TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An Observer-blind Study to Rank Different Formulations of GSK Biologicals' Investigational RSV Vaccine (GSK3003891A) Administered to Healthy Women
Brief Summary: The purpose of this study is to rank different RSV vaccine dosages of antigen (or formulations) based on safety/reactogenicity and immune response data. The formulations eliciting strong immune responses while maintaining an acceptable safety profile will be considered for further evaluation, including in studies vaccinating pregnant women.


Options:
A: Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load (Twice daily on Day 2 through Day 11 and once on Day 12)
B: Number of Subjects With Any Grade 2 and Grade 3 General Adverse Events (AEs) - Solicited and Unsolicited (During the 7-day (Days 0-6) post-vaccination period); Number of Subjects With Grade 2 and Grade 3 Fever (During the 7-day (Days 0-6) post-vaccination period); Number of Subjects With Related Serious Adverse Events (SAEs) (During the 7-day (Days 0-6) post-vaccination period); Neutralizing Antibody Titers Against RSV-A Subtype (At Day 0); Neutralizing Antibody Titers Against RSV-A Subtype (At Day 30); Palivizumab Competing Antibody (PCA) Concentrations (At Day 0); Pavilizumab Competing Antibody (PCA) Concentrations (At Day 30)
C: To test the efficacy of a handwashing promotion intervention for prevention of intrahousehold transmission of influenza virus in a rural setting in Bangladesh (17 months)
D: Number of Participants With Solicited Adverse Events (AEs) by Grade (Measured from Day 0 through Day 28); Number of Participants With Unsolicited AEs by Grade (Measured from Day 0 through Day 28); Number of Participants With Serious Adverse Events (SAEs) (Measured from Day 0 through Day 56); Number of Participants Infected With RSV Vaccine Virus (Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28 for nasal washes, and at Days 0, 56 for serum RSV-neutralizing antibodies); Peak Titer of Vaccine Virus Shed (Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28); Duration of Vaccine Virus Shedding in Nasal Washes (Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28. Last day positive is reported.); Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titer (Measured at Day 0 and Day 56); Serum Antibody Responses to RSV F Glycoprotein as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) (Measured at Day 56)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Addressing the Health Concerns of VA Women With Sexual Trauma
Brief Summary: Lifetime sexual trauma (ST) (i.e., behaviors that range from unwanted sexual touching to attempted or completed rape) is a significant social and public health problem among women Veterans. For women Veterans, lifetime ST can occur prior to, during or after military service. ST is associated with multiple difficulties and risks, including posttraumatic stress disorder (PTSD), intimate partner violence (IPV), and alcohol misuse. Providing an effective, integrated, and low-cost intervention that targets ST-related risks for women Veterans with lifetime ST would advance clinical care for these vulnerable women.

This research will develop and assess a computer-delivered intervention (Safety and Health Experiences Program; SHE) that will provide a screening and brief behavior intervention for women Veterans with any lifetime ST. More specifically, the intervention, SHE, will address interrelated health concerns for women Veterans with ST (i.e. alcohol misuse, IPV, and PTSD). SHE will be designed to provide individualized assessment, feedback, and referrals for women Veterans with any lifetime ST. SHE will take place within a primary care setting. Primary care visits are frequent points of health care contact for women Veterans making the visit itself the ideal, and possibly only, opportunity to provide behavioral interventions.

This study will lay the groundwork for a larger clinical trial of the SHE program in multiple VA primary care settings. If effective, the intervention, SHE, represents an innovative and low cost service for early identification and intervention that could be implemented nationwide with ease and speed to address the needs of women Veterans with lifetime ST. The long-term goal of the project is to make a significant impact on advancing health services research by introducing and testing a novel and potentially powerful service tool that may improve service delivery to address the co-occurring health concerns for women Veterans with any lifetime ST.


Options:
A: Change in Number of Health Risks (Two months); Change in Number of Health Risks (Four months)
B: Change in PTSD Checklist (PCL-M) score from baseline to end of treatment (approximately 2 weeks)
C: Drug Abuse Screening Test (DAST-10) (6 months); Alcohol Use Disorders Identification Test (AUDIT) (6 months); Cigarettes (Estimated Number) (14 days preceding 6 week, 3 month and 6 month follow-up); Amount of Alcohol Use (14 days prior to 6 week, 3 month, 6 month follow-up); Marijuana Use Frequency (14 days prior to 6 week, 3 month, 6 month follow-up)
D: condom use (4.5 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: RAUORA: Cytisine Versus Varenicline for Smoking Cessation
Brief Summary: To evaluate the effectiveness, safety, and cost-effectiveness of cytisine plus behavioural support compared to varenicline plus behavioural support for smoking cessation, in indigenous Māori (or family of Māori) who smoke and are motivated to quit.


