TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics for the Prevention of Relapse in Long-term Stabilized Schizophrenic Patients: a Randomized, Single-blind, Longitudinal Trial
Brief Summary: The main objective of the trial is to evaluate, how long an antipsychotic relapse-prevention should be continued and to which time a patient with schizophrenia is protected enough, so that a withdrawal or reduction of the medication seems appropriate. Relapse is defined as primary outcome.


Options:
A: Relapse (Every 2 weeks up to 26 weeks)
B: Determine comparative efficacy in patients with schizophrenia of non-inferiority of IM olanzapine depot high and low doses versus oral olanzapine based on exacerbation rates after 6 months of maintenance treatment; Determine comparative efficacy in patients with schizophrenia of superiority of IM olanzapine depot low, med and high doses versus very low dose based on time to exacerbation of symptoms of schizophrenia
C: The difference in change from baseline to the 12-week time point between bifeprunox and placebo using the Positive and Negative Syndrome Scale (PANSS). (12 weeks)
D: Clinical Global Impression every 2 weeks; Simpson and Angus Rating Scale for Extrapyramidal Effects every 2 weeks; Barnes Rating Scale for Drug-Induced Akathisia every 2 weeks; Abnormal Involuntary Movement Scale every 2 weeks; Drug Attitude Inventory every 2 weeks; Calgary Depression Scale for Schizophrenia every 2 weeks; Brief Psychiatric Rating Scale every 2 weeks

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Two Human Milk Fortifiers in Preterm Infants
Brief Summary: The purpose of this study is to assess growth of preterm infants fed human milk supplemented with one of two commercially available human milk fortifiers.


Options:
A: growth during first three weeks of intervention (first three weeks during intervention before 36 weeks of gestation)
B: Weight Gain (Study Day 1 to Study Day 29 (or discharge, whichever happens first))
C: Weight gain due to fat mass (4 weeks)
D: Weight gain (From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Mobile Application as an Adjunct to Medical Advice to Promote Healthy Habits (Diet and Sport) in a Population of Patients Obese or Overweight Adults Patients
Brief Summary: INTRODUCTION: Obesity is the most common metabolic problem and its genesis and maintenance there is always a positive energy balance, with less energy expenditure than that obtained from the intake. Low physical activity is often an important factor in this lower spending. Medical advice is useful for determining changes in the habits of life of patients, however, the changes produced by the council do not last over time, so it would be necessary to establish enforcement mechanisms as with mobile technology, because it could improve the adhesion of obese patients to therapy. OBJECTIVE: Primary: To evaluate the effectiveness of an app as an adjunct to medical advice to promote healthy living habits (sport and diet) to lose weight in a population of obese or overweight adult patients. MATERIAL AND METHODS: Open randomized controlled clinical trial with clinical practice (health advice for physical activity and sport). STUDY POPULATION: Obese or overweight adults patients of Araba aged between 18-45 years who be in Contemplation stage with smartphone. Variables: Primary endpoint: Weight (kg); Secondary variables: BMI (kg/cm2); blood pressure (mm Hg); heart rate; Plasma cholesterol (mg / dl); HbA1c; score on the satisfaction questionnaire; index of physical exercise (IPAQ) (METs); quitting tobacco (yes / no); Waist circumference (cm). Statistical analysis: The primary endpoint (weight reduction) will be evaluated by covariance analysis adjusting by baseline weight, and other confounding variables (sex, age, level of education..) Simple size: 48 patients by arm plus 20% to cover losses to follow.


Options:
A: Fat mass (0, 3, and 12 months); Energy intake (0, 3 months); Body weight (0, 3, 12 months); Insulin resistance (HOMA-IR) (0, 3, 12 months); Glucose levels (0, 3,12 months); Glucose variability (0, 3,12 months); Sleep assessment (0, 3,12 months); Adherence (0, 3,12 months)
B: Weight Change From Baseline to 24 Weeks (24 weeks)
C: weight reduction (at 6 months)
D: Change in Body Weight (Baseline to 12 months); Physical Activity-Active Minutes/Day (12 months); Physical Activity-Steps/Day (12 months); Food Frequency Questionnaire (FFQ) (12 months); Healthy Eating Index (HEI) (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Bakery Products for Non-Coeliac Gluten Sensitive Consumers
Brief Summary: The aim of the study is to produce a tolerable alternative to normal wheat bread which would be suitable for subjects with self-reported non-coeliac gluten sensitivity (NCGS). The bread would be made from wheat so, in contrast to gluten-free bread, would be more comparable to standard bread. To make this bread, the investigators will use advanced enzyme technology and/or novel formulations to target the digestion or removal of wheat proteins, which might be involved in the etiology of non-coeliac gluten sensitivity, preferentially over other those that are more useful for baking quality. The investigators will determine palatability and tolerance of this new product in a human cross-over, randomised, blind and placebo-controlled intervention study.

