TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS - Cardiovascular OutcoMes for People Using Anticoagulation StrategieS).
Brief Summary: The primary objectives of this study are:

* To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD);
* To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.


Options:
A: Feasibility of Phase III Trial (36 months (24 Months Recruitment + 12 months Follow Up))
B: Incident dementia determined by a formal diagnosis of dementia by a neurologist (24 months); Moderate decline in cognitive function based on results of the Alzheimer's Disease Assessment Scale and the Disability Assessment for Dementia. (24 months)
C: The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death (For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.); The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria (For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.)
D: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Physical Activity in Churchgoing Latinas: Fe en Acción (Faith in Action)
Brief Summary: The low prevalence of moderate-to-vigorous physical activity (MVPA) among adult Latinas likely contributes to the high rates of cancer and other chronic diseases in this population. The goals of the current study, based largely upon the core principles of the Social Ecological Model, are to design, implement, and evaluate an innovative multi-level intervention promoting physical activity among churchgoing Latinas.

The evidenced-based intervention targets three "tiers" of environmental influences (i.e., church, immediate neighborhood surrounding the church, and community) on activity, as well as MVPA-related personal factors (i.e.., interpersonal, cultural, and perceived environmental variables). The physical activity intervention will be compared with an attention-control condition providing health education on cancer screening and prevention.

Sixteen churches will be randomly assigned to either the physical activity intervention or the attention-control condition. The primary aim of the study is to determine whether a multi-level intervention will increase MVPA among Latina churchgoers in the intervention condition relative to the attention-control condition.


Options:
A: Attendance at Cervical Cancer Screening at clinics included in Trial (within 60 days from recruitment into study)
B: Patient Satisfaction in the 2 Interventions (within 6 months of PAP); CIS Experience of Patients in Arm II and the Effect of the Intervention on Their Follow-up Colposcopy (within 6 months of PAP)
C: Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA) (assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported); Self-report Leisure-time MVPA (assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported)
D: Participant attends cervical cancer screening (Within 7 months of the intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Awareness Fetal Movements and Focussing Interventions Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial.
Brief Summary: Rates of stillbirth in Scotland are among the highest in resource rich countries. The majority of stillbirths occur in normally formed infants, with (retrospective) evidence of placental insufficiency being the commonest clinical finding. Maternal perception of decreased fetal movements appears to be an early biomarker both of placental insufficiency and subsequent stillbirth.

The study proposed here will test the hypothesis that rates of stillbirth will be reduced by introduction of a package of care consisting of strategies for increasing pregnant women's awareness of the need for prompt reporting of decreased fetal movements, followed by a management plan for identification of placental insufficiency with timely delivery in confirmed cases. The odds of stillbirth fell by 30% after the introduction of a similar package of care in Norway but the efficacy of this intervention (and possible adverse effects and implications for service delivery) have not been tested in a randomized trial.

The investigators plan a stepped wedge cluster design trial, in which hospitals in Scotland and Ireland will be randomized to the timing of introduction of the care package. Outcomes (including the primary outcome of stillbirth) will be derived from Scotland and Ireland's detailed routinely collected maternity data, allowing the investigators to robustly test the hypothesis. A nested qualitative study will examine the acceptability of the intervention to patients and health care providers and identify process issues (barriers to implementation).


Options:
A: 180 day rehospitalization rate (at 180 days post-discharge)
B: Rates of stillbirth (36 months)
C: parental anxiety (at discharge from the acute ward. An average stay in the acute ward is about 5 hours.)
D: Stroke Symptom and Response Knowledge Assessment (student) (Up to 3 days from baseline); Assessment of child's communication to parent regarding stroke symptoms. (Up to 7 days from baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacokinetic Evaluations of Ixekizumab Following Subcutaneous Administration Using Prefilled Syringe or Auto-Injector in Patients With Moderate-to-Severe Plaque Psoriasis
Brief Summary: The purpose of this study is to evaluate the serum concentration of ixekizumab after administration using either prefilled syringe or auto-injector in participants with moderate to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety extension.


