TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Propranolol vs Prednisolone for Infant Hemangiomas-A Clinical and Molecular Study
Brief Summary: Hemangiomas are relatively common lesions in infants. Most go away spontaneously after one year of life and do not need treatment. Others require treatment because they cause significant symptoms such as pain, or difficulty with breathing, eating or ambulating. Steroids have classically been used to treat hemangiomas and help to shrink them in 1/3 - 2/3 of patients. Unfortunately, steroids have many side effects in babies so physicians have sought other ways to treat them. Recently, the use of propranolol, a heart medication, was serendipitously found to reduce the size of hemangiomas. It appears to have many fewer side effects than steroids but it is not yet known if it works as well as steroids. This study seeks to compare the effect and the side effects of propranolol versus steroids for treating hemangiomas that cause symptoms in infants.


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: 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.)
C: Hemangioma outcome (1 year)
D: Decrease in Size of Hemangioma (Length x Width) in Square mm (4-5 months after initiating therapy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This 2 arm study will compare the effect of Avastin + irinotecan versus temozolomide, in combination with conventional involved field radiotherapy, in patients with newly diagnosed glioblastoma and a non-methylated MGMT promoter. Patients will be randomized 3:1 to receive Avastin 10mg/kg iv every 2 weeks + irinotecan 125mg/m2 iv every 2 weeks, or temozolomide 75mg/m2 po daily during radiotherapy followed by 6 cycles of temozolomide 150-200mg/m2 po daily on days 1-5 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Options:
A: Percentage of Participants Alive 6 Months After Start of Treatment (6 months); Overall Survival (OS) (Baseline until death (up to 691 days))
B: Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator (Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)); Co-Primary: Overall Survival (OS) (Randomization until OS Event (Until data cutoff= 28 February 2013 [up to 42.2 months]))
C: Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months (6 months)
D: Progression Free Survival (PFS) (Baseline at 6 weeks and then every 6 weeks to discontinuation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This 2 arm study will compare the effect of Avastin + irinotecan versus temozolomide, in combination with conventional involved field radiotherapy, in patients with newly diagnosed glioblastoma and a non-methylated MGMT promoter. Patients will be randomized 3:1 to receive Avastin 10mg/kg iv every 2 weeks + irinotecan 125mg/m2 iv every 2 weeks, or temozolomide 75mg/m2 po daily during radiotherapy followed by 6 cycles of temozolomide 150-200mg/m2 po daily on days 1-5 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Options:
A: Overall Survival (2.5 years)
B: 1. Percentage of patients with a histologically confirmed malignant glioma (grade III or IV -WHO) without definite residual contrast agent-accumulating tumour in the early post-operative control MRI (within 72 hours of the operation). (Within 72 hours after surgery); 2. Progression-free survival 6 months after primary surgical treatment of a malignant gli-oma in patients with histologically confirmed malignant glioma (grade III or IV -WHO). (Within 6 month after surgery)
C: Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months (6 months)
D: Overall Survival (During treatment and every three months from end of treatment through end of study or approximately up to 5 years.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: TIPPS - Thrombophilia in Pregnancy Prophylaxis Study: A Multicentre, Multinational, Randomized Control Trial of Prophylaxis Low Molecular Weight Heparin (LMWH) in High-risk Thrombophilic Women.
Brief Summary: The TIPPS trial seeks to determine the safety and effectiveness of low-molecular-weight heparin (LMWH), an anticoagulant, in preventing placenta mediated pregnancy complications and venous thromboembolism (VTE) in women with thrombophilia. Thus, the principal research question is: can LMWH prevent thrombosis in the leg veins, pulmonary arteries and placental vessels, thereby reducing the risk of deep vein thrombosis, pulmonary embolism (PE), intrauterine growth restriction (IUGR), preeclampsia, miscarriage and stillbirth?


Options:
A: The primary objective of the study is to identify if LMWH prophylaxis in thrombophilic pregnant women results in a greater than 33% relative risk reduction in the composite outcome measure (VTE, pre-eclampsia, IUGR and fetal loss) (6 weeks post-partum)
B: Successful pregnancy outcome
C: Pregnancy outcome (During the treatment)
D: placental syndrome or thromboembolic event (9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: TIPPS - Thrombophilia in Pregnancy Prophylaxis Study: A Multicentre, Multinational, Randomized Control Trial of Prophylaxis Low Molecular Weight Heparin (LMWH) in High-risk Thrombophilic Women.
Brief Summary: The TIPPS trial seeks to determine the safety and effectiveness of low-molecular-weight heparin (LMWH), an anticoagulant, in preventing placenta mediated pregnancy complications and venous thromboembolism (VTE) in women with thrombophilia. Thus, the principal research question is: can LMWH prevent thrombosis in the leg veins, pulmonary arteries and placental vessels, thereby reducing the risk of deep vein thrombosis, pulmonary embolism (PE), intrauterine growth restriction (IUGR), preeclampsia, miscarriage and stillbirth?


