TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Postpartum Weight Loss in Overweight Women
Brief Summary: The purpose of this study is to evaluate, in a five-year randomized controlled trial, the efficacy of an intervention (AMP - ACTIVE MOTHERS POSTPARTUM) to increase physical activity and promote a healthy diet (decreased calorie and fat intake) for weight loss among postpartum women who were overweight or obese prior to pregnancy. The hypothesis is that the proportion of women losing at least 10% of BMI from baseline to 12 months post-intervention will be significantly greater in the AMP intervention arm than in the minimal care arm.


Options:
A: Percent of women whose gestational weight gain exceeds Institute of Medicine recommendations (Delivery (when the baby is delivered))
B: Weight for Length Body Mass Index (BMI will be assessed at three years of age for the study participants)
C: BMI change from baseline to 12 months post-intervention (24 months postpartum) will be assessed via self-report and validated by in-person weight measurement. The proportion of women who lose 10% of baseline BMI
D: Postpartum weight loss (12 months after delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Postpartum Weight Loss in Overweight Women
Brief Summary: The purpose of this study is to evaluate, in a five-year randomized controlled trial, the efficacy of an intervention (AMP - ACTIVE MOTHERS POSTPARTUM) to increase physical activity and promote a healthy diet (decreased calorie and fat intake) for weight loss among postpartum women who were overweight or obese prior to pregnancy. The hypothesis is that the proportion of women losing at least 10% of BMI from baseline to 12 months post-intervention will be significantly greater in the AMP intervention arm than in the minimal care arm.


Options:
A: BMI change from baseline to 12 months post-intervention (24 months postpartum) will be assessed via self-report and validated by in-person weight measurement. The proportion of women who lose 10% of baseline BMI
B: Infant weight for height (One year after study entry)
C: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)
D: Postpartum weight retention (no more than 1.5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Conservative Treatment of Postprostatectomy Incontinence
Brief Summary: The primary purpose of this study is to test the effectiveness, impact on quality of life, and durability of non-surgical therapies for incontinence persisting at least one year after surgery. The study is a a prospective, controlled, randomized trial comparing an 8-week, multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring with bladder diaries, regular office visits, bladder control techniques, and fluid management) to the same program with the addition of biofeedback and pelvic muscle electrical stimulation.


Options:
A: Erectile function score by a validated symptom questionnaire (IIEF) (At 3 months, 6 months and 1 year); Time to continence after surgery (At 3 months, 6 months and 1 year)
B: self reported continence (no need for wearing a pad)at 3 months (One year)
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Conservative Treatment of Postprostatectomy Incontinence
Brief Summary: The primary purpose of this study is to test the effectiveness, impact on quality of life, and durability of non-surgical therapies for incontinence persisting at least one year after surgery. The study is a a prospective, controlled, randomized trial comparing an 8-week, multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring with bladder diaries, regular office visits, bladder control techniques, and fluid management) to the same program with the addition of biofeedback and pelvic muscle electrical stimulation.


Options:
A: 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)
B: improves muscle strength of the pelvic floor at 3 months (baseline and 3 months)
C: Incontinence Visual Analogue Scale (I-VAS) (7 months)
D: Percent Change in Incontinence Episodes on Bladder Diary (2 months); Percent Change in Incontinence Episodes Per Week on Bladder Diary (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Training in Type 2 Diabetes and Hypertension
Brief Summary: The coexistence of diabetes and hypertension is damaging to cardiac and peripheral vascular structure and function. Although several health organizations endorse exercise training as a treatment for type 2 diabetes, most studies of exercise and diabetes have focused on controlling blood sugar but not on cardiovascular health. The aim of this study is to determine if exercise training reduces blood pressure and improves cardiovascular health in persons who have both type 2 diabetes and hypertension. An equal number of men and women will be enrolled, and another aim of the study is to examine gender differences in response to exercise training.


Options:
A: Blood pressure at 6 months (6 months)
B: change in arterial stiffness (one year)
C: 6-minute walk test at 6 month follow-up (Measured at baseline and Month 6 follow-up)
D: average daily step count (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Training in Type 2 Diabetes and Hypertension
Brief Summary: The coexistence of diabetes and hypertension is damaging to cardiac and peripheral vascular structure and function. Although several health organizations endorse exercise training as a treatment for type 2 diabetes, most studies of exercise and diabetes have focused on controlling blood sugar but not on cardiovascular health. The aim of this study is to determine if exercise training reduces blood pressure and improves cardiovascular health in persons who have both type 2 diabetes and hypertension. An equal number of men and women will be enrolled, and another aim of the study is to examine gender differences in response to exercise training.


