TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Omega-3 for Depression and Other Cardiac Risk Factors-2
Brief Summary: The purpose of this 10 week randomized, placebo-controlled, double-blind clinical trial is to determine whether antidepressant augmentation with two grams of EPA omega-3 per day is superior to antidepressant therapy alone for major depression in patients with coronary heart disease (CHD).


Options:
A: Beck Depression Inventory-II (BDI-II) (Change from baseline to 10 weeks (post-treatment))
B: Percentage of Participants with major depressive episode (for Study 1); Changes in Hamilton Depression Rating Scale (HDRS) (for Study 2) (Weeks 0 to 24)
C: Montgomery-Asberg Depression Rating Scale (MADRS) (baseline to 3 months)
D: Endpoint Hamilton Depression Rating Scale (HAMD) Scores Adjusted for Age, Sex, Treatment Site, and Baseline HAMD Scores. (Week 12); Endpoint Red Blood Cell/Plasma EPA Values Adjusted for Age, Sex, Treatment Site, and Baseline Red Blood Cell/Plasma EPA Values. (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Omega-3 for Depression and Other Cardiac Risk Factors-2
Brief Summary: The purpose of this 10 week randomized, placebo-controlled, double-blind clinical trial is to determine whether antidepressant augmentation with two grams of EPA omega-3 per day is superior to antidepressant therapy alone for major depression in patients with coronary heart disease (CHD).


Options:
A: Beck Depression Inventory-II (BDI-II) (Change from baseline to 10 weeks (post-treatment))
B: Major cardiovascular events, which comprises fatal cardiovascular diseases (CVD), non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal stroke and cardiac interventions (PCI and CABG) (monitored during intervention)
C: Absolute Composite Stress Score (Baseline; 12 weeks); Change From Baseline to 12 Weeks in Individual Scaled Scores (Baseline; 12 weeks)
D: Hamilton Depression Rating Scale (Measured at 16 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Web- and Mobile Phone-based Intervention to Prevent Obesity in 4-year-olds (MINISTOP): a Population-based Randomized Controlled Trial
Brief Summary: This study aims to evaluate the effects of a mobile phone-based dietary and physical activity intervention on body fatness, dietary intake and physical activity of preschoolers


Options:
A: Increase physical activity (2010); Increase the intake of fiber (2010); Decrease fat intake (2010); Decrease television and other screen time (2010); Decrease obesity (2010)
B: Body fat (At the end of the intervention and at a six month follow-up)
C: Change in intake of the target vegetable (Change in intake of the target vegetable from Baseline to day 14)
D: body mass index (three years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Web- and Mobile Phone-based Intervention to Prevent Obesity in 4-year-olds (MINISTOP): a Population-based Randomized Controlled Trial
Brief Summary: This study aims to evaluate the effects of a mobile phone-based dietary and physical activity intervention on body fatness, dietary intake and physical activity of preschoolers


Options:
A: Absolute change in mean accelerometry counts over 6 days (baseline, end of intervention, six months after end of intervention)
B: Body fat (At the end of the intervention and at a six month follow-up)
C: Change of BMI Z-score for preschoolers (Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up)
D: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Web- and Mobile Phone-based Intervention to Prevent Obesity in 4-year-olds (MINISTOP): a Population-based Randomized Controlled Trial
Brief Summary: This study aims to evaluate the effects of a mobile phone-based dietary and physical activity intervention on body fatness, dietary intake and physical activity of preschoolers


Options:
A: Body fat (At the end of the intervention and at a six month follow-up)
B: Infant weight for height (One year after study entry)
C: % Body Fat (Boys) (Baseline and 3 years); BMI Z-score (Boys) (Baseline and three years); % Body Fat (Girls) (Baseline and 3 years); BMI Z-score (Girls) (Baseline and three years)
D: Physical Activity Level (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Physical Literacy (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Dietary Intake (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Web- and Mobile Phone-based Intervention to Prevent Obesity in 4-year-olds (MINISTOP): a Population-based Randomized Controlled Trial
Brief Summary: This study aims to evaluate the effects of a mobile phone-based dietary and physical activity intervention on body fatness, dietary intake and physical activity of preschoolers


