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NCT ID: NCT01292317 Completed - Clinical trials for Contrast Media Induced Nephropathy (CIN)

Neutrophil Gelatinase-associated Lipocalin (NGAL) and Contrast Media Induced Nephropathy

Start date: January 2011
Phase: N/A
Study type: Interventional

Introduction: Patients with pre-existing impaired renal function are prone to develop acute contrast media induced nephropathy (CIN). Neutrophil gelatinase-associated Lipocalin (NGAL), a new biomarker predictive for acute renal injury has been shown to be capable for earlier diagnosis of acute contrast media induced nephropathy (CIN) in patients undergoing cardiac surgery. Intravenous volume load is a widely accepted prophylaxis. In this randomized and controlled study, only patients with the need for an intra-arterial contrast media (CM) application will be included and receive a standardized, weight-based, intravenous hydration before investigation. It is the aim of this study: 1. to evaluate the magnitude of a risk for contrast media induced nephropathy (CIN) following intra-arterial angiography in a well defined group of high-risk patients. 2. to use urinary Neutrophil gelatinase-associated Lipocalin (NGAL) as an early predictor of contrast media induced nephropathy (CIN) after contrast media (CM) application. 3. to evaluate the clinical benefit of an early post-procedural i.v. hydration as compared to only pre-procedural volume expansion. Patients with markedly increased urinary Neutrophil gelatinase-associated Lipocalin (NGAL) after investigation will be randomized into one of two study groups: Patients of Group A will undergo standard treatment consisting of unrestricted oral fluid intake. Patients of Group B will additionally receive 3-4 ml/kg BW/h 0.9 % saline intravenously for 6 hours. Endpoints: Primary endpoint: contrast media induced nephropathy (CIN) defined by an increase greater than 25% of baseline serum creatinine. Secondary endpoint: NGAL, Cystatin C, and creatinine values, need for renal replacement therapy, death.

NCT ID: NCT01291914 Completed - Clinical trials for Osteoarthritis, Knee

Study of FX005 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

Start date: December 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of FX005 for the treatment of pain in patients with osteoarthritis of the knee.

NCT ID: NCT01290679 Completed - Hepatitis C Clinical Trials

An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants

QUEST-2
Start date: March 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.

NCT ID: NCT01289002 Completed - Clinical trials for Coronary Artery Disease

e-BioMatrix PostMarket Registry

eBMX-PMR
Start date: April 2008
Phase:
Study type: Observational

The purpose of this registry is to capture clinical data of the BioMatrix™ and BioMatrix Flex™ (Biolimus A9™-Eluting) stent systems in relation to safety and effectiveness.

NCT ID: NCT01287845 Completed - Diagnostic Imaging Clinical Trials

PET/CT (Positron Emission Tomography/Computed Tomography) Imaging for Safety and Tolerability and Diagnostic Performance of BAY1075553 in Patients With Prostate Cancer and Healthy Volunteers

Start date: February 2011
Phase: Phase 1
Study type: Interventional

PET/CT imaging study for evaluation of safety and tolerability and diagnostic performance of BAY1075553 in patients with prostate cancer and in healthy volunteers

NCT ID: NCT01286077 Completed - Multiple Myeloma Clinical Trials

Velcade Consolidation Bone Study

Start date: September 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the effect of bortezomib on myeloma-related bone disease, analyzing bone mineral density (BMD) in patients with Multiple Myeloma (MMY) who have received high dose chemotherapy and autologous stem cell transplantation for primary treatment of MMY (single- or double-transplant). Eligible patients will be randomized (study treatment assigned by chance like flipping a coin) to either bortezomib or observation alone. Patients in the bortezomib arm will receive treatment of bortezomib for a total of 4 cycles. All subjects will be followed for a total of 24 months after randomization.

NCT ID: NCT01285726 Completed - Clinical trials for Chronic Renal Failure

Initiative for Patient Outcomes in Dialysis - Peritoneal Dialysis (PD) (IPOD-PD Study)

IPOD-PD
Start date: January 2011
Phase: N/A
Study type: Observational

The aim of the study is to asses the hydration status of incident peritoneal dialysis (PD) patients and its evolution over a period of four years, independent of the PD treatment modality (APD or CAPD) and the PD solution type.

NCT ID: NCT01285609 Completed - Clinical trials for Lung Cancer - Non Small Cell Squamous

Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin

Start date: January 16, 2011
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.

NCT ID: NCT01285401 Completed - Clinical trials for Relapsing-Remitting Multiple Sclerosis

Supplementation of VigantOL® Oil Versus Placebo as Add-on in Patients With Relapsing Remitting Multiple Sclerosis Receiving Rebif® Treatment

SOLAR
Start date: March 2011
Phase: Phase 2
Study type: Interventional

The drug being tested is called VigantOL® oil - a very effective form of Vitamin D hormone supplement (cholecalciferol). Low levels of Vitamin D have been described to be associated with a higher risk of developing Multiple Sclerosis (MS), and it is known that up to 90% of patients with Multiple Sclerosis have Vitamin D deficiency. Rebif® is known to be an effective treatment for slowing down the progression of MS. The purpose of this research trial is to evaluate if VigantOL® oil on top of Rebif® has any benefit on the progression of MS compared to Rebif® and placebo. Disease activity will be assessed by clinical examination and Magnetic Resonance Imaging (MRI). The planned study treatment duration for each study participant is 48 weeks, and the study consists of a total of 8 visits. Study participants who are already passed Week 48 at the time of approval of Protocol Amendment 5 will have a study duration of 96 weeks and a total of 12 visits. During the study, the participant will undergo physical examination, neurological assessments, safety assessments, blood tests and urinalysis (including pregnancy tests).

NCT ID: NCT01284972 Completed - Clinical trials for Total Ankle Prosthesis

HINTEGRA Total Ankle Prosthesis Follow-up

Start date: February 2009
Phase: N/A
Study type: Observational

The Hintegra® Total Ankle Prosthesis is a non constrained, three-component prosthesis that consists of a flat tibial component, an anatomically-shaped talar component, and a high-density polyethylene inlay. The Hintegra ankle was specifically developed as an attempt to address the needs of minimal bone resection, extended bone support, proper ligament balancing, and minimal contact stressed within and around the prosthesis. The objective of this study is to evaluate the safety and efficacy of the HINTEGRA® Total Ankle prosthesis at short and mid term follow up.