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NCT ID: NCT02792231 Completed - Clinical trials for Relapsing Multiple Scelrosis

Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.

ASCLEPIOS II
Start date: August 26, 2016
Phase: Phase 3
Study type: Interventional

To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis

NCT ID: NCT02790450 Completed - Clinical trials for Idiopathic Pulmonary Arterial Hypertension

Acute Effects of Benzbromaron on the Pulmonary Circulation

Start date: October 2015
Phase: Phase 2
Study type: Interventional

Actual studies suggest that a calcium activated chlorid channel (TMEM16A) may play a relevant role in the pathogenesis of pulmonary arterial hypertension (PAH). The inhibition of this channel led to pulmonary vasorelaxation in preclinical studies. Benzbromarone is a well known inhibitor of the TMEM16A channel and is used in patients with gout. In this pilot study the investigators plan to investigate if Benzbromarone has an acute effect on the pulmonary arteries in humans. This will be investigated within the frame of a right heart catheterization performed in patients with known PAH due to clinical reasons. The investigators hypothesize that the application of Benzbromarone leads to pulmonary vasodilation, which can be recognized by the decrease in pulmonary vascular resistance. In addition, the change in pulmonary and systemic arterial pressure, pulmonary arterial wedge pressure, heart rate and arterial oxygen saturation will be assessed. Due to clinical reasons patients will receive NO (15 ppm) during right heart catheterization. Hemodynamic changes upon NO and Benzbromarone may be compared.

NCT ID: NCT02789501 Completed - Clinical trials for End-stage Renal Disease

Comparison of a TauroLock™ Based Regimen to 4% Citrate as Lock Solution in Tunneled Haemodialysis Catheters for the Prevention of Bacteraemia and Dysfunction

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

Catheter infections and dysfunctions are a major cause of morbidity and mortality in haemodialysis patients. According to the US Renal Data System, infection is the second leading cause of death in dialysis patients and the leading cause of catheter removal and morbidity in patients with end-stage renal disease. There is evidence that catheter lock solutions containing taurolidine reduce the risk of catheter related infections and improve catheter patency. Lock solutions have a local, but no systemic effect. In this study a taurolidine based lock regimen (TauroLock™-Hep500, Tauropharm, Waldbüttelbrunn, Germany, 2x/week and TauroLock™-U25.000, Tauropharm, Waldbüttelbrunn, Germany, 1x/ week) will be compared to 4% citrate (CitraFlow™ 4%, MedXL, Montreal, Canada, 3x/week) as standard lock solution. The objective of this study is to evaluate if a TauroLock™ based regimen to lock tunneled haemodialysis catheters has reducing effects on catheter related blood stream infections and catheter dysfunctions.

NCT ID: NCT02789449 Completed - Clinical trials for Hypertension Pulmonary

Estimation of Pulmonary Capillary Blood Volume in Pre- and Postcapillary Pulmonary Hypertension

Start date: November 2015
Phase:
Study type: Observational

The aim of the study is to investigate the role of the non-invasive assessment of nitric oxyde (NO) diffusion capacity (DLNO) in the differential diagnosis of different forms of pulmonary hypertension (PH). DLNO alone and in combination with the measurement of carbon monoxide (CO) diffusion capacity (DLCO) may help to differentiate between pre- and postcapillary forms of pulmonary hypertension. This hypothesis is based on the fact that NO has a much higher affinity to hemoglobin as compared to CO and may therefore its decrease may more specifically identify the limiting factors between the alveolar space and the lung capillaries including left heart failure (cardiac edema). As there are no available published data yet to answer this question investigators aim to perform a small pilot study. The results of this study may allow the planning of a prospective study.

NCT ID: NCT02788513 Completed - Alzheimer Disease Clinical Trials

BI 425809 in Patients With Cognitive Impairment Due to Alzheimer's Disease.

Start date: August 11, 2016
Phase: Phase 2
Study type: Interventional

The study is designed to compare the effects of BI 425809 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.

