TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation
Brief Summary: RATIONALE: Giving combination chemotherapy before a stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the transplanted stem cells. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. If the patient's stem cells are to be transplanted, the patient is also treated with a monoclonal antibody, such as gemtuzumab ozogamicin, to kill any remaining cancer cells or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab ozogamicin followed by stem cell transplant in treating acute myeloid leukemia.

PURPOSE: This randomized phase III trial is studying combination chemotherapy, gemtuzumab ozogamicin, and stem cell transplant to see how well they work compared to combination chemotherapy and peripheral stem cell transplant alone in treating patients with acute myeloid leukemia.


Options:
A: overall survival; relapse-free survival
B: Complete remission (CR)-rate after induction therapy (after the second induction cycle); Relapse-free survival, one year after consolidation therapy with high-dose cytarabine considering different temporal sequences (1-3-5 versus 1-2-3) of the consolidation therapy (One year after consolidation therapy); Event-free survival (two years)
C: Overall Survival (Induction Phase) (Assessed during the first 4 months, then at least every three months for 2 years. then every six months until 5 years after study entry and every 12 months thereafter.); Disease-free Survival (Consolidation Phase) (Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter.)
D: Objective best response rate (complete remission (CR) and partial remission (PR)) (12 months after randomization of the last patient)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation
Brief Summary: RATIONALE: Giving combination chemotherapy before a stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the transplanted stem cells. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. If the patient's stem cells are to be transplanted, the patient is also treated with a monoclonal antibody, such as gemtuzumab ozogamicin, to kill any remaining cancer cells or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab ozogamicin followed by stem cell transplant in treating acute myeloid leukemia.

PURPOSE: This randomized phase III trial is studying combination chemotherapy, gemtuzumab ozogamicin, and stem cell transplant to see how well they work compared to combination chemotherapy and peripheral stem cell transplant alone in treating patients with acute myeloid leukemia.


Options:
A: Overall Survival (Induction Phase) (Assessed during the first 4 months, then at least every three months for 2 years. then every six months until 5 years after study entry and every 12 months thereafter.); Disease-free Survival (Consolidation Phase) (Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter.)
B: Event free survival (after 5 years)
C: overall survival; relapse-free survival
D: relapse-free survival (two years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating stage III or stage IV Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage III or stage IV Hodgkin's lymphoma.


Options:
A: Freedom from first progression at 5 years (After a median of 5 years from start of the study)
B: 3-year progression-free survival (3 years)
C: Event-free survival (from randomization to early discontinuation of protocol treatment, no CR/CRu after 8 cycles, relapse, progression or death)
D: Overall survival; Reduction of late treatment-related toxicity; Maintenance of failure-free survival rate

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis
Brief Summary: The purposes of this study are to determine:

1. Whether drotrecogin alfa (activated) helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa (activated).
2. Whether drotrecogin alfa (activated) minimizes long term disabilities associated with severe sepsis.
3. The side effects that might be associated with drotrecogin alfa (activated) administration to children with severe sepsis.


Options:
A: 90-day mortality (90 day)
B: That drotrecogin alfa (activated) compared with placebo reduces severe-sepsis-induced organ dysfunction (3 Years)
C: Demonstrate in adult patients with severe sepsis who are receiving drotrecogin alfa (activated) that concomitant treatment with heparin is equivalent to treatment with placebo as determined by 28-day all-cause mortality.
D: 28-Day All-Cause Mortality (Day 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Trial of Prophylactic Heparin in Patients With Severe Sepsis and Higher Disease Severity Who Are Undergoing Treatment With Drotrecogin Alfa (Activated)
Brief Summary: The purpose of this study is to evaluate the relative efficacy and safety of prophylactic heparin co-administration during drotrecogin alfa (activated) infusion in the treatment of severe sepsis in the adult.


Options:
A: 28-Day All-Cause Mortality (Day 28)
B: 90-day mortality (90 day)
C: Mean Change in Protein C Levels From Day 1 to Day 7 (Day 1, Day 7)
D: Demonstrate in adult patients with severe sepsis who are receiving drotrecogin alfa (activated) that concomitant treatment with heparin is equivalent to treatment with placebo as determined by 28-day all-cause mortality.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: HORIZON-PFT: Pivotal Fracture Trial
Brief Summary: HORIZON-PFT (Pivotal Fracture Trial) will study the effect of zoledronic acid, given once per year, on the treatment of osteoporosis in women past menopause. Hip and vertebral fractures are the most devastating consequences of osteoporosis. HORIZON-PFT is designed to determine the benefits of zoledronic acid in fracture reduction at both the hip and spine.


