TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Identification of Prognostic Biomarkers by fMRI of Acceptance and Commitment Therapy in Suicidal Behavior Disorder
Brief Summary: Suicidal behaviors (SB) are a major health problem in France:10,000 suicides and 220,000 suicide attempts every year. SB management is therefore a major public health issue. Recently, investigators have demonstrated the interest of acceptance and commitment therapy (ACT) as an add-on treatment to reduce intensity and severity of suicidal ideation in depressed patients having a history of suicide attempt within previous year (i.e actual SB disorder according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5)). Based on structural and functional findings, it is admitted orbitofrontal and ventral prefrontal cortices play a role in suicidal vulnerability. Interestingly, previous functional MRI (fMRI) studies have also reported the modulation of these regions by ACT in subjects suffering from chronic pain. fMRI could thus be an interesting tool to identify biomarkers of SB and its improvement by ACT.

The aim of study is to investigate neural biomarkers of ACT efficiency in patients with SB disorder. Patients having a history of SB within previous year were randomized in an ACT program (21 patients) or relaxation program (21 patients) during 7 weeks. Before and after the completion of the group, they performed 3 tasks during fMRI: implicit emotional visualization, Cyberball game, motivational task Investigators will compare cerebral activations between groups, between pre and post intervention as well as measure baseline cerebral activations associated with improvement of suicidal ideation during follow up.


Options:
A: Change in BHS Scores (Baseline, 6 weeks, and 12 weeks)
B: Suicide re-attempt rate reduction using the Columbia Suicide Severity Rating Scale (C-SSRS) (At 2 years after the intervention)
C: Variation of cerebral activation when viewing angry versus neural faces during an implicit emotional visualization task (At 2 weeks after group completion); Variation of cerebral activation when viewing angry versus neural faces during an implicit emotional visualization task (At 2 weeks after group completion); Baseline activation when viewing angry vs. neutral faces during an implicit emotional visualization task (At 3 months after therapy)
D: Repeat Suicide Attempts (1, 2, and 3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of School Based Intervention for Promoting Mental Health Literacy Among Teachers: A Randomized Controlled Trial
Brief Summary: Significantly higher prevalence of emotional and behavioural problems have been reported from Pakistan.This higher prevalence along with stigma of psychiatric problems and limited child \& adolescent mental health services in Pakistan means that it is important to consider alternate methods for promoting psychological and emotional well-being of our youth. Schools can thus act as a natural platform for mental health promotion as schools context has almost as much impact on students' emotional health as the family context.

Teachers' role in the school mental health initiatives cannot be overemphasized. Teachers own knowledge and beliefs regarding mental health influence the way they respond to students mental health crisis. Recognizing the need for wider implementation of evidence based school mental health interventions in the region and to help in addressing the mental health literacy of educators in resource constrained settings, World Health Organization, Eastern Mediterranean Region (WHO-EMRO) has developed a concise and practical manual of school mental health in December 2014. In the absence of any "whole school approach" study from Pakistan focusing on teachers training and addressing all the various evidence based components of promotion of positive mental health, Investigators aim to conduct a pilot randomized controlled trial to assess effectiveness of training based on WHO-EMRO manual, in addition to its feasibility \& acceptability in improving teachers' mental health literacy and self-efficacy in dealing with students mental health issues.

HYPOTHESIS:

For teachers:

* School mental health training intervention will significantly improve teacher's mental health literacy \& self-efficacy compared to wait list control group.
* At 3 months follow-up, control group teachers' mental health literacy will also improve compared to baseline due to contamination of information provided, across groups within the same school.

All hypothesis pertains to individual level.

For students:

Mental health training of teachers would lead to an overall improvement in student's outcome measure (student's emotional and behavioural difficulties) at 3 months follow-up.


Options:
A: Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months (baseline and after 4-months of intervention); Change from baseline in the daily time using TV/computer/video games at 4 months (baseline and after 4-months of intervention)
B: Parenting practices (One month and six months post-intervention)
C: Teachers' knowledge (At the end of 3 days workshop)
D: Percent of Participants Who Develop Major Depression and Anxiety Disorders (One year); General Health Questionnaire (GHQ) Scores (One year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pivotal Phase III, Open-label, Randomized, Controlled Multi-center Study of the Efficacy of L19IL2/L19TNF Neoadjuvant Intratumoral Treatment Followed by Surgery Versus Surgery Alone in Clinical Stage III B/C Melanoma Patients
Brief Summary: Phase III, open-label, randomized, controlled multi-center study of the efficacy of L19IL2/L19TNF neoadjuvant intratumoral treatment in Stage III B/C melanoma patients.


