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NCT ID: NCT02096237 Completed - Allergic Asthma Clinical Trials

Extracorporeal SPecific IgE Removal From the Plasma of Allergic Asthma Patients (ESPIRA-study)

ESPIRA
Start date: December 2013
Phase: N/A
Study type: Interventional

In this study patients suffering from Immunoglobulin E (IgE) mediated asthma are treated with a method, called immune apheresis, that removes IgE from blood. In order to achieve this blood is taken continuously from the patient and then separated into plasma and blood cells by centrifuge. The plasma passes the new IgE adsorber where the IgE is specifically bound. The "cleaned" plasma re-joined with the blood cells is given back to the patient. In total each patient randomized to the apheresis group will undergo 3 treatments per week (i.e. 1 cycle) every 4 weeks over a time period of 3 months, that means 9 apheresis treatments in 3 cycles in total. Study hypothesis is that the new IgE adsorber is capable of reducing IgE in plasma/serum by at least 50% measured before the first treatment in the first cycle and after the last treatment in the last treatment cycle. The new adsorber can be safely used in patients. A group of patients with conventional drug treatment and no apheresis treatment serves as control.

NCT ID: NCT02095626 Completed - Clinical trials for PGD Primary Graft Dysfunction

Study in Intensive Care Patients Regarding the Effect of Inhaled AP-301 After Primary Graft Dysfunction After Lung Transplantation

Start date: June 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the effect of orally inhaled AP-301 on primary graft dysfunction after lung transplantation.

NCT ID: NCT02094859 Completed - Clinical trials for Accurate Blood Glucose Monitoring in Critical Care Setting

GlucoClearTM System ICU Study

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

The primary purpose of this Study is evaluation of the safety and performance of the GlucoClear System (System). The primary safety objective will be assessed by: • Evaluation of any serious adverse device effects upon Sensor insertion through Sensor removal and a follow-up assessment one week (7 ± 3 days) after Sensor removal. The primary performance objective will be evaluated using the following criteria: 15/20% Performance: Blood glucose measurements from the System must meet the ISO 15197 15/20% accuracy criteria (at least 95% of the matched pairs within ± 15 mg/dL of Comparator values ≤ 75 mg/dL and within ±20% of Comparator values > 75 mg/dL).

NCT ID: NCT02093897 Completed - Clinical trials for Congenital Hemophilia A

Pharmacokinetic, Efficacy, and Safety Study of Recombinant Factor VIII Single Chain (rVIII-SingleChain) in Children With Severe Hemophilia A

Start date: March 2014
Phase: Phase 3
Study type: Interventional

This is an international, multicenter, open-label study to assess the efficacy, safety, and pharmacokinetic (PK) profile of rVIII-SingleChain in pediatric patients with severe hemophilia A. A minimum of 25 previously treated subjects ≥ 6 to < 12 years of age and at least 25 subjects < 6 years of age who have undergone > 50 exposure days (EDs) with a previous Factor VIII (FVIII) product are planned to be enrolled. Subjects will be assigned to either an on-demand or prophylaxis treatment regimen for the treatment of bleeding episodes and will receive rVIII-SingleChain at a dose to be determined by the investigator. Hemostatic efficacy will be assessed by the subject/caregiver and the investigator who will assess overall efficacy by a 4-point scale.

NCT ID: NCT02092818 Completed - Clinical trials for Hypertension, Pulmonary

EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

EXPERT
Start date: May 31, 2014
Phase:
Study type: Observational

In accordance with the regulatory guidance this registry has been designed to collect information about the long-term safety of Adempas in real clinical practice outside the regulated environment of a controlled clinical study.

NCT ID: NCT02092376 Completed - Clinical trials for Bariatric Surgery Candidate

The Link Between Obesity And Vitamin D in Bariatric Patients With Omega-loop Bypass Surgery

LOAD
Start date: March 2014
Phase: Phase 4
Study type: Interventional

The aim of the study is to increase vitamin D concentrations or to keep it on high level, respectively, by supplementing with vitamin D3 in a different dose regime, and to improve the overall health status in bariatric patients. In this project, the vitamin D status, the parameters of inflammation, bone turnover, insulin resistance, liver and depression score of bariatric patients are expected to improve, due to supplementation of a loading dose compared to the standard therapy.

NCT ID: NCT02090556 Completed - Clinical trials for Rheumatoid Arthritis

Long-term Experience With Abatacept SC in Routine Clinical Practice

ASCORE
Start date: March 26, 2013
Phase:
Study type: Observational

The purpose of this study is to estimate the retention rate of Abatacept SC over 24 months in routine clinical practice, in rheumatoid arthritis patients, in each country involved in the study. The purpose of the UK substudy is to explore whether integrating self-assessment into routine care could maintain tight control (of inflammation/disease activity) and at potentially lower cost resulting in improved health outcomes and cost-effectiveness.

NCT ID: NCT02090504 Completed - Alcohol Dependence Clinical Trials

Comparative Study of Gamma-hydroxy Butyrate Versus Oxazepam in the Treatment of Alcohol Withdrawal Syndrome

GATE I
Start date: February 2002
Phase: Phase 4
Study type: Interventional

Benzodiazepines (BDZs) are the gold standard in the treatment of alcohol withdrawal syndrome (AWS). Gamma-Hydroxybutyric acid also known as sodium oxybate (SMO) has been tested as a treatment for AWS with encouraging results. Aim of this phase IV, multicenter randomized double-blind, double dummy study is to evaluate the efficacy of SMO in comparison to oxazepam in the treatment of alcohol withdrawal symptoms (AWS).

NCT ID: NCT02087189 Completed - Clinical trials for ICD/CRT-D Indication

TD01 Master Study (Safety and Efficacy Study)

Start date: August 2014
Phase:
Study type: Observational

This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD lead.

NCT ID: NCT02086929 Completed - Clinical trials for Major Depressive Disorder

Trazodone Once a Day in Major Depression Disorder

Start date: December 2012
Phase: Phase 3
Study type: Interventional

The study objective is to evaluate the efficacy and safety of trazodone OAD vs venlafaxine extended release (venlafaxine XR) after an 8-week treatment period in patients with major depressive disorder.