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.
Analysis of spontaneous movements in young infants from video recordings is recommended as an early medical assessment tool for prediction of cerebral palsy in high-risk infants. Such video recording have previously been performed in follow-up programs at hospitals using semi standardized video set-ups. The research group behind this study develops a smart-phone application that makes it possible for parents to video film their infant spontaneous movements at home, upload and send the video for analysis at the hospital provided by experts. The objectives of the study are to assess the feasibility of the In-Motion app for video recording of infant spontaneous movements, upload and send the video to St. Olavs Hospital in Trondheim, Norway, for assessment, and how parents experience this. 90-120 high-risk infants from Norway, Denmark, Belgium, USA, Great Britain and India will participate. Parents will record their infant spontaneous movements and answer questionnaires. Video quality will be evaluated by experts within the field and their use for computer-based assessment will be evaluated.
Breast cancer is rarely curable after metastasis, and the therapeutic options are limited. Interestingly, the host immune response is strongly predictive for the effect of chemotherapy in subgroups of patients with breast cancer. The aim is to release the brake on the immune response by use of ipilimumab, which blocks CTLA-4 and may deplete regulatory T cells, combined with nivolumab (anti PD1). Importantly, it is possible that non-responders to nivolumab/ipilimumab (nivo/ipi) can be turned responders by use of immunogenic chemotherapy.
In the present study the investigators aim to examine the presence of bacteria in the disc and Modic Changes (MCs) (bone). A prospective study with 1-year follow-up of two patient populations undergoing elective spinal surgery (spinal fusion or disc herniation surgery) will be conducted. Patients previously operated on at index level will also be included, and evaluated as sub-groups. The following tissues are collected: dermis, sub-fascial tissue, nucleus pulposus, annulus fibrosus, and endplates. Endplate biopsies are only performed in patients undergoing fusion surgery. All tissue samples undergoing culturing should be processed within 4 hours of sampling. The time for sampling and culture processing are noted for each sample.In short, 1 mL enrichment broth (Brain Heart Infusion, BHI) is added to each tissue sample and further homogenized using sterile beads or a mortar. In addition, a control sample containing only enrichment broth is included. The control sample also undergoes the homogenization step. Each sample is plated onto three agar plates: blood and chocolate for aerobic culturing and anaerobic medium (HM0 or FAA) anaerobic culturing. The blood and chocolate agar plates and the enrichment broth are incubated in 35oC (5% CO2) and the anaerobic plates are incubated anaerobically for a total of 14 days. On day 3 and 7, the enrichment broth is plated onto a chocolate and an anaerobic agar for aerobic and anaerobic incubation respectively. Aerobic plates are read every 1-2 days and the anaerobic plates are read every 2-3 days. All growth is identified and recorded. Colonies considered relevant are frozen at -80oC. The pre-specification of microbiological results; significant growth, no growth and probable contamination (< 5 single colonies on primary plate and no growth from enrichement broth or no growth on primary plate, but growth from enrichement broth). Main endpoint for bacteriology is significant growth or no growth. A prespecification of PCR results in the probable contamination group seems to be premature, due to high risk of contamination. We will perform sensitivity analysis as the samples are analyzed, and PCR and histology will be used in combination to determine if a probable contamination should be considered in the significant growth group or in the no growth group. In addition to a pre-specified evaluation of growth or not, microbiologists and the pathologist are blinded to the knowledge of case or control. The clinicians are blinded to the results of aerob/anaerobe cultivation, PCR and histological report. Hence, the decision of no bacterial growth, probable contamination or significant growth cannot be influenced by information of case or control. Blood-samples are collected to characterize gene expression patterns and related markers to gain insight into molecular mechanisms that may be important for low back pain (LBP) and the development of MCs
The purpose of this study was to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy of ravulizumab in pediatric participants with paroxysmal nocturnal hemoglobinuria (PNH).
The study will explore barriers in the process of achieving informed consent from critically ill patients
This project aims to evaluate a rehabilitation program as treatment and uncover potential pathophysiological mechanisms of a newly identified chronic condition named "Post Pulmonary Embolism Syndrome" (PPS).
The purpose of the study is to assess the efficacy and safety of single-agent olaparib as a maintenance treatment in patients with relapsed High Grade Serous Ovarian Cancer (including patients with primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer who do not have known deleterious or suspected deleterious germline BRCA mutations (non-gBRCAm) and who had responded following platinum based chemotherapy
Among patients treated for locally advanced rectal cancer with neo-adjuvant radio-chemotherapy, about 15% will have complete clinical response in terms of no visible tumor or ulcerations on the site of the primary tumor, or whitening of the rectal wall or telangiectasia. In this Norwegian national multicenter observational study, patients with complete clinical response (cCR) after neo-adjuvant treatment for rectal cancer as defined by national guidelines, will be invited to a Watch&Wait program with a specially designed follow-up in order to see if the tumor has disappeared permanently, or if there is regrowth of the tumor. Primary endpoint is the true regrowth rate in an unselected national cohort of patients.
Phototherapy with narrow band (nb) ultraviolet B (UVB) is a safe and effective but time consuming treatment option for patients with widespread eczema. Despite efficacy we know little about how it works, and even less why some patients fail to respond. Tintle et al showed that nb-UVB induced strong suppression of the Th2 and Th22 axes in patients with atopic dermatitis (AD), and also normalized the epidermal barrier function. We want to map the very early changes in gene expression after UVB-treatment in order to shed light on disease mechanisms, which eventually could lead to better treatment options.
This is a 2-year randomized controlled trial to test the effect of dietary carbohydrates, both quality and quantity, on changes in internal body fat mass. Up to 250 women and men with obesity are recruited in Bergen, Norway, and randomized to one of the following normo- and isocaloric dietary patterns (same amount of protein, polyunsaturated fatty acids and moderate energy, 2,000 - 2,500 kcal per day): 1) a low-fat high-carbohydrate diet primarily with refined (e.g., flour-based) carbohydrate sources, 2) a low-fat high-carbohydrate diet based on minimally refined (e.g., cellular) carbohydrate sources, and 3) a very-high-fat low-carbohydrate diet.