Options:
A: Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 (Baseline and 12 weeks)
B: Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score (Week 16)
C: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)); PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration))
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacokinetic Evaluations of Ixekizumab Following Subcutaneous Administration Using Prefilled Syringe or Auto-Injector in Patients With Moderate-to-Severe Plaque Psoriasis
Brief Summary: The purpose of this study is to evaluate the serum concentration of ixekizumab after administration using either prefilled syringe or auto-injector in participants with moderate to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety extension.


Options:
A: Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.
B: The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo. (13 weeks)
C: Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline (Baseline to Week 16)
D: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)); PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacokinetic Evaluations of Ixekizumab Following Subcutaneous Administration Using Prefilled Syringe or Auto-Injector in Patients With Moderate-to-Severe Plaque Psoriasis
Brief Summary: The purpose of this study is to evaluate the serum concentration of ixekizumab after administration using either prefilled syringe or auto-injector in participants with moderate to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety extension.


Options:
A: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (Baseline to week 16)
B: Number of Patients Experiencing One or More Adverse Events Occurring From Week 0 Through Week 12 (from week 0 to week 12)
C: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)); PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration))
D: Number of Participants Who Achieved Pain Assessment Severity Index (PASI) 90 at Week 52. (Baseline, Week 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacokinetic Evaluations of Ixekizumab Following Subcutaneous Administration Using Prefilled Syringe or Auto-Injector in Patients With Moderate-to-Severe Plaque Psoriasis
Brief Summary: The purpose of this study is to evaluate the serum concentration of ixekizumab after administration using either prefilled syringe or auto-injector in participants with moderate to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety extension.


Options:
A: Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Number of Participants With Treatment Emergent Adverse Events (3 months); Pharmacokinetics Parameter : Skin Flux of INCB018424 (Days 8, 15, 22, and 28); Pharmacokinetics Parameter : Bioavailability of INCB018424 (Days 8, 15, 22, and 28)
B: Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24 (Week 24)
C: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) (Week 16)
D: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)); PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacokinetic Evaluations of Ixekizumab Following Subcutaneous Administration Using Prefilled Syringe or Auto-Injector in Patients With Moderate-to-Severe Plaque Psoriasis
Brief Summary: The purpose of this study is to evaluate the serum concentration of ixekizumab after administration using either prefilled syringe or auto-injector in participants with moderate to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety extension.


Options:
A: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)); PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration))
B: PASI 75 (16 weeks); Physician Global Assessment, PGA (16 weeks)
C: Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study) (Week 12 (or end of trial if prior to Week 12)); Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Base Study) (Baseline and Week 12 (or end of trial if prior to Week 12)); Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study) (Up to 12 weeks)
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A When Administered Subcutaneously Versus Intramuscularly in Adults Aged 50 Years or Older
Brief Summary: The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of GSK Biologicals' Herpes Zoster (HZ) vaccine (GSK 1437173A) when administered subcutaneously (SC) as compared to intramuscularly (IM) to people 50 years of age and older.


Options:
A: Number of Subjects With Confirmed Herpes Zoster (HZ) Cases (During the entire study period (3 to 5 year period following Day 0))
B: Number of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group (At 1 month post-Dose 2 (Month 3)); Antibody Concentrations Against Glycoprotein E (Anti-gE) (At 1 month post-Dose 2 (Month 3 for GSK1437173A Group adn Month 5 for Control Group)); Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens (At 1 month post-Dose 1 (Month 1)); Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens (At 1 month post-Dose 1 (Month 1))
C: Reduce burden of illness due to herpes zoster (HZ) (Incidence of postherpetic neuralgia (PHN), where PHN is defined as HZ-associated pain greater than or equal to 3 persisting or appearing more than 30 days after the onset of the HZ rash)
D: Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL) (Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)); Anti-gE Antibody Concentrations (Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)); Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations (At two months after Dose 1 (M2) and one month after Dose 2 (M3)); Descriptive Statistics of Anti-gE Antibody Concentrations (Before vaccination (PRE), at two months after dose 1 (M2) and one month after Dose 2 (M3)); Number of Subjects With Solicited Local Symptoms (During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses); Number of Subjects With Solicited General Symptoms (During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses); Mean Number of Days With Local Symptoms (During the 7 day (Days 0-6) post vaccination, after each dose (D)); Mean Number of Days With General Symptoms (During the 7 day (Days 0-6) post vaccination, after each dose (D)); Number of Subjects With Potential Immune-Mediated Disorders (pIMDs) (From Month 0 to Month 3); Number of Subjects With Unsolicited Adverse Events (AEs) (Within 30 days (Days 0-29) post vaccination period); Number of Subjects With Serious Adverse Events (SAEs) (From Month 0 to Month 3)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Trial Comparing the Efficacy and Safety of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily With Tiotropium 18 mcg Once Daily Over 24 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of this 24 week study is to evaluate the spirometric lung function effect (trough FEV1) of Umeclidinium/Vilanterol 62.5/25 once daily compared to Tiotropium 18 mcg once daily along with safety assessments in subjects with COPD.


