TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Placebo-controlled, Parallel Group, Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome Not Adequately Controlled by Somatostatin Analog (SSA) Therapy
Brief Summary: The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy.


Options:
A: Percentage of Days With Subcutaneous Octreotide as Rescue Medication (16-week DB phase)
B: Central Review-based Progression-Free Survival (Up to 3 years)
C: Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks (Baseline and 12 Weeks); Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period (First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.6 Weeks)); Number of Participants With TEAEs in the Open-Label Extension Period (First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 54.3 Weeks))
D: Progression-Free Survival (PFS) (From randomisation up to the last tumour assessment (scheduled at 96 weeks). Radiological scans were performed every 12 weeks during the first year and every 24 weeks during the second year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Helicobacter Pylori Eradication to Prevent Gastric Cancer in Subjects With Family History of Gastric Cancer: A Randomized Controlled Study
Brief Summary: This study evaluate whether treatment of Helicobacter pylori infection reduces the incidence of gastric cancer in subjects with family history of gastric cancer.


Options:
A: Precancerous gastric lesions (7 years); Gastric cancer incidence (15 years)
B: Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of gastric tumor. (we set the time frame as at least three years.)
C: Gastric cancer incidence (6 years after last participant enrollment)
D: Helicobacter pylori eradication determined by 13C-urea breath test. (4-6 weeks following the completion of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1, Single Center Study Using Omalizumab in Subjects With Atopic Dermatitis
Brief Summary: A phase 1 single center study in which omalizumab is dosed normally (according to the product insert) in subjects with atopic dermatitis.


Options:
A: Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 (baseline to Week 12)
B: N/A
C: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4 (Baseline (pre-dose on Day 1) and Week 4)
D: Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16 (Baseline to Week 16)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: 1) Impact Evaluation of Behavior Change Communication and Micronutrient Supplementation Interventions on Infant and Young Child Feeding (IYCF) Practices and on Childhood Stunting and Anaemia 2) Evaluation of the Public Health Impact of a Market-based Approach to Improving Diet Quality of Infants and Young Children Through the Use of Sprinkles in Bangladesh
Brief Summary: This complex evaluation of a large-scale program uses a cluster-randomized design where 20 geographic clusters (subdistricts) were randomized to study two sets of interventions. For the evaluation of behavior change interventions only, the 20 clusters were randomized to 10 intensive and 10 non-intensive interventions areas. For a sub-study to evaluate a market-based model for delivering micronutrient powders (MNP) along with behavior change interventions, there was subsequent randomization to comparison area, MNP-only area, Behavior Change Communication (BCC)-only area and MNP+BCC areas.


Options:
A: Study the effect of a standard two-encounter postnatal lactation counseling protocol on the initiation and maintenance of exclusive breastfeeding in mothers
B: Exclusive breastfeeding (EBF) among children 0-6 months of age (4 years after baseline); Child anthropometry (height, weight) among children 24-48 months of age (4 years after baseline); Complementary feeding among children 6-23.9 months of age (4 years after baseline); Anemia among children 6-23.9 months (4 years after baseline)
C: Number of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding Intervention (through study completion, an average of 6 months)
D: Number of eligible participants who consent and complete study intervention (1-4 days postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: 1) Impact Evaluation of Behavior Change Communication and Micronutrient Supplementation Interventions on Infant and Young Child Feeding (IYCF) Practices and on Childhood Stunting and Anaemia 2) Evaluation of the Public Health Impact of a Market-based Approach to Improving Diet Quality of Infants and Young Children Through the Use of Sprinkles in Bangladesh
Brief Summary: This complex evaluation of a large-scale program uses a cluster-randomized design where 20 geographic clusters (subdistricts) were randomized to study two sets of interventions. For the evaluation of behavior change interventions only, the 20 clusters were randomized to 10 intensive and 10 non-intensive interventions areas. For a sub-study to evaluate a market-based model for delivering micronutrient powders (MNP) along with behavior change interventions, there was subsequent randomization to comparison area, MNP-only area, Behavior Change Communication (BCC)-only area and MNP+BCC areas.


