TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Partnering With Media and Vaccination Program to Improve Infant and Young Child Feeding
Brief Summary: Infant and young child feeding (IYCF) is a key determinant of under-nutrition and overweight in young children. In Mexico, breastfeeding extends well into the second half of infancy, but animal-source foods, cereals, and legumes are not regularly provided to the child by 9 mo. This study evaluates whether knowledge and practices about dietary diversity and food consistency can be improved using a two-component intervention strategy in semi-urban communities in Mexico. The two components will deliver appropriate complementary feeding messages using: (a) nurses during the 1st National Vaccination Week (NVW); and (b) radio messages and interviews. The intervention is evaluated using a cluster randomized design in small semi-urban communities in two states in Mexico with pre- and post-test questionnaires designed to assess changes in feeding behaviors.


Options:
A: BMI and aerobic fitness (1 schoolyear)
B: BMI variation from baseline (12 months)
C: Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment (0, 3 months); Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment (0, 3 months); Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment (0, 3 month)
D: Provision of flesh-food or vitamin A-rich food (Change from baseline to 5 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Partnering With Media and Vaccination Program to Improve Infant and Young Child Feeding
Brief Summary: Infant and young child feeding (IYCF) is a key determinant of under-nutrition and overweight in young children. In Mexico, breastfeeding extends well into the second half of infancy, but animal-source foods, cereals, and legumes are not regularly provided to the child by 9 mo. This study evaluates whether knowledge and practices about dietary diversity and food consistency can be improved using a two-component intervention strategy in semi-urban communities in Mexico. The two components will deliver appropriate complementary feeding messages using: (a) nurses during the 1st National Vaccination Week (NVW); and (b) radio messages and interviews. The intervention is evaluated using a cluster randomized design in small semi-urban communities in two states in Mexico with pre- and post-test questionnaires designed to assess changes in feeding behaviors.


Options:
A: Food intake (1 month)
B: Change in child's fruit and vegetable intake as measured by short dietary screener (Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up); Change in child's fruit and vegetable intake as measured by 24-hour dietary recall (Baseline to 4 months, 16-month follow-up, and 28-month follow-up); Change in child's intake of sugar-sweetened beverages and processed snacks as measured by short dietary questionnaire (Baseline to 4 months, 12-month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up); Change in child's intake of sugar-sweetened beverages and processed snacks as measured by 24-hour dietary recall (Baseline to 4 months, 16-month follow-up, and 28-month follow-up); Change in child's caloric intake as a percent of estimated energy requirements (Baseline to 4 months, 16-month follow-up, and 28-month follow-up); Change in child's dermal carotenoid levels (Baseline to 4 months, 16-month follow-up, and 28-month follow-up); Change in child's diet quality (Baseline to 4 months, 16-month follow-up, and 28-month follow-up)
C: Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds. (baseline, 8 months and 14 months)
D: Provision of flesh-food or vitamin A-rich food (Change from baseline to 5 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Partnering With Media and Vaccination Program to Improve Infant and Young Child Feeding
Brief Summary: Infant and young child feeding (IYCF) is a key determinant of under-nutrition and overweight in young children. In Mexico, breastfeeding extends well into the second half of infancy, but animal-source foods, cereals, and legumes are not regularly provided to the child by 9 mo. This study evaluates whether knowledge and practices about dietary diversity and food consistency can be improved using a two-component intervention strategy in semi-urban communities in Mexico. The two components will deliver appropriate complementary feeding messages using: (a) nurses during the 1st National Vaccination Week (NVW); and (b) radio messages and interviews. The intervention is evaluated using a cluster randomized design in small semi-urban communities in two states in Mexico with pre- and post-test questionnaires designed to assess changes in feeding behaviors.


Options:
A: Stunting in Children at 18 mo (18 months of age)
B: Intake of nutrients; Serum lipid and lipoprotein concentrations; Growth and development; Smoking; Physical activity level and fitness; Intima-media thickness of arteries and rate of NO-induced vasodilatation
C: Provision of flesh-food or vitamin A-rich food (Change from baseline to 5 months)
D: Vitamin D plasma concentrations (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Partnering With Media and Vaccination Program to Improve Infant and Young Child Feeding
Brief Summary: Infant and young child feeding (IYCF) is a key determinant of under-nutrition and overweight in young children. In Mexico, breastfeeding extends well into the second half of infancy, but animal-source foods, cereals, and legumes are not regularly provided to the child by 9 mo. This study evaluates whether knowledge and practices about dietary diversity and food consistency can be improved using a two-component intervention strategy in semi-urban communities in Mexico. The two components will deliver appropriate complementary feeding messages using: (a) nurses during the 1st National Vaccination Week (NVW); and (b) radio messages and interviews. The intervention is evaluated using a cluster randomized design in small semi-urban communities in two states in Mexico with pre- and post-test questionnaires designed to assess changes in feeding behaviors.


