TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer
Brief Summary: The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy


Options:
A: Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1 (From first dose to database lock (Up to 18 months)); Number of Participants With Dose Limiting Toxicities (DLTs) - Part 2 (9 weeks after first dose); Number of Participants With Adverse Events (AEs) - Part 2 (Deaths are from first dose to database lock (Up to 24 months). AEs and SAEs are from first dose to 30 days post last dose); Number of Participants With Laboratory Abnormalities in Hepatic Tests - Part 2 (From first dose to 30 days post last dose); Number of Participants With Laboratory Abnormalities in Thyroid Tests - Part 2 (From first dose to 30 days post last dose)
B: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) in Participants With Solid Tumors (Parts A and A1) (Up to 28 days in Cycle 1); Number of Participants Who Experienced an Adverse Event (AE) (Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)); Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Integrated Radiology and Oncology (IRO): Melanoma Participants (Parts B Plus D) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)); ORR According to RECIST 1.1 as Assessed by Independent Review Committee (IRC): Non-Small Cell Lung Cancer (NSCLC) Participants (Parts C Plus F) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015))
C: Overall Survival (OS) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Percentage of Participants Experiencing Adverse Events (AEs) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Percentage of Participants Discontinuing Study Drug Due to AEs (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months))
D: Progression-Free Survival in Participants With PD-L1 Expression >= 5% (From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Rivaroxaban Versus Warfarin in Acute Ischemic Stroke With Atrial Fibrillation: Acute Stroke With Xarelto to Reduce Intracranial Bleeding, Recurrent Embolic Stroke, and Hospital Stay, Phase 2, Conceptual Multicenter Trial
Brief Summary: Rationale Acute ischemic stroke due to atrial fibrillation (AF) carries a high risk for early recurrence. In acute stage, guidelines recommend aspirin, but do not recommend anticoagulation due to the increased risk of intracranial bleeding. Since, aspirin has a limited efficacy of preventing recurrent stroke in AF, expert consensus suggests early anticoagulation in non-severe stroke with AF. The current practice for acute ischemic stroke patients with AF is delayed warfarin administration with aspirin use for non-minor stroke or immediate warfarin administration (sometimes with heparin bridging) for minor stroke. However, conventional anticoagulation with warfarin in acute ischemic stroke with AF has the following limitations: 1) risk of intracranial bleeding particularly in acute stage, 2) delayed action and transient paradoxical thrombogenic tendency due to the inhibition of protein C, resulting in the risk of early recurrent embolic stroke, and 3) prolongation of hospitalization waiting for full anticoagulation. In contrast, as compared to warfarin, rivaroxaban is advantageous for reduced risk of intracranial bleeding and immediate anticoagulation efficacy.

Goal The current trial will examine whether early initiation (within 5 days from stroke onset) of rivaroxaban as compared to conventional warfarin would reduce intracranial bleeding, recurrent embolic stroke, and hospital stay in patients with acute ischemic stroke due to AF.


Options:
A: Incidence Rate of the Composite Efficacy Outcome (Adjudicated) (From randomization until the efficacy cut-off date (median 326 days)); Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated) (From randomization until the efficacy cut-off date (median 326 days))
B: Number of Participants With a Composite Endpoint of Fatal Stroke, Recurrent Ischemic Stroke, or TIA (180 days)
C: New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death (every 4 months)
D: Number of Participants With Intracranial Bleeding and/or Recurrent Ischemic Lesion as Confirmed by MRI Imaging (1 month after randomization)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Rivaroxaban Versus Warfarin in Acute Ischemic Stroke With Atrial Fibrillation: Acute Stroke With Xarelto to Reduce Intracranial Bleeding, Recurrent Embolic Stroke, and Hospital Stay, Phase 2, Conceptual Multicenter Trial
Brief Summary: Rationale Acute ischemic stroke due to atrial fibrillation (AF) carries a high risk for early recurrence. In acute stage, guidelines recommend aspirin, but do not recommend anticoagulation due to the increased risk of intracranial bleeding. Since, aspirin has a limited efficacy of preventing recurrent stroke in AF, expert consensus suggests early anticoagulation in non-severe stroke with AF. The current practice for acute ischemic stroke patients with AF is delayed warfarin administration with aspirin use for non-minor stroke or immediate warfarin administration (sometimes with heparin bridging) for minor stroke. However, conventional anticoagulation with warfarin in acute ischemic stroke with AF has the following limitations: 1) risk of intracranial bleeding particularly in acute stage, 2) delayed action and transient paradoxical thrombogenic tendency due to the inhibition of protein C, resulting in the risk of early recurrent embolic stroke, and 3) prolongation of hospitalization waiting for full anticoagulation. In contrast, as compared to warfarin, rivaroxaban is advantageous for reduced risk of intracranial bleeding and immediate anticoagulation efficacy.

