TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Salud al Día: Engaging Latino Parents in Pediatric Primary Care
Brief Summary: Objective: To conduct a pilot randomized controlled trial comparing the effectiveness of a parent support intervention consisting of periodic text messages and educational support (video, collateral materials),and usual care on the healthcare engagement of limited English proficient (LEP) Latino parents during participants' child's first year and to examine its impact on healthcare utilization and primary care quality.


Options:
A: Up to Date Well Child Care (24 months); Emergency/Urgent Care Utilization (24 months); Parent experience of care (12 months)
B: The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants. (one year)
C: Change from Baseline in Mean steps/day at 3 months (3 months); Change from Baseline in Mean Steps/day at 1 month (1 month)
D: HbA1c (30 Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cost-effectiveness and Cost-utility of Liberal vs Restrictive Red Blood Cell Transfusion Strategies in Patients With Acute Myocardial Infarction and Anaemia. The REALITY (REstrictive And LIberal Transfusion Strategies in Patients With Acute mYocardial Infarction) Randomized Trial.
Brief Summary: Anemia in patients with myocardial infarction (MI) is a relatively frequent issue, resulting in poorer outcome. There is equipoise regarding which transfusion strategy is best, and there is an international consensus on the urgent need for a randomized trial.

The investigators hypothesize that a "restrictive" transfusion strategy is at least non-inferior to a "liberal" transfusion strategy on 30-day outcomes of MI patients with anemia. Given the costs and risks of transfusion, a cost-effectiveness and cost-utility analysis becomes key to determining the role of each strategy.


Options:
A: Enrollment rate (Time Frame: 6 months); Non-adherence (30 days)
B: the proportion of patients transfused with homologous red blood cells (RBC) (At 30 days post-operatively)
C: Cost-effectiveness ratio at 30 days (30 days)
D: Functional ability (Measured 10 days after surgery + repeated measurement during 90 days after surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cost-effectiveness and Cost-utility of Liberal vs Restrictive Red Blood Cell Transfusion Strategies in Patients With Acute Myocardial Infarction and Anaemia. The REALITY (REstrictive And LIberal Transfusion Strategies in Patients With Acute mYocardial Infarction) Randomized Trial.
Brief Summary: Anemia in patients with myocardial infarction (MI) is a relatively frequent issue, resulting in poorer outcome. There is equipoise regarding which transfusion strategy is best, and there is an international consensus on the urgent need for a randomized trial.

The investigators hypothesize that a "restrictive" transfusion strategy is at least non-inferior to a "liberal" transfusion strategy on 30-day outcomes of MI patients with anemia. Given the costs and risks of transfusion, a cost-effectiveness and cost-utility analysis becomes key to determining the role of each strategy.


Options:
A: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
B: Cost-effectiveness ratio at 30 days (30 days)
C: The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS. (Through post-operative day 7, hospital discharge, or death, whichever occurs first)
D: Total Number of Units Transfused (From randomization until discharge from admission for delivery, an average of 2-3 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cost-effectiveness and Cost-utility of Liberal vs Restrictive Red Blood Cell Transfusion Strategies in Patients With Acute Myocardial Infarction and Anaemia. The REALITY (REstrictive And LIberal Transfusion Strategies in Patients With Acute mYocardial Infarction) Randomized Trial.
Brief Summary: Anemia in patients with myocardial infarction (MI) is a relatively frequent issue, resulting in poorer outcome. There is equipoise regarding which transfusion strategy is best, and there is an international consensus on the urgent need for a randomized trial.

The investigators hypothesize that a "restrictive" transfusion strategy is at least non-inferior to a "liberal" transfusion strategy on 30-day outcomes of MI patients with anemia. Given the costs and risks of transfusion, a cost-effectiveness and cost-utility analysis becomes key to determining the role of each strategy.


Options:
A: Myocardial Injury (Upto 60 days)
B: Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups. (60 days following randomisation)
C: Hemoglobin difference (14 days)
D: Cost-effectiveness ratio at 30 days (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cost-effectiveness and Cost-utility of Liberal vs Restrictive Red Blood Cell Transfusion Strategies in Patients With Acute Myocardial Infarction and Anaemia. The REALITY (REstrictive And LIberal Transfusion Strategies in Patients With Acute mYocardial Infarction) Randomized Trial.
Brief Summary: Anemia in patients with myocardial infarction (MI) is a relatively frequent issue, resulting in poorer outcome. There is equipoise regarding which transfusion strategy is best, and there is an international consensus on the urgent need for a randomized trial.

