TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Long Term, Randomised, Double Blind, Placebo-controlled Study to Determine the Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Patients With Type 2 Diabetes Mellitus
Brief Summary: Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes This study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used alone or added to other diabetes treatments.


Options:
A: Primary Efficacy Outcome MACE Events (Time to first event. Information collected during study period (anticipated to be up to 7.5 years).); Primary Safety Outcome MACE Events (Time to first event. Information collected during study period (anticipated to be up to 7.5 years).)
B: Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke (Randomization (day 0) up to 2.9 years)
C: Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period (Median of 1.65 person years for CV follow-up time period)
D: Changes in Endothelial Function (FMD - Flow Mediated Dilatation) From Baseline to 12 Weeks (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD (Ethos)
Brief Summary: This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.


Options:
A: Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI and FF/VI (Up to Week 52)
B: Adjusted Rate of Moderate or Severe Exacerbations (52-week treatment period)
C: FEV1 AUC0-4 (at Week 24); Change From Baseline in Morning Pre-dose Trough FEV1 (at Week 24)
D: Moderate and severe COPD exacerbation rate over 52 weeks of treatment (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD (Ethos)
Brief Summary: This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.


Options:
A: Rate of COPD Exacerbations (52 weeks)
B: Trough Forced Expiratory Volume in One Second (FEV1) Following 26 Weeks of Treatment to Demonstrate the Non-inferiority of QVA149 110/50 μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d (26 weeks)
C: Change From Baseline in 24-hour Weighted-mean Serial FEV1 on Treatment Day 84 (Baseline and Day 84)
D: Adjusted Rate of Moderate or Severe Exacerbations (52-week treatment period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Transdisciplinary Research on Energetics (TREC) and Cancer Cross Center Study / Obesity and Weight Loss in Endometrial Cancer Survivors: A Randomized, Multi-site Trial (Lifestyle Beyond Cancer Study)
Brief Summary: This randomized, controlled study evaluates the efficacy of weigh loss interventions in endometrial cancer survivors, using novel technology-based weight loss platforms. This is a multi-site, pilot feasibility study which will provide preliminary data to support a larger NIH funded, mult-center trial.


Options:
A: Weight loss (2 years)
B: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)
C: Change in Weight (kilograms) (Change from Baseline Weight at 6 months); Serum biomarker: Change in levels of Insulin-like growth factor-binding protein 1 (IGFBP-1), in ng/mL (Change from Baseline IGFBP-1 at 6 months); Serum biomarker: Change in levels of Adiponectin, in ug/mL (Change from Baseline Adiponectin at 6 months); Serum biomarker: Change in levels of Vascular Endothelial Growth Factor (VEGF), in pg/mL (Change from Baseline VEGF at 6 months); Serum biomarker: Change in Interleukin 1-beta (IL1-beta), in pg/mL (Change from Baseline IL1-beta at 6 months); Serum biomarker: Change in Interleukin 2 (IL2), in pg/mL (Change from Baseline IL2 at 6 months); Serum biomarker: Change in Interleukin 6 (IL6), in pg/mL (Change from Baseline IL6 at 6 months); Serum biomarker: Change in Interleukin 7 (IL7), in pg/mL (Change from Baseline IL7 at 6 months); Serum biomarker: Change in Interleukin 8 (IL8), in pg/mL (Change from Baseline IL8 at 6 months); Serum biomarker: Change in C reactive protein (CRP), in mg/L (Change from Baseline CRP at 6 months)
D: Weight loss (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Implementation of Brief Cognitive Behavioral Therapy in CBOCs
Brief Summary: The purpose of this study is to determine the effectiveness of a brief cognitive behavioral therapy (bCBT) intervention for Veterans with depression delivered by mental health providers located at VA Community Based Outpatient Clinics (CBOC's) associated with the Houston and Oklahoma City VAMCs.


Options:
A: Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline. (Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.)
B: Measure of Non-transferrin-bound Iron (four hours after transfusion)
C: We will test the hypothesis that the transfusion of red cells of lesser storage age, (5 days or less) will produce less changes of pulmonary function and immune activation than will transfusion of red cells of conventional storage age (median 21 days). (At the end of the transfusion as compared to the beginning of the transfusion)
D: Non-transferrin-bound Iron Level (AUC) (0, 2, 4, 6, 8, 10, 12, 14 and 24 after transfusion)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention for Diabetes With Education, Advancement and Support (IDEAS) Study
Brief Summary: This study aims to evaluate a culturally appropriate, low cost and sustainable management plan for patients with type 2 diabetes mellitus (T2DM). Various randomized controlled trials confirmed that T2DM can be delayed with lifestyle intervention and programmes which promote improvements in diet, increased physical activity and weight loss. Translation of lifestyle intervention to real-life settings however remains a major challenge.

