TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Study Comparing the Incidence of Cardiovascular Events Between High-dose ARB Monotherapy and Combination Therapy With ARB and Calcium Channel Blocker in Japanese Elderly Hypertensive Patients at High Cardiovascular Risk
Brief Summary: The purpose of this study is to investigate whether high-dose angiotensin II receptor blocker (ARB) monotherapy or combination therapy with ARB and calcium channel blockers is more effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients not adequately controlled by standard dose ARB alone.


Options:
A: N/A
B: The rate of decline of glomerular filtration rate (GFR).GFR is measured at baseline,and at 6,12,18,24,30 and 36 months after randomization
C: A composite of fatal and non-fatal cardiovascular events: Cerebrovascular events (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, stroke of undetermined etiology and transient ischemic attack) (36 Months); Coronary events (sudden death, myocardial infarction, angina pectoris, asymptomatic myocardial ischemia) (36 Months); Heart failure (36 Months); Vascular events (aortic aneurysm, aortic dissection, and arteriosclerotic diseases) (36 Months); Diabetic complications (nephropathy, retinopathy and neuropathy) (36 Months); Renal dysfunction (doubling of serum creatinine, end stage renal diseases) (36 Months); All cause mortality (36 Months)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Study Comparing the Incidence of Cardiovascular Events Between High-dose ARB Monotherapy and Combination Therapy With ARB and Calcium Channel Blocker in Japanese Elderly Hypertensive Patients at High Cardiovascular Risk
Brief Summary: The purpose of this study is to investigate whether high-dose angiotensin II receptor blocker (ARB) monotherapy or combination therapy with ARB and calcium channel blockers is more effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients not adequately controlled by standard dose ARB alone.


Options:
A: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
B: BP measurement (Measured at 6 months)
C: A composite of fatal and non-fatal cardiovascular events: Cerebrovascular events (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, stroke of undetermined etiology and transient ischemic attack) (36 Months); Coronary events (sudden death, myocardial infarction, angina pectoris, asymptomatic myocardial ischemia) (36 Months); Heart failure (36 Months); Vascular events (aortic aneurysm, aortic dissection, and arteriosclerotic diseases) (36 Months); Diabetic complications (nephropathy, retinopathy and neuropathy) (36 Months); Renal dysfunction (doubling of serum creatinine, end stage renal diseases) (36 Months); All cause mortality (36 Months)
D: Time to the first occurrence of microalbuminuria defined as excretion of greater than 35 mg albumin/g urine creatinine for women and greater than 25 mg albumin/g urine creatinine for men in morning spot urine (Time to the first occurrence)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Study Comparing the Incidence of Cardiovascular Events Between High-dose ARB Monotherapy and Combination Therapy With ARB and Calcium Channel Blocker in Japanese Elderly Hypertensive Patients at High Cardiovascular Risk
Brief Summary: The purpose of this study is to investigate whether high-dose angiotensin II receptor blocker (ARB) monotherapy or combination therapy with ARB and calcium channel blockers is more effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients not adequately controlled by standard dose ARB alone.


Options:
A: Change from baseline diastolic blood pressure after 8 weeks; Change from baseline systolic blood pressure after 8 weeks
B: A composite of fatal and non-fatal cardiovascular events: Cerebrovascular events (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, stroke of undetermined etiology and transient ischemic attack) (36 Months); Coronary events (sudden death, myocardial infarction, angina pectoris, asymptomatic myocardial ischemia) (36 Months); Heart failure (36 Months); Vascular events (aortic aneurysm, aortic dissection, and arteriosclerotic diseases) (36 Months); Diabetic complications (nephropathy, retinopathy and neuropathy) (36 Months); Renal dysfunction (doubling of serum creatinine, end stage renal diseases) (36 Months); All cause mortality (36 Months)
C: Changes in estimated glomerular filtration rate (Changes in eGFR at month 6)
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized Study on Two Parallel Groups Comparing Dopexamine and Norepinephrine in Combination to Epinephrine Alone on Systemic and Pulmonary Hemodynamics, Gastric Mucosal Perfusion, and Oxidative Stress in Septic Shock
Brief Summary: In septic shock, when volume resuscitation fails to restore mean arterial pressure, catecholamines such as dopamine, dobutamine, epinephrine, or norepinephrine are used, either alone or in combination. Although they allow hemodynamic success to be obtained, they can leave some regional blood flows impaired, especially the hepatosplanchnic perfusion, which contributes to multiple organ failure.

Dopexamine is a structural and synthetic analog of dopamine that exerts systemic and gut vasodilation and stimulates cardiac contraction. In experimental models, dopexamine has been shown to exert anti-inflammatory properties and to protect the hepatic ultra structure. The combination of dopexamine and norepinephrine could therefore constitute an interesting alternative in treating septic shock patients. This study will test the efficacy (on gastric mucosal blood flow, hepatic damage and oxidative stress) and safety of the combination of dopexamine and norepinephrine (compared to those of epinephrine alone) in the treatment of patients with septic shock.