Options:
A: Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum (Baseline, Month 24)
B: Incidence of hip fxs; Incidence of new vertebral fxs
C: Number of Participants With New Vertebral Fractures (36 months)
D: Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: HORIZON-PFT: Pivotal Fracture Trial
Brief Summary: HORIZON-PFT (Pivotal Fracture Trial) will study the effect of zoledronic acid, given once per year, on the treatment of osteoporosis in women past menopause. Hip and vertebral fractures are the most devastating consequences of osteoporosis. HORIZON-PFT is designed to determine the benefits of zoledronic acid in fracture reduction at both the hip and spine.


Options:
A: Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions (Baseline through End of Study (up to 7.5 years)); Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions (Baseline through End of Study (up to 7.5 years))
B: Effects of arzoxifene on bone fractures and bone mass (5 years); Effects of arzoxifene on getting breast cancer (5 years); The safety of arzoxifene and any side effects (5 years)
C: N/A
D: Incidence of hip fxs; Incidence of new vertebral fxs

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: HORIZON-PFT: Pivotal Fracture Trial
Brief Summary: HORIZON-PFT (Pivotal Fracture Trial) will study the effect of zoledronic acid, given once per year, on the treatment of osteoporosis in women past menopause. Hip and vertebral fractures are the most devastating consequences of osteoporosis. HORIZON-PFT is designed to determine the benefits of zoledronic acid in fracture reduction at both the hip and spine.


Options:
A: Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum (Baseline, Month 24)
B: Significant reduction in rate of clinical fractures after surgical repair of hip fracture
C: Incidence of hip fxs; Incidence of new vertebral fxs
D: To compare % change in Lumbar Spine BMD from Baseline to Month 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Family Psychoeducation: Efficacy in Child Mood Disorders
Brief Summary: The purpose of this study is to evaluate the effectiveness of a Multifamily Psychoeducation Group for the families of children with mood disorders.


Options:
A: Relapse of depressive symptoms (Measured at Months 3 and 9)
B: Mood Severity Index (Measured at Months 6 and 12)
C: Alcohol Use Behaviors (Average number of drinks as recorded on the Timeline Follow-Back (subject-reported) measure daily over the 12-week acute phase.); Depressive Symptoms (Average score as measured by participant's report on the Beck Depression Inventory (BDI).)
D: recurrence of depression (52 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis
Brief Summary: This was a Phase II, randomized, open-label, rater-blinded, three-arm study comparing two different doses of alemtuzumab (Lemtrada™) and one dose of subcutaneous (SC) interferon beta-1a (Rebif®) in participants with early, active relapsing-remitting multiple sclerosis (MS) who had not been previously treated with MS therapies other than steroids. The study was conducted for an initial period of 3 years and a follow-up to 5 years or more.


Options:
A: Adjusted Annualized Relapse Rate (ARR) (Up to 144 weeks)
B: Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months) (Baseline to Month 24)
C: Annualized Relapse Rate (2 years)
D: Probability of Participants With Sustained Accumulation of Disability (SAD) (Up to 3 years); Annualized Relapse Rate (Up to 3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis
Brief Summary: This was a Phase II, randomized, open-label, rater-blinded, three-arm study comparing two different doses of alemtuzumab (Lemtrada™) and one dose of subcutaneous (SC) interferon beta-1a (Rebif®) in participants with early, active relapsing-remitting multiple sclerosis (MS) who had not been previously treated with MS therapies other than steroids. The study was conducted for an initial period of 3 years and a follow-up to 5 years or more.


Options:
A: Probability of Participants With Sustained Accumulation of Disability (SAD) (Up to 3 years); Annualized Relapse Rate (Up to 3 years)
B: Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate (Core treatment period between 48 - 152 weeks depending on time of enrollment)
C: The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24. (Weeks 12, 16, 20, and 24)
D: Annualized Relapse Rate [ARR]: Poisson Regression Estimates (108 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis
Brief Summary: This was a Phase II, randomized, open-label, rater-blinded, three-arm study comparing two different doses of alemtuzumab (Lemtrada™) and one dose of subcutaneous (SC) interferon beta-1a (Rebif®) in participants with early, active relapsing-remitting multiple sclerosis (MS) who had not been previously treated with MS therapies other than steroids. The study was conducted for an initial period of 3 years and a follow-up to 5 years or more.


Options:
A: Time to First Relapse (Baseline up to 96 weeks)
B: Probability of Participants With Sustained Accumulation of Disability (SAD) (Up to 3 years); Annualized Relapse Rate (Up to 3 years)
C: Annualized Relapse Rate (ARR) at 1 Year (1 Year)
D: Number of Participants With Anti-DAC HYP Binding Antibodies (ADAbs): Electrochemiluminescent (ECL) Anti-Drug Antibody (ADA) Assay (Up to 44 weeks); Number of Participants With Anti-DAC HYP Neutralizing Antibodies (NAbs): ECL ADA Assay (Up to 44 weeks); TP-DI Sub-study: Area-Under-the-Curve From Zero to Infinity (AUCinf) of Each Probe Drug (Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and at 0.5 and 1, 2, 3, 4, 6, 8, 10 , 24, 48, 72 and 96 hours post-probe drug cocktail administration); TP-DI Sub-study: Dextromethorphan to Dextrorphan Urine Concentration Ratio (Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and for 12 hours after probe-drug cocktail administration)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Multinational, Randomized, Parallel Group, Double-blind Trial of Clopidogrel Versus Placebo in High-risk Patients Aged 45 Years and Older, at Risk of Atherothrombotic Events, and Who Are Receiving Background Therapy Including Low-dose ASA.
Brief Summary: RATIONALE:

