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NCT ID: NCT00804856 Completed - Clinical trials for Leukemia, Myeloid, Acute

Phase I/IIa Trial to Investigate BI 6727 (Volasertib) as Monotherapy or in Combination With Cytarabine in Acute Myeloid Leukaemia

Start date: November 27, 2008
Phase: Phase 2
Study type: Interventional

The trial will be performed in two parts, a phase I part and a phase IIa part. In the phase I part of the trial, BI 6727 will be investigated as monotherapy and in combination with low dose cytarabine (LD-Ara-C) in patients with relapsed/refractory AML that are not eligible for intensive treatment. The dose of BI 6727 will be escalated to determine the maximum tolerated dose (MTD) of BI 6727 monotherapy and BI 6727 in combination with LD-Ara-C in AML patients. In the phase IIa part, the combination of BI 6727 at MTD with LD-Ara-C and LD-Ara-C monotherapy will be investigated to explore the efficacy of the combination schedule in comparison to LD-Ara-C monotherapy in previously untreated AML patients that are not eligible for intensive treatment.

NCT ID: NCT00804219 Completed - Clinical trials for Tick-borne Encephalitis

Humoral and Cellular Immunity of Low and High-responders After Tick-borne Encephalitis Vaccination

Start date: December 2008
Phase: Phase 4
Study type: Interventional

The phenomenon of no- and low-responsiveness has been described after applications of different vaccines (e.g. hepatitis B, TBE) and is concerning about 2-10% of the vaccinees. The aim of this project is to investigate the humoral and cellular immune responses of low-responders after TBE vaccination in order to find parameters regarding immunoregulation against TBE. It is of interest if non-responsiveness is a general immunological deficit of a distinct patient group or if it is a antigen-specific phenomenon.

NCT ID: NCT00803504 Completed - Clinical trials for Primary Open Angle Glaucoma

Correlation of Optic Disk Morphology and Ocular Perfusion Parameters in Patients With Primary Open Angle Glaucoma

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

Glaucoma is one of the most common causes of blindness in the industrialized nations. For a long time glaucoma has been defined as a disease in which high intraocular pressure (IOP) leads to irreversible optic disc damage and subsequent visual field loss. However, recent investigations show that IOP is not the only factor that is involved in the glaucomatous process leading to retinal ganglion cell death. The role of vascular factors in the pathogenesis of glaucoma has recently received much attention based on animal experiments and epidemiological studies. It is, however, assumed that vascular factors do not contribute to same degree in all glaucoma patients. Generally, it is believed that a vascular component is more important in normal tension glaucoma patients and patients with underlying cardiovascular disease. Little is, however, known about a potential association between optic nerve head morphology and ocular perfusion in POAG patients. The current study seeks to gain insight into this association by assessing ocular blood flow parameters with a number of noninvasive technologies.

NCT ID: NCT00803049 Completed - Multiple Sclerosis Clinical Trials

Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis

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

The primary objective of this study is to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) patients with relapse. The secondary objective is to document the long-term efficacy on disability progression, relapse rate and Magnetic Resonance Imaging (MRI) parameters.

NCT ID: NCT00800735 Completed - Clinical trials for Hepatitis C, Chronic

A Study of PEGASYS (Pegylated-interferon Alfa-2a) With or Without Ribavirin in Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols

Start date: April 2009
Phase: Phase 3
Study type: Interventional

This single arm study will provide treatment or re-treatment with PEGASYS as monotherapy or in combination with ribavirin (Copegus), to patients with chronic hepatitis C (CHC) who have participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment was promised or deemed appropriate following completion of the original protocol ('donor' protocol). Patients who qualify for treatment or re-treatment will begin PEGASYS monotherapy, at a maximum dose of 180 µg weekly, or combination therapy with Copegus, 800-1200 mg daily, as continuation of treatment after the wash-out period defined in their donor protocol. PEGASYS treatment is not to exceed the approved treatment duration of 48 weeks in genotype G1 with a treatment-free follow up period of 24 weeks.

NCT ID: NCT00800384 Completed - Clinical trials for Ventricular Tachycardia

Shockless Implant Evaluation

SIMPLE
Start date: January 2009
Phase: N/A
Study type: Interventional

This trial will assess the safety of defibrillator testing and the influence of defibrillation testing on the efficacy of clinical shocks. The trial will test the hypothesis that implantable cardioverter defibrillator (ICD) implantation without defibrillation testing (DT) is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death. It will also test the hypothesis, that defibrillation testing increases the peri-operative (30 days) complication rate of ICD implantation.

NCT ID: NCT00800046 Completed - Clinical trials for Mitral Regurgitation

A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study

CINCH-2
Start date: November 2008
Phase: N/A
Study type: Interventional

Prospective single-arm study of the AccuCinch® Ventriculoplasty System in the treatment of mitral valve regurgitation through subvalvular mitral repair. Purpose: To demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® Ventriculoplasty System to reduce mitral valve regurgitation through subvalvular mitral repair.

NCT ID: NCT00799877 Completed - Clinical trials for Chronic Plaque Psoriasis

Chronic Plaque Psoriasis (Ps) Registry

Start date: September 26, 2008
Phase:
Study type: Observational

The purpose of this study is to evaluate the long-term safety of Humira® in Adult Patients with Chronic Plaque Psoriasis (Ps).

NCT ID: NCT00799656 Completed - Pain Clinical Trials

Efficacy and Safety Study of Ataciguat Versus Placebo in Patients With Neuropathic Pain

SERENEATI
Start date: November 2008
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to assess the efficacy of ataciguat versus placebo in reducing pain intensity in patients with neuropathic pain. The secondary objective is to assess the safety and tolerability of ataciguat versus placebo.

NCT ID: NCT00798434 Completed - Clinical trials for Urinary Bladder, Overactive

A Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder.

SOFIA
Start date: June 2008
Phase: Phase 4
Study type: Interventional

The drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at unwanted times and has been shown to help patients with overactive bladder syndrome pass urine less frequently than before treatment. It is postulated that this drug will also prove effective in elderly patients (aged > 65 years) and that the ability to change dose between 4 and 8mg will allow each patient to have an optimised treatment.