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NCT ID: NCT01534819 Active, not recruiting - Aortic Aneurysm Clinical Trials

ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)

ANCHOR
Start date: April 2012
Phase:
Study type: Observational

The ANCHOR registry is a multi-center, post-market, non-interventional, non-randomized, prospective study. Subjects must sign an ICF prior to obtaining any study specific information. Subjects are eligible to be consented up to 30 days post-procedure. Enrolled subjects will be followed as per local 'standard of care' for up to 5 years post procedure. Study recommended follow-up is per SVS and ESVS guidance.

NCT ID: NCT01534715 Completed - Clinical trials for Chronic Lymphocytic Leukemia

IMGN529 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

Start date: January 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the safety and tolerability of IMGN529 in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).

NCT ID: NCT01534234 Active, not recruiting - Clinical trials for Heart Failure NYHA Class III and Ambulatory IV

Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D

RESPOND-CRT
Start date: January 2012
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the safety and effectiveness of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac Resynchronization Therapy with Defibrillation (CRT-D) device (Model 9770) in combination with the SonRtip Lead, which includes a SonR sensor in the tip of the atrial pacing lead, and compatible SmartView programming software. This study will evaluate the effectiveness of the automatic optimization algorithm in increasing the rate of patients responding to the therapy as compared to an echocardiographic optimization method. This study will also evaluate the safety and effectiveness of the SonRtip atrial pacing lead.

NCT ID: NCT01532453 Terminated - Actinic Keratoses Clinical Trials

Prevention of UV-induced Carcinogenic Skin Alterations in Immunosuppressed Solid Organ Transplanted Patients

Start date: November 2010
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to investigate the prevention of actinic keratoses and squamous cell carcinomas by local application of MD-3511356 in comparison to standard sun protection measures in immunosuppressed solid organ transplant recipients.

NCT ID: NCT01532427 Completed - Liver Cirrhosis Clinical Trials

ALFApump System Post Marketing Surveillance Registry

2011-AAR-004
Start date: June 2012
Phase:
Study type: Observational [Patient Registry]

This is a post market surveillance registry to monitor the safety and performance of the ALFApump system.

NCT ID: NCT01532310 Completed - Clinical trials for Systemic Lupus Erythematosus

Belimumab (BENLYSTA®) Pregnancy Registry

Start date: July 16, 2012
Phase:
Study type: Observational [Patient Registry]

This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. It will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization.

NCT ID: NCT01532076 Terminated - Clinical trials for Osteoporotic Fractures

Effectiveness of Adipose Tissue Derived Mesenchymal Stem Cells as Osteogenic Component in Composite Grafts

ROBUST
Start date: June 2012
Phase: Phase 2
Study type: Interventional

Failure rates of up to 30% are reported after proximal humeral fractures despite angular-stable devices. This may devastate not only the functional outcome but also the independence of elderly patients. To increase bone mineral density and thereby holding-strength augmentation is an option. Autologous bone-graft, as current gold-standard, though is questionable in osteoporosis since osteoprogenitors are dysfunctional and the harvesting-morbidity considerable. Adipose tissue seems an alternative cell-source even in presence of osteoporosis. Stromal vascular fraction (SVF) cells isolated from lipoaspirates display osteogenic and vasculogenic potential and can be harvested in high numbers. Expansion associated with costly good-manufacturers-practice facilities is avoidable, so are repeated interventions. These cells have been successfully used to generate osteogenic composite grafts with intrinsic vascularity in preclinical models. For translation into clinical practice after a 20 patient external pilot a prospective randomized controlled trial with 270 patients is planned. For the trial lipoaspiration precedes open reduction and internal fixation in individuals over 60 years presenting with a proximal humeral fracture after low-energy trauma. Cells are isolated (Cellution®800/CRS) and wrapped around hydroxyapatite microgranules after embedding in a fibrin-gel for augmentation of the typical bone-void. Clinical/radiological follow-up is at 6 and 12 weeks for immediate complications and after 6, 9 and 12 months. Functional assessment is performed after 6 weeks, 6 and 12 months using the Quick-Dash- and Constant-Score. The primary outcome is a reduction in secondary dislocation by 50% during the first postoperative year. Secondary dislocation is diagnosed on plain radiographs by an independent board certified radiologist specialised in musculoskeletal imaging if one or more of the following criteria are met: - More than 20° varus collapse of the humeral head fragment in relation to the humeral shaft - Screw penetration through the humeral head

