TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Open-Label Study to Assess Humoral and Intestinal Polio Immunity Following a Three-Dose Trivalent Inactivated Polio Vaccine Schedule Relative to Two Sequential Schedules of IPV/Bivalent Oral Polio Vaccines
Brief Summary: The rationale for this study (IPV 002ABMG) is to evaluate and compare three doses of IPV, two doses of IPV plus one bOPV, and one dose of IPV plus two doses of bOPV in order to provide evidence for better immunization policy making in regions of the world that must switch to use of IPV/bOPV schedules in the 2014-2015 time frame. The goal is to identify the best option optimizing humoral immune responses, intestinal immunity and thereby prevent community transmission as well as preventing VAPP. Specifically, the study seeks to show that both of the sequential regimens are equivalent (not-inferior) to the 3-dose IPV regimen in the seroconversion rates to both type 1 and type 3 poliovirus such that not more than 10% of subjects fall below the 95% confidence interval observed for the 3-dose IPV alone regimen and the geometric mean titers (GMTs) are no more than 2/3 logs less than those for the 3-dose IPV regimen. In addition, the study will evaluate by a novel method (poliovirus shedding index), the adequacy of IPV vaccines in inducing intestinal immunity, specifically by reducing the shedding of poliovirus type 2 after an OPV challenge. The hypotheses of the study are:

* A 3-dose IPV/bOPV sequential schedule including 1 or 2 doses of bOPV is non-inferior in terms of types 1 and 3 seroconversion rates and GMTs to a 3-dose IPV schedule.
* Two and possibly 1 IPV dose(s) provides significant seroconversion rates and GMTs to type 2 poliovirus and sufficient priming to induce a rapid immune response in the context of an oral challenge at 7 months of age.
* Three, 2, and possibly 1 dose of IPV will induce intestinal immunity to poliovirus type 2 as measured by a combination of quantity of virus in stools and duration of shedding (shedding index).

In addition to these 3 hypotheses, the study will explore the following hypothesis:

• Co-administration of bOPV and rotavirus at 16 weeks of age (the second rotavirus dose) provides similar antirotavirus IgA seroconversion rates and GMCs compared to subjects receiving rotavirus vaccine together with IPV.


Options:
A: Change in the stool poliovirus excretion after mOPV2 challenge (shedding index) (Within 28 days of mOPV2 challenge); Seroconversion and seroprotection to type 1, 2 and 3 poliovirus (At 6 and 14 weeks, and then before and 1 week after mOPV2 challenge)
B: Seroconversion by measuring level of poliovirus antibodies in serum. Also, measure of virus titer in stools to indirectly assess the level of intestinal mucosal immunity
C: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 (At Month 3, one month after the third vaccine dose)
D: Types 1 and 3 poliovirus humoral immune response (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Livslots Angered - A Randomized Controlled Trial of a Community-based Health-promoting and Disease-preventive Program for Older Foreign Born Adults
Brief Summary: The overarching aim with this study was to develop, implement and evaluate a health promoting programme for people from Finland or the Western Balkan region, who were 70 years of age or older and independent daily activites (1). The aim of the programme was to prevent or delay dependence in daily activities, health decline, and frailty. The study focused on both evaluation and implementation and the data collection finished in 2016


Options:
A: adherence to dietary sodium targets as assessed from 3-day food recalls (baseline and 4 months); average daily interdialytic weight gain (IDWG) (IDWG gathered with each dialysis treatment); average pulse pressure from pre-dialysis blood pressures (with each dialysis treatment)
B: HbA1c (30 Weeks)
C: Change of Activities of Daily Life (ADL) (change from baseline at 6 months and 1 year); Change of Sense of Coherence (KASAM) (change from basline at 6 months and 1 year)
D: Change from Baseline in Mean steps/day at 3 months (3 months); Change from Baseline in Mean Steps/day at 1 month (1 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality
Brief Summary: The aim of the present study is to investigate the possible effects of supplementation with 1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality during a follow-up period of 2 years in an elderly population after having experienced an acute myocardial infarction.

