TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Eating Behavior in Adolescents
Brief Summary: This study will explore the eating habits of adolescents and determine if eating behavior is linked to genetics.

Healthy adolescents between 13 and 17 years of age may be eligible for this study. Candidates come to the NIH Clinical Center at 8:00 AM to be screened with the following:

* Medical history and brief physical examination, including height, weight, and body fat measurements. Body fat is measured using a device called a Bod Pod. The adolescent sits inside the device for about 5 minutes and the machine determines body fat by measuring air movement. The adolescent must wear a tight-fitting swimsuit for this test.
* Urine test to look for sugar or protein in the urine and to test for pregnancy in females.
* Blood tests for routine chemistries and for gene studies related to eating behaviors.
* Questionnaires and interviews about the adolescent s general health and eating habits.
* Acclimatization to test meal conditions for the study. The adolescent is given a breakfast shake to drink.

Participants come to the NIH Clinical Center at 10:30 AM for laboratory meal testing. At this visit, the adolescent does the following:

* Eats food from a buffet of everyday foods that most kids eat.
* Fills out questionnaires.
* Tastes and rates the flavor of a variety of snack foods.


Options:
A: N/A
B: The primary outcome measure that will be used to test the study hypothesis is change in Body Mass Index (BMI). The mean change from baseline in individual BMIs between the two groups will be compared at two time-points; at week 52 and week 100.
C: Change in Body Mass Index (BMI) (3-month)
D: Change in BMI from baseline (18 months and 36 months); Change in Insulin resistance from baseline (3; 6; 9; 12; 15; 18; 24; 30 and 36 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 54 Week, Randomized, Double-blind, Parallel-group, Multicenter Study Evaluating the Long-term Gastrointestinal (GI) Safety and Tolerability of Aliskiren (300 mg) Compared to Ramipril (10 mg) in Patients With Essential Hypertension
Brief Summary: This study will evaluate the long-term gastrointestinal (GI) safety and efficacy of aliskiren (300 mg) compared to ramipril (10mg) in patients ≥ 50 years with essential hypertension.


Options:
A: To measure the tolerability and effectiveness of MK8141 in lowering 24-hour mean ambulatory blood pressure versus placebo after 4 weeks of treatment. (after 4 weeks of treatment)
B: Change from baseline in mean sitting diastolic blood pressure after 8 weeks
C: Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization (up to End of Study (78 months))
D: Percentage of Participants With Colonic Pathology (54 weeks); Summary of the End of Study Colonoscopy Results (54 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacist Intervention for Low-Literacy in Cardiovascular Disease
Brief Summary: Many people who have recently left the hospital have difficulties managing their medications, and medication errors are common. Patients with low health literacy levels may have a particularly difficult time understanding medication dosing and instructions. This study will evaluate a literacy-focused program that provides educational assistance from pharmacists at the time of hospital discharge to people hospitalized with heart problems.


Options:
A: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)
B: ADEs (Measured 30 and 90 days after hospital discharge); Medication appropriateness (Measured 30 and 90 days after hospital discharge by the Hanlon et al. Medication Appropriateness Index); Complications related to medications, including the number of hospital readmissions, unscheduled visits to emergency departments or urgent care facilities, and physician visits related to a medication problem or ADE (Measured 30 and 90 days after hospital discharge); Cost-effectiveness of the minimal or enhanced treatment compared to usual care (Measured 30 and 90 days after hospital discharge)
C: Improvement in proportion of quality indicators achieved, for target diseases as a most responsible or primary diagnosis, between groups. (in hospital)
D: The probability of developing medication errors over a certain period of time and recommendations to avoid such errors. (2 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacist Intervention for Low-Literacy in Cardiovascular Disease
Brief Summary: Many people who have recently left the hospital have difficulties managing their medications, and medication errors are common. Patients with low health literacy levels may have a particularly difficult time understanding medication dosing and instructions. This study will evaluate a literacy-focused program that provides educational assistance from pharmacists at the time of hospital discharge to people hospitalized with heart problems.


Options:
A: Readmissions (30 days); Admissions (180 days); Emergency Department Visits (180 days); Composite Endpoint, Admissions or Emergency Department Visits (180 days)
B: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)
C: Medication adherence assessment method (one month)
D: Cardiac Medication Use (3 and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacist Intervention for Low-Literacy in Cardiovascular Disease
Brief Summary: Many people who have recently left the hospital have difficulties managing their medications, and medication errors are common. Patients with low health literacy levels may have a particularly difficult time understanding medication dosing and instructions. This study will evaluate a literacy-focused program that provides educational assistance from pharmacists at the time of hospital discharge to people hospitalized with heart problems.


