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NCT ID: NCT00820911 Completed - Clinical trials for Kidney Transplantation

Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients

Start date: September 2008
Phase: Phase 2
Study type: Interventional

This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.

NCT ID: NCT00820352 Completed - Clinical trials for Hypertension, Pulmonary

Safety and Efficacy of Bosentan in Patients With Diastolic Heart Failure and Secondary Pulmonary Hypertension

BADDHY
Start date: January 2009
Phase: Phase 3
Study type: Interventional

Heart failure is a major medical and socioeconomic problem in western industrial countries, especially with aging populations. Heart failure with normal left ventricle systolic function (heart failure with preserved ejection fraction, HFPEF, heart failure with normal ejection fraction, HFNEF) are common causes of hospitalization mainly in the elderly population and are frequently associated with pulmonary hypertension. It is commonly seen, that patients with left heart disease and pulmonary hypertension with right ventricle dysfunction have a worse prognosis. The investigators hypothesize, that an additional treatment with Bosentan in this patients will improve their exercise capacity, symptoms, hemodynamics and quality of life.

NCT ID: NCT00820131 Completed - Chronic Pain Clinical Trials

Chronic Pain After Inguinal Hernia Repair

GRIP-ME
Start date: January 2008
Phase: Phase 4
Study type: Interventional

Chronic pain after inguinal hernia repair has become a major concern. Although tension-free Lichtenstein technique is used and new lightweight meshes have been developed, still up to 40 % of patients complain of some kind of pain even one year after surgery. The necessity of mesh-fixation using sutures, could be causative. However, current data do not provide evidence whether suture fixation in Lichtenstein repair might be the reason for chronic postoperative pain. A newly developed selfgrip-mesh enables sutureless fixation of the mesh in open inguinal hernia repair. Hereby a polypropylene mesh is combined with a resorbable polylactic-acid gripping system. Thereby the rate of chronic postoperative pain could be decreased. Two techniques of inguinal hernia repair will be evaluated: 1. open anterior mesh repair using conventional Lichtenstein technique (sutures for mesh-fixation) 2. open anterior mesh repair using a selfgrip mesh (polylactic-acid gripping system for mesh fixation) Postoperative pain will be evaluated by visual analog scale and Mc Gill pain questionaire at the 10th day, as well as 3 and 15 months postoperatively.

NCT ID: NCT00820079 Completed - Clinical trials for Gastroesophageal Reflux

ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)

Start date: December 2008
Phase: Phase 2
Study type: Interventional

Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.

NCT ID: NCT00816660 Completed - Clinical trials for Von Willebrand Disease

Pharmacokinetic, Safety and Tolerability Study of Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex in Type 3 Von Willebrand Disease

Start date: December 1, 2008
Phase: Phase 1
Study type: Interventional

The objectives of this study are to evaluate the immediate tolerability and safety of rVWF:rFVIII in subjects with Type 3 Von Willebrand Disease after administration of various dosages of VWF:RCo.

NCT ID: NCT00814723 Completed - Clinical trials for Hypercholesterolemia

Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk

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

Patients with coronary heart disease (CHD) or CHD equivalent (e. g. diabetes mellitus) often have abnormalities in lipids (hypercholesterolemia). Besides, hypercholesterolemia is an evident risk factor for atherosclerosis. Hitherto, there are only few studies of patients with primary hypercholesterolemia where the combination therapy with statins (HMG-Co-reductase inhibitors) and ezetimib was investigated. This combination therapy should be more effective in reducing low density lipoprotein cholesterol (LDL-C) and total cholesterol levels compared to monotherapy.

