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NCT ID: NCT01499667 Terminated - Clinical trials for Relapsing Remitting Multiple Sclerosis (RRMS)

Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod

TOFIINGO
Start date: September 2011
Phase: Phase 3
Study type: Interventional

This study evaluated disease control during different lengths of treatment transition from natalizumab to fingolimod.

NCT ID: NCT01476514 Terminated - Hyperekplexia Clinical Trials

Effects of Mutations of the Glycine Gene Associated With Hyperekplexia on Central Pain Processing

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

Mutations in genes affecting pain transmission start to be known, the investigators are investigating a mutation in a glycine channel, which has an influence on pain modulation. Pain modulation is the ability of the central nervous system to enhance or diminish the sensation of pain. The investigators therefore will test patients and healthy volunteers with quantitative sensory tests, basically determining the point at which a stimulation just starts to induce pain. These tests are reliable and permit a direct comparison between healthy volunteers and patients with the affected glycine gene.

NCT ID: NCT01463800 Terminated - Clinical trials for Heart Defects, Congenital

Rehabilitation in Patients With Congenital Heart Disease

CARE-GUCH
Start date: May 2011
Phase: N/A
Study type: Interventional

Exercise intolerance is a major burden for patients with complex congenital heart disease (CHD), significantly affecting their quality of life. Cardiopulmonary exercise testing provides a reliable tool both for assessing exercise capacity of CHD patients and for risk stratification and is becoming part of the routine clinical assessment of these patients. Exercise has an effect on the muscular, metabolic and circulatory systems. While exercise training has been widely studied in chronic heart failure, its efficacy in adults with CHD remain unknown. The investigators hypothesize that structured exercise training will improve exercise intolerance, in particular peak VO2. The aim of this multicenter, randomized study is to evaluate the impact of structured exercise training on exercise intolerance in patients with complex CHD.

NCT ID: NCT01433354 Terminated - Fragile X Syndrome Clinical Trials

Long-term, Safety and Tolerability Study of AFQ056 in Adolescent Patients With Fragile X Syndrome (Open-label)

Start date: November 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in eligible adolescent patients with FXS who have participated in the CAFQ056B2214 study, the PK study CAFQ056B2131, or another study of AFQ056 which included FXS patients below 18 years of age provided the patient is at least 12 years of age at the time of entry into the current study.

NCT ID: NCT01412528 Terminated - Allergy Clinical Trials

Phase II Study to Standardize Allergen Extracts: Determination of Biological Activity in HEP Units

Start date: August 2009
Phase: Phase 2
Study type: Interventional

Today a variety of diagnostic tools to detect allergenic agents are available such as skin tests, provocation tests and blood tests. Due to its high sensitivity and low costs the skin prick test is the most commonly used test to identify allergies in patients. By using this kind of skin test, up to 25 different agents can be tested in parallel, rendering the skin prick test a cheap, easy-to-handle and rapid diagnostic tool. However, as research proceeds, new tools appear with the intention to make future applications even more convenient -for both, the patient and the physician. For that purpose the development of the so called "Easyprick" Allergen Test System is under way, consisting of a foil that carries ready-to-use, allergen-soaked sponges which can easily be applied to the skin after pricking. Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic and non-allergenic components. In order to control variability and to achieve consistency and reproducibility for optimal safety and sensitivity/specificity, it is essential to standardize the amount of allergen used in prick tests. The present study aims to standardize eight allergen extracts by using this method. Standardized extracts will then be applied in the Easyprick Allergen Test System which will be evaluated and compared to the conventional prick test in a second study. - Trial with medicinal product

NCT ID: NCT01411514 Terminated - Multiple Sclerosis Clinical Trials

Oral Prednisone Taper Versus Placebo for the Treatment of Acute Relapses in Multiple Sclerosis

Start date: August 2011
Phase: Phase 4
Study type: Interventional

The management of MS-patients requires treatment with immune-modifying or immune-suppressive agents to prevent new relapses and progression of disability. Several studies have evaluated the effect of steroid treatment on clinical recovery after an acute relapse. An important unanswered clinical question is, whether or not an oral tapering dose of corticosteroids offers any additional advantage over intravenous methylprednisolone alone in improving neurologic recovery as well as safety and tolerability after a relapse. This study aims to compare the efficacy, tolerability and safety of tapering doses of oral prednisone and placebo after short-term high-dose i.v. methylprednisolone on the recovery from an acute relapse in patients with clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RR-MS) and primary (PP-MS) or secondary progressive multiple sclerosis (SP-MS) with superimposed relapses. Patients will be treated during 25 days with de-escaling doses of prednisone or placebo. The primary analysis will test whether placebo is equivalent to oral prednisone taper on the recovery status as measured by EDSS change from baseline to 3 months after baseline.

NCT ID: NCT01408745 Terminated - Clinical trials for Sternum Wound Infection

Sternal Closure With STERNUMFIX in Patients With High Risk

STEPHIX
Start date: June 2008
Phase: Phase 4
Study type: Interventional

The primary objective is to establish if the SternumFix System improves sternal closure. The study should test the hypothesis that in a high risk patient population with increased risk for the development of sternal wound complications SternumFix will reduce the incidence of sternal healing complications. The control group will be treated with wire cerclage, the standard method of sternal closure.

NCT ID: NCT01405417 Terminated - Achalasia Clinical Trials

Endoscopic Peroral Myotomy for Treatment of Achalasia

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

This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center setting.

NCT ID: NCT01389856 Terminated - Clinical trials for Persistent Pulmonary Hypertension of the Newborn

Persistent Pulmonary Hypertension of the Newborn

FUTURE 4
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a supporting and safe therapy and to evaluate the pharmacokinetics of bosentan and its metabolites.

NCT ID: NCT01375179 Terminated - Ulcerative Colitis Clinical Trials

Efficacy & Safety in Moderately Active Refractory Ulcerative Colitis Patients

Start date: December 2010
Phase: Phase 2
Study type: Interventional

This study is designed as a proof of concept of KRP203 for induction of remission in ulcerative colitis (UC). The purpose of this study is to evaluate clinical benefit of KRP203 in subjects with moderately active refractory ulcerative colitis. The study will provide safety and tolerability data in this subject population up to eight weeks of treatment with KRP203. Additionally, this study will evaluate the duration of a clinical response to KRP203 by following up responding subjects for an additional 12 weeks.