TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Symptomatic Pulmonary Arterial Hypertension Associated With Sickle Cell Disease
Brief Summary: The study will assess the effect of bosentan on pulmonary vascular resistance and exercise capacity in sickle cell disease (SCD) patients diagnosed with pulmonary arterial hypertension. It consists of 3 phases: Screening, Treatment and Follow-up. During the Screening visit, the study doctor will decide if patients meet the study requirements. All potential patients will have a diagnosis of increased pulmonary artery pressures that is shown by right heart catheterization conducted shortly prior to start of study treatment. Patients will be asked to perform exercise capacity test (walking as far as possible for 6 minutes). Following the Baseline visit, the treatment phase consists of 4 additional clinic visits during which the good and bad effects of the drug are reviewed and exercise capacity test will be repeated. Patients will be treated for 16 weeks. Blood samples will be collected every month, or more often, if needed. At the end of the study, patients will be asked to repeat the right heart catheterization and exercise capacity test. After completion of the study, patients will have the option of enrolling in a long-term follow-up study where all patients will receive active drug. Patients electing not to participate in the extension study will be followed up for safety assessments for about 28 days after the end of the study treatment.


Options:
A: Change from Baseline to End of Study in 6MWT distance. A mean difference from placebo of at least 35 m is considered clinically relevant. (16 weeks)
B: Change From Baseline to Week 16 in Exercise Capacity, as Measured by 6-minute Walk Distance (6MWD) (From baseline to Week 16)
C: Exercise Capacity; Pulmonary artery systolic pressure
D: Time to First Confirmed Morbidity/Mortality Event up to the End of Study (From baseline to end of study, approximately 86 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Symptomatic Pulmonary Arterial Hypertension Associated With Sickle Cell Disease
Brief Summary: The study will assess the effect of bosentan on pulmonary vascular resistance and exercise capacity in sickle cell disease (SCD) patients diagnosed with pulmonary arterial hypertension. It consists of 3 phases: Screening, Treatment and Follow-up. During the Screening visit, the study doctor will decide if patients meet the study requirements. All potential patients will have a diagnosis of increased pulmonary artery pressures that is shown by right heart catheterization conducted shortly prior to start of study treatment. Patients will be asked to perform exercise capacity test (walking as far as possible for 6 minutes). Following the Baseline visit, the treatment phase consists of 4 additional clinic visits during which the good and bad effects of the drug are reviewed and exercise capacity test will be repeated. Patients will be treated for 16 weeks. Blood samples will be collected every month, or more often, if needed. At the end of the study, patients will be asked to repeat the right heart catheterization and exercise capacity test. After completion of the study, patients will have the option of enrolling in a long-term follow-up study where all patients will receive active drug. Patients electing not to participate in the extension study will be followed up for safety assessments for about 28 days after the end of the study treatment.


Options:
A: Change from Baseline to End of Study in 6MWT distance. A mean difference from placebo of at least 35 m is considered clinically relevant. (16 weeks)
B: Change from Baseline to End of Study in 6MWT distance. A mean difference from placebo of at least 35 m is considered clinically relevant. (16 weeks)
C: Acute Chest Syndrome (Chest x-rays (CXR) were ordered for trial eligibility, as a result of clinical indications, or at discharge or 72 hours if no prior CXR.)
D: Change from baseline to all assessed time points in 6MWT, in Borg dyspnea index, and in modified NYHA functional class.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: International, Multicenter, Randomized, Parallel Group, Double-blind Study, in Patients With Acute Symptomatic Deep Vein Thrombosis of the Lower Limbs, Demonstrating the Bioequipotency at Steady State of Equimolar Doses of SSR126517E (3.0 mg) Once a Week and SR34006 (2.5 mg) Once a Week, Documenting the Safety and Efficacy of Both Compounds During a 6-month Treatment, and Demonstrating the Neutralizing Effect of SSR29261 on the SSR126517E-induced Anti-Xa Activity
Brief Summary: The three purposes of this study are the following:

* To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux (SSR126517) with that of idraparinux (SR34006), taking into account new events of deep venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk;
* To compare the activities of idrabiotaparinux and idraparinux directly in blood during and after a 6-month treatment;
* To check the ability of avidin (SSR29261) to reverse the blood thinning activity of idrabiotaparinux at the end of a 6-month treatment period.


