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NCT ID: NCT00754520 Active, not recruiting - Osteoarthritis Clinical Trials

A Study Comparing Ceramic-on-metal Articulation to Metal-on-metal Articulation in Cementless Primary Hip Arthroplasty

Start date: May 2009
Phase: N/A
Study type: Interventional

The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup.

NCT ID: NCT00731575 Active, not recruiting - Asthma Clinical Trials

Viral Inception of Asthma: Prospective Study From Infancy to School-age

VINKU2
Start date: June 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to study prospectively the early clinical and immunological events in children susceptible to rhinovirus induced early wheezing (i.e., recently found highest risk factor for recurrent wheezing/asthma) and the efficacy of systemic corticosteroid to modify these events. Up to 50% of children suffer from acute wheezing before school-age. The prevalence of childhood asthma is 5-7%. Although pediatric asthma is mainly allergic, the exacerbations are associated with respiratory viral infections in 95% of cases. The means to predict asthma from environmental factors have been limited mainly to sensitization to aeroallergens (3-fold risk), which start to develop usually at 2-3 years of age. VINKU 1-study (orig. VINKU-study) discovered simultaneously with two other groups, that early wheezing associated with rhinovirus, the "common cold" virus, is the strongest predictor of recurrent wheezing/asthma (up to 10-fold risky). Noteworthily, viral infections work as risk markers already during infancy, a lot earlier than the sensitization to aeroallergens. The investigators also found retrospectively that early wheezers affected by rhinovirus responded to 3 day course of oral prednisolone (inexpensive and widely available treatment): recurrent wheezing decreased by 50% during following 12 months and the difference appeared to continue. VINKU 5V-study is currently investigating the clinical history, prevalence of asthma and airway hyperreactivity of these same children at school-age. The mechanism of rhinovirus associated risk or why they respond to prednisolone are largely unknown. However, the susceptibility to rhinovirus infections is associated with atopy and therefore it is possible these children may have impaired anti-inflammatory (Treg) responses and more likely to wheeze with any pro-inflammatory response (Th1 or Th2). Moreover, they may not effectively clear viruses, because they can not limit rhinovirus to nose and it spreads to lower airways and causes wheezing. VINKU 2-study will prospectively investigate the immunological events in young first-time wheezers affected by rhinovirus, and prospectively study the clinical efficacy of systemic corticosteroid in them. Most likely these children will benefit from the drug in terms of less recurrent wheezing, the investigators will also explore immunological effects of the drug and their link to clinical efficacy. The results are expected to give basis for the prevention of asthma and for the development of new treatment strategies and they can be directly applied to clinical medicine.

NCT ID: NCT00718263 Active, not recruiting - Clinical trials for Myelogenous Leukemia, Chronic

Efficacy and Safety of Nilotinib Patients With Newly Diagnosed CML - CP (Chronic Myelogenous Leukemia - Chronic Phase)

PHCHBS-WD4070
Start date: April 2008
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and tolerability of nilotinib after failure of imatinib therapy or imatinib therapy after nilotinib failure.

NCT ID: NCT00695981 Active, not recruiting - Rotator Cuff Tear Clinical Trials

Operative Versus Non-operative Management of Rotator Cuff Tear

Start date: June 2008
Phase: N/A
Study type: Interventional

This study aims at determining the effectiveness and cost-effectiveness of surgical management of full-thickness rotator cuff tears compared to conservative treatment. The research setting is prospective, randomised, and controlled. The aim of the study is to search out evidence based data of indications for rotator cuff repair. The investigators also aim at offering patients the most efficient and effective treatment and reduce the number of operations that do not have sufficient effectiveness. The data obtained will facilitate developing guidelines for referrals to a specialist when rotator cuff tear is suspected. The investigators hypothesize that there are subgroups of patients suffering from rotator cuff tears that benefit from surgery whereas other subgroups are best treated conservatively.

NCT ID: NCT00657969 Active, not recruiting - Stroke Clinical Trials

Looking For Genetic and Environmental Risk Factors and Therapeutic Aspects in Cervical Artery Dissections

CADISP
Start date: July 2005
Phase: N/A
Study type: Observational

The main purpose of this study is to look for genetic and environmental risk factors of cervical artery dissections, a major cause of ischemic stroke in young adults, in a large multicenter case-control trial

NCT ID: NCT00637013 Active, not recruiting - Clinical trials for Subacromial Impingement Syndrome

Operative Versus Non-operative Management of Subacromial Impingement

Start date: June 2008
Phase: N/A
Study type: Interventional

The study aims at determining the effectiveness and cost-effectiveness of surgical management of subacromial impingement (including partial tears) compared to conservative treatment. The research setting is prospective, randomised, and controlled. The aim of the study is to search out evidence based data of indications for subacromial decompression. The investigators also aim at offering patients the most efficient and effective treatment and reduce the number of operations that do not have sufficient effectiveness. The data obtained will facilitate developing guidelines for referrals to a specialist when subacromial impingement is suspected. The investigators hypothesise that there are subgroups of patients suffering from subacromial impingement that benefit from surgery whereas other subgroups are best treated conservatively.

