TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes
Brief Summary: The objective of the study is to assess the effect of low-calorie diets with normal (18%) vs. high (35%) protein (mainly coming from animal source) composition on body weight and carbohydrates metabolism in overweight and obese subjects with pre-diabetes or diabetes. A dietary intervention is carried out during 6 months in 100 subjects who are individually randomized to an energy-restricted diet with two types of macronutrients composition: 1) 35% protein, 30% fat and 35% carbohydrates and 2) 18% protein, 30% fat and 52% carbohydrates. Around 80% of total protein in diet comes from animal source (of whom around 40% from lean red meat). Subjects are provided with weekly menus and different recipes to use them as part of the diet. Monitoring visits with the nutritionist will be performed every 15 days. At the beginning of the study, after 3 and 6 months, the following parameters are determined: anthropometric (weight, waist circumference, body mass index and body composition), blood pressure, dietary (72-hours dietary registry) and exercise and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoproteins A1 and B, iron, transferring, ferritin, uric acid, glucose, HbA1c, insulin, adiponectin and resistin). Urine samples are also collected to assess microalbuminuria and ureic nitrogen.


Options:
A: Number of women who lose weight when following 1 of 2 different calorie-restricted diets (18 months)
B: area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months; area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months; HbA1C at baseline, 3 months and 6 months; weight at baseline, 3 months and 6 months; waist circumference at baseline, 3 months and 6 months
C: Change in glucose. (After 3 and 6 months of intervention.); Change in glycated hemoglobin. (After 3 and 6 months of intervention.); Change in insulin resistance (HOMA index). (After 3 and 6 months of intervention.)
D: Liver fat (Sept 2008)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Efficacy of Denosumab in Patients With Thalassemia Major and Osteoporosis: A Randomized, Placebo-controlled, Single-site, Double Blind Phase 2b Clinical Trial
Brief Summary: This is a single-site, randomized, placebo-controlled, double blind phase 2b clinical trial. Patients with Thalassemia will participate in this study and will be treated with Denosumab or placebo. The effect of Denosumab on lumbar spine BMD in patients with Thalassemia Major and Osteoporosis will be evaluated as compared with control (placebo) at 12 months.


Options:
A: The percent change in the lumbar spine BMD (12 months)
B: Bone density by means of bone densitometry with dual energy x-ray absorptiometry (DEXA) at three body sites (lumbar region, femoral head, wrist) prior to treatment initiation the start and at the end of treatment; N-telopeptide of type I collagen (NTx) levels, TRACP-5b, with ELISA, prior to the start of treatment initiation and every 3 or 6 months; Serum Bone alkaline phosphatase, Osteocalcin, OPG and S-RANKL with ELISA, prior to the start of treatment initiation, and every 3 or 6 months
C: Change in Lumbar Spine Bone Mineral Density (BMD) by DXA (Baseline to 18 Months) (0 to 18 months); Change in Whole Body Bone Mineral Content (BMC) by DXA (Baseline to 18 Months) (Baseline to 18 months)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating System Change to Advance Learning and Take Evidence to Scale (ESCALATES)
Brief Summary: The purpose of this study is to evaluate approximately eight grants that will test interventions to improve cardiovascular disease prevention. The investigators will collect and analyze qualitative data to identify the most effective combinations of intervention strategies. The investigators will observe grantees and selected practices to understand why and how those combinations are effective. The investigators will also gather data from the grantees to assess how effective the interventions are.


Options:
A: Changes in provider knowledge and performance from baseline on intrapartum, postpartum and newborn care (12-24 months)
B: Percentage of participants with AMI, coronary artery bypass graft, PCI or IVD, and who had documentation of used of aspirin or another antithrombotic during the measurement period. (Quarterly for 4 years); Percentage of participants with diagnosis of hypertension and whose blood pressure was adequately controlled (<140/90 mmHg) during the measurement period. (Quarterly for 4 years); Percentage of participants considered at high risk of cardiovascular events who were prescribed or were on a statin therapy during the measurement period. (Quarterly for 4 years); Percentage of participants who were screened for tobacco use and received cessation counseling intervention if identified as a tobacco user. (Quarterly for 4 years)
C: Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage (Baseline, Midline (6 months), Endline (12 months))
D: The Primary Outcome is a Composite of the Following Three Clinical Outcomes: 1) Severe PPH Defined as Blood Loss ≥1000 ml or; 2) Postpartum Laparotomy for Bleeding or; 3) Postpartum Maternal Death From Bleeding. Please See Below for Further Details. (Postpartum until discharge from the health facility (up to 42 days))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Open, Comparative, Within Patient Controlled Multicenter Phase 3 Study of Blue Light Cystoscopy With Cysview and White Light Cystoscopy Using KARL STORZ D-Light C PDD Flexible Videoscope System in Detection of Bladder Cancer in Patients With Bladder Cancer
Brief Summary: The purpose of this study is to investigate if blue light cystoscopy with Cysview improves detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the KARL STORZ D-Light C PDD Flexible Videoscope System. Another purpose is to investigate if Cysview and blue light is safe and effective when used repeatedly.