It has been estimated 6-10% of the population are sensitive to gluten who do not have coeliac disease (CD). Three breads will be produced and tested in this study against a suitable reference based on standard wheat flour and baking process


Options:
A: Small-bowel mucosal morphology and inflammation (One year)
B: Intestinal mucosal gluten-dependent immune response before and after a gluten-free diet (12 months)
C: Change in the presence and severity of overall and individual gastrointestinal symptoms (daily diary cards via a 100-mm VAS to score) (These will be assessed daily during baseline week (0), treatment week (1, 4, 7 and 10) and washout week (3, 6 and 9))
D: Identification of FODMAP intollerance in IBS subjects (4 weeks); Identification of NCGS in IBS subjects who responded to low FODMAPs diet (3 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient Decision Aid (PDA) for Antidepressant Use In Pregnancy
Brief Summary: The purpose of this pilot study is to examine the feasibility of conducting a multi-site randomized controlled trial whose aim will be to evaluate the effectiveness of a Patient Decision Aid (PDA) for antidepressant use in pregnancy.


Options:
A: Treatment Retention (3 months)
B: Recruitment Rate (Up to one year from when the study starts enrolling participants)
C: Veterans RAND-12 Mental Component Score (VR-12 MCS) (one year)
D: Shared Decision Making Questionnaire (CollaboRATE) (Level of Shared Decision Making at end of treatment (this will be at approximately week 8))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Noninvasive brain stimulations (NIBS) will be used in healthy volunteers and in chronic stroke patients to improve bimanual activities and motor learning.

Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying bimanual activities and motor learning in healthy volunteers and in chronic stroke patients.

A neuro-rehabilitation robot (REA2PLAN, AXINESIS, Louvain-la-Neuve, Belgium) will be used for motor learning.


Options:
A: Box and Block Test; Data Collected = Number of Blocks Moved (Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)); Fugl-Meyer Upper Extremity Motor Test (Baseline/pretest; posttest given between days 17-22 (posttest days 3 -8)); Fractionated Reaction Time (Baseline/pretest; posttest given between days 17-22 (posttest days 3-8))
B: bimanual coordination (up to 2 hours after intervention. Recall test at 1 week and up to,2,3,4 weeks after the intervention)
C: Change from baseline in walking abilities, balance and mobility in Six minutes walking test (6MWT) (1)A week prior to treatment beginning 2) the week after treatment end 3) three months follow up.)
D: Fugl Meyer Assessment (Upper extremity) of motor recovery following stroke (assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Noninvasive brain stimulations (NIBS) will be used in healthy volunteers and in chronic stroke patients to improve bimanual activities and motor learning.

Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying bimanual activities and motor learning in healthy volunteers and in chronic stroke patients.

A neuro-rehabilitation robot (REA2PLAN, AXINESIS, Louvain-la-Neuve, Belgium) will be used for motor learning.


Options:
A: bimanual coordination (up to 2 hours after intervention. Recall test at 1 week and up to,2,3,4 weeks after the intervention)
B: Change in Behavioural Inattention Test (BIT) (6 months post intervention)
C: JTT (crossover design, four different sessions with four different interventions)
D: Change of Fugl-Meyer assessment (FMA) score (Change from baseline in FMA score on the 3rd intervention day; change from baseline in FMA score at 1 week post intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Task Sharing for the Care of Severe Mental Disorders in a Low-income Country: a Randomised, Controlled Non-inferiority Trial
Brief Summary: Task sharing mental health care through integration of mental health into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries. In Ethiopia, it is estimated that only around 10% of people with severe mental disorders (SMDs) ever receive evidence-based treatment for their condition, largely due to scarcity of specialist mental health services. A task-sharing model of mental health care in PHC would be more affordable and accessible to the majority of persons with SMD who do not currently receive evidence-based mental health care. Furthermore, task sharing mental health care with PHC is about to be scaled up in Ethiopia in line with the National Mental Health Strategy. However, the effectiveness of the task sharing model of mental health care for people with SMD has not been evaluated systematically in a low-income country. In this study we propose to investigate non-inferiority of a task sharing model of mental health care in PHC compared to a less accessible, but more specialist, psychiatric nurse-led model of care. The specialist model of care has been demonstrated to be acceptable and associated with improved clinical outcomes for persons with SMD engaged in the service in Ethiopia thus making this an appropriate comparison model against which to evaluate non-inferiority of the task sharing model.