Options:
A: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
B: Continuous abstinence from smoking (Six months post-quit date)
C: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
D: Determine the efficacy of combined therapy (VRN+nicotine patches) versus monotherapy (VRN+placebo patches) in smoking cessation assessed as continuous abstinence rate (CAR) from week 2 to week 12. (Participants will be followed for the duration of treatment, 12 weeks.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial to Improve the South African Government's Community Health Workers' Capacities to Deliver Evidence-based Interventions for Optimizing HIV Outcomes and Reducing Its Comorbidities
Brief Summary: The purpose of this study is to address the United States Office of AIDS Research highest priorities: improving the workforce, reducing health disparities, and addressing HIV comorbidities. UCLA will randomize the government-funded community health workers (CHW) from 16 clinics in matched rural areas in the Eastern Cape in South Africa to either: 1) the Accountable Condition (AC) in which additional monitoring and accountability systems that Philani routinely uses are implemented or 2) a Control Condition (CC), of initial Philani training, but ongoing supervision and monitoring consistent with local government practices.


Options:
A: Number of significantly improved child and maternal outcomes (2 Years)
B: Retention in care in care 6 months post-transfer (6 months); Retention in care 12 months post-transfer (12 months); Retention in care 24 months post-transfer (24 months)
C: Change from Baseline in Mental Health of Children and Caregivers (Administered to caregivers and school-aged children in each cohort three times: once within 15 days prior to the start of the intervention, once within 15 days of intervention completion, and again 4 months following intervention completion.)
D: Scale name unabbreviated: "La escala de Adopción del Rol Materno (ARM) de la Doctora María del Carmen Garrido Hidalgo y la Doctora Marleny Marchán Coronado". (4 Months); Perceived Maternal Parenting Self-Efficacy (PMP S-E) by Dr. Christopher R. Barnes and Dr. Elvidina N. Adamson-Macedo: measures maternal self-efficacy. (4 months); "Perinatal Infant Care Social Support Scale" (PICSS) by Dr. Patricia Leahy-Warren: Construct: measures social support and has been widely applied in first-time mothers. (4 months); "Bond between parents and children of MSc Alix Nathalya Vargas Vásquez and Doctor Myriam Patricia Pardo Torres" (4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial to Improve the South African Government's Community Health Workers' Capacities to Deliver Evidence-based Interventions for Optimizing HIV Outcomes and Reducing Its Comorbidities
Brief Summary: The purpose of this study is to address the United States Office of AIDS Research highest priorities: improving the workforce, reducing health disparities, and addressing HIV comorbidities. UCLA will randomize the government-funded community health workers (CHW) from 16 clinics in matched rural areas in the Eastern Cape in South Africa to either: 1) the Accountable Condition (AC) in which additional monitoring and accountability systems that Philani routinely uses are implemented or 2) a Control Condition (CC), of initial Philani training, but ongoing supervision and monitoring consistent with local government practices.


Options:
A: Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery (3 years)
B: Complications detected (3 days after delivery); Successful referrals (10 days after delivery (survey and administrative records)); Care Seeking Behavior around complications and well baby check-up (10 days after delivery (survey)); Knowledge of danger signs (10 days after delivery (survey)); Breastfeeding (10 days and 9 weeks after delivery (survey))
C: DSS Investigated and Substantiated Child Maltreatment Rates (0 - 12 Years of Child Age)
D: Number of significantly improved child and maternal outcomes (2 Years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial to Improve the South African Government's Community Health Workers' Capacities to Deliver Evidence-based Interventions for Optimizing HIV Outcomes and Reducing Its Comorbidities
Brief Summary: The purpose of this study is to address the United States Office of AIDS Research highest priorities: improving the workforce, reducing health disparities, and addressing HIV comorbidities. UCLA will randomize the government-funded community health workers (CHW) from 16 clinics in matched rural areas in the Eastern Cape in South Africa to either: 1) the Accountable Condition (AC) in which additional monitoring and accountability systems that Philani routinely uses are implemented or 2) a Control Condition (CC), of initial Philani training, but ongoing supervision and monitoring consistent with local government practices.


