TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-Week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components Delivered Once Daily (AM) Via a Novel Dry Powder Inhaler Compared With Placebo in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The Purpose of this study is to assess the efficacy and safety of two strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)


Options:
A: Standardized Dyspnea Score at Isotime During Exercise (2 Weeks)
B: Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours (h) Post-dose at Day 168 (Baseline (BL) to Day 168); Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169 (Baseline to Day 169)
C: All cause mortality at 3 years
D: Change in Lung Function (FEV1) (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A RCT to Test the Effectiveness of a Telephone Intervention to Improve the Mental Health of Community Dwelling Women Abused by Their Intimate Partners
Brief Summary: The purpose of this study is to determine if a telephone social support and empowerment intervention is more effective than usual community services in improving the mental health of community-dwelling women abused by their intimate partners.


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: Child Developmental Outcomes (Month 11/Endline after end of Phase 1's 16 biweekly sessions (Arm 1 with & without fathers, Arm 2 with and without fathers, and Arm 3). Arms A and B created after the Month 11/Endline survey.); Child Developmental Outcomes (Month 35-37/Follow-Up survey (Arms 3, A and B), two years after end of Phase 1's 16 biweekly sessions); Parenting Practices (HOME Observation for Measurement of the Environment - HOME) (Month 11/Endline survey (Arm 1 with and without fathers, Arm 2 with and without Fathers, Arm 3).); Parenting Practices (HOME Observation for Measurement of the Environment - HOME) (Month 35-37 Follow-up Survey (Arms 3, A and B).)
C: Eyberg Child Behavior Inventory (Baseline, post- intervention and 12-month post-intervention follow-up); Parenting Young Children Scale (Supporting Positive Behaviour subscale; Setting Limits subscale) (Baseline, post- intervention and 12-month post-intervention follow-up); Sinovuyo Observational Coding System (Baseline, post- intervention and 12-month post-intervention follow-up)
D: depression (On completion of intervention and six months post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A RCT to Test the Effectiveness of a Telephone Intervention to Improve the Mental Health of Community Dwelling Women Abused by Their Intimate Partners
Brief Summary: The purpose of this study is to determine if a telephone social support and empowerment intervention is more effective than usual community services in improving the mental health of community-dwelling women abused by their intimate partners.


Options:
A: Depression (10-16 weeks); Posttraumatic Stress Symptoms (10-16 weeks)
B: Reduction in Post-traumatic Stress Reaction Symptoms Among Participants (1-week before intervention, 3-weeks later)
C: PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS) (4 & 9 months after completion of treatment)
D: depression (On completion of intervention and six months post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A RCT to Test the Effectiveness of a Telephone Intervention to Improve the Mental Health of Community Dwelling Women Abused by Their Intimate Partners
Brief Summary: The purpose of this study is to determine if a telephone social support and empowerment intervention is more effective than usual community services in improving the mental health of community-dwelling women abused by their intimate partners.


Options:
A: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
B: depression (On completion of intervention and six months post-intervention)
C: Discussion-opportunity about risk of partner abuse during physician-patient medical encounter (audiotaped data); Detection of partner abuse during physician-patient medical encounter (audio taped data)
D: Intimate partner violence (One year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A RCT to Test the Effectiveness of a Telephone Intervention to Improve the Mental Health of Community Dwelling Women Abused by Their Intimate Partners
Brief Summary: The purpose of this study is to determine if a telephone social support and empowerment intervention is more effective than usual community services in improving the mental health of community-dwelling women abused by their intimate partners.


Options:
A: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)
B: depression (On completion of intervention and six months post-intervention)
C: Change from baseline in WHO Quality of Life-BREF at 6, 12, 18, and 24 months (Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
D: condom use (4.5 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A RCT to Test the Effectiveness of a Telephone Intervention to Improve the Mental Health of Community Dwelling Women Abused by Their Intimate Partners
Brief Summary: The purpose of this study is to determine if a telephone social support and empowerment intervention is more effective than usual community services in improving the mental health of community-dwelling women abused by their intimate partners.