Options:
A: Systemic and regional hemodynamics (during the first 48 hours from the onset of septic shock)
B: Standing Dose of Norepinephrine Which is Required to Maintain a Mean Arterial Pressure (MAP) of 65 mmHg - Hour 1 (1 hour after initiation of angiotensin II (ATII)); Standing Dose of Norepinephrine Which is Required to Maintain a MAP of 65 mmHg - Hour 2 (2 hours after initiation of ATII)
C: Gastric mucosal blood flow assessed using a laser-Doppler flowmeter
D: Hospital Mortality (prior to discharge or 60 days, whichever comes first)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Multi-Center, Double-Blind, Randomized, Parallel Group, Carotid B-mode Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety, and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Atorvastatin Alone, in Subjects With Mixed Hyperlipidemia
Brief Summary: The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To look at ultrasound images taken in the carotid arteries and to look at various lipids in the blood of people with mixed hyperlipidemia


Options:
A: Change in intima media thickness as measured by carotid ultrasound
B: The time to first occurrence of a major cardiovascular disease event
C: Change in intima media thickness as measures by carotid ultrasound
D: Annualized Rate of Change in Mean of the Maximum (MeanMax) CIMT Measurements From Each of the 12 Carotid Artery Sites Based on All Scans Performed During the 104-Week Study Period (From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Multi-Center, Double-Blind, Randomized, Parallel Group, Carotid B-mode Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety, and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Atorvastatin Alone, in Subjects With Mixed Hyperlipidemia
Brief Summary: The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To look at ultrasound images taken in the carotid arteries and to look at various lipids in the blood of people with mixed hyperlipidemia


Options:
A: N/A
B: Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses (48 heures)
C: Change in intima media thickness as measured by carotid ultrasound
D: Restenosis of the treated infrapopliteal artery (12 months); Major amputation (12 months); Clinical driven-target lesion revascularization (12 months); Major cardiovascular events (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Multi-Center, Double-Blind, Randomized, Parallel Group, Carotid B-mode Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety, and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Atorvastatin Alone, in Subjects With Mixed Hyperlipidemia
Brief Summary: The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To look at ultrasound images taken in the carotid arteries and to look at various lipids in the blood of people with mixed hyperlipidemia


Options:
A: Change in intima media thickness as measured by carotid ultrasound
B: Number of Participants Who Are Alive and Free of Invasive Mechanical Ventilation or ECMO Through Day 28 (Day 1 to Day 28 (28 days))
C: the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism (28 days)
D: Number of patients with symptomatic or asymptomatic VTE (28 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Multi Center, Double Blind, Randomized, Parallel Group Evaluation Of The Fixed Combination Torcetrapib/Atorvastatin, Administered Orally, Once Daily (Qd), Compared With Atorvastatin Alone, On The Occurrence Of Major Cardiovascular Events In Subjects With Coronary Heart Disease Or Risk Equivalents
Brief Summary: The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To demonstrate if torcetrapib/atorvastatin can reduce the risk for major cardiovascular disease events, when compared to atorvastatin alone, in patients with coronary heart disease or risk equivalents


Options:
A: N/A
B: Change in intima media thickness as measures by carotid ultrasound
C: To demonstrate the effect of pactimibe versus placebo, when added to usual medical care, on the intima-media thickness (IMT) of the carotid arteries in subjects with heterozygous familial hypercholesterolemia (HeFH) and carotid atherosclerosis.
D: The time to first occurrence of a major cardiovascular disease event

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses
Brief Summary: The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS).

Secondary objectives were:

* to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale \[EDSS\], the burden of disease as measured by Magnetic Resonance Imaging \[MRI\] and patient-reported fatigue;
* to evaluate the safety and tolerability of teriflunomide.


Options:
A: The Number of T1-Gadolinium Enhancing Lesions During Months 7-9 (9 months)
B: Annualized Confirmed Relapse Rate (From randomization to end of study (Week 108))
C: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period (Week 96)
D: Annualized Relapse Rate [ARR]: Poisson Regression Estimates (108 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses
Brief Summary: The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS).

Secondary objectives were:

* to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale \[EDSS\], the burden of disease as measured by Magnetic Resonance Imaging \[MRI\] and patient-reported fatigue;
* to evaluate the safety and tolerability of teriflunomide.


Options:
A: Annualized Relapse Rate [ARR]: Poisson Regression Estimates (108 weeks)
B: Core Treatment Period: Time to Conversion to Clinically Deﬁnite Multiple Sclerosis (CDMS) (Up to a maximum of 108 weeks depending on time of enrollment)
C: Core Treatment Period: Overview of Failures (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled); Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled)
D: Number of patients with adverse events (Up to a maximum of 532 weeks (4 weeks after last treatment intake) or until teriflunomide is commercially available in the country where patient lives)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses
Brief Summary: The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS).