The hypothesis is that this supplementation on top of modern therapy will reduce the combined cardiovascular end-point of death, non-fatal myocardial infarction, stroke, revascularizations or hospitalization for new or worsened heart failure with at least 30%.


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: Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure. (24months)
C: Survival free of atrial fibrillation (12 months)
D: Atrial tachycardia and atrial fibrillation burden (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality
Brief Summary: The aim of the present study is to investigate the possible effects of supplementation with 1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality during a follow-up period of 2 years in an elderly population after having experienced an acute myocardial infarction.

The hypothesis is that this supplementation on top of modern therapy will reduce the combined cardiovascular end-point of death, non-fatal myocardial infarction, stroke, revascularizations or hospitalization for new or worsened heart failure with at least 30%.


Options:
A: Occurrence of appropriate ICD intervention (shock or antitachycardia pacing) for spontaneous ventricular tachyarrhythmias, or all-cause mortality
B: Number of Participants With Invasive Cancer of Any Type (5 years); Number of Participants With a Major Cardiovascular Event (5 years)
C: Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure. (24months)
D: Death, all-cause (Up to 7 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality
Brief Summary: The aim of the present study is to investigate the possible effects of supplementation with 1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality during a follow-up period of 2 years in an elderly population after having experienced an acute myocardial infarction.

The hypothesis is that this supplementation on top of modern therapy will reduce the combined cardiovascular end-point of death, non-fatal myocardial infarction, stroke, revascularizations or hospitalization for new or worsened heart failure with at least 30%.


Options:
A: Sudden cardiac death (12 months)
B: Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure. (24months)
C: Survival free of atrial fibrillation (12 months)
D: Weight loss (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality
Brief Summary: The aim of the present study is to investigate the possible effects of supplementation with 1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality during a follow-up period of 2 years in an elderly population after having experienced an acute myocardial infarction.

The hypothesis is that this supplementation on top of modern therapy will reduce the combined cardiovascular end-point of death, non-fatal myocardial infarction, stroke, revascularizations or hospitalization for new or worsened heart failure with at least 30%.


Options:
A: Cardiovascular mortality (From entry into the study (baseline: 2002-2006) through study completion); All-cause mortality (From entry into the study (baseline: 2002-2006) through study completion); Major cardiovascular events (From entry into the study (baseline: 2002-2006) until November 2009)
B: Differences in mean systolic blood pressure in the two diet/sport arms (4 months)
C: Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure. (24months)
D: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality
Brief Summary: The aim of the present study is to investigate the possible effects of supplementation with 1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality during a follow-up period of 2 years in an elderly population after having experienced an acute myocardial infarction.

The hypothesis is that this supplementation on top of modern therapy will reduce the combined cardiovascular end-point of death, non-fatal myocardial infarction, stroke, revascularizations or hospitalization for new or worsened heart failure with at least 30%.


Options:
A: Number of Participants With Invasive Cancer of Any Type (5 years); Number of Participants With a Major Cardiovascular Event (5 years)
B: Sudden cardiac death (12 months)
C: Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure. (24months)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality
Brief Summary: The aim of the present study is to investigate the possible effects of supplementation with 1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality during a follow-up period of 2 years in an elderly population after having experienced an acute myocardial infarction.

The hypothesis is that this supplementation on top of modern therapy will reduce the combined cardiovascular end-point of death, non-fatal myocardial infarction, stroke, revascularizations or hospitalization for new or worsened heart failure with at least 30%.