Options:
A: Number of extra lesions revealed by blue light compared to the resection performed in white light (2 to 6 weeks after resection)
B: Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light (Day 0); Comparison of the Proportions of Patients in the White Light Cystoscopy and Hexvix Groups Who Underwent TURB for a Histologically-confirmed Ta or T1 Tumor Who Had a Recurrence ( CIS, Ta, T1 or T2-T4 Tumor) Within 9 Months. (9 months)
C: Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy (At time of cystoscopy procedure)
D: Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year. (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility, Safety, and Efficacy of Transendoscopic Enteral Tubing in Fecal Microbiota Transplantation
Brief Summary: No technique by placing a tube through anus into cecum for whole colon administration. This study aimed to evaluate the feasibility, safety, and efficacy of transendoscopic enteral tubing (TET) in fecal microbiota transplantation (FMT) through whole colon.


Options:
A: co-primary endpoint of clinical remission, as well as reduction of Mayo endoscopic inflammation score (at 12 weeks after treatment.)
B: Clinical remission (Up to one year)
C: durability of clinical remission (One year)
D: Recurrence of CDI up to 8 Weeks (Up to Week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Prevention of Stroke in Children With Sickle Cell Disease in Sub-Saharan Africa II
Brief Summary: The overall goal of this proposal is to conduct a partial double-blind randomized Phase III clinical trial for primary stroke prevention in children with sickle cell anemia (SCA) in sub-Saharan Africa.


Options:
A: Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)); Liver Iron Content (LIC) Change-from-baseline (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months))
B: Treatment Differences of the Change in Qualitative Splenic Function From Baseline (Before initiation of treatment and at 2 years)
C: Fetal Hemoglobin (HbF) Response Following Six Months of Hydroxyurea Therapy (6 months after starting daily hydroxyurea therapy)
D: Incidence rate of clinical stroke or TIA (3 Years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients With Moderate-to-Severe Plaque Psoriasis
Brief Summary: The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.


Options:
A: Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12 (12 weeks)
B: Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score (Week 16)
C: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline (Week 12)
D: Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100) (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients With Moderate-to-Severe Plaque Psoriasis
Brief Summary: The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.


Options:
A: Change from baseline in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the ascending aorta at Week 16 for patients randomized to adalimumab as compared to patients randomized to placebo (Baseline, Week 16 and Week 52 or 68)
B: The Percentage of Patients With at Least 75% Reduction in Psoriasis Area and Severity Index (PASI 75) Response at Week 16 (Week 16)
C: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline (Week 12)
D: Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 (Baseline, Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Week 16); Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Week 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Thrombotic Status in Patients With Acute Coronary Syndrome
Brief Summary: Impaired thrombotic status is associated with adverse cardiovascular events. Patients with acute coronary syndrome (ACS) are at increased cardiovascular risk. The aim of the study is to determine the usefulness of thrombotic status assessment in a large cohort of ACS patients, managed with contemporary treatments, to identify patients at risk of thrombosis and those at risk of bleeding complications.


Options:
A: The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority) (Up to 4 years); The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority) (Up to 4 years); The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety (Up to 4 years)
B: Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (From start of study treatment until follow-up (up to 390 days))
C: Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants (Randomization (Day 1) to first event (CV death, MI, ischemic stroke), up to March 2011, approximately 2 years); Event Rate of Confirmed Major Bleeding Using Thrombolysis in Myocardial Infarction (TIMI) Criteria During the Treatment Period - Treated Participants (From first dose to first occurrence of event (TIMI major bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years)
D: Co-primary endpoints of Major Adverse Cardiovascular Events (MACE) and major bleeding (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Sedentary Behaviour In University Students Using A Text Message-Based Intervention
Brief Summary: The primary purpose of the current study was to determine whether a text message intervention would increase break frequency and length of break from sitting, time spent standing, and time spent in light and moderate intensity physical activity in university students


