TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementing, Evaluating, and Scaling Up of the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) Program
Brief Summary: This study will evaluate the implementation of the Strengthening a Palliative Approach in Long-Term Care (SPA-LTC) program using a cross-jurisdictional, effectiveness-implementation type II hybrid design (dual testing of clinical and implementation interventions) to assess the implementation (feasibility, fidelity, reach, sustainability) and effectiveness (family satisfaction, staff knowledge and confidence implementing a palliative approach to care, hospital use).


Options:
A: Number of Emergency Department Visits in the Resident's Last Year of Life (All residents in the home who died one year prior to the implementation and one year prior to the date of death for all residents in the home who die during the study intervention period.)
B: Incidence of hospitalizations in emergency care units (18 months)
C: NPI-NH agitation/aggression (8 weeks and 12 weeks)
D: Change in knowledge of and self-efficacy concerning ACP (One questionnaire at baseline (T0), one questionnaire at follow-up (T1, 8 months after T0))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Replication of Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes (CANVAS Trial)
Brief Summary: Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.


Options:
A: Relative hazard of 3-P MACE (composite outcome of Stroke, MI, and Mortality) (Through study completion (a median of 163-219 days))
B: Composite outcome of Stroke, MI, and Mortality (Through study completion (a median of 120-140 days))
C: Relative hazard of composite outcome of Stroke, MI, and Mortality (Through study completion (a median of 120-140 days))
D: Relative hazard of composite outcome of Stroke, MI, and Mortality (Through study completion (a median of 118-123 days))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Replication of the SAVOR-TIMI Diabetes Trial in Healthcare Claims
Brief Summary: Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.


Options:
A: Relative hazard of 3-P MACE (composite outcome of Stroke, MI, and Mortality) (Through study completion (a median of 276-312 days))
B: Composite Cardiovascular (CV) Outcome (From treatment initiation to end of follow-up, up to 53 months)
C: Relative hazard of composite outcome of Stroke, MI, and Mortality (Through study completion (a median of 118-123 days))
D: Relative hazard of composite outcome of Stroke, MI, and Mortality (Through study completion (a median of 134-151 days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Replication of the CARMELINA Diabetes Trial in Healthcare Claims
Brief Summary: Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.


Options:
A: Relative hazard of composite outcome of ACS/unstable angina, Stroke, MI, and Mortality (Through study completion (a median of 118 days))
B: Relative hazard of composite outcome of Stroke, MI, and Mortality (Through study completion (a median of 118-123 days))
C: Composite outcome of Stroke, MI, and Mortality (Through study completion (a median of 120-140 days))
D: Composite outcome of Stroke, MI, and Mortality (Through study completion (a median of 120-140 days))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Replication of the LEADER Diabetes Trial in Healthcare Claims
Brief Summary: Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.


Options:
A: Relative hazard of 3-P MACE (composite outcome of Stroke, MI, and Mortality) (Through study completion (a median of 276-312 days))
B: Composite Cardiovascular (CV) Outcome (From treatment initiation to end of follow-up, up to 53 months)
C: Relative hazard of composite outcome of Stroke, MI, and Mortality (Through study completion (a median of 154-188 days))
D: Composite outcome of Stroke, MI, and Mortality (Through study completion (a median of 120-140 days))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Replication of the TECOS Diabetes Trial in Healthcare Claims
Brief Summary: Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.


Options:
A: Relative hazard of composite outcome of ACS/unstable angina, Stroke, MI, and Mortality (Through study completion (a median of 118 days))
B: Composite outcome of Stroke, MI, and Mortality (Through study completion (a median of 120-140 days))
C: Relative hazard of composite outcome of Stroke, MI, and Mortality (Through study completion (a median of 118-123 days))
D: Relative hazard of composite outcome of Stroke, MI, and Mortality (Through study completion (a median of 120-140 days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination With Nivolumab and Ipilimumab Versus Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk
Brief Summary: This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio at approximately 180 sites.