Options:
A: Mean Severity-weighted Admission Medication History (AMH) Error Score (Attempted to obtain the day after admission)
B: Effects on hospital visits (1 year)
C: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacist Intervention for Low-Literacy in Cardiovascular Disease
Brief Summary: Many people who have recently left the hospital have difficulties managing their medications, and medication errors are common. Patients with low health literacy levels may have a particularly difficult time understanding medication dosing and instructions. This study will evaluate a literacy-focused program that provides educational assistance from pharmacists at the time of hospital discharge to people hospitalized with heart problems.


Options:
A: Composite measure of proportion of patients at risk of an adverse event from specified prescribing. (Change in proportion of patients prescribed a high risk drug between baseline and 12 months after the intervention)
B: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)
C: Composite of readmission to hospital or death. (30 days after hospital discharge)
D: Medication adherence (One month after patients receive intervention materials)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacist Intervention for Low-Literacy in Cardiovascular Disease
Brief Summary: Many people who have recently left the hospital have difficulties managing their medications, and medication errors are common. Patients with low health literacy levels may have a particularly difficult time understanding medication dosing and instructions. This study will evaluate a literacy-focused program that provides educational assistance from pharmacists at the time of hospital discharge to people hospitalized with heart problems.


Options:
A: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)
B: Total Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge. (30 days after discharge)
C: Any Hospital Readmission (180-day from indexed hospital discharge)
D: Number of patients hospitalized due to COPD worsening (180 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacist Intervention for Low-Literacy in Cardiovascular Disease
Brief Summary: Many people who have recently left the hospital have difficulties managing their medications, and medication errors are common. Patients with low health literacy levels may have a particularly difficult time understanding medication dosing and instructions. This study will evaluate a literacy-focused program that provides educational assistance from pharmacists at the time of hospital discharge to people hospitalized with heart problems.


Options:
A: Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Including Hospitals at Least Statewide) (Hospitalization to a hospital or ED visit within 30 days of discharge (checking at least all same state facilities))
B: Improvement in proportion of quality indicators achieved, for target diseases as a most responsible or primary diagnosis, between groups. (in hospital)
C: Effects on hospital visits (1 year)
D: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacist Intervention for Low-Literacy in Cardiovascular Disease
Brief Summary: Many people who have recently left the hospital have difficulties managing their medications, and medication errors are common. Patients with low health literacy levels may have a particularly difficult time understanding medication dosing and instructions. This study will evaluate a literacy-focused program that provides educational assistance from pharmacists at the time of hospital discharge to people hospitalized with heart problems.


Options:
A: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)
B: Combined Emergency Department Visits and Inpatient Readmissions (30 days after discharge from hospital); Combined Emergency Department Visits and Inpatient Readmissions (90 days after discharge from hospital); Combined Emergency Department Visits and Inpatient Readmissions (180 days after discharge from hospital)
C: Hospital readmission rate (all cause) (90 days)
D: Total Number of Rehospitalizations (Emergency Department Visits Plus Hospital Admissions) in the 30 Days After Discharge. (30 days after discharge)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Manual and Manipulative Therapy for Low Back Pain in Military Active Duty Personnel: A Feasibility Study
Brief Summary: The specific aims of this research project are to determine feasibility of, and the comparative treatment effect size for, conducting a larger clinical trial of Manual/Manipulative Therapy (M/MT) in restoring peak performance in military personnel in operational environments and to evaluate the ability of the addition of M/MT to standard care to decrease pain and increase function for patients with low back pain.

The following two hypotheses will guide the data collection:

1. The primary hypothesis is that the addition of acourse of M/MT to standard care for low back pain will decrease pain at 4 weeks when compared to standard care alone
2. In addition, the secondary hypothesis will be that the addition of a course of M/MT to standard care for low back pain will decrease pain and increase function over 2 and 4 weeks when compared to standard care alone


Options:
A: SF-36, Roland Morris Disability Questionnaire, Quebec back pain disability (before intervention)
B: Percentage of Participants With Reduction in Pain Intensity (Baseline up to Day 29); Change From Baseline in Pain Intensity at Day 29 (Baseline and Day 29)
C: Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) (Baseline, Week 16)
D: Decreased pain (Baseline, 2 weeks, 4 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: MAPS (Men After Prostate Surgery) : Conservative Treatment for Men With Urinary Incontinence After Prostate Surgery; Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training and Biofeedback [MAPS]
Brief Summary: RATIONALE: Personalized training by a health professional may improve urinary incontinence. It is not yet known whether pelvic floor muscle training and biofeedback are more effective than standard therapy in improving urinary continence after radical prostatectomy or transurethral resection of the prostate.

