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NCT ID: NCT00329576 Completed - Hepatitis B Clinical Trials

Evaluate Immune Response Approximately 5 to 6 Years After Receiving Different Formulations of GSK Bio Hep B Vaccine

Start date: May 2006
Phase: Phase 4
Study type: Interventional

To evaluate the persistence of antibodies against hepatitis B, approximately 5 to 6 years after the first dose of the hepatitis B in the primary vaccination study.

NCT ID: NCT00328289 Completed - Hypotension Clinical Trials

Effect of Intradialytic Electrical Muscle Stimulation and Passive Leg Mobilisation on Blood Pressure and Dialysis Efficacy

Start date: May 2006
Phase: N/A
Study type: Interventional

Hypothesis: Intradialytic blood pressure and dialysis efficacy (in terms of urea removal) improve under electrical muscle stimulation or passive leg movement on a treadmill.

NCT ID: NCT00328068 Recruiting - Spondyloarthritis Clinical Trials

Assessment of SpondyloArthritis Society (ASAS) Classification and Diagnostic Criteria for Early Axial Spondyloarthritis (SpA)

Start date: July 2006
Phase: N/A
Study type: Observational

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.

NCT ID: NCT00327691 Completed - Clinical trials for Cardiovascular Disease

A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels

TNT
Start date: April 1998
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT00327613 Completed - Glaucoma Clinical Trials

Plasma Levels of Matrix Metalloproteinases (MMPs) and Degree of DNA Fragmentation in Pseudoexfoliation (PEX) Glaucoma

Start date: June 2005
Phase: N/A
Study type: Observational

Glaucoma is a worldwide leading cause of blindness. The key feature of this ocular neuropathy is characterized by an excavating optic nerve head. Loss of retinal ganglion cells is the final end point in blinding diseases of the optic nerve such as glaucoma. It is known that neuronal cell death in glaucoma occurs by apoptotic mechanism. In earlier studies, the investigators demonstrated that the process of apoptosis is reflected in circulating leukocytes by different parameters, like differential messenger ribonucleic acid (mRNA) expression and an increased fragmentation of the deoxyribonucleic acid (DNA). Such alterations point out a relationship between cellular stress and apoptotic events. Based on the results of mRNA-expression, the investigators also expect alterations on the protein level. This study is, therefore, designed to characterize the proteome related to the proteins involved in cell death related pathways. Thus the expression pattern of several proteins in leukocytes from patients with primary open angle glaucoma will be analyzed by techniques like Western-blot and tandem mass spectrometry. These samples will be compared with healthy controls. In addition, they will be also compared with samples from patients with Parkinson's disease. Since glaucoma is a neurodegenerative disease, these patients will be included as a positive control in this study.

NCT ID: NCT00327509 Completed - Glaucoma Clinical Trials

mRNA Expression in Lymphocytes of Glaucoma Patients

Start date: January 2004
Phase: N/A
Study type: Observational

The aim of the study is to compare messenger ribonucleic acid (mRNA) expression of various genes in lymphocytes between glaucoma patients and sex and age-matched healthy subjects. A secondary objective is to analyze the impact of different forms of glaucoma or of a vasospastic propensity on the findings.

NCT ID: NCT00327171 Completed - Neoplasms Clinical Trials

Study of AVE0005 (VEGF Trap) in Patients With Chemoresistant Advanced Ovarian Cancer

Start date: May 2006
Phase: Phase 2
Study type: Interventional

This study evaluated outcomes in participants with advanced ovarian epithelial adenocarcinoma receiving aflibercept. The primary objective was to compare the objective response rate of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) 4.0 mg/kg and 2.0 mg/kg, administered intravenously (IV) every 2 weeks with historical control in participants with advanced ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma resistant to platinum and topotecan and/or liposomal doxorubicin. The secondary objectives was to further assess efficacy, safety, pharmacokinetics, potential biological and pharmacogenomic markers of study drug activity, and health-related quality of life. This study employed an Independent Review Committee (IRC) for radiological tumor assessments. For all tumor assessment-related efficacy variables, two analyses were performed: the primary analysis was based on Independent Review Committee (IRC) reviewed data and the secondary analysis was based on Investigator evaluation. If an endpoint was evaluated by the IRC, the IRC reviewed data is reported for this study.

NCT ID: NCT00327145 Completed - Hypertension Clinical Trials

A Study to Evaluate the Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled on Monotherapy

Start date: March 2006
Phase: Phase 3
Study type: Interventional

This study is designed to provide additional efficacy and safety data for a treatment strategy based on the combination valsartan with amlodipine in hypertensive patients previously treated with monotherapy and remaining uncontrolled. A naturalistic approach will be taken comparing two different doses, i.e. 160mg of valsartan with amlodipine 5mg and 10mg with possible addition of HCTZ

NCT ID: NCT00326976 Completed - Clinical trials for Myocardial Infarction

Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury

Start date: August 2006
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate whether FX06 is capable of limiting infarct size following balloon catheterization for acute myocardial infarction.

NCT ID: NCT00326014 Completed - Open-Angle Glaucoma Clinical Trials

A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

Start date: April 2003
Phase: Phase 4
Study type: Interventional

To evaluate the safety and efficacy of a new trabecular bypass that is implanted in conjunction with cataract surgery in open angle glaucoma subjects.