Options:
A: Change in body weight from baseline (4 weeks)
B: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)
C: Body fat (At the end of the intervention and at a six month follow-up)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Web- and Mobile Phone-based Intervention to Prevent Obesity in 4-year-olds (MINISTOP): a Population-based Randomized Controlled Trial
Brief Summary: This study aims to evaluate the effects of a mobile phone-based dietary and physical activity intervention on body fatness, dietary intake and physical activity of preschoolers


Options:
A: 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).)
B: 1-year, and 3-year changes from baseline in questionaires scores for knowledge, attitudes, and habits of children, parents and teachers in regards to a healthy lifestyle. (3 years)
C: Body fat (At the end of the intervention and at a six month follow-up)
D: Waist Circumference (5 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Web- and Mobile Phone-based Intervention to Prevent Obesity in 4-year-olds (MINISTOP): a Population-based Randomized Controlled Trial
Brief Summary: This study aims to evaluate the effects of a mobile phone-based dietary and physical activity intervention on body fatness, dietary intake and physical activity of preschoolers


Options:
A: 1-year, and 3-year changes from baseline in questionaires scores for knowledge, attitudes, and habits of children, parents and teachers in regards to a healthy lifestyle. (3 years)
B: Body fat (At the end of the intervention and at a six month follow-up)
C: Primary Outcome Measure: BMI (6 months, 1 year, 2 year, 5 year)
D: Body mass index (2005, 2006, 2007, 2008); nutrition behavior (2005, 2006, 2007, 2008); physical activity (2005, 2006, 2007, 2008)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Nutrition on the Microbiome in Pregnant Women and the Use of Micronutrient Supplemented Probiotic Yogurt to Improve Outcomes
Brief Summary: The purpose of this study is to determine whether a difference exists in the gut, oral, vaginal and human milk microbiome of under-nourished pregnant women as compared to healthy and obese pregnant women. In addition, the investigators are setting out to determine if a micronutrient enriched probiotic yogurt can improve the microbiome and pregnancy outcomes of under-nourished pregnant women.


Options:
A: Effect of VSL#3 probiotic administration on breast milk (2 months)
B: all cause mortality at three months of age (3 months); incidence and severity of necrotizing enterocolitis by Bell's staging at Three months (3 months); occurrence of bacterial or fungal infection per blood,csf or urine cultures at three months (3 months)
C: Characterization of gut, oral, vaginal and human milk microbiomes (Monthly for an average of four months)
D: Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts (Weekly during the first 6 months after birth)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II Randomized Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Antitumor Activity of Debio 1143 Combined With Concurrent Chemo-Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck.
Brief Summary: The use of multiple drugs in a single clinical trial or as a therapeutic strategy has become common, particularly in the treatment of cancer. Because traditional trials are designed to evaluate one agent at a time, the evaluation of therapies in combination requires specialized trial designs. In place of the traditional separate phase I and II trials, this trial uses a single phase I/II clinical trial to evaluate simultaneously the safety and efficacy of combination dose levels, and select the optimal combination dose.

Therefore, this is a two part trial of Debio 1143 combined with concurrent cisplatin and radiotherapy (CRT) in participants with previously untreated stage III, IVa or IVb head and neck cancer. The trial begins with an initial period of dose escalation (Phase I) to investigate the maximum tolerated dose (MTD) of Debio 1143 that can safely be given in combination with CRT.

Using the MTD determined in the Phase I portion, the randomized phase II trial in 94 participants compares Debio 1143 to placebo, both with concomitant CRT. The aim is to evaluate the efficacy and safety of Debio 1143.


Options:
A: Progression-free survival (From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months))
B: Overall survival after treatment with the test tri-therapy (TPF: docetaxel plus cisplatin and 5-FU) or the control treatment (PF: Cisplatin plus 5-FU) followed by chemoradiotherapy.
C: N/A
D: Phase II: Percentage of participants achieving Locoregional Control (LRC) at 18 months from the end of chemo-radiation therapy (CRT) (within 4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study
Brief Summary: To provide better care and preventive services for people with both depression and diabetes, the investigators propose to develop and test whether interventions to reduce depressive symptoms can be integrated into routine diabetes clinics in India. The investigators will gather feedback from patients in India through focus group discussions and individual interviews so they can culturally-adapt a model of combined depression and diabetes care. The investigators will then evaluate the effectiveness and costs of this care model in a trial at four diabetes clinics in India. It is expected that results from this study can guide how to incorporate mental health care into routine diabetes clinics in low-resource settings.


