Coronary Artery Disease

Paraoxanase 1

Thiobarbituric Acid Reactive Substances

Thiol Groups

Serum Oxidative Status as a Potential Predictor of Coronary Artery Disease.

The presence of coronary artery disease is defined as the presence of any atherosclerotic plaque leading to any percentage of coronary artery stenosis. The severity of coronary artery disease is defined either as significant or non significant. A Non significant coronary artery disease is defined as any coronary artery stenosis less than or equal to 49%. A Significant coronary artery disease is defined as any coronary artery stenosis more than 49%.

Prof. Tony hayek MD

Director, Department of Internal Medicine E

This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.

This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.
C1-esterase inhibitor (Cinryze)

C1-esterase Inhibitor (Cinryze)

Sex: Female, Male

Over the course of hospitalization for the acute NMO exacerbations, subjects will be monitored daily for frequency of adverse events.

Number of Adverse Safety Events During Hospitalization

Frequency of Serious Adverse Events.

Percentage of Subjects Withdrawing Due to Adverse Events.

ALT elevations were considered "mild" if they rose to less than 4-fold baseline levels.

Change From Baseline in Hematology, Chemistry, and Urinalysis Parameters.

The Kurtzke Expanded Disability Status Scale (EDSS) was developed to measure the disability status of patients with multiple sclerosis. It allows an objective quantification of the level of functioning that could be widely and reproducibly used by researchers and health care providers.
The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. In addition, it also provides eight subscale measurements called Functional System (FS) scores.

Expanded Disability Status Score (EDSS)

Overall Study

Michael Levy, MD, PhD

Neuromyelitis Optica

C1-esterase inhibitor (Cinryze)

Johns Hopkins Hospital

C1-esterase Inhibitor (Cinryze) for Acute Treatment of Neuromyelitis Optica Exacerbation

Phase 1b Study of C1-esterase Inhibitor (Cinryze) With Standard of Care for Acute Treatment of Neuromyelitis Optica Exacerbations

Michael Levy

Assistant Professor

ViroPharma

Patients receiving clopidogrel 75 mg/day as prescribed by their physician, and are extensive metabolizers by CYP2C19 genotype

Patients receiving prasugrel 5 or 10 mg/day as prescribed by their physician

Cardiovascular Disease

Medco Health Solutions, Inc

Genotype Guided Comparison of Clopidogrel and Prasugrel Outcomes Study

To assess the non-inferiority of clopidogrel therapy in patients with cardiovascular disease who are CYP2C19 extensive metabolizers (identified by genetic testing) compared to prasugrel therapy (non-genotyped) on the composite primary end point of cardiovascular death, hospitalization for acute coronary syndrome (nonfatal MI or unstable angina), nonfatal stroke or coronary revascularization

Number of hospitalizations and ER visits for other cardiovascular events not included in the primary composite endpoint.
the primary (composite) endpoint and the individual components of the primary end point in subjects who are CYP2C19 intermediate metabolizers (IM) with clopidogrel EM and prasugrel populations
the primary (composite) endpoint and the individual components of the primary end point in the population of CYP2C19 intermediate and extensive metabolizers with the prasugrel population.

Eric Stanek

Vice President, Research

Medco Health Solutions, Inc.

Bipolar Disorder

Schizophrenia

University of Iowa Hospitals and Clinics

Antipsychotics and Blood Vessel Function

Cardiovascular Complications of First-line, Second-generation Antipsychotics

% dilation of the brachial artery in response to 5 minutes of ischemia

% dilation of forearm blood vessels in response to pharmacological challenge measured using plethysmography

Requests for de-identified data may be presented to the principal investigator with a statistical analysis plan.

esterase/infarkts

Serum Oxidative Status as a Potential Predictor of Coronary Artery Disease.

C1-esterase Inhibitor (Cinryze) for Acute Treatment of Neuromyelitis Optica Exacerbation

Genotype Guided Comparison of Clopidogrel and Prasugrel Outcomes Study

Antipsychotics and Blood Vessel Function

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