemic clamp method. In addition inflammatory factors and clinical recovery will be measured.


Options:
A: Number of lymph nodes (After aortic lymphadenectomy is completed)
B: Insulin resistance (3 weeks)
C: postoperative pain measured by a 10 point numeric rating scale (around one week)
D: Number of harvested lymph nodes (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study to Enhance Motor Acute Recovery With Intensive Training After Stroke
Brief Summary: Stroke often results in limitation of arm movements, from which many people do not fully recover. We believe that early and intensive therapy is important to enhance recovery of arm movements after stroke. We are doing this research study to see how much arm movements improve with intensive therapy in patients have had a stroke in the past 6 weeks.


Options:
A: Dynamic sitting balance and trunk control (Change from Baseline at week 5); Stepping (Change from Baseline at week 5)
B: Fugl-Meyer Upper Extremity (FM-UE) (from baseline to day 3 post-training)
C: Community Balance and Mobility Scale (Pre treatment and Post treatment (6 weeks))
D: Change in Upper Limb function (Baseline and posttest (an average of 2 weeks from baseline))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study to Enhance Motor Acute Recovery With Intensive Training After Stroke
Brief Summary: Stroke often results in limitation of arm movements, from which many people do not fully recover. We believe that early and intensive therapy is important to enhance recovery of arm movements after stroke. We are doing this research study to see how much arm movements improve with intensive therapy in patients have had a stroke in the past 6 weeks.


Options:
A: Change in Upper Limb function (Baseline and posttest (an average of 2 weeks from baseline))
B: Jebsen Taylor Hand Function Test (2 weeks); Cortical Excitability (1 hour); Cortical Oscillations - EEG (15 minutes)
C: Fugl-Meyer Upper Extremity (FM-UE) (from baseline to day 3 post-training)
D: Motor Skill Retention (Day 9)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Sham-Procedure Controlled Study to Assess the Clinical Efficacy and Safety of ISIS 396443 Administered Intrathecally in Patients With Later-onset Spinal Muscular Atrophy
Brief Summary: The primary objective of this study is to examine the clinical efficacy of nusinersen (ISIS 396443) administered intrathecally to participants with later-onset Spinal Muscular Atrophy (SMA). The secondary objective is to examine the safety and tolerability of nusinersen administered intrathecally to participants with later-onset SMA.


Options:
A: Change From Baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE) Score at Month 15 (Baseline and Month 15)
B: Safety Labs (-4 wks, 0, 2 wks, 3 mo, 6 mo, 9 mo, 12 mo for safety labs; throughout for AEs); Efficacy, Measured Through Motor Function Assessments (-4wks, 0, 3 mo, 6 mo, 12 mo); Modified Hammersmith Change From Baseline to 6 Months (0 months, 6 months)
C: Percentage of Motor Milestones Responders (assessed at the later of the Day 183, Day 302, or Day 394 study visits); Time to Death or Permanent Ventilation (Day 91, Day 182, Day 273, Day 364, Day 394)
D: Manual Muscle Test (Medical Research Council scale-MRC), the Hammersmith Motor Ability Score (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Peer to Peer Delivery of Behavioral Activation
Brief Summary: The goal of this study is to test the feasibility, acceptability and preliminary impact of peer-delivered Behavioral Activation (BA) for depressed older adults (60+) who are Naturally Occurring Retirement Communities (NORC) residents or senior center participants.


Options:
A: depression symptom severity (3-6 months)
B: PHQ9 Depression Score (3 months post-partm)
C: Change from baseline in Patient Health Questionnaire (PHQ-9) (Weekly during treatment period of 12 weeks); Change from baseline in Patient Health Questionnaire (PHQ-9) (24 hours); Change from baseline in Patient Health Questionnaire (PHQ-9) (12 months); Change from baseline in Patient Health Questionnaire (PHQ-9) (24 months); Change from baseline in Patient Health Questionnaire (PHQ-9) (Monthly, 0-24 months)
D: Proportion of Peer to Peer Coaches Who Undergo Behavioral Activation Training and Achieve Certification (4 weeks prior to Baseline); Number of Peer to Peer Clients Who Attend > 80% of Behavioral Activation Sessions (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Identification and Description of Severe Asthma Patients in a Cross-sectional Study-the IDEAL Study
Brief Summary: This will be a non-drug interventional cross-sectional study, where the screening visit and study visit can occur on the same day. Investigational product will not be administered. Approximately 790 subjects with severe asthma will be screened to achieve a total of at least 750 evaluable study subjects. The study will not include a run-in or follow-up period. This study will provide a more reliable description of the severe asthma patient landscape with respect to the potential eligibility for treatment with mepolizumab, omalizumab, and reslizumab. This study aims to estimate the potential overlap of patients eligible for treatment with mepolizumab and those eligible for treatment with omalizumab and/or reslizumab. Additionally, the current study will also ascertain and describe reslizumab eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient population.


Options:
A: Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second (Baseline and Week 24); Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months (Baseline to Week 24)
B: Number of Participants Who Experienced On-treatment Adverse Events (AE) and On-treatment Serious Adverse Events (SAE) (Baseline (Week 0) to Week 240)
C: Number of severe asthma patients eligible for one or more biologic treatments for asthma (Day 1)
D: Maximum Percentage Decrease in Forced Expiratory Volume in 1 Second (FEV1) at 3 to 7 Hours Post Allergen Challenge (Days 42 and 84 at pre-allergen challenge and at 180, 240, 300, 360, and 420 minutes (3-7 hours) post allergen challenge); Time-Adjusted Area Under the Curve for the Percent Decrease From Pre-Allergen Challenge in Forced Expiratory Volume in 1 Second (FEV1) From 3 to 7 Hours Post Allergen Challenge (Days 42 and 84 at pre-challenge and at 180, 240, 300, 360, and 420 minutes (3-7 hours) post challenge)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Preschoolers Activity Trial - a Pilot Randomized Controlled to Increase Physical Activity and Reduce Sedentary Behaviour
Brief Summary: The purpose of this pilot study is to test the efficacy of the physical activity (PA) intervention protocol to increase preschoolers overall PA levels and time spent in moderate to vigorous PA (MVPA) at the day care setting. The PA intervention includes the Healthy Opportunities for Preschoolers manual, a compilation of locomotor, gross motor and movement based activities developed for preschoolers and successfully piloted for feasibility in 3 to 5 year old preschoolers by Drs. Viviene Temple, Justen O'Connor, and Patti-Jean Naylor. As well, the PA intervention includes educational workshops for the day care providers, ongoing biweekly facilitation and troubleshooting sessions with a Master Trainer, and the equipment necessary to implement the program. The study is also evaluating the efficacy of the PA intervention to decrease the amount of time spent in sedentary behaviour at the day care setting.

Secondary objectives include evaluating the effects of the PA intervention on preschool children's anthropometrics, and fundamental and gross motor skills. In addition, the intervention is also assessing the effects of the program on day care provider's attitudes, control beliefs, and self-efficacy toward incorporating PA into the day care curriculum.


Options:
A: Increase MVPA (6 months)
B: Bottle use frequency (Beverage container assessment done at 12,15,18,21 and 24 months)
C: Change in Weight Status (baseline and 2 year follow-up)
D: Body mass index percentile ranking (5 months)

Answer: A