Options:
A: The proportion of participants who have a response to treatment when assessed by change in the symptoms of depressive symptoms measured by Beck Depression Inventory (0 months, 1 month, 6 months)
B: Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors (24-months post-intervention)
C: Change in scores on the Oxford Measure of Psychosocial Adjustment & World Health Organization Disability Assessment Schedule, 2.0 (WHODAS 2.0) (Administered at 4 timepoints: (1) baseline; (2) within 15 days of YRI completion; (3) 6 months post-YRI; (4) 12 months post-YRI)
D: Timeline Followback alcohol use (percent drinking days) (longitudinal alcohol use from baseline (past 30 days) to 9 month post-intervention follow up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between Standard and New Alternative Formats of the Summary-of-Findings Tables in Cochrane Review Users. A Non-inferiority Randomized Controlled Trial
Brief Summary: The investigators will conduct a parallel two-armed, non-inferiority randomized trial comparing new alternative formats of summary of findings tables (SoF) tables with current formats. The investigators will contact Cochrane review users by email and will ask them to fill a questionnaire developed using the "Survey Monkey" online system. The survey will include questions about baseline information (demographic characteristics, background, number of visits to the Cochrane Library, familiarity with the GRADE system, etc.). Then, participants will be stratified (health professional, guideline developer, researcher) and randomly assigned to one of the two SoF table formats, either the alternative (Table A) or the current one (Table C). Participants will be asked to answer questions to determine understanding, accessibility, and satisfaction with the formats to which they were randomized. Finally, the investigators will show them the table format to which they were not initially allocated in order to test their preference for either one.


Options:
A: Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4. (4 weeks post-treatment)
B: Understanding of key findings (30 minutes)
C: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) (Baseline and Week 4)
D: Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline (Week 4 follow-up visit)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between Standard and New Alternative Formats of the Summary-of-Findings Tables in Cochrane Review Users. A Non-inferiority Randomized Controlled Trial
Brief Summary: The investigators will conduct a parallel two-armed, non-inferiority randomized trial comparing new alternative formats of summary of findings tables (SoF) tables with current formats. The investigators will contact Cochrane review users by email and will ask them to fill a questionnaire developed using the "Survey Monkey" online system. The survey will include questions about baseline information (demographic characteristics, background, number of visits to the Cochrane Library, familiarity with the GRADE system, etc.). Then, participants will be stratified (health professional, guideline developer, researcher) and randomly assigned to one of the two SoF table formats, either the alternative (Table A) or the current one (Table C). Participants will be asked to answer questions to determine understanding, accessibility, and satisfaction with the formats to which they were randomized. Finally, the investigators will show them the table format to which they were not initially allocated in order to test their preference for either one.


Options:
A: Understanding of key findings (30 minutes)
B: nutritional status (9 months)
C: Dual Sugar Absorption Test (12 weeks); Dual Sugar Absorption Test (24 weeks)
D: Mean (± standard deviation) weight gain (kg) (from 12 to 24 months of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between Standard and New Alternative Formats of the Summary-of-Findings Tables in Cochrane Review Users. A Non-inferiority Randomized Controlled Trial
Brief Summary: The investigators will conduct a parallel two-armed, non-inferiority randomized trial comparing new alternative formats of summary of findings tables (SoF) tables with current formats. The investigators will contact Cochrane review users by email and will ask them to fill a questionnaire developed using the "Survey Monkey" online system. The survey will include questions about baseline information (demographic characteristics, background, number of visits to the Cochrane Library, familiarity with the GRADE system, etc.). Then, participants will be stratified (health professional, guideline developer, researcher) and randomly assigned to one of the two SoF table formats, either the alternative (Table A) or the current one (Table C). Participants will be asked to answer questions to determine understanding, accessibility, and satisfaction with the formats to which they were randomized. Finally, the investigators will show them the table format to which they were not initially allocated in order to test their preference for either one.


