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 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.
The functional outcome and quality of life after treatment for an infected hip arthroplasty have been found to be significantly worse compared to an uncomplicated arthroplasty. However, the type of revision surgery chosen to treat the infection plays a role for the functional outcome. The concept of DAIR (debridement, antibiotics and implant retention) has been shown to yield god results with respect to infection control in cases of early infection with a stable implant and better functional results than a to-stage revision. In patients where infection control was achieved after just one DAIR procedure the functional outcome was comparable to an uncomplicated primary arthroplasty. However, it is not known if the operative approach used for the primary and revision surgery plays a role for the functional result after treatment of an infected total hip arthroplasty with DAIR. The project's aim is to investigate if the choice of the operative approach (transgluteal or posterior) for the primary hip replacement and the revision surgery has an influence on the functional result after debridement and implant retention for an infected total hip replacement.
The purpose of this randomised, multicentre, double-blind, placebo-controlled, phase Ib/IIa study is to assess the safety, tolerability and efficacy of eASCs (Cx611) administered intravenously as adjunctive therapy, therefore in addition to standard of care (SoC) therapy, to patients with severe community-acquired bacterial pneumonia (sCABP). The completion of this study will contribute to the basic knowledge on stem cells and their mode-of-action, and has a large translational character, i.e. to document the safety and explore the efficacy of Cx611 in patients with sCABP.
The objective of this study is to investigate the effectiveness of prehospital diagnosis and, when appropriate, of intravenous thrombolytic treatment of ischemic stroke. At the same time, we will take the opportunity to do an explorative study with the aim to further improve the intervention by biomarkers, and outcome measures volumetric measured by MRI images. The intervention study aim to: - Determine the time from symptom onset to thrombolytic treatment in the Mobila Stroke Unit (MSU) compared to the conventional model - Determine the number of patients receiving thrombolytic treatment within the 4.5 hrs window in the MSU compared to the conventional model - Determine if thrombolytic treatment in the MSU, when adjusted for time, results in better mRS- and Barthel outcome compared to treatment in the conventional model The explorative study aim to - Determine if final IS infarction volume estimated by MRI, is independently correlated with time from symptom onset to thrombolytic treatment - Define cut-off values for GFAP and RBP4 combined that with sufficient specificity and sensitivity can distinguish ICH from IS - Determine the influence of time to treatment on pro-inflammatory markers after stroke Hypothesis Intervention study I. The Treat - NASPP MSU model is feasible and reduces onset to treatment time less than 15 min II. The number of patient treated with thrombolysis within 4.5 hrs of symptom onset is significantly increased in the Treat-NASPP MSU model III. Treatment in the Treat-NASPP MSU model does not result in increased day 90 mRS and Barthel as compared to the conventional model when adjusted for time IV. Prehospital thrombolytic treatment of stroke does not increase the risk of secondary cerebral bleeding as compared to in-hospital thrombolytic treatment of stroke (cerebral bleeding worsening within 36 hrs less than 4 per cent, Norsk hjerneslagregister) Explorative study V. The final infarct volume, estimated by MRI, is significantly reduced when thrombolytic treatment is initiated already in the MSU VI. Biomarkers is a valid tool in the hyper acute phase of cerebral illness to exclude contraindication to thrombolysis VII. Reduced onset to treatment time results in lower levels of selected pro-inflammatory molecules
This is a single-center, prospective, controlled, double-blind, randomized study. A total of 50 renal transplant recipients diagnosed with post-transplantation diabetes mellitus (PTDM) will be included more than 1 year after transplantation and randomized 1:1 to empagliflozin (Jardiance®) 10 mg or placebo once daily for 24 weeks. Patients with estimated glomerular filtration rate below 30 mL/min will be excluded. Oral glucose tolerance test, 72h continuous glucose monitoring (iPro™2), measurement of arterial stiffness, body composition (including visceral fat), 24h blood pressure and 24h urinary glucose excretion will be performed at baseline and after 24 weeks in addition to standard safety measurements. Two safety visits will be performed at week 8 and 16. All concomitant medication, diet and exercise will be kept stable during the study period. The objective of the present study is to answer whether empagliflozin safely and effectively improves glucose metabolism together with weight loss in renal transplant recipients with PTDM.
Action tremor of the arms can be an invalidizing symptom of diseases such as Essential Tremor, Dystonic Tremor, Parkinson's disease and Multiple Sclerosis. In this study we compare the efficacy and safety of two different brain targets for deep brain stimulation (DBS) that both are known to reduce action tremor of the arms. These two targets are called the VIM nucleus of the thalamus (VIM) and the posterior subthalamic area (PSA), which includes the Zona Incerta. Both targets can be reached by one lead (wirh four electrode contact). Patients that are found eligible for DBS because of severe action tremor of the arms are invited to participate. After randomization, half of them are stimulated first in the VIM for 3 months and then in the PSA for 3 months, and the other half first in the PSA and then VIM for 3 months each. Tremor severity is scored on a clinical quantitative scale at baseline and at the end of each of these two 3-month periods, and eventual side-effects are registered. The best target is then selected and after another 6 months scoring is repeated. We intend to provide robust data about whether one of the two targets is superior to the other both regarding ability to reduce tremor efficiently and to avoid or minimize side-effects, or if there is no significant difference between the two targets. We also carefully check the exact position of the active electrode contact in the brain and compare this with efficacy and safety evaluations. Long-term follow-up is planned after 3, 5, 7 and 10 years.
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.
The HILT study is a prospective, single-blinded, randomized controlled trial comparing a high-intensity exercise training intervention with usual care among adult lung transplant recipients. Patients randomized to the training intervention arm will undergo individually tailored high-intensity exercise training (80-95% of maximum heart rate) three hours per week for 20 weeks. Training will be conducted at local fitness centers on a one-on-one basis.
This was a dose-finding study to evaluate the efficacy, safety and tolerability of 3 different doses of LIK066 compared to placebo or empagliflozin in T2DM patients with heart failure
This was a randomized, controlled, open-label, Phase 3 multicenter study which enrolled patients with RRMM following 2-4 lines of prior therapy and who were refractory to lenalidomide in the last line of therapy as demonstrated by disease progression on or within 60 days of completion of the last dose of lenalidomide. Patients received either melflufen+dex or pomalidomide+dex.