TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Open-Label Study to Assess the Long-Term Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD)
Brief Summary: The purpose of this study is to determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.


Options:
A: Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment (From randomisation to day 14)
B: Difference between the proportion of patients who discontinued on-demand esomeprazole treatment versus continuous esomeprazole treatment due to unsatisfactory treatment as determined by the investigator in consultation with the patient (6 months)
C: The Rates of Complete Symptom Relief (at the 20 weeks after the end of initial treatment.)
D: Mean Change From Baseline to Month 12 for Hemoglobin Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Hematocrit Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Red Blood Cell Count Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Platelet Count Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for White Blood Cell Count Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Creatinine Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Calcium Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Total Bilirubin Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values (Baseline and Month 12); Mean Change From Baseline to Month 12 for Serum Gastrin Levels (Baseline and Month 12); Mean Change From Baseline to Month 12 for Systolic Blood Pressure (Baseline and Month 12); Mean Change From Baseline to Month 12 for Diastolic Blood Pressure (Baseline and Month 12); Mean Change From Baseline to Month 12 for Pulse Rate (Baseline and Month 12); Changes From Baseline to Final Visit in Antrum Biopsy Results (Baseline and Final Visit (up to 12 months)); Changes From Baseline to Final Visit in Fundus Biopsy Results (Baseline and Final Visit (up to 12 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Polyethylene Glycol Laxative (Macrogol 4000;Forlax®) for Treatment of Chronic Constipation in Children : A Phase III, Bicentric, Randomized, Double-blind, Lactulose Controlled Study.
Brief Summary: The purpose of this study is to determine whether Forlax® is more effective than placebo in relieving chronic constipation in children who may also suffer from soiling or faecal incontinence.


Options:
A: therapeutic success (passing ≥ 3 stools per week, with no loosening of stool). (the number and consistency of the stool will be recorded at 6th week of intervention)
B: Symptom Based Weekly Total Sum Score (TSS) Over 52 Weeks (Baseline (Week 0), Week 1, 2, 3, 4, 8, 12, 26, 52); Change From Baseline in Total Sum Score (TSS) at Week 52 (Baseline, Week 52); Short Term Change of Total Sum Score (TSS): Average of Weeks 1 to 8 Minus Baseline (Average of Weeks 1 to 8); Long Term Change of Total Sum Score (TSS): Average of Weeks 26 and 52 Minus Baseline (Average of Weeks 26 and 52); Overall Change of Total Sum Score (TSS): Average of all Diaries Obtained Minus Baseline (Average up to 52 weeks); Dose Range Determination: Mean Dose Based on Sachets Used (Up to 52 weeks.); Dose Range Determination: Mean Dose per Kilogram Body Weight Based on Sachets Used (Up to 52 weeks)
C: Bowel movement frequency (week 4)
D: Efficacy (4 weeks of observation); Efficacy (7 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating Efficacy of Milk Fortified With Bifidus DR10-Oligosaccharides, Zinc and Iron in Reducing Morbidity Due to Diarrhea, Pneumonia and Improving Growth and Development in Children Ages 13-36 Months
Brief Summary: The purpose of the study is to evaluate effect or fortifying milk with pre and probiotics or with micronutrients on prevention of diarrhea, pneumonia and other childhood illnesses and improvement in growth and development.


Options:
A: N/A
B: Immune failure (For at least 6 months)
C: Diarrhea; Pneumonia; Febrile illness; Growth; Development; Activity
D: Change in length and length-for-age Z-score (9 to 18 mo of age); Change in weight and weight-for-age Z-score (9 to 18 mo of age); Incidence of diarrhea and laboratory-confirmed malaria infection (9 to 18 mo of age); Change in plasma zinc concentration (9 to 18 mo of age); Change in body composition (9 to 18 mo of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating Efficacy of Milk Fortified With Bifidus DR10-Oligosaccharides, Zinc and Iron in Reducing Morbidity Due to Diarrhea, Pneumonia and Improving Growth and Development in Children Ages 13-36 Months
Brief Summary: The purpose of the study is to evaluate effect or fortifying milk with pre and probiotics or with micronutrients on prevention of diarrhea, pneumonia and other childhood illnesses and improvement in growth and development.


