TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Family-Based Prevention of Mental Health Problems in HIV/AIDS-Affected Children (R34MH084679-01A1)
Brief Summary: The research will examine the following Specific Aims:

Specific Aim 1: To adapt a U.S.-developed family-focused and strengths-based prevention program to the context of HIV/AIDS-affected families in Rwanda (the Family-Strengthening Intervention in Rwanda or "FSI-R") using prior qualitative findings and CAB input.

Specific Aim 2: To deliver the intervention to a small group of families to collect preliminary data on intervention feasibility, acceptability, and to further refine the intervention manual for the FSI-R.

Specific Aim 3: To conduct a pilot feasibility study of the FSI-R with 80 families.

In pursuit of Specific Aim 3, this research will (a) conduct a preliminary exploratory analysis to examine the extent to which the FSI-R for HIV/AIDS-affected families is associated with improved caregiver-child relationships using measures of family connectedness, good parenting, and social support. Hypothesis 1: Participants in the FSI-R will demonstrate increases in protective processes compared to usual care controls not exposed to the FSI-R. It will also (b) conduct a preliminary exploratory analysis to determine the extent to which improved caregiver-child relationships are sustained four months after the conclusion of the FSI-R. Hypothesis 2: Four months after the conclusion of the intervention, participants in the FSI-R will demonstrate increases in protective processes compared to usual care controls not exposed to the FSI-R.


Options:
A: Implementation - Reach (From baseline to 6 months); Clinical Effectiveness - AUDIT (From baseline to 6 months)
B: Change from Baseline in Mental Health of Children and Caregivers (Administered to caregivers and school-aged children in each cohort three times: once within 15 days prior to the start of the intervention, once within 15 days of intervention completion, and again 4 months following intervention completion.)
C: Parenting Behavior Assessment (adapted from multiple scales for this context) (1 month); Parenting Self-Efficacy and Beliefs Assessment (adapted from other scales for this context; includes unique items developed for this context) (1 month); Child Behavior Assessment (items adapted from the Strengths and Difficulties Questionnaire) (1 month); Parent-Child Interaction Observation (1 month); Child Cognitive / Pre-Academic Abilities and Emotional Well-being (1 month)
D: Changes in thyroid morphology and thyroid function tests in morbidly obese patients following significant weight loss after bariatric surgery (> 3 month or when relevant weight loss has been achieved)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation Of Bupivacaine, EXPAREL®: A Phase 4 Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal
Brief Summary: This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospitalization costs.


Options:
A: Number of Subjects With Breast Implant Rupture (12 to 24 months post surgery)
B: Total Opioid Burden (Wound closure to time hospital discharge order written or Day 30, whichever is sooner); Health Economic Benefit (Wound closure to time hospital discharge order written or Day 30, whichever is sooner.)
C: Total Opioid Burden (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner); Health Economic Benefits (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.); Health Economic Benefit (Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.)
D: Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores (through 72 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 16-week, Randomized, Placebo-controlled, Double Blind, and Parallel Group Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease
Brief Summary: The objective of the Biopsy trial is to investigate the effect of roflumilast 500 µg tablets once daily versus placebo on inflammation parameters in bronchial biopsy tissue specimen and additional in sputum and blood serum. Also data on safety status will be obtained.

Patients to be included required to have moderate to severe COPD associated with chronic bronchitis. The total duration of this randomized, multicentre, phase III trial is 24 weeks maximum.


