TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Morbidity and Mortality in Symptomatic Patients With Pulmonary Arterial Hypertension - A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Prospective, Event Driven Phase IV Study
Brief Summary: COMPASS-2 is a Phase 4, prospective, randomized, double-blind, placebo-controlled, event-driven study evaluating the effect of bosentan on the time to first confirmed morbidity/mortality event in patients with symptomatic PAH already receiving sildenafil therapy. Patients must have been receiving doses of sildenafil equal to or greater than 20 mg t.i.d. for at least 12 weeks prior to being randomized.

The study continued until the predefined target number of morbidity/mortality events was reached.


Options:
A: Change From Baseline in the Total Distance Walked During 6-Minute Walk Test (6MWT) at Week 12 (Baseline and Week 12)
B: Time to First Confirmed Morbidity/Mortality Event up to the End of Study (From baseline to end of study, approximately 86 months)
C: Number of Participants With Adverse Events (AEs) (Baseline (Double-Blind Period) up to Week 243 (End of Open-Label Period))
D: 6 minutes walking distance

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label, Sequential Cohort, Dose Escalation Study to Evaluate the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Brief Summary: The purpose of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with low or Intermediate-1 risk MDS. In addition, the study will evaluate the platelet response to romiplostim.


Options:
A: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase I (From Cycle 1, Day 1 (C1D1) until at least 30 days post-investigational product discontinuation (longer for AEs considered related to study participation)); Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I (After Baseline (C1D1), on-treatment and 30 day follow-up); Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I (After Baseline (C1D1), on-treatment and 30 day follow-up); Number of Participants With a Change From Baseline in Creatinine of >=26.5 Micromoles/Liter (UMOL/L) in Phase I (After Baseline (C1D1), on-treatment and 30 day follow-up); Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I (Screening, C1D1, C2D1, C2D8, C2D15, C3D1, C4D1, C4D22, C5D1, C5D8, C6D1, C6D15); Number of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase I (C2D4, C2D8, C5D8, C6D15); Mean Day 1 Scheduled Pre-chemotherapy Platelet Count Evaluated Across Cycles 1 to 6 in Phase II (Day 1 (averaged across cycles 1 to 6))
B: Part A: Number of Participants With Adverse Events (Treatment period (4 weeks) plus treatment extension (1 year)); Part B: Number of Participants With Adverse Events (Treatment period (8 weeks) plus treatment extension (1 year))
C: Safety and tolerability endpoints will consist of the evaluation of adverse events (AE), and changes from baseline in vital signs and clinical laboratory parameters (Approximately 42 weeks)
D: Change in baseline platelet count from the first day of the second cycle of chemotherapy to the lowest count observed (nadir) during the cycle(21 days) (throughout entire study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label, Sequential Cohort, Dose Escalation Study to Evaluate the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Brief Summary: The purpose of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with low or Intermediate-1 risk MDS. In addition, the study will evaluate the platelet response to romiplostim.


Options:
A: How Many WAS Patients Will Achieve Platelet Counts Above 50,000/ul. (12 weeks)
B: Part A: Number of Participants With Adverse Events (Treatment period (4 weeks) plus treatment extension (1 year)); Part B: Number of Participants With Adverse Events (Treatment period (8 weeks) plus treatment extension (1 year))
C: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period through interim follow-up visit (up to 16 weeks))
D: The proportion of patients who die or have bleeding of WHO grade 2 or above by WHO criteria during the first 30 days from the first dose of trial treatment, or planned first dose for those participants who do not receive treatment. (The first 30 days from first dose of trial treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label, Sequential Cohort, Dose Escalation Study to Evaluate the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Brief Summary: The purpose of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with low or Intermediate-1 risk MDS. In addition, the study will evaluate the platelet response to romiplostim.


Options:
A: reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy) (2010)
B: Daily hemostatic assessments will be conducted to determine presence of WHO Grade 2 bleeding or greater.
C: The Portion of Drug Responders as Defined by Hematologic Improvements (12-16 weeks)
D: Part A: Number of Participants With Adverse Events (Treatment period (4 weeks) plus treatment extension (1 year)); Part B: Number of Participants With Adverse Events (Treatment period (8 weeks) plus treatment extension (1 year))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label, Sequential Cohort, Dose Escalation Study to Evaluate the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Brief Summary: The purpose of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with low or Intermediate-1 risk MDS. In addition, the study will evaluate the platelet response to romiplostim.


