TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 Compared to Remicade in Patients With Active Crohn's Disease
Brief Summary: This study is to assess noninferiority in efficacy and to assess overall safety of CT P13 compared to Remicade in patients with active Crohn's disease up to Week 54.


Options:
A: clinical remission (52 weeks)
B: Treatment success as defined by the proportion of subjects in clinical remission (i.e. complete discontinuation of prednisone therapy and a CDAI score of <150) at week 14, and maintenance of clinical remission between study weeks 14 and 50 (one year)
C: Proportion of patients in remission at the end of the 24 month followup period. Remission is defined as a HBS< or = 4 without use of steroids for the treatment of CD. the primary analysis will be performed at the level of the practice. (24 months)
D: The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 (at Week 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Associations of Exposure to Bisphenol A With Blood Pressure and Epigenetic Change
Brief Summary: * Bisphenol A(BPA) is an endocrine disrupting chemical, which mimics the action of estrogen.
* Previous studies reported that BPA exposure is associated with increased risk of cardiovascular diseases.
* Exposure to BPA occur mainly through oral route, and epoxy coating of canned food is one of the well established source.
* The investigators hypothesis is that increased BPA exposure from canned beverage would disrupt normal physiology in a short term.
* In the present trial the investigators are to investigate whether increased BPA exposure by consuming canned beverage actually affect cardiovascular indices and epigenetic feature.
* For this aim, the investigators will conduct a cross-over trial.


Options:
A: Blood Pressure (2 hours after consuming beverage)
B: Glycemic control (6 months)
C: insulin sensitivity as determined by euglycemic clamp tests (8 weeks)
D: Vascular function (Measured at weeks 4 and 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preconditioning Shields Against Vascular Events in Surgery: A Multi-centre Feasibility Trial of Preconditioning Against Adverse Events in Major Vascular Surgery (Preconditioning-SAVES)
Brief Summary: Major vascular surgery involves operations to repair swollen blood vessels, clear debris from blocked arteries or bypass blocked blood vessels. Patients with these problems are a high-risk surgical group as they have generalized blood vessel disease. These puts them at risk of major complications around the time of surgery such as heart attacks , strokes and death. The mortality following repair of a swollen main artery in the abdomen is about 1 in 20. This contrasts poorly with the 1 per 100 risk of death following a heart bypass. Simple and cost-effective methods are needed to reduce the risks of major vascular surgery. Remote ischaemic preconditioning (RIPC) may be such a technique. To induce RIPC, the blood supply to muscle in the patient's arm is interrupted for about 5 minutes. It is then restored for a further five minutes. This cycle is repeated three more times. The blood supply is interrupted simply by inflating a blood pressure cuff to maximum pressure. This repeated brief interruption of the muscular blood supply sends signals to critical organs such as the brain and heart, which are rendered temporarily resistant to damage from reduced blood supply. Several small randomized clinical trials in patients undergoing different types of major vascular surgery have demonstrated a potential benefit. This large, multi-centre trial aims to determine whether RIPC can reduce complications in routine practice.


Options:
A: Reduction in myocardial infarction (4 to 5 years)
B: Serum troponin levels (3 days)
C: Carotide-femoral pulse velocity (24 h); Augmentation index (24 h)
D: Incidence of AKI within the 7 days after the surgery (Within 7 days after the surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized, Multi-center Phase 2 Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) for the Treatment of Acute Respiratory Distress Syndrome (ARDS)
Brief Summary: This was a Phase 2a, randomized, double-blind, placebo-controlled, multi-center trial to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) infusion in patients with Acute Respiratory Distress Syndrome (ARDS).


Options:
A: Numbers of Patients Occurred Pre-specified Infusion Associated Events Occurring Within 6 Hours of Study Infusion (6 hours); Numbers of Patients Occurred Any Cardiac Arrest or Death Within 24 Hours of Study Infusion (24 hours); Numbers of Patients Occurred Any Unexpected Severe Adverse Events (Including All-cause Deaths) (12 months)
B: Ventilator free-days (28 days)
C: Ventilator-free Days During Days 1-28 (Measured at Day 28)
D: All cause mortality (28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multinational, Randomized, Open Label Parallel Arm Trial With Blinded Outcome Adjudication Quantifying the Efficacy of SENATOR in Reducing Adverse Drug Reactions in Older Hospitalized Subjects
Brief Summary: Primary Objective: To quantify the benefits of the SENATOR decision support software on the reduction of ADR rates in older hospitalized patients. Secondary Objectives: To evaluate the effect of SENATOR with regard to use of appropriate non-pharmacological therapies in subjects with one core geriatric syndrome.