Options:
A: cardiovascular deaths and hospitalization for cardiovascular causes (5 years)
B: Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure. (24months)
C: Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome (90 days); Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome (90 days); Stroke-related Mortality, Primary Safety Outcome (90 days)
D: Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization. (Total follow-up time of up to approximately 6 years.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Giving Omega-3 Fatty Acids to Elderly Patients Diagnosed With Acute Myocardial Infarction to Investigate the Effect on Cardiovascular Morbidity and Mortality
Brief Summary: The aim of the present study is to investigate the possible effects of supplementation with 1.8 g/day of n-3 polyunsaturated fatty acids on cardiovascular morbidity and mortality during a follow-up period of 2 years in an elderly population after having experienced an acute myocardial infarction.

The hypothesis is that this supplementation on top of modern therapy will reduce the combined cardiovascular end-point of death, non-fatal myocardial infarction, stroke, revascularizations or hospitalization for new or worsened heart failure with at least 30%.


Options:
A: Optical density of macular pigment (12 months)
B: Combined total mortality, first event of non-fatal myocardial infarction, stroke, revascularization or hospital admission for new or worsened heart failure. (24months)
C: Surgical Arm: Proportion of study SVGs which are totally occluded on cardiac CT angiography at 1-year post-CABG and death due to CV or unknown causes. (1 year post-operative); Pharmacological Arm: Proportion of patients with ≥1 graft (saphenous or arterial) totally (100%) occluded on cardiac CT angiography at 1-year post-CABG and death due to CV or unknown causes, comparing the fish-oil to placebo groups. (1-year post-operative)
D: Changes from baseline in global cognitive composite score (2 years); Changes from baseline in macular degeneration (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery
Brief Summary: Worldwide over 2 million adults (\>30,000 Canadians) undergo heart surgery annually. Although heart surgery provides important survival benefits, it is associated with potential major complications such as death, stroke, and heart attack. There is promising evidence that measurement of heart injury markers after surgery will identify patients at risk of death or major complications.

This study will determine the current incidence of major complications in a representative sample of 15,000 contemporary adult patients undergoing heart surgery. Knowing the current burden of complications will inform clinicians, administrators, government and granting agencies about resources required to address the problem. This study will also establish the role of measuring heart injury markers to identify important heart injury after heart surgery and the proportion that would go undetected without routine heart injury marker monitoring. This information will facilitate further studies of timely interventions. In summary, the VISION Cardiac Surgery Study addresses fundamental questions that will have profound public health implications given the millions of adults worldwide who undergo heart surgery annually.


Options:
A: Progression-free Survival (PFS) (Median observation time at time of analysis was approximately 21 months); Final Analysis: Time to Progression-free Survival Event (Median observation time was approximately 66.4 months)
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: Major Adverse Cardiac and Cerebrovascular Events (MACCEs) (up to 90 days after surgery)
D: All-cause mortality at 30-days after surgery (30 days after surgery); Myocardial injuries that were not identified clinically during the first 5 days after surgery (5 days after surgery); Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device (30 days after surgery); Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device (1 year after surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in theMEA115588 or MEA115575 Trials
Brief Summary: This is a multi-centre, open-label long-term safety study of 100 milligram (mg) mepolizumab administered subcutaneously (SC) every 4 weeks for 12 months in addition to standard of care in subjects who have severe, refractory asthma and a history of eosinophilic inflammation. Subjects who completed either MEA115588 or MEA115575 will be offered the opportunity to consent for this study.


Options:
A: Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions (From Baseline visit until the follow-up visit (approximately [approx.] week 60 [12 weeks post-last dose]))
B: N/A
C: Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period (Baseline to end of the fixed-dose steroid treatment period (Week 24)); Percentage of Participants With at Least 1 Adverse Event (Baseline to end of the study (Week 68))
D: Safety and tolerability in healthy volunteers.Assessed using clinical safety assessments and blood and urine analysis (Throughout the study); Safety and tolerability in mild asthmatics.Assessed using clinical safety assessments and blood and urine analysis. (Throughout the study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in theMEA115588 or MEA115575 Trials
Brief Summary: This is a multi-centre, open-label long-term safety study of 100 milligram (mg) mepolizumab administered subcutaneously (SC) every 4 weeks for 12 months in addition to standard of care in subjects who have severe, refractory asthma and a history of eosinophilic inflammation. Subjects who completed either MEA115588 or MEA115575 will be offered the opportunity to consent for this study.