Options:
A: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 52 weeks of treatment); COPD Exacerbation Rate (Moderate or Severe) (52 weeks treatment period)
B: Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue. (16 weeks); Change in Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue (Baseline to 16 weeks)
C: change in FEV1 from baseline during the treatment period; number of COPD exacerbations.
D: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (Change from baseline over 24 weeks of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Respiratory Muscle Training and Respiratory Exercise in Exercise Tolerance, Performing Daily Life Activities and Quality of Life of Patients With COPD.
Brief Summary: In patients with chronic obstructive pulmonary disease (COPD) breaths at an abnormally high lung volume causes the inspiratory muscle to operate at non-optimal lengths, which reduce their maximal contractile forces. In addition, causes non thoraco abdominal synchronize, reduced inspiratory muscle strength and is associated with dyspnea and decreased exercise capacity. For these patients inspiratory muscle training (IMT) is a widely employed form of rehabilitation also targeting the respiratory muscle. In addition, patients often experience shortness of breath and a decline in exercise tolerance, resulting in disability in the performance of activities of daily living (ADL). The aims of this trial are to evaluate the effects of inspiratory muscle training associated with aerobic training on strength and endurance of inspiratory muscle, thoracic abdominal synchrony, exercise tolerance and quality of life patients with COPD. To compare the responses with the effects of aerobic training plus exercises of the trunk and upper limbs, and stretching of large muscle groups of the trunk. To compare difference in the perception of dyspnea during the ADL set (Borg Scale) with perception of dyspnea self-reported in the Medical Research Council (MRC), the London Chest Activity of Daily Living (LCADL) and the Pulmonary Functional Status and Dyspnea Questionnaire - Modified version (PFSDQ-M) before start the protocol. To investigate changes on perception of dyspnea (Borg scale), metabolic and ventilatory responses during a standard set of ADL tasks after a physical training and to evaluate and compare changes on perception of dyspnea. The hypothesis are that the ventilatory efficiency during the performance of ADL and the dyspnea reported from borg scale, the LCADL and the PFSDQ-M that quantifies the functional performance (change in activity levels) are improved during the IMT in conjunction with general exercise training in patients with COPD. The MIT increases the strength and endurance of inspiratory muscle, the exercise capacity and the quality of life compared to the general physical training. However, compared to the thorax abdominal synchronizes, higher modification is verified in the general physical training group with specific exercise to torso, limbs and stretching of the higher muscle group.


Options:
A: ventilator dependent status
B: Sustained Maximal Inspiratory Pressure (SMIP) (Change from baseline to 8 weeks and 24 weeks)
C: N/A
D: Change from baseline in dyspnea at 4th day (At baseline and at the 4th day of the study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Allopurinol Compared to Allopurinol Alone in Subjects With Gout Who Have Had an Inadequate Hypouricemic Response to Standard of Care Allopurinol.
Brief Summary: This study that compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who have had an inadequate response to allopurinol.


Options:
A: Reduction in serum uric acid levels (2 years)
B: Percentage of Participants With Primary Major Adverse Cardiovascular Events (MACE) Composite (75% Interim Analysis) (Up to last dose of study drug (approximately 83 months)); Percentage of Participants With Primary MACE Composite (Final Analysis) (Up to last dose of study drug (approximately 83 months))
C: Proportion of Subjects With an sUA Level That is < 6.0 mg/dL (6 Months, analysis after all subjects complete 12 months)
D: Plasma Uric Acid (PUA) Responder (Months 3 and 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Milnacipran for the Pain, Sensory Sensitization and Mood Changes in Knee Osteoarthritis
Brief Summary: The patients are asked to take part in this study because you have chronic pain as a result of knee osteoarthritis. This study is done to investigate the pain relieving effects of the study drug Savella (milnacipran HCl) for people who experience chronic osteoarthritis pain. The purpose of this research is to look at how the study drug can be used to benefit people who experience osteoarthritis knee pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug is already approved by the Food and Drug Administration for people with fibromyalgia but it has not yet been approved for people with knee osteoarthritis.


Options:
A: Brain Regional Gray Matter Density (2 weeks)
B: Change From Baseline in the Weekly Mean of the 24-Hour Average Pain Score at 8 Weeks (Baseline, 8 weeks (blinded endpoint))
C: McGill Pain Questionnaire - Short Form (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.); PamSys Actigraph Data (48 hours after visit 3); Pain Anxiety Symptoms Scale (PASS) (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.); Pain Disability Index (PDI) (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.); Center for Epidemiological Studies Depression Scale CESD-10 (CES-D 10) (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.); Pain Visual Analogue Scale (Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.)
D: Change in Brief Pain Inventory (BPI) 24-hour Average Rating (Baseline, Week 4, Week 7, Week 13)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinician Promotion of Healthy Diet and Activity to Reduce Obesity Among Adolescents
Brief Summary: This study will test an 18-month intervention designed to increase physical activity, reduce sedentary practices and promote healthy diets or reduce tobacco use and exposure among preteens who obtain orthodontic care. Relevance: If successful, this study may inform policies that would promote all specialists (orthodontists, physicians, general dentists) to deliver brief counseling for diet, physical activity, and tobacco prevention.