Tertiary Objectives: to examine the association of SENATOR use with subject survival, morbidity and health related quality of life.

Health Economic Objective: To examine the potential health economic consequences of using SENATOR.

There are two study phases:

Phase I: Prospective multinational, multicentre observational study to estimate the baseline adjudicated medical and surgical ADR rates by clinical subspeciality in 6 international sites.

Phase II: Prospective multinational, multicentre, block randomized, two parallel arm, open label, controlled trial, with blinded outcome ascertainment, of the efficacy of SENATOR software in reducing ADRs in older hospitalized subjects.


Options:
A: The primary outcome will be unintentional medication discrepancies in admission orders and discharge orders with potential for patient harm (6 months prior to implementation of intervention to 21 months during intervention)
B: The probability of developing medication errors over a certain period of time and recommendations to avoid such errors. (2 months)
C: Incident adverse drug reactions (ADRs). at least one likely or certain, non-trivial hospital acquired ADR. (Day 14 of hospital stay or discharge, which ever comes first)
D: Number of patients with at least one preventable medication error (Day 1 (medical prescription at hospital admission)); Number of patients with at least one preventable medication error (Phase 2 (maximum 105 days))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multinational, Randomized, Open Label Parallel Arm Trial With Blinded Outcome Adjudication Quantifying the Efficacy of SENATOR in Reducing Adverse Drug Reactions in Older Hospitalized Subjects
Brief Summary: Primary Objective: To quantify the benefits of the SENATOR decision support software on the reduction of ADR rates in older hospitalized patients. Secondary Objectives: To evaluate the effect of SENATOR with regard to use of appropriate non-pharmacological therapies in subjects with one core geriatric syndrome.

Tertiary Objectives: to examine the association of SENATOR use with subject survival, morbidity and health related quality of life.

Health Economic Objective: To examine the potential health economic consequences of using SENATOR.

There are two study phases:

Phase I: Prospective multinational, multicentre observational study to estimate the baseline adjudicated medical and surgical ADR rates by clinical subspeciality in 6 international sites.

Phase II: Prospective multinational, multicentre, block randomized, two parallel arm, open label, controlled trial, with blinded outcome ascertainment, of the efficacy of SENATOR software in reducing ADRs in older hospitalized subjects.


Options:
A: Improvement in proportion of quality indicators achieved, for target diseases as a most responsible or primary diagnosis, between groups. (in hospital)
B: Readmissions (30 days); Admissions (180 days); Emergency Department Visits (180 days); Composite Endpoint, Admissions or Emergency Department Visits (180 days)
C: Incident adverse drug reactions (ADRs). at least one likely or certain, non-trivial hospital acquired ADR. (Day 14 of hospital stay or discharge, which ever comes first)
D: Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB) (12-months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Fecal transPlantAtion on MiCrobotia and hosT in Crohn's Disease
Brief Summary: Crohn's disease is a chronic and relapsing inflammatory bowel disease. Many data show that the intestinal flora is involved in the disease and it has been show that patients with Crohn's disease exhibit an abnormal fecal flora that might play a role in inflammation. The purpose of this study is to determine the effect of the fecal flora transplantation on Crohn's disease.


Options:
A: FT success defined by : Sorensen's index [receiver 6 weeks after FT vs donor] > Sorensen's index [receiver 6 weeks after FT vs receiver before FT]) with Sorensen's index [receiver 6 weeks after FT vs donor] ≥ 0.6. (6 weeks after FT)
B: The primary outcome of the randomized trial is remission of UC defined as a Mayo score < 3 with an endoscopic Mayo score = 0 at the end of the trial Transplant Therapy in Ulcerative Colitis (9 weeks)
C: Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores (8 weeks)
D: Clinical Response (4 weeks following GMT Treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving the Nutrition Status of 6 to 8 Months Old Children Through Diet Diversification and Better Dietary Intakes in the Kabale and Kisoro Districts in South-Western Uganda
Brief Summary: Undernutrition and growth restriction due to poor diet and inadequate nutrient intake continues to be a global challenge, particularly in the developing countries including Uganda. The etiology of inadequate nutrient supply to infants may relate to lack of resources or knowledge or a combination of both. Poor nutrient intake and impaired growth may affect brain and cognitive development.