The investigators therefore propose a diabetes management trial for T2DM patients using telemedicine. This project's innovations include the use of information technology to deliver messages to the physicians while similarly involving family members of diabetics to manage the patient's condition collectively. This creates a sense of well-being, empowering the individual as well as the community to be responsible for their own health and well-being


Options:
A: Hemoglobin A1c
B: HbA1c; Muscular strength
C: Change in Hemoglobin A1c (3 months, 6 months, 12 months)
D: Change in the proportion of patients achieving glycaemic and BP control (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: COMPASS Trial: a Direct Aspiration First Pass Technique
Brief Summary: Intravenous (IV) tissue plasminogen activator (tPA) administration has been shown to be safe and effective for treatment of AIS within 3 hours of symptom onset, and newer evidence has shown potential benefit out to 4.5 hours. Mechanical thrombectomy for AIS patients has been shown in clinical trials to be safe up to 8 hours after symptom onset. Recent trials utilizing advanced imaging to identify patients with large vessel occlusions amenable to intra-arterial thrombectomy (IAT) have shown superiority endovascular therapy over medical therapy to result in improved patient functional outcomes. Pilot data utilizing the ADAPT approach has shown superior technical results with similar functional outcomes while lowering procedure time and device costs versus traditional stent retriever as a first line therapy approaches


Options:
A: Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. (at 90 days post randomization); Death Due to Any Cause (within 90 days post randomization); Symptomatic Intracranial Hemorrhage (within the first 30 hours post IV rt-PA)
B: 90-day global disability assess via the modified Rankin Scale score (mRS) (2 years)
C: Perfect reperfusion rate (24 hours)
D: favorable clinical response (day 30)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Potential Role of Gum Arabic as Fetal Hemoglobin Agent in Sudanese Sickle Cell Anemia Patients
Brief Summary: The purpose of this study is to determine whether Gum Arabic is effective as fetal hemoglobin inducing agent for sickle cell anemia patients.


Options:
A: In vitro response of HbAA and HbSS erythroid cells to NRF2 activation by sulforaphane. (3 months); Safety, physiological effects and cellular effects of daily consumption of broccoli sprout homogenate in a cohort of Hb SS/SB0 thalassemia adult SCD patients (1-2 years)
B: Treatment Differences of the Change in Qualitative Splenic Function From Baseline (Before initiation of treatment and at 2 years)
C: The primary endpoint of the study will be the level of fetal hemoglobin after three months (12 weeks)
D: Pain Rating Using Visual Analog Scale at Day 1 and Day 5 (Day 1 and Day 5)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIa Randomized Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Non-ischemic Heart Failure
Brief Summary: A phase IIa study to assess the safety and preliminary efficacy of intravenous dose of ischemia-tolerant Allogeneic Mesenchymal Bone Marrow Cells in subjects with non-ischemic heart failure.


Options:
A: Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation (One month post-catheterization)
B: Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation (one month post-catheterization)
C: Efficacy between groups post-index procedure (39 weeks post-index)
D: Safety Will be Evaluated by Number of AE (Total AEs and SAEs within 450 days post-infusion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU)
Brief Summary: Stress ulcer prophylaxis (SUP) is standard of care in the intensive care unit (ICU), however the quantity and quality of evidence is low and potential harm has been reported.

The aim of the SUP-ICU trial is to asses the overall benefits and harms of SUP with proton pump inhibitor in adult critically ill patients in the ICU.


Options:
A: ulcer complication (bleeding/perforation/obstruction) (up to 12 months)
B: Determine whether biventricular pacing optimized by trans thoracic echocardiography of left ventricular will improve the heart function (immediately after heart surgery in patients with LVSD)
C: Mortality (90 days)
D: The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Effects of Clinical Decision Making Support Systems on Maternal and Neonatal Mortality and Morbidity in Ghana: a Cluster Randomized Controlled Trial
Brief Summary: Introduction Maternal and neonatal mortality continue to be to be prominent public health issues in sub Saharan Africa including Ghana, with slow progress made towards attainment of Millennium Development Goals (MDG) 4 \& 5. Studies have identified poor quality of maternal and child healthcare as a major challenge to the prevention of neonatal and maternal deaths. Effective interventions are required to make significant inroads in these areas.

Objective To evaluate the effect of a SMS text messaging intervention to support clinical decision making by frontline health care professionals on neonatal and maternal mortality.

Methods We propose to conduct a randomized controlled trial in the Eastern region of Ghana, involving 8 intervention and 8 control districts. The intervention consists of text messaging of standard protocols for maternal and neonatal care to front line health care providers in the region. A total of 17,040 pregnant women who are receiving care (including antenatal, delivery and post-natal) at any of the hospitals in the selected districts in the region will be monitored through monthly aggregate data on outcome measures such as neonatal and maternal deaths from eclampsia, postpartum haemorrhage, puerperal sepsis, birth asphyxia, low birth weight and neonatal sepsis. Cord sepsis will also be included as neonatal sepsis for this study. Also, a quality of care assessment in four sampled districts to measure adherence to the safe motherhood protocol will be conducted. Stata software package.55 and MLwiN software version 2.2456 will be employed in data analysis. Descriptive analysis will be carried out to explore baseline characteristics of study groups while logistic regression will be applied to evaluate the effect of the intervention. A two-tailed statistical significant level of 0.05 will be used.