Options:
A: Systolic and Diastolic Blood Pressure (SBP, DBP) (24 months); Total Cholesterol (24 months); Physical Health-related Quality of Life Score (24 months)
B: Brief Psychiatric Rating Scale, Expanded Version (BPRS-E) (12 months post-randomisation (18 months for secondary outcome))
C: Reduction in symptoms of major depression (Measured at Months 12, 18, and 24)
D: Change in PTSD Symptom Severity (PDS) (Baseline, 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Task Sharing for the Care of Severe Mental Disorders in a Low-income Country: a Randomised, Controlled Non-inferiority Trial
Brief Summary: Task sharing mental health care through integration of mental health into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries. In Ethiopia, it is estimated that only around 10% of people with severe mental disorders (SMDs) ever receive evidence-based treatment for their condition, largely due to scarcity of specialist mental health services. A task-sharing model of mental health care in PHC would be more affordable and accessible to the majority of persons with SMD who do not currently receive evidence-based mental health care. Furthermore, task sharing mental health care with PHC is about to be scaled up in Ethiopia in line with the National Mental Health Strategy. However, the effectiveness of the task sharing model of mental health care for people with SMD has not been evaluated systematically in a low-income country. In this study we propose to investigate non-inferiority of a task sharing model of mental health care in PHC compared to a less accessible, but more specialist, psychiatric nurse-led model of care. The specialist model of care has been demonstrated to be acceptable and associated with improved clinical outcomes for persons with SMD engaged in the service in Ethiopia thus making this an appropriate comparison model against which to evaluate non-inferiority of the task sharing model.


Options:
A: Linear growth: Mean change from baseline in length-for-age Z-scores at at 9-, 12- and 15-months-old (Length-for-age Z-scores: Baseline (6 months-old), Month 9, Month 12 and Month 15)
B: Brief Psychiatric Rating Scale, Expanded Version (BPRS-E) (12 months post-randomisation (18 months for secondary outcome))
C: Absolute change pre/post intervention (VHV ICCM training) in proportion of U5s receiving (a) antimalarial for fever (b) ORS/Zn for diarrhea (c) Abx for pneumonia (pre- (Dec 2010) post- (Dec 2012) intervention (2 years))
D: Recovery Under the Integrated Program and the Standard Protocol (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Task Sharing for the Care of Severe Mental Disorders in a Low-income Country: a Randomised, Controlled Non-inferiority Trial
Brief Summary: Task sharing mental health care through integration of mental health into primary health care (PHC) is advocated as a means of narrowing the treatment gap for mental disorders in low-income countries. In Ethiopia, it is estimated that only around 10% of people with severe mental disorders (SMDs) ever receive evidence-based treatment for their condition, largely due to scarcity of specialist mental health services. A task-sharing model of mental health care in PHC would be more affordable and accessible to the majority of persons with SMD who do not currently receive evidence-based mental health care. Furthermore, task sharing mental health care with PHC is about to be scaled up in Ethiopia in line with the National Mental Health Strategy. However, the effectiveness of the task sharing model of mental health care for people with SMD has not been evaluated systematically in a low-income country. In this study we propose to investigate non-inferiority of a task sharing model of mental health care in PHC compared to a less accessible, but more specialist, psychiatric nurse-led model of care. The specialist model of care has been demonstrated to be acceptable and associated with improved clinical outcomes for persons with SMD engaged in the service in Ethiopia thus making this an appropriate comparison model against which to evaluate non-inferiority of the task sharing model.


Options:
A: Change of depression symptom from baseline at 3 and 6 months (0-3-6 months); Change of anxiety symptom from baseline at 3 and 6 months (0-3-6 months); Change of chronic pain symptom from baseline at 3 and 6 months (0-3-6 months); Change of anger from baseline at 3 and 6 months (0-3-6 months); Change of PTSD symptom from baseline at 3 and 6 months (0-3-6 months)
B: Brief Psychiatric Rating Scale, Expanded Version (BPRS-E) (12 months post-randomisation (18 months for secondary outcome))
C: the DCM intervention results in improved outcomes compared with CAU at both the provider (e.g., greater adherence to quality indicators) and patient levels (e.g., greater reduction in depressive symptoms) (16 weeks)
D: Load of traumatic symptoms measured via the CAPS (Clinician-administered PTSD scale) (3 months, 6 months and 1 year after completion of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Yoga for Health-related Quality of Life in Adult Cancer: A Randomized Controlled Feasibility Trial
Brief Summary: A feasibility study to determine the appropriateness of yoga intervention to improve health-related quality of life in adult cancer patients.