NCT ID: NCT00622700 Active, not recruiting - Multiple Sclerosis Clinical Trials

Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis

TOPIC
Start date: February 2008
Phase: Phase 3
Study type: Interventional

The primary objective is to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS). The secondary objectives are: - To demonstrate the effect of teriflunomide, in comparison to placebo, on: - Reducing conversion to definite multiple sclerosis (DMS) - Reducing annualized relapse rate (ARR) - Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI) - Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS) - Proportion of disability-free participants as assessed by the EDSS - Reducing participant-reported fatigue - To evaluate the safety and tolerability of teriflunomide - To evaluate the pharmacokinetics (PK) of teriflunomide - Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes

NCT ID: NCT00617838 Active, not recruiting - Celiac Disease Clinical Trials

Celiac Disease Prevention

Start date: October 2007
Phase: N/A
Study type: Interventional

Celiac disease is an autoimmune disease induced by wheat gluten. Destruction of epithelial cells and microvilli on gut mucosa is causing a "flat mucosa" and an absorption defect. The diagnosis is based on typical microscopical finding in biopsy specimens but serum antibodies to tissue transglutaminase and certain gliadin peptides are strongly associated with the pathology. Severe diarrhoea associated with growth disturbance in infancy was historically characterising the disease but is nowadays rare. Clinically more mild forms including silent disease are very common. Studies based on antibody screening and biopsies done in autoantibody positive subjects have confirmed a frequency of about 1-2% in adult population. Undiagnosed disease is associated with deficiencies of nutrients and vitamins leading to various chronic symptoms like anaemia, osteoporosis and general fatigue. It has also been recently found that undiagnosed celiac disease may be associated with general underachievement in society probably associated with common psychological symptoms like fatigue and depression during the adolescence. The disease is treated by complete elimination of wheat, rye and barley in the diet, which is laborious and causing considerable extra costs in nutrition. Much progress has been recently made in understanding of the genetic background and immune markers associated with the disease as well as in understanding those patterns of gluten introduction in infancy, which might be connected to a high disease risk. Our aim in this study is in the first phase to identify children at high genetic risk (around 10%) and in a follow-up study to define: 1. Are the age, dose of gluten and presence of simultaneous breast feeding at the introduction of gluten associated with the risk of celiac disease? 2. Is it possible to decrease the frequency of celiac disease by nutritional counselling? 3. Is it possible to predict development of celiac disease by immunological tests before the development of mucosal lesion If we can confirm, that optimising the conditions at the introduction of wheat gluten in infancy diet significantly reduces the disease incidence, will this have an important effect on the nutritional recommendations concerning the diet in infancy. Combining genetic screening and immunological tests might also offer a way to reduce the frequency of celiac disease and help in early diagnosis and organisation of an adequate treatment

NCT ID: NCT00571129 Active, not recruiting - Clinical trials for Lacrimal Duct Obstruction

Endoscopic Dacryocystorhinostomy Prospective Research

Start date: September 2004
Phase: N/A
Study type: Interventional

Endoscopic dacryocystorhinostomy (EN-DCR) is an effective procedure when treating saccal and postsaccal obstructions of the nasolacrimal pathway. The benefit of silicone tubing after DCR is still controversial. We conducted a prospective, randomized study in order to evaluate 1) the necessity of bicanalicular silicone tubes after primary EN-DCR, 2) efficacy of the perioperative Mitomycin C for the prevention of adheesion and re-stenosis of rhinostomy site in revision EN-DCR, 3) the subjective symptoms and QoL changes before and after DCR-operation.

NCT ID: NCT00552903 Active, not recruiting - Heart Failure Clinical Trials

Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease

TerVa
Start date: November 2007
Phase: Phase 3
Study type: Interventional

A randomised trial with individual patients as units of observation will be carried out. Health coaching is used to modify health behaviour and thus improve disease control and health status, as well as use of health care services. A personal health coach is assigned to each patient and they are in weekly contact through telephone. The intervention lasts for 12 months. No intervention is offered to the patients in the control arm.