Options:
A: The feasibility of treating patients with unresectable melanoma and palpable lymph node metastases that harbor the BRAF mutation with neoadjuvant vemurafenib. (24 months)
B: Pathological response rate (From baseline to 6 weeks)
C: Recurrence-free survival (RFS) rate (1 year after randomization)
D: Recurrence-free Survival (RFS) (up to 36 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pivotal Phase III, Open-label, Randomized, Controlled Multi-center Study of the Efficacy of L19IL2/L19TNF Neoadjuvant Intratumoral Treatment Followed by Surgery Versus Surgery Alone in Clinical Stage III B/C Melanoma Patients
Brief Summary: Phase III, open-label, randomized, controlled multi-center study of the efficacy of L19IL2/L19TNF neoadjuvant intratumoral treatment in Stage III B/C melanoma patients.


Options:
A: Recurrence-free survival (RFS) rate (1 year after randomization)
B: Progression-free Survival (PFS) - Initial Treatment Period (Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)); Interim Overall Survival (OS) - Initial Treatment Period (Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)); Final Overall Survival (OS) - Initial Treatment Period (Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019))
C: Disease-free survival
D: Progression-free Survival (PFS) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Radiology Plus Oncology Review (IRO) (Up to approximately 12 months (through first pre-specified statistical analysis cut-off date of 03-Sep-2014)); Percentage of Participants With Overall Survival (OS) at 12 Months (Month 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Synbiotic on Postoperative Complications After Liver Transplantation - A Randomized Double-blind Clinical Trial
Brief Summary: The purpose of this study is to evaluate the use of synbiotic in patients after liver transplantation and assess the effect of these agents on postoperative infections, antibiotic use, length of hospital stay, mortality and nutritional status.


Options:
A: To maintain normal bowel function and significantly moderate or obviate Immunosuppression Associated Diarrhea following kidney transplantation, utilizing a daily questionnaire, stool cultures and C. Difficile. (5 months)
B: All-cause postoperative mortality (90 days after the date of liver transplantation); Postoperative infection (30 days from the date of liver transplantation)
C: Evaluate the effect of synbiotic on postoperative infection after liver transplantation (15 days)
D: Change in p-cresol plasma concentration (one month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Field Efficacy Of Insecticide Treated Uniforms And Skin Repellents To Reduce Malaria Incidence In Military Personnel On Active Duty In Regions Of Hyperendemicity
Brief Summary: Purpose

While there is strong evidence that permethrin treated clothing prevents insect bites there is insufficient evidence from trials to demonstrate a reduction in infections. The evidence that topical insect repellants prevent malaria is more robust, but studies in civilian suffer from poor compliance. It is not known if there is an added benefit from combining the two. The effectiveness of permethrin-treated uniforms with and without DEET lotion are compared in a 2x2 design in Mgambo Jeshi la Kujenga Taifa (JKT) military camp in Tanga region.

The four arms are: 1) combined intervention group receiving permethrin treated uniform (PTU) and 30% DEET (diethyl toluamide) liposome formula; 2) permethrin intervention group receiving PTU and placebo lotion; 3) DEET intervention group receiving untreated army combat uniform (ACU) and 30% DEET liposome formula; 4) placebo group receiving untreated ACU and placebo lotion. Both participants and investigators will be blinded to treatment allocation.

The outcome measure is the incidence of Plasmodium falciparum malaria infection measured by Polymerase Chain Reaction every month by active case detection.


Options:
A: Change from baseline in malaria prevalence at 6 months (6 months)
B: Incidence of Plasmodium falciparum malaria through monthly measurement of malaria positivity by direct polymerase chain reaction (PCR) to detect parasite DNA (Monthly active case detection for 12 months)
C: reduction in malaria incidence (monthly over 7 months)
D: Plasmodium spp. infection diagnosed by RDT (Assessed weekly, longitudinally over 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors
Brief Summary: The primary objective of this pilot study is to determine the effect of weight loss on a wide range of biomarkers associated with risk of breast cancer recurrence in overweight and obese breast cancer survivors. We hypothesized that weight loss would result in a statistically significant improvement in biomarkers associated with risk of breast cancer recurrence.