The investigators hypothesize that a "restrictive" transfusion strategy is at least non-inferior to a "liberal" transfusion strategy on 30-day outcomes of MI patients with anemia. Given the costs and risks of transfusion, a cost-effectiveness and cost-utility analysis becomes key to determining the role of each strategy.


Options:
A: Modified Rankin Scale (mRS) (12 months post)
B: Myocardial Injury (Upto 60 days)
C: Cost-effectiveness ratio at 30 days (30 days)
D: Incidence of Blood Stream Infection (1 week after randomization and weekly thereafter through discarge from hospital)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart Twice Daily and Biphasic Insulin Aspart Twice Daily in Subjects With Type 2 Diabetes Mellitus Before, During and After Ramadan
Brief Summary: This trial is conducted in Africa and Asia. The aim of this trial is to compare efficacy and safety of insulin degludec/insulin aspart twice daily and biphasic insulin aspart twice daily in subjects with type 2 diabetes mellitus before, during and after Ramadan.


Options:
A: Difference in mean 4-point SMBG during days 23-30 of treatment between the two groups. (days 23-30 of treatment)
B: Change in HbA1c (%) (Glycosylated Haemoglobin) (From week 0 to end of Ramadan (day 29 of Ramadan))
C: Postprandial glucose (mg/dl) (180 minutes)
D: Percentage of Participants With at Least One Symptomatic Hypoglycemic Event (Up to 30 days (Day 1 through last day of Ramadan))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects With Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CORRECTION)
Brief Summary: A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in participants with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)


Options:
A: Safety evaluated by physical examinations, vital signs, laboratory tests and patient monitoring and evaluation.
B: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (Baseline; Weeks 24 to 36); Median Time to First Major Adverse Cardiovascular Event (MACE) (Up to Week 208)
C: Check Pittsburgh Sleep Quality Index and restless leg syndrome index: in 1st and 3rd months
D: The % of target ultrafiltration achieved (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects With Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CORRECTION)
Brief Summary: A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in participants with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)


Options:
A: Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) (Baseline up to Week 16 (End of Study (EoS])); Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) (Baseline, End of Treatment (EoT) (Day 26 for TIW Dosing or Day 29 for BIW Dosing)); Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) (Baseline, Week 8 (2 Weeks of Follow Up))
B: Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis) (Up to 4.3 person-years for CV follow-up time period); Mean Change From Baseline in Hgb Levels Over the Evaluation Period (Week 28 to Week 52) (Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52))
C: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (Baseline; Weeks 24 to 36); Median Time to First Major Adverse Cardiovascular Event (MACE) (Up to Week 208)
D: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (Baseline; Weeks 24 to 36); Median Time to First Major Adverse Cardiovascular Event (MACE) (Up to Week 208)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The "RADIANCE-HTN" Study. A Study of the ReCor Medical Paradise System in Clinical Hypertension
Brief Summary: RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO) designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects.


Options:
A: Change in Office Systolic Blood Pressure (Baseline to 6 months post-randomization)
B: To investigate the combined effect of aliskiren and valsartan on vascular structure, assessed by wall to lumen ratio of retinal arterioles, in hypertensive patients. (After 8 weeks of treatment with aliskiren versus placebo)
C: Freedom of AF or other atrial arrhythmias (1 year)
D: Solo Cohort - Mean Difference in Average Daytime Ambulatory Systolic BP (from baseline to 2 months post procedure); Trio Cohort - Median Change in Daytime Ambulatory Systolic BP (from baseline to 2 months post procedure)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: USDA Healthy Incentives Pilot (HIP)
Brief Summary: The USDA Healthy Incentives Pilot (HIP) evaluated the impact of a 30% financial incentive on fruit and vegetable intake among adult participants in the USDA Supplemental Nutrition and Assistance Program (SNAP).


Options:
A: Targeted fruit and vegetable (TFV) intake (Intake in prior 24 hours; assessed in two follow-up rounds (4-6 mo and 9-11 mo post-implementation) with 10% replicate subsample in each round; data pooled across two follow-up rounds and replicate samples for primary analysis)
B: Linear growth in children below 3 years of age (Measured 50 months after randomization (endline survey 2019))
C: Sexually Transmitted Infections (18 months); Schooling (12 months/24 months)
D: Change from Baseline in nutritionally related biochemical measures at 22 months (At baseline and 22 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: USDA Healthy Incentives Pilot (HIP)
Brief Summary: The USDA Healthy Incentives Pilot (HIP) evaluated the impact of a 30% financial incentive on fruit and vegetable intake among adult participants in the USDA Supplemental Nutrition and Assistance Program (SNAP).


