TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind Study to Assess the Impact of Normalization of Hemoglobin Compared to Partial Correction of Hemoglobin With EPREX�/ERYPO� on Left Ventricular Structure in Early Hemodialysis Patients (RWJ-22512)
Brief Summary: The purpose of this study in early hemodialysis patients (on dialysis 3 to 18 months) is to assess the effect of correction versus partial correction of anemia using epoetin alfa on heart pumping function.


Options:
A: Changes in Fatigue Symptom Inventory (FSI) (Baseline and week 4); Changes in Fatigue Symptom Inventory (FSI) (Baseline and week 8); Changes in Fatigue Symptom Inventory (FSI) (Baseline and week 12)
B: Change from baseline in Physical Component Summary of Kidney Disease Quality of Life-36 questionnaire at 6 weeks, 12 weeks, and 24 weeks. (Baseline, 6 weeks, 12 weeks, and 24 weeks)
C: change in quadriceps muscle endurance during intermittent submaximal contractions (6 days); change in exercise-induced markers of oxidative stress (8 days)
D: Percent change in left ventricular volume index (LVVI) at Week 96.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind Study to Assess the Impact of Normalization of Hemoglobin Compared to Partial Correction of Hemoglobin With EPREX�/ERYPO� on Left Ventricular Structure in Early Hemodialysis Patients (RWJ-22512)
Brief Summary: The purpose of this study in early hemodialysis patients (on dialysis 3 to 18 months) is to assess the effect of correction versus partial correction of anemia using epoetin alfa on heart pumping function.


Options:
A: Mean Hb Change Level During the Last Four Weeks of Treatment (Week 22 to week 26); Mean Weekly Epoetin Dosage Per kg Body Weight During the Last Four Weeks of Treatment (Week 22 to week 26)
B: Percent change in left ventricular volume index (LVVI) at Week 96.
C: Hemoglobin level
D: Local pain due to s.c. injection (by VAS). (After each injection)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Alendronate Suppress Aortic and Coronary Artery Calcification and Improve Bone Mineral Density in Chronic Peritoneal Dialysis Patients?
Brief Summary: Alendronate is a safe and effective drug for treating osteoporosis in post-menopausal women. However, its safety and efficacy in increasing bone mineral density in chronic peritoneal dialysis (PD) patients have not been investigated. Etidronate, another bisphosphonate, can suppress the extent of coronary artery calcification in chronic hemodialysis patients. The hypothesis of this study is that alendronate can increase bone mineral density and suppress aortic and coronary artery calcification in chronic peritoneal dialysis patients.


Options:
A: Number of Participants With New Vertebral Fractures at 18 Months (18 months)
B: Number of Participants With New Vertebral Fractures (36 months)
C: extent of aortic and coronary artery calcification with and without the use of alendronate; bone mineral density with and without the use of alendronate
D: Time to first occurrence of coronary death, non-fatal myocardial infarction (MI), or hospitalized acute coronary syndrome other than MI combined after an expected 5 to 7.5 years of follow-up.; Time to first occurrence of invasive breast cancer after an expected 5 to 7.5 years of follow-up.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Weekly PROCRIT (Epoetin Alfa) on Anemia and Quality of Life in Children With Cancer Undergoing Myelosuppressive Chemotherapy
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of once- weekly dosing of PROCRITÂ® (a glycoprotein that stimulates red blood cell production) versus placebo in the treatment of anemia in children with cancer undergoing chemotherapy, and to assess its effect on the quality of life.


Options:
A: Change in the patient-reported Pediatric Quality of Life Inventory (PedsQL Inventory) from baseline to the last assessment.
B: Progression-free Survival (PFS) Rate at 3 Years (Assessed every 3 months until progression up to 4 years and 8 months)
C: Progression Free Survival (From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years))
D: Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP) (from week 5 to EOTP)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Weekly PROCRIT (Epoetin Alfa) on Anemia and Quality of Life in Children With Cancer Undergoing Myelosuppressive Chemotherapy
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of once- weekly dosing of PROCRITÂ® (a glycoprotein that stimulates red blood cell production) versus placebo in the treatment of anemia in children with cancer undergoing chemotherapy, and to assess its effect on the quality of life.


