TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Liberal Transfusion Strategy to Prevent Mortality and Anaemia-associated, Ischaemic Events in Elderly Non-cardiac Surgical Patients
Brief Summary: In this prospective, multicentre, open, randomised, controlled clinical trial elderly patients (≥ 70 years) undergoing intermediate- or high-risk non-cardiac surgery will be randomised either to a liberal group (patients receive a RBC unit each time Hb falls ≤ 9 g/dl (≤ 5.6mmol/l) with a target range for the post-transfusion Hb level of 9-10.5 g/dl (5.6-6.5 mmol/l)) or restrictive group (patients receive a single RBC unit each time Hb falls ≤ 7.5 g/dl (≤ 4.7 mmol/l) with a target range for the post-transfusion Hb level of 7.5-9 g/dl (4.7-5.6 mmol/l). Primary efficacy endpoint: is a composite of death from any cause and anaemia-associated, ischaemic events (defined as acute myocardial infarction, acute ischaemic stroke, acute kidney injury stage III, acute mesenteric ischaemia, acute peripheral vascular ischaemia) within 90 days after surgery.


Options:
A: Quality of Life (QOL)/Function based on the FACT-BMT scale (3 years)
B: FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status (Before each cylces of chemotherapy in up to six months, and before transfusion, and daily in seven days after transfusion)
C: Occurrence of a composite endpoint (90 days)
D: Cost-effectiveness ratio at 30 days (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2a, Double-blind, Parallel Group, Randomised, Placebo Controlled, Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of OBE022 added-on to Atosiban, After Oral Administration in Pregnant Women With Threatened Spontaneous Preterm Labour
Brief Summary: This is a proof-of-concept study in 2 parts.

In Part A, patients will receive OBE022 open-label in order to assess the safety and pharmacokinetics in pregnant women with spontaneous preterm labour with a gestational age between 28 0/7 and 33 6/7 weeks.

Part B has a double-blind, randomised, placebo controlled, parallel group and multicentre design and will assess the efficacy, safety and pharmacokinetics in pregnant women with threatened spontaneous preterm labour with a gestational age between 24 0/7 and 33 6/7 weeks.

All patients in part A and part B must receive atosiban infusion for 48 hours as standard of care treatment. Patients from Part A will receive OBE022 open label. Patients from Part B will be randomised to receive OBE022 or matching placebo. IMP treatment duration will be up to 7 days. IMP treatment will be stopped in case of delivery prior to Day 7.


Options:
A: The Primary Outcome Measure of This Research is to Compare the Efficacy of the Three Clinically Used Tocolytic Agents in a Prospective Study That Will Allow Direct Comparison of Outcomes in Women With Confirmed Preterm Labor. (3-5 days after delivery)
B: Reduction of preterm birth (before 48 hours, allowing use of corticosteroids). (36 months)
C: Incidence of delivery within 2 days (48 h) from start of IMP administration (48 hours); Incidence of delivery within 7 days (168 h) from start of IMP administration (168 hours); Incidence of delivery before 37 weeks of GA (Up to 13 weeks from start of IMP administration); Time to delivery measured from start of IMP administration (Up to 17 weeks from start of IMP administration)
D: Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation (4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: This is a study to compare the efficacy of bimekizumab versus placebo and an active comparator in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).


Options:
A: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 (Week 16); Percentage of Participants With an Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 16 (Week 16)
B: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 (Week 16); Percentage of Participants With an Investigator's Global Assessment (IGA) Response (Clear or Almost Clear With at Least 2-Category Improvement Relative to Baseline) at Week 16 (Week 16)
C: Percentage of Participants With a PASI 75 Response at Week 12 (Baseline and week 12)
D: Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. (Twelve Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Brief Summary: This is a study to compare the efficacy of bimekizumab versus placebo and an active comparator in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).


Options:
A: Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48 (Week 48)
B: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 (12 Weeks); Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 (12 Weeks)
C: Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68 (Week 68)
D: Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 (Week 16); Percentage of Participants With an Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least a 2-category Improvement From Baseline) Response at Week 16 (Week 16)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: High Flow Nasal Therapy Versus Noninvasive Ventilation in Mild to Moderate Acute Hypercapnic Respiratory Failure: A Non-inferiority Randomized Trial
Brief Summary: Randomized multicenter non-inferiority trial comparing High flow nasal therapy (HFNT) versus Noninvasive ventilation (NIV) in patients with chronic obstructive pulmonary disease (COPD) and acute hypercapnic respiratory failure.


