TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation: Prospective, Multi-centre, Parallel-group, Non-inferiority Trial (RE-LY Study)
Brief Summary: The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.


Options:
A: Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on total cardiovascular events (One year)
B: Reduction in cardiac events (2)
C: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)
D: CV Death or Heart Failure Hospitalization (24 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation: Prospective, Multi-centre, Parallel-group, Non-inferiority Trial (RE-LY Study)
Brief Summary: The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.


Options:
A: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)
B: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE (For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180))
C: Composite of Recurrent VTE or VTE Death at 36 Months (36 months); Composite of Recurrent VTE or VTE Death at 18 Months (18 months)
D: Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding (Up to 2 days after the last dose)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation: Prospective, Multi-centre, Parallel-group, Non-inferiority Trial (RE-LY Study)
Brief Summary: The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.


Options:
A: Number of Participants With a Composite Endpoint of Stroke and Systemic Embolic Events (SEE) in Participants Who Were Administered DU-176b Compared With Placebo (Randomization up to the time of onset of the initial composite event of stroke or systemic embolic event, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time)); Number of Participants With Stroke and Systemic Embolic Events (SEE), Including Subcomponents of Stroke and Composite Event of Ischemic Stroke and SEE in Participants Who Were Administered DU-176b Compared With Placebo (Randomization up to the time of onset of the initial composite event of stroke or systemic embolic event, or study discontinuation, or end of study (whichever comes first), up to 3 years 2 months postdose (maximum follow-up time))
B: Incidence Rate of the Composite Efficacy Outcome (Adjudicated) (From randomization until the efficacy cut-off date (median 326 days)); Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated) (From randomization until the efficacy cut-off date (median 326 days))
C: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)
D: Composite outcome of recurrent ischemic stroke, symptomatic intracerebral hemorrhage, or all-cause mortality (90 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation: Prospective, Multi-centre, Parallel-group, Non-inferiority Trial (RE-LY Study)
Brief Summary: The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.


Options:
A: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)
B: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
C: Recurrent deep venous thrombosis or venous thromboembolism (6 months); Occurrence of fatal or major bleeding (6 months); Mortality related to massive pulmonary embolism (6 months)
D: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE (For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation: Prospective, Multi-centre, Parallel-group, Non-inferiority Trial (RE-LY Study)
Brief Summary: The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.


Options:
A: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)
B: 6 Month Bleeding Rate (Up to 6 months)
C: Recurrent deep venous thrombosis or venous thromboembolism (6 months); Occurrence of fatal or major bleeding (6 months); Mortality related to massive pulmonary embolism (6 months)
D: Symptomatic DVT (3 months); Symptomatic PE (3 months); Unsuspected PE and DVT (3 months); Worsening of pulmonary vascular or venous obstruction (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: SimCare: Physician Intervention to Improve Diabetes Care
Brief Summary: This randomized trial will test the hypotheses that (a) a physician opinion leader intervention, (b) a "narrative process trace" physician feedback intervention, or (c) the combined intervention (a + b), are no more effective than (d) usual care in improving the clinical care of adult patients with type 2 diabetes.


Options:
A: Comparison of change in diabetes quality of care between intervention and usual care group. (6 months follow-up)
B: Combined outcome of BP<130/80 mmHG, HgbA1C<8%, and LDL<100mg/dl at 1 year; the primary analysis will compare the intervention to usual care with respect to the percentage of diabetic individuals achieving all three therapeutic goals (one year)
C: glycemic control (All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians); lipid control (All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians)
D: Hemoglobin A1c (12 months); Systolic Blood Pressure (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: SimCare: Physician Intervention to Improve Diabetes Care
Brief Summary: This randomized trial will test the hypotheses that (a) a physician opinion leader intervention, (b) a "narrative process trace" physician feedback intervention, or (c) the combined intervention (a + b), are no more effective than (d) usual care in improving the clinical care of adult patients with type 2 diabetes.