Options:
A: Incidence of Any Adjudicated Bleeding Events (14 days); Incidence of Adverse Events (1 month); Incidence of Adverse Drug Reactions (1 month); Plasma Concentration of DU-176b (14 days); Plasma Concentration of D21-2393 (14 days)
B: Number of Participants With Venous Thromboembolisms and/or Major Hemorrhages to Day 11 (11 days)
C: Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters (Day 183); Avidin neutralizing effect substudy: decrease in anti-Xa activity between the start and end of the avidin infusion (Day 183 to Day 188)
D: symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: International, Multicenter, Randomized, Parallel Group, Double-blind Study, in Patients With Acute Symptomatic Deep Vein Thrombosis of the Lower Limbs, Demonstrating the Bioequipotency at Steady State of Equimolar Doses of SSR126517E (3.0 mg) Once a Week and SR34006 (2.5 mg) Once a Week, Documenting the Safety and Efficacy of Both Compounds During a 6-month Treatment, and Demonstrating the Neutralizing Effect of SSR29261 on the SSR126517E-induced Anti-Xa Activity
Brief Summary: The three purposes of this study are the following:

* To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux (SSR126517) with that of idraparinux (SR34006), taking into account new events of deep venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk;
* To compare the activities of idrabiotaparinux and idraparinux directly in blood during and after a 6-month treatment;
* To check the ability of avidin (SSR29261) to reverse the blood thinning activity of idrabiotaparinux at the end of a 6-month treatment period.


Options:
A: symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.
B: Bioequipotency sub-study: idrabiotaparinux/idraparinux ratio for pharmacodynamic exposure parameters (Day 183); Avidin neutralizing effect substudy: decrease in anti-Xa activity between the start and end of the avidin infusion (Day 183 to Day 188)
C: Efficacy: Percent Change From Baseline in Anti-fXa Activity at the Nadir (Parts I and II) (Baseline to +2 minutes or +5 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II))
D: symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Controlled Trial of an Interactive CD-Program on 6 Months Readmission Rate in Patients With Heart Failure
Brief Summary: The purpose of this study is to determine whether extra education of patients with chronic heart failure can reduce 6 months readmission rate to hospital.


Options:
A: Lifestyle (3 months); Quality of Life (QoL) (3 months); Behavioral flexibility (3 months)
B: Readmission and death rate at 6 months' follow up.
C: Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via: (Baseline, 6 and 12 months)
D: Change in self-care behaviour measured with the validated European Heart Failure Self Care Behaviour Scale(EHFScB scale) (at 3, 6 and 12 months); Change in health related quality of life measured with the generic short-form health survey with 36 questions (SF36), EuroQol five Dimensions (EQ-5D) and the disease-specific Minnesota Living with Heart Failure Questionnaire (MLHFQ) (at 3, 6 and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Controlled Trial of an Interactive CD-Program on 6 Months Readmission Rate in Patients With Heart Failure
Brief Summary: The purpose of this study is to determine whether extra education of patients with chronic heart failure can reduce 6 months readmission rate to hospital.


Options:
A: Understanding (Directly proceeding the clinical encounter); Decisional Conflict (Directly proceeding the clinical visit); Treatment Action, adherence (Directly proceeding the clinical encounter, 6 months after the clinical encounter)
B: - Rate of influenza immunization among subjects
C: Adherence; Self-efficacy; Quality of life
D: Readmission and death rate at 6 months' follow up.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme, Phase III Study to Compare the Preventive Effect of Recurrent Brain Infarction and Safety of Aggrenox (Combination Drug Containing Sustained-release Dipyridamole 200 mg/Acetylsalicylic Acid 25 mg) Twice Daily vs. Acetylsalicylic Acid 81 mg Once Daily
Brief Summary: Phase III study to compare the preventive effect of recurrent brain infarction and safety of Aggrenox (combination drug containing sustained-release dipyridamole 200 mg/acetylsalicylic acid 25 mg) twice daily vs. acetylsalicylic acid 81 mg once daily


Options:
A: Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal) (Up to 124 weeks)
B: Any stroke at 90 days; Stroke severity
C: Telephone Modified Rankin Scale (Centralised, Blinded Assessment) (90 days)
D: Comparison of the frequency of mRS 0, 1, 2 at 90 days (at 90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme, Phase III Study to Compare the Preventive Effect of Recurrent Brain Infarction and Safety of Aggrenox (Combination Drug Containing Sustained-release Dipyridamole 200 mg/Acetylsalicylic Acid 25 mg) Twice Daily vs. Acetylsalicylic Acid 81 mg Once Daily
Brief Summary: Phase III study to compare the preventive effect of recurrent brain infarction and safety of Aggrenox (combination drug containing sustained-release dipyridamole 200 mg/acetylsalicylic acid 25 mg) twice daily vs. acetylsalicylic acid 81 mg once daily


Options:
A: Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal) (Up to 124 weeks)
B: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)
C: Any stroke at 90 days; Stroke severity
D: Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes (Up to 90 days); Major Hemorrhage (Up to 90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Chemotherapy-induced Menopause by Temporary Ovarian Suppression With Triptorelin Vs. Control in Young Breast Cancer Patients. A Randomized Phase III Multicenter Study [PROMISE]
Brief Summary: RATIONALE: Chemotherapy may cause early menopause in premenopausal women. Triptorelin may prevent this from happening.