Options:
A: Post-prandial levels of provitamin A and vitamin A (Nine post-prandial blood samples will be taken over twelve hours)
B: Morbidity (0 months, 6 months, 12 months); Growth (0 months, 6 months, 12 months); Development (0 months, 6 months, 12 months); School performance (0 months, 6 months, 12 months); Status Indicators for iron, zinc, vitamin A and iodine (0 months, 6 months, 12 months)
C: Diarrhea; Pneumonia; Febrile illness; Growth; Development; Activity
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating Efficacy of Milk Fortified With Bifidus DR10-Oligosaccharides, Zinc and Iron in Reducing Morbidity Due to Diarrhea, Pneumonia and Improving Growth and Development in Children Ages 13-36 Months
Brief Summary: The purpose of the study is to evaluate effect or fortifying milk with pre and probiotics or with micronutrients on prevention of diarrhea, pneumonia and other childhood illnesses and improvement in growth and development.


Options:
A: Mean birth weight (9 months)
B: Morbidity (0 months, 6 months, 12 months); Growth (0 months, 6 months, 12 months); Development (0 months, 6 months, 12 months); School performance (0 months, 6 months, 12 months); Status Indicators for iron, zinc, vitamin A and iodine (0 months, 6 months, 12 months)
C: Diarrhea; Pneumonia; Febrile illness; Growth; Development; Activity
D: Anthropometry (6 months); Micronutrient status (6 months); Cognition (6 months); absentism (6 months); morbidity (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating Efficacy of Milk Fortified With Bifidus DR10-Oligosaccharides, Zinc and Iron in Reducing Morbidity Due to Diarrhea, Pneumonia and Improving Growth and Development in Children Ages 13-36 Months
Brief Summary: The purpose of the study is to evaluate effect or fortifying milk with pre and probiotics or with micronutrients on prevention of diarrhea, pneumonia and other childhood illnesses and improvement in growth and development.


Options:
A: Common infections in children
B: Incidence of infectious diseases
C: Diarrhea; Pneumonia; Febrile illness; Growth; Development; Activity
D: Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism (16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating Efficacy of Milk Fortified With Bifidus DR10-Oligosaccharides, Zinc and Iron in Reducing Morbidity Due to Diarrhea, Pneumonia and Improving Growth and Development in Children Ages 13-36 Months
Brief Summary: The purpose of the study is to evaluate effect or fortifying milk with pre and probiotics or with micronutrients on prevention of diarrhea, pneumonia and other childhood illnesses and improvement in growth and development.


Options:
A: Morbidity (0 months, 6 months, 12 months); Growth (0 months, 6 months, 12 months); Development (0 months, 6 months, 12 months); School performance (0 months, 6 months, 12 months); Status Indicators for iron, zinc, vitamin A and iodine (0 months, 6 months, 12 months)
B: Diarrhea; Pneumonia; Febrile illness; Growth; Development; Activity
C: Plasma zinc concentration (1 month)
D: Incidence acute diarrheal disease and acute respiratory infection (Up to 16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind, Placebo Controlled, Crossover Design, Multicenter Study of Intravenous Ferumoxytol Compared With Placebo
Brief Summary: This crossover safety study will evaluate the safety of a single dose of ferumoxytol compared to placebo in patients with chronic kidney disease.


Options:
A: composite of 12 month mortality and the change over 12 months in left ventricular mass by cine-MRI, (12 months); a composite of 12 month mortality and the change over 12 months in the SF-36 RAND physical health composite (12 months)
B: Safety evaluated by physical examinations, vital signs, laboratory tests and patient monitoring and evaluation.
C: change in quadriceps muscle endurance during intermittent submaximal contractions (6 days); change in exercise-induced markers of oxidative stress (8 days)
D: Frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment (6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Dialectical Behavioral Therapy and Escitalopram on Impulsive Aggression, Affective Instability and Cognitive Processing in Borderline Personality Disorder
Brief Summary: Subjects will receive six months of DBT, consisting of one 90-minute group and one 60-minute individual session per week as well as telephone availability of the individual therapist. Half the subjects will concurrently receive escitalopram while half will receive placebo, in a randomized double-blind design.


