TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Maintenance Treatment of Anemia in End Stage Renal Disease Patients on Stable Dialysis
Brief Summary: This study was conducted to explore a new therapy for anemia in participants with end stage renal disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin (which contains iron) is important for the transport of oxygen in your blood. The purpose of this study was to evaluate if roxadustat is effective and safe in the maintenance treatment of anemia in ESRD participants on stable dialysis. Roxadustat was compared to epoetin alfa and darbepoetin alfa, commercially available medicines for treatment of anemia.


Options:
A: Change From Baseline (BL) to the Average Hemoglobin (Hb) in Weeks 28-36 Without Rescue Therapy [EU (EMA)] (Baseline and weeks 28 to 36); Change From BL to the Average Hb in Weeks 28 to 52 Regardless of Rescue Therapy [US (FDA)] (Baseline and weeks 28 to 52)
B: Average of Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM) Over 6-hour Post Dosing on Day 57 (Up to 6 hours post dose on Day 57)
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: Percentage of Participants With a Hemoglobin (Hb) Response to Treatment at Two Consecutive Visits During the First 24 Weeks of Treatment Without Rescue Therapy Prior to Hb Response (Baseline to week 24); Hb Change From Baseline (BL) to the Average Hb in Weeks 28-52 Regardless of Rescue Therapy (Baseline and weeks 28 to 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Healthy Lifestyle Behaviors in Primary Schoolchildren: Evaluation and Implementation of an Online Video Intervention for Parents
Brief Summary: 1. Development of a method for parents of primary schoolchildren to teach parents parenting skills to obtain health gain in the family through videos and online feedback.
2. Effect- and procesevaluation of this methodology.
3. Development of an implementation guide together with VIGEZ as primary partner and in association with partner organisations on the field.


Options:
A: Group differences in percentage of mothers who meet breastfeeding and complementary feeding recommendations and percentage of mothers who introduce sugar sweetened beverages over time as assessed by the Child Feeding Assessment. (2 weeks - 24 months postpartum); Group differences in mean scores for infant feeding style subscales assessed using the Infant Feeding Behavior Questionnaire. (2 months-12 months postpartum); Group differences in in mean scores for toddler feeding style subscales assessed using the Toddler Feeding Behavior Questionnaire (TFBQ). (24 months postpartum); Group differences in children's fruit and vegetable intake, sugar sweetened beverage (SSB) consumption, snacks, and desserts over time. (6 and 24 months postpartum); Group differences in children's physical activity levels as assessed by accelerometry. (18 months-24 months postpartum); Group differences in children's reported physical activity, screen time and other sedentary activities over time as assessed by the Child Physical Activity Assessment. (2 weeks-24 months postpartum); Group differences in children's mean BMI z-scores over time as assessed through child weight and length measurements over time. (2 weeks-24 months postpartum)
B: Number of parents engaging with the HENRY programme measured using Centre level process data (12 month post randomisation (allowing 3 months for Optimisation intervention implementation and collecting data from 1- 2 HENRY courses per site).)
C: Change from Baseline in physical activity level of children at 1 and 4 months (After 1 and 4 months); Change from Baseline in sedentary behavior of children at 1 and 4 months (After 1 and 4 months); Change from Baseline in healthy diet of children at 1 and 4 months (After 1 and 4 months)
D: Body mass index (2005, 2006, 2007, 2008); nutrition behavior (2005, 2006, 2007, 2008); physical activity (2005, 2006, 2007, 2008)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Filipinos Fit and Trim Weight Loss for Diabetes Prevention Program
Brief Summary: Filipino Americans (FA) are the second largest (3.4 million) Asian group in the US. and have one of the highest prevalences of obesity and type 2 diabetes mellitus compared to non-Hispanic whites, African Americans and Hispanics. However, FA have been underrepresented in health related research, particularly in diabetes prevention. This proposed pilot study is the first clinical trial to assess preliminary estimates of the short-term effect of the novel social networking diabetes prevention program lifestyle intervention for this high-risk population.