Options:
A: Exclusive breastfeeding (EBF) among children 0-6 months of age (4 years after baseline); Child anthropometry (height, weight) among children 24-48 months of age (4 years after baseline); Complementary feeding among children 6-23.9 months of age (4 years after baseline); Anemia among children 6-23.9 months (4 years after baseline)
B: Hemoglobin (Start of study (T=0), End of study (T=4months))
C: Hemoglobin concentration (End of the 30-day fortification period)
D: Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: 1) Impact Evaluation of Behavior Change Communication and Micronutrient Supplementation Interventions on Infant and Young Child Feeding (IYCF) Practices and on Childhood Stunting and Anaemia 2) Evaluation of the Public Health Impact of a Market-based Approach to Improving Diet Quality of Infants and Young Children Through the Use of Sprinkles in Bangladesh
Brief Summary: This complex evaluation of a large-scale program uses a cluster-randomized design where 20 geographic clusters (subdistricts) were randomized to study two sets of interventions. For the evaluation of behavior change interventions only, the 20 clusters were randomized to 10 intensive and 10 non-intensive interventions areas. For a sub-study to evaluate a market-based model for delivering micronutrient powders (MNP) along with behavior change interventions, there was subsequent randomization to comparison area, MNP-only area, Behavior Change Communication (BCC)-only area and MNP+BCC areas.


Options:
A: Infant length at 18 months (18 months of age. Protocol and Statistical Analysis Plan are available at https://osf.io/w93hy.); Infant hemoglobin at 18 months (18 months)
B: Exclusive breastfeeding (EBF) among children 0-6 months of age (4 years after baseline); Child anthropometry (height, weight) among children 24-48 months of age (4 years after baseline); Complementary feeding among children 6-23.9 months of age (4 years after baseline); Anemia among children 6-23.9 months (4 years after baseline)
C: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (Protocol 008)
Brief Summary: The purpose of this study is to evaluate the safety of two doses (6 Development Units \[DU\] and 12 DU) of MK-8237 sublingual tablets compared to Placebo in adolescents with house dust mite-induced allergic rhinitis/rhinoconjunctivitis. The primary hypothesis is that at least one dose of MK-8237 sublingual tablet is safe and well-tolerated in adolescents with house dust mite-induced allergic rhinitis/rhinoconjunctivitis.


Options:
A: Total Combined Score (TCS) During the Peak Ragweed Season (RS) (The 15-day period during the ragweed season with the highest moving pollen average)
B: Immunological mechanisms of SLIT by phenotyping different subsets of cytokine positive T cells, regulatory T cells, and memory T cells in peripheral blood of subjects before, during and after immunotherapy. (12 and 24 months); -Expression of "immunoregulatory" cytokines by CD4+ T (12 and 24 months); cells (12 and 24 months); - Helper, regulatory and memory T cell subsets (12 and 24 months); (a) Helper T cells (12 and 24 months); (b) Regulatory T cells (12 and 24 months); b1- Regulatory T cell phenotype (12 and 24 months); b2- Regulatory T cell function (12 and 24 months)
C: Percentage of Participants Who Experienced At Least One Adverse Event (AE) (From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days); Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (From first dose to last dose of treatment, up to 28 days)
D: determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo (September 2009)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Good Schools Study: Cluster Randomised Controlled Trial of a Program to Prevent Violence Against Children in Schools
Brief Summary: The purpose of this study is to determine whether use of the Good Schools Toolkit is effective in reducing violence against children in primary schools.


Options:
A: Depression - Patient Health Questionnaire (1 week post-intervention)
B: Parenting Behavior Assessment (adapted from multiple scales for this context) (1 month); Parenting Self-Efficacy and Beliefs Assessment (adapted from other scales for this context; includes unique items developed for this context) (1 month); Child Behavior Assessment (items adapted from the Strengths and Difficulties Questionnaire) (1 month); Parent-Child Interaction Observation (1 month); Child Cognitive / Pre-Academic Abilities and Emotional Well-being (1 month)
C: Physical Violence From School Staff (2-year follow-up)
D: Unprotected vaginal and anal sex (Baseline); Unprotected vaginal and anal sex (6 month follow-up); Unprotected vaginal and anal sex (12-month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study on Mindfulness for Tobacco and Alcohol in University Students
Brief Summary: A. The study follows a randomized controlled design with approximately 60 smokers with a history of alcohol abuse age 18-29. The study will compare a 7-week mindfulness intervention to a matched 7-week education intervention to evaluate intervention effect on smoking cessation and reduction in alcohol use. The primary hypothesis is that the mindfulness intervention will yield statistically significantly higher smoking abstinence than controls as measured by carbon monoxide breath test and Time Line Follow Back at at the end of treatment (2-weeks post smoking cessation attempt).


