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NCT ID: NCT02013739 Completed - Clinical trials for Chronic Heart Failure

Description of Insulin Resistance in Patients With Chronic Heart Failure

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

The purpose of this study is to describe insulin resistance in a general chronic heart failure population, in combination with muscle strength, body composition and cardiac function. It is assumed that insulin resistance is increased in CHF patient, and that this is related to decreased muscle strength and decreased lean tissue mass.

NCT ID: NCT02013271 Completed - Clinical trials for Femoral Artery Occlusion

Lutonix® DCB for Treatment of Long Lesions in Femoropopliteal Arteries

Start date: December 2013
Phase:
Study type: Observational

To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA

NCT ID: NCT02013024 Completed - Clinical trials for Cryopreservation of Embryos

The Effect of Vitrification Versus Slow Freezing on Day 3: a Randomised Controlled Trial.

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

Randomized controlled trial (RCT) testing the hypothesis that vitrification is superior to slow freezing.

NCT ID: NCT02010424 Completed - Fertility Clinical Trials

Evaluation of Group Culture in WOW Dishes of Human Embryos in Order to Optimize the Single Embryo Transfer (SET) Strategy.

WOW
Start date: January 2014
Phase: N/A
Study type: Interventional

In cattle less than 10% of the embryos develop to the blastocyst stage when embryos are cultured individually, however when bovine embryos are cultured in groups a typical 25-35% of blastocysts can be observed. This tendency, i.e. improved embryo development in group culture, has also been demonstrated in other mammalian species, such as mouse, cat and human. The main reason for this beneficial outcome of group culture has been ascribed to the presence of autocrine factors, which are factors secreted by preimplantation embryos that act upon the embryo itself or the neighboring embryos . Although group culture systems are common in in vitro production systems for animal embryos, it is rarely done in human settings, where individual follow-up of the embryo during the whole culture period is of utmost importance. Recently a CE-labelled culture device has been designed for human embryos, that allow to combine the benefits of both group culture approaches and individual culture. The WOW dish is commercially available by Primo Vision and consists of 9 small microwells on the bottom of the plate, so that the embryos can be cultivated individually in a microwell, but covered by the same drop of culture medium. In this clinical randomized trial, 158 patients will be included of which half of the fertilized oocytes will be cultured individually (standard culture system) and half of the fertilized oocytes will be cultured in group in a WOW dish, both during five days of culture. The aim of this study is to increase the number of blastocysts suitable for transfer or cryopreservation by culturing the embryos in WOW dishes.

NCT ID: NCT02010255 Completed - Clinical trials for Chronic HCV Infection

Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant

Start date: January 2014
Phase: Phase 2
Study type: Interventional

This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection. - Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant; - Cohort B: post-liver transplant, with or without cirrhosis; - Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups) - Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.

NCT ID: NCT02010073 Completed - Clinical trials for Acute Respiratory Distress Syndrome

Large Observational Study to UNderstand the Global Impact of Severe Acute Respiratory FailurE

LUNG-SAFE
Start date: February 2014
Phase: N/A
Study type: Observational

We wish to prospectively assess the burden of, management and therapeutic approaches to, and outcomes from acute hypoxaemic respiratory failure requiring ventilatory support, during the winter months in both the northern and southern hemispheres. We wish to specifically examine the contribution of ARDS as defined by the Berlin Definition to the burden of hypoxaemic respiratory failure. Why? The purpose of this study is to provide new and current data on the disease burden of acute hypoxemic respiratory failure and ARDS. It will answer the following questions: - What is the frequency and disease burden of acute hypoxaemic respiratory failure in winter? - What are the aetiologies of acute hypoxaemic respiratory failure requiring ventilatory support? - What is the incidence of ARDS based on the Berlin definition within this patient cohort? - What is the mortality from ARDS within this cohort, and how does this vary based on ARDS severity? - What is the natural history of ARDS? - What are the key patterns of therapeutic resource utilization, particularly approaches to sustain gas exchange, in these patients? When? The study is performed over a 4 week period between February 1st and March 31st 2014 in the Northern Hemisphere and June 1st to August 31st in the Southern Hemisphere. What data is required? A basic dataset is collected on all patients admitted with acute acute hypoxaemic respiratory failure requiring ventilatory support, with a more detailed dataset collected on patients diagnosed with ARDS.

NCT ID: NCT02009826 Completed - Schizophrenia Clinical Trials

Psychosis-Associated Neuroinflammation in Schizophrenia

PANS
Start date: November 2013
Phase: N/A
Study type: Observational

Previous research has suggested central nervous system inflammatory activity to be critically involved in disease development and progression in schizophrenia, with a complex interplay of inflammatory mechanisms leading to the development of brain abnormalities and medical symptoms related to schizophrenia. However, the mutual interactions of different inflammatory pathways and their relation to disease course have not been sufficiently studied. This study therefore aims to explore the interaction of neuroinflammatory mechanisms in patients with schizophrenia and to assess whether the inflammatory activity in schizophrenia is state-dependent and occurs mainly during psychotic episodes.

NCT ID: NCT02008916 Completed - Clinical trials for Spondylitis, Ankylosing

16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients

MEASURE 3
Start date: January 14, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.

NCT ID: NCT02008890 Completed - Clinical trials for Palmoplantar Pustular Psoriasis

Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab

Start date: December 26, 2013
Phase: Phase 3
Study type: Interventional

A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks

NCT ID: NCT02007629 Completed - Clinical trials for Hypertension, Pulmonary

Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor

RESPITE
Start date: February 18, 2014
Phase: Phase 3
Study type: Interventional

BAY63-2521 Riociguat leads to the relaxation of smooth muscle cells in pulmonary arteria and may also inhibit abnormal remodeling of lung blood vessels. In patients with pulmonary arterial hypertension Riociguat showed to reduce the pulmonary blood pressure and improved the right heart function without unacceptable side effects. Here dose of Riociguat will be adjusted over 8 weeks then a Maintenance Phase of 16 weeks follows. Patients with Pulmonary Arterial Hypertension treated with stable doses of Phosphodiesterase Type-5 Inhibitors (Eg Sildenafil, Tadalafil) not appropriately responding to therapy will be included. Based on previous evidence and on the different modes of action an improvement of exercise capacity, heart function and quality of life may be expected if PDE5i treatment is transitioned to riociguat. Where Riociguat is pending market approval or reimbursement once the treatment phase is completed drug can be made available for another 18 months (Extended Drug Supply Phase - EDSP) under study conditions. Patients may also transition at the end of the maintenance period or any time during the EDSP to any program that is intended to provide riociguat until drug approval/reimbursement, e.g. a long-term extension study, compassionate use or named patient program. Study termination is also possible at any time.