Options:
A: Weight maintenance 12 months after weight loss intervention (15 months)
B: Count of Participants Who Completed the Study (Baseline to 6-months)
C: BMI Z score (12 months)
D: weight reduction (at 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: RANDOMIZED DOUBLE-BLIND CONTROLLED THE USE OF PHOTOTHERAPY IN FIBROMIÁLGICOS WITH TEMPOROMANDIBULAR JOINT DYSFUNCTION
Brief Summary: Temporomandibular joint dysfunction is described as a multifactorial disease and can be directly linked to other diseases, being of structural factors of the Stomatognathic System or not, such as fibromyalgia. Studies show the interconnection of Temporomandibular Dysfunctions with fibromyalgia. Thus, this project aims to evaluate the effect of Phototherapy on fibromiálgicos patients with temporomandibular dysfunction This is a Randomized, Controlled and double-blind, with the intention to treat. In this way the sample of 61 patients with Fibromyalgia, Temporomandibular joint Dysfunction associated with ages between 35 to 58 years, females who are selected after the inclusion/exclusion criteria, will be randomly distributed in homogeneous groups and the placebo group (P), Phototherapy (FT) group, group of physical activity (A) aerobic and aerobic physical activity + Phototherapy Group (FT + A). Will be used as a means of analysis before and after interventions the following parameters: Pain: clinical evaluation, evaluation of pain by Visual analog scale of pain (EVA), McGill Pain Questionnarire and pressure Algometria. Still we will evaluate the dosage of serotonin, indirectly, by saliva. Quality of life: own illness as questionnaires FIQ (Fibromyalgia Impact Questionnaire), Medical Outcomes Study 36-item Short-Form Health Survey SF-36 and also will assess the quality of sleep, with polysomnography. The treatments will total in 10 sessions held twice a week, and the FT and FT + groups to receive Phototherapy enforcement will be used a portable cluster 9 diodes, where will be delivered 39.3 Joules in tender points of fibromyalgia and TMJ, groups and FT + to carry out aerobic activity in 75% of your MHR for 50 min and the P group will receive the application of Phototherapy of 0 Joules (IE, the equipment does not emit any power). Statistical analysis will be compared using the t test intra-group-Student, one-tail and paired and can be used the Kruskal-Wallis test, the statistical analysis of significance 0.05 for both tests.


Options:
A: Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score (wks 12)
B: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)
C: Pain (10 sessions, in 5 weeks, 2 times a week)
D: The primary outcome measure will be the change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final week of Qigong treatment. (7 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: RANDOMIZED DOUBLE-BLIND CONTROLLED THE USE OF PHOTOTHERAPY IN FIBROMIÁLGICOS WITH TEMPOROMANDIBULAR JOINT DYSFUNCTION
Brief Summary: Temporomandibular joint dysfunction is described as a multifactorial disease and can be directly linked to other diseases, being of structural factors of the Stomatognathic System or not, such as fibromyalgia. Studies show the interconnection of Temporomandibular Dysfunctions with fibromyalgia. Thus, this project aims to evaluate the effect of Phototherapy on fibromiálgicos patients with temporomandibular dysfunction This is a Randomized, Controlled and double-blind, with the intention to treat. In this way the sample of 61 patients with Fibromyalgia, Temporomandibular joint Dysfunction associated with ages between 35 to 58 years, females who are selected after the inclusion/exclusion criteria, will be randomly distributed in homogeneous groups and the placebo group (P), Phototherapy (FT) group, group of physical activity (A) aerobic and aerobic physical activity + Phototherapy Group (FT + A). Will be used as a means of analysis before and after interventions the following parameters: Pain: clinical evaluation, evaluation of pain by Visual analog scale of pain (EVA), McGill Pain Questionnarire and pressure Algometria. Still we will evaluate the dosage of serotonin, indirectly, by saliva. Quality of life: own illness as questionnaires FIQ (Fibromyalgia Impact Questionnaire), Medical Outcomes Study 36-item Short-Form Health Survey SF-36 and also will assess the quality of sleep, with polysomnography. The treatments will total in 10 sessions held twice a week, and the FT and FT + groups to receive Phototherapy enforcement will be used a portable cluster 9 diodes, where will be delivered 39.3 Joules in tender points of fibromyalgia and TMJ, groups and FT + to carry out aerobic activity in 75% of your MHR for 50 min and the P group will receive the application of Phototherapy of 0 Joules (IE, the equipment does not emit any power). Statistical analysis will be compared using the t test intra-group-Student, one-tail and paired and can be used the Kruskal-Wallis test, the statistical analysis of significance 0.05 for both tests.