Options:
A: Change in length of break from sitting in minutes (baseline, 2, 4, and 6 weeks); Change in frequency of break from sitting in minutes (baseline, 2, 4, and 6 weeks); Change in minutes spent standing (baseline, 2, 4, and 6 weeks); Change in minutes spent in light intensity physical activity (baseline, 2, 4, and 6 weeks); Change in minutes spent in moderate intensity physical activity (baseline, 2, 4, and 6 weeks)
B: Average daily sedentary minutes (4 weeks)
C: Weight reduction (1 year)
D: Change in objective physical activity (PA) (Baseline, 5 weeks, 3 months, 1 year); Change in objective sedentary behaviour (Baseline, 5 weeks, 3 months, 1 year); Change in self-reported physical activity (PA) (Baseline, 5 weeks, 3 months, 1 year); Change in self-reported sedentary behaviour (Baseline, 5 weeks, 3 months, 1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Open-Label Study of Single Agent Pembrolizumab vs Physicians' Choice of Single Agent Docetaxel, Paclitaxel, or Irinotecan in Subjects With Advanced/Metastatic Adenocarcinoma and Squamous Cell Carcinoma of the Esophagus That Have Progressed After First-Line Standard Therapy (KEYNOTE-181)
Brief Summary: In this study, participants with advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the esophagogastric junction (EGJ) that had progressed after first-line standard therapy were randomized to receive either pembrolizumab (MK-3475) OR the Investigator's choice of standard chemotherapy with paclitaxel, docetaxel, or irinotecan.

The primary study hypothesis was that treatment with pembrolizumab would prolong overall survival (OS) as compared to treatment with standard chemotherapy.


Options:
A: Overall Survival Time (OS) (Randomization up to 27.5 months)
B: overall survival
C: OS Rate at 6 months primary endpoint for phase II (6 months after randomization); overall survival (OS) co-primary endpoint for phase III (from date of randomization to 1 year after end of treatment); Objective Overall Response Rate (ORR) co-primary endpoint for phase III (from randomization for the time of treatment with a maximum of 1 year)
D: Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus (Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)); Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10) (Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)); Overall Survival (OS) in All Participants (Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The QUIT Smoking Study: A Pilot Randomized Controlled Trial of Financial Incentives, Text Messaging, and Usual Care to Help Homeless Smokers Quit Smoking
Brief Summary: The QUIT (Quitting with Usual Care, Incentives, and Technology) Smoking Study is a 3-arm pilot randomized controlled trial that will test the effect of 2 different experimental smoking cessation interventions relative to a control condition in homeless cigarette smokers. All participants will receive free transdermal nicotine patches and weekly in-person smoking cessation counseling. In addition, participants randomized to the first experimental condition will receive financial rewards for biochemically-verified smoking abstinence, and participants randomized to the second experimental condition will be enrolled in a text messaging program to support smoking abstinence.


Options:
A: 7-day point prevalence abstinence from smoking (6 months after enrollment)
B: Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks (Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study period)
C: Effectiveness of counseling intervention vs. control intervention on smoking cessation rates of participants enrolled in study (4 yrs)
D: A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking (From study enrollment through six month follow-up); A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking (From study enrollment through six month follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Apixaban Versus Antiplatelet Drugs or no Antithrombotic Drugs After Anticoagulation-associated Intracerebral Haemorrhage in Patients With Atrial Fibrillation: A Randomised Phase II Clinical Trial
Brief Summary: There is a marked lack of evidence on the optimal prevention of ischaemic stroke in patients with atrial fibrillation and a recent intracerebral haemorrhage (ICH) during treatment with oral anticoagulation. These patients are currently treated with vitamin K antagonists, DOACs, antiplatelet drugs, or no antithrombotic treatment, depending on personal and institutional preferences. Treatment with a direct oral anticoagulant like apixaban might be an attractive alternative in terms of a low risk of recurrent ICH, while at the same time being effective for the prevention of ischaemic stroke. This study aims to obtain reliable estimates of the rates of vascular death or non-fatal stroke in patients with atrial fibrillation and a recent anticoagulation-associated intracerebral haemorrhage who are treated with apixaban versus those who are treated with antiplatelet drugs or no antithrombotic drug at all.