Options:
A: Arterial partial pressure of carbon dioxide (PaCO2) (2 hours after randomization)
B: Failure of the ventilation system (One week)
C: percentage of patients who developed postoperative hypoxemia (defined as PaO2/FiO2 ratio <300) (1 hour after tracheal extubation (day 1))
D: All-cause day-28 mortality (28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: High Flow Nasal Therapy Versus Noninvasive Ventilation in Mild to Moderate Acute Hypercapnic Respiratory Failure: A Non-inferiority Randomized Trial
Brief Summary: Randomized multicenter non-inferiority trial comparing High flow nasal therapy (HFNT) versus Noninvasive ventilation (NIV) in patients with chronic obstructive pulmonary disease (COPD) and acute hypercapnic respiratory failure.


Options:
A: mortality rates (day 28)
B: Arterial partial pressure of carbon dioxide (PaCO2) (2 hours after randomization)
C: Reintubation at Day 7 (up to 7 days)
D: Inspiratory muscle effort : oesophageal pressure (Poes) and the oesophageal pressure time product (PTPoes) (Every 30 minutes for 90 minutes)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementing an Integrated RMNCH Intervention by Community Health Workers in Achham and Dolakha: National Pilot
Brief Summary: The investigators will conduct a cluster-controlled, stepped wedge implementation science trial of a bundled reproductive, maternal, neonatal, and child healthcare (RMNCH) delivery intervention within an approximate population of 300,000 people in rural Nepal. This intervention integrates five evidence-based approaches for reproductive, maternal, newborn, and child health focused on the "golden 1000 days" from conception through age two: 1) Community Health Worker model of home-based care to monitor and increase utilization of services, maternal and neonatal health knowledge, self-efficacy, social support, and emergency planning among mothers; 2) Continuous surveillance of all pregnancies and children via an integrated electronic medical record; 3) Delivering community-based integrated management of newborn and childhood illness (CB-IMNCI) via CHWs; 4) Group antenatal and postnatal care to improve care delivery and reduce mortality during the "golden 1000 days" from conception to age two; and 5) Balanced counseling to increase post-partum contraception.


Options:
A: Institutional Birth Rate (3 years); Under-Two Mortality Rate (3 years); Post-Partum Contraceptive Prevalence Rate (3 years)
B: Number of Children Who Received Early and Appropriate Treatment for Pneumonia. (one year); Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) (one year)
C: Post day 1 Neonatal mortality (birth to 28 days of age) in the communities receiving the intervention(cohort of infants born to women identified through pregnancy surveillance) (Over 30 Months); Neonatal mortality (from birth to 28 days of age) in the cohort identified through pregnancy surveillance (Over 30 Months); Post day 1 neonatal mortality (1 to 28 days of age) in the population of newborns who are more likely to have greater impact from the intervention i.e. those born at home and available in the study area within 7 days of birth (30 months); Neonatal mortality (from birth to 28 days of age) in the population more likely to benefit from the intervention (30 months); Infant mortality (birth to 365 days) in the communities receiving the intervention. (30 months)
D: Percentage of change in number of children under five in intervention area who receive appropriate Integrated Community Case Management Treatment from a Community Health Worker for presumed pneumonia. (March 2013 - November 2014 (8 months)); Percentage of change in number of children under five in intervention area who receive appropriate Integrated Community Case Management Treatment from a Community Health Worker for diarrhea (March 2013 - November 2014 (8 months)); Percentage of change in number of children under five in intervention area who receive Integrated Community Case Management Treatment from a Community Health Worker for fever. (March 2013 - November 2014 (8 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Controlled Clinical Trial Evaluating the Superiority of Preimplantation Genetic Screening (PGS) and Deferred Transfer of Cryopreserved Embryos Over "Freeze-Only" Deferred Transfer Without PGS or Immediate Embryo Transfer During a "Fresh" In Vitro Fertilization Cycle
Brief Summary: The trial objective is to determine whether the deferred transfer of embryos following cryopreservation at the blastocyst stage following pre-implantation genetic screening (PGS-FET) improves live birthrates compared to both the deferred transfer of cryopreserved embryos without PGS (FET) and immediate transfer at the conclusion of a "fresh" in vitro fertilization (IVF) cycle (Fresh). Additionally, whether "freeze-only" (FET) improves live birth rates compared to "fresh" will be determined.


Options:
A: Ongoing pregnancy (Gestational week 20)
B: Cumulative live birth rate (22 months)
C: Live Birth (up to 9 months or time of birth)
D: implantation rate (4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial to Evaluate the Effects of Repeated Periods of Modified Fasting to Support Healthy Natural Weight Management and Prevention of Weight Gain in Overweight But Generally Healthy Adults Over the Winter Holiday Period
Brief Summary: The purpose of this study is to assess the effects of repeated periods of modified fasting in support of healthy weight management and prevention of weight gain over the winter holiday period (mid-November to early January) in comparison to regular diet and activity.