Goal The current trial will examine whether early initiation (within 5 days from stroke onset) of rivaroxaban as compared to conventional warfarin would reduce intracranial bleeding, recurrent embolic stroke, and hospital stay in patients with acute ischemic stroke due to AF.


Options:
A: Composite outcome of recurrent ischemic stroke, symptomatic intracerebral hemorrhage, or all-cause mortality (90 days)
B: 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)
C: Number of Participants With Intracranial Bleeding and/or Recurrent Ischemic Lesion as Confirmed by MRI Imaging (1 month after randomization)
D: Composite outcome of the combined incidence of:recurrent symptomatic ischaemic stroke,symptomatic intracranial haemorrhage and systemic embolism (At 90 days from randomisation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Patients Undergoing Cardiac Surgery
Brief Summary: TRICS-III is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in high risk patients having cardiac surgery using a non-inferiority trial design.


Options:
A: Mortality (90 day)
B: Composite score of any one of the following events occurring 6 months after cardiac surgery: (1) all-cause mortality; (2) myocardial infarction; (3) new onset renal failure requiring dialysis; or (4) new focal neurological deficit (stroke). (Within 6 months after cardiac surgery.)
C: Number of Participants in Need for Bank Blood Transfusion (At discharge)
D: Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit (Up to hospital discharge or postoperative day 28 (whichever occurs first))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Patients Undergoing Cardiac Surgery
Brief Summary: TRICS-III is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in high risk patients having cardiac surgery using a non-inferiority trial design.


Options:
A: N/A
B: Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit (Up to hospital discharge or postoperative day 28 (whichever occurs first))
C: Composite endpoint of postoperative SIRS and at least one major organ dysfunction (day-7)
D: Incidence of Delirium (Participants will be followed for the duration of the hospital stay, an average of 5 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Patients Undergoing Cardiac Surgery
Brief Summary: TRICS-III is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in high risk patients having cardiac surgery using a non-inferiority trial design.


Options:
A: Glasgow Outcome Scale (at 6 months after injury)
B: Occurrence of a composite endpoint (90 days)
C: Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit (Up to hospital discharge or postoperative day 28 (whichever occurs first))
D: 90-day mortality (after 90 days from study enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Patients Undergoing Cardiac Surgery
Brief Summary: TRICS-III is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in high risk patients having cardiac surgery using a non-inferiority trial design.


Options:
A: Cost-effectiveness ratio at 30 days (30 days)
B: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
C: Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit (Up to hospital discharge or postoperative day 28 (whichever occurs first))
D: Methodology of the pilot study (up to 30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Patients Undergoing Cardiac Surgery
Brief Summary: TRICS-III is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in high risk patients having cardiac surgery using a non-inferiority trial design.


Options:
A: To compare mortality between groups 28 day after ICU admission (28 days after ICU admission)
B: Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit (Up to hospital discharge or postoperative day 28 (whichever occurs first))
C: Methodology of the pilot study (up to 30 days)
D: Occurrence of a composite endpoint (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Stopping Postpartum Vitamin A Supplementation: Are we Missing Concealed Benefit?
Brief Summary: The purpose of this study is to evaluate the effect of post-partum maternal vitamin A supplementation on breast milk bioactive compounds and immune status, growth and morbidity of children in the first four months of life.