PURPOSE: This randomized phase III trial is studying triptorelin to see how well it works in preventing early menopause in premenopausal women who are receiving chemotherapy for stage I, stage II, or stage III breast cancer that has been removed by surgery.


Options:
A: Chemotherapy-induced early menopause as measured by follicle-stimulating hormone, 17 beta estradiol levels, and menstrual activity resumption at 1 year following the completion of chemotherapy
B: Resumption of menstruation (1 year)
C: Disease-free Survival (5-year estimates, reported at a median follow-up of 67 months.)
D: Disease-free Survival (5-year estimate reported at a median follow-up of 72 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Transfer of Skills From LapSimGyn VR-Simulator to a Laparoscopic Salpingectomy
Brief Summary: The purpose is to determine if skills obtained by training in the laparoscopic virtual reality simulator LapSimGyn can be transferred to a real laparoscopic operation measured as improved score in a technical skills assessment.


Options:
A: Rating Scale Score (1 day)
B: Fugl Meyer Assessment Scale (four and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up)
C: Action Research Arm Test (ARAT) (End of treatment at 8 weeks post enrolment)
D: Motor and Strength Outcome Measure Using Box and Block Test (From baseline to 1 month post therapy); Motor and Strength Outcome Measure Using Fugl-Meyer Score (From baseline to 1 month post therapy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of Intravenous Versus Oral Administration of Prednisolone in the Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease
Brief Summary: Treatment with systemic corticosteroids for acute exacerbations of COPD results in the improvement of clinical outcomes. The optimal route of administration has not been rigorously studied in COPD. Upon hospitalization, corticosteroids are administered intravenously in many hospitals. Oral administration is more convenient, though, because there is no need for intravenous access, less personnel is required for starting and monitoring therapy, and material costs are smaller.

The investigators hypothesized that oral administration is not inferior to intravenous administration of prednisolone in the treatment of patients hospitalized for an acute exacerbation of COPD.


Options:
A: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment (Baseline and Week 24); Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment (Baseline and Week 12)
B: Baseline Pre-bronchodilator FEV1 (L) (Day 1); End-value Pre-bronchodilator FEV1 (L) (Measured at clinic visits: 1, 4, 8 and 12 weeks)
C: Treatment failure defined as: death from any cause; admission to the intensive care unit; readmission to the hospital because of COPD; and the necessity to intensify pharmacologic treatment
D: Identifying new patient subtypes and endpoints for COPD (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Study of Sequential Versus Combination Chemotherapy in Patients With Previously Untreated Advanced Colorectal Carcinoma
Brief Summary: Primary objective:To assess the efficacy, defined as overall survival, of sequential versus combination chemotherapy for advanced colorectal cancer (CRC).

Methodology Open, randomised multicenter phase III study. Randomisation by centre will be centralized. 820 patiënts with histologically proven advanced CRC; not amenable to curative surgery. Measurable or evaluable disease. Age 18 years and above. WHO performance status 0-2.

Test products:

Arm A: First line: capecitabine capecitabine 1250 mg/m2 orally b.i.d. on day 1-14 (q3),until progression or unacceptable toxicity. Second line: irinotecan 350 mg/m2 IV infusion on day 1 (q3),until progression or unacceptable toxicity. Third line: oxaliplatin 130 mg/m2 IV infusion on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3). Arm B: First line: irinotecan 250 mg/m2 IV infusion in 30 minutes on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3), until progression or unacceptable toxicity. Second line: oxaliplatin 130 mg/m2 IV on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3), until progression or unacceptable toxicity.

Patients will be followed by CT-scan every 9 weeks for response while on treatment, or at any other moment when progression is suspected. After cessation of chemotherapy, patients will be followed every 3 months until death. Clinical and laboratory toxicity/symptomatology will be graded according to NCI common criteria.