Options:
A: Growth trajectories (using BMI, waist circumference), body composition (3 months)
B: Increase physical activity (2010); Increase the intake of fiber (2010); Decrease fat intake (2010); Decrease television and other screen time (2010); Decrease obesity (2010)
C: Change in child's fruit and vegetable intake as measured by short dietary screener (Baseline to 4 months, 12 month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up); Change in child's fruit and vegetable intake as measured by 24-hour dietary recall (Baseline to 4 months, 16-month follow-up, and 28-month follow-up); Change in child's intake of sugar-sweetened beverages and processed snacks as measured by short dietary questionnaire (Baseline to 4 months, 12-month follow-up, 16-month follow-up, 24-month follow-up, and 28-month follow-up); Change in child's intake of sugar-sweetened beverages and processed snacks as measured by 24-hour dietary recall (Baseline to 4 months, 16-month follow-up, and 28-month follow-up); Change in child's caloric intake as a percent of estimated energy requirements (Baseline to 4 months, 16-month follow-up, and 28-month follow-up); Change in child's dermal carotenoid levels (Baseline to 4 months, 16-month follow-up, and 28-month follow-up); Change in child's diet quality (Baseline to 4 months, 16-month follow-up, and 28-month follow-up)
D: Provision of flesh-food or vitamin A-rich food (Change from baseline to 5 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Placebo-Controlled, Parallel-group, Double-Blind, Dose Response Finding Clinical Trial to Study the Efficacy and Safety of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance Who Have Inadequate Glycemic Control on Diet/Exercise Therapy
Brief Summary: This study is being done to evaluate the safety, efficacy, and dose level of sitagliptin (MK-0431/ONO-5435) used once daily (qd) in Japanese participants with impaired glucose tolerance who have inadequate glycemic control using diet and exercise therapy.


Options:
A: Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for Meal Tolerance Test (MTT) at Week 8 (Baseline (Week 0) and Week 8); Percentage of Participants Who Experienced One or More Adverse Events (AEs) (Up to 10 weeks); Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE) (Up to 8 weeks)
B: Triglyceride concentration in serum (Before and up to 8-hours post-injection)
C: Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism (120 minutes after exenatide or placebo injection)
D: Change in Weight Reported at 14 Weeks (Baseline and 14 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 157 in Subjects With Mild Atopic Asthma
Brief Summary: The purpose of this study is to assess the late and early asthmatic response after an allergen inhalation challenge in adults with mild atopic asthma after receiving multiple doses of tezepelumab (AMG 157), as well as the safety, tolerability, immunogenicity, and pharmacokinetics of multiple doses of tezepelumab in adults with mild atopic asthma.


Options:
A: Maximum Percentage Decrease in Forced Expiratory Volume in 1 Second (FEV1) at 3 to 7 Hours Post Allergen Challenge (Days 42 and 84 at pre-allergen challenge and at 180, 240, 300, 360, and 420 minutes (3-7 hours) post allergen challenge); Time-Adjusted Area Under the Curve for the Percent Decrease From Pre-Allergen Challenge in Forced Expiratory Volume in 1 Second (FEV1) From 3 to 7 Hours Post Allergen Challenge (Days 42 and 84 at pre-challenge and at 180, 240, 300, 360, and 420 minutes (3-7 hours) post challenge)
B: Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions (From Baseline visit until the follow-up visit (approximately [approx.] week 60 [12 weeks post-last dose]))
C: adenosine, PC20, forced expiratory volume in one second (FEV1)
D: Rate of protocol-defined asthma exacerbations (new or increased asthma symptoms that lead to treatment with systemic corticosteroids or to hospitalization) from baseline to Week 36 (36 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mid-and Long-term Efficacy of Ventilation Non-invasive and Continuos Positive Airway Pressure in Obesity Hypoventilation Syndrome
Brief Summary: Primary objectives: evaluate the efficacy of noninvasive ventilation (NIV) treatment versus continuous positive airway pressure (CPAP) and life style modification treatment in Obesity Hypoventilation Syndrome (OHS), with PCO2 (first phase) and days of hospitalization (second phase) analyzed as a primary variables and percentage of dropouts for medical reasons and mortality as operative variables. As secondary variables: Measure functional and clinical improvement during sleep and wakefulness, quality of life, echocardiography and the incidence and blood pressure and evolution of cardiovascular events. Objectives secondaries:role of apneogenic sleep events on molecular inflammation, endothelial damage and the genesis of diurnal hypercapnia. Methods:prospective, randomized controlled trial. Patients with OHS will be divided initially into two groups based on their apnea-hypopnea index (AHI) score, \>=30 and \< 30, using conventional polysomnography. The AHI \>=30 group will be randomized to CPAP, NIV or life style modification treatments. The AHI \<=30 groups will be randomized to NIV or life style modification treatments. Treatment efficacy at the medium- and long-term will be analyzed by comparing groups. The role of apneic events and leptin in the genesis of daytime alveolar hypoventilation will be analyzed by comparing the daytime PCO2/AHI coefficient between responders and non-responders to CPAP treatment, and the evolution of leptin levels in the four branches of the study. The role of apneic events in metabolic and biochemical alterations and endothelial dysfunction will be analyzed by comparing basal and post-treatment levels of related substances between groups, with and without significant AHI.