Expected outcome We hypothesize that the intervention will improve both maternal and neonatal service delivery and health outcomes in the intervention areas.


Options:
A: systolic blood pressure (change from baseline to 12-month of follow-up)
B: extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring (two years)
C: Proportion of clinical failure by day 7 compared among the 3 study arms. (10 months)
D: Number of neonatal deaths (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)
Brief Summary: A 12-week, prospective, multi-center, randomized, double-blind, placebo controlled, Phase 3 study in L-Dopa responsive PD patients with motor fluctuations ("OFF" episodes), designed to determine the efficacy, safety and tolerability of APL-130277.


Options:
A: Mean Change From Pre-Dose to 30 Minutes Post-Dose in The Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III Motor Examination (MDS-UPDRS Part III) Score at Maintenance Visit 4 (MV4) - Week 12 (At t=0 (just prior to dosing) and t=30 minutes at MV4 (Week 12 of the Maintenance Treatment Phase).)
B: Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise (9 to 26 weeks)
C: Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3) (Baseline, 16 weeks); Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration (Baseline and 16 weeks); Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work) (Baseline, 16 weeks); Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6) (Baseline, 16 weeks); Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work) (Baseline, 16 weeks)
D: Number of Participants With Treatment-Emergent Adverse Events [Safety & Tolerability] (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nutritive Efficacy and Safety of a Modified Infant Formula With a Reduced Protein: Content and Improved Protein Quality: LactPro-Minus
Brief Summary: Formula contains significantly higher total protein concentrations than breast milk. Therefore formula-fed infants have a significantly higher total protein intake in the first few months compared to exclusively breast-fed infants.

The aim is to examine the nutritive efficacy and safety of a modified infant formula with a reduced protein content and improved protein quality in a prospective, double-blind, controled, randomized study. Primary outcome measures are weight gain and growth of young infants under 12 weeks of dietary intake of the new infant formula. Metabolic effects of the qualitative and quantitative changes in the protein content of the new formula will be recorded. Two groups of healthy bottle-fed infants will be compared. The treatment group will be fed for 3 months with an infant formula with decreased protein content. At the same time the protein body of the new formula is modified by enrichment with bovine alpha-lactalbumin.

A control group receives a isocaloric conventional infant formula and a protein body consisting of whey protein and casein in a ratio of 60:40, without specific accumulation of alpha-lactalbumin over the same time-period.

A group of breastmilk fed infants will serve as a reference group. In regular anthropometric controls growth and thriving of the study participants is documented and compared between the different groups.


Options:
A: Mean weight gain (6 months)
B: Composite measure of Growth (1 year)
C: Analysis of IGF-1 value (4 months)
D: Weight Gain Velocity (up to 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of the Immediately Postpartum Insertion of the Etonogestrel Releasing Implant on Infant Growth and Development
Brief Summary: This study aims to assess whether there is change in the growth and development of newborns whose mothers will have a etonogestrel (ENG) releasing implant inserted in the first 24 to 48 hours of delivery compared with those with standard implant insertion (6 week postpartum).


Options:
A: Expulsion rate (6 months); The percentage of females seeking contraception (6 months)
B: neonatal growth (12 months)
C: Implant utilization as measured by the proportion of women using LNG contraceptive implants at 6 months after delivery in women randomized to insertion within 5 days of delivery (immediate insertion) or 6-8 weeks after delivery (delayed insertion). (6 months)
D: IUD Use (6 months postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Brief Summary: The primary objective of the study was to evaluate whether progression-free survival (PFS) was prolonged with the addition of veliparib to standard platinum-based chemotherapy (carboplatin/paclitaxel \[C/P\]) and continued as maintenance therapy compared with chemotherapy alone.


Options:
A: investigator-determined progression-free survival (every 12 weeks until progression or up to 30 months (whichever occurs first))
B: Progression-Free Survival (PFS) (Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months))
C: Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1) (From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.); Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1) (From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.); Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 3 vs Arm 1) (From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.)
D: Progression-free Survival (Duration of time from start of treatment to time of progression, approximately 4 years and 6 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Brief Summary: The primary objective of the study was to evaluate whether progression-free survival (PFS) was prolonged with the addition of veliparib to standard platinum-based chemotherapy (carboplatin/paclitaxel \[C/P\]) and continued as maintenance therapy compared with chemotherapy alone.


Options:
A: Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.); Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.)
B: Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1) (From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.); Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1) (From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.); Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 3 vs Arm 1) (From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.)
C: Progression free survival (up to 18 months)
D: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) (Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)

Answer: B