Options:
A: Overall Survival (From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA).)
B: Progression-free survival (last progression of the last patient)
C: Overall survival (study duration)
D: Progression free survival (every course for first three courses, then every other course)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility and Impact of Qigong as Compared to Aerobic Exercise in the Treatment of Childhood Chronic Musculoskeletal Pain: A Pilot Randomized Controlled Trial.
Brief Summary: This study is comparing two different exercise programs, Qi Gong (gentle stretching, and breathing) with an aerobics program (boxing and dancing) to see if children with chronic pain or fibromyalgia are able to take part in the program. We would also like to know if it is easy to take part in an exercise program.

We hypothesize that children with chronic musculoskeletal pain and FM, who engage in Qigong fitness training, will be more compliant, and have an equivalent or possibly superior improvement on measures of motor function (peak power, endurance, and metabolic efficiency) compared to children given an aerobic fitness exercise program.


Options:
A: Pain Diary - Average Daily Pain (Baseline,12 weeks, and 26 weeks); Pain Diary - Average Daily Activity Limitations (Baseline,12 weeks, and 26 weeks); Adaptive Coping - Coping Attempts (Baseline,12 weeks, and 26 weeks)
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: Juvenile Arthritis Quality of Life Questionnaire (JAQQ) (Baseline (prior to randomization) and 3 months after intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open, Randomized, Multicenter Study of the Safety, Tolerability, & Immunogenicity of VAQTA™ Given Concomitantly With PROQUAD™ and PREVNAR™ in Healthy Children 12 Months of Age
Brief Summary: Hepatitis A vaccine will be given either alone or together with measles, mumps, rubella, and varicella vaccine and pneumococcal 7-valent conjugate vaccine at the first dose and together with measles, mumps, rubella, and varicella \[Oka/Merck\] virus vaccine at the second dose. Immunogenicity and safety data will be collected after each dose of vaccine.


Options:
A: Post vacc: rectal fever >39°C
B: Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV) (At Day 42 after vaccination); Concentration of Antibodies to Varicella Virus (VZV) (At Day 42 after vaccination); Number of Subjects With Seroresponse for Antibodies to Mumps Virus (At Day 42 after vaccination); Number of Subjects With Seroresponse for Antibodies to Measles Virus (At Day 42 after vaccination); Number of Subjects With Seroresponse for Antibodies to Rubella Virus (At Day 42 after vaccination); Concentration of Antibodies to Hepatitis A Virus (HAV) (At Day 42 after vaccination); Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (At Day 42 after vaccination)
C: Antibody Response to Hepatitis A - Participants With a Serological Response (4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)); Antibody Response to Varicella - Participants With a Serological Response (6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)); Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers (6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)); Participants With 1 or More Systemic Adverse Experience (6 weeks post dose 1); Participants With 1 or More Systemic Adverse Experience (4 weeks post dose 2); Participants With 1 or More Systemic Adverse Experience. (6 months); Participants With 1 or More Injection-site Adverse Experience (6 weeks post dose 1); Participants With 1 or More Injection-site Adverse Experience (4 weeks post dose 2); Participants With 1 or More Injection-site Adverse Experience (6 months); Participants With Elevated Temperature (≥102.2F/ ≥39.0C) (6 weeks post dose 1); Participants With Elevated Temperature (≥102.2F/ ≥39.0C) (4 weeks post dose 2); Participants With Elevated Temperature (≥102.2F/ ≥39.0C) (6 months); Participants With 1 or More Serious Vaccine-related Adverse Experience (6 weeks post dose 1); Participants With 1 or More Serious Vaccine-related Adverse Experience (4 weeks post dose 2); Participants With 1 or More Serious Vaccine-related Adverse Experience (6 months)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Neuroscience-Guided Remediation of Cognitive Deficits in Schizophrenia
Brief Summary: This study will determine the effectiveness of reward-intensive, computer-based targeted cognitive training in improving neurocognitive deficits in people with schizophrenia.


Options:
A: Change from Baseline in Cognitive Function after 12 Weeks and 28 Weeks (Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment)
B: Cognitive performance as measured by a neuropsychological battery (Measured at Weeks 8, 14, and 8 and Month 6 follow-up)
C: Change from Baseline in MATRICS Consensus Cognitive Battery scores at 12 weeks (Baseline and after 12 weeks.); Change from Baseline in VO2Max (maximal oxygen consumption) at 12 weeks (Baseline and after 12 weeks); Change from Baseline in 6-Minute Walk Test (6MWT) score at 12 weeks (Baseline and after 12 weeks); Change from Baseline in Daily Functioning Assessments at 12 weeks (Baseline and after 12 weeks)
D: Change from Baseline Social Cognition at 6 months (Baseline (Intake)/6 months follow-up after trianing completion)

Answer: B