Options:
A: Live Birth (after delivery)
B: The primary objective of the study is to identify if LMWH prophylaxis in thrombophilic pregnant women results in a greater than 33% relative risk reduction in the composite outcome measure (VTE, pre-eclampsia, IUGR and fetal loss) (6 weeks post-partum)
C: Study Feasibility: Mean Recruitment Rate Per Center Per Month (24 months)
D: placental syndrome or thromboembolic event (9 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of a Physical-activity-promoting Environment on Motor Skills, Physical Activity, Quality of Life and BMI of Children in Childcare Settings (Youp'là Bouge)
Brief Summary: The purpose of the study is to evaluate the effect of a project promoting unstructured spontaneous physical activity (PA) through an adaptation of the built environment and the provision of a supportive social environment of childcare centers on motor skills, physical activity, desire to move around, body mass index (BMI), quality of life and PA and behavior of the family.


Options:
A: Motor skills (1 school year)
B: BMI and aerobic fitness (1 schoolyear)
C: Anthropometric Variables (every two years)
D: Waist circumference (10 months); BMI-Z score (10 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Developing and Testing a Tamoxifen Prophylaxis Decision Aid
Brief Summary: RATIONALE: Evaluating a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent breast cancer may be helpful for women at increased risk of breast cancer.

PURPOSE: This randomized phase I/II trial is studying tamoxifen citrate decision aids for women at increased risk of breast cancer.


Options:
A: Decisional Conflict Scale (3 months)
B: decisional conflict scale (Change from baseline in decisional conflict at 3 months)
C: Knowledge, realistic expectations and decisional conflict 3 weeks after using the decision aid.
D: Development and testing of a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent primary breast cancer

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Study Comparing Irradiation at a Dose of 80 Gy to Irradiation at 70 Gy in Unfavorable Prostate Cancers Associated With Prolonged Hormonal Therapy
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating patients with prostate cancer.

PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens in treating patients with prostate cancer receiving hormone therapy.


Options:
A: Biochemical or clinical progression-free survival at 5 years (5 years)
B: Conventional Radiotherapy (CIMRT) Versus Hypofractionated Radiotherapy (HIMRT) (8.5 years)
C: Freedom from failure
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Fibrinogen and Bleeding After Cardiac Surgery
Brief Summary: The study hypothesis is that prophylactic fibrinogen infusion reduces postoperative bleeding and transfusion requirements after coronary artery bypass surgery (CABG) in patients with endogenous fibrinogen levels in the lower normal range. 60 patients will be included in a prospective, randomized double-blind placebo-controlled single center study.


Options:
A: To evaluate safety of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing cardiac surgery (2 years); Blood loss first 12 postoperative hours (12h)
B: Death in hospital within four weeks of injury (causes of death will be described to assess whether deaths were due to haemorrhage or vascular occlusion). (Death, discharge or four weeks post randomisation whichever occurs first.)
C: Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed (At 1 and 4 hours after the end of infusion); Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR) (30 minutes after end of infusion)
D: Total amount of transfused red cell concentrate (24 hours after start of surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry
Brief Summary: This study aims to evaluate, in a randomized controlled trial, tobacco treatments of varying intensities for smokers hospitalized on acute psychiatric inpatient units.


Options:
A: Number of Participants With Smoking Cessation (12 WEEK)
B: reducers (week-24 from baseline)
C: smoking cessation (52 weeks)
D: smoking status (baseline, 3, 6, 12, and 18 months follow-up); commitment to abstinence (baseline, 3, 6, 12, and 18 months); quit attempts (3, 6, 12, and 18 months follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry
Brief Summary: This study aims to evaluate, in a randomized controlled trial, tobacco treatments of varying intensities for smokers hospitalized on acute psychiatric inpatient units.


Options:
A: urine carcinogen biomarker of exposure, NNAL (week 24)
B: Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers) (number of cigarettes/day as assessed at week 24)
C: smoking status (baseline, 3, 6, 12, and 18 months follow-up); commitment to abstinence (baseline, 3, 6, 12, and 18 months); quit attempts (3, 6, 12, and 18 months follow-up)
D: Determine Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes (Up to 1 year); Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes (Up to 1 year); Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes (up to 1 year); Changes in withdrawal symptoms (up to 1 year); Subjective nicotine effect will be analyzed (up to 1 year); Changes in feelings and emotions (up to 1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry
Brief Summary: This study aims to evaluate, in a randomized controlled trial, tobacco treatments of varying intensities for smokers hospitalized on acute psychiatric inpatient units.


