Clinical trials

The study examines whether there are radiological criteria that can give an indication if a dorsally displaced distal radius fracture remains stable without the needs for surgery after closed reduction in patients between 18 and 65 years of age.

The need for better follow-up of AMI patients combined with recent developments in the digital area prompted the Department of Cardiology (HJE) at Oslo University Hospital (OUS) Ullevål, in collaboration with the Department of Digital Health Research (DIG) at OUS to develop a digital solution for long-term follow-up after AMI. The overall goal of the digital solution is to increase knowledge and awareness about important lifestyle measures and CV risk factors in patients who have survived an AMI, and to make it easy for the patients to monitor their own risk factors and attainment of treatment goals during long-term follow-up. Further, the HeartCheck seeks to provide guidance to ensure medication adherence. In this project, we study whether this newly developed app (HeartCheck), through education, regular reminders and easily understandable goals for secondary prevention, can improve risk factor control and drug adherence during long-term follow-up after AMI. A randomized controlled trial (RCT) is the chosen study design, being the gold standard for testing effectiveness of interventions.

SILENT-LN is a prospective observational cohort study of adults with systemic lupus erythematosus, including participants with no renal involvement, suspected renal involvement, active lupus nephritis, previous lupus nephritis, or inactive lupus nephritis. The study will measure pre-specified blood and urine biomarkers longitudinally during routine clinical care. The study will evaluate whether blood and urine biomarker concentrations and biomarker panel scores are associated with active lupus nephritis, incident lupus nephritis, renal flare, treatment response, remission or inactive renal disease, kidney biopsy findings, and long-term renal outcomes. Participants will provide blood and urine samples during routine clinical follow-up visits and at visits where renal involvement is clinically suspected. Clinical data, standard laboratory tests, disease activity assessments, kidney function measures, treatment information, and kidney biopsy findings, when available, will be recorded. A predefined increase or persistent elevation in blood or urine biomarker levels will trigger a structured renal assessment, and kidney biopsy or re-biopsy may be performed if the integrated clinical assessment indicates suspected renal involvement, renal flare, or uncertainty regarding renal inflammatory activity and the procedure is considered safe and clinically appropriate. The study is currently conducted at Oslo University Hospital, Riks Hospital and may expand to additional centers following funding and regulatory approvals.

The goal of this clinical trial is to learn if there are differences in the effectiveness of decompression surgery alone versus decompression combined with extended fusion in patients with a previous lumbar spinal fusion who now present with symptoms of lumbar adjacent segment stenosis (LASS). The main questions it aims to answer are: * Does decompression alone differ from decompression combined with extended fusion with regard to clinical outcomes two years after surgery? * Are there any clinical or radiological characteristics that can predict better or worse outcomes two years after surgery? * Are there any differences between the treatment groups in terms of health economics? Researchers will compare decompression surgery alone versus decompression combined with extended fusion to see if there are any differences in treatment effect. Participants will: * Be randomized to one of the two surgical procedures * Visit the clinic four times postoperatively (at three months, 1, 2 and 5 years) for checkups and tests * Respond to questionnaires before surgery, and three months, 1, 2 and 5 years postoperatively

The goal of this study is to investigate the effects of personalized exercise treatment on dynamic balance and physical function in comparison with regular follow-up in adults with rare-neuromuscular disorders: Charcot-Marie-Tooth (CMT), Facioscapulohumeral Muscular Dystrophy (FSHD), and Myotonic Dystrophy Type 1 (DM1). The key objectives are: 1. To investigate if the intervention group experiences improvements in dynamic balance that are superior to the control group 2. To investigate if the intervention group experiences long-term improvements in dynamic balance that are superior to the control group during the follow-up 3. To investigate if improvements in dynamic balance are associated with improvements in physical activity, body composition, estimated motor units, metabolomics, muscle echnogenecity and volume, and other indicators of health and quality of life. This is a national study and will involve 120 individuals with rare-neuromuscular disorders from Norway's four health regions.

