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NCT ID: NCT01870401 Completed - Clinical trials for Critical Limb Ischemia

Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

Start date: June 3, 2013
Phase: N/A
Study type: Interventional

To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.

NCT ID: NCT01870089 Terminated - Clinical trials for Acute Respiratory Failure

SmartCare Driven Pressure Support-Non Invasive Ventilation Feasibility Study

Start date: May 2013
Phase: N/A
Study type: Interventional

Knowledge-based systems were initially developped to automatically adapt pressure support settings during invasive ventilation, and proved to be at least as efficient as experienced clinicians. Non-invasive ventilation has become the standard of care for patients suffering from acute hypercapnic respiratory failure (ARF)and has reduced the need for endotracheal intubation in these patients, thus reducing their hospital mortality. NIV success or failure is closely related to the tolerance of NIV treatment, which is tightly correlated to patient-ventilator synchrony. As severe asynchronies frequently occurs during NIV (namely in more than 40% of patients) and as the occurence of asynchronies is related to the use of high pressure support levels, to the presence of leaks and/or to non optimal expiratory trigger settings, very frequent ventilator settings adaptations should allow reducing patient-ventilator asynchronies but require the presence of an experienced clinician at the bedside during NIV treatment. A computer-driven ventilator settings adaptation has the adavantage of permitting very frequent ventilator settings adaptation whithout requiring the presence of an experienced clinician at the bedside and could possibly improve patient-ventilator interaction. The aim of the present study is to test the faisability of using the Smartcare NIV computer-driven system to automatically adapt ventilator settings during non invasive ventilation delivered because of acute respiratory failure.

NCT ID: NCT01869855 Completed - Clinical trials for Chronic Subdural Hematoma

A Prospective Randomized Study Evaluating the Recurrence Rate of Chronic Subdural Hematoma After Placing a Subperiosteal Drainage Compared to a Subdural Drainage

Start date: April 2013
Phase: N/A
Study type: Interventional

The aim of our study is to investigate in randomized controlled fashion whether the recurrence and complication rate, after insertion of subperiosteal drainage in the treatment of chronic subdural haematoma, is higher compared to insertion of subdural drainage. We hypothesize that patients treated with a subperiosteal drainage do not show higher recurrence rates than those treated with a subdural drainage, and suffer less complications.

NCT ID: NCT01868269 Active, not recruiting - Neuroblastoma Clinical Trials

Opsoclonus Myoclonus Syndrome/Dancing Eye Syndrome (OMS/DES) in Children With and Without Neuroblastoma (NBpos and NBneg)Opsoclonus Myoclonus Syndrome/Dancing Eye Syndrome (OMS/DES) in Children With and Without Neuroblastoma (NBpos and NBneg)

Start date: April 18, 2013
Phase: Phase 3
Study type: Interventional

The OMS/DES study is a multinational European Trial for Children with the Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome. This trial brought on the way by specialists of the EPNS (European Paediatric Neurology Society), the GPOH (Gesellschaft für Pädiatrische Hematologic und Oncologie) and the SIOPEN (SIOP (International Society Oncology Pediatric) Europe Neuroblastoma). This protocol will investigate an escalating treatment schedule starting with a corticosteroid standard treatment with dexamethasone pulses (first step), which is followed, if response has been inadequate after 3 months of treatment, by the addition of CP (second step) and, if still no sufficient improvement, by the replacement of CP by Rituximab (third step). Treatment intensification is decided on the basis of standardized scoring of OMS/DES severity.

NCT ID: NCT01866215 Completed - Healthy Subjects Clinical Trials

Effects of Exercise on Fructose Metabolism

FruEx2
Start date: May 2013
Phase: N/A
Study type: Interventional

A high fructose diet increases fasting and post-prandial triglyceride (TG) concentrations in sedentary healthy human subjects.These effects may be secondary to fructose-induced hepatic de novo lipogenesis. Recent evidence indicate that exercise can prevent fructose induced dyslipidemia.This study will evaluate 1. how exercise effects the metabolic fate of oral fructose 1a) when exercise is performed before fructose ingestion 1b) when exercise is performed after fructose ingestion Metabolic effects of exercise will be assessed in healthy male subjects by measuring fructose oxidation (13CO2 production), fructose conversion into glucose (13C glucose concentrations in blood) and hepatic fructose conversion into lipid (13C palmitate-very low density lipoprotein (VLDL) concentrations in blood) after ingestion of 13C-labelled fructose meals 2. how fructose and protein modulate muscle glycogen and intramyocellular lipid repletion after exercise Healthy male subjects will be fed various fructose, glucose, lipid and whey protein meals after a glycogen/intramyocellular lipid depleting exercise. The effects of meals' composition will be assessed after 24 hours by measuring intramyocellular lipids and glycogen using proton-magnetic resonance spectroscopy (MRS).

NCT ID: NCT01866137 Completed - Stress Clinical Trials

Copeptin During a Standardized Psychological Stress Test

PsyCo
Start date: March 2013
Phase: N/A
Study type: Observational

The aim of the PsyCo Study is to determine whether psychological Stress has an influence on copeptin levels.

NCT ID: NCT01864278 Completed - Clinical trials for Peripheral Artery Disease

Lutonix Global SFA Registry

Start date: December 2012
Phase: N/A
Study type: Observational [Patient Registry]

The registry will enroll patients with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects will be treated with the LUTONIX Drug Coated PTA Dilatation Catheter carrying the CE Mark per current Instructions for Use(IFU) and followed clinically for a minimum of 2 years.

NCT ID: NCT01863004 Terminated - Dysferlinopathy Clinical Trials

Proteasomal Inhibition for Patients With Mis-sense Mutated Dysferlin

Dysferlin
Start date: December 2012
Phase: Phase 1
Study type: Interventional

Dysferlin is a protein with an important role in the repair of muscle surface membranes. Mutations in dysferlin cause different forms of muscular dystrophies. Dysferlinopathies are inherited in an autosomal recessive manner, and many patients with this disease harbor mis-sense mutations in at least one of their two pathogenic DYSF alleles. These patients have significantly reduced or absent dysferlin levels in skeletal muscle, suggesting that dysferlin encoded by mis-sense alleles is rapidly degraded by the cell's quality-control system. In a series of in-vitro experiments we showed that mis-sense mutated dysferlin can be salvaged from degradation by proteasomal inhibition. This resulted in an increase of functional dysferlin protein and a subsequent repair of plasma membranes of cultured patient-derived muscle cells. In this proof-of-concept study we would like to test wether proteasomal inhibition can salvage mis-sense mutated dysferlin in patients harboring certain dysferlin mis-sense mutations.

NCT ID: NCT01861925 Completed - Corneal Topography Clinical Trials

Study of Clinical Performance of Corneal Topography Measurement Using an Optical Biometer

Start date: June 2013
Phase: N/A
Study type: Observational

The purpose of this study is to quantify in-vivo repeatability of a new corneal topography measurement mode of an optical biometer, and the clinical performance of measurement in comparison to reference devices.

NCT ID: NCT01860209 Completed - Clinical trials for Obstructive Sleep Apnea

Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome in End Stage Renal Disease Patients

SASinHD
Start date: March 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effect of decreasing fluid overload by hemodialysis on the severity of obstructive sleep apnea, in patients with end stage chronic kidney disease on intermittent hemodialysis. It aims further to investigate the relationship between overhydration, nocturnal rostral fluid shift and the severity of sleep apnea.