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NCT ID: NCT01464476 Terminated - Clinical trials for Cardiovascular Diseases

Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2)

SHIELD-2
Start date: November 2011
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of Azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with Implantable Cardioverter Defibrillators (ICDs)

NCT ID: NCT01463410 Terminated - Clinical trials for Acute Myeloid Leukemia (AML)

Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler

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

This clinical study will demonstrate the accuracy of the chromosomal aberration and gene mutation markers of the AMLProfiler molecular diagnostic assay and generate clinical performance data to support a Pre-Market Approval (PMA) submission to the Food and Drug Administration for in vitro diagnostic use within the United States of America. The objective is to demonstrate the positive and negative percent agreement of each marker by comparing AMLProfiler results from multiple clinical participating sites with data generated using a laboratory developed bi-directional sequencing method generated at the molecular diagnostic reference lab. The AMLProfiler assay is a qualitative in vitro diagnostic test for the detection of AML or APL specific chromosomal aberrations (specific recurrent translocations and inversions), as well as expression of specific genetic markers in RNA extracted from bone marrow aspirates of patients with Acute Myeloid Leukemia.

NCT ID: NCT01455116 Terminated - Septic Shock Clinical Trials

The Cooling And Surviving Septic Shock Study (CASS)

CASS
Start date: November 2011
Phase: Phase 2/Phase 3
Study type: Interventional

Septic shock is in critically ill patients is a condition associated with a high rate of organ failure and hereto attributable mortality ~45-55% Hypothesis: Mild Induced Hypothermia reduces the mortality of critically ill patients with septic shock by reducing organ metabolism, counteracting on microcirculatory thrombosis, genetically downregulating tissue apoptosis and by reducing bacterial growth rate and toxin production.

NCT ID: NCT01452347 Terminated - Clinical trials for Heart Valve Diseases

Dabigatran Etexilate in Patients With Mechanical Heart Valves

RE-ALIGN
Start date: October 2011
Phase: Phase 2
Study type: Interventional

To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.

NCT ID: NCT01449292 Terminated - Pulmonary Emphysema Clinical Trials

Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)

ASPIRE
Start date: June 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System treatment plus optimal medical therapy compared in patients with advanced upper lobe predominant (ULP) heterogeneous emphysema.

NCT ID: NCT01439867 Terminated - Clinical trials for Chronic Kidney Disease

Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism

Start date: June 22, 2012
Phase: Phase 2
Study type: Interventional

The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).