* Atherothrombosis is a progressive and generalized vascular disease resulting in events leading to myocardial infarction (heart attack), stroke, and vascular death.
* In patients at risk for this disease, it is characterized by an unpredictable, sudden disruption of atherosclerotic plaques, which may lead to total occlusion of artery due to formation of a clot. The use of aspirin (blood thinner agent) for reducing those major ischemic events is either indicated, or recommended by international guidelines. However, aspirin fails to prevent a high percentage of such life-threatening events. Therefore, more effective blood thinning therapy may provide additional clinical benefit to such patients.
* The results of the CURE trial in patients with unstable angina demonstrate the additional benefit of long-term treatment (up to one year) with clopidogrel, (a blood thinner agent), when administered in combination with standard therapy including aspirin. The purpose of CHARISMA is to investigate whether a similar clinical benefit of clopidogrel may apply to a broad population of high-risk patients receiving low-dose aspirin therapy. Such population includes patients with previous cardiovascular, neurovascular or peripheral arterial manifestations of atherothrombosis and patients with combinations of recognized risk factors for atherosclerosis.

OBJECTIVES:

* To assess the efficacy of clopidogrel 75 mg once-daily by comparison with a placebo, in preventing cardiovascular morbidity/mortality. The study will compare the efficacy of the two regimens in preventing the occurrence of major cardiovascular complications (stroke, heart attack, cardiovascular death) in high-risk patients who are otherwise receiving low-dose aspirin therapy (75-162 mg daily).
* To evaluate the safety of clopidogrel in this population, and more specifically the incidence of fatal or severe bleeding (as per GUSTO definition), in order to estimate the global benefit of clopidogrel in this patient population.


Options:
A: Occurrence of myocardial infarction,stroke or cardiovascular death.
B: Death and the composite outcome of death, non-fatal reinfarction or stroke
C: Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date (9 months)
D: A composite of all-cause mortality, recurrent MI, revascularisation with PCI or CABG, ischemic stroke, incident heart failure, malignant ventricular arrhythmia, or resuscitated cardiac arrest. (Estimated follow-up min 6 months - max 6.25 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Multinational, Randomized, Parallel Group, Double-blind Trial of Clopidogrel Versus Placebo in High-risk Patients Aged 45 Years and Older, at Risk of Atherothrombotic Events, and Who Are Receiving Background Therapy Including Low-dose ASA.
Brief Summary: RATIONALE:

* Atherothrombosis is a progressive and generalized vascular disease resulting in events leading to myocardial infarction (heart attack), stroke, and vascular death.
* In patients at risk for this disease, it is characterized by an unpredictable, sudden disruption of atherosclerotic plaques, which may lead to total occlusion of artery due to formation of a clot. The use of aspirin (blood thinner agent) for reducing those major ischemic events is either indicated, or recommended by international guidelines. However, aspirin fails to prevent a high percentage of such life-threatening events. Therefore, more effective blood thinning therapy may provide additional clinical benefit to such patients.
* The results of the CURE trial in patients with unstable angina demonstrate the additional benefit of long-term treatment (up to one year) with clopidogrel, (a blood thinner agent), when administered in combination with standard therapy including aspirin. The purpose of CHARISMA is to investigate whether a similar clinical benefit of clopidogrel may apply to a broad population of high-risk patients receiving low-dose aspirin therapy. Such population includes patients with previous cardiovascular, neurovascular or peripheral arterial manifestations of atherothrombosis and patients with combinations of recognized risk factors for atherosclerosis.

OBJECTIVES:

* To assess the efficacy of clopidogrel 75 mg once-daily by comparison with a placebo, in preventing cardiovascular morbidity/mortality. The study will compare the efficacy of the two regimens in preventing the occurrence of major cardiovascular complications (stroke, heart attack, cardiovascular death) in high-risk patients who are otherwise receiving low-dose aspirin therapy (75-162 mg daily).
* To evaluate the safety of clopidogrel in this population, and more specifically the incidence of fatal or severe bleeding (as per GUSTO definition), in order to estimate the global benefit of clopidogrel in this patient population.


Options:
A: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)
B: Cardiovascular events (five years)
C: Glomerular Filtration Rate; Adverse Events
D: Occurrence of myocardial infarction,stroke or cardiovascular death.

Answer: D