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.
Earlier studies have shown that pharmacists detect and solve drug related problems (DRPs) when they are a part of the multidisciplinary treatment-team at hospital wards. However, in the Norwegian health care system, there is a lack of studies on the effect of pharmacist intervention on clinically relevant outcomes. Hospital readmissions has both clinical and economical negative effects, and time outside the hospital until an eventual readmission is considered as a clinical relevant outcome measure. The investigators are conducting a randomized controlled trial at an internal medicine ward at Oslo University Hospital. 400 acute admitted patients using minimum 4 regular drugs from minimum 2 drug groups will be enrolled in the study. Patients randomized to the Control group will receive standard care (without a pharmacist involved) and patients randomized to the Intervention group will receive a pharmacist in their treatment team during the hospital stay. The study hypothesis is that including a pharmacist in the multidisciplinary treatment team at a hospital ward, will improve the patients drug treatment, hence lead to an increased time outside the hospital until an eventual readmission. The inclusion of patients was completed March 17th 2016 With 399 patients randomised. The last day of follow-up on readmission and mortality was December 31, 2017. The Application process for outcome data to the Norwegian Patient Registry and the Norwegian Cause of Death Registry started in June 2017 and lasted until May 2018. Huge workload at the Registers entails a very long processing time for outcome data. On May 25, 2018 the statistical analysis plan was finalized and signed, hereunder the analysis population defined and the endpoint analyses detailed. Outcome datafiles from patient registries was prepared for analysis May 29 to June 6, 2018. Blinded outcome analyses was conducted June 8, 2018. _______________________________ The investigators have obtained approval for a protocol amendment to use the data from the study in further analyses togheter with data from 100 new patients admitted to the internal medicine ward. The hypothesis is that a set of patient characteristics can identify patients who are at high risk of drug-related readmissions and who would benefit most from the pharmaceutical intervention.The investigators aim to identify these patients by building a statistical model based on significant variables from the 399 patients collected in the randomised controlled trial. The statistical model will be validated using data from 100 new patients admitted to the internal medicine ward. The inclusion of patients to this New sample was finalised July 6th 2018 (primary completion). Data on hospital readmissions and death will be collected from the Norwegian Patient Registry and the Norwegian Cause of Death Registry in June 2020.
Eligible patients that sign an informed consent will be randomized to operation with volar locking plate or cast immobilization. Primary follow-up after 1 year.
Infliximab is the active ingredient in a drug currently sold by the trade names Remicade, Remsima and Inflectra. Infliximab neutralizes tumor necrosis factor (TNF) α, a chemical messenger (cytokine) in the immune system, and belongs to a class of drugs called "TNF inhibitors". 8-55% of patients receiving infliximab have an infusion reaction. Infusion reactions are unintended reactions that occur during infusion of the drug and up to 14 days after. The incidence varies widely in different studies and seems difficult to determine due to variations in reporting of reactions, different definitions of reactions and retrospective data collection. The aim of this study is to estimate the incidence of infusion related reactions and investigate risk factors and immunological mechanisms of infusion reactions to infliximab in patients with a chronic inflammatory disease.
The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. Follow-up evaluations will be conducted through 5 years post implantation.
Regular exercise has several positive health effects including increased physical fitness and muscle mass. It is well known that increased muscle mass is associated with increased resting energy expenditure which may facilitate weight loss and maintenance. Previous studies have, however, failed to show any consistent association between the intensity of physical exercise and energy expenditure, or relate the variance in these adaptations to genetic variability. Whether high-intensity exercise (HIE) is associated with improved health related quality of life in severely obese patients remains unknown. This PhD-project is based on a planned randomised controlled study including 50 or more treatment seeking morbidly obese patients who will be randomised to either a 24 week moderate-intensity exercise (MIE) programme or a 24 week high-intensity exercise (HIE) programme. The investigators main hypothesis is that patients randomised to the HIE-program will achieve higher energy expenditure during rest and physical activity after treatment than those allocated to the MIE-programme. In addition, the investigators hypothesise that the HIE-group will achieve a better health related quality of life than the MIE-group after treatment. The investigators also hypothesize that inter-individual variability in adaptation to the two training regimens may be due to genetic factors. If the investigators hypotheses are confirmed, this project might have beneficial clinical implications for future obesity treatment strategies.
The study is a comparative effectiveness study with comparision of two cohorts of patients with stroke in North of Norway and in Denmark. At baseline information is collected from the stroke registries in both countries. Time points for follow up are at 3 and 12 months post-stroke. Data are collected from medical charts and with use of telephone interview in addition to self-report questionnaires. The study will provide information about functional status, health related quality of life and rehabilitation needs. Information about rehabilitation services in both countries are collected and compared, and analysed in relation to patients outcome.
The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested Centers.
Patients who suffer an ischemic stroke in the occipital lobe often experience Visual Field defects. Visual Field defects are negatively correlated to falling, institutionalisation, rehabilitation outcome and quality of life. Patients are often not properly examined and seldom receive rehabilitation. NOR-OCCIP aims to evaluate the Natural history of Visual Field defects after occipital infarction and to determine whether rehabilitation is effective.
The purpose of Phase 1b of this study is to: - Asses the safety, tolerability and activity of carfilzomib, alone and in combination with induction chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL). - Determine the maximum tolerated dose (MTD) and to recommend a phase 2 dose of carfilzomib in combination with induction chemotherapy. The purpose of Phase 2 of this study is to compare the rate of complete remission (CR) of carfilzomib in combination with vincristine, dexamethasone, PEG asparaginase, daunorubicin (VXLD) at the end of induction therapy to an appropriate external control.
The project aims to compare the histopathological and molecular characteristics of tumour tissue from metastases with similar analyses of the primary tumour in the lung, where it is available. The investigators will therefore perform analysis of blood samples if possible, to identify predictive markers in blood samples.