Options:
A: Incidence of adverse events (throughout study)
B: Change in the patient-reported Pediatric Quality of Life Inventory (PedsQL Inventory) from baseline to the last assessment.
C: Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP) (from week 5 to EOTP)
D: Occurrences of red blood cell transfusion (from study day 29 (week 5) to week 17)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Weekly PROCRIT (Epoetin Alfa) on Anemia and Quality of Life in Children With Cancer Undergoing Myelosuppressive Chemotherapy
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of once- weekly dosing of PROCRITÂ® (a glycoprotein that stimulates red blood cell production) versus placebo in the treatment of anemia in children with cancer undergoing chemotherapy, and to assess its effect on the quality of life.


Options:
A: Incidence of adverse events (throughout study)
B: The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)
C: Change in the patient-reported Pediatric Quality of Life Inventory (PedsQL Inventory) from baseline to the last assessment.
D: The primary objective of this study is to demonstrate that the administration of epoetin alfa to critically ill subjects reduces the proportion of subjects requiring red blood cell (RBC) transfusion as compared with placebo at Study Day 29.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase III Trial Comparing Induction Chemotherapy With Cisplatin/5-fluorouracil (PF) or Docetaxel/Cisplatin/5-fluorouracil (TPF) Plus Chemoradiotherapy (CRT) Versus CRT Alone as First-line Treatment or Unresectable Locally Advanced Head and Neck Cancer (LAHNC).
Brief Summary: Primary Objective:

* Phase II: To determine the best treatment scheme (TPF vs. PF).
* Phase III: To compare the time to progression and the treatment failure at the 3 arms.

Secondary objectives:

* To evaluate the safety at the 3 arms.
* To compare the progression , overall survival and locoregional control at the 3 arms.


Options:
A: Phase II: Clinical objective response rate, at the end of inducted chemotherapy (groups A and B) and at the end of combined treatment (groups A, B and C). (16 weeks); Phase III: Surveillance with no progression after two years. (2 years)
B: N/A
C: Phase II: Percentage of participants achieving Locoregional Control (LRC) at 18 months from the end of chemo-radiation therapy (CRT) (within 4 years)
D: Efficacy (18 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12 Month Study to Assess Safety and Efficacy of Meridia (Sibutramine Hydrochloride Monohydrate) 10 and 15 mg in Obese Adolescents
Brief Summary: The purpose of this study is to assess the effectiveness of sibutramine on weight loss, reduction in body size and improvement in metabolic risk factors and safety in obese adolescents.


Options:
A: Change in Body Mass Index (BMI) (3-month)
B: Absolute change in body mass index (BMI) from baseline to endpoint. (12 months)
C: Treatment Failure (Loss of Glycemic Control) (Study duration - 2 years to 6.5 years of follow up from randomization)
D: Reduction in BMI (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient Based Strategy to Reduce Errors in Diabetes Care
Brief Summary: This project evaluates a HPMG effort to reduce error rates through customized direct feedback of diabetes quality of care data to diabetes patients and their physicians. HPMG has routinely provided patients with personalized feedback of glucose and cholesterol test results since about 1997. This project will implement and evaluate the impact of this intervention on diabetes medical error rates and resource use.


Options:
A: The following dependant variables were measured in this study;; Diabetes medical error in the 12 months post-intervention, Glycated hemoglobin (A1c) values and A1c test rates in the 12 months post-intervention, and; LDL-cholesterol levels and test rates in the 12 months post-intervention.
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: The difference in change in estimated cardiovascular risk between advanced care and usual care groups (3 months)
D: Patient is receiving a statin (July 2009 to April 2010)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient Based Strategy to Reduce Errors in Diabetes Care
Brief Summary: This project evaluates a HPMG effort to reduce error rates through customized direct feedback of diabetes quality of care data to diabetes patients and their physicians. HPMG has routinely provided patients with personalized feedback of glucose and cholesterol test results since about 1997. This project will implement and evaluate the impact of this intervention on diabetes medical error rates and resource use.