Options:
A: A composite of the CV endpoints of CV death, non-fatal acute myocardial infarction, non-fatal stroke, hospital admission for heart failure, and new hospitalisation for unstable angina or transient ischaemic attack. (Reviewed 6-monthly; average patient follow up, 4.5 years)
B: Days of hospitalization (at least three years); PaCO2 (at the end of first two months)
C: Apnea-Hypopnea Index (Baseline and 180 Days)
D: proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group after 90 days of treatment during the investigation. (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: RCT Evaluation of the Durham Connects Universal Newborn Nurse Home Visiting Program
Brief Summary: The aim of this randomized controlled trial (RCT) is to evaluate the impact and mechanisms of the Durham Connects (DC) brief universal nurse home-visiting program to prevent child maltreatment and improve child well-being. It is the first-ever RCT of a home-visiting program that is designed to prevent child maltreatment in an entire community population.

Evaluation of program impact will test three hypotheses: 1) Random assignment to the Durham Connects Program will be associated with lower rates of child maltreatment and emergency department maltreatment-related injuries, better pediatric care, better parental functioning, and better child well-being than assignment as control; 2) Intervention effect sizes will be larger for higher-risk groups; and 3) Community resource use and enhanced family functioning will mediate the positive impact of Durham Connects on outcomes.


Options:
A: DSS Investigated and Substantiated Child Maltreatment Rates (0 - 12 Years of Child Age)
B: DSS Investigated and Substantiated Child Maltreatment Rates (0 - 12 Years of Child Age)
C: maternal-infant interaction (12 months)
D: Attendance at one or more routine postpartum visits (8 weeks postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Trial Comparing Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer (XParTS II)
Brief Summary: The aim of this study is to elucidate the efficacy and safety of XP and SP for first-line treatment of Advanced Gastric Cancer.


Options:
A: Recurrence of the original cancer (From the beginning to end of the study); Development of a new gastric cancer (From beginning to end of study); Death due to any cause (From the beginning to the end of study); Adverse events (From beginning to end of study); Clinical laboratory tests (From beginning to end of study)
B: Overall survival (every course for first three courses, then every other course)
C: median survival
D: Progression-free survival rate (at 24weeks from patient enrollment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Remote Ischemic Preconditioning in Patients Undergoing On-pump Coronary Artery Bypass Graft Surgery With Crystalloid Cardioplegic Arrest
Brief Summary: Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion reduces myocardial injury in patients undergoing on-pump coronary artery bypass (CABG) surgery with cross-clamp fibrillation or blood cardioplegia for myocardial protection. The present study assesses protection of heart, brain and kidney by RIPC under crystalloid cardioplegic arrest. The study also addresses safety and clinical outcome.


Options:
A: Major adverse cardiac and cerebral events (One year post-surgery)
B: Troponin T area under the curve (72 hours)
C: Perioperative extent of myocardial injury as measured by cardiac troponin I serum release over 72 hours after CABG surgery and its area under the curve (AUC). (72 hours postoperatively after CABG surgery)
D: In-hospital death (Postoperative 30 days); Myocardial infarction (Postoperative 30 days); Stroke (Postoperative 30 days); Respiratory failure (Postoperative 30 days); Renal dysfunction (Postoperative 30 days); Renal failure (Postoperative 30 days); Cardiogenic shock (Postoperative 30 days); Gastrointestinal complication (Postoperative 30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Remote Ischemic Preconditioning in Patients Undergoing On-pump Coronary Artery Bypass Graft Surgery With Crystalloid Cardioplegic Arrest
Brief Summary: Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion reduces myocardial injury in patients undergoing on-pump coronary artery bypass (CABG) surgery with cross-clamp fibrillation or blood cardioplegia for myocardial protection. The present study assesses protection of heart, brain and kidney by RIPC under crystalloid cardioplegic arrest. The study also addresses safety and clinical outcome.


