There are about 5161 clinical studies being (or have been) conducted in Norway. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily in the evening) over 48 weeks, compared to placebo, in children (6 to 11 years old) with moderate persistent asthma.
Colonoscopy is commonly used in screening for colorectal cancer. A refined technique of colonoscopy involving the use of water as the sole modality to aid colonoscope insertion, water exchange, has been described in recent research papers to decrease patient discomfort and pain, and to reduce the need for sedation during colonoscopy when compared with standard air insufflation. Carbon dioxide insufflation has been described to decrease patient discomfort after colonoscopy. No randomized trial has so far compared the use of water exchange to carbon dioxide insufflation. Our hypothesis is that water exchange inflicts less discomfort to patients undergoing colonoscopy than carbon dioxide insufflation. Patients undergoing screening colonoscopy in two centers in Norway, one center in Poland and one center in The Netherlands will be enrolled and randomized to examination of either of the two methods.
This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs. Placebo plus Fulvestrant in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), aromatase inhibitor (AI)-treated, locally advanced or metastatic breast cancer whose disease progressed on or after mammalian target of rapamycin inhibitor (mTORi)-based treatment. Patients were randomized in 2:1 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg. Randomization was stratified according to visceral disease status (present or absent).
The purpose of this study is to determine whether a nutrition intervention during a rehabilitation stay followed by nutritional advice after discharge, can improve the nutritional status of the patients after 3 months.
The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.
The Re-Shape CV-Risk Study is a clinical study where renal adrenergic denervation (RDN) is done in high risk patients with treatment-resistant hypertension. RDN is a mini-invasive, percutaneous technique where an ablation catheter is inserted through a femoral artery into the renal arteries, for destruction of the adrenergic nerve bundles in the artery adventitia by means of radio-frequency ablation. RDN leads to sympathetic denervation of the kidneys, which in the "Symplicity trials" led to an impressive reduction of blood pressure (- 33 /-11 mmHg). In a pilot study, where 40 % of the patients had diabetes, RDN seemed to have beneficial effects not only on blood pressure, but also on insulin sensitivity and hyperinsulinaemia. The investigators aim to introduce RDN as a clinical study where blood pressure reduction and methodical, technical aspects will be evaluated, but more importantly, also additional effects of RDN on sub-clinical organ damage (endothelial function, vascular stiffness, fundus-, heart-, kidney injury), quality of life, arrhythmia, and glucose metabolism. The investigators hypothesis is that RDN will have positive effect on glucose metabolism, QOL and sub-clinical organ damage.
The purpose of this study is to study the predictive value of SensoDetect-BERA as a diagnostic tool in clinical practice for schizophrenia and bipolar disorder.
Background: Despite the introduction of highly effective antiretroviral therapy (ART) regimes, which control the HIV infection and results in increases in CD4 cell counts and an undetectable viral load, many patients suffer from increased morbidity. There is evidence that presence of antibodies against the C5 region of gp120 strongly correlates with slower disease progression, and that loss of antibody responses to this region are associated with progression. Investigational product: Vacc-C5 is a single heterodimeric peptide-based HIV therapeutic vaccine corresponding to the C5 region on gp120 and the external domain of gp41. The vaccine is intended to create a non-neutralizing antibody against C5 region. Study objectives: 1. To evaluate safety of the vaccination regimens 2. To evaluate C5-specific humoral immune responses (antibodies), T cell responses, T cell activation markers and other immune markers.
Background: In Norway each year 130-150 children are born with heart disease that requires lifelong medical follow-up. Children with heart defects have reduced motor skills and reduced physical capacity compared with healthy peers. Increased knowledge in the children themselves and the general public, along with psychosocial interventions improve the child's ability to cope with the consequences of their disease. Descriptions of the experiences that Norwegian children with heart disease and their parents have about participation in rehabilitation programs is limited. Geilomo children's hospital has 75 years experience in rehabilitation of children with chronic illness, and started in 2005 to welcome children with heart disease. At present there is no rehabilitation institutions in Norway that has a special group programs for children with heart disease. Geilomo want to establish such a group for children aged 6-7 years and 11-12 years. Main objective: The investigators will use of methods to learn more about the following: Study 1: The purpose is to generate knowledge about how children with heart disease and their relatives experience participation in a rehabilitation program at Geilomo children's hospital. Overarching question: How do children with heart disease and their guardians to participate in a rehabilitation program, and the impact of this on their daily life afterwards? Study 2: The purpose is to help a) to give the children an increased level of activity in the home environment. Question: Will children with heart disease increase their activity levels at home after a stay at Geilomo? 2b) for the children to improve their physical fitness. Question: Will children with heart disease have improved their physical condition three months after a stay at Geilomo? Work schedule: The project will have a duration of 3 years. The project will seek approval of the Regional Committee for Medical Research Ethics in May 2012. Interview Guide, information sheet and consent form has been prepared. Data collection for the study 2AB can start in March 2013. The first interviews will be conducted after 3 months, in June 2013. Data collection is expected to be completed in December 2013. The analysis will take place in parallel with the interview work. In 2014 and 2015 completed the writing of articles (3 pieces) and publication of results. Method: In order to shed light on the problem in study 1, the investigators will use semi-structured interview. 16 children and 16 parents to be interviewed after 3 months. Study 2a) To get information about their child's activity level in the home environment the investigators will use structured questionnaires. It is one form for children (36 persons) and another form for their parents (36 persons). Study 2b) All children (36 persons) conducting physical fitness test at the first visit and after three months. Children can be referred from across the country via the referral form. Dr. Henrik Holm (OUS) and Dr. Asle Hirth (HUS) determines participation according to inclusion and exclusion criteria. Parents submit a written consent on behalf of themselves and their children. Scientific significance: This application describes two related studies, both of which are expected to provide important information that can provide better services for children with heart disease.