Options:
A: Fibromyalgia Impact Questionnaire (Assessed following 12 week intervention)
B: Health-related quality of life among patients with fibromyalgia (FIQ: Fibromyalgia Impact Questionnaire) (6 months)
C: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)
D: Pain (10 sessions, in 5 weeks, 2 times a week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: RANDOMIZED DOUBLE-BLIND CONTROLLED THE USE OF PHOTOTHERAPY IN FIBROMIÁLGICOS WITH TEMPOROMANDIBULAR JOINT DYSFUNCTION
Brief Summary: Temporomandibular joint dysfunction is described as a multifactorial disease and can be directly linked to other diseases, being of structural factors of the Stomatognathic System or not, such as fibromyalgia. Studies show the interconnection of Temporomandibular Dysfunctions with fibromyalgia. Thus, this project aims to evaluate the effect of Phototherapy on fibromiálgicos patients with temporomandibular dysfunction This is a Randomized, Controlled and double-blind, with the intention to treat. In this way the sample of 61 patients with Fibromyalgia, Temporomandibular joint Dysfunction associated with ages between 35 to 58 years, females who are selected after the inclusion/exclusion criteria, will be randomly distributed in homogeneous groups and the placebo group (P), Phototherapy (FT) group, group of physical activity (A) aerobic and aerobic physical activity + Phototherapy Group (FT + A). Will be used as a means of analysis before and after interventions the following parameters: Pain: clinical evaluation, evaluation of pain by Visual analog scale of pain (EVA), McGill Pain Questionnarire and pressure Algometria. Still we will evaluate the dosage of serotonin, indirectly, by saliva. Quality of life: own illness as questionnaires FIQ (Fibromyalgia Impact Questionnaire), Medical Outcomes Study 36-item Short-Form Health Survey SF-36 and also will assess the quality of sleep, with polysomnography. The treatments will total in 10 sessions held twice a week, and the FT and FT + groups to receive Phototherapy enforcement will be used a portable cluster 9 diodes, where will be delivered 39.3 Joules in tender points of fibromyalgia and TMJ, groups and FT + to carry out aerobic activity in 75% of your MHR for 50 min and the P group will receive the application of Phototherapy of 0 Joules (IE, the equipment does not emit any power). Statistical analysis will be compared using the t test intra-group-Student, one-tail and paired and can be used the Kruskal-Wallis test, the statistical analysis of significance 0.05 for both tests.


Options:
A: Pain (10 sessions, in 5 weeks, 2 times a week)
B: Health-related quality of life among patients with fibromyalgia (FIQ: Fibromyalgia Impact Questionnaire) (6 months)
C: Change in Fibromyalgia Impact Questionnaire (FIQ) from baseline to 24 weeks (Week 0, Week 24)
D: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind Randomized Placebo-controlled, Parallel-group 12 Week Study to Investigate the Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Type 2 Diabetic Patients; EFFECT II
Brief Summary: This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in up to 5 centres in Sweden to assess the effect of Omega-3 carboxylic acids and dapagliflozin on liver fat in patients with Type 2 diabetes with fatty liver (\>5.5% as measured with magnetic resonance imaging (MRI))