Options:
A: Targeted fruit and vegetable (TFV) intake (Intake in prior 24 hours; assessed in two follow-up rounds (4-6 mo and 9-11 mo post-implementation) with 10% replicate subsample in each round; data pooled across two follow-up rounds and replicate samples for primary analysis)
B: Recovery rate in the outpatient therapeutic program (At 6 week)
C: Growth (Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months); Hemoglobin (Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months)
D: Change from Baseline in nutritionally related biochemical measures at 22 months (At baseline and 22 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: USDA Healthy Incentives Pilot (HIP)
Brief Summary: The USDA Healthy Incentives Pilot (HIP) evaluated the impact of a 30% financial incentive on fruit and vegetable intake among adult participants in the USDA Supplemental Nutrition and Assistance Program (SNAP).


Options:
A: Change from baseline in Total Kilocalorie intake at 16 weeks (16 weeks); Change from baseline in reported levels of household food security at 16 weeks (16 weeks); Change from baseline in Healthy Eating Index (HEI) Score at 16 weeks (16 weeks); Change from baseline in daily servings of fruits and vegetable (added together) at 16 weeks (16 weeks); Change from baseline in daily total, in grams, of added sugars at 16 weeks (16 weeks)
B: Change in physical activity (Participants' physical activity will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-intervention)
C: Targeted fruit and vegetable (TFV) intake (Intake in prior 24 hours; assessed in two follow-up rounds (4-6 mo and 9-11 mo post-implementation) with 10% replicate subsample in each round; data pooled across two follow-up rounds and replicate samples for primary analysis)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single-Arm, Open-Label, Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally-Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection (EXPEDITION-4)
Brief Summary: The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment with the ABT-493/ABT-530 combination regimen in adults with chronic HCV genotype 1 - 6 infection and chronic severe renal impairment.


Options:
A: Sustained Virologic Response (SVR)Rate (1.5 year)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) (Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)); Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods (Up to Week 14); Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period (Up to Week 12)
C: There is no specific primary outcome measure but we indicated below (see Description) a list of potential outcome measures according to the objectives. (From recruitment to the end of the cohort, with a minimum of one medical visit per year (the duration of follow-up is 7-8 years))
D: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) (12 weeks after the last actual dose of study drug)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended Follow-up of a Randomized Placebo-controlled Trial of Local Steroid Injection in Carpal Tunnel Syndrome
Brief Summary: Between 2008 and 2012 the investigators performed a single-center randomized double-blind placebo-controlled trial to assess the efficacy of local injection of two different doses of methylprednisolone (80 mg and 40 mg) in patients with carpal tunnel syndrome (CTS), aged 18 to 70 years, not previously treated with steroid injection. The primary outcomes were change in the CTS symptom severity score at 10 weeks and rate of carpal tunnel release surgery on the study hand at 1 year. In the trial 111 patients were randomized (37 in each of the 3 groups: 80 mg methylprednisolone, 40 mg methylprednisolone and placebo) and all completed the 1-year follow-up. The investiators plan an extended follow-up 5 to 7 years after injection.


Options:
A: Percentage of Participants Achieving Sustained Remission Rate At Week 104 (Week 104)
B: Carpal Tunnel Syndrome Assessment Questionnaire- function scale (12 months)
C: The CTS symptom severity score after treatment. (10 weeks); Rate of surgery (52 weeks)
D: Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand (5 to 7 years); Symptom Severity Score (5-7 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Chronic Respiratory Failure in COPD Patients With Non-invasive Ventilation: Starting at Home and Selecting the Right Patient
Brief Summary: Rationale:

Application of long-term non-invasive ventilation (NIV) in stable chronic obstructive pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure (CHRF) has recently been shown to improve survival and quality of life when applied with sufficiently high inspiratory pressures and adequate backup breathing frequencies (so called high-intensity NIV). However, for a broader implementation of this therapy in a potentially large group of patients, important issues have to be solved. First, the initiation of high-intensity NIV, currently performed in the hospital, is often time-consuming, expensive and inconvenient for patients. Secondly, although clinicians recognise that not all patients benefit, it is not known which factors predict a positive response.

Objectives:

1. To investigate whether home initiation of chronic NIV in stable COPD patients with CHRF is non-inferior to inpatient initiation.
2. To investigate predictors of a favourable response to chronic NIV in COPD patients with CHRF.