Options:
A: Percent interlimb difference, change over 12 months. (Baseline and 12 months)
B: Proportion of participants with completed assessments at 6 months (6 months)
C: Quality of Life
D: Change in body weight (0, 6, 12, 18 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Oxytocin-based Pharmacotherapy for Autism Spectrum Disorders: Investigating the Neural and Behavioral Effects of a Promising Intervention Approach
Brief Summary: The current trial aims to explore the neural and behavioral effects of oxytocin in autism spectrum disorders (ASD). Oxytocin is a nonapeptide produced by the paraventricular and supraoptic nuclei of the hypothalamus and is known to play a pivotal role in a variety of complex social behaviors. Initial studies showed that intranasal administration of oxytocin can have a positive effect on social functioning in ASD.

However, future studies are necessary to explore whether and how oxytocin effects neural processes in the brain underlying these behavioral improvements. This trial will not only measure behavioral enhancements, but will specifically focus on elucidating the associated neurophysiological changes by guiding the administration of oxytocin with regular neurophysiological assessments.


Options:
A: Extent of Absorption of Memantine (Part One) (Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose); Change in Total Raw Score of Social Responsiveness Scale (From Baseline to Week 12)
B: Treatment Responder (12 Weeks (from Baseline [Week 0] to Endpoint [Week 12]))
C: Percentage of Patients Relapsing by Week 16 (From end of Phase 1 (Date of randomization) to Week 16 of Phase 2 and end of treatment)
D: Change From Baseline in Brain Activity During Task (Task-based fMRI) After a Single Dose of Nasal Spray (Value at 30 minutes minus value at baseline); Change From Baseline in Brain Activity During Task (Task-based fMRI) After 4 Weeks of Nasal Spray (Value at 4 weeks minus value at baseline); Change From Baseline in Brain Activity During Task (Task-based fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray (Value at 8 weeks minus value at baseline); Change From Baseline in Brain Activity During Task (Task-based fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray (Value at 52 weeks minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray (Value at 30 minutes minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 4 Weeks of Nasal Spray (Value at 4 weeks minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray (Value at 8 weeks minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray (Value at 52 weeks minus value at baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Oxytocin-based Pharmacotherapy for Autism Spectrum Disorders: Investigating the Neural and Behavioral Effects of a Promising Intervention Approach
Brief Summary: The current trial aims to explore the neural and behavioral effects of oxytocin in autism spectrum disorders (ASD). Oxytocin is a nonapeptide produced by the paraventricular and supraoptic nuclei of the hypothalamus and is known to play a pivotal role in a variety of complex social behaviors. Initial studies showed that intranasal administration of oxytocin can have a positive effect on social functioning in ASD.

However, future studies are necessary to explore whether and how oxytocin effects neural processes in the brain underlying these behavioral improvements. This trial will not only measure behavioral enhancements, but will specifically focus on elucidating the associated neurophysiological changes by guiding the administration of oxytocin with regular neurophysiological assessments.


Options:
A: Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale (6 Weeks)
B: Buss-Durkee Hostility Inventory; Barratt Impulsiveness Scale
C: Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents (week 10); Percentage of Participants Who Were Autism Spectrum Disorder Respondents (week 10)
D: Change From Baseline in Brain Activity During Task (Task-based fMRI) After a Single Dose of Nasal Spray (Value at 30 minutes minus value at baseline); Change From Baseline in Brain Activity During Task (Task-based fMRI) After 4 Weeks of Nasal Spray (Value at 4 weeks minus value at baseline); Change From Baseline in Brain Activity During Task (Task-based fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray (Value at 8 weeks minus value at baseline); Change From Baseline in Brain Activity During Task (Task-based fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray (Value at 52 weeks minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray (Value at 30 minutes minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 4 Weeks of Nasal Spray (Value at 4 weeks minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray (Value at 8 weeks minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray (Value at 52 weeks minus value at baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Oxytocin-based Pharmacotherapy for Autism Spectrum Disorders: Investigating the Neural and Behavioral Effects of a Promising Intervention Approach
Brief Summary: The current trial aims to explore the neural and behavioral effects of oxytocin in autism spectrum disorders (ASD). Oxytocin is a nonapeptide produced by the paraventricular and supraoptic nuclei of the hypothalamus and is known to play a pivotal role in a variety of complex social behaviors. Initial studies showed that intranasal administration of oxytocin can have a positive effect on social functioning in ASD.

However, future studies are necessary to explore whether and how oxytocin effects neural processes in the brain underlying these behavioral improvements. This trial will not only measure behavioral enhancements, but will specifically focus on elucidating the associated neurophysiological changes by guiding the administration of oxytocin with regular neurophysiological assessments.