Options:
A: postoperative serum troponin I levels (postoperatibe 1, 6, 12, 24, 48, 72 hr)
B: Decrease of tissue oxygen saturation below 95 % of baseline (4 hours)
C: Perioperative extent of myocardial injury as measured by cardiac troponin I serum release over 72 hours after CABG surgery and its area under the curve (AUC). (72 hours postoperatively after CABG surgery)
D: Myocardial injury after PCI. (24 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of NBP for Children of Divorce 15 Years Later
Brief Summary: The project is a 15-year follow-up of 240 young adults whose families participated in an experimental evaluation of the New Beginnings Program (NBP), a preventive intervention for divorced families. The NBP was provided in late childhood; the follow-up occurred in young adulthood. Families were randomly assigned to one of three conditions: mother program (MP), dual-component mother and child program (MPCP), or literature-control (LC) condition. Programs were designed to change several putative mediators of children's post-divorce mental health problems using empirically-supported change strategies. The investigators expected that the NBP would have either main or risk by program interactive effects on mental health and substance use problems and disorders, developmental tasks, parent-young adult relationships, physical health problems, and competencies, such that YAs who participated in NBP will have better functioning than YAs in the control condition. The investigators expected that the NBP will have either main or risk by program interactive effects on mothers' mental health; those in the NBP are expected to have fewer mental health problems than those in the control condition.


Options:
A: Diagnosis of mental health disorder (15 year follow-up)
B: Self-reported drunkenness (12 months); Self-reported drunkenness (30 months)
C: Substance use will be assessed using items extracted from the Monitoring the Future Study. (Three years); Adolescent unsafe sexual behavior will be measured using Jemmott, Jemmott, and Fong's (1998) 37-item Sexual Behavior instrument. (Three years)
D: Drug use frequency and quantity at 1-, 3- and 12-months post-intervention. (1 year post treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of NBP for Children of Divorce 15 Years Later
Brief Summary: The project is a 15-year follow-up of 240 young adults whose families participated in an experimental evaluation of the New Beginnings Program (NBP), a preventive intervention for divorced families. The NBP was provided in late childhood; the follow-up occurred in young adulthood. Families were randomly assigned to one of three conditions: mother program (MP), dual-component mother and child program (MPCP), or literature-control (LC) condition. Programs were designed to change several putative mediators of children's post-divorce mental health problems using empirically-supported change strategies. The investigators expected that the NBP would have either main or risk by program interactive effects on mental health and substance use problems and disorders, developmental tasks, parent-young adult relationships, physical health problems, and competencies, such that YAs who participated in NBP will have better functioning than YAs in the control condition. The investigators expected that the NBP will have either main or risk by program interactive effects on mothers' mental health; those in the NBP are expected to have fewer mental health problems than those in the control condition.


Options:
A: rates of pregnancy and out-of-wedlock child birth (At age 19); educational achievement, including graduation from high school and participation in various types of post-high school education (At age 19); participation in the work force, including enrollment in the armed services (At age 19); use of welfare (At age 19); use of substances (cigarettes, alcohol, and illegal drugs) (At age 19); involvement with the criminal justice system (arrests, convictions, incarcerations, etc.) (At age 19)
B: Time to onset and severity of drug use (2 years); Frequency and Quantity of Drinking (2 years); Problem drinking symptoms (2 years)
C: Efficacy of Motivation and Problem Solving (MAPS) in Cancer Risk Reduction (6 months)
D: Diagnosis of mental health disorder (15 year follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of NBP for Children of Divorce 15 Years Later
Brief Summary: The project is a 15-year follow-up of 240 young adults whose families participated in an experimental evaluation of the New Beginnings Program (NBP), a preventive intervention for divorced families. The NBP was provided in late childhood; the follow-up occurred in young adulthood. Families were randomly assigned to one of three conditions: mother program (MP), dual-component mother and child program (MPCP), or literature-control (LC) condition. Programs were designed to change several putative mediators of children's post-divorce mental health problems using empirically-supported change strategies. The investigators expected that the NBP would have either main or risk by program interactive effects on mental health and substance use problems and disorders, developmental tasks, parent-young adult relationships, physical health problems, and competencies, such that YAs who participated in NBP will have better functioning than YAs in the control condition. The investigators expected that the NBP will have either main or risk by program interactive effects on mothers' mental health; those in the NBP are expected to have fewer mental health problems than those in the control condition.


Options:
A: Presence or absence of a depressive episode (child) (T4 (9 months after completion of the programme))
B: Diagnosis of mental health disorder (15 year follow-up)
C: Onset of a probable or definite depressive episodes (i.e., Depression Symptom Rating greater or equal to 4) (Time to a score of 4 or higher between baseline and 9 months using survival analysis)
D: use of Internet site (2 months)

Answer: B