Options:
A: Recovery measured as physical recovery measured in questionnaire (4-6 weeks)
B: Feasibility of Patient Recruitment to Yoga Intervention (10 weeks)
C: Change in Cardiorespiratory fitness (pre-NACRT (baseline), post-NACRT (an average of 6 weeks))
D: Change in psychosocial status (from baseline to 24 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Assessing the Dose-response Relationship of FE 999049 in Controlled Ovarian Stimulation in Japanese Women Undergoing an Assisted Reproductive Technology Programme
Brief Summary: This trial investigates the effects of several doses of FE 999049 in Japanese women undergoing IVF/ICSI treatment.


Options:
A: Number of good-quality blastocysts on Day 5 after oocyte retrieval (On Day 5 after oocyte retrieval)
B: Number of patients obtaining 5-12 oocytes during COH (2 years)
C: Number of oocytes retrieved (End of stimulation (max 16 days after investigational medicinal product (IMP) start))
D: Number of metaphase II oocytes retrieved during the course of one treatment cycle (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Modifying Eating and Lifestyles at School (MEALS) Study
Brief Summary: The purpose of this study is to examine the impact of introducing healthier, chef-enhanced foods and/or environmental modifications (choice architecture) on selection and consumption of school foods among elementary and middle school students.


Options:
A: Change of Child Body Composition (Baseline to 6 months); Change Parent Body Composition (Baseline to 6 months)
B: Change in the selection of meal components (Selection of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation); Change in the consumption of meal components (consumption of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation)
C: Change in Body Mass Index (BMI) (Baseline to 24 months)
D: Overweight and obesity according to IOTF references (0-1-2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Modifying Eating and Lifestyles at School (MEALS) Study
Brief Summary: The purpose of this study is to examine the impact of introducing healthier, chef-enhanced foods and/or environmental modifications (choice architecture) on selection and consumption of school foods among elementary and middle school students.


Options:
A: Change in body weight from baseline (4 weeks)
B: Change in the selection of meal components (Selection of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation); Change in the consumption of meal components (consumption of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation)
C: Change of energy intake. (24 hours)
D: Visual Analogue Scale (Four hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Modifying Eating and Lifestyles at School (MEALS) Study
Brief Summary: The purpose of this study is to examine the impact of introducing healthier, chef-enhanced foods and/or environmental modifications (choice architecture) on selection and consumption of school foods among elementary and middle school students.


Options:
A: 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)
B: Change in the selection of meal components (Selection of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation); Change in the consumption of meal components (consumption of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation)
C: Number of Targeted Products Selected Relative to Others (up to 8 months)
D: Change of Child Body Composition (Baseline to 6 months); Change Parent Body Composition (Baseline to 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Explanatory Clinical Trial of a Novel Parent Intervention for Childhood Anxiety (SPACE)
Brief Summary: Childhood anxiety disorders are very common, carry tremendous personal and societal costs, frequently do not respond adequately to treatment, and involving parents in treatment has so far not enhanced outcomes. Explanatory clinical trials are needed to identify parent specific mechanisms of change that are not targeted in direct child treatment, and to identify markers of who is most likely to benefit from parent intervention. This study is an explanatory clinical trial of a parent based intervention and of cognitive behavioral therapy, and an investigation of biological and behavioral moderators of treatment response.


Options:
A: Clinical Global Impression - Improvement Scale (Measured at Week 12)
B: Clinical Global Impression Scale Improvement and Severity (After 12 weeks of treatment); Pediatric Anxiety Rating Scale (After 12 weeks of treatment)
C: Evidence of therapy effects on anxiety symptoms are established by assessments of clinical status, symptoms, affective style, sleep,parent-child interactions using rating scales, self-report measures, and behavioral observations. (16 weeks)
D: Changes in dental anxiety (3 months and 12 months from baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Double-blind, Dose-finding, Placebo-controlled Study to Assess the Safety and Efficacy of a Single Oral Administration of OBE001 to Improve Embryo Implantation Following IVF or ICSI
Brief Summary: The primary objective of this study is to assess the increase in clinical pregnancy rate after administration of a range of single oral doses of OBE001, an oral oxytocin antagonist, compared to placebo.


Options:
A: Live Birth (1 year)
B: EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat (about 6 weeks post ET day)
C: Intra-uterine pregnancy with fetal heart beat at 10 weeks (10 weeks post ET day)
D: implantation rate (4 weeks)

Answer: B