Options:
A: Number of LTC residents on vitamin D (16 months)
B: glycemic control (All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians); lipid control (All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians)
C: Proportion of admitted injured adolescents receiving each element of the alcohol screening, brief intervention and referral to treatment (SBIRT) protocol (54 months)
D: Cumulative Incidence of ART Initiation 14 Days After Clinical Eligibility in Treatment Eligible HIV-infected Patients (14 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: SimCare: Physician Intervention to Improve Diabetes Care
Brief Summary: This randomized trial will test the hypotheses that (a) a physician opinion leader intervention, (b) a "narrative process trace" physician feedback intervention, or (c) the combined intervention (a + b), are no more effective than (d) usual care in improving the clinical care of adult patients with type 2 diabetes.


Options:
A: Episiotomies; Oxytocin use in third stage of labor
B: difference in change in systolic BP between the intervention and usual care groups (6 months)
C: glycemic control (All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians); lipid control (All A1c and LDL values and test dates were recorded for a defined 12-month period before and after the date of intervention for all diabetes patients under the care of study physicians)
D: The proportion of patients starting bisphosphonate treatment within 6 months of fracture (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Gemcitabine, Alone or in Combination With Cisplatin, in Patients With Advanced or Metastatic Cholangiocarcinomas and Other Biliary Tract Tumors: A Multicentre, Randomized Phase III Study
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, 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 whether gemcitabine is more effective with or without cisplatin in treating cholangiocarcinoma or biliary tract tumors.

PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine alone in treating patients with unresectable locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors.


Options:
A: objective response rate (baseline and every 8 weeks)
B: Progression-free survival [PFS] (approx. 25 months)
C: Progression Free Survival (up to 1032 days)
D: Overall Survival (From date of randomisation till date of death or last date of follow-up (up to 5 years))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sometimes, the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether fludarabine is more effective than observation in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works compared to observation only in treating patients with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia.


Options:
A: N/A
B: quality of life (1 year); functional health (1 year); falls (1 year); cognition (1 year); emotional health (1 year); mental health (1 year); physical health (1 year); pain (1 year); intraoperative awareness (30-90 days); all-cause mortality (1 year); surgical wound infection (1 year); nerve injury (30-90 days); stroke (1 year); delirium (30-90days); Stomach Ulcer (30-90 days); Gastrointestinal Bleed (30-90 days); Pneumonia (1 year); Respiratory Failure (1 year); Respiratory Arrest (1 year); Pulmonary Embolism (1 year); Deep Vein Thrombosis (1 year); Angina (1 year); Atrial Fibrillation (1 year); Congestive Heart Failure (1 year); Cardiac Arrest (1 year); Heart Attack (1 year)
C: Progression-free Survival (PFS) (Median observation time at time of analysis was approximately 21 months); Final Analysis: Time to Progression-free Survival Event (Median observation time was approximately 66.4 months)
D: Deaths in one year after non-cardiac surgery in patients with and without PMI (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC # 704865) Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women With Newly Diagnosed, Previously Untreated, Stage III or IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Brief Summary: This randomized phase III trial studies carboplatin, paclitaxel, and bevacizumab to see how well they work compared to carboplatin, paclitaxel, and placebo in treating patients with stage III or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin, paclitaxel, and placebo in treating ovarian epithelial, primary peritoneal, or fallopian tube cancer.


Options:
A: Duration of recurrence free survival.
B: quality of life (weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy); progression free survival (every 6 months)
C: Progression Free Suvaival (During the protocol treatment then 18 months from the last day of the protocol treatment)
D: Progression-free Survival (From study entry until first disease progression, death or date of last contact, up to 6 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC # 704865) Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women With Newly Diagnosed, Previously Untreated, Stage III or IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Brief Summary: This randomized phase III trial studies carboplatin, paclitaxel, and bevacizumab to see how well they work compared to carboplatin, paclitaxel, and placebo in treating patients with stage III or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin, paclitaxel, and placebo in treating ovarian epithelial, primary peritoneal, or fallopian tube cancer.