This study has a multi-centre, phase II, randomised, open-label clinical trial with blinded outcome assessment design.


Options:
A: Fatal or non-fatal symptomatic ICH. (2 years)
B: The number of participants recruited per site per month (in the pilot phase of the trial) (1 year after trial initiation); Recurrent symptomatic spontaneous intracranial haemorrhage (in the safety phase of the trial) (1 year after randomisation)
C: BP Study: Efficacy (3 months from randomisation); BP Study: Feasibility (3 months from randomisation); BP Study: Safety (3 months from randomisation); Imaging Study: Efficacy (12 months from randomisation); Imaging Study: Safety (12 months from randomisation)
D: Number of patients who experience the combination of vascular death or non-fatal stroke (cerebral infarction, intracerebral haemorrhage, or subarachnoid haemorrhage) (Throughout the study. Patients will be followed up between 12 (minimum) and 72 (maximum) months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Comparison of Transcervical Foley Bulb With Vaginal Misoprostol to Vaginal Misoprostol Alone for Induction of Labor
Brief Summary: A randomized, prospective trial will be offered to women admitted to the Roosevelt Hospital labor floor for labor induction. The hypothesis is that the simultaneous use of a foley bulb together with vaginal misoprostol will result in shorter induction to delivery time compared with vaginal misoprostol alone


Options:
A: Time From Start of Labor Induction to Vaginal Delivery (72 hours)
B: caesarean section rate (1 year)
C: Delivery Rate (Within 24 hours)
D: The Time Interval From Induction to Delivery: All Participants (Day 1); Time (Hours) From Induction to Delivery: Nulliparous (Day 1); Time (Hours) From Induction to Delivery: Multiparous (Day 1); Time From Induction to Delivery: VD (Day 1); Time From Induction to Delivery: CD (Day 1); Per Treatment Protocol: Time (Hours) From Induction to Delivery (day 1)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Comparison of Transcervical Foley Bulb With Vaginal Misoprostol to Vaginal Misoprostol Alone for Induction of Labor
Brief Summary: A randomized, prospective trial will be offered to women admitted to the Roosevelt Hospital labor floor for labor induction. The hypothesis is that the simultaneous use of a foley bulb together with vaginal misoprostol will result in shorter induction to delivery time compared with vaginal misoprostol alone


Options:
A: Caesarean section rate for non-reassuring fetal status. (Up to 2 days after cervical ripening)
B: Time from treatment start to delivery (At delivery)
C: The Time Interval From Induction to Delivery: All Participants (Day 1); Time (Hours) From Induction to Delivery: Nulliparous (Day 1); Time (Hours) From Induction to Delivery: Multiparous (Day 1); Time From Induction to Delivery: VD (Day 1); Time From Induction to Delivery: CD (Day 1); Per Treatment Protocol: Time (Hours) From Induction to Delivery (day 1)
D: Average Time in Hours From Insertion of the Catheter Until Delivery (At the end of the study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Stand & Move at Work: A Group Randomized Trial
Brief Summary: A trial testing the efficacy of sit-stand workstations on decreasing sitting time and increasing light-intensity physical activity in samples of office worksites.


Options:
A: Mean Change in Light-intensity Physical Activity at Work From Baseline to 12 Months (1 year); Mean Change in Sitting Time at Work From Baseline to 12 Months (1 year)
B: sitting time (one week); self-reported context-specific sitting time (one week); standing time (one week); breaks from sitting (one week)
C: Change from baseline in workplace sitting time at 4 and 8 weeks (Baseline (week 0), Mid-intervention (4 weeks), End-intervention (8 weeks))
D: Change from control week and intervention week in total energy expenditure (TEE) (week 1 and week 2); Resting energy expenditure (REE) (Baseline (day 0)); Change from control week and intervention week in physical activity energy expenditure (PAEE) (week 1 and week 2); Change from control week and intervention week in daily time spent in sedentary (SB) (week 1 and week 2); Change from control week and intervention week in light (LIPA), moderate and vigorous (MVPA) intensity activities (week 1 and week 2); Change from control week and intervention week in number of breaks in sedentary time (BST) (week 1 and week 2); Change from control week and intervention week in time spent sitting (TSS) (week 1 and week 2); Change from control week and intervention week in time spent standing (TSst) (week 1 and week 2); Change from control week and intervention week in time spent walking (TSW) (week 1 and week 2); Change from control week and intervention week in number of steps (week 1 and week 2)

Answer: A