TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT)
Brief Summary: The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy in reducing cardiovascular mortality, aborted cardiac arrest, and heart failure hospitalization in patients who have heart failure with preserved systolic function.


Options:
A: Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date (Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)); Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated) (Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011))
B: Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90 (Baseline and Day 90)
C: Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First (Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.)
D: Albuminuria (Screening, (Low-risk: year 1, 2 and 3), (high-risk: week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE� (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic Therapy
Brief Summary: The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an immunosuppressant or drug used to suppress the immune system) or a combination of both for up to 34 weeks. This research study will involve approximately 500 patients. The main study involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks (approximately 5 months) is optional for patients who successfully complete the main study. A country-specific study extension of open label infliximab treatment for an additional 1 year is optional for patients who successfully complete the main study extension.


Options:
A: Percentage of Participants With Corticosteriod-free Clinical Remission (Week 26)
B: Fatigue score (20 weeks)
C: Number of Patients Reporting Side Effects (8 weeks or 16 weeks)
D: Corticosteroid-free remission (At the end of the study treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE� (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic Therapy
Brief Summary: The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an immunosuppressant or drug used to suppress the immune system) or a combination of both for up to 34 weeks. This research study will involve approximately 500 patients. The main study involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks (approximately 5 months) is optional for patients who successfully complete the main study. A country-specific study extension of open label infliximab treatment for an additional 1 year is optional for patients who successfully complete the main study extension.


Options:
A: Sustained clinical remission for the precision dosing group vs. the conventional IFX maintenance dosing group (52 weeks)
B: Occurrence of disease worsening (52 weeks)
C: Percentage of Participants With Corticosteriod-free Clinical Remission (Week 26)
D: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE� (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic Therapy
Brief Summary: The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an immunosuppressant or drug used to suppress the immune system) or a combination of both for up to 34 weeks. This research study will involve approximately 500 patients. The main study involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks (approximately 5 months) is optional for patients who successfully complete the main study. A country-specific study extension of open label infliximab treatment for an additional 1 year is optional for patients who successfully complete the main study extension.


Options:
A: In the population with CRP ≥ 10 mg/L at baseline; Clinical response at week 6; Clinical response at week 6 and week 26
B: Number of Participants in Population 1 With a Clinical Response at Week 8 (Week 8)
C: Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12 (Week 0 to Week 12)
D: Percentage of Participants With Corticosteriod-free Clinical Remission (Week 26)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE� (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic Therapy
Brief Summary: The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an immunosuppressant or drug used to suppress the immune system) or a combination of both for up to 34 weeks. This research study will involve approximately 500 patients. The main study involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks (approximately 5 months) is optional for patients who successfully complete the main study. A country-specific study extension of open label infliximab treatment for an additional 1 year is optional for patients who successfully complete the main study extension.


Options:
A: number of 3-months periods with remission (3 yrs)
B: Percentage of Participants With Corticosteriod-free Clinical Remission (Week 26)
C: The primary endpoint was therapeutic failure at one year, defined as CDAI score ≥200 and an increase of ≥60 points from baseline, or study drug discontinuation due to lack of efficacy or intolerable adverse drug reaction. (12 months)
D: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE� (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic Therapy
Brief Summary: The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an immunosuppressant or drug used to suppress the immune system) or a combination of both for up to 34 weeks. This research study will involve approximately 500 patients. The main study involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks (approximately 5 months) is optional for patients who successfully complete the main study. A country-specific study extension of open label infliximab treatment for an additional 1 year is optional for patients who successfully complete the main study extension.


Options:
A: The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 (at Week 6)
B: Percentage of Participants With Corticosteriod-free Clinical Remission (Week 26)
C: Treatment success as defined by the proportion of subjects in clinical remission (i.e. complete discontinuation of prednisone therapy and a CDAI score of <150) at week 14, and maintenance of clinical remission between study weeks 14 and 50 (one year)
D: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE� (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic Therapy
Brief Summary: The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an immunosuppressant or drug used to suppress the immune system) or a combination of both for up to 34 weeks. This research study will involve approximately 500 patients. The main study involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks (approximately 5 months) is optional for patients who successfully complete the main study. A country-specific study extension of open label infliximab treatment for an additional 1 year is optional for patients who successfully complete the main study extension.


Options:
A: To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC). (6 weeks)
B: Clinical remission (CDAI score of <150) (Week 11)
C: Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments (Baseline, Week 10); Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments (Baseline, Week 10)
D: Percentage of Participants With Corticosteriod-free Clinical Remission (Week 26)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of cinacalcet compared with placebo in patients with stage 3 and 4 Chronic Kidney Disease (CKD).


Options:
A: Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks
B: Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event) (From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years)
C: Number of Participants With Mean PTH ≤ 300 pg/mL (Efficacy Assessment Phase (weeks 17 to 23))
D: The Number of Participants Who Achieve a Mean Intact Parathyroid Hormone (iPTH) Value Between 150 to 300 pg/mL During the Evaluation Period (Weeks 21 to 28). (Weeks 21 to 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of cinacalcet compared with placebo in patients with stage 3 and 4 Chronic Kidney Disease (CKD).


Options:
A: Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12 (Baseline and month 12)
B: Proportion of subjects with a mean reduction of greater than or equal to 30% in iPTH at 32 weeks
C: The percentage change in urinary protein to creatinine ratio (UPCR) from baseline to the last measurement during treatment. (baseline and 6 months)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Olanzapine Versus Divalproex and Placebo in the Treatment of Mild to Moderate Mania Associated With Bipolar I Disorder
Brief Summary: The goals of this study are:

A. To determine whether olanzapine can help patients with bipolar disorder who currently have mild to moderate mania.

B. To assess the safety of olanzapine and any side effects that might be associated with it, as well as the quality of life and functioning of patients treated with olanzapine.