Options:
A: Child cognitive development, behavior, and health (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years); Child social-emotional development (At-risk sample: Up to 6 years; Not-at risk sample: Up to 1 year); Child depression (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years)
B: Depressive symptoms (Measured at baseline); Depressive symptoms (Measured at 3 weeks); Depressive symptoms (Measured at 3 months); Depressive symptoms (Measured at 6 months)
C: Number of significantly improved child and maternal outcomes (2 Years)
D: The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at baseline); The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at 3 weeks postpartum); The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at 3 months postpartum); The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at 6 months postpartum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Low-molecular Heparin Infusion as Anticoagulation for Nocturnal Home Hemodialysis
Brief Summary: There is a lack of data in the literature about the use of low-molecular weight heparin (LMWH) as anticoagulation for nocturnal home hemodialysis (NHHD). This study aims to evaluate the efficacy and safety of LMWH, administered by infusion method, as compared to unfractionated heparin as anticoagulation for NHHD treatment.


Options:
A: Patency of hemodialysis circuit (20 weeks)
B: absolute and relative change in coronary artery calcification score (18 months); absolute and relative change in thoracic aortic calcification score (18 months); absolute and relative change in pulse wave velocity (18 months)
C: Prothrombin time (Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis); Activated partial thromboplastin time (Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis); Anti-Xa level (Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis; 24 hours after administration of LMWH); Dialyser urea and creatinine clearances (At 15 mins after starting hemodialysis and 15 mins before the end of hemodialysis); Dialyser thrombus score (At the end of hemodialysis (8th hour))
D: change in dialysis adequacy (every midweek dialysis session through study duration, ie 2x4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Apixaban for Primary Prevention of Venous Thromboembolism in Patients With Multiple Myeloma Receiving Immunomodulatory Therapy
Brief Summary: Patients living with multiple myeloma (MM) have an increased risk of venous thromboembolism (VTE) due to the disease itself and the use of targeted therapies, including immunomodulatory drugs (IMiDs). Prevention of VTE has become a major management challenge during MM treatment. There is a paucity of data with respect to the non-vitamin K oral anticoagulants (NOACs) in the cancer population. However, the NOACs offer comparable efficacy but improved safety compared with warfarin. Apixaban has shown excellent safety and efficacy for treatment and prevention of recurrent VTE (1,2). The safety and efficacy of apixaban for primary prevention of VTE in MM patients has not been established.

Aim #1: To quantify the 6-month rate of major and clinically relevant non-major bleeding in MM patients receiving IMiDs who are prescribed apixaban 2.5 mg orally twice daily for primary prevention of VTE.

Hypothesis #1: The 6-month rate of major and clinically relevant non-major bleeding in MM patients receiving IMiDs who are prescribed apixaban 2.5 mg orally twice daily for primary prevention of VTE will be ≤3% (2). Although the MM population, in general, has a higher medical acuity than that of the previous large randomized controlled trials of apixaban, we will be selecting a stable population of MM patients who are appropriate for immunomodulatory therapy.

Aim #2: To quantify 6-month rate of symptomatic VTE in MM patients receiving IMiDs who are prescribed apixaban 2.5 mg orally twice daily for primary prevention of VTE.

Hypothesis #2: The 6-month rate of symptomatic VTE in MM patients receiving IMiDs who are prescribed apixaban 2.5 mg orally twice daily for primary prevention of VTE will be \<7% (3). Although additional therapies for MM such as dexamethasone and erythropoietin-stimulating agents may further increase the risk of VTE, the rate of incident VTE should be reduced to \<7% with apixaban.


Options:
A: Frequency of Symptomatic Venous Thromboembolism (6 months); Frequency of Major and Clinically Relevant Non-major Bleeding (6 months)
B: Incidence of venous thromboembolism reduction
C: disease response (up to day 1 of cycle 6)
D: Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) (Up to Day 180); Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH) (From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study With NIVOlumab or Continuation of Therapy as an Early SWITCH Approach in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) and Disease Control After 3 Months of Treatment With a Tyrosine Kinase Inhibitor
Brief Summary: This study aims to assess the survival benefit from an early switch approach from sunitinib or pazopanib (10-12 weeks of 1st-line therapy) to nivolumab (anti-angiogenic to immunotherapy switch).