Options:
A: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
B: Severity of Violence Against Women (6 months); Women's Experience with Battering (6 months); Safety Behavior Checklist (6 months); Decisional Conflict Scale (6 months)
C: condom use (4.5 months)
D: depression (On completion of intervention and six months post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A RCT to Test the Effectiveness of a Telephone Intervention to Improve the Mental Health of Community Dwelling Women Abused by Their Intimate Partners
Brief Summary: The purpose of this study is to determine if a telephone social support and empowerment intervention is more effective than usual community services in improving the mental health of community-dwelling women abused by their intimate partners.


Options:
A: Change in alcohol consumption Score as assessed by the AUDIT-C tool . (6 months)
B: Number of Participants With Combined Common Mental Disorders (CMDs, i.e. Anxiety and Depression). (6 weeks postpartum)
C: depression (On completion of intervention and six months post-intervention)
D: Remission (i.e. recovery from depression) (6 months post child birth)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of Dietary Prevention of Type 1 Diabetes Associated Beta-cell Autoimmunity in Children at Genetic Risk
Brief Summary: The purpose of this study is to determine whether weaning to whey-based hydrolysed formula or essentially bovine insulin free whey-based FINDIA formula instead of standard cow's milk based formula is effective in the prevention of type 1 diabetes associated beta-cell autoimmunity in children at genetic risk of type 1 diabetes.


Options:
A: Positivity for two or more diabetes-associated autoantibodies and/or clinical type 1 diabetes (10 years)
B: Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator (60 days)
C: Beta-cell autoantibodies (3,6,12,24,36,48,60,72 months)
D: Number of Participants With Type 1 Diabetes Mellitus (12 and 18 months and annually from 2 years up to 14 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of Dietary Prevention of Type 1 Diabetes Associated Beta-cell Autoimmunity in Children at Genetic Risk
Brief Summary: The purpose of this study is to determine whether weaning to whey-based hydrolysed formula or essentially bovine insulin free whey-based FINDIA formula instead of standard cow's milk based formula is effective in the prevention of type 1 diabetes associated beta-cell autoimmunity in children at genetic risk of type 1 diabetes.


Options:
A: Intestinal permeability will be determined at the age of 3, 6, 9 and 12 months with the lactulose/mannitol test Intestinal permeability at the age of 9 months assessed with the lactulose/mannitol test (3, 6, 9 and 12 months)
B: Positivity for two or more diabetes-associated autoantibodies and/or clinical type 1 diabetes (10 years)
C: Beta-cell autoantibodies (3,6,12,24,36,48,60,72 months)
D: Number of Participants With Type 1 Diabetes Mellitus (12 and 18 months and annually from 2 years up to 14 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of Dietary Prevention of Type 1 Diabetes Associated Beta-cell Autoimmunity in Children at Genetic Risk
Brief Summary: The purpose of this study is to determine whether weaning to whey-based hydrolysed formula or essentially bovine insulin free whey-based FINDIA formula instead of standard cow's milk based formula is effective in the prevention of type 1 diabetes associated beta-cell autoimmunity in children at genetic risk of type 1 diabetes.


Options:
A: Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator (60 days)
B: infants' intake, length of feeding and patterning of feeding of Nutramigen relative to Enfamil (infant-led feeding condition) (0.5-8.5 months)
C: Beta-cell autoantibodies (3,6,12,24,36,48,60,72 months)
D: Positivity for two or more diabetes-associated autoantibodies and/or clinical type 1 diabetes (10 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV Study on the Effects of Sildenafil in Combination With Pulmonary Rehabilitation Program on Exercise Tolerance in Patients With COPD and Pulmonary Hypertension
Brief Summary: Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD), the investigators hypothesized that sildenafil might improve pulmonary hemodynamics and increase exercise tolerance in this condition.


Options:
A: Mean Pulmonary Artery Pressure Measured by Right Heart Catheterization (baseline and 12 weeks)
B: The primary end point of efficacy was improvement in exercise tolerance as assessed by the un-encouraged 6 minute walk test (6MWT) compared to baseline after 6 weeks of treatment (6 weeks)
C: Endurance time (3 months)
D: Number of Participants With Adverse Events (AEs) (Baseline (Double-Blind Period) up to Week 243 (End of Open-Label Period))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-Blind, Placebo- Controlled, Parallel Group, Efficacy and Safety Study to Evaluate the Effects of Oral Administration of Lixivaptan in Patients With Congestive Heart Failure
Brief Summary: The purpose of this study is to evaluate the effects of oral lixivaptan capsules in patients with congestive heart failure.


