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NCT ID: NCT01489150 Completed - Clinical trials for Hypercapnic Respiratory Failure

Use of EtCO2 as a PaCO2 Predictor Under Non Invasive Ventilation (NIV) in Cases of Acute Hypercapnic Respiratory Failure

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

In patients treated by Non invasive ventilation (NIV) due to acute hypercapnic respiratory failure, the interest of using the End-tidal Co2 measurement device "Capnostream" to evaluate PaCo2 and PaCo2 variations over time will be evaluated. Measurements will be done under normal expiration and under prolonged active and passive expiration maneuvers.

NCT ID: NCT01489111 Completed - Clinical trials for Congenital Bleeding Disorder

Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.

pathfinder™3
Start date: August 3, 2012
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of this trial is to evaluate the haemostatic effect of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.

NCT ID: NCT01487837 Completed - Hemorrhage Clinical Trials

Fibrinogen for Treatment of Pediatric Dilutional Coagulopathy. FibPaed Study.

Start date: January 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare two different thromboelastometry (ROTEM) trigger levels for administration of human fibrinogen concentrate (Haemocomplettan P) in the treatment of perioperative dilutional coagulopathy during major pediatric surgery. The study hypothesis is that administration of fibrinogen concentrate triggered by a ROTEM FibTEM MCF < 13 mm might reduce the total amount of transfused red cell concentrate during 24 hours after start of surgery as compared to a trigger level of ROTEM FibTEM MCF < 8 mm.

NCT ID: NCT01487551 Completed - Systemic Sclerosis Clinical Trials

An Open-Label Study to Evaluate Biomarkers and Safety in Systemic Sclerosis Patients Treated With ABR-215757 (Paquinimod)

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

The primary objective is to study changes in disease related biomarkers in patients with progressive SSc during treatment with ABR-215757. The secondary objectives are to assess the safety and tolerability of ABR-215757,to assess disease activity and quality of life (QoL)during treatment with ABR-215757 and to assess the plasma levels of ABR-215757 during the study.

NCT ID: NCT01485991 Completed - Hepatitis C Clinical Trials

TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy

ATTAIN
Start date: February 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously failed PegIFN.

NCT ID: NCT01485575 Recruiting - Macular Edema Clinical Trials

Intraoperative Utility of Brilliant Blue g (Bbg) and Indocyanine Green (Icg) Assisted Chromovitrectomy

Start date: November 2011
Phase:
Study type: Observational

Intravitreal dyes are intended to make the surgical extraction of the Internal limiting membrane (ILM) safer and more complete. However, the search for an adequate vitaly dye is ongoing. The most commonly used vital dye is Indocyanine green (ICG), although it is not approved for intravitreal use and has been associated with ocular toxicity. The reason for its continued popularity seems to be that it stains the ILM better than the approved and less toxic alternative substances Brilliant Blue G (BBG) and Trypan blue (TB). According to anecdotal reports from surgeons, another reason for ICGs popularity may be the fact that it seems to make ILM removal easier. Ultimately, the intention of the investigators research is to identify possible modifications to existing dyes to reach improved intraoperative dye utility combined with a favorable safety profile. Protocol was amended and approved concerning additional use of basal membrane of deceased donors.

NCT ID: NCT01484899 Completed - Clinical trials for Pulmonary Hypertension

Smoking: a Risk Factor for Pulmonary Arterial Hypertension?

DACH
Start date: September 2011
Phase: N/A
Study type: Observational

Environmental factors may play a role in the genesis of pulmonary hypertension, especially in endothelial dysfunction. One widespread environmental factor associated with systemic endothelial dysfunction is cigarette smoke. It may well be that cigarette smoking is not only a risk factor for systemic but also for pulmonary vascular diseases and herewith may interact with other risk factors such as a genetic background and associated conditions. The existing studies which deal with this subject are only small single center case control studies providing less data. Therefore a large European multicenter study is necessary. The investigators hypothesis are: - a history of tobacco smoke exposure is highly prevalent in patients with PAH compared to the unaffected general population. - a history of tobacco smoke exposure is more prevalent in patients with PAH compared to CTEPH.

