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NCT ID: NCT00808197 Completed - Regional Blood Flow Clinical Trials

Choroidal Blood Flow and Progression of Age-Related Macular Degeneration in the Fellow Eye in Patients With Unilateral Choroidal Neovascularisation

Start date: n/a
Phase: N/A
Study type: Interventional

Age-related macular degeneration (AMD) is the chief cause of severe and irreversible loss of vision in developed countries. The prevalence of AMD increases dramatically with age. The early stage (or dry AMD) is associated with minimal visual impairment and is characterized by large drusen and pigmentary abnormalities in the macula. The late stage is a neovascular, exudative form. This so called exudative AMD includes serous or hemorrhagic detachment of retinal pigment epithelium and choroidal neovascularization leading to severe loss of vision (20/200 or worse). Patients with unilateral CNV (choroidal neovascularisation) have a significant risk of CNV developing in the second eye. Choroidal blood flow is of great importance for normal visual function. Several reports have provided evidence suggesting that choroidal blood flow is decreased in subjects with AMD. In late stages of AMD angiogenesis leads to the formation of choroidal neovascularization that can cause severe visual impairment by disrupting normal macular function. The purpose of this evaluation is to investigate a possible link between alterations in choroidal blood flow and the development of CNV and serous detachment in the fellow eye of patients with AMD and unilateral neovascular maculopathy. This longitudinal study may provide important findings with respect to natural history and visual prognosis of patients with neovascularized AMD. Ocular blood flow will be determined by non-invasive methods, including laser Doppler flowmetry and laser interferometry

NCT ID: NCT00808067 Completed - Atrial Fibrillation Clinical Trials

RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial

Start date: November 2008
Phase: Phase 3
Study type: Interventional

The purposes of this study are: 1. To evaluate the long-term safety of dabigatran etexilate 2. To assess the effect of a knowledge translation intervention on patient outcomes

NCT ID: NCT00807287 Completed - Critically Ill Clinical Trials

Evaluation of Two Methods of Jejunal Placement of Enteral Feeding Tubes in Critically Ill Patients

Start date: February 2005
Phase: N/A
Study type: Interventional

In patients with high gastric residual volumes jejunal feeding is recommended. Jejunal feeding tubes can be placed in different ways. The endoscopic technique yields a success rate between 90 and 98% for a correct jejunal placement. However, it requires endoscopic equipment and trained staff. In contrast in small uncontrolled trials different unguided techniques resulted in success rates up to 75%, only. In this prospective randomized trial the success rate of a correct jejunal placement with the endoscopic technique is compared with the unguided frictional technique. The investigators hypothesize that the success rate of the unguided frictional placement method will be lower than the success rate of the endoscopic method.

NCT ID: NCT00807248 Completed - Clinical trials for Major Depressive Disorder

Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder

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

To compare the efficacy of escitalopram fixed dose 20 mg/day in combination with fixed doses of gaboxadol (5 and 10 mg/day) versus escitalopram fixed dose 20 mg/day after 8 weeks of treatment in patients with Major Depressive Disorder

NCT ID: NCT00806741 Completed - Healthy Clinical Trials

Role of Nitric Oxide in Optic Nerve Head Blood Flow Regulation During Isometric Exercise in Healthy Humans

Start date: September 2009
Phase: N/A
Study type: Interventional

Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance to changes in perfusion pressure. In the eye, several studies have reported that retinal blood flow is autoregulated over a wide range of ocular perfusion pressures. The investigators recently showed that nitric oxide (NO) is a key metabolite in the regulation of vascular tone in the eye and plays an important role in the blood flow autoregulation of the choroidal circulation. However, no data is yet available for the optic nerve head. Thus, the present study is designed to test the hypothesis that NO plays also a role in optic nerve head blood flow autoregulation. Therefore, subjects will perform squatting to increase systemic perfusion pressure during administration of either a nitric oxide synthase inhibitor (L-NMMA), an α-receptor agonist (phenylephrine) or placebo. Optic nerve head blood flow will be continuously measured during the procedure to investigate optic nerve head autoregulation.

NCT ID: NCT00806533 Completed - Surgery Clinical Trials

Non-Interventional (Observational) Post-Authorization Safety Study of HES 130/0.42 in Paediatric Patients

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

This observational (non-interventional) post-authorization safety study (PASS) will investigate the application of Venofundin 6% and of Tetraspan 6% in children with special regard to drug safety.

NCT ID: NCT00806026 Completed - Clinical trials for Idiopathic Restless Legs Syndrome

Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

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

This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.

NCT ID: NCT00805350 Completed - Primary Insomnia Clinical Trials

Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties

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

Primary objective: - To assess the efficacy of eplivanserin 5mg/day in comparison to placebo after 6 weeks of treatment on sleep maintenance of insomniac patients, as measured by Polysomnography Wake Time After Sleep Onset (PSG-WASO) and Polysomnography Number of Awakenings (PSG-NAW). Secondary objectives: - To evaluate the effects of eplivanserin 5mg/day as compared to placebo after 6 weeks of treatment on other sleep parameters measured by PSG recordings (Total Sleep Time - PSG-TST, Sleep Efficiency - PSG-SE, Latency to Persistent Sleep - PSG-LPS) and reported by patients (Wake Time After Sleep Onset - pr-WASO, Number of Awakenings - pr-NAW, Total Sleep Time - pr-TST, Quality of Sleep - QoS and Refreshing Quality of Sleep - RqoS). - To evaluate the effects of eplivanserin 5mg/day on sleep architecture compared to placebo. - To evaluate the effect of eplivanserin 5mg/day on daytime functioning using the Sleep Impact Scale (SIS), as compared with placebo after 6 weeks of treatment. - To evaluate patient's impression of treatment effects using the Patient's Global Impression questionnaire. - To evaluate the potential for next-day residual effects (using patient's morning questionnaire and psychometric tests) with eplivanserin 5mg/day as compared to placebo. - To evaluate the potential for rebound insomnia following abrupt discontinuation of eplivanserin 5mg/day in comparison with placebo. - To evaluate the effect of eplivanserin, compared to placebo, on the quality of life of patients with primary insomnia using the SF-36 Health Survey. - To evaluate the clinical safety and tolerability of eplivanserin 5mg/day compared to placebo.

NCT ID: NCT00805194 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer

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

The present trial will be performed to evaluate whether BIBF 1120 in combination with standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more effective as compared to placebo in combination with standard therapy of docetaxel. A secondary aim is to obtain safety information as well as information on quality of life of patients treated with BIBF 1120 in combination to standard therapy with docetaxel. In addition, blood will be collected for pharmacokinetic analysis.

NCT ID: NCT00804986 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study for Patients With Type 2 Diabetes Mellitus

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

A multicenter, multinational, randomized,double-blind, placebo-controlled study in patients with Type 2 Diabetes Mellitus (T2DM). Patients with inadequate glycemic control using diet and exercise alone, or in combination with metformin, will be enrolled. The primary objective of this study is to test the hypothesis that LY2428757 given to patients with T2DM inadequately controlled with diet and exercise alone, or metformin monotherapy, produces a significant decrease in the mean hemoglobin A1c (HbA1c) from baseline to endpoint at 12 weeks as compared to placebo. Trial consists of 12 weeks of double-blind treatment and 4-week safety follow-up.