NCT ID: NCT02786576 Completed - Clinical trials for Hidradenitis Suppurativa

Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients - a Multi cOuNtry studY in Real Life Setting

HARMONY
Start date: July 5, 2016
Phase:
Study type: Observational

This study will assess the effects of adalimumab treatment in moderate to severe Hidradenitis Suppurativa (HS) patients in the real world setting. The objectives of this study are to estimate the effectiveness of adalimumab treatment on disease severity, to estimate the impact of adalimumab treatment on patients' quality of life, psychological effect, work productivity and healthcare resource utilization and to describe treatment practices over the study period.

NCT ID: NCT02785731 Completed - Ovarian Neoplasms Clinical Trials

Evaluation of Multiple Biomarkers to Estimate Risk of Ovarian Cancer in Patients With a Pelvic Mass.

Start date: July 14, 2016
Phase:
Study type: Observational

ANGLE has developed the Parsortix™ Cell Separation System (Parsortix), an automated system capable of harvesting rare circulating cells for analysis from a sample of peripheral blood based on cellular size and deformability. In a small pilot study, scientists at the Medical University of Vienna demonstrated that measurement of a combination of mRNA markers extracted from CTCs captured using the Parsortix system could be used to identify women with ovarian cancer. This study is designed to provide specimens for optimization of an assay using clinical and biomarker information (i.e. demographics, imaging results and/or serum tumor markers) in combination with mRNA extracted from rare cells in the blood of women presenting with a pelvic mass for the detection of malignancy. Primary Objective: Optimization of an assay for the differentiation of women with benign pelvic masses from those with malignant pelvic masses using mRNA markers extracted from CTCs isolated from whole blood. Multiple serum tumor markers and mRNA markers will be measured, and the results will be compared to the actual clinical diagnosis made for each patient through other recognized methods (e.g. histopathology). The blood samples collected in the course of this study will be used to finalize the selection of mRNA and/or serum tumor markers to be evaluated in future prospective studies. Exploratory Objective: Use statistical modeling to determine the need for and/or preliminary design of a mathematical algorithm to combine the multiple serum tumor and/or mRNA markers for estimation of the risk of ovarian cancer.

NCT ID: NCT02782741 Completed - Clinical trials for Glycogen Storage Disease Type II;Pompe's Disease

Study to Compare the Efficacy and Safety of Enzyme Replacement Therapies Avalglucosidase Alfa and Alglucosidase Alfa Administered Every Other Week in Patients With Late-onset Pompe Disease Who Have Not Been Previously Treated for Pompe Disease

COMET
Start date: November 2, 2016
Phase: Phase 3
Study type: Interventional

Primary Objective: To determine the effect of avalglucosidase alfa treatment on respiratory muscle strength measured by percent (%) predicted forced vital capacity (FVC) in the upright position, as compared to alglucosidase alfa. Secondary Objective: To determine the safety and effect of avalglucosidase alfa treatment on functional endurance (6-minute walk test, inspiratory muscle strength (maximum inspiratory pressure), expiratory muscle strength (maximum expiratory pressure), lower extremity muscle strength (hand-held dynamometry), motor function (Quick Motor Function Test), and health-related quality of life (Short Form-12).

NCT ID: NCT02782104 Completed - Clinical trials for Depressive Disorder, Treatment-Resistant

A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression

SUSTAIN-3
Start date: June 9, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of esketamine nasal spray in participants with treatment-resistant depression (TRD).

NCT ID: NCT02782013 Completed - Sepsis Clinical Trials

Study of Progression of Community Acquired Pneumonia in the Hospital

PROGRESS
Start date: August 25, 2009
Phase:
Study type: Observational

Pneumonia is a common infectious disease of the lung, often requiring treatment in the hospital. Clinical scoring systems are available, identifying patients not requiring hospitalization. However, the course of disease of patients in the hospital remains hard to predict. While most patients will recover quickly, some will, despite appropriate treatment, develop a severe course leading to sepsis and systemic responses resulting in organ dysfunction. The PROGRESS study aims to identify clinical, genetic, and other molecular markers and combinations thereof predicting a severe course of pneumonia in the hospital. Such predictors will, for instance, support decisions on earlier transfer of patients to intensive care and thus improving outcome.