Options:
A: Percentage of Participants With Asthma Exacerbation (Baseline up to Week 12)
B: Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions (From Baseline visit until the follow-up visit (approximately [approx.] week 60 [12 weeks post-last dose]))
C: The primary outcome measure is the late asthmatic response (LAR) in patients treated with huMAb OX40L versus placebo (16 weeks after the first dose)
D: Rate of Asthma Exacerbations Over the 48 Week Treatment Period (48 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Stratified and Controlled Clinical Trial With Split-virion, Non-adjuvanted Influenza A/H1N1 Vaccines in Healthy Pregnant Women
Brief Summary: Since October 2009, H1N1 influenza vaccine has developed and approved of immunization in population in China. However, there was little epidemiological evidence of safety when vaccinated in healthy pregnant women. The main objective of this study is to assess the safety of split-virion inactivated H1N1 vaccine without adjuvant when administered in healthy pregnant women. It is a stratified and controlled clinical trial in healthy pregnant women. And participants were included up to 226 healthy pregnant women aged 18 -35 years old who have no history of novel influenza H1N1 infection or novel influenza H1N1 vaccination. The pregnancy week ranged from 5 weeks to 32 weeks. Subjects were divided into 2 groups: vaccinated group（122） and unvaccinated group（104）. Subjects in the vaccinated group were administered one dose of 15μg H1N1 vaccine. Subjects in the unvaccinated group received no vaccine as controls. Safety will be measured by assessment of pregnancy outcomes. And observation time for pregnancy outcomes was lasting for 28 days postpartum since vaccinated; and protective effect was observed for six months.


Options:
A: Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessment). (Duration of study.); Proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 40 against the influenza A/H7N7 virus. (28 days after receipt of the second dose of vaccine (approximately Day 56).); Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group and serum hemagglutination inhibition (HAI) antibody titers in each group. (1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.)
B: CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection (2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009)
C: Adverse Pregnancy Outcomes (0-28 days postpartum)
D: the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay (21 days after each vaccination)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Second RCT Evaluation of the Durham Connects Universal Newborn Nurse Home Visiting Program
Brief Summary: The aim of this randomized controlled trial (RCT) is to conduct a second, independent evaluation the implementation and impact of the Durham Connects (DC) brief universal nurse home-visiting program to prevent child maltreatment and improve child and family health and well-being. Durham Connects is the first home-visiting program that is designed to prevent child maltreatment and improve health and well-being outcomes in an entire community population.

Program evaluation will test four hypotheses: 1) The program can be implemented with population reach, fidelity to the manualized intervention protocol, and reliability in assessment of family risk; 2) Random assignment to the Durham Connects program will be associated with lower rates of child maltreatment and emergency department maltreatment-related injuries, better pediatric care, better parental functioning, and better child well-being than assignment as control; 2) Intervention effect sizes will be larger for higher-risk groups; and 3) Community resource use and enhanced family functioning will mediate the positive impact of Durham Connects on outcomes.


Options:
A: 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))
B: Maternal stress and anxiety (Baselibne to 12 weeks); Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques (12 weeks); Breast milk cortisol concentrations at 12 weeks (12 weeks); Infant behaviour measured using a 3-day diary at 12 weeks (12 weeks); Infant weight and body composition measured using stable isotopes at 12 weeks (12 weeks); Physiological changes (maternal saliva cortisol, breast milk cortisol and milk volume) before and after physiological-mini test in intervention group at 2,6 and 12 weeks. (2,6,12 weeks)
C: DSS Investigated and Substantiated Child Maltreatment Rates (0 - 12 Years of Child Age)
D: Change in Post-natal depression (6 weeks following child birth)

Answer: C