Options:
A: To assess the primary outcome of provider adherence to tobacco use treatment guidelines, we will conduct patient exit interviews with 80 smokers pre and post-intervention at each of the 18 study sites (2880 smokers pre and post). (prior to and approximately 12 months following each site's enrollment in the study); Compare the effectiveness of the three intervention arms on provider behavior for aiding patient's tobacco cessation (June 2013-June 2017)
B: Change in Body Mass Index (Baseline, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24 months)
C: Patient report (Within 3 days of the dental encounter)
D: Number of smokers referred to tobacco cessation website (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinician Promotion of Healthy Diet and Activity to Reduce Obesity Among Adolescents
Brief Summary: This study will test an 18-month intervention designed to increase physical activity, reduce sedentary practices and promote healthy diets or reduce tobacco use and exposure among preteens who obtain orthodontic care. Relevance: If successful, this study may inform policies that would promote all specialists (orthodontists, physicians, general dentists) to deliver brief counseling for diet, physical activity, and tobacco prevention.


Options:
A: Percent Body Fat (Baseline and One year)
B: Body mass index (Baseline-adjusted post-intervention scores at 4 months); C-reactive protein (Baseline-adjusted post-intervention scores at 4 months); Interleukin-6 (Baseline-adjusted post-intervention scores at 4 months); Total Cholesterol (Baseline-adjusted post-intervention scores at 4 months)
C: Change in Body Mass Index (Baseline, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24 months)
D: Change From Baseline in Percent Students Eating the School Breakfast Per School (Change from baseline (SY1) in average school year school-level breakfast participation at the end of one school year (SY2).)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Transition From Acute to Chronic Pain After Inguinal Hernia, Hysterectomy and Thoracotomy : Analysis of Risk Factors and Association With Genetic Polymorphisms
Brief Summary: The treatment of postoperative pain continues to be inadequate in the investigators practice setting.

Inadequate pain treatment not only contributes to postoperative complications in the short term but can also be a factor that favors the development of chronic postoperative pain and diminishes long-term quality of life. Risk factors that can lead to a transition to chronic pain need to be analyzed.


Options:
A: Evaluation of chronic postsurgical pain. (After 3 and 12 months of surgery.)
B: analgesic consumption of level 3 in the two treated groups (24 hours)
C: total morphine consumption (7 days after surgery)
D: Quality of recovery 40(QoR-40) score (24hours after operation day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Transition From Acute to Chronic Pain After Inguinal Hernia, Hysterectomy and Thoracotomy : Analysis of Risk Factors and Association With Genetic Polymorphisms
Brief Summary: The treatment of postoperative pain continues to be inadequate in the investigators practice setting.

Inadequate pain treatment not only contributes to postoperative complications in the short term but can also be a factor that favors the development of chronic postoperative pain and diminishes long-term quality of life. Risk factors that can lead to a transition to chronic pain need to be analyzed.


Options:
A: analgesic consumption of level 3 in the two treated groups (24 hours)
B: Evaluation of chronic postsurgical pain. (After 3 and 12 months of surgery.)
C: VAS and McGill PRI(R)2 scores for phantom and stump pain are recorded 48 and 24 hours before, and 4 and 10 days, 1 and 6 months after amputation. Phantom and stump pain intensity are the endpoints of the study. (six months)
D: occurrence of chronic pain (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Family Influences to Prevent Childhood Obesity: An Integrated Research and Outreach Program for Parents of Montana 4-H Youth
Brief Summary: The main goal of this project is to develop, deliver, and assess the efficacy of a parent-centered educational program (4-Health) designed to prevent preteen children from becoming overweight.


Options:
A: Change child body mass index z-score. (Baseline, end of program, 6 month follow up)
B: Waist circumference (10 months); BMI-Z score (10 months)
C: N/A
D: BMI percentile change (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double-blind, Placebo-controlled, Dose-ranging Phase II Study of APD421 for the Prevention of Post-operative Nausea and Vomiting
Brief Summary: To assess the efficacy and safety of different doses of APD421 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.