PURPOSE: This randomized phase III trial is studying pelvic floor muscle training and biofeedback to see how well it works compared with standard therapy in men who have undergone radical prostatectomy or transurethral resection.


Options:
A: self reported continence (no need for wearing a pad)at 3 months (One year)
B: HRQOL urinary irritative score (12 month)
C: Subjective report of urinary continence at 12 months; Incremental cost per quality-adjusted year
D: Percent Change in Incontinence Episodes on Bladder Diary (2 months); Percent Change in Incontinence Episodes Per Week on Bladder Diary (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: MAPS (Men After Prostate Surgery) : Conservative Treatment for Men With Urinary Incontinence After Prostate Surgery; Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training and Biofeedback [MAPS]
Brief Summary: RATIONALE: Personalized training by a health professional may improve urinary incontinence. It is not yet known whether pelvic floor muscle training and biofeedback are more effective than standard therapy in improving urinary continence after radical prostatectomy or transurethral resection of the prostate.

PURPOSE: This randomized phase III trial is studying pelvic floor muscle training and biofeedback to see how well it works compared with standard therapy in men who have undergone radical prostatectomy or transurethral resection.


Options:
A: Recovery of urinary continence (postoperative 1 month)
B: Subjective report of urinary continence at 12 months; Incremental cost per quality-adjusted year
C: improves muscle strength of the pelvic floor at 3 months (baseline and 3 months)
D: Amount of Urinary Leakage (Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment); Frequency of Daily Urinary Leakage (Measured at baseline, 3 months after baseline, and then 6 months after the baseline assessment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Smoking Quit Line in the Military
Brief Summary: Rates of cigarette smoking in the military are high. Tobacco telephone quit lines are telephone-based services that provide information and guidance to people who want to quit smoking. This study will evaluate the effectiveness of a tobacco quit line program, in addition to nicotine replacement patches, at helping people in the military quit smoking cigarettes.


Options:
A: Smoking cessation (14 months post baseline)
B: Continuous Abstinence (Measured at Year 1)
C: 7-day point-prevalence abstinence at 2 weeks and 6 month follow-up
D: Whether the intervention increases the proportion of tobacco users (age 18 and older) who receive help within the domains of A3-5 (Assess, Assist, and/or Arrange) at the index office visit, as reported by exiting patients

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Novel Multimodal Intervention for Children With ADHD and Impaired Mood
Brief Summary: This study will evaluate the effectiveness of an integrative group psychosocial therapy combined with stimulant medication in treating children with attention deficit hyperactivity disorder plus impairments in mood.


Options:
A: Mood Severity Index Measures Severity of Mood Symptoms (MSI).Range of 0-116; Clinicians Give to Parents and Child to Get Composite Score; Higher Scores=Greater Severity; 0-10=no Symptoms, 11-20=Mild Symptoms, 21to 35 =Moderate Symptoms and >35 is Severe (measured at week 12 (endpoint))
B: Rule Violations During Direct Classroom Observation at Endpoint (Week 8) (Endpoint (Week 8))
C: N/A
D: Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMIV/V. (change from baseline on ADHD symptoms at 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Laparoscopic Surgery and Pentoxifylline Therapy for Treatment of Endometriosis-Associated Infertility: A Preliminary Study
Brief Summary: To prove efficacy of an immunomodulator called pentoxifylline in the treatment of endometriosis in infertile patients undergoing laparoscopy surgery


Options:
A: Number of ovulating patients (1-2 months)
B: Determine the cost-effectiveness of fast track to IVF versus conventional infertility treatment by conducting a randomized clinical trial to compare success rates and costs, as well as the associated complications of treatment. (at end of study)
C: Whole body insulin action (3 months)
D: Pregnancy rate (6 months follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Laparoscopic Surgery and Pentoxifylline Therapy for Treatment of Endometriosis-Associated Infertility: A Preliminary Study
Brief Summary: To prove efficacy of an immunomodulator called pentoxifylline in the treatment of endometriosis in infertile patients undergoing laparoscopy surgery


Options:
A: Determine the cost-effectiveness of fast track to IVF versus conventional infertility treatment by conducting a randomized clinical trial to compare success rates and costs, as well as the associated complications of treatment. (at end of study)
B: pregnancy rate (3 momths)
C: Pregnancy rate (6 months follow-up)
D: Number of ovulating patients (1-2 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Role of Pioglitazone and Berberine in Treatment of Non-alcoholic Fatty Liver Disease(NAFLD) Patients With Impaired Glucose Regulation or Type 2 Diabetes Mellitus
Brief Summary: The purpose of this study is to evaluate the effects and safety of pioglitazone and berberine on the basis of lifestyle intervention to non-alcoholic fatty liver disease patients with impaired glucose regulation or type 2 diabetes mellitus.