Options:
A: Progression-free Survival (PFS) (PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause as determined by the Independent Radiology Committee (IRC) per RECIST 1.1, assessed for up to 17 months.)
B: Duration of Progression-Free Survival (PFS) per RECIST 1.1 as determined by blinded independent radiology committee (BIRC) (Up to 23 months after first subject randomized)
C: Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1 (From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)); Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) (From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)); Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC) (From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months))
D: Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT) (First dose of study drug (Cycle 1 Day 1) to end of first 4 weeks of therapy (Cycle 1)); Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 (RP2) Dose (First dose of study drug (Cycle 1 Day 1) to end of Cycle 2 (1 cycle = 28 days/4 weeks)); Phase 2: Progression-Free Survival (PFS) (Date of randomization into Phase 2 (Cycle 1 Day 1) to the date of first documentation of disease progression or death (whichever occurred first), assessed up to data cutoff date (13 Jun 2014), up to approximately 2 years and 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Hybrid Effectiveness-implementation Trial of Go NAPSACC: A Childcare-based Obesity Prevention Program
Brief Summary: This study will compare the effectiveness and cost of Basic and Enhanced delivery models for Go NAPSACC on child care centers' use of evidence-based nutrition and physical activity practices. Technical assistance (TA) coaches from Child Care Aware of Kentucky will lead delivery. Half of the TA coaches will deliver Go NAPSACC using the Basic model and the other half will deliver the program using the Enhanced model. It is hypothesized that the Enhanced model will result in greater use of evidence-based nutrition and physical activity practices and will also be more cost effective.


Options:
A: 1-year, and 3-year changes from baseline in questionaires scores for knowledge, attitudes, and habits of children, parents and teachers in regards to a healthy lifestyle. (3 years)
B: Fidelity to WISE Evidence-Based Practices using the WISE fidelity observational measure (Through study completion, an average of 2 years)
C: Mean Nutrition Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up)); Mean Physical Activity Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up))
D: Change in The Environment and Policy Assessment and Observation tool (EPAO) score (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Hybrid Effectiveness-implementation Trial of Go NAPSACC: A Childcare-based Obesity Prevention Program
Brief Summary: This study will compare the effectiveness and cost of Basic and Enhanced delivery models for Go NAPSACC on child care centers' use of evidence-based nutrition and physical activity practices. Technical assistance (TA) coaches from Child Care Aware of Kentucky will lead delivery. Half of the TA coaches will deliver Go NAPSACC using the Basic model and the other half will deliver the program using the Enhanced model. It is hypothesized that the Enhanced model will result in greater use of evidence-based nutrition and physical activity practices and will also be more cost effective.


Options:
A: Mean Nutrition Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up)); Mean Physical Activity Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up))
B: Fidelity to WISE Evidence-Based Practices using the WISE fidelity observational measure (Through study completion, an average of 2 years)
C: Difference Between Interventions in Vegetable Intake (One meal per week for each intervention (Study weeks 1, 2, 3, and 4))
D: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Hybrid Effectiveness-implementation Trial of Go NAPSACC: A Childcare-based Obesity Prevention Program
Brief Summary: This study will compare the effectiveness and cost of Basic and Enhanced delivery models for Go NAPSACC on child care centers' use of evidence-based nutrition and physical activity practices. Technical assistance (TA) coaches from Child Care Aware of Kentucky will lead delivery. Half of the TA coaches will deliver Go NAPSACC using the Basic model and the other half will deliver the program using the Enhanced model. It is hypothesized that the Enhanced model will result in greater use of evidence-based nutrition and physical activity practices and will also be more cost effective.