Options:
A: colorectal cancer screening (15 months)
B: Personal Health Partner (PHP) assessment with electronic health record (EHR) data exchange before pediatric primary care visits (2 week -1day before doctor's appointment and 1 week after appointment)
C: The following dependant variables were measured in this study;; Diabetes medical error in the 12 months post-intervention, Glycated hemoglobin (A1c) values and A1c test rates in the 12 months post-intervention, and; LDL-cholesterol levels and test rates in the 12 months post-intervention.
D: Percentage of participants with controlled blood pressure, as defined by the following criteria: less than 130/80 mm Hg for participants with diabetes or chronic kidney disease; less than 140/90 mm Hg for all other participants (Measured at Year 1)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient Based Strategy to Reduce Errors in Diabetes Care
Brief Summary: This project evaluates a HPMG effort to reduce error rates through customized direct feedback of diabetes quality of care data to diabetes patients and their physicians. HPMG has routinely provided patients with personalized feedback of glucose and cholesterol test results since about 1997. This project will implement and evaluate the impact of this intervention on diabetes medical error rates and resource use.


Options:
A: Informed choice (2 weeks post intervention); Involvement in screening decision (2 weeks post intervention)
B: Patient's satisfaction and confidence with the information given. (Within two weeks after receiving the information and after 3 months.)
C: The following dependant variables were measured in this study;; Diabetes medical error in the 12 months post-intervention, Glycated hemoglobin (A1c) values and A1c test rates in the 12 months post-intervention, and; LDL-cholesterol levels and test rates in the 12 months post-intervention.
D: Fecal Occult Blood Test (FOBT) completion rate (4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient Based Strategy to Reduce Errors in Diabetes Care
Brief Summary: This project evaluates a HPMG effort to reduce error rates through customized direct feedback of diabetes quality of care data to diabetes patients and their physicians. HPMG has routinely provided patients with personalized feedback of glucose and cholesterol test results since about 1997. This project will implement and evaluate the impact of this intervention on diabetes medical error rates and resource use.


Options:
A: Efficacy of inclusion of eligible CRC-patients for MSI testing by pathologists.; Efficacy of referral of patients who are MSI positive to a clinical geneticist by surgeons.
B: EFFECT AMI Composite Quality Indicator in the year after report cards published (April 1, 2004 - March 31, 2005); EFFECT CHF Composite Quality Indicator in the year after report cards published (April 1, 2004 - March 31, 2005)
C: The following dependant variables were measured in this study;; Diabetes medical error in the 12 months post-intervention, Glycated hemoglobin (A1c) values and A1c test rates in the 12 months post-intervention, and; LDL-cholesterol levels and test rates in the 12 months post-intervention.
D: Proportion of patients treated appropriately with respect to lipid-lowering therapy within four months after lipid testing (Measured at 2 years); Rate of appropriate treatment among patients with high blood pressure (Measured at 2 years)

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 First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period (Time to first event in "Intended Treatment Period": started on day of randomization, ended at efficacy cut-off date (date target number of primary efficacy events [448] was expected to have occurred; set to 30-Jan-2011, prior to unblinding).); Rate of Adjudicated Stroke or Systemic Embolism (SE) During the Intended Treatment Period ("Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).)
C: Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants (Randomization (Day 1) to first event (CV death, MI, ischemic stroke), up to March 2011, approximately 2 years); Event Rate of Confirmed Major Bleeding Using Thrombolysis in Myocardial Infarction (TIMI) Criteria During the Treatment Period - Treated Participants (From first dose to first occurrence of event (TIMI major bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years)
D: Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up)

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: Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke (Randomization up to 15 months)
C: The primary endpoint of this study is a composite of all-cause death, myocardial infarction, and stroke or systemic embolism. (Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).)
D: Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition (6 Months)

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: Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE (12 months from time of randomization)
B: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)
C: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (6- or 12-month study treatment period)
D: Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation (Day 1 up to 12 Months); Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation (Day 1 up to 12 months)

Answer: B
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: Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up)
B: The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority) (Up to 4 years); The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority) (Up to 4 years); The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety (Up to 4 years)
C: Time to First Event (Death, Stroke, Major Bleed) (Time to event)
D: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)

Answer: D
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 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))
B: Percentage of Patients With Any Adverse Event (AE) (From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days))
C: Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period (Time to first event in "Intended Treatment Period": started on day of randomization, ended at efficacy cut-off date (date target number of primary efficacy events [448] was expected to have occurred; set to 30-Jan-2011, prior to unblinding).); Rate of Adjudicated Stroke or Systemic Embolism (SE) During the Intended Treatment Period ("Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).)
D: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)

Answer: D