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NCT ID: NCT01368666 Terminated - Clinical trials for Aortic Valve Replacement

Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark

CAVALIER
Start date: February 23, 2010
Phase: N/A
Study type: Interventional

The primary objective of this clinical investigation is to assess the safety and effectiveness of the Perceval S valve at 12 months after implantation when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

NCT ID: NCT01361555 Terminated - Depression Clinical Trials

Long-term Safety and Tolerability of BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression

Start date: August 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.

NCT ID: NCT01357629 Terminated - Alzheimer´s Disease Clinical Trials

Observational Follow-up Extension Study of AFF002 and AFF004A in Patients With Alzheimer's Disease

Start date: July 2011
Phase: N/A
Study type: Observational

This study examines the long term Safety Follow-up of first patients vaccinated with AD02.

NCT ID: NCT01353638 Terminated - Clinical trials for End Stage Renal Disease

Safety and Efficacy of the Addition of Alanyl-Glutamine-Dipeptide to Dialysis Solution in Peritoneal Dialysis

Start date: April 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Peritoneal dialysis (PD) is a cost effective and safe form of renal replacement therapy in patients suffering from end stage renal disease. However currently available PDF (peritoneal dialysis fluids) are not biocompatible for the peritoneal cavity and its cells. Acute cytotoxic effects of the majority of the current glucose-based PDF are caused by low pH, lactate, high glucose and its degradation products (GDP). Toxic effects of PDF can thus be extended to suppression of mesothelial HSR (heat shock reactions) following PDF exposure resulting in increased susceptibility of mesothelial cells against PDF exposure: PDF inherent stress factors fail to adequately induce HSP as effectors of the cellular stress response - the adequate HRS rather seems to be blocked. Hence, therapeutic approaches to activate and enhance the HSR will reduce peritoneal damage and organ failure and improve the survival of organisms. Preclinical results demonstrated that supplementation of PDF with pharmacological doses of alanyl-glutamine restored HSP expression and increased the resistance of mesothelial cells in in-vitro models of PD and preserved peritoneal integrity in in-vivo models of PD. After these positive preclinical results, this study shall now clarify, whether the addition of alanyl-glutamine to the most commonly used glucose-based PDF is safe and tolerable. Therefore PDFs will be drained in a randomized cross-over study. Main outcomes measures will be total HSP expression in peritoneal cells and changes of the peritoneal transport kinetics and the presence/absence/severity of side effects.

NCT ID: NCT01351038 Terminated - Clinical trials for Resectable Type II Gastric Adenocarcinoma

Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma

Start date: n/a
Phase: Phase 2
Study type: Interventional

This is an open label, multicenter, single-arm phase II trial with primary eqirubicine-oxaliplatin-capecitabine chemotherapy and concurrent Pmab in patients with resectable, histologically proven gastric or esophageal cancer.

NCT ID: NCT01345669 Terminated - Clinical trials for Head and Neck Neoplasms

LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

Start date: October 17, 2011
Phase: Phase 3
Study type: Interventional

This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.

NCT ID: NCT01345630 Terminated - HIV-1 Clinical Trials

Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1

MODERN
Start date: September 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabine/tenofovir also administered once daily each in combination with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48 of treatment.

NCT ID: NCT01336530 Terminated - Clinical trials for Radiation-induced Oesophagitis

Tepilta® Versus Oxetacaine, Antacids and Placebo

Start date: April 2011
Phase: Phase 3
Study type: Interventional

This is a randomised, double-blind, placebo-controlled, therapeutic confirmatory multicentre trial with 4 parallel treatment groups. The design is adaptive group-sequential with two interim analyses, possible sample size re-estimation after the first or second interim analysis and drop-the-loser approach. The study design was primarily chosen to show superior efficacy of Tepilta® compared to the single components and to placebo. Evaluation of safety is a secondary objective.

NCT ID: NCT01333891 Terminated - Healthy Clinical Trials

Choroidal Thickness During Changes in Intraocular Pressure and Arterial Blood Pressure

Start date: December 2012
Phase: N/A
Study type: Interventional

Age-related macular degeneration (AMD) and glaucoma are among the leading causes of blindness in the western world. Elevated intraocular pressure (IOP) is a well known major risk factor for glaucoma. In addition, there is growing evidence that vascular factors, including arterial hypertension and hypotension, may play a role in the pathogenesis of AMD and glaucoma. To gain more insight into these mechanisms in humans is the primary goal of the present study. Optical coherence tomography (OCT) delivers three dimensional, volumetric reflectivity information through transparent media in vivo. Moreover, the images show a high choroidal penetration and a resolution comparable to an histologic examination when infrared light sources are used. Because of its non-invasive character, OCT provides an ideal method for diagnosis and monitoring of retinal and choroidal abnormalities. The present study aims to investigate whether choroidal thickness is temporarily altered by changes in IOP or systemic hemodynamic parameters. IOP will be increased by the use of a suction cup technique, mean arterial blood pressure will be altered by intravenously administered Phenylephrine or Sodium-Nitroprusside.

NCT ID: NCT01328093 Terminated - Schizophrenia Clinical Trials

A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients

Start date: April 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether weight gain will be significantly less in LY2140023 than aripiprazole in patients with schizophrenia.