Options:
A: Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain. (6 months)
B: Six-minute walk distance (Measured at baseline and follow-up study visits); Summary performance score (Measured at baseline and follow-up study visits)
C: Blood pressure at 6 months (6 months)
D: 6-minute walk test at 6 month follow-up (Measured at baseline and Month 6 follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: ONO-7436 Phase II Study - A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of ONO-7436 for the Prevention of Cancer Chemotherapy-Induced Nausea and Vomiting in Japan
Brief Summary: The purpose of this study is to examine the efficacy and safety of ONO-7436 for the prevention of cancer chemotherapy-induced nausea and vomiting in patients with malignant tumor


Options:
A: Effect of aprepitant on cyclophosphamide and 4-hydroxycyclophosphamide pharmacokinetics as measured by plasma AUC (05/2005 to 10/2010)
B: Plasma levels of study drugs will be taken on Day 1 & 8. (taken on Day 1 & 8.)
C: Patient proportion of complete response (no vomiting and no rescue treatment).
D: Percentage of Participants Who Achieved a Complete Response in the Overall Phase (0-120 Hours) Following Initiation of the First Cycle of an Oxaliplatin Based Moderately Emetogenic Chemotherapy (MEC) Regimen (0 to 120 hours in the first cycle of chemotherapy)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder.


Options:
A: Change in mean number of micturitions per 24 hrs (Within a 12-week treatment period)
B: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (Baseline, Week 12)
C: Total number of urinary incontinence episodes per week
D: Patient Perception of Bladder Condition at 12 weeks of treatment compared to placebo.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized, Multicenter Study of the Initiation of Four Dosing Regimens of PROCRIT (Epoetin Alfa) for the Treatment of Anemia of Chronic Kidney Disease (CKD). Protocol Addendum: Due to Space Constraints, See Detailed Description for Full Title of Addendum.
Brief Summary: The primary objective of this study is to compare the change in hemoglobin (Hb) from study start to the end of the study between the every 2 week and the every 4 week dosing regimens in patients with anemia of chronic kidney disease (CKD) initiated on PROCRIT (epoetin alfa). Protocol Addendum: The primary objective of the open-label extension portion of this study is to evaluate if epoetin alfa 40,000 Units given under the skin every six weeks, can maintain hemoglobin within the range of 11-12 g/dL in patients with anemia of CKD.


Options:
A: Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks (Baseline and 24 weeks)
B: Change in hemoglobin (Hb) from baseline to the end of the study; Primarily interested in the change in Hb between Q2W vs Q4W groups. Protocol Addendum: Hb change from baseline to end of open-label extension (no more than 36 weeks)
C: The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range (Weeks 16-28)
D: Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period (Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized, Multicenter Study of the Initiation of Four Dosing Regimens of PROCRIT (Epoetin Alfa) for the Treatment of Anemia of Chronic Kidney Disease (CKD). Protocol Addendum: Due to Space Constraints, See Detailed Description for Full Title of Addendum.
Brief Summary: The primary objective of this study is to compare the change in hemoglobin (Hb) from study start to the end of the study between the every 2 week and the every 4 week dosing regimens in patients with anemia of chronic kidney disease (CKD) initiated on PROCRIT (epoetin alfa). Protocol Addendum: The primary objective of the open-label extension portion of this study is to evaluate if epoetin alfa 40,000 Units given under the skin every six weeks, can maintain hemoglobin within the range of 11-12 g/dL in patients with anemia of CKD.


Options:
A: Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22 (From baseline through Week 22)
B: The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)
C: Median Time to First Cardiovascular Event (Up to 4 years)
D: Change in hemoglobin (Hb) from baseline to the end of the study; Primarily interested in the change in Hb between Q2W vs Q4W groups. Protocol Addendum: Hb change from baseline to end of open-label extension (no more than 36 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Study of the Efficacy and Safety of the Microbicide Carraguard® in Preventing HIV Seroconversion in Women
Brief Summary: The purposes of this study are to determine whether Carraguard® Gel can prevent the transmission of HIV when used during vaginal intercourse, and to confirm that the gel is safe for vaginal use.