Options:
A: Overall survival (OS) (128 of events in max. 72 months)
B: 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)
C: Progression-Free Survival (PFS) (From initiation of treatment up to follow-up period (up to 3 years))
D: Progression Free Survival (PFS) Per Independent Central Radiology Review (Until disease progression or discontinuation of treatment due to unacceptable toxicity up to 30-Jun-2014 (discontinuation))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Dimethyl Fumarate Treatment of Primary Progressive Multiple Sclerosis
Brief Summary: This study aims to evaluate safety and efficacy of dimethyl fumarate treatment in patients with primary progressive multiple sclerosis (PPMS).

Half of the patients will receive dimethyl fumarate and the other half will receive placebo.


Options:
A: Number of new or enlarged gadolinium contrast enhancing lesions (Gd-CELs) on monthly brain MRIs collected between Weeks 8 to 24 in daclizumab- vs. placebo-treated patients
B: Adjusted Annualized Relapse Rate (ARR) (Up to 144 weeks)
C: Neurofilament light chain in the cerebrospinal fluid (CSF) (0-48 weeks)
D: Annualized Relapse Rate (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Workplace "Sit Less and Move More" Web-based Program (Walk@WorkSpain) on Occupational Sedentary Behavior, Habitual Physical Activity, Physical Risk Factors for Chronic Disease and Efficiency-related Outcomes in Spanish Office Employees
Brief Summary: This study assesses the short and mid-term impacts of a workplace web-based intervention (Walk@WorkSpain, W@WS) on self-reported occupational sitting time, step counts, activity-related energy expenditure, physical risk factors for chronic disease and efficiency-related outcomes in Spanish office employees. Half of participants had access to the W@WS website program while the other half was asked to maintain habitual behaviour.


Options:
A: Change from baseline occupational sitting time (minutes/day) at post-intervention (19 weeks) and two months follow-up. (Baseline,19 weeks, two months follow-up); Change from baseline step counts (steps/day) at post-intervention (19 weeks) and two months follow-up (Baseline,19 weeks, two months follow-up)
B: Change from baseline in workplace sitting time at 4 and 8 weeks (Baseline (week 0), Mid-intervention (4 weeks), End-intervention (8 weeks))
C: Change from baseline in physical activity and sedentariness at 12 months (Baseline, 12 months)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Workplace "Sit Less and Move More" Web-based Program (Walk@WorkSpain) on Occupational Sedentary Behavior, Habitual Physical Activity, Physical Risk Factors for Chronic Disease and Efficiency-related Outcomes in Spanish Office Employees
Brief Summary: This study assesses the short and mid-term impacts of a workplace web-based intervention (Walk@WorkSpain, W@WS) on self-reported occupational sitting time, step counts, activity-related energy expenditure, physical risk factors for chronic disease and efficiency-related outcomes in Spanish office employees. Half of participants had access to the W@WS website program while the other half was asked to maintain habitual behaviour.


Options:
A: Change from baseline occupational sitting time (minutes/day) at post-intervention (19 weeks) and two months follow-up. (Baseline,19 weeks, two months follow-up); Change from baseline step counts (steps/day) at post-intervention (19 weeks) and two months follow-up (Baseline,19 weeks, two months follow-up)
B: Change from baseline in workplace sitting time at 4 and 8 weeks (Baseline (week 0), Mid-intervention (4 weeks), End-intervention (8 weeks))
C: sitting time (one week); self-reported context-specific sitting time (one week); standing time (one week); breaks from sitting (one week)
D: Average steps per day (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 BIOmarker Driven Trial With Nivolumab and Ipilimumab or VEGFR tKi in Naïve Metastatic Kidney Cancer
Brief Summary: Disease and Stage: naïve metastatic kidney cancer.

A multicenter, randomized, a Phase 2 BIOmarker driven trial with Nivolumab and Ipilimumab or VEGFR tKi in naïve metastatic Kidney cancer


Options:
A: Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation (From date of first dose to date of last dose plus 100 days (assessed up to March 2016, approximately 49 months))
B: Overall Survival (OS) (Baseline up to Month 80)
C: ORR evaluation according to molecular groups (ccRCC1 to 4) and assigned treatment (54 months)
D: Progression-free Survival (PFS) of Subjects With Advanced Renal Cell Cancer (RCC) Randomized to Treatment With Tivozanib or Sorafenib (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks.)

Answer: C