TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind Placebo Controlled Study of Atorvastatin as Prevention of CHD in High Risk Patients With Non-Insulin Dependent Diabetes Mellitus (Collaborative Atorvastatin Study - CARDS)
Brief Summary: A study to assess the efficacy of once daily atorvastatin 10 mg versus placebo on cardiovascular endpoints in patients with non-insulin-dependent diabetes mellitus (NIDDM) who have a history of either hypertension, retinopathy, microalbuminuria, macroalbuminuria, or who currently smoke, but who do not have established corornary heart disease or other macrovascular disease.


Options:
A: Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) (Up to approximately 9 years)
B: Raw Urine Osmolality value at 12 week follow-up, adjusted for baseline (UOsm in mOsm/Kg) (12 weeks follow-up)
C: Time from randomization to the occurrence of a primary clinical endpoint; i.e. major coronary event or CABG or other coronary revascularization procedure; or unstable angina or resuscitated cardiac arrest or stroke.
D: Relative reduction in circulating osteoprotegerin levels (18 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind Placebo Controlled Study of Atorvastatin as Prevention of CHD in High Risk Patients With Non-Insulin Dependent Diabetes Mellitus (Collaborative Atorvastatin Study - CARDS)
Brief Summary: A study to assess the efficacy of once daily atorvastatin 10 mg versus placebo on cardiovascular endpoints in patients with non-insulin-dependent diabetes mellitus (NIDDM) who have a history of either hypertension, retinopathy, microalbuminuria, macroalbuminuria, or who currently smoke, but who do not have established corornary heart disease or other macrovascular disease.


Options:
A: Androgen secretion (0, 3, 6 months); Glucose metabolism (0, (3), 6 months)
B: Time from randomization to the occurrence of a primary clinical endpoint; i.e. major coronary event or CABG or other coronary revascularization procedure; or unstable angina or resuscitated cardiac arrest or stroke.
C: From the 48 hour holter monitoring the number of ischemic episodes will be assessed at baseline (week 1), week 18 and at the final visit (week 26).
D: The incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106 (106 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind Placebo Controlled Study of Atorvastatin as Prevention of CHD in High Risk Patients With Non-Insulin Dependent Diabetes Mellitus (Collaborative Atorvastatin Study - CARDS)
Brief Summary: A study to assess the efficacy of once daily atorvastatin 10 mg versus placebo on cardiovascular endpoints in patients with non-insulin-dependent diabetes mellitus (NIDDM) who have a history of either hypertension, retinopathy, microalbuminuria, macroalbuminuria, or who currently smoke, but who do not have established corornary heart disease or other macrovascular disease.


Options:
A: Time from randomization to the occurrence of a primary clinical endpoint; i.e. major coronary event or CABG or other coronary revascularization procedure; or unstable angina or resuscitated cardiac arrest or stroke.
B: Changing LDL Cholesterol (36 months)
C: attack number (1 year)
D: Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization) (up to 5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Effect of Intravenous Aflibercept Administered Every 2 Weeks in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
Brief Summary: This study was designed to characterize the effect of aflibercept in participants with advanced chemoresistant ovarian cancer.

Primary objective: Compare the effect of aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) to placebo treatment on repeat paracentesis in symptomatic malignant ascites in participants with advanced ovarian cancer

Secondary objectives: Safety, tolerability, paracentesis-related parameters, participant-reported outcome.


Options:
A: Time to Repeat Paracentesis (TRP) (From Day 1 up to 6 months from randomization)
B: Progression-free survival (Apr 2013)
C: Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1 (Week 24)
D: Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (From randomization until PD or death, whichever occurred first (up to 28 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Effect of Intravenous Aflibercept Administered Every 2 Weeks in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
Brief Summary: This study was designed to characterize the effect of aflibercept in participants with advanced chemoresistant ovarian cancer.

Primary objective: Compare the effect of aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) to placebo treatment on repeat paracentesis in symptomatic malignant ascites in participants with advanced ovarian cancer

Secondary objectives: Safety, tolerability, paracentesis-related parameters, participant-reported outcome.