Options:
A: Time to repeat therapeutic paracentesis (12 weeks)
B: To assess the efficacy and safety of lixivaptan treatment in congestive heart failure (CHF) patients with volume expansion. (8 weeks)
C: The average daily area under the curve of change from baseline in serum sodium level up to Day 4 within the double-blind on therapy period.; and/or; The average daily area under the curve of change from baseline in serum sodium level up to Day 30 within the double-blind on therapy period.
D: Dyspnea Improvement Measured by Likert Scale at 8 and 24 Hours (8 and 24 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Disseminating a Model Intervention to Promote Improved ADHD Care in the Community
Brief Summary: The American Academy of Pediatrics (AAP) has established a set of consensus guidelines for pediatricians to follow. These guidelines can be challenging to implement in typical community-based practices. Cincinnati Children's Hospital Medical Center (CCHMC) has developed a program called the ADHD Collaborative to promote the adoption of these guidelines among community pediatricians. The program focuses on modifying the office system using academic detailing and quality improvement (QI) methodology to accommodate prescribed practice changes. The ADHD Collaborative has been very successful at recruiting practices in the Greater Cincinnati area, changing practice behaviors, and sustaining these practice behaviors over time at minimal cost to the project and to the office practice. Now that sustainability and effectiveness have been established, the next step is to modify the ADHD Collaborative model to make it amenable to widespread dissemination. The primary goal of the proposed study is to modify the ADHD Collaborative intervention to make it transportable and then evaluate this version in terms of effectiveness, consumer satisfaction, and costs.. A transportable intervention is described that utilizes telehealth videoconferencing, a web portal, and long-distance data collection. Initially, three pediatric practices will be recruited to test and refine the distal intervention delivery methodology. Then, eight new pediatric practices will be randomly assigned to receive the distal intervention or to a control group (treatment as usual). Information about pediatric practice behavior will be collected at baseline, 6-months, and 1-year post-baseline. The study design will allow for a preliminary assessment of the feasibility and effectiveness of the distal intervention in terms of rates of evidence-based practice behaviors to patients, change in pediatrician attitudes, consumer satisfaction, and costs.


Options:
A: Physician ADHD Practice Behavior (Baseline and 6 months)
B: HbA1c (Last measurement within 12 months before - and 15 months after nurse participation in the course)
C: Change From Baseline Antibiotic Consumption at 18 Months, in Primary Care (up to 18 months); Antibiotic Monthly Sales Data and Quality Indicators Monthly Prescribing Rates. (May 2012- September 2014)
D: Episiotomies; Oxytocin use in third stage of labor

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice Multinational, Prospective, Non-randomized, Multi-centre, Non-interventional Trial
Brief Summary: To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use.


Options:
A: MACE (Cardiac death, clinically driven TLR, MI / AMI (STEMI / NSTEMI) (6 months)
B: Late lumen loss (6 months)
C: angiographic binary restenosis (12 months)
D: Target Lesion Percent Stenosis (at 1 Year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel Group Study To Compare Discontinuation Symptoms In Abrupt Discontinuation Versus A 1-Week Tapering Regimen In Subjects With MDD Treated For 24 Weeks With Open-Label 50 mg DVS SR Formulation
Brief Summary: Study Comparing Discontinuation Symptoms in subjects with Major Depressive Disorder treated for 24 Weeks with Open-label 50 mg Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR)


Options:
A: Percentage of Participants With Depressive Recurrence After Time (t) in Days (Every Visit from Week 34 up to Week 86 (Maintenance Phase))
B: Number of patients who fully discontinued their antidepressant medication after 6 months. (6 months)
C: Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase (Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182))
D: Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185 (Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Controlled, Multidose, Multicentre, Adaptive Phase II/III Study in Infants With Proliferating Infantile Hemangiomas (IHs) Requiring Systemic Therapy to Compare 4 Regimens of Propranolol (1 or 3 mg/kg/Day for 3 or 6 Months) to Placebo (Double Blind).
Brief Summary: There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a good benefit/risk profile. Based on the recent findings of encouraging results obtained with propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is expected to be of significant benefit in the management of the condition. The present study has been designed to confirm efficacy of propranolol in severe IH by demonstrating superiority over placebo and to document the safety profile of propranolol in this indication.