Secondary objectives were:

* to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale \[EDSS\], the burden of disease as measured by Magnetic Resonance Imaging \[MRI\] and patient-reported fatigue;
* to evaluate the safety and tolerability of teriflunomide.


Options:
A: Relapse Rate: Number of Confirmed Relapses During the Double Blind Study Period (Up to Month 24)
B: Number of new or enlarged gadolinium contrast enhancing lesions (Gd-CELs) on monthly brain MRIs collected between Weeks 8 to 24 in daclizumab- vs. placebo-treated patients
C: Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6 (Month 3 and Month 6)
D: Annualized Relapse Rate [ARR]: Poisson Regression Estimates (108 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses
Brief Summary: The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS).

Secondary objectives were:

* to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale \[EDSS\], the burden of disease as measured by Magnetic Resonance Imaging \[MRI\] and patient-reported fatigue;
* to evaluate the safety and tolerability of teriflunomide.


Options:
A: Annualized Relapse Rate [ARR]: Poisson Regression Estimates (108 weeks)
B: Overview of Adverse Events [AE] (from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)); Overview of AE With Potential Risk of Occurence (from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)); Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA] (from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max))
C: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs (Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)); Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab (Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose)
D: Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate (Core treatment period between 48 - 152 weeks depending on time of enrollment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Increasing CRC Screening in Health Plan Members
Brief Summary: The purpose of this study is to determine the effectiveness of a two-component intervention, that combines academic detailing at the medical practice level and distribution of decision aids at the patient level, on adherence to colorectal cancer screening guidelines.


Options:
A: Completion of colorectal cancer screening
B: Patient knowledge (Immediately after patient visit)
C: Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score (24 weeks)
D: The primary outcome measure was total medical costs (capped at $200,000 per individual per year) and pharmacy costs.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Growth of Genitalia Interna and the Bone Mineralization Under Hormonal Replacement Therapy and the Presence of Aortic Root Dilatation in Girls With Turner Syndrome
Brief Summary: The purpose of this study is to examine whether a larger dosage of estrogen than the one used today will secure the development of a normal sized uterus and increase the strength of the bones in girls and young women with Turner syndrome.

The purpose is also to evaluate whether aortic dilatation is present in this group of patients, and if the estrogen dosage will influence the emotional well-being and self-esteem of the patients.


Options:
A: The size of the uterus evaluated by magnetic resonance (MR)-scan (5 years); Bones evaluated by dual-energy X-ray absorptiometry (DEXA)-scan (5 years)
B: N/A
C: N/A
D: Change in 24 hour ambulatory blood pressure (Before each washout period, then at 0, 3, 6 and 12 months of each treatment); Bone mineral density measurements (DEXA) (Baseline, 14 and 24 months); Uterine ultrasound scan to assess uterine volume, endometrial thickness, and uterine artery blood flow (Before each washout period, then at 0, 3, 6 and 12 months of each treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Pediatric Safety and Quality With Health Care IT
Brief Summary: This study includes four projects aimed to improve the quality and safety of pediatric care through the implementation of four clinical decision support services in the electronic health record (EHR). The four projects will measure the effect of each clinical decision support feature including: weight-based dosing; smart forms for chronic conditions; guideline reminders; and a results manager to track abnormal lab result follow-up.

Hypothesis: Implementation of the clinical decision support features will decrease medication errors and adverse drug events, assist physicians in adhering to clinical practice guidelines and protocols for certain chronic illnesses, improve physician follow-up for abnormal lab results, and overall improve the safety and quality of pediatric clinical practice.


Options:
A: Enhanced goal-consistent care (up to 2 years); PEACE (up to 2 years)
B: Reduce concomitant orders for warfarin and tmp/smx (7 months)
C: Impact on rates of medication errors (1 year)
D: Intervention acceptance (6 months (May 2010-Nov2010))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Pediatric Safety and Quality With Health Care IT
Brief Summary: This study includes four projects aimed to improve the quality and safety of pediatric care through the implementation of four clinical decision support services in the electronic health record (EHR). The four projects will measure the effect of each clinical decision support feature including: weight-based dosing; smart forms for chronic conditions; guideline reminders; and a results manager to track abnormal lab result follow-up.

Hypothesis: Implementation of the clinical decision support features will decrease medication errors and adverse drug events, assist physicians in adhering to clinical practice guidelines and protocols for certain chronic illnesses, improve physician follow-up for abnormal lab results, and overall improve the safety and quality of pediatric clinical practice.


Options:
A: Proportion of visits to primary care clinic associated with antibiotic prescriptions (30 days)
B: Proportion of patients reporting a decision for "immediate antibiotics." (After index consultation)
C: Impact on rates of medication errors (1 year)
D: antibiotic prescription rate of physicians (5 years)

Answer: C