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NCT ID: NCT00249873 Completed - Atrial Fibrillation Clinical Trials

Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE A)

Start date: June 2003
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if the combination of clopidogrel 75mg once daily (od) plus aspirin 100mg daily (recommended dose) is better than aspirin alone (100mg daily recommended dose) for preventing vascular events such as stroke and heart attack during approximately three years of follow-up in patients with atrial fibrillation associated with at least one major risk factor of vascular event such as elderly, blood pressure increase, history of stroke or transient ischemic attack or left ventricular dysfunction etc. The study will also accept patients with atrial fibrillation and unwilling to take oral anticoagulant therapy.

NCT ID: NCT00249795 Completed - Atrial Fibrillation Clinical Trials

Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I)

ACTIVE I
Start date: June 2003
Phase: Phase 3
Study type: Interventional

The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular events.

NCT ID: NCT00249249 Completed - Dyslipidemia Clinical Trials

Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels

Start date: October 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of pitavastatin with that of atorvastatin.

NCT ID: NCT00248170 Completed - Breast Cancer Clinical Trials

Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer

FACE
Start date: December 2005
Phase: Phase 3
Study type: Interventional

Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.

NCT ID: NCT00247962 Completed - Clinical trials for Ankylosing Spondylitis

Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis

Start date: December 2005
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.

NCT ID: NCT00247793 Completed - Cardiac Surgery Clinical Trials

Immunonutrition in Cardiac Surgery

Start date: July 1996
Phase: N/A
Study type: Interventional

Effect of two preoperative oral immune-enhancing nutritional supplements in patients at high risk of infection after cardiac surgery: a randomized placebo-controlled study. Introduction: In our first study we showed that the use of a preoperative oral immune-enhancing nutritional supplement (OIENS) resulted in an improved patients’ host-defence with a reduction in postoperative infectious morbidity in ‘high-risk’ cardiac surgery patients. The use of the OIENS resulted also in less postoperative organ dysfunction. Experimental studies have shown that additional glycine results in less ischemia-reperfusion damage and that glycine has anti-inflammatory properties. Objective: The use of an OIENS in the preoperative period in patients at high risk of infection after elective cardiac surgery with the use of cardiopulmonary bypass (CPB) results in a reduction in infections as in our first study. The addition of 9.6 gram glycine per sachet OIENS results in a further reduction in postoperative dysfunction. Design: A prospective randomized placebo controlled study with two oral immune enhancing nutritional formula’s and an isocaloric control formula. Patients: Seventy-four consecutive patients undergoing cardiac surgery with the use of an CPB who met one or more of the following inclusion criteria: Age 70 years or older, mitral valve replacement or cardiac ejection fraction less then 40%. Exclusion criteria were age < 18 years, proven malignancy, use of corticosteroids, severe renal and liver failure. Definition of a protocol violation was the intake of less then 5 L or more then 10 L of the nutritional supplement in the preoperative period. Intervention: Patients were split up in three groups by concealed randomisation. One group received the arginine, omega3-PUFAs and nucleotides enriched formula (OIENS). Another group received the OIENS further enriched with glycine (OIENS+glyc). The control group received an isocaloric nutritional supplement without the enrichments.

NCT ID: NCT00247741 Completed - Spinal Anesthesia Clinical Trials

Spinal Anesthesia With Articaine and Lidocaine for Outpatient Surgery.

Start date: November 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare two short-acting local anesthetics, articaine and lidocaine, for spinal anesthesia in day-case surgery. The onset time of the sensory- and motor block, recovery time until discharge and complications will be studied.

NCT ID: NCT00247715 Completed - Dyspepsia Clinical Trials

Comparison of a "Step-Up" Versus a "Step-Down" Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study)

Start date: October 2003
Phase: N/A
Study type: Interventional

The purpose of this study was to determine which treatment strategy, the step-up or the step-down treatment strategy, is the most cost-effective treatment for patients with new onset dyspepsia in primary care.

NCT ID: NCT00246961 Completed - Breast Cancer Clinical Trials

Arimidex Observational: Reason for and Effect of Change From Tamoxifen

ARREST
Start date: July 2004
Phase: Phase 4
Study type: Observational

The purpose of this study is to analyse the effect on quality of life after 3 months of treatment after changing adjuvant therapy from tamoxifen to Arimidex.

NCT ID: NCT00246714 Completed - Endotoxemia Clinical Trials

Pathophysiology and Clinical Relevance of Endotoxin Tolerance in Humans

Start date: October 2005
Phase: Phase 1
Study type: Interventional

A number of diseases lead to a so called systemic inflammatory response syndrome (SIRS). This excessive response is self-destructive and leads to major complications of the initial disease: dysfunction of the microcirculation, systemic vasodilation, and increased capillary leakage and oedema. Animal studies have shown that pre-treatment with endotoxin (lipopolysaccharide or LPS) suppress the excessive immune response and when rechallenged, the animal survive a normally lethal dose of endotoxin. Besides a diminished cytokine response, an increased production of leucocytes in the bone marrow and an increased phagocytosis after pre-treatment with endotoxin is seen. The combination of these factors: diminished systemic inflammatory response and increased cellular immunity makes that endotoxin tolerance is a useful tool for preventing the complications after an excessive inflammatory response. Further, the presence of cross-tolerance has also been shown: Endotoxin tolerant mice survive more after induction of a normally lethal fungal infection. Endotoxin tolerance is also protective for ischemia/reperfusion injury in kidneys, heart and liver. Little data is known about endotoxin tolerance in human. The purpose of this study is to induce a state of tolerance through 2 different administration schedules and monitor the effect of tolerance on pro- and anti-inflammatory cytokines, other inflammatory parameters and different proteins involved in the signalling pathway. The effects of tolerance on vascular reactivity will be determined. Finally, the effect of tolerance on ischemia-reperfusion injury will be investigated.