C. To assess how olanzapine compares to divalproex.


Options:
A: Safety outcome measures
B: To test the superiority of olanzapine compared with divalproex in improving overall manic symptomatology in patients with mild to moderate; mania associated with bipolar I disorder, as measured by reductions on the Young Mania Rating Scale (YMRS) total score from baseline to the endpoint of Study Period II (3-week acute therapy phase).
C: Sedation Score (Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9); Young Mania Rating Scale (YMRS) Scores (Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9)
D: Young Mania Rating Scale (YMRS) (Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #498 - Open Versus Endovascular Repair (OVER) Trial for Abdominal Aortic Aneurysms
Brief Summary: A multi-center, randomized clinical trial that will compare endovascular repair with standard open surgery in the repair of abdominal aortic aneurysms (AAA). Long and short-term results as well as the cost and quality of life associated with these two strategies for AAA repair will be compared.


Options:
A: All-cause Mortality (Participants were followed for the duration of the study, up to 9 years)
B: combined operative mortality and morbidity (5-8 years)
C: all cause mortality at 3 years (3 years)
D: Death and major adverse events (4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #498 - Open Versus Endovascular Repair (OVER) Trial for Abdominal Aortic Aneurysms
Brief Summary: A multi-center, randomized clinical trial that will compare endovascular repair with standard open surgery in the repair of abdominal aortic aneurysms (AAA). Long and short-term results as well as the cost and quality of life associated with these two strategies for AAA repair will be compared.


Options:
A: Mortality at 30 days after the treatment(endovascular repair versus conventional repair) (30 days after the treatment)
B: all cause mortality at 3 years (3 years)
C: Death and major adverse events (4 years)
D: All-cause Mortality (Participants were followed for the duration of the study, up to 9 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: CSP #498 - Open Versus Endovascular Repair (OVER) Trial for Abdominal Aortic Aneurysms
Brief Summary: A multi-center, randomized clinical trial that will compare endovascular repair with standard open surgery in the repair of abdominal aortic aneurysms (AAA). Long and short-term results as well as the cost and quality of life associated with these two strategies for AAA repair will be compared.


Options:
A: all cause mortality at 3 years (3 years)
B: All-cause Mortality (Participants were followed for the duration of the study, up to 9 years)
C: Number of Subjects That Experienced Rupture or Aneurysm Related Death (3 years)
D: combined operative mortality and morbidity (5-8 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial Comparing Daily Atropine Versus Weekend Atropine
Brief Summary: The goals of this study are:

* To compare the visual acuity outcome in the amblyopic eye after 17 weeks of daily use of atropine versus weekend-only use of atropine.
* To compare the proportion of patients achieving a complete treatment response (defined as amblyopic eye acuity \>20/25 or equal to that of the sound eye in the absence of a reduction in the sound eye acuity from baseline) with daily atropine versus weekend-only atropine.


Options:
A: Visual acuity
B: Visual acuity in the amblyopic eye (6 months)
C: The primary outcome measure was logMAR visual acuity, measured 6-weekly for 18 weeks in refractive adaptation phase. In occlusion phase measured 2-weekly until no further gains
D: Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks (24 weeks); Mean (SD) of Amblyopic Eye Visual Acuity at 24 Weeks (24 weeks); Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks (Baseline to 24 weeks); Mean Change in Amblyopic Eye Visual Acuity From Baseline to 24 Weeks (Baseline to 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial Comparing Daily Atropine Versus Weekend Atropine
Brief Summary: The goals of this study are:

* To compare the visual acuity outcome in the amblyopic eye after 17 weeks of daily use of atropine versus weekend-only use of atropine.
* To compare the proportion of patients achieving a complete treatment response (defined as amblyopic eye acuity \>20/25 or equal to that of the sound eye in the absence of a reduction in the sound eye acuity from baseline) with daily atropine versus weekend-only atropine.


Options:
A: The change of visual acuity from baseline to week six post randomisation visit between the two arms in each group. (6 weeks)
B: Visual acuity
C: Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks (24 weeks); Mean (SD) of Amblyopic Eye Visual Acuity at 24 Weeks (24 weeks); Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks (Baseline to 24 weeks); Mean Change in Amblyopic Eye Visual Acuity From Baseline to 24 Weeks (Baseline to 24 weeks)
D: Change in Distance Visual Acuity From Baseline in the Younger Cohort (5 to <13 Years) (Baseline and 16 weeks); Mean Amblyopic Eye Visual Acuity (Younger Cohort) (16 Weeks from baseline); Mean Change in Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years) (Baseline and 16 weeks); Mean Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years) (16 weeks); Distribution of Change in Amblyopic-eye Visual Acuity (Baseline and 16 weeks); Distribution of Amblyopic-eye Visual Acuity (At 16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination With a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2*0201-Positive Patients With Previously Treated Unresectable Stage III or IV Melanoma
Brief Summary: The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response \[PR/CR\]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.


Options:
A: Recurrence-free survival (RFS) rate (1 year after randomization)
B: Recurrence-free Survival (RFS) (up to 36 months)
C: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone (From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks))
D: Adverse Events (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination With a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2*0201-Positive Patients With Previously Treated Unresectable Stage III or IV Melanoma
Brief Summary: The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response \[PR/CR\]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.


Options:
A: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone (From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks))
B: Relapse-free Survival (RFS) (Approximately 3.5 years)
C: Overall Survival (From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).); Progression-free Survival (From randomization (initiated January 2010) to December 30 2010.)
D: Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participants (6 months); Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among Participants With PD-L1-positive Tumor Expression (6 months)

Answer: A