Options:
A: Incidence of Postoperative Nausea and Vomiting (postoperative 24 hours)
B: Painscore during mobilization (2-24 hours after extubation time.)
C: Pain 6 hours postoperatively (6 hours postoperatively); Pain 3 hours postoperatively (3 hours postoperatively); Pain 24 hours postoperatively (24 hours postoperatively); Pain (2-7 days postoperatively)
D: Post-operative Nausea or Vomiting (24 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Helicobacter Pylori Eradication on the New Tumor Development After Endoscopic Resection of Gastric Tumors
Brief Summary: The purpose of this study is to determine whether Helicobacter pylori eradication could reduce the new tumor development after endoscopic resection of gastric tumor.


Options:
A: Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of gastric tumor. (we set the time frame as at least three years.)
B: Helicobacter pylori eradication determined by 13C-urea breath test. (4-6 weeks following the completion of treatment)
C: Successful helicobacter eradication, change in premalignant gastric lesion, and change in gastric cancer incidence rate (12 years)
D: Gastric cancer mortality (15 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Febuxostat Compared to Febuxostat Alone at Lowering Serum Uric Acid and Resolving Tophi in Subjects With Tophaceous Gout
Brief Summary: This study will compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with febuxostat to febuxostat alone in patients with tophaceaous gout.


Options:
A: Percentage of Participants With Primary Major Adverse Cardiovascular Events (MACE) Composite (75% Interim Analysis) (Up to last dose of study drug (approximately 83 months)); Percentage of Participants With Primary MACE Composite (Final Analysis) (Up to last dose of study drug (approximately 83 months))
B: Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) (Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)); Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol. (Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)); Cohort 1 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%)) (Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)); Cohort 1 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%)) (Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)); Cohort 2 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) (Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)); Cohort 2 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol. (Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)); Cohort 2 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%)) (Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)); Cohort 2 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%)) (Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose))
C: Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6 (6 months, analysis after all subjects complete 12 months)
D: Reduction in serum uric acid levels (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b, Multicenter, Randomized, Double Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Short-Course Antimicrobial Therapy for Young Children With Acute Otitis Media (AOM) and Impact on Antimicrobial Resistance
Brief Summary: The investigators will study whether, in young children with acute otitis media (AOM), shortening length of antibiotic treatment as a strategy for reducing antimicrobial resistance provides satisfactory clinical outcome. This is a Phase 2b multicenter, randomized, double-blind, placebo-controlled clinical trial in 600 children aged 6 through 23 months comparing the efficacy of consistent reduced-duration antimicrobial treatment (5 days) with that of consistent standard-duration treatment (10 days) for each episode of AOM developing during a single respiratory season (October 1 through May 31).


Options:
A: The Distribution of Children Categorized as Treatment Failure (TF) at or Before the Day 12-14 End-of-Treatment Visit Specific to the Index Episode of AOM (From 72 hours after randomization until day 21 of the index episode. The mean day for this visit was 13.2.)
B: Body composition (4 months)
C: Evaluate the efficacy of fermented milk and rice administered daily for a total duration of 3 months on the appearance of common respiratory and gastrointestinal infections in schoolchildren aged between 12 and 48 months. (3 months)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Non-invasive Chromosomal Examination of Trisomy
Brief Summary: The purpose of this blinded, multi-center, prospective, case-controlled study is to compare the Ariosa Harmony™ Prenatal Test for trisomy 21 detection with a standard first-trimester prenatal screening test consisting of serum screening (PAPP-A,free beta-hCG \[β-hCG\] or total hCG) and a nuchal translucency (NT) measurement (i.e. combined first trimester screening) in a general screened population.

The performance characteristics of these two test modalities will be assessed relative to the clinical reference standard of genetic analysis of the fetus or phenotypic characterization and genetic analysis of the newborn.


Options:
A: Comparison of screen positive rates between investigational testing results and conventional screening results (standard of care). (12 months)
B: Classification of fetal status as affected or not affected for Trisomy 21 based on Artemis Health Test on maternal blood. (10 months)
C: The RNA study is an observational trial whose primary aim is to document the performance (sensitivity and specificity) of a laboratory developed test (LDT), using fetal nucleic acid in maternal plasma to identify Down syndrome in early pregnancy. (Within 1st and 2nd trimesters)
D: Difference in sensitivity and specificity of Ariosa Harmony™ Prenatal Test (AUCt) and combined first-trimester screening for detection of T21. (Enrollment to delivery)

Answer: D