NCT ID: NCT01436123 Terminated - Clinical trials for Coronary Artery Disease

Plasmonic Photothermal and Stem Cell Therapy of Atherosclerosis Versus Stenting

NANOM PCI
Start date: December 2010
Phase: Phase 1
Study type: Interventional

Intensive therapy with rosuvastatin 40 mg and ApoA-I Milano reduces the total atheroma volume (TAV) up to 6.38 or 14.1 mm3 respectively. Our previous bench studies PLASMONICS and NANOM First-in-Man trial documented TAV reduction up to unprecedented 79.4 and 60.3 mm3 respectively with high level of safety and feasibility. The completed randomized two arm (1:1) study (NANOM-PCI) with parallel assignment (n=62) assessed (NCT01436123) the safety and feasibility of the delivery technique for nanoparticles (NP) using micro-injection catheter (with intravascular intramural injection of allogeneous stem cells carrying NP after MSCT-, IVUS- and OCT-guided mapping of the vessel), and plasmonic photothermal therapy of atherosclerosis combined with stenting (Nano group, n=32) versus stenting with Xience V cage (Stenting group, n=30). The primary outcome was TAV at 12 months. The mean reduction of TAV at 12 months in Nano group was -84.1 mm3 (95% CI: SD 28.3; min -52.4 mm3, max -99.1 mm3; p<0.05) versus +12.4 mm3 in case of stenting (p<0.05 between groups). 42/62 patients (68%) in Nano group passed the Glagov threshold of a 40% plaque burden with mean plaque burden (PB) 36.2% (95% CI: SD 9.3%, min 30.9%, max 44.5%). The increase of the minimal lumen diameter was 61.2 and 63.3% at 12 month follow up in groups respectively. The serial assessment of VH-IVUS showed a significant decrease at 12 months in the dense calcium area, fibrous and fibro-fatty tissue with fulminant necrosis due to thermolysis in Nano-group, whereas an increase of fibrous and fibro-fatty components in stenting arm. We have documented 2 vs 3 cases of the definite thrombosis and 3 vs 5 cases of target lesion revascularization in groups respectively. The analysis of the event-free survival of the ongoing clinical follow-up shows the significantly lower risk of cardiovascular death in Nano group if compare with conventional stenting (93.4% vs 86.7%; p<0.05). Plasmonic resonance-mediated therapy using noble-metal NP associated with significant regression of coronary atherosclerosis. Tested delivery approach has acceptable safety and efficacy for atheroregression below a 40% PB. The investigators hypothesize that multistep approach with the use of stent in acute care unit, and then subsequent transcatheter micro-injection with nanoparticles can resolve atherosclerosis, stop and regress atherogenesis, remodulate or even rejuvenate arteries. Stem cells in patch can be good carriers for nanoparticles as well as high-effective metabolic vectors (paracrine-like regulation of alive cells and via bioactive products of cell lysis after detonation of nanoparticles) for the treatment of plaque on site. Gold nanoparticles with silica-iron oxide shells promise high-energy plasmonic photothermic burning or melting effect under the near-infrared laser irradiation onto the lesion. Thus the investigators expect complex two-side effect on the plaque with protected lumen and adventitia. Novel discoveries in atherogenesis, and development of nanobiotechnologies with potentials for the management of atherosclerosis leads us to the quest of new approaches. The investigators still cannot really effectively treat atherosclerosis. The investigators management is more symptomatic, and lipid-pool or inflammation-oriented! The investigators cannot manage non-organic part (mineral deposits, calcified necrotic core, partially collagen and fibrotic tissue) and total plaque volume Surgery and invasive procedures is just focused on blood flow restoration (just manipulate the form of plaque) + concerns of clinical and technical restrictions (incl. alien body - stent) + risk of restenosis or subacute 'fatal' in-stent atherothrombosis + graft survival/ occlusion + surgery-related complications High rate of short- and long-term complications and readmissions. Regression of atherosclerosis in fact is still a dream. The investigators offer an alternative to stenting and may be cardiac artery bypass surgery (CABG). Our approach can really allow to rejuvenate arteries, Plasmonic photothermal therapy (PPTT) can burn plaque, but stem cells and bioengineered structures promise restoration of the vessel wall. Our personal previous data showed that PPTT can 1.6-fold reduce a volume of plaque with most optimal long-term result in subsets with the use of SPCs as a delivery approach. The most optimal delivery systems of NPs into the plaque are the on-artery bioengineered patch and ferro-magnetic approach.

NCT ID: NCT01435356 Terminated - Clinical trials for Urinary Bladder Neoplasms

Safety and Efficacy Study of MAGE-A3 + AS-15 in Patients With Muscle-invasive Bladder Cancer After Cystectomy

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

The purpose of this clinical trial was to demonstrate the benefit of the immunotherapeutic product recMAGE-A3 + AS-15 given to patients with bladder cancer after removal of the bladder. A course of 13 injections was administered over 27 months.

NCT ID: NCT01433354 Terminated - Fragile X Syndrome Clinical Trials

Long-term, Safety and Tolerability Study of AFQ056 in Adolescent Patients With Fragile X Syndrome (Open-label)

Start date: November 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in eligible adolescent patients with FXS who have participated in the CAFQ056B2214 study, the PK study CAFQ056B2131, or another study of AFQ056 which included FXS patients below 18 years of age provided the patient is at least 12 years of age at the time of entry into the current study.

NCT ID: NCT01429363 Terminated - Clinical trials for Lumbar Spine Disc Herniation

Targeted Disc Decompression (TDD) for Contained Herniated Lumbar Discs

TDD
Start date: August 2011
Phase: N/A
Study type: Interventional

The prospective Clinical Series (CS) aims to prove the hypothesis that Targeted Disc Decompression (TDD) reduces the pain in patients suffering from radicular leg pain secondary to a contained focal disc protrusion (Lumboradicular Syndrome). Secondary objective will be to prove that the treatment Group will have less disability and better quality of life.