Options:
A: To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program; a physical activity skill development program; and a parent-centered dietary modification + physical activity skill development program.
B: change in adiposity (baseline, 6 month follow-up)
C: Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE (6 weeks)
D: Mean Nutrition Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up)); Mean Physical Activity Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Study on Long-term Outcome and Potential Usefulness fo an Intervention Aimed at Reducing Adverse Effects in Patients With Refractory Epilepsy
Brief Summary: Over 1 million people in the European Union (EU) suffer from chronic refractory epilepsy. Their quality of life (QoL) is severely affected by seizures and by the adverse effect of antiepileptic drug (AED) treatment. Several new AEDs have been introduced in recent years, but their impact on the long-term outcome in these patients has been inadequately explored. Preliminary data from the U.S. suggests that using a standardize toll to quantitate adverse AED effects can improve outcome, but the general applicability of these findings is unclear.

Objectives: 1) To assess prospectively AED utilization patterns in patients with refractory epilepsy ; 2) to assess how such treatments and other variables correlated with seizure control, adverse effects, and QoL in these patients; 3) to establish the impact of a standardized evaluation of adverse effects on clinical outcome.

Methods: The project included a core observational study and a randomized intervention in a subcohort.

In the core (observational) study, 1,000 consecutive refractory epilepsy patients were enrolled and followed-up prospectively at 10 centres in Italy. The following parameters were recorded at 0 (entry), 6, 12 and 18 months: (i) drug therapy; (ii) seizure frequency; (iii) adverse events based on medical examination and non-structured interview; (iii) treatment costs and, (iv) for patients above age 16, standardized questionnaires for adverse effects (AEP), depressive symptoms (Becks Depression Scale, BDS), QoL (QOLIE-31) and clinical global impression (CGI). The primary outcome (changes in QOLIE-31 scores) will be related to the other variables measured.

In the randomized intervention, the subcohort meeting specific eligibility criteria (age \>16 years, no progressive disorder, AEP score\>=45 ) was randomized to two groups. In the intervention group, AEP score results were made available to the physician at each visit, while in the other group AEP scores were only made available at the end of follow-up. Primary outcome were changes in AEP score.


Options:
A: To evaluate patient willingness to use STAR (Symptom Tracking and Reporting for Patients), an Internet-based system for cancer patients to self-report common toxicity symptoms, performance status, and quality of life. (conclusion of study); To evaluate the impact of STAR on clinical outcomes (2 years)
B: Quality Of Life In Epilepsy (QOLIE)-31 global score (Month 18); Adverse Events Profiles (AEP) score (Month 18)
C: Risky drinking (6, 12, 18, 24 months)
D: Heart Failure-specific Quality of Life (twelve-month followup)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementation of First-trimester Screening and Prevention of Preeclampsia: a Stepped Wedge Cluster-randomized Trial in Asia
Brief Summary: This implementation study aims to evaluate the efficacy, acceptability, and safety of first-trimester screening and prevention for preterm-preeclampsia. It is a multicenter stepped wedge cluster randomized trial including maternity / diagnostic units from ten regions in Asia. The study involves a period where no intervention will take place at all recruiting units, and then at regular intervals, one cluster will be randomized to transit from non-intervention group to intervention group in which first-trimester screening for preterm-preeclampsia by the Bayes based method followed by the commencement of low-dose aspirin in high-risk women.


Options:
A: Pregnancy rate (Five weeks after embryo transfer)
B: Delivery with preterm-preeclampsia (Before 37 weeks of gestation)
C: Incidence of Preterm Birth (At delivery)
D: Prevention of preeclampsia (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet-based Supervised Exercise Program in Systemic Lupus Erythematosus: A Randomized Controlled Trial
Brief Summary: This pilot study is a randomized controlled trial to assess the effect of an individualized supervised exercise program in patients with systemic lupus erythematosus (SLE) compared to treatment-as-usual (TAU).