Options:
A: Addiction Severity Index (ASI) - Alcohol (change) (Baseline, 2 months, 4 months, 6 months, 12 months); Addiction Severity Index (ASI) - Drugs (change) (Baseline, 2 months, 4 months, 6 months, 12 months); Change on Urine Drug Test (change) (Baseline, 2 months, 4 months, 6 months, 12 months)
B: Smoking Abstinence (2 weeks post quit day)
C: Pain severity, pain functional interference (Baseline, immediately following treatment, and at 3 month follow-up); Opioid craving (Baseline, immediately following treatment, and at 3 month follow-up); Opioid misuse behaviors (Baseline, immediately following treatment, and at 3 month follow-up); Well-being (Baseline, immediately following treatment, and at 3 month follow-up)
D: Feasibility of attrition (12 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study on Mindfulness for Tobacco and Alcohol in University Students
Brief Summary: A. The study follows a randomized controlled design with approximately 60 smokers with a history of alcohol abuse age 18-29. The study will compare a 7-week mindfulness intervention to a matched 7-week education intervention to evaluate intervention effect on smoking cessation and reduction in alcohol use. The primary hypothesis is that the mindfulness intervention will yield statistically significantly higher smoking abstinence than controls as measured by carbon monoxide breath test and Time Line Follow Back at at the end of treatment (2-weeks post smoking cessation attempt).


Options:
A: Smoking Abstinence (2 weeks post quit day)
B: 7-day point prevalence (3 months and 6 months post treatment)
C: 30-day point prevalence abstinence (12 month post randomization)
D: 7-day point prevalence by self report (at 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Single-blind, Placebo-controlled, Combined 2-fold Cross-over and Group-comparison, Dose-escalation Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Single Oral Doses of BAY 85-3934 in Subjects With Chronic Kidney Disease (CKD)
Brief Summary: Primary objective was to assess in subjects with CKD: Safety and tolerability of molidustat (BAY 85-3934), effects of molidustat on non-invasive hemodynamics Secondary objectives were to assess: Effects on pharmacodynamic parameters of erythropoiesis (erythropoietin, reticulocytes, erythrocytes, hemoglobin, hematocrit), pharmacokinetics of molidustat, exploratory biomarkers, ie, midregional pro-atrial natriuretic peptide, midregional pro-adrenomedullin, plasma renin activity, and optionally B-type natriuretic peptide, vascular endothelial growth factor, cyclic guanosine monophosphate, cyclic adenosine monophosphate, and noradrenaline


Options:
A: Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) (Weeks 40 to 52)
B: Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period (Pre-treatment; Week 6)
C: Maximum Change From Baseline in Hb During Weeks 3-13 (Baseline, Weeks 3-13)
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise: A Randomised Controlled Pilot Trial
Brief Summary: The propose of this study is to evaluate the feasibility and the clinical efficiency of feedback-controlled robotics-assisted treadmill exercise (RATE) technology for cardiovascular rehabilitation early after stroke. The investigators hypothesize that feedback-controlled RATE might be suitable and effective to improve cardiovascular fitness and functional carryover in non-ambulatory individuals with sub-acute stroke.


