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NCT ID: NCT00993551 Completed - Cleft Palate Clinical Trials

Timing of Primary Surgery for Cleft Palate

TOPS
Start date: July 2010
Phase: N/A
Study type: Interventional

This trial is a randomised controlled trial with a parallel design taking place in centres across the UK, Scandinavia and Brazil. 650 infants with a diagnosis of isolated cleft palate who are considered medically fit for operation at 6 months, and who meet the inclusion criteria, will be included in the trial and randomised to receive either: - Surgery at age 6 months, OR - Surgery at age 12 months. The main objective is to determine whether surgery for cleft palate, using a Sommerlad technique, at age 6 months, when compared to surgery using the same technique at age 12 months, improves velopharyngeal function at age 5 years. All infants will be followed up at age 12 months, 3 years and five years for the assessment of the primary outcomes( at age 5 years) and secondary outcomes.

NCT ID: NCT00993382 Completed - Clinical trials for Ventricular Arrhythmia

Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death

ALPHEE
Start date: September 2009
Phase: Phase 2
Study type: Interventional

The Primary Objective was to assess the efficacy of celivarone for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death. Secondary Objectives were: - To assess the tolerability and safety of the different dose regimens of celivarone in the selected population. - To document SSR149744 plasma levels during the study.

NCT ID: NCT00993343 Completed - Clinical trials for Graft-versus-host Disease

Randomized Trial Comparing Sirolimus and Tacrolimus Versus Cyclosporine and Methotrexate as Graft-versus-host Disease (GVHD) Prophylaxis After Allogeneic Stem Cell Transplantation

Start date: September 2007
Phase: Phase 3
Study type: Interventional

To evaluate if rapamune + tacrolimus immunosuppressive prophylaxis is better than the established therapy using cyclosporine and methotrexate, a Nordic prospective multicenter randomized study will be performed. Patients will be randomized to treatment with rapamune combined with tacrolimus, or the established therapy using cyclosporine and methotrexate.

NCT ID: NCT00993226 Completed - Postoperative Pain Clinical Trials

An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy

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

The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on the efficacy and safety of the product.

NCT ID: NCT00992784 Completed - Influenza Clinical Trials

Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine in Elderly People

Start date: October 15, 2009
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety of GSK Biologicals' influenza vaccine. Elderly subjects were randomized in the primary study (NCT00760617) and will now receive the same vaccine for the third time. For this study the masking is "observer-blind" for elderly subjects and "open" for young adult subjects.

NCT ID: NCT00992641 Completed - Clinical trials for Cardiovascular Diseases

The Effect of Nordic Recommended Diet on the Features of Metabolic Syndrome - Multicentre Study

SYSDIET
Start date: August 2009
Phase: N/A
Study type: Interventional

SYSDIET (Systems biology in controlled dietary interventions and cohort studies) is one of the three centres in the NCoE Food, Nutrition and Health, 2007-2011. It consists of 12 partners from five Nordic countries working on multidisciplinary fields of science related to nutritional biology. The main objective of SYSDIET is to reveal mechanisms by which Nordic foods and diets could be modified to promote health and prevent insulin resistance, type 2 diabetes and cardiovascular diseases, all of which being connected to metabolic syndrome. Furthermore, the aim is to build up a Nordic platform for cohort studies and carefully conducted multi-centre dietary intervention studies, where novel nutritional systems biology tools can be applied besides human studies also in animal and cell culture studies. In order to achieve the main objective a Nordic multi-centre randomized controlled human intervention study is being conducted in 2009-2010 in 6-8 centres of SYSDIET consortium. Health of the Nordic populations has substantially improved during the last 30 years. This is due e.g. to marked decline in cardiovascular morbidity and mortality. However, during the last 10-20 years increasing obesity and sedentary lifestyle have resulted in an increase of metabolic syndrome and type 2 diabetes. Having this background, the aim of the SYSDIET consortium is to carry out a controlled, randomized dietary intervention study in persons with features of metabolic syndrome to find out the effects of a healthy Nordic food on major abnormalities in metabolic syndrome. Altogether 167 persons aged 30 to 65 years were recruited from 6-8 centers (40-60 subjects/center) of the SYSDIET cohort. The main inclusion criterion is BMI 27-38 kg/m2. The subjects should also have at least two other IDF criteria for metabolic syndrome. Recruited persons will start the study by following their conventional diet for one month as a run-in period. After that subjects will be randomly assigned into Experimental- or Control-diet-group for 6 months. Experimental diet is rich in whole grain products, berries, fruits, vegetables and fish, and its fat intake is modified according to current Nordic recommendations. Control diet is based on the current information of the mean dietary intake and food consumption. The diets will be realized according to eating habits in each Nordic country.

NCT ID: NCT00989833 Completed - Clinical trials for Exercise Induced Asthma

Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients

MIA
Start date: September 2009
Phase: Phase 2
Study type: Interventional

1. The primary objective of this study is: - To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol on an as-needed basis compared to the use of terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma 2. The secondary objectives of this study are: - To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol as-needed compared to regular once daily use of budesonide plus terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma - To evaluate safety of budesonide/formoterol as-needed, terbutaline as-needed and regular use of budesonide + terbutaline as-needed as terms of adverse event

NCT ID: NCT00989222 Completed - Radius Fractures Clinical Trials

Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius?

Start date: January 2006
Phase: N/A
Study type: Interventional

Promising results have been reported after volar locked plating of unstable dorsally displaced fractures of the distal radius. It offers stable fixation and early mobilization. The investigators' aim is to test if volar locked plating results in better patient-perceived, objective functional and radiological outcomes compared to the less invasive external fixation that has been the standard operation for decades.

NCT ID: NCT00989131 Completed - Clinical trials for Fallopian Tube Cancer

Study of Paclitaxel in Patients With Ovarian Cancer

Start date: February 2009
Phase: Phase 3
Study type: Interventional

RATIONALE: Paclitaxel is one of the most widely used human anticancer agents. Paclitaxel has a low degree of solubility and Cremophor EL is typically used as the solubiliser. Cremophor EL is known to cause hypersensitivity reactions that can be life-threatening. As Paclical® does not contain Cremophor EL, hypersensitivity reactions can be expected to be less. PURPOSE: To study the efficay and safety of two different formulations of paclitaxel, Paclical® and Taxol®.

NCT ID: NCT00988572 Completed - Dizziness Clinical Trials

Vestibular Rehabilitation for Patients With Fall-related Wrist Fractures

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

Dizziness has been identified as a risk factor for fall and vestibular asymmetry has been found among patients with fall-related wrist fractures as well as among patients with hip-fracture. Since wrist fracture is a risk factor for hip-fracture, much effort is focused on preventing falls for risk-groups. Therefore, it would be interesting to find out if it is possible to influence vestibular asymmetry with vestibular rehabilitation. The aim of this study is therefore to find out if vestibular rehabilitation can have any effect on vestibular function among patients with fall-related wrist fracture.