Options:
A: Number of cigarettes smoked per day (End of 6 week intervention)
B: Rate of Smoking Abstinence (18 months & 24 months post study enrollment)
C: smoking status (baseline, 3, 6, 12, and 18 months follow-up); commitment to abstinence (baseline, 3, 6, 12, and 18 months); quit attempts (3, 6, 12, and 18 months follow-up)
D: smoking cessation (52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry
Brief Summary: This study aims to evaluate, in a randomized controlled trial, tobacco treatments of varying intensities for smokers hospitalized on acute psychiatric inpatient units.


Options:
A: Traditional smoking cessation rate (5 years); Change from baseline in the number of traditional cigarette smoked (6, 12, 24, 36 and 60 months.)
B: reducers (week-24 from baseline)
C: smoking status (baseline, 3, 6, 12, and 18 months follow-up); commitment to abstinence (baseline, 3, 6, 12, and 18 months); quit attempts (3, 6, 12, and 18 months follow-up)
D: verified abstinence 6 months (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry
Brief Summary: This study aims to evaluate, in a randomized controlled trial, tobacco treatments of varying intensities for smokers hospitalized on acute psychiatric inpatient units.


Options:
A: urine carcinogen biomarker of exposure, NNAL (week 24)
B: smoking cessation (52 weeks)
C: Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline (week-12); Sustained smoking abstinence at week-12 (week 12)
D: smoking status (baseline, 3, 6, 12, and 18 months follow-up); commitment to abstinence (baseline, 3, 6, 12, and 18 months); quit attempts (3, 6, 12, and 18 months follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry
Brief Summary: This study aims to evaluate, in a randomized controlled trial, tobacco treatments of varying intensities for smokers hospitalized on acute psychiatric inpatient units.


Options:
A: Results in Abstinence Rates (1 Year)
B: smoking status (baseline, 3, 6, 12, and 18 months follow-up); commitment to abstinence (baseline, 3, 6, 12, and 18 months); quit attempts (3, 6, 12, and 18 months follow-up)
C: Smoking abstinence: Self reported abstinence (6 or more months without smoking) confirmed by an expired air carbon monoxide concentration of 6 parts per millions or less (12 months after initiation of study)
D: Percentage of Participants With 30-day Abstinence (6-months post enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous MEDI-528 in Adults With Uncontrolled Asthma
Brief Summary: To study the effectiveness and safety of multiple-doses of MEDI-528 on asthma control in adult participants with uncontrolled, moderate-to-severe, persistent asthma.


Options:
A: The primary objective is to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12. (12 weeks)
B: Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis) (Day 92)
C: Number of Clinically Significant Exacerbations of Asthma Per Year (From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose)
D: Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 (Day 1 and 92)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous MEDI-528 in Adults With Uncontrolled Asthma
Brief Summary: To study the effectiveness and safety of multiple-doses of MEDI-528 on asthma control in adult participants with uncontrolled, moderate-to-severe, persistent asthma.


Options:
A: Percentage of Participants With Asthma Exacerbation (Baseline up to Week 12)
B: Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis) (Day 92)
C: Number of Clinically Significant Exacerbations of Asthma Per Year (From randomization (Week 0) to Week 52 or early withdrawal (EW))
D: Rate of protocol-defined asthma exacerbations (new or increased asthma symptoms that lead to treatment with systemic corticosteroids or to hospitalization) from baseline to Week 36 (36 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome
Brief Summary: The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.


Options:
A: Proteinuria (at baseline and after 6 and 12 mo of treatment)
B: effect of linagliptin compared to placebo on basal production and release of nitric oxide (NO) from renal vasculature (Changes from baseline after 4 weeks of treatment with linagliptin and placebo)
C: Percentage of Participants With Primary Major Adverse Cardiac Events (MACE) (From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).)
D: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome
Brief Summary: The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.


Options:
A: Change in Weight Reported at 14 Weeks (Baseline and 14 weeks)
B: Triglyceride concentration in serum (Before and up to 8-hours post-injection)
C: Percentage of Participants With Primary Major Adverse Cardiac Events (MACE) (From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).)
D: Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for Meal Tolerance Test (MTT) at Week 8 (Baseline (Week 0) and Week 8); Percentage of Participants Who Experienced One or More Adverse Events (AEs) (Up to 10 weeks); Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE) (Up to 8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome
Brief Summary: The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.


Options:
A: Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke. (From randomisation to individual end of observation, up to 4.6 years)
B: Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death (Up to 4.6 years)
C: Change in left ventricular (LV) Mass by Cardiac MRI at 52 weeks (Baseline and 52 weeks)
D: Percentage of Participants With Primary Major Adverse Cardiac Events (MACE) (From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled on Metformin Monotherapy
Brief Summary: The purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin.


Options:
A: Change in HbA1c From Baseline to Week 52 (Day 1 (Baseline) and Week 52)
B: Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 (Baseline and Week 52)
C: Absolute Change in the Endothelial Progenitor Cell (EPC) Number (V0, V2 (month 4), V4 (12 month))
D: HbA1c (after 26 weeks of treatment)

Answer: A