Options:
A: N/A
B: Breast milk immune regulators (Four months)
C: Change in carotenoids in serum and breast milk (1 and 3 weeks)
D: Seric retinol (six months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Tailored Text Message Intervention for Pregnant Smokers (MiQuit): a Pilot Trial
Brief Summary: The overall aim of the study is to estimate the likely impact of the MiQuit text message based smoking cessation service for pregnant smokers and to establish robust estimates for the key factors which would be required in order to design a larger definitive trial of this intervention(MiQuit).

These key factors include: the range of recruitment rates in different centres; quit rates amongst participants; feasibility of assessing smoking status of participants in later pregnancy; and the likely effect of MiQuit when women are offered this in National Health Service (NHS) settings.


Options:
A: Point prevalence abstinence at 6 months (6 months after beginning treatment)
B: End-of-intervention Varenicline Adherence (4 Weeks)
C: Smoking abstinence (Six months post-treatment)
D: Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy. (36 weeks gestation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Tailored Text Message Intervention for Pregnant Smokers (MiQuit): a Pilot Trial
Brief Summary: The overall aim of the study is to estimate the likely impact of the MiQuit text message based smoking cessation service for pregnant smokers and to establish robust estimates for the key factors which would be required in order to design a larger definitive trial of this intervention(MiQuit).

These key factors include: the range of recruitment rates in different centres; quit rates amongst participants; feasibility of assessing smoking status of participants in later pregnancy; and the likely effect of MiQuit when women are offered this in National Health Service (NHS) settings.


Options:
A: smoking abstinence (12 months); smoking abstinence (12 months); smoking abstinence (12 months)
B: Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy. (36 weeks gestation)
C: Longest duration of abstinence (Week 24)
D: Point prevalence abstinence of 7 days (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Tailored Text Message Intervention for Pregnant Smokers (MiQuit): a Pilot Trial
Brief Summary: The overall aim of the study is to estimate the likely impact of the MiQuit text message based smoking cessation service for pregnant smokers and to establish robust estimates for the key factors which would be required in order to design a larger definitive trial of this intervention(MiQuit).

These key factors include: the range of recruitment rates in different centres; quit rates amongst participants; feasibility of assessing smoking status of participants in later pregnancy; and the likely effect of MiQuit when women are offered this in National Health Service (NHS) settings.


Options:
A: Exclusive breastfeeding (0-6 months following delivery); Immediate breastfeeding (1 hour following delivery)
B: Contraceptive uptake (10 weeks postpartum; 24 weeks postpartum); Facility Delivery (Postpartum); Exclusive Breastfeeding (24 weeks postpartum)
C: Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy. (36 weeks gestation)
D: Vaccines received (Electronic Health Record) (up to a year of follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Tailored Text Message Intervention for Pregnant Smokers (MiQuit): a Pilot Trial
Brief Summary: The overall aim of the study is to estimate the likely impact of the MiQuit text message based smoking cessation service for pregnant smokers and to establish robust estimates for the key factors which would be required in order to design a larger definitive trial of this intervention(MiQuit).

These key factors include: the range of recruitment rates in different centres; quit rates amongst participants; feasibility of assessing smoking status of participants in later pregnancy; and the likely effect of MiQuit when women are offered this in National Health Service (NHS) settings.


Options:
A: Biochemically-validated smoking cessation (middle and late pregnancy)
B: Smoking Behavior (Self-report Confirmed by Expired Breath CO) (8 week follow up); Urinary Cotinine (8 week follow-up)
C: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
D: Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy. (36 weeks gestation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Tailored Text Message Intervention for Pregnant Smokers (MiQuit): a Pilot Trial
Brief Summary: The overall aim of the study is to estimate the likely impact of the MiQuit text message based smoking cessation service for pregnant smokers and to establish robust estimates for the key factors which would be required in order to design a larger definitive trial of this intervention(MiQuit).