This study aims to evaluate nutrient intake, growth and cognitive function among children between 6 and 36 months living in the fertile Kabale and Kisoro region in south-western Uganda. The investigators hypothesize that nutrition education to mothers can bring about improved dietary intake and nutritional status among children aged 6-36 months.

A follow-up study was conducted during the period January - July 2022.


Options:
A: Remission (i.e. recovery from depression) and depressive symptoms, assessed by the PHQ-9 (6 months post-child birth)
B: Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards) (6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years)
C: Change in intimate partner violence (12 months, 24 months)
D: Age-appropriate Social-Emotional Development of Children Under 2 Years (6 months post-intervention); Maternal Depression/Anxiety (6 months post-intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving the Nutrition Status of 6 to 8 Months Old Children Through Diet Diversification and Better Dietary Intakes in the Kabale and Kisoro Districts in South-Western Uganda
Brief Summary: Undernutrition and growth restriction due to poor diet and inadequate nutrient intake continues to be a global challenge, particularly in the developing countries including Uganda. The etiology of inadequate nutrient supply to infants may relate to lack of resources or knowledge or a combination of both. Poor nutrient intake and impaired growth may affect brain and cognitive development.

This study aims to evaluate nutrient intake, growth and cognitive function among children between 6 and 36 months living in the fertile Kabale and Kisoro region in south-western Uganda. The investigators hypothesize that nutrition education to mothers can bring about improved dietary intake and nutritional status among children aged 6-36 months.

A follow-up study was conducted during the period January - July 2022.


Options:
A: Linear Growth (6-18 mos of age)
B: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)
C: Change in Height/Length for Age Z Score (Baseline, 6 months)
D: Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards) (6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving the Nutrition Status of 6 to 8 Months Old Children Through Diet Diversification and Better Dietary Intakes in the Kabale and Kisoro Districts in South-Western Uganda
Brief Summary: Undernutrition and growth restriction due to poor diet and inadequate nutrient intake continues to be a global challenge, particularly in the developing countries including Uganda. The etiology of inadequate nutrient supply to infants may relate to lack of resources or knowledge or a combination of both. Poor nutrient intake and impaired growth may affect brain and cognitive development.

This study aims to evaluate nutrient intake, growth and cognitive function among children between 6 and 36 months living in the fertile Kabale and Kisoro region in south-western Uganda. The investigators hypothesize that nutrition education to mothers can bring about improved dietary intake and nutritional status among children aged 6-36 months.

A follow-up study was conducted during the period January - July 2022.


Options:
A: Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards) (6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years)
B: Height-for-age z-score (At the end of one year); Child development outcomes (At the end of one year)
C: To compare developmental outcomes of children who were enrolled in the PDC to children who did not receive PDC services and to the general population. (April 2014 to March 2019)
D: Change from baseline in prevalence of child wasting (baseline, and then at each study visit (every 6 months over 36 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving the Nutrition Status of 6 to 8 Months Old Children Through Diet Diversification and Better Dietary Intakes in the Kabale and Kisoro Districts in South-Western Uganda
Brief Summary: Undernutrition and growth restriction due to poor diet and inadequate nutrient intake continues to be a global challenge, particularly in the developing countries including Uganda. The etiology of inadequate nutrient supply to infants may relate to lack of resources or knowledge or a combination of both. Poor nutrient intake and impaired growth may affect brain and cognitive development.

This study aims to evaluate nutrient intake, growth and cognitive function among children between 6 and 36 months living in the fertile Kabale and Kisoro region in south-western Uganda. The investigators hypothesize that nutrition education to mothers can bring about improved dietary intake and nutritional status among children aged 6-36 months.

A follow-up study was conducted during the period January - July 2022.


Options:
A: Incidence of dental caries (Baseline and 3 years)
B: Visiting the dentist during pregnancy and up to two months postpartum for the mother and visiting the dentist before 18 months for the child. (During pregnancy and up to two months post partum (mother); up to 18 months (child))
C: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)
D: Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards) (6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Clinical Trial Examining Cognitive Remediation Plus Standard Treatment Versus Standard Treatment in Participants at Ultra-High Risk of Psychosis. - Effect on Cognitive Functioning, Functional Outcome and Symptomatology.
Brief Summary: Cognitive deficits are known to be a core feature of schizophrenia and seem to become manifest in the prodromal or Ultra-High Risk (UHR) state of psychosis. The cognitive deficits are known to pose a critical barrier to functional recovery. Hence it is of vital importance to find intervention strategies that can alleviate these cognitive deficits and consequently improve daily functioning, and quality of life, as well as the prognosis for UHR-patients. The investigators will examine whether:

* Cognitive remediation therapy will be superior to standard treatment in improving cognitive functioning in UHR- patients (null hypothesis: No difference between the two groups).
* Cognitive remediation therapy will be superior to standard treatment in improving psychosocial functioning and clinical symptoms in UHR-patients (null hypothesis: No difference between the two groups).