Options:
A: Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days)
B: Time to Repeat Paracentesis (TRP) (From Day 1 up to 6 months from randomization)
C: objective response rate by RECIST 1.1 (6 months after treatment initiation)
D: Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria (The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Effect of Intravenous Aflibercept Administered Every 2 Weeks in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
Brief Summary: This study was designed to characterize the effect of aflibercept in participants with advanced chemoresistant ovarian cancer.

Primary objective: Compare the effect of aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) to placebo treatment on repeat paracentesis in symptomatic malignant ascites in participants with advanced ovarian cancer

Secondary objectives: Safety, tolerability, paracentesis-related parameters, participant-reported outcome.


Options:
A: Incidence of Dose Limiting Toxicities (DLT) of Experimental Regimens (Up to 28 days); Progression Free Survival (PFS) (Phase II) (From study enrollment to the investigator determined date of progression or death due to any cause, whichever occurs first, assessed up to 5 years); PFS (Phase III) (From study enrollment to the investigator determined date of progression or death due to any cause, whichever occurs first, assessed up to 5 years.); Overall Survival (OS) (Phase III) (From study enrollment to the date of death regardless of the cause, assessed up to 5 years)
B: Phase I Primary Objective: MTD (4 months); Phase II Primary Objective: PFS (from the date of randomization to the date of documented progression disease, recurrence or death (whichever occurs first), assessed up to 64 months)
C: Time to Repeat Paracentesis (TRP) (From Day 1 up to 6 months from randomization)
D: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 102-Week, Open Label, Multicenter Trial To Investigate The Efficacy Of Macugen For The Preservation Of Visual Function In Subjects With Neovascular Age-Related Macular Degeneration (AMD) And To Assess The Benefit Of Treating Early Choroidal Neovascularization (CNV).
Brief Summary: The purpose of this study is to determine the benefits of treating subjects with neovascular age-related macular degeneration (AMD) at an earlier stage of choroidal neovascularization (CNV) as compared to those with established CNV. Additionally, the study would like to determine the efficacy of Macugen in preserving visual function in those subjects having CNV secondary to neovascular AMD.


Options:
A: EDTRS visual acuity score (0week(baseline), 6week, 12week, 18week, 24week, 30week, 36week, 42week, 48week)
B: N/A
C: N/A
D: Mean Change From Baseline Through Week 54 in Distance Visual Acuity (VA) in Subjects With Early and Established CNV Lesions (Baseline through Week 54)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An 8-week, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Valsartan/HCTZ/Amlodipine Compared to Valsartan/HCTZ, Valsartan/Amlodipine, and HCTZ/Amlodipine in Patients With Moderate to Severe Hypertension.
Brief Summary: The purpose of this study is to determine the safety and efficacy of the various combinations of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.


Options:
A: Composite cardiovascular events including fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, admission due to heart failure, coronary intervention and sudden cardiac death (At least 3 years of mean follow up period)
B: Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP). (baseline to 12 weeks)
C: N/A
D: Change from baseline diastolic blood pressure after 8 weeks; Change from baseline systolic blood pressure after 8 weeks

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An 8-week, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Valsartan/HCTZ/Amlodipine Compared to Valsartan/HCTZ, Valsartan/Amlodipine, and HCTZ/Amlodipine in Patients With Moderate to Severe Hypertension.
Brief Summary: The purpose of this study is to determine the safety and efficacy of the various combinations of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.


Options:
A: Change from baseline diastolic blood pressure after 8 weeks; Change from baseline systolic blood pressure after 8 weeks
B: Changes in estimated glomerular filtration rate (Changes in eGFR at month 6)
C: Change From Baseline to Week 12 in Seated Diastolic Blood Pressure (SeDBP). (baseline to 12 weeks)
D: Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event (For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Young Adult With Acute Lymphoblastic Leukemia (ALL) : a Multicentric Protocol. GRAALL 2005 : T ALL or B ALL Non Ph GRAALL 2005 R : B ALL Non Ph CD20+ GRAAPH 2005 : ALL Ph
Brief Summary: This study is a multicenter trial of treatment for young ALL patients. All ALL patients will receive the same steroid pre-phase in order to evaluate sensitivity or resistance. Then, patients will be included into 3 specific trials according to biological features (immunophenotype, cytogenetics, and molecular biology).

Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL) 2005:

* T ALL or B ALL non Ph (N=810 patients planned).
* GRAALL 2005 R: B ALL non Ph CD20+ (N=220 patients planned).
* GRAAPH 2005: ALL Ph+ (N=270 patients planned)


Options:
A: Event free survival for all patients (January 2014); GRAAPH: Percentage of patients with minimum residual disease (MRD) < 10-4 after induction and/or consolidation (= salvage) (January 2014)
B: Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) (Up to Day 180); Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH) (From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks))
C: first episode of objectively documented, symptomatic or asymptomatic VTE (DVT and/or PE) (7 months)
D: Percentage of Patients With Venous Thromboembolisms (12 weeks); Percentage of Patients Who Experienced Clinically Significant Bleeding Events. (13 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect Of LDL-Cholesterol, Lowering Beyond Currently Recommended Minimum Targets On Coronary Heart Disesse (CHD) Recurrence In Patients With Pre-Existing CHD
Brief Summary: The primary objective of this study is to determine the degree of additional reduction in cardiovascular risk that was accrued to patients by lowering their LDL-C beyond the currently accepted minimum target level for patients with pre-existing CHD. Secondary objectives include the safety profile of this treatment strategy, its cost-effectiveness, effect on other atherosclerotic-related events and procedures, and total mortality.


Options:
A: Median Percent Change in Triglycerides From Baseline to Week 8. (Baseline to 8 weeks)
B: Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes. (Assessed at Week 52, Last observation carried forward (LOCF))
C: The primary outcome is the time to occurrence of a major; cardiovascular event, defined as the composite outcome of the; following clinical endpoints; CHD death; Non-fatal/Non-procedure related MI; Resuscitated cardiac arrest or fatal/non-fatal stroke
D: Time to Major Cardiac Event (Cardiovascular Death, Stroke, Myocardial Infarction, Hospitalization Due to Unstable Angina or Arterial Revascularization) (up to 5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind, Double Dummy, Randomised, Multicentre Study to Compare the Efficacy and Safety of Fulvestrant 250mg With Arimidex 1mg as a Secondary-line Therapy in the Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer
Brief Summary: This study will evaluate the efficacy and safety of Faslodex as secondary-line treatment compared with Arimidex in oestrogen receptor positive postmenopausal advanced breast cancer.


Options:
A: Clinical Benefit Rate (assessed every 3 cycles while on treatment, assessed every 3 months when follow up <2 years, every 6 months between 2-3 years,no specific requirements after 3 years)
B: Time to Tumor Progression (Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.)
C: Time to Disease Progression (TTP)
D: Progression-free survival (every 3 months during treatment and, at time of discontinuation from treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Control Trial of Commercial Weight Loss Programme in a Community Based Sample of Obese Adults.
Brief Summary: The objective is to compare the effectiveness of 4 different commercial weight-loss diets available to adults in the UK.

This is achieved with a 6 month multi-centre randomised unblinded controlled trial of

* Dr Atkins' New Diet Revolution,
* The slimFast Plan,
* The weight Watchers Pure Points Programme,
* Rosemary Conley's "Eat Yourself Slim" Diet \& Fitness Plan.
* No diet (control)

Subjects are a community based sample of 300 (60 per group) otherwise healthy overweight and obese adults.

Main outcome measures are weight and body fat change over 6 months.


Options:
A: body weight (12 months)
B: Weight loss; Fat loss
C: body weight (prior to and after 4, 8, and 12 months of dieting)
D: Percent Change in Body Weight From Baseline to 48 Weeks (Baseline, 48 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Laparoscopic Roux-en-Y Gastric Bypass vs. Laparoscopic BPD-Duodenal Switch for Superobesity (BMI > 50 kg/m2)- A Randomized Clinical Trial
Brief Summary: The purpose of this study is to compare the outcome in a broad perspective after laparoscopic Roux-en-Y gastric bypass and laparoscopic BPD-duodenal switch in the treatment of superobesity (body mass index \[BMI\] \> 50 kg/m2).