NCT ID: NCT00814047 Completed - Ocular Physiology Clinical Trials

The Effect of an α2-Adrenoceptor Antagonist (Yohimbine) on Dynamic Autoregulation in the Human Middle Cerebral Artery and Ophthalmic Artery

Start date: n/a
Phase: Phase 4
Study type: Interventional

Blood flow autoregulation is defined as the ability of a tissue to maintain a relatively constant flow, despite moderate alterations in perfusion pressure. Similar to the cerebral, renal, coronary and skeletal muscle circulations, the ocular vascular bed shows the property of flow autoregulation. This homeostatic mechanism allows blood supply to the eye to match metabolic demand during daily activities, such as changes in posture, or in more critical conditions. Autoregulation has been found to be a complex phenomenon, showing heterogeneity in its site and time course of action. Since metabolic, myogenic, neurogenic and possibly endothelium-related mechanisms may be involved, several factors may vary depending on the challenging stimulus, the vessel tone, or the degree of impairment of autoregulation. To study the dynamics of ocular autoregulation, it is necessary to introduce a step disturbance (stimulus) in ocular perfusion pressure and to record the responses of ocular blood flow continuously before and after this step disturbance. The investigators have employed a mechanical noninvasive technique to induce an ocular perfusion pressure step disturbance without drugs or changes in the concentration of vasoactive substances in the blood by using the thigh cuff technique inducing a small step decrease in ocular perfusion pressure. With this technique the investigators could show significant differences in the time response of blood velocities in the ophthalmic and middle cerebral artery. This clearly indicates different mechanisms to be responsible for autoregulatory mechanisms distal to the vessels. Interestingly our results indicate that in the ophthalmic artery a late vasoconstriction occurs. Many previous investigations have demonstrated that sympathetic nerve stimulation causes vasoconstriction in the ocular circulation. Accordingly, the present study tests the hypothesis that α2-adrenoceptors are involved in the dynamic regulation of blood flow in the ophthalmic and middle cerebral artery after a step decrease in perfusion pressure.

NCT ID: NCT00814008 Completed - Clinical trials for Diabetes Mellitus, Type 1

The Relationship Between Stage of Diabetic Retinopathy and Retinal Blood Flow in Patients With IDDM During Euglycemic Clamp

Start date: March 1999
Phase: Phase 2
Study type: Interventional

Impaired retinal blood flow has been implicated in the pathogenesis of diabetic retinopathy. Patel et al. (1992) showed that retinal blood flow increases with the level of diabetic retinopathy. Grunwald et al. (1996) reported that patients with insulin dependent diabetes mellitus (IDDM) of relatively short duration have increased retinal blood flow, even before the onset of diabetic retinopathy. On the other hand the data of Bursell et al. (1996) indicate that IDDM patients have reduced retinal blood flow, when they have normal blood glucose levels, but this study may have considerable methodological limitations. Acute elevations of blood glucose levels, however, result in an increase in retinal blood flow (Grunwald et al. 1987, Bursell et al. 1996). Based on previous experimental data the investigators hypothesize that ocular blood flow is increased in early diabetes and reduced at later stages of the disease. Previous studies have demonstrated that metabolic conditions such as hyperglycemia influence outcome parameters and thereby might have confounded results regarding ocular blood flow in diabetic retinopathy. The investigators will therefore study patients with IDDM during euglycemic conditions.

NCT ID: NCT00813709 Completed - Multiple Sclerosis Clinical Trials

Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)

REFLEXION
Start date: December 2008
Phase: Phase 3
Study type: Interventional

REFLEXION is a double blind extension of the study 27025 (NCT00404352) (REFLEX). The purpose of the study is to obtain long-term follow-up data in subjects with clinically definite multiple sclerosis (MS) and subjects with a first demyelinating event at high risk of converting to MS, treated with fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF).

NCT ID: NCT00813410 Completed - Type 1 Diabetes Clinical Trials

Evaluation of a Novel Method for Integrating Insulin Delivery and Glucose Sensing in Adipose Tissue of Diabetic Patients

Start date: February 2007
Phase: N/A
Study type: Interventional

The study seeks to use microdialysis and microperfusion techniques to assess the feasibility of performing insulin delivery and glucose sensing at a single subcutaneous tissue site.