These key factors include: the range of recruitment rates in different centres; quit rates amongst participants; feasibility of assessing smoking status of participants in later pregnancy; and the likely effect of MiQuit when women are offered this in National Health Service (NHS) settings.


Options:
A: Number of Participants Who Report Starting Any Modern Method of Contraception Since the Start of the Study (4-months post-encouragement)
B: The Proportion who tested for HIV over 2 months follow-up (2 months following the first text message)
C: Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy. (36 weeks gestation)
D: Rate of Premature birth (before 37 weeks gestation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: School Wellness Policy: RCT to Implement & Evaluate Impact on Childhood Obesity
Brief Summary: Our long-term objective is to reduce the rates and risk of childhood obesity via school-based nutrition and physical activity policies. Using a randomized design, we propose to monitor and evaluate how Connecticut's first-ranked District Wellness Policy, in the New Haven Public School district, is implemented and determine its impact on children's obesogenic behaviors, weight outcomes, and school performance. This study is designed to significantly advance empirical research on school wellness policies and to provide important evidence to guide future interventions in schools and communities - translating science to improved health of the public.


Options:
A: Post-Intervention Bicycling to School (During weeks 3-5 of the intervention)
B: Reduction in prevalence of obesity (Changes from baseline in prevalence of obesity at 3 academic years)
C: change from baseline in meeting physical activity recommendation at 1 month (baseline and 1 month); change from baseline in physical activity recommendation at 7 months (baseline and 7 months); change from baseline in meeting screen time recommendation at 1 month (baseline and 1 month); change from baseline in meeting screen time recommendation at 7 month (baseline and 7 month)
D: Change in body mass index (BMI). (Baseline through Follow-up: Grades 5-6-7-8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Intravenous Acetaminophen on Post-operative Pain and Narcotic Consumption in Vaginal Reconstructive Surgery Patients: A Randomized Controlled Trial
Brief Summary: This randomized controlled trial will evaluate the effects of perioperative intravenous (IV) acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing vaginal reconstructive surgery. One hundred subjects will be randomly assigned to receive either IV acetaminophen or IV placebo. Those in the IV acetaminophen group will receive 1000mg IV every 6 hours for 24 hours beginning prior to anesthesia induction. The control group will receive placebo saline infusions at the same time intervals. All subjects will receive as needed (prn) IV narcotic for additional pain relief. Visual analog scales (VAS) regarding pain will be evaluated at 18 and 24 hours postoperative and immediately prior to discharge. We will also collect total IV narcotic consumption. We hypothesize that subjects receiving IV acetaminophen will have lower VAS scores and decreased total narcotic consumption in comparison to the control group.


Options:
A: Pain While Active - 18 hr (18 hours); Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery (24 hours)
B: Surgical Success (24 months); Anatomic Failure (24 months); Urinary Distress Inventory at 6 Months (6 months)
C: Urinary Tract Infections (three weeks post-operative)
D: To compare rates of de novo dyspareunia in women with and without vaginal dilator use following surgery for pelvic organ prolapse with posterior repair (colporrhaphy). (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The ProtecT Trial - Evaluating the Effectiveness of Treatments for Clinically Localised Prostate Cancer
Brief Summary: RATIONALE: Radical prostatectomy is surgery to remove the entire prostate. Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Sometimes the tumor may not need treatment until it progresses. In this case, active surveillance may be sufficient. It is not yet known which treatment regimen is more effective for localized prostate cancer.

PURPOSE: This randomized phase III trial is studying active monitoring to see how well it works compared with radical prostatectomy or radiation therapy in treating patients with localized prostate cancer.


Options:
A: Time to treatment failure (TTF)
B: Overall survival (1:Not applicable)
C: Overall Survival (Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry)
D: Disease specific mortality (Median 15 years follow up)

Answer: D