Options:
A: Weight loss (1 year)
B: Revised QUICKI (RQUICKI) (Baseline); RQUICKI (day 29); RQUICKI (day 31)
C: Change in HSCRP ( high sensitivity C-reactive protein) at 6 and 12 months (Every 6 months- baseline, 6 month and 12 month)
D: Body weight (52 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I/II Study of Anti-CD19 Chimeric Antigen Receptor-Expressing T Cells in Pediatric Patients Affected by Relapsed/refractory CD19+ Acute Lymphoblastic Leukemia and Non Hodgkin Lymphoma
Brief Summary: The primary objective of this phase I study is to evaluate the safety and to establish the recommended dose of CD19-CART01 infused in pediatric patients affected by relapsed/refractory B-ALL or NHL with measurable Bone Marrow (BM) involvement. The phase II extension is aimed at testing the efficacy of the treatment at the optimal dose defined in the phase I.


Options:
A: Overall Response Rate (ORR) (From first dose to disease progression, end of study, the start of another anticancer therapy, or hematopoietic stem cell transplantation (up to approximately 24 months))
B: Phase I - Identification of the dose limiting toxicity (DLT) (4 weeks after CAR T cell infusion); Phase II - Efficacy (4 weeks after CAR T cell infusion)
C: Number of Participants With Dose-Limiting Toxicity (DLT) (From first dose of the combination agent until 1 month (28 days) after JCAR017 infusion (pre- JCAR017 cohort) or from JCAR017 infusion until 1 month (28 days) after the first dose of combination agent (post-JCAR017 cohort)); Complete Response Rate (CRR) (At 3 and 6 months post-JCAR017 infusion.)
D: Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0 (2 years post infusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of the Effect of Dietary Salt Reduction on Blood Pressure and Other Cardiovascular Parameters in Kidney Transplant Recipients
Brief Summary: Cardiovascular morbidity and mortality is increased in kidney transplant patients. High blood pressure (BP) contributes significantly to this risk and is also associated with shortened allograft survival. Salt reduction lowers BP in the general population and there is emerging data that salt reduction also effectively lowers BP in chronic kidney disease (CKD). Kidney transplant patients, by definition have CKD, but they differ fundamentally from the general CKD population in that they are on medications which can predispose to high blood pressure, their kidneys are denervated, and they often have reasonable excretory kidney function.

The proposed study will be an eight-week randomised, controlled trial assessing the effect of intensive dietary salt advice on cardiovascular risk factors in kidney transplant patients. The primary outcome is office BP readings, with the effect on 24-hour ambulatory blood pressure, proteinuria, arterial stiffness and endothelial function being studied as secondary outcomes.


Options:
A: 24 hour blood pressure (Two weeks after start of each intervention)
B: Quality of life (12 months)
C: Change in pre-dialysis systolic blood pressure
D: Office systolic and diastolic BP readings (9 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine
Brief Summary: Cholera is a life-threatening disease if prompt actions are not taken. The most recent estimates of the global burden of cholera estimate that there are more than 1.3 billion people at risk. Of which, 2.86 million (range: 1.3-4.0 million) will contract cholera and 95,000 (21,000-143,000) will die each year. A safe, effective, and affordable killed whole-cell oral cholera vaccine (OCV) is now being used widely to prevent cholera in areas at risk. This regimen demonstrated 65% efficacy retained for at least 3 years and even up to 5 years in an endemic setting.

The primary aim of this project is to determine changes in the vibriocidal geometric mean titers (GMT) in subjects who receive the second dose of oral cholera vaccine (OCV) at different intervals: 2 weeks, or 6 months following the first dose of vaccine. Secondary aims include a) vibriocidal antibody response rates in subjects who receive OCV at 2 weeks or 6 months following the first dose of vaccine, b) age specific serum vibriocidal GMTs following the second dose among participants given the second dose of OCV at intervals of 2 weeks or 6 months following the first dose of vaccine, c) GMT and antibody response rates of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) anti-lipopolysaccharide (anti-LPS) as measured by ELISA following the second dose among participants given the second dose of OCV at intervals of 2 weeks or 6 months following the first dose of vaccine. Our hypothesis is that the vibriocidal GMT following the second dose, when given after 6 months will not be inferior to the response when the second dose is given according to the standard interval of two weeks.