Options:
A: Lipid profile - Plasma levels of total cholesterol (mg/dl), VLDL-chol (mg/dl) HDL-chol (mg/dl), LDL-chol (mg/dl), triglycerides (mg/dl), Apolipoprotein AI and AII (mg/dl) and Apolipoprotein B (mg/dl) (3 months); Insulin sensitivity as measured by the Hyperinsulinemic-Euglycemic Clamp (3 months); Cytokine response - Plasma levels of TNF-α (pg/ml), IL-6 (pg/ml), IFN-type I (pg/ml), IL-10 (pg/ml)and IL-1ra (pg/ml) (3 months)
B: change of DASH questionnaire (Baseline, 6, 12, 24 weeks)
C: Peak oxygen uptake (VO2peak) (12-weeks)
D: Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24. (Baseline, 24 weeks); Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index) (0 to 52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: To Share or Not To Share (2Share) - Group Intervention to Support Disclosure Decisions After Suicide Attempt
Brief Summary: The purpose of the study is to evaluate the group-based intervention "To Share Or Not To Share" in a German clinical setting. Feasibility and efficacy of the program will be tested in a pilot randomized-controlled trial.


Options:
A: Clinical Global Impression (CGI): Improvement (1-7): score 3 ( a little better) associated with a hopelessness scale score < 8 (this means that the suicide risk is low)
B: Self-stigma related to suicide attempt (2 weeks)
C: Suicidal behavior and ideation (Weeks 4, 12, and 24)
D: Occurrence of suicidal event assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: To Share or Not To Share (2Share) - Group Intervention to Support Disclosure Decisions After Suicide Attempt
Brief Summary: The purpose of the study is to evaluate the group-based intervention "To Share Or Not To Share" in a German clinical setting. Feasibility and efficacy of the program will be tested in a pilot randomized-controlled trial.


Options:
A: Suicidal thoughts or attempts (Measured at Year 2)
B: assessing change in number of suicide attempts/self-harming acts (baseline, 0, 12, 24 and 52 weeks after the start of the inpatient treatment)
C: Self-stigma related to suicide attempt (2 weeks)
D: Reduced Self-harm (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: To Share or Not To Share (2Share) - Group Intervention to Support Disclosure Decisions After Suicide Attempt
Brief Summary: The purpose of the study is to evaluate the group-based intervention "To Share Or Not To Share" in a German clinical setting. Feasibility and efficacy of the program will be tested in a pilot randomized-controlled trial.


Options:
A: Suicide behavior defined by self poisoning or other suicidal attempts in the emergency departments of the region. Death by suicide will be identified by the examination of information obtained from the national death statistics office (INSERM). (2 years)
B: Self-stigma related to suicide attempt (2 weeks)
C: Change from baseline Adult Suicidal Ideation at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Measurement of Hopelessness at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Interpersonal Needs at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Service Utilization at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months); Change from baseline Suicidality at 1-month, 2-month and 3-month (Baseline, 1 month, 2 months, 3 months)
D: Time to Suicide Attempt (Up to 18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Korea Red Ginseng on Non-alcoholic Fatty Liver Disease
Brief Summary: Korea Red Ginseng (KRG) has effect on liver function


Options:
A: The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS). (approximately 12 months from enrollment)
B: Evaluate the effects of VSL#3 on metabolic, endocrine, lipidomic, metabolomic and inflammatory markers and microbiota variation of pediatric patients with BMI>90° (1 year)
C: The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24. (24 weeks)
D: Liver enzyme (1year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: EdoxabaN for IntraCranial Hemorrhage Survivors with Atrial Fibrillation (ENRICH-AF)
Brief Summary: To assess whether edoxaban (60/30 mg daily) compared to non-antithrombotic medical therapy (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk of stroke (composite of ischemic, hemorrhagic and unspecified stroke) or systemic embolism in high-risk atrial fibrillation (CHA2DS2-VASc ≥2) patients with previous intracranial hemorrhage.


Options:
A: Fatal or non-fatal symptomatic ICH. (2 years)
B: Symptomatic intracranial haemorrhage (24 months)
C: 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.)
D: Stroke or Systemic Embolism (From randomization until the common study end date (average of 3 years)); Major hemorrhage (From randomization until the common study end date (median 2 years))

Answer: D