Options:
A: The primary endpoint is the reduction in hepatic triglyceride content from baseline to week 24. (24 weeks)
B: Improvement of laboratory markers of inflammation and oxidative stress, such as concentrations of TNF-alpha, lipopolysaccharide (LPS), adiponectin, catepsin D, cytokeratin-18. (4 months); Improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile, transaminases serum levels (4 months)
C: Change in Liver Fat (24 weeks); Change in Liver Fibrosis (24 weeks); Change in Liver Injury (24 weeks)
D: Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo) (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Open-Label, Assessor-Blind, Noninferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
Brief Summary: Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase. The purpose of the present study is to provide additional efficacy and safety data compared to approved, porcine-derived, enterically-coated and encapsulated pancreatic enzyme replacement therapy. The primary efficacy endpoint of the study will be comparative efficacy measured as the change in the coefficient of fat absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).

Liprotamase is stable in stomach and digestive fluids allowing administration in a variety of convenient formulations and with a number of foods without enteric coating.


Options:
A: Treatment Difference in Coefficient of Fat Absorption (CFA) Change From Baseline (Baseline, 7 weeks)
B: Coefficient of Fat Absorption (%) (5 days)
C: Change from open label baseline to end of 6 day double blind treatment period in Coefficient of Fat Absorption (CFA) (Open label baseline, end of 6 day double blind treatment period)
D: Incremental gain in weight, length, and head circumference (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-level Communications and Access Strategies to Improve the Food Environment:B'More Healthy: Retailer Rewards (BHRR)
Brief Summary: The overarching goal of B'More Healthy Retail Rewards (BHRR) is to develop, implement, and evaluate a pilot multi-level communications and pricing intervention to improve access to and consumption of healthy foods in low-income areas of Baltimore City, Maryland. BHRR has three primary aims: (1) to conduct formative research with representatives of multiple levels of the Baltimore food environment (i.e., local wholesalers, retail food store owners, and consumers) in order to select key foods for promotion, and determine appropriate communications and healthy food price reduction strategies, (2) to pilot the multi-level program with 2 local wholesale stores, and 24 small corner stores and their customers, and assess program implementation through detailed process evaluation, and (3) to assess impact of multilevel health communications and pricing strategies, combined and separately, on consumer dietary patterns and food source use, food purchasing behaviors, psychosocial variables, food security, and individual weight and height.


Options:
A: Rate Support of a Label on a 1 (not at all) to 7 (a great deal) Scale. (Immediately following the presentation of the labels.)
B: Triglycerides blood level (baseline); Triglycerides blood levels (3 months); Triglycerides blood Levels (6 months); Triglycerides blood levels (9 months)
C: Change in average student water consumption at lunch (March 2013-June 2013, up to 4 months)
D: Healthy food purchasing and related-psychosocial factors (Up to 8 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Interactive Web-Based Education and Interactive Voice Response (Automated Follow-up) Programs on CPAP Adherence for the Treatment of Obstructive Sleep Apnea
Brief Summary: The primary and well-known challenge with continuous positive airway pressure (CPAP) is the incomplete adherence of patients to this therapy. Successfully improving CPAP use is likely through emphasizing patient education regarding the risks associated with obstructive sleep apnea (OSA), potential benefits of therapy, teaching techniques to acclimate to CPAP, and providing a system of accountability through a follow-up process. With the changing landscape of healthcare reimbursement which emphasizes achieving positive clinical outcomes, discovering more automated and self-directed methods of educating and follow-up is needed.

The investigators plan to investigate the impact of adjunct Web education and automated follow-up on CPAP use and other measurements of patient engagement. The specific aims of this pilot study are as follows:

1. Assess impact of Telemedicine mechanisms on CPAP use 3 months after initiating therapy in comparison to usual standard of care.
2. Assess impact of Telemedicine mechanisms on functional outcomes and parameters of healthcare utilization at 3 months after initiation of therapy in comparison to usual standard of care.