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)
B: Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo (Baseline and 6 weeks)
C: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
D: Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 (Week 26)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Trial Comparing the Efficacy and Safety of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily With Tiotropium 18 mcg Once Daily Over 24 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of this 24 week study is to evaluate the spirometric lung function effect (trough FEV1) of Umeclidinium/Vilanterol 62.5/25 once daily compared to Tiotropium 18 mcg once daily along with safety assessments in subjects with COPD.


Options:
A: Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose (Day 43, 60 minutes post-dose after 6 weeks of each treatment)
B: Inspiratory Capacity (IC) Peak Value (Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours)
C: Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks (12 weeks)
D: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Trial Comparing the Efficacy and Safety of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily With Tiotropium 18 mcg Once Daily Over 24 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of this 24 week study is to evaluate the spirometric lung function effect (trough FEV1) of Umeclidinium/Vilanterol 62.5/25 once daily compared to Tiotropium 18 mcg once daily along with safety assessments in subjects with COPD.


Options:
A: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Baseline (BL) and Day 85)
B: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
C: Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period (From the first dose of study medication up to 52 weeks); Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period (From the first dose of study medication up to 52 weeks)
D: Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1) (Day 7 and Day 8 of each treatment period (up to Study Day 50)); Final Dose-response Model for Trough FEV1 for ED50 (Potency) Parameter (Day 7 and Day 8 of each treatment period (up to Study Day 50)); Final Dose-response Model Parameter β-FEV1MB-S0 for Trough FEV1 (Day 7 and Day 8 of each treatment period (up to Study Day 50)); Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 8 of Each Treatment Period (Baseline and Day 8 of each treatment period (up to Study Day 50))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: 3% Hypertonic Saline to Reduce Hospitalization Rate in Acute Viral Bronchiolitis: a Randomized Double Blind Clinical Trial
Brief Summary: The purpose of this study is to determine whether nebulized hypertonic saline solution reduces the admission rate 48 hours after initial treatment in the emergency department, when compared to normal saline solution (control).


Options:
A: compare the rate of admission to hospital between the study and control groups (1 hour after treatment ends)
B: Admission rate (24 hours)
C: length of hospital stay (2 years)
D: Mean Change in Clinical Severity Score (2 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: 3% Hypertonic Saline to Reduce Hospitalization Rate in Acute Viral Bronchiolitis: a Randomized Double Blind Clinical Trial
Brief Summary: The purpose of this study is to determine whether nebulized hypertonic saline solution reduces the admission rate 48 hours after initial treatment in the emergency department, when compared to normal saline solution (control).


Options:
A: Length of Stay in the Study-LOS--Intention to Treat Analysis (Time of first study treatment until time of discharge); Length of Stay in the Study-LOS by Per Protocol Analysis (Time of first study treatment until time of discharge)
B: Admission rate (24 hours)
C: Change in Bronchiolitis Severity Score (Baseline and up to 24 hours of hospital stay)
D: Time to 'fit for discharge' (This was judged to be when the infant was feeding adequately [taking >75% of usual intake] and was in air with a saturation of at least 92% for 6 hours, to reflect clinical practice.)

Answer: B