Options:
A: Kaplan-Meier Estimates for Median Time to Death From Any Cause (Day 1 (randomization) to 42 months); Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause (Day 1 (randomization) to 42 months); Number of Participants Who Died (42 months)
B: Part A: Number of Participants With Adverse Events (Treatment period (4 weeks) plus treatment extension (1 year)); Part B: Number of Participants With Adverse Events (Treatment period (8 weeks) plus treatment extension (1 year))
C: Safety and tolerability parameters including non-hematological laboratory Grade 3/Grade 4 toxicities, change in bone marrow blast counts from baseline and adverse events reporting. (Approximately 46 months)
D: Participants Who Achieved Red Blood Cell (RBC) -Transfusion Independence (Up to 2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind, Randomized, Placebo Controlled Trial With Metformin in Non-Alcoholic Fatty Liver Disease (NAFLD)
Brief Summary: The study evaluates the use of the antidiabetic medicine metformin in nonalcoholic fatty liver disease.


Options:
A: Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) (Baseline (Visit 2; Week 0) to Visit 8 (Week 52))
B: Insulin Resistance and Glucose Homeostasis (baseline and 6 weeks)
C: Serum adipocytokines levels (52 weeks)
D: Grade of steatosis as judged by repeat biopsy (6 mo)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Trial of Polyphenon E for Cervical Cancer Prevention
Brief Summary: This randomized phase II trial is studying green tea extract to see how well it works compared to a placebo in preventing cervical cancer in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia. Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of green tea extract may stop cervical cancer from forming in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia. It is not yet known whether green tea extract is more effective than a placebo in preventing cervical cancer in patients with human papillomavirus and low-grade cervical intraepithelial neoplasia.


Options:
A: Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score) (Baseline (pre-intervention) and end of study (time to surgery for those with malignant findings or up to 8 weeks for those with benign biopsies, post-intervention)); Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention (End of study)
B: Recurrence/Number/Size of metachronous colorectal adenoma(s) (1 year)
C: Rate of Progression to Prostate Cancer (PCa) (12 months); Rate of Progression From HGPIN to ASAP or PCa (12 months)
D: Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease (4 months); Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia (4 months); No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia (4 months); Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer (4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: RENEW: Reach Out to Enhance Wellness in Older Survivors
Brief Summary: RATIONALE: Exercise and dietary counseling may improve physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.

PURPOSE: This randomized clinical trial is studying two different schedules of exercise and dietary counseling to compare how well they work in improving physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.


Options:
A: Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study) (6 months)
B: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)
C: Weight loss (2 years)
D: Weight loss (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: RENEW: Reach Out to Enhance Wellness in Older Survivors
Brief Summary: RATIONALE: Exercise and dietary counseling may improve physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.

PURPOSE: This randomized clinical trial is studying two different schedules of exercise and dietary counseling to compare how well they work in improving physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.


Options:
A: Change in FACIT-TS questionnaire score (Baseline, 6 months)
B: Exercise behavior
C: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)
D: quality of life, fatigue, and body weight (baseline, 6 months, 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: RENEW: Reach Out to Enhance Wellness in Older Survivors
Brief Summary: RATIONALE: Exercise and dietary counseling may improve physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.

PURPOSE: This randomized clinical trial is studying two different schedules of exercise and dietary counseling to compare how well they work in improving physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.


Options:
A: Feasibility of Patient Recruitment to Yoga Intervention (10 weeks)
B: Measurement of Cardio Pulmonary exercise test related parameters (VO2 at AT) pre and post neoadjuvant chemoradiotherapy in rectal cancer patients. (2 years)
C: Change in Cardiorespiratory fitness (pre-NACRT (baseline), post-NACRT (an average of 6 weeks))
D: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: RENEW: Reach Out to Enhance Wellness in Older Survivors
Brief Summary: RATIONALE: Exercise and dietary counseling may improve physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.

PURPOSE: This randomized clinical trial is studying two different schedules of exercise and dietary counseling to compare how well they work in improving physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.


Options:
A: Changes from Baseline in Exercise, Diet, and Posttraumatic Growth Inventory(PTGI) (baseline, 3month, 6month, and 12month)
B: Change from Baseline in Body Composition (At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis)
C: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)
D: Weight loss (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: RENEW: Reach Out to Enhance Wellness in Older Survivors
Brief Summary: RATIONALE: Exercise and dietary counseling may improve physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.

