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 is to compare median two-year clinical outcome after OCT guided vs. standard guided revascularization of patients requiring complex bifurcation stent implantation
The project focuses on investigating problematic medication use, especially overuse of potentially addictive drugs among the elderly. The investigators aim firstly to develop and validate instruments for detecting and describing behavioral aspects and consequences of dependence on, and misuse of, prescription medication among elderly. In addition to evaluating diagnostic utility of screening instruments, the investigators aim to identify and report characteristics, risk factors and consequences of medication misuse and dependence among the elderly.
INTRO-HCV is a multicentre randomised controlled clinical trial that will compare the efficacy of integrated treatment of chronic hepatitis C virus infection (HCV) within medically assisted rehabilitation (MAR) clinics providing opioid substitution therapy (OST) compared to standard treatment. The trial will recruit approximately 250 HCV infected in Bergen and Stavanger and about 1000 in a linked observational study. Intervention: Integrating diagnostic and treatment follow-up for HCV treatment into MAR outpatient clinics in Bergen and Stavanger including testing for HCV, counselling and treatment evaluation and treatment delivery. Primary objectives: Compare the effect of integrated HCV treatment assessed with sustained virological response at 12 weeks between the MAR outpatient clinics in Bergen and Stavanger (intervention arm) with standard treatment provided after referral to infectious disease clinics among patients who receive OST having HCV Secondary objectives: Compare treatment adherence between the intervention and control arms, and assess changes in quality of life, fatigue and psychological well-being before and after HCV treatment, as well as changes in drug use, infection related risk behavior, and risk of reinfection among those with sustained virological response. Main endpoint: Sustained virological response of HCV at 12 weeks (± 10 days) Study population: The target group will be patients receiving care with MAR from involved outpatient clinics in Bergen, Sandnes and Stavanger who are chronically infected with HCV and eligible for treatment according to national guidelines. Study duration: Participants will be included and followed up at least annually for the total study duration between 2017 and 2021. Expected outcome: This study will inform on the relative advantages and disadvantages of an integrated treatment program for HCV into MAR compared to standard care aiming to increase access to treatment and improved treatment adherence. If the integrated treatment structure is found to be safe and efficacious, it can be considered for further scale-up.
Sleep disturbances are common in pregnancy, and the incidence increases during the third trimester. Light and specially the blue wavelengths of light, is affecting sleep and the circadian rhythm. The main aim of this randomized controlled study is to investigate the effect of Blue-blocking glasses (BB-glasses) used in the evening and night on sleep and mood in pregnant women in the third trimester. The outcome measures assess sleep variables, alertness, melatonin level, sleepiness (subjectively), mood and symptoms of anxiety and depression. In addition we want to measure the pregnancy related sleep problems, alcohol intake, physical activity and perceives stress in the study population, and the association with daily/nightly light exposure.
The TAME Cardiac Arrest trial will study the ability of higher arterial carbon dioxide (PaCO2) levels to reduce brain damage, comparing giving patients 'normal' to 'slightly higher than normal' blood PaCO2 levels and assessing their ability to return to normal life-tasks. It will be the largest trial ever conducted in heart attack patients in the intensive care unit. This therapy is cost free and, if shown to be effective, will improve thousands of lives, transform clinical practice, and yield major savings.
This post authorization safety study is designed as prospective non interventional study for patients with newly diagnosed multiple myeloma who are not eligible for transplant. The objective is to compare the incidence of cardiovascular events between patients treated with a first-line lenalidomide containing regimen and those treated with a first-line non-lenalidomide containing regimen. Treatment in both cohorts will be done according to standard care. The study will gather risk factor information at baseline and throughout follow-up. Any cardiovascular event occurring will be assessed by an independent committee. Other safety endpoints will be collected through standard procedures. Observation period will be 3 years on treatment, with an additional evaluation of cardiovascular events 6 months' post treatment and a follow up period until 5 years after inclusion. During follow up the incidence of second primary malignancies (SPM) and overall survival will be assessed.
The study consists of 4 sub-studies, as follows: - Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991; - Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991; - Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab; - Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab. - OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.
This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of upadacitinib 15 mg and 30 mg QD versus placebo for the prevention of structural progression. The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg and 30 mg QD in participants who have completed Period 1.
This study aims to test an easily implementable web-based cognitive behaviour therapy (CBT) self-help intervention designed for non-cardiac chest pain patients, and compare effectiveness and cost-effectiveness to treatment as usual in an randomized controlled trial (RCT).
The Nor-Hand study is a hospital-based observational study including 300 patients with evidence of hand OA by ultrasound and/or clinical examination. The baseline examination (2016-17) consists of functional tests and joint assessment of the hands, medical assessment, pain sensitization tests, ultrasound (hands, acromioclavicular joint, hips, knees and feet), computer tomography (CT) and Magnetic Resonance Imaging (MRI) of the dominant hand, conventional radiographs of the hands and feet, fluorescence optical imaging of the hands, collection of blood and urine samples as well as self-reported demographic factors and OA-related questionnaires. Two follow-up examinations are planned after 3 (2019-20) and 8 years (2024-25), respectively. Cross-sectional analyses will be used to investigate agreements and associations between different relevant measures at the baseline examination, whereas the longitudinal data will be used for evaluation of predictors for clinical outcomes and disease progression.