Options:
A: Time to HIV seroconversion during trial participation (evaluated quarterly)
B: Effectiveness (30 months); Safety (30 months)
C: Combined incidence of HIV-1 and HIV-2
D: Combined incidence of HIV-1 and HIV-2 in the study. (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-blind, Three-arm, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)
Brief Summary: The purpose of the study is to determine if cladribine tablets are a safe and effective treatment for relapsing-remitting multiple sclerosis (RRMS).


Options:
A: Freedom of relapse (Within 2 years)
B: Annualized Qualifying Relapse Rate (Week 96)
C: Adjusted Annualized Relapse Rate Between Baseline and Week 52 (Baseline through Week 52)
D: Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain (Week 12 to Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-blind, Three-arm, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)
Brief Summary: The purpose of the study is to determine if cladribine tablets are a safe and effective treatment for relapsing-remitting multiple sclerosis (RRMS).


Options:
A: Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint (up to 36 months after the last patient was randomized)
B: Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6 (Baseline, Month 6)
C: Part A: Number of Participants With Adverse Events (AEs) (Baseline (Week 0) to Week 24); Part B: Rate of Development of New Active Lesions Over 24 Weeks (Baseline (Week 0) to Week 24)
D: Annualized Qualifying Relapse Rate (Week 96)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Vigorous Exercise on Motor Function and Functional Fitness in Juvenile Arthritis
Brief Summary: The objectives of this study are to study the effect of formal exercise training on motor function and overall physical fitness in children with arthritis. A 12-week comprehensive exercise program will be used. Formal exercise training will be compared to Qi gong.


Options:
A: PATIENT-RATED LOW BACK PAIN (3 and 12 months)
B: walking economy at completion of the exercise program; PEAK power, muscular endurance, and subjective function at completion of the exercise program
C: Accrual rates; Compliance with therapy; Acceptability of exercise program; Degree of conditioning of subjects at baseline; Proportion of completed exercise tests and questionnaires; Dropout rates; Estimates of the effect sizes for exercise tests and questionnaire data
D: Change in Functional Disability (Baseline, 8 weeks, 16 weeks, 10 months, 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Sucrose Analgesia in Reducing Pain Responses in Infants Born to Diabetic and Non-diabetic Mothers: A Randomized Controlled Trial
Brief Summary: This study will examine the safety and effectiveness of sugar water to relieve pain in newborn infants during painful blood tests and injections. Infants of diabetic mothers who receive repeated blood tests will be compared to infants of healthy mothers who receive routine painful procedures.

We believe that administration of sucrose analgesia for every painful cutaneous procedure performed after delivery will result in less pain during the newborn infant screening test.


Options:
A: - Infant pain score during the newborn screening test, assessed by the Premature Infant Pain Profile (PIPP), or individual parameters of PIPP (facial grimace, heart rate, oxygen saturation)
B: The primary objective is to show decrease of pain response in the treatment group as measured by the PIPP (Premature Infant Pain Profile) score (PIPP score before, during and after eye exam)
C: Pain Profile (During the Procedure)
D: skin blood flow response (perfusion units, PU) (immediately prior to heel lance, at heel lance, 5 minutes post heel lance (3 time points))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Sucrose Analgesia in Reducing Pain Responses in Infants Born to Diabetic and Non-diabetic Mothers: A Randomized Controlled Trial
Brief Summary: This study will examine the safety and effectiveness of sugar water to relieve pain in newborn infants during painful blood tests and injections. Infants of diabetic mothers who receive repeated blood tests will be compared to infants of healthy mothers who receive routine painful procedures.

We believe that administration of sucrose analgesia for every painful cutaneous procedure performed after delivery will result in less pain during the newborn infant screening test.