Options:
A: Frequency of subsequent episodes of deliberate self harm and time elapsed to future episodes of deliberate self harm (16 weeks and 68 weeks); Severity of suicidal ideation, level of depressive symptoms (16 weeks and 68 weeks)
B: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
C: Measures of impulsivity, aggression, affective impulsivity, immediate and delayed memory, and cognitive processing at baseline, 6 months and 9 months
D: Suicide attempts (measured by the Columbia Suicide Severity Rating Scale) (6-months); Suicidal ideation (measured by the Beck Suicide Scale (BSS)) (6-months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Dialectical Behavioral Therapy and Escitalopram on Impulsive Aggression, Affective Instability and Cognitive Processing in Borderline Personality Disorder
Brief Summary: Subjects will receive six months of DBT, consisting of one 90-minute group and one 60-minute individual session per week as well as telephone availability of the individual therapist. Half the subjects will concurrently receive escitalopram while half will receive placebo, in a randomized double-blind design.


Options:
A: Measures of impulsivity, aggression, affective impulsivity, immediate and delayed memory, and cognitive processing at baseline, 6 months and 9 months
B: drinking - measured using the TLFB (12 weeks); craving - measured using the OCDS (12 weeks); aggression - measured using the STAE (12 weeks)
C: Outcome Questionnaire -45.2 (Lambert et al., 2004) (3 months)
D: The acceptability of the intervention to patients (within 6 months of study completion); The feasibility of intervention delivery at the ER setting (within 6 months of study completion); Patient recruitment (Baseline); The proportion of participating patients who can be reached by telephone contact at the 3-month follow-up. (3 months); The proportion of participating patients who can be reached by telephone contact at the 6-month follow-up. (6 months); The proportion of participating patients who can be traced from the hospital record at the 3-month. (3 months); The proportion of participating patients who can be traced from the hospital record at the 6-month. (6 months); The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 6-month. (6 months); The proportion of participating patients whose identity card number can be linked to the nationwide self-harm registry at the 3-month. (3 months); Change in scores on a self-report suicidal behaviors assessment from baseline to 3 months (Baseline, 3 months); Change in scores on a self-report suicidal behaviors assessment from baseline to 6 months (Baseline, 6 months); Number of repeat self-harm episodes per person in 3 months after intervention based on hospital records (3 months); Number of repeat self-harm episodes per person in 3 months after intervention recorded in the nationwide self-harm registry (3 months); Number of repeat self-harm episodes per person in 6 months after intervention based on hospital records (6 months); Number of repeat self-harm episodes per person in 6 months after intervention recorded in the nationwide self-harm registry (6 months); Time to next self-harm repetition (in days) following randomization (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial Comparing Docetaxel Every Third Week to Biweekly Docetaxel Monotherapy in Metastatic Hormone Refractory Prostate Cancer Patients - PROSTY Trial
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which schedule of docetaxel and prednisone is more effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying two different schedules of docetaxel and prednisone to compare how well they work in treating patients with metastatic prostate cancer.


Options:
A: Radiographic Progression-Free Survival (PFS) (Up to 44 months); Overall Survival (OS) (Up to 66 months)
B: Time to treatment failure (TTF)
C: Overall survival at 36 months; Progression-free survival (biological progression and/or clinical progression) at 24 months; Quality of life; Treatment costs; Toxicity and tolerance; Tumor profiles of gene expression as measured by biochips with DNA and tissue microarrays
D: Overall Survival (Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: "Safeguard the Household" - A Study of HIV Antiretroviral Therapy Treatment Strategies Appropriate for a Resource Poor Country
Brief Summary: The purpose of this study is to determine the effectiveness of several anti-HIV treatment strategies in resource-poor South African communities. The strategies being studied are using specially trained doctors or nurses to administer HIV care.


Options:
A: Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study); All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study)
B: Cumulative Treatment Failure Rate of Participants on First Line Antiretroviral Therapy Monitored by Primary Health Care Nurses (Investigative Arm)is Not Inferior to the Cumulative Treatment Failure Rate of Participants Monitored by Doctors (Control Arm). (96 weeks)
C: Lost to Follow-up (12 months)
D: Virologic suppression at 6 months (6 months); Virologic failure at all time intervals from ART initiation (these primary outcomes added to expanded trial protocol November 2007) (Typically every 24 weeks); Adherence measured by pill counts (this primary outcome added to expanded trial protocol November 2007) (Typically weekly to monthly)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: "Safeguard the Household" - A Study of HIV Antiretroviral Therapy Treatment Strategies Appropriate for a Resource Poor Country
Brief Summary: The purpose of this study is to determine the effectiveness of several anti-HIV treatment strategies in resource-poor South African communities. The strategies being studied are using specially trained doctors or nurses to administer HIV care.