Options:
A: Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs. (6 months); Primary Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at W24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of W24 Photographs. (6 months)
B: Decrease in Size of Hemangioma (Length x Width) in Square mm (4-5 months after initiating therapy)
C: To document the efficacy of Imiquimod 5% cream in the treatment of hemangioma of infancy. (Cream is applied for 4 months. Visits occured at month 1, 2, 4, and 8.)
D: Hemangioma outcome (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Telemonitoring Versus Usual Care in a High Risk Elderly Population.
Brief Summary: Background: Older adults with multiple chronic illnesses are at risk for worsening functional and medical status with ensuing hospitalization. One goal of medical care is to prevent this decline. One method that may help slow this functional and medical decline is home telemonitoring.

Specific aim: To determine the effectiveness of home telemonitoring compared to usual care in reducing combined outcomes of hospitalization and emergency room visits in an at risk population over 60 years of age.

Materials and Methods: This will be a randomized trial of 200 patients into one of two interventions. Home telemonitoring involves the use of a computer device at home which records biometric and symptom data from patients. This information is monitored by mid level providers associated with the primary care medical practice. Usual care involves patients who make appointments with their providers as problems arise and utilize ongoing support like a 24 hours nurse line. The study participants are adults over 60 years of age within the highest 10% on elderly risk assessment (ERA) scores. Patients will have initial evaluations of gait, quality of life (SF12), Kokmen test of mental status, and PHQ 9. Patients will be followed for 1 year for primary outcomes of hospitalizations and emergency room visits. Secondary analysis will include quality of life, compliance with the device and attitudes about telemonitoring. Sample size is based upon an 80% power to detect a 36% difference between the groups. The primary analysis will involve Cox proportional time to event analysis comparing both interventions for telemonitoring or usual care. Secondary analysis will use T-test comparisons for continuous variables (quality of life, attitudes) and chi square for proportional analysis.


Options:
A: Rate of Heart Failure Related (HFR) Hospitalizations (6 months); Freedom From a Device/System-related Complication (DSRC). (6 months); Freedom From Pressure Sensor Failure (6 months)
B: To assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine (90 days)
C: Mean # Participants Who Had Hospitalizations or ED Visits Compared to Usual Care in a High Risk Group of Adults ≥ 60 Years of Age With Mixed Chronic Disease. (12 months)
D: Blood Pressure Control (Baseline, 6 months, 12 months, 18 months); Mean Systolic Blood Pressure (Baseline, 6 months, 12 months, 18 months, 54 months); Mean Diastolic Blood Pressure (Baseline, 6 months, 12 months, 18 months, 54 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Telemonitoring Versus Usual Care in a High Risk Elderly Population.
Brief Summary: Background: Older adults with multiple chronic illnesses are at risk for worsening functional and medical status with ensuing hospitalization. One goal of medical care is to prevent this decline. One method that may help slow this functional and medical decline is home telemonitoring.

Specific aim: To determine the effectiveness of home telemonitoring compared to usual care in reducing combined outcomes of hospitalization and emergency room visits in an at risk population over 60 years of age.

Materials and Methods: This will be a randomized trial of 200 patients into one of two interventions. Home telemonitoring involves the use of a computer device at home which records biometric and symptom data from patients. This information is monitored by mid level providers associated with the primary care medical practice. Usual care involves patients who make appointments with their providers as problems arise and utilize ongoing support like a 24 hours nurse line. The study participants are adults over 60 years of age within the highest 10% on elderly risk assessment (ERA) scores. Patients will have initial evaluations of gait, quality of life (SF12), Kokmen test of mental status, and PHQ 9. Patients will be followed for 1 year for primary outcomes of hospitalizations and emergency room visits. Secondary analysis will include quality of life, compliance with the device and attitudes about telemonitoring. Sample size is based upon an 80% power to detect a 36% difference between the groups. The primary analysis will involve Cox proportional time to event analysis comparing both interventions for telemonitoring or usual care. Secondary analysis will use T-test comparisons for continuous variables (quality of life, attitudes) and chi square for proportional analysis.


Options:
A: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
B: Hospital readmission (30 days)
C: Mean # Participants Who Had Hospitalizations or ED Visits Compared to Usual Care in a High Risk Group of Adults ≥ 60 Years of Age With Mixed Chronic Disease. (12 months)
D: Depressive Symptoms (CES-D Score) (Baseline, 12 month FU)

Answer: C