Options:
A: Neonatal pain scales: Neonatal infant pain Scale (NIPS), Neonatal Facial Coding System (NFCS) and Premature Infant Pain Profile (PIPP) (before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection)
B: - Infant pain score during the newborn screening test, assessed by the Premature Infant Pain Profile (PIPP), or individual parameters of PIPP (facial grimace, heart rate, oxygen saturation)
C: The University of Wisconsin Children's Hospital Pain Scale will measure the primary outcome acute behavioral pain response. Measure will be recorded at baseline, immediately after immunizations and 3 minutes following immunizations
D: Premature Infant Pain Profile (PIPP) scale rate (0-21) (15 seconds before and Within 30 seconds after heel lance)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Sucrose Analgesia in Reducing Pain Responses in Infants Born to Diabetic and Non-diabetic Mothers: A Randomized Controlled Trial
Brief Summary: This study will examine the safety and effectiveness of sugar water to relieve pain in newborn infants during painful blood tests and injections. Infants of diabetic mothers who receive repeated blood tests will be compared to infants of healthy mothers who receive routine painful procedures.

We believe that administration of sucrose analgesia for every painful cutaneous procedure performed after delivery will result in less pain during the newborn infant screening test.


Options:
A: The primary objective is to show decrease of pain response in the treatment group as measured by the PIPP (Premature Infant Pain Profile) score (PIPP score before, during and after eye exam)
B: Premature Infant Pain Profile (two hours)
C: - Infant pain score during the newborn screening test, assessed by the Premature Infant Pain Profile (PIPP), or individual parameters of PIPP (facial grimace, heart rate, oxygen saturation)
D: skin blood flow response (perfusion units, PU) (immediately prior to heel lance, at heel lance, 5 minutes post heel lance (3 time points))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Montelukast Shorten Corticosteroid Therapy In Children With Mild To Moderate Acute Asthma?
Brief Summary: The primary objective of this study is to evaluate if children with acute asthma given a single dose of oral prednisolone with a subsequent daily five-day course of oral Montelukast will achieve a therapeutic failure rate at day 8 not significantly higher than those given six daily doses of oral prednisolone. Secondary objectives include comparison of the two groups with respect to the changes in symptoms, beta2 agonists, clinical asthma score and days without asthma by day 8.


Options:
A: Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours. (4 hours)
B: N/A
C: Improvement in forced expiratory volume in 1 second [FEV1] within the first 60 minutes after administration (within the first 60 minutes after administration)
D: Therapeutic failure rate (From randomization at discharge from the Emergency Department to day 8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Montelukast Shorten Corticosteroid Therapy In Children With Mild To Moderate Acute Asthma?
Brief Summary: The primary objective of this study is to evaluate if children with acute asthma given a single dose of oral prednisolone with a subsequent daily five-day course of oral Montelukast will achieve a therapeutic failure rate at day 8 not significantly higher than those given six daily doses of oral prednisolone. Secondary objectives include comparison of the two groups with respect to the changes in symptoms, beta2 agonists, clinical asthma score and days without asthma by day 8.


Options:
A: N/A
B: Therapeutic failure rate (From randomization at discharge from the Emergency Department to day 8)
C: N/A
D: Reduction in modified pulmonary index score (MPIS) to less than 9 at the end of 4 hours. (4 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet Telehealth for Pediatric Asthma Case Management
Brief Summary: The original and primary aim of this study is to evaluate the effects of CHESS with Nurse Case Management on asthma control (symptom-free days), and adherence factors of children aged 4-12. The investigators have expanded the scope of the specific aims. The criteria for their expanded aim is to also interview low-income African-American caregivers to gain an understanding of how they conceptualize their child's asthma, and what they consider to be barriers or facilitators to managing their child's asthma. There is no change in the investigators' original aim.


Options:
A: to determine the impact of a site-independent, remote, telemedicine consultation system on decision making in the Emergency Department, regarding the decision to treat or not to treat with thrombolytics (90 days); to assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine versus telephone only (90 days); to assess the appropriateness of thrombolytic treatment decisions in telemedicine versus telephone-only consultations (90 days); to assess the completeness of the data collection in telemedicine versus telephone-only consultations. (90 days)
B: Changes of glycosilated haemoglobin (HbA1c) (At least 12 weeks from baseline (visit 3))
C: Treatment Completion (13 weeks); PTSD Checklist-Military (PCL-M) (26 weeks); Beck Depression Inventory-II (BDI-II) (26 weeks)
D: Percentage Changed in Adherence Score (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores); Number of Symptom-free Days (Baseline compared to the mean of the combined 3, 6, 9, and 12 month scores)

Answer: D