Options:
A: Change in subthreshold psychotic (positive and negative) symptoms (Change from pretreatment (assessed for the 3 months prior to randomization) to 12 month reassessment)
B: Scale Of Prodromal Symptoms total score (8 weeks)
C: Transition to PANSS defined first-episode psychosis (Baseline, 1, 2, 3, 4, 8, 12 weeks, 6, and 12 months)
D: Brief Assessment of Cognition in Schizophrenia (BACS) (6 and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Foley Bulb Induction With and Without Simultaneous Use of Oxytocin
Brief Summary: This study is considering current standard oxytocin dosing regimen in combination with Foley bulb for cervical ripening is associated with improved outcomes including greater percentage of women delivered within or less than 24 hours. The investigators will also assess other maternal and neonatal outcomes including risk of infection (i.e. chorioamnionitis), bleeding, uterine atony, cesarean delivery and use of regional analgesia.

Participants will be randomly assigned to one of the 2 arms of the study: use of oxytocin or no oxytocin while the Foley bulb is in place. As part of standard of care for inductions, Foley bulbs will be placed for all participants. Study participants who are randomly assigned to the use of oxytocin will receive oxytocin at the time the Foley bulb is placed. Study participants randomly assigned to no oxytocin will receive the oxytocin once the Foley bulb is removed.

After delivery, information will be collected from participant's chart on the outcome of pregnancy such as gestational age at delivery, type of delivery (vaginal or cesarean section), and baby's outcome (such as birth weight, APGAR scores, and any complications).


Options:
A: caesarean section rate (1 year)
B: Delivery rate (proportion) (Within 24 hours)
C: induction time to delivery (Time from induction to delivery, average 12-28 hours)
D: Time to Delivery (an average of 20 hours, up to 40 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Foley Bulb Induction With and Without Simultaneous Use of Oxytocin
Brief Summary: This study is considering current standard oxytocin dosing regimen in combination with Foley bulb for cervical ripening is associated with improved outcomes including greater percentage of women delivered within or less than 24 hours. The investigators will also assess other maternal and neonatal outcomes including risk of infection (i.e. chorioamnionitis), bleeding, uterine atony, cesarean delivery and use of regional analgesia.

Participants will be randomly assigned to one of the 2 arms of the study: use of oxytocin or no oxytocin while the Foley bulb is in place. As part of standard of care for inductions, Foley bulbs will be placed for all participants. Study participants who are randomly assigned to the use of oxytocin will receive oxytocin at the time the Foley bulb is placed. Study participants randomly assigned to no oxytocin will receive the oxytocin once the Foley bulb is removed.

After delivery, information will be collected from participant's chart on the outcome of pregnancy such as gestational age at delivery, type of delivery (vaginal or cesarean section), and baby's outcome (such as birth weight, APGAR scores, and any complications).


Options:
A: Time Of Start Of Induction Of Labor To Delivery (Hours)
B: induction time to delivery (Time from induction to delivery, average 12-28 hours)
C: Attainment of vaginal delivery within 24 hours. (24 hours)
D: Time to Delivery (Hours between start of induction to delivery); Length of Stay (Days between admit to hospital and discharge); Severe RDS (enrollment through neonatal discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase2, Multi-Center, Multi-national, Randomized, Double-blind, Placebo-controlled Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of RPC4046 in Adult Subjects With Eosinophilic Esophagitis
Brief Summary: The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment of Eosinophilic Esophagitis (EoE). This trial consists of two phases: 16 weeks of double-blind treatment and 52 weeks of open-label extension.


Options:
A: Mean Eosinophil Count (Week 16)
B: Percentage of Subjects With ≤6 Peak Eosinophils/High-power Field (HPF) (Week 12)
C: Absolute Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 10 (Baseline, Week 10)
D: Number of Participants With Improvement of Espohageal Eosinophilia (3 Months)

Answer: A