Options:
A: Severe Anemia
B: Change in weight in 2 years
C: nutritional status (9 months)
D: Understanding of key findings (30 minutes)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between Standard and New Alternative Formats of the Summary-of-Findings Tables in Cochrane Review Users. A Non-inferiority Randomized Controlled Trial
Brief Summary: The investigators will conduct a parallel two-armed, non-inferiority randomized trial comparing new alternative formats of summary of findings tables (SoF) tables with current formats. The investigators will contact Cochrane review users by email and will ask them to fill a questionnaire developed using the "Survey Monkey" online system. The survey will include questions about baseline information (demographic characteristics, background, number of visits to the Cochrane Library, familiarity with the GRADE system, etc.). Then, participants will be stratified (health professional, guideline developer, researcher) and randomly assigned to one of the two SoF table formats, either the alternative (Table A) or the current one (Table C). Participants will be asked to answer questions to determine understanding, accessibility, and satisfaction with the formats to which they were randomized. Finally, the investigators will show them the table format to which they were not initially allocated in order to test their preference for either one.


Options:
A: Prevalence of sexually transmitted infections measured in laboratory testing (Chlamydia, Gonorrhea, Syphilis, Trichomonas, Mycoplasma genitalium, HSV-2, HIV) (4, 8, and 12 months)
B: Understanding of key findings (30 minutes)
C: Number of Participants Completing Secondary School [Sit 10th Standard Exam] (May-August 2016 (cohort one) and May-August 2017 (cohort two)); Number of Participants Married [by Trial End Line] (May-August 2016 (cohort one) and May-August 2017 (cohort two))
D: Self-report of Ever Having Sexual Intercourse (24 months post-intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Alirocumab in Patients With Primary Hypercholesterolemia Not Treated With a Statin
Brief Summary: Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of Alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin lipid modifying background therapy or as monotherapy in comparison with placebo in participants with primary hypercholesterolemia not treated with a statin.

Secondary Objective:

* To evaluate the effects on other lipid parameters of Alirocumab 150 mg Q4W versus placebo.
* To evaluate the safety and tolerability of Alirocumab 150 mg Q4W.

Alirocumab 75 mg Q2W was added as a calibrator arm.


Options:
A: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis) (From Baseline to Week 24)
B: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis (From Baseline to Week 24)
C: Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization (Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.)
D: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis (From Baseline to Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Interactive Computer-assisted Screening for Mental Health in Primary Care
Brief Summary: The current protocol pertains to the evaluation of the interactive computer-assisted screening (iCAS) tool through a pilot randomized control trial. The purpose of this evaluation is to determine the efficacy of the iCAS tool in improving clinician's detection of common mental health conditions (i.e. major depression/generalized anxiety/post-traumatic stress disorder/alcohol dependence), and patients' discussion on mental health.


Options:
A: Implementation Status (up to 3 years); Any Drinking Days in Last 30 Days (6 months); Risky Drinking Days in the Last 30 Days (6 months); Illicit Drug-use Within the Last 30 Days (6 months); Overall Quality of Life (6 months); Physical Subscale Quality of Life (6 months); Mental Subscale Quality of Life (6 months); Patient Had Any Drink Within the Last 30 Days (6 months); Patient Had Illicit Drug Use Within the Last 30 Days (6 months); Patient Had Any Drink or Drug Use Within the Last 30 Days (6 months); Patients, Within the Last 6 Months Have Received Other Addiction Treatment (6 months); Patients Partook in HIV Risky Behavior in the Last 6 Months (6 months); Patients Partook in HIV Testing in the Last 6 Months (6 months)
B: Clinician Detection (probable, sub-clinical, confirmed) of major depression or generalized anxiety or post-traumatic stress disorder or alcohol dependence (Day 1); Patient discussion on mental health (Day 1)
C: Satisfaction with the health coach intervention as assessed by surveys (From enrollment until the end of the intervention at 36 weeks of gestation.); Satisfaction with the health coach intervention as assessed by phone interviews (From enrollment until the end of the intervention at 36 weeks of gestation.)
D: Acceptability and utility of the ProAsk intervention (12 months)

Answer: B