NCT ID: NCT01483092 Completed - Iron Absorption Clinical Trials

Effect of Inulin on Iron Absorption in Humans

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

Prebiotics are non-digestible food ingredients that beneficially affect the host by selectively stimulating the growth or activity of species in the colon that can improve host health. Inulin-type fructans (inulin and oligofructose) are natural food ingredients with prebiotic activity. Fermentation of inulin and oligofructose by lactic acid producing bacteria results in an increase in bacterial biomass and the production of SCFA (acetate, propionate and butyrate), lactic acid and the gases CO2 and H2. They are naturally present in significant amounts in several vegetables such as garlic, artichoke, onion, asparagus, leek and wheat (1-4%). Based on consumption data, the daily intake of inulin in Europe varies between 3.2 and 11.3g mainly from wheat (2-7.8g/d). However, this might have changed recently since inulin and oligofructose are used by the food industry either as sucrose and fat replacements or due to their health benefits for the human host. Several human absorption studies evaluated the effect of inulin/oligofructose on mineral absorption. It was shown that calcium and magnesium absorption was positively influenced. Until now, the positive effect on iron absorption was only shown in animals. The influence on human iron absorption was investigated twice. Both studies reported no effect of inulin/oligofructose on iron absorption, but this was most likely due to poorly conceived study designs. The aim of the present study is to demonstrate that inulin consumption over several weeks can lead to enhanced iron absorption in humans under optimized conditions.

NCT ID: NCT01482676 Completed - Clinical trials for Prostatic Hyperplasia

The Role of microRNAs in Organ Remodeling in Lower Urinary Tract Dysfunction

Start date: October 2010
Phase: N/A
Study type: Observational

Urgency, frequency and incomplete emptying are the key symptoms of lower urinary tract dysfunction, including bladder pain syndrome/interstitial cystitis, and overactive bladder syndrome. Lower urinary tract dysfunction is associated with cellular stress, leading to changes in gene expression and consequent organ remodeling. MicroRNAs are small regulatory molecules, affecting protein synthesis. They are quickly winning recognition as potential therapeutic agents. The investigators will perform a comparative study of mRNAs changed in lower urinary tract dysfunction and address the role of differentially expressed miRNAs in regulation of the genes, important for bladder function. The experimental approach, combining the analysis of human biopsy material with the in vitro cell-based models, will allow the investigators to elucidate the effects of miRNAs on the expression of receptors, contractile proteins and tight junction proteins. Once the disease-induced miRNAs have been characterised and their target genes validated, it will be possible to influence their expression levels thus counter-acting their effects. The investigators' work addresses fundamental mechanisms of signal transduction in urothelium and smooth muscle during cellular stress caused by inflammation or bladder outlet obstruction, and its regulation in the diseased state. The investigators' findings will further the knowledge of the molecular mechanisms of lower urinary tract dysfunction and have implications for diagnosis and treatment. Additionally, they have relevance for other clinical conditions, where miRNAs are implicated.

NCT ID: NCT01482273 Completed - Venous Thrombosis Clinical Trials

Ultrasound-enhanced Thrombolysis Versus Standard Catheter Directed Thrombolysis for Ilio-femoral Deep Vein Thrombosis

BERNUTIFUL
Start date: November 2011
Phase: N/A
Study type: Interventional

Patients with deep vein thrombosis (DVT) of the ilio-femoral veins have increased risk for developing post-thrombotic syndrome (PTS) and recurrent venous thromboembolism compared to more distal DVT. There's evidence that the early removal of the obstructing thrombus by catheter directed thrombolysis (CDT) reduces the risk of developing a PTS, and a higher degree of thrombolysis is associated with lower incidence of PTS, better quality of life and lower risk of recurrent venous thromboembolism. A further development is ultrasound-enhanced thrombolysis combining CDT with a sophisticated catheter system that employs high-frequency, low-dose ultrasound. In vitro experiments showed that adding ultrasound to thrombolytic drugs accelerates thrombolysis while Ultrasound exposure alone results in no thrombolysis, however the superiority of ultrasound-enhanced thrombolysis over standard CDT has never been formally assessed in vivo. The hypothesis for this study is that ultrasound-enhanced thrombolysis reaches a higher degree of thrombolysis than standard CDT in patients with symptomatic ilio-femoral DVT.