Options:
A: The difference in change in estimated cardiovascular risk between advanced care and usual care groups (3 months)
B: Cumulative Treatment Failure Rate of Participants on First Line Antiretroviral Therapy Monitored by Primary Health Care Nurses (Investigative Arm)is Not Inferior to the Cumulative Treatment Failure Rate of Participants Monitored by Doctors (Control Arm). (96 weeks)
C: Blood pressure control (Measured by zero blood pressure measurements at baseline and 2, 4, 6, 8, and 9 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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi Center, Double Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease Subjects
Brief Summary: A 2 phase study to evaluate disease progression in Parkinson's disease patients taking rasagiline


Options:
A: UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment (6 months)
B: Canadian Occupational Performance Measure (COPM) (3 months)
C: Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline (12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w)
D: Sleep and Fatigue (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Rheumatologists are discussing, whether rehabilitation of patients with low back pain (LBP) can be improved. At present patients with LBP start treatment as soon as possible, this also applies for patients with chronic low back pain (CLBP) - pain lasting over 12 weeks. At Glostrup University Hospital department of Physical Medicine/rheumatology we use a method (method A) where an interdisciplinary team gives the patients a treatment composed of various topics. This includes among other things education, physical team training, exercises in swimming pool, stretching exercises, and occupational therapy. A different method (method B) originates from the Rehabilitation centre in Karlslunde led by Teddy Oefeldt. Here they focus strictly on dynamic training of muscles in the back and the buttocks. A therapist, who in the beginning partly carries the patient through the exercises, assists this training.

In both methods, individually considerations are taken, but to a greater extend in method B. The treatment will extend over a three months period.

A few earlier investigations have compared these two methods, but they have not been systematized to such a degree, that they gave any final conclusions. Therefore, we initialized an investigation including a larger number of patients, where the two methods are compared from the results the patients achieve after 3, 6, 12 and 24 months.

286 consecutive patients were included and randomized to one of the two methods. Those, who did not wish to participate in the investigation, were treated according to the department's normal procedure (Method A)


Options:
A: Brief Pain Inventory Interference (Measured at Year 1); HSCL-20 Depression Severity (Measured at Year 1)
B: Pain, physical functioning, coping efficacy, positive and negative emotional affect, and depression (6 months after treatment)
C: Oswestry Disability Index; Cost-effectiveness (full economic analysis)
D: Pain VAS

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Rheumatologists are discussing, whether rehabilitation of patients with low back pain (LBP) can be improved. At present patients with LBP start treatment as soon as possible, this also applies for patients with chronic low back pain (CLBP) - pain lasting over 12 weeks. At Glostrup University Hospital department of Physical Medicine/rheumatology we use a method (method A) where an interdisciplinary team gives the patients a treatment composed of various topics. This includes among other things education, physical team training, exercises in swimming pool, stretching exercises, and occupational therapy. A different method (method B) originates from the Rehabilitation centre in Karlslunde led by Teddy Oefeldt. Here they focus strictly on dynamic training of muscles in the back and the buttocks. A therapist, who in the beginning partly carries the patient through the exercises, assists this training.

In both methods, individually considerations are taken, but to a greater extend in method B. The treatment will extend over a three months period.

A few earlier investigations have compared these two methods, but they have not been systematized to such a degree, that they gave any final conclusions. Therefore, we initialized an investigation including a larger number of patients, where the two methods are compared from the results the patients achieve after 3, 6, 12 and 24 months.

286 consecutive patients were included and randomized to one of the two methods. Those, who did not wish to participate in the investigation, were treated according to the department's normal procedure (Method A)


Options:
A: Pain Intensity (2 months after randomisation); Disability (2 months after randomisation)
B: Muscle activity onset in transversus abdominal muscle (1 year)
C: Change from baseline of Disability using the Roland Morris Disability Questionnaire at 3 months, 1, 2 and 5 years (3 months, 1, 2 and 5 years)
D: Pain VAS

Answer: D