Options:
A: Progression-free Survival (From study entry until first disease progression, death or date of last contact, up to 6 years)
B: Progression-Free Survival (PFS), as Assessed by BIRC Per RECIST Version 1.1 in All Participants Randomized to the Study (From the date of randomization until the time of death or PD (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)); PFS, as Assessed by BIRC Per RECIST Version 1.1 in Participants With High Folate Receptor Alpha Level (≥ 75% of Tumor Staining) (From the date of randomization until the time of death or PD (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm))
C: Progression-free Survival (PFS) Differences Between Ixabepilone Alone and Ixabepilone + Bevacizumab (Up to 37 months)
D: Overall Objective Response (1 year after end inclusion)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC # 704865) Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women With Newly Diagnosed, Previously Untreated, Stage III or IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Brief Summary: This randomized phase III trial studies carboplatin, paclitaxel, and bevacizumab to see how well they work compared to carboplatin, paclitaxel, and placebo in treating patients with stage III or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin, paclitaxel, and placebo in treating ovarian epithelial, primary peritoneal, or fallopian tube cancer.


Options:
A: Progression free survival (up to 18 months)
B: Progression Free Survival (2 years)
C: Progression-free Survival (From study entry until first disease progression, death or date of last contact, up to 6 years)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC # 704865) Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women With Newly Diagnosed, Previously Untreated, Stage III or IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Brief Summary: This randomized phase III trial studies carboplatin, paclitaxel, and bevacizumab to see how well they work compared to carboplatin, paclitaxel, and placebo in treating patients with stage III or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin, paclitaxel, and placebo in treating ovarian epithelial, primary peritoneal, or fallopian tube cancer.


Options:
A: Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually
B: overall survival (OS) (Patients will be followed up for a minimum of 5 years after registration/randomisation or until death)
C: Evaluation and comparison of early surgical complications of primary surgery and Interval debulking surgery. (thirty days); Evaluation and comparison of late surgical complications of primary surgery and Interval debulking surgery (six months); Evaluation of the progression free survival (PFS) (Thirty-six months)
D: Progression-free Survival (From study entry until first disease progression, death or date of last contact, up to 6 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC # 704865) Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women With Newly Diagnosed, Previously Untreated, Stage III or IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Brief Summary: This randomized phase III trial studies carboplatin, paclitaxel, and bevacizumab to see how well they work compared to carboplatin, paclitaxel, and placebo in treating patients with stage III or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin, paclitaxel, and placebo in treating ovarian epithelial, primary peritoneal, or fallopian tube cancer.


Options:
A: Progression free survival (30 months)
B: Overall Objective Response (1 year after end inclusion)
C: Progression-free Survival (From study entry until first disease progression, death or date of last contact, up to 6 years)
D: Complete response rate (average 24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Genetic Counseling for Newly Diagnosed Breast Cancer Patients
Brief Summary: RATIONALE: Genetics education and counseling may help patients make treatment decisions. It is not yet known how genetic counseling or usual care influence patient treatment decisions for breast cancer.

PURPOSE: This randomized clinical trial is studying how well genetic counseling works compared to usual care in helping patients with newly diagnosed ductal carcinoma in situ, stage I, stage II, or stage IIIA breast cancer make treatment decisions.


Options:
A: Determine the non-inferiority/equivalency of telephone genetic counseling to standard in-person genetic counseling (6 &12-month follow-up)
B: Definitive surgery choice as measured by self-reported and medical record verification at 6 months after randomization (1, 6, and 12 months); Quality of life as measured by functional assessment of cancer therapy for breast cancer (FACT-B) at 1, 6, and 12 months after randomization (1, 6, and 12 months); Distress as measured by Impact of Events Scale Brief Symptom Inventory at 1, 6, and 12 months after randomization (1, 6, and 12 months); Knowledge as assessed by Genetic Testing Knowledge Measure at 1 month after randomization (1 month); Decision outcomes as assessed by Decisional Conflict Scale Satisfaction with Decision Scale at 1 and 6 months after randomization (1 and 6 months)
C: Contraceptive Continuation (4 and 7 months post-enrollment)
D: Prostate Specific Antigen (PSA) Screening Rates (Up to Month 3); Patient Knowledge Survey Score (Day 1); Decision Quality Score (Day 1); Percentage of Participants Who Make Informed Choice (Day 1)

Answer: B