PURPOSE: This randomized clinical trial is studying two different schedules of exercise and dietary counseling to compare how well they work in improving physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.


Options:
A: Quality of life as measured by Functional Assessment of Cancer Therapy for General Cancer (FACT-G) and Functional Assessment of Cancer Therapy for Fatigue (FACT-F) at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Weight loss as measured by weight, body mass index (BMI), waist circumference, Weight Efficacy Life Style Questionnaire, Three Factor Eating Inventory Questionnaire, and Leisure Score index at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Functional status as measured by ECOG performance status, and short-form health survey with 36 questions (SF-36) (baseline, 3, 6, and 12 months); Comorbidities as measured by Charlson Co-Morbidity Score at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months)
B: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)
C: Weight loss (2 years)
D: Weight loss (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: RENEW: Reach Out to Enhance Wellness in Older Survivors
Brief Summary: RATIONALE: Exercise and dietary counseling may improve physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.

PURPOSE: This randomized clinical trial is studying two different schedules of exercise and dietary counseling to compare how well they work in improving physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.


Options:
A: Change in body weight (0, 6, 12, 18 weeks)
B: Identify changes in energy balance and insulin sensitivity parameters in overweight breast cancer survivors after a behavioral weight loss intervention. (Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.); Determine whether the addition of resistance training to a behavioral weight loss intervention preserves muscle mass and improves weight loss or insulin sensitivity in breast cancer survivors. (Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.)
C: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)
D: Quality of Life

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting
Brief Summary: The purpose of this study is to characterize current management of patients with either heart failure or prior myocardial infarction and left ventricular dysfunction and to assess the effect of education, specific clinical guidelines, reminder systems, comprehensive disease state management tools, benchmarked quality reports, and academic detailing on the use of evidence-based heart failure therapies in cardiology practices. This study is a quality improvement initiative that is being conducted through review of patient records.


Options:
A: All cause mortality (5 years)
B: Combination of all-cause mortality and first hospitalization (time to first event), where all-cause mortality is defined as death from all causes.
C: N/A
D: To Evaluate Over the Aggregate IMPROVE-HF Practice Sites the Relative Changes in 7 Performance Measures at 24 Months Compared With Baseline and Determine the Number of Performance Measures That Achieved a Relative 20% or Greater Positive Change. (24 Month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Trial Comparing Conventional Adjuvant Temozolomide With Dose-Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known which schedule of temozolomide when given together with radiation therapy is more effective in treating glioblastoma or gliosarcoma.

PURPOSE: This randomized phase III trial is studying two different schedules of temozolomide to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed glioblastoma or gliosarcoma.


Options:
A: Median Overall Survival Time (From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.)
B: 6 Month Progression-free Survival (First day of treatment until progression or until 6 months mark)
C: Overall Survival (OS) (From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.); Progression-free Survival (PFS) (From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.)
D: Overall survival (OS) (Day of surgery until death of any cause assessed up to 34 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Trial Comparing Conventional Adjuvant Temozolomide With Dose-Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known which schedule of temozolomide when given together with radiation therapy is more effective in treating glioblastoma or gliosarcoma.

PURPOSE: This randomized phase III trial is studying two different schedules of temozolomide to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed glioblastoma or gliosarcoma.


Options:
A: Overall Survival (OS) Time (Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012))
B: Overall Survival (During treatment and every three months from end of treatment through end of study or approximately up to 5 years.)
C: Median Overall Survival Time (From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.)
D: Overall Survival (7 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Multicenter, Randomised, Double-blind, Placebo Controlled, Dose Finding Study of Subcutaneously Administered Interferon Beta-1a for Maintenance of Remission in Patients With Crohn's Disease
Brief Summary: The purpose of this study is to determine the safety and efficacy of interferon beta-1a in maintaining remission in patients with Crohn's disease.


Options:
A: Percentage of Participants With Mucosal Healing and No Deep Ulcerations (48 weeks after Randomization)
B: The primary efficacy endpoint was the proportion of patients who maintained remission (relapse-free) and did not receive any additional treatment for the management of Crohn's disease by week 26.
C: Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores (8 weeks)
D: Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 (Week 6); Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 (Week 52)

Answer: B