Options:
A: adverse events (immediate events - 30 minutes after each dose, adverse events - for 3 days following dose, serious adverse events throughout study - 28 days)
B: Receipt of 2 complete or nearly complete swallowed doses of oral cholera vaccine (after completion of the vaccination campaign)
C: Number of participants with a single dose regimen oral cholera vaccine Shanchol will get protection (7 days to 6 months)
D: Change in Vibriocidal GMT (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Implementation of a Peer Mentorship Intervention (PREVAIL) to Reduce Suicide Attempts Among High-Risk Adults
Brief Summary: Amid consistently worsening suicide rates, in 2012 the U.S.Surgeon General's National Strategy for Suicide Prevention proposed to "change the narrative" about suicide prevention to include a focus on promoting hope and belongingness. Despite hopelessness and thwarted belongingness being among the most replicated risk factors for suicide, many widely implemented suicide prevention efforts instead emphasize the identification of acute suicide risk and referral to mental health treatment services. However, there are very few health service interventions known to reduce suicides among those identified as high risk. Those interventions shown to be effective have not achieved the wide scale implementation necessary to alter the trend of increasing suicide deaths. New interventions are needed, and one promising, scalable intervention with a novel approach to addressing the risk factors advocated by the Surgeon General is peer mentorship. A peer mentorship intervention, PREVAIL, has been piloted in a two-site randomized controlled trial (N=70) and is acceptable and feasible with enrollment of nearly half of eligible high-risk patients, mean completion of over 6 mentorship sessions, and 85% of sessions meeting fidelity standards for addressing the intended targets of hope and belongingness.

The aims of this hybrid effectiveness-implementation study are:

Specific Aim 1: Determine the effectiveness of the PREVAIL peer mentorship intervention for reducing suicide attempts and suicidal ideation among recently hospitalized adult psychiatric patients at high risk for suicide.

Specific Aim 2: Examine the mechanisms of peer mentorship by measuring the effects of PREVAIL on potential mediators,including hope and belongingness.

Specific Aim 3: Identify barriers and facilitators to implementation of PREVAIL.


Options:
A: Brief Psychiatric Rating Scale (BPRS) scores; Scores on Client Observation and Client Interview, tools designed for this study
B: Suicide attempts (measured by the Columbia Suicide Severity Rating Scale) (6-months); Suicidal ideation (measured by the Beck Suicide Scale (BSS)) (6-months)
C: Number of suicide re-attempters (six months)
D: Change in the self-rating of affective reactivity (ARI-S) (Assessed at Baseline, at week 5, week 10 and week 11.); Clinical Global Impression - Improvement (CGI-I) total score of 1 or 2 (much improved, very much improved). (assessed at weeks 5, 10, and 11.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Implementation of a Peer Mentorship Intervention (PREVAIL) to Reduce Suicide Attempts Among High-Risk Adults
Brief Summary: Amid consistently worsening suicide rates, in 2012 the U.S.Surgeon General's National Strategy for Suicide Prevention proposed to "change the narrative" about suicide prevention to include a focus on promoting hope and belongingness. Despite hopelessness and thwarted belongingness being among the most replicated risk factors for suicide, many widely implemented suicide prevention efforts instead emphasize the identification of acute suicide risk and referral to mental health treatment services. However, there are very few health service interventions known to reduce suicides among those identified as high risk. Those interventions shown to be effective have not achieved the wide scale implementation necessary to alter the trend of increasing suicide deaths. New interventions are needed, and one promising, scalable intervention with a novel approach to addressing the risk factors advocated by the Surgeon General is peer mentorship. A peer mentorship intervention, PREVAIL, has been piloted in a two-site randomized controlled trial (N=70) and is acceptable and feasible with enrollment of nearly half of eligible high-risk patients, mean completion of over 6 mentorship sessions, and 85% of sessions meeting fidelity standards for addressing the intended targets of hope and belongingness.

The aims of this hybrid effectiveness-implementation study are:

Specific Aim 1: Determine the effectiveness of the PREVAIL peer mentorship intervention for reducing suicide attempts and suicidal ideation among recently hospitalized adult psychiatric patients at high risk for suicide.

Specific Aim 2: Examine the mechanisms of peer mentorship by measuring the effects of PREVAIL on potential mediators,including hope and belongingness.

Specific Aim 3: Identify barriers and facilitators to implementation of PREVAIL.


Options:
A: Persons repeating a suicidal act (One, two and three years)
B: Scale for Suicidal Ideation (Baseline, post-treatment, 1, 3, 6, 12 months)
C: Suicide attempts (measured by the Columbia Suicide Severity Rating Scale) (6-months); Suicidal ideation (measured by the Beck Suicide Scale (BSS)) (6-months)
D: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)

Answer: C