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NCT ID: NCT00993720 Completed - Diabetes Mellitus Clinical Trials

Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes

Start date: October 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of the study is to investigate the effect of Victoza (a GLP-1 receptor agonist)on insulin-dose, risk of hypoglycemia and gastric emptying rate during hypoglycemia in patients with type 1 diabetes.

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: NCT00993304 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Trial to Assess the Effect of Liraglutide on Blood Triglyceride (Fat) Levels After a Meal in Type 2 Diabetics

Start date: October 2009
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe. The aim of this trial is to investigate whether a new compound, liraglutide, reduces the level of lipids (fat), including cholesterol, in the blood of type 2 diabetics, following a meal with high fat content.

NCT ID: NCT00992888 Completed - Alcoholic Hepatitis Clinical Trials

Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis

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

The purpose of this study is to investigate the role of endotoxins and the endotoxin mediated immune activation pathway in patients with alcoholic hepatitis. Also, to determine the effect of Liver assist (liver dialyses) intervention on these parameters in patients with severe alcoholic hepatitis.

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: NCT00992589 Completed - Clinical trials for Gastroesophageal Reflux

Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)

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

The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with placebo in the treatment of gastrointestinal esophageal reflux disease (GERD) in infants 1 to 11 months of age.

NCT ID: NCT00992576 Completed - Constipation Clinical Trials

Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain

HMX3501
Start date: January 2010
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to establish an optimal hydromorphone - naloxone ratio with an improved bowel function for constipated pain patients.

NCT ID: NCT00990977 Completed - Breast Cancer Clinical Trials

Mindfulness and Cancer Mamma - Clinical Trial MBSR Among Women Operated for Breast Cancer

MICA
Start date: March 2008
Phase: Phase 2/Phase 3
Study type: Interventional

The number of Danish women treated for breast cancer rise every year, though survival rates have improved, women can still expect to experience the diverse late effects reported by this group of patients. Mindfulness labels the ability to be aware of the present moment - thereby avoiding speculations about both past and present. Mindfulness based stress-reduction (MBSR) is an 8-week program, covering 24 contact-hours and 45 minutes daily home practice. The program aims at developing participants' coping resources and developing participants' mindful awareness. Thus the program consists of guided meditations, guided body scan(a specific awareness exercise)and through meditation, yoga and psychoeducation concerning stress and stress-reactions, while meditation and bodyscan is practiced at home by the use of specific audio-CDs guiding the patient. The MBSR-program have shoved promising results among patients with anxiety-disorders, depression and chronic pain. Smaller studies have also found positive effects of the program among cancer patients. The investigators want to evaluate the effect of the MBSR program on levels of anxiety and depression as well as the possible influence of mindfulness training on health behaviors and existential concerns. The study are based on the following hypotheses: - report of anxiety and depression will decrease among cases - better compliance will lead to more decrease in levels of anxiety and depression - cases will make lifestyle changes suitable with recommendations for BC patients in post-treatment phase of the illness - decreased level of anxiety and depression will reflect improved spiritual well-being - improved spiritual wellbeing will lead to decreased report of physical symptoms All participants in this randomized controlled trial will fill out questionnaires at enrollment and as 1, 6 and 12 months follow-up. Based on results from this trial clinicians and patients will be able to make decisions regarding post-treatment psychosocial intervention and researchers will have initial evidence of the effect of the intervention and thus possible indications for research on mindfulness among patients diagnosed with cancer at other stages or sites.

NCT ID: NCT00990678 Completed - HIV Seropositive Clinical Trials

Study of Vitamin D Supplementation to Male HIV Sero-positive Patients

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

The investigators want to investigate if HIV sero-positive males benefit from vitamin D supplementation. The study runs in 16 weeks and the participants are treated with one of three placebo controlled regimes (tablets): 1. Calcium 2. Calcium and 25-hydroxy-vitamin D 3. Calcium and 25-hydroxy-vitamin D and 1,25-dihydroxyvitamin D The endpoints are: - Serum vitamin D - Parathyroid hormone - ionized calcium - T-lymphocyte fractions (naïve, mature, Tregs) - Osteocalcin (bone metabolism)