Options:
A: Change in 10 Meter Walk Test From Baseline in Gait Speed (Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up))
B: change of functional ambulation category point (baseline, during training (2weeks), post training (4weeks) & followed for 2months after training)
C: Fugl-Meyer Assessment (FMA) (An expected average of 4 weeks)
D: Peak Oxygen Uptake (V'O2peak) (4 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical and Cost Effectiveness of Staff Training in Positive Behaviour Support (PBS) for Treating Challenging Behaviour in People With Intellectual Disability: A Cluster Randomised Controlled Trial
Brief Summary: Many people with intellectual disability have challenging behaviour which often has serious consequences such as the prescription of long term medication, in-patient admissions and disruption of normal daily activities. Community intellectual disability services may have difficulties in helping people with challenging behavior. Available research suggests that Positive Behavior Support (PBS), a training system that teaches staff how to manage these situations, can benefit service users who may show improvements in challenging behavior and quality of life. The investigators do not know of any study so far that has examined the clinical and cost effectiveness of PBS that is provided by staff in routine clinical practice in community intellectual disability services. If PBS proved to be better than treatment as usual, it would have important implications for the management of a very vulnerable group of service users. In this trial, health staff will receive accredited training in PBS available in a manual written by PBS experts. It will give details of how to understand challenging behavior and develop a management plan and how to implement it and monitor whether it has achieved its goals. Twenty community intellectual disability services and 260 service users with mild to severe intellectual disability and challenging behavior will be invited to take part in the study. The sample size calculations are based on our pilot study and allow for non participation of 10% and inflation due to the number of community intellectual disability teams and staff that will take part. The teams will be randomly allocated into one of two conditions. Half will be in the PBS arm (but will also have treatment as usual) and half will be in the treatment as usual only group. The investigators will carry out assessments of challenging behavior, use of services, quality of life, mental health, aggression and family and paid carer burden at six and 12 months. The investigators will monitor treatment fidelity and the investigators will talk to a sample of paid and family carers, service users, staff and managers about what they think of the treatment and how best the investigators can deliver it in routine care. The main outcome is reduction in challenging behavior at one year after the randomization. The investigators will also carry out a health economic evaluation to examine the costs and consequences of staff training in PBS.


Options:
A: Aberrant Behavior Checklist scale (6 months)
B: Child Behaviour Check List (CBCL) (12 months)
C: Challenging Behaviour (12 months)
D: Clinical Global Impression--Improvement score (Every two weeks); Affective Reactivity Index (ARI) (Every two weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigation of the Effects of a Synbiotic on Liver Fat, Disease Biomarkers and Intestinal Microbiota in Non-alcoholic Fatty Liver Disease
Brief Summary: Non-alcoholic fatty liver disease (NAFLD) is a liver condition in which fat builds up in the liver not caused by alcohol. The liver is an organ that is not designed to build up fat. NAFLD is common in people who have too much body fat in their abdomen or who have diabetes (high blood sugar), but does not always exist with these conditions. NAFLD can also occur in thin people too. NAFLD can be harmful to the liver and may cause the liver to fail over time. NAFLD may also cause adult (or type 2) diabetes and also heart disease. In people who already have diabetes, NAFLD can cause glucose (sugar) levels to be too high.

Our intestines (guts) contain healthy bacteria and some harmful bacteria (bugs). This balance of healthy and harmful bugs is essential for the normal workings of our intestine to digest food. Providing these bacteria do not leak out into the blood they do not cause harm. If the balance of healthy to harmful bugs is upset, the harmful can cause problems and leak out into the blood. Because the liver is connected to the intestine by blood vessels the harmful bacteria can get to the liver and cause problems. These bacteria can cause the liver and the body to build up too much fat and might cause NAFLD and obesity. In this study, we will test the effects of a supplement (synbiotic) taken during the day, that contains a mixture of 'good' healthy bacteria (probiotic) and a sugar (prebiotic) that is not broken down and absorbed into the blood. We will test whether the synbiotic supplement has beneficial effects on the NAFLD liver condition and on factors linked to too much body fat, diabetes and heart disease.


Options:
A: The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS). (approximately 12 months from enrollment)
B: Change in Liver Fat (baseline and 12 months); Change in Enhanced Liver Fibrosis Score (ELF) (baseline and 12 months); Change in NAFLD Fibrosis Score (baseline and 12 months); Change in Bifidobacterium Spp. (baseline and 12 months)
C: Optical density of macular pigment (12 months)
D: Time to first relapse of atrial fibrillation (After a three weeks loading phase)

Answer: B