Options:
A: Aberrant Behavior Checklist - Social Withdrawal Subscale (Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8)
B: Change From Baseline in Brain Activity During Task (Task-based fMRI) After a Single Dose of Nasal Spray (Value at 30 minutes minus value at baseline); Change From Baseline in Brain Activity During Task (Task-based fMRI) After 4 Weeks of Nasal Spray (Value at 4 weeks minus value at baseline); Change From Baseline in Brain Activity During Task (Task-based fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray (Value at 8 weeks minus value at baseline); Change From Baseline in Brain Activity During Task (Task-based fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray (Value at 52 weeks minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray (Value at 30 minutes minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 4 Weeks of Nasal Spray (Value at 4 weeks minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray (Value at 8 weeks minus value at baseline); Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray (Value at 52 weeks minus value at baseline)
C: Clinical Global Impression - Severity (Week 12); Clinical Global Impression - Improvement (Week 12)
D: Aberrant Behavior Checklist Hyperactivity Subscale (Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Preterm newborns are born with lower vitamin D stores. Although vitamin D supplementation is recommended there is no consensus regarding the adequate dose of supplementation for preterm infants.


Options:
A: Serum concentration of 25(OH) D at 36 weeks postmenstrual age. (36 weeks); Prevalence of vitamin D deficiency at 36 weeks postmenstrual age. (36 weeks)
B: Change in Serum Hepcidin With Vitamin D Intervention for Children With Chronic Kidney Disease (change from baseline to up to three months)
C: Number of Infants With Recurrent Wheezing (up to 12 months adjusted age)
D: Weight gain in children (2 Months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: International, Randomized, Open Label Study to Compare the Safety and Efficacy of Lixisenatide vs. Sulfonylurea on Top of Basal Insulin Treatment in Type 2 Diabetes Mellitus Subjects Who Elect to Fast During Ramadan
Brief Summary: Primary Objective:

To compare the safety, in terms of percentage of patients with symptomatic documented hypoglycemia during Ramadan fast, of lixisenatide versus sulfonylurea (SU).

Secondary Objectives:

* To assess effect of lixisenatide versus SU on:
* Changes in glycemic control;
* Changes in body weight.
* To assess overall safety of lixisenatide and SU.


Options:
A: Hypoglycemia (29 days of Ramadan); Hyperglycemia (29 days of Ramadan)
B: Change in HbA1c (Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan))
C: Proportion of Participants With at Least One Symptomatic Hypoglycemic Event (30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10))
D: Percentage of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose ≤70 mg/dL; 3.9 mmol/L) (Approximately 30 days (from start to end of Ramadan holy month))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-Blind, Placebo-Controlled, Exploratory Phase IIa Study To Assess The Safety And Efficacy Of Orally Administered Epeleuton In NAFLD Patients.
Brief Summary: The purpose of this randomised, double-blind, placebo-controlled, parallel group study is to assess the safety and efficacy of orally administered Epeleuton capsules versus placebo in the treatment of adult patients with Non Alcoholic Fatty Liver Disease (NAFLD)


Options:
A: Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and After 96 Weeks of Treatment. (baseline and 96 weeks)
B: Number of Participants With Improvement of >= 2 Points in NAFLD Activity Score (NAS) (48 weeks)
C: Change in Serum ALT (Alanine Aminotransferase) From Baseline to Week 16 (16 Weeks); Change in Liver Stiffness Measurements by Transient Elastography From Baseline to Week 16 (16 Weeks); Number of Treatment Emergent Adverse Events (TEAEs) in Each Treatment Group Leading to Treatment Discontinuation (20 Weeks)
D: Liver enzyme (1year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Feeding America's Bravest: Mediterranean Diet-Based Interventions to Change Firefighters' Eating Habits and Improve Cardiovascular Risk Profiles
Brief Summary: The purpose of this study is to modify the food culture of the fire service by motivating firefighters and their families to incorporate Mediterranean diet principles at work and home through behavior change strategies that involve education, participation and incentives. The ultimate purpose is to lower firefighters' risks for CVD and cancer by successfully getting more firefighters and their families to adopt and incorporate the healthy eating principles behind the Mediterranean diet.


Options:
A: Changes in Body Weight From Baseline (baseline and 6 months)
B: Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death) after a median follow-up of 7 years. (Seven Years)
C: Changes in Mediterranean diet scale (6, 12, and 24 months)
D: Change in body weight (kg) (26 weeks)

Answer: C