Options:
A: effectiveness in terms of weight loss, reduction in co-morbidity and quality of life (5 years)
B: To assess the efficacy of bariatric surgery in inducing partial or total remission of type 2 diabetes mellitus, as compared to standard medical anti-diabetic care (STC). (10 years)
C: weight loss (5 years)
D: BMI (5 y); Metabolic normalization (5y); Gastro-intestinal side effects (5y)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, International, Multi-centre Study on ASAS Classification Criteria for SpA
Brief Summary: Background:

Existing criteria for AS/SpA such as mod. New York, ESSG, or Amor criteria for classification and/or diagnosis of spondyloarthritis have limitations when applied to early disease. Moreover, MRI is not part of any of the established criteria and the precise role of MRI in early axial disease has not been fully defined yet. Even less is known about sacroiliac (SI) changes in SpA patients with peripheral symptoms. A pilot study using data from 'paper patients' led to new candidate criteria for early spondyloarthritis. Subsequently, the members of the ASAS International Working Group decided to conduct a prospective multi-centre study to evaluate (validate) the new candidate criteria, and to assess their performance as diagnostic criteria.

Aims of the study:

1. To evaluate the new candidate criteria for axial SpA in a multi-centre setting.
2. To assess the potential role of the new candidate criteria to be used as diagnostic criteria. To accomplish this, inclusion of consecutive and undiagnosed patients is mandatory as are longer periods of follow-up .
3. To compare criteria encompassing the whole group of SpA such as ESSG and Amor criteria against criteria which are tailored to either predominant axial disease or predominant peripheral disease. To accomplish this, both patients with predominant axial disease (back pain) but also patient with predominant peripheral disease (arthritis/enthesitis) will be included.


Options:
A: Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) (6 month treatment duration)
B: Treatment Response (using ASAS criteria) of at least 20% and absolute improvement of at least 10 units on a 0-100 scale in at least 3 of the 4 domains (Up to 4 years); Absence of deterioration (using ASAS criteria) of at least 20% and absolute improvement of at least 10 units on a 0-100 scale in the potential remaining ASAS domain (Up to 4 years)
C: Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20). (Week 12); Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score (Week 104)
D: Diagnosis of Spondyloarthritis (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, International, Multi-centre Study on ASAS Classification Criteria for SpA
Brief Summary: Background:

Existing criteria for AS/SpA such as mod. New York, ESSG, or Amor criteria for classification and/or diagnosis of spondyloarthritis have limitations when applied to early disease. Moreover, MRI is not part of any of the established criteria and the precise role of MRI in early axial disease has not been fully defined yet. Even less is known about sacroiliac (SI) changes in SpA patients with peripheral symptoms. A pilot study using data from 'paper patients' led to new candidate criteria for early spondyloarthritis. Subsequently, the members of the ASAS International Working Group decided to conduct a prospective multi-centre study to evaluate (validate) the new candidate criteria, and to assess their performance as diagnostic criteria.

Aims of the study:

1. To evaluate the new candidate criteria for axial SpA in a multi-centre setting.
2. To assess the potential role of the new candidate criteria to be used as diagnostic criteria. To accomplish this, inclusion of consecutive and undiagnosed patients is mandatory as are longer periods of follow-up .
3. To compare criteria encompassing the whole group of SpA such as ESSG and Amor criteria against criteria which are tailored to either predominant axial disease or predominant peripheral disease. To accomplish this, both patients with predominant axial disease (back pain) but also patient with predominant peripheral disease (arthritis/enthesitis) will be included.


Options:
A: The primary endpoint of this study was the proportion of subjects who achieved an ASAS 20 response at week 24.
B: ASAS 40 at week 12
C: Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20) (16 weeks)
D: Diagnosis of Spondyloarthritis (2 years)

Answer: D