Study design:

The study is 1:1 two-arm parallel group randomised controlled trial comparing the usual inpatient NIV initiation to home initiation.

Study population: Seventy-two COPD patients with a NIV indication (COPD GOLD stage III or IV; partial arterial carbon dioxide pressure (PaCO2) \> 6.0 kPa in stable condition, i.e. no COPD exacerbation for 4 weeks and a pH \> 7.35), a sufficient social network at home, without severe cardiac comorbidities, will be included.

Intervention: Home initiation of NIV will be compared with standard in-hospital initiation. NIV at home will be titrated by a specialised nurse of our home mechanical ventilation centre (HMV) on transcutaneously measured gas exchange and respiratory electromyography and will be adjusted with the use of telemedicine.

Main study parameters/endpoints:

1. To investigate non-inferiority of home initiation, the change in arterial carbon dioxide pressure after 3 months treatment will be the primary outcome. Secondary outcomes are safety, change in lung function, health-related quality of life (HRQoL) and costs.
2. To investigate predictors of a favourable response, patient demographics, and baseline data on lung function as well as measures of respiratory muscle activity, arterial blood gases, comorbidities, inflammatory blood markers and anxiety and depressions scores will be collected of all patients.


Options:
A: Total direct cost of hospitalization, $ (From date of admission to date of discharge, an expected average of 4 days)
B: Total cost of hospitalization, $ (Day of admission to day of discharge)
C: Mortality, dependence, psychoscial outcome; Mortality, dependence and psychosocial outcome (6 months endpoint)
D: Change in daytime PaCO2 (Baseline, 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: MOBILE Trial. Mechanical and Oral Antibiotic Bowel Preparation Versus no Bowel preparatIon for eLEctive Colectomy - a Multicenter, Prospective, Randomized, Controlled Trial.
Brief Summary: Enchanced recovery after surgery (ERAS) protocols aim to provide safer and quicker recovery postoperatively. One of the elements in ERAS protocols is that bowel is not prepared before colorectal surgery. However, several recent retrospective register studies have suggested that mechanical bowel preparation combined to oral antibiotics before colectomy reduces complications compared to no preparation at all. This trial compares these two strategies to find out whether complications can indeed be reduced by mechanically preparing the bowel with oral antibiotics.


Options:
A: %/type Surgical wound infections rated per infection classifications of NNIS/CDC (with in 30 days post-op)
B: Wound infection (up to 30 days after surgery)
C: Surgical site infection (CDC criteria) (30 days from operation)
D: anastomotic leakage and/or abscess (30 days postoperatively)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Open-Label, Active-Controlled Study of Efficacy and Safety of FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease on Dialysis
Brief Summary: This is a randomized, multicenter, open-label, active-controlled study of the treatment of anemia in subjects with CKD on dialysis, with treatment up to 52 weeks.


Options:
A: Percentage of Participants Achieving a Successful Hemoglobin Response (Weeks 19 and 20)
B: Number of participants with adverse events (Approximately 9 weeks); Blood pressure (Approximately 9 weeks); Heart rate (Approximately 9 weeks); Cmax (Pre-dose and up to 48 h post-dose); Cmax/D (Pre-dose and up to 48 h post-dose); AUC (Pre-dose and up to 48 h post-dose); AUC/D (Pre-dose and up to 48 h post-dose); Heart rate over 1 min (Pre-dose and up to 24 h post-dose); Standing blood pressure procedure (Starting from 2 h post-dose and up to 4 h post-dose); Impedance cardiography (Pre-dose and up tp 8 h post-dose)
C: Rate of rise in Hb (Hemoglobin) level (g/dL/week) (Up to 8 weeks); Responder rate: proportion of responders among the subjects (Week 21 to 24)
D: Hb mean change from baseline (Weeks 23 to 27.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease Not on Dialysis
Brief Summary: This is a randomized, multicenter, double-blind, placebo-controlled study of the treatment of anemia in subjects with CKD not on dialysis, with treatment up to 52 weeks.


Options:
A: Change in Hb from baseline to the average level (Weeks 7 to 9 inclusive.)
B: Number (%) of Participants With an Hb Response by Week 17 (Up to Week 17)
C: Mean Hb (Hemoglobin) level (From week 30 to 36); Change in hemoglobin level from baseline to the average during the evaluation period (Baseline and week 30 to 36)
D: Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52) (Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52))

Answer: A