Options:
A: Improvement in hepatic histology (after 96 weeks of treatment)
B: To assess the efficacy of Silymarin as defined by an improvement in non-alcoholic steatosis (NAS) activity score by at least 30% from baseline compared to placebo (12 months)
C: Improved metabolic parameters(glucose, lipid, liver enzymes, etc.) (16 weeks)
D: Evaluate the effects of VSL#3 on metabolic, endocrine, lipidomic, metabolomic and inflammatory markers and microbiota variation of pediatric patients with BMI>90° (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Role of Pioglitazone and Berberine in Treatment of Non-alcoholic Fatty Liver Disease(NAFLD) Patients With Impaired Glucose Regulation or Type 2 Diabetes Mellitus
Brief Summary: The purpose of this study is to evaluate the effects and safety of pioglitazone and berberine on the basis of lifestyle intervention to non-alcoholic fatty liver disease patients with impaired glucose regulation or type 2 diabetes mellitus.


Options:
A: Improved metabolic parameters(glucose, lipid, liver enzymes, etc.) (16 weeks)
B: Liver histology (Kleiner criteria, Hepatology 2005) (6 months.)
C: Major Cardiovascular Events (5 years)
D: Hepatic Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) (baseline to 72 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Three-phase Study Designed to Test the Efficacy, Tolerability and Safety of the Combination of Ziprasidone With Selective Serotonin Reuptake Inhibitors (SSRI) for Patients With Major Depressive Disorder (MDD) That do Not Sufficiently Respond to Treatment With SSRIs.
Brief Summary: The purpose of this study is to see if adding the study drug, ziprasidone, to an antidepressant medication helps improve symptoms of Major Depressive Disorder (MDD). We are studying the drug's effectiveness in treating depression, as well as its safety when it is added to another drug.

Hypothesis A: There will be a difference in the percentage of responders in the two treatment conditions during phase 2; response rates will be higher for the ziprasidone group.


Options:
A: To test the hypothesis that the efficacy associated with direct switch from SSRI to duloxetine is non-inferior to start-taper switch
B: Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set (Baseline and Week 14); Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol (Baseline and Week 14)
C: The Primary Outcome Measure Will be Response Rates (50% Decrease in HAM-D-17 Scores) During Phase 2 (8 Weeks)
D: Percentage of Subjects Who Met Criteria for Remission Based on the Montgomery-Asberg Depression Rating Scale (MADRS) (12 weeks); Akathisia (12 weeks); Weight (Baseline through12 weeks); Parkinsonism (12weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Narrow Band Versus Conventional Endoscopic Imaging for Screening Colonoscopy in a Private Practice Setting - A Large Prospective Randomized Trial
Brief Summary: Narrow Band Imaging (NBI) with high-definition (HDTV) visualization has been implemented into GI endoscopy with the purpose to better highlight endoluminal pathological structures by improving their contrast. Previous studies from referral centers could not show significant differences in terms of colonoscopic adenoma detection rate, but either very high adenoma rates or some numerical differences suggested that some benefit may exist which may become evident with average adenoma rates and/or large case numbers.

In a prospective randomized trial performed exclusively in a multicenter private practice setting involving 6 examiners with substantial life-time experience (\>10.000 colonoscopies) 1200 patients will undergo HDTV screening colonoscopy with either NBI or conventional imaging technique on instrument withdrawal. Primary outcome measure is the adenoma detection rate (ADR; i.e. number of adenomas per patient).


Options:
A: 1. Compare the miss rate of standard white light imaging compared to NBI for detection of colon polyps with NBI (2 years)
B: adenoma detection rate (number of polyps/number of patients examined) (6 months)
C: adenoma detection rate for position 1 compared to position 2
D: The primary outcome is whether the patient is a responder or not after 8 weeks treatment.; The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.; The patient will judge their symptoms of pain or burning centered in the upper abdomen on a four-graded scale (none, mild, moderate or severe).

Answer: B