Options:
A: A composite of the CV endpoints of CV death, non-fatal acute myocardial infarction, non-fatal stroke, hospital admission for heart failure, and new hospitalisation for unstable angina or transient ischaemic attack. (Reviewed 6-monthly; average patient follow up, 4.5 years)
B: Hopkins Verbal Learning Test-Revised (HVLT-R) (Change from baseline at 6 months and 1 year); Digit Symbol Subtest (DS) (Change from baseline at 6 months and 1 year); Mini Mental State Evaluation Exam (MMSE) (Change from baseline at 6 months and 1 year); Stroop Color and Word Test (SCW) (Change from baseline at 6 months and 1 year); The Psychomotor Vigilance Task (PVT) (Change from baseline at 6 months and 1 year); Epworth Sleepiness Scale [ESS] (Change from baseline at 6 months and 1 year)
C: Effect of intensive intervention on CPAP adherence (24 months)
D: Average hours of CPAP use per night: experimental pathway vs. traditional pathway (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Interactive Web-Based Education and Interactive Voice Response (Automated Follow-up) Programs on CPAP Adherence for the Treatment of Obstructive Sleep Apnea
Brief Summary: The primary and well-known challenge with continuous positive airway pressure (CPAP) is the incomplete adherence of patients to this therapy. Successfully improving CPAP use is likely through emphasizing patient education regarding the risks associated with obstructive sleep apnea (OSA), potential benefits of therapy, teaching techniques to acclimate to CPAP, and providing a system of accountability through a follow-up process. With the changing landscape of healthcare reimbursement which emphasizes achieving positive clinical outcomes, discovering more automated and self-directed methods of educating and follow-up is needed.

The investigators plan to investigate the impact of adjunct Web education and automated follow-up on CPAP use and other measurements of patient engagement. The specific aims of this pilot study are as follows:

1. Assess impact of Telemedicine mechanisms on CPAP use 3 months after initiating therapy in comparison to usual standard of care.
2. Assess impact of Telemedicine mechanisms on functional outcomes and parameters of healthcare utilization at 3 months after initiation of therapy in comparison to usual standard of care.


Options:
A: Brain Natriuretic Peptide values (Baseline, 6 months); Self-care practices measured through Self-Care of Heart Failure Index scores and interviews (baseline, 6 months); Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews (baseline, 6 months)
B: Average hours of CPAP use per night: experimental pathway vs. traditional pathway (3 months)
C: Target goal of HbA1c (< 7.0%) without hypoglycemia (24 weeks)
D: Child BMI

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Double-dummy, Randomized, Placebo-controlled, Phase IIa Study on the Efficacy and Tolerability of a 14-day Treatment With Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Patients With Eosinophilic Esophagitis
Brief Summary: The purpose of this study is to assess the efficacy of a low and high dose of a budesonide effervescent tablet and oral viscous budesonide suspension vs. placebo for the induction treatment of active eosinophilic esophagitis.


Options:
A: Absolute Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 10 (Baseline, Week 10)
B: 1. Reduction of eosinophils in the oesophagus 2. Safety and tolerability of mepolizumab
C: The primary endpoint in this study is the number of patients (responder) with a reduction of 75% or more in eosinophils per HPF (distal or proximal esophagus) from baseline to week 13. (13 weeks)
D: Rate of histological remission (2 weeks (LOCF)); Change in the mean numbers of eos (2 weeks (LOCF))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Grab a Cup, Fill it up! An Intervention to Promote Convenience of Drinking Water and Increase Student Water Consumption During School Lunch.
Brief Summary: This study, randomized, delivered, and analyzed at the school level, evaluated the effect of simple, structural changes to school lunch rooms to make drinking water easier for students during lunch time. Half of the schools received posters promoting drinking water and installed cup dispensers stocked with cups next to lunchroom water fountains, while the other half received no intervention. The intervention outcomes were average water consumption and the proportion of students in the lunchroom who opted to drink water, as well as the proportion of students with sugary drinks at lunch. No identifying information on individual children was collected.


Options:
A: Sweetened beverages purchased (2 week condition blocks)
B: Body mass index (one year)
C: Change in average student water consumption at lunch (March 2013-June 2013, up to 4 months)
D: BMI z-score (via measured weight and height) of preschooler (~2 years post baseline)

Answer: C