NCT ID: NCT01531660 Completed - Physical Activity Clinical Trials

Active Over 45: A Step-up Jogging Program in Inactive Female Hospital Staff Aged 45+

Start date: April 2004
Phase: N/A
Study type: Interventional

Background: Inactive individuals face motivational obstacles for becoming and staying physically active. Therefore, sustainable physical activity promotion programs tailored to reach inactive individuals are needed. Purpose: to test the effect (long and short-term) and feasibility of a training program and to evaluate the association between the baseline motivation to become physical activity and the change in physical activity and performance. Design: uncontrolled trail Setting/participants: inactive, female hospital staff aged 45 and older from the University Hospital Zurich Intervention: 3-month step-up jogging program Main outcome measures: physical performance and level of physical activity

NCT ID: NCT01530399 Terminated - Bleeding Clinical Trials

Phase II Study to Compare MDCO-2010 vs Placebo and Tranexamic Acid in Patients Undergoing Cardiac Surgery

Start date: March 2012
Phase: Phase 2
Study type: Interventional

The objective of this study is to determine the dose response relationship regarding blood loss, PK, PD and clinical outcomes of MDCO-2010 in comparison to placebo and tranexamic acid in patients undergoing primary cardiac surgery with cardiopulmonary bypass. The aim of the study is to define minimally effective dose of MDCO-2010.

NCT ID: NCT01529554 Completed - Clinical trials for Acute Coronary Syndromes

Controlled Level EVERolimus in Acute Coronary Syndromes

CLEVER-ACS
Start date: January 8, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Acute myocardial infarction (AMI) constitutes the major cause of death in most nations and death rates and morbidity remain substantial in the years thereafter. Inflammation is a hallmark throughout the distinct stages of atherosclerotic lesion formation preceding AMI as well as at the time of plaque rupture and during the post-infarct repair phase. Harnessing its harmful consequences constitutes an attractive therapeutic approach to address this unmet medical need. The objectives of this study are to evaluate the effects of mTOR inhibition (everolimus) on infarct size, myocardial function and inflammation in patients with ST-Elevation Myocardial Infarction. The efficacy objectives are: 1. (1° endpoint): To assess the effect of mTOR inhibition (everolimus) on myocardial infarct size as change from baseline (12-72 hours after percutaneous coronary intervention) to 30 days follow-up measured by MRI (Late Gadolinium Enhancement (LGE) for transmurality). 2. (2° endpoint): To evaluate microvascular obstruction (MVO) as change from baseline (12-72 hours after percutaneous coronary intervention) to 30 days follow-up evaluated by MRI. 3. (3° endpoints): 1. Change of left ventricular volume from baseline (12-72 hours after percutaneous coronary intervention) to 30 days follow-up measured by MRI. 2. Change of biomarkers from time of coronary angiography to 30 days follow-up including a time-course (AUC). Biomarkers comprise hs-TnT, NT-proBNP, hs-CRP, IL-6 and inflammatory biomarkers OPG, sRANKL, OPN and CCN1. The safety objectives are: To explore the effect of mTOR inhibition (everolimus) on several clinical and safety laboratory parameters including plasma lipid levels and blood count. This will be complemented by analysis of inflammatory cell subsets in coronary thrombi and peripheral blood (CD4+ T helper lymphocyte subsets, monocyte subsets).