Harmful alcohol use is a common cause of hospital admissions and the leading cause of liver cirrhosis. Timely detection of liver disease is crucial to prevent liver disease progression and reduce alcohol-related harms. The hypothesis is that proactive assessment of liver health during hospitalization may motivate reductions in alcohol use and thereby prevent disease complications and recurrent admissions more effectively than usual care. The study will recruit 500 patients at risk of alcohol-related liver disease who are admitted for inpatient care for any reason. Recruitment will be done at 8 Norwegian hospitals over an 18-month period. Participants will be randomized to liver elastography (liver stiffness measurement) and personalized alcohol counselling, or to usual care. After discharge, participants will be followed with study visits after 3, 6 and 12 months. Assessments during follow-up include self-reported alcohol use, the alcohol biomarker PEth and health-related quality of life. The primary outcome is the number of emergency hospital admissions for any reason within 2 years, collected from the Norwegian Patient Registry. The study has very low risk for the participants, with no invasive procedures or risks associated with the intervention. The potential benefit is considerably greater, with opportunities for improved health, prognosis, and quality of life for a large patient group for whom effective interventions are largely lacking. The study has very low risk for the participants, with no invasive procedures or risks associated with the intervention. The potential benefit is considerably greater, with opportunities for improved health, prognosis, and quality of life for a large patient group for whom effective interventions are largely lacking.

This study investigates whether an advanced MRI technique called Quantitative Susceptibility Mapping (QSM) can improve the differentiation of white matter lesions in people aged 50-70 years with multiple sclerosis (MS). In older individuals with MS, white matter changes seen on MRI may be related to MS or to other types of white matter changes, most commonly age-related changes or chronic small vessel disease. These conditions can appear similar on conventional MRI scans, making interpretation challenging. Participants will undergo routine clinical MRI, including a short additional QSM sequence, as well as brief cognitive and physical assessments. A comparison group with cerebral small vessel disease will also be included. The goal of the study is to determine whether QSM can provide more precise lesion characterization and support more accurate clinical interpretation of MRI findings in older patients with MS.

Patients who have undergone arthrodesis of the first metatarsophalangeal joint due to hallux valgus or hallux rigidus are invited to participate in this study, which aims to investigate how the foot functions after this operation. Patients between 18 and 60 years of age at the time of surgery are eligible to participate. Questionnaires will be distributed to assess current sports function compared with function prior to surgery. Particular focus will be placed on function during cross-country skiing.

This prospective diagnostic accuracy study compares computed tomography (CT) and multiparametric magnetic resonance imaging (MRI) using the Vesical Imaging-Reporting and Data System (VI-RADS) for local staging of newly diagnosed bladder cancer. All participants undergo both imaging modalities prior to transurethral resection of the bladder tumor (TURBT) or cystectomy. Histopathology serves as the reference standard.

This study will compare two bariatric surgical interventions in terms of weight loss, gastroesophageal reflux, and effects on obesity-related comorbid conditions in morbidly obese patients.

A national, randomized, clinical trial (phase III) investigating radiotherapy with protons compared with photons for patients with squamous cell carcinoma of the head and neck area eligible for radiotherapy, either radical or postoperative, with curative intent. Comparative dose plans with protons and photons will be prepared, and the probability of toxicity evaluated with NTCP models. Patients with presumed benefit from protons will be randomized 1:1 to treatment with protons or photons. The number of randomized participants will be 400. The primary endpoint is "combined toxicity burden" - dry mouth, difficulty swallowing, pain and affected speech in the period after the end of radiotherapy to 12 months after treatment.

This feasibility study will evaluate the accuracy of telementored eFAST (Extended Focused Assessment with Sonography in Trauma) in detecting abdominal free fluid in patients who have recently undergone liver surgery. The primary goal is to determine how well the remote-guided ultrasound can identify fluid accumulation compared to conventional ultrasound performed by a radiologist. Participants in this study will be examined with ultrasound, supported in real-time by a remote expert, to assess its accuracy and other relevant performance metrics.

People with nerve damage can develop nerve pain. The pain can sometimes be severe and unpredictable, causing odd or alarming sensations - for example, lightning-like or electric shock feelings in the area served by the damaged nerve. The investigators will examine a treatment for nerve pain in the legs caused by nerve damage, which can occur after a herniated disc or a bone fracture, with or without surgery. Previous research suggests that spinal cord stimulation can relieve nerve pain in the legs after surgery or injury, but its effectiveness is still debated. Other studies show that multidisciplinary treatment helps people with long-term pain to improve their quality of life and to better cope in life. National and international guidelines recommend this kind of multidisciplinary care for long-term pain. There has yet been published research on spinal cord stimulation combined with multidisciplinary treatment as a bundle intervention. The investigators therefore want to find out whether this combined approach can reduce nerve pain in the legs and improve physical functioning.

The objective of the study is to obtain knowledge about the treatment of patients who are offered intensive trauma treatment at Nydalen DPS (NDPS) and Søndre Oslo DPS (SODPS). The treatment takes place on an outpatient basis over two weeks. Up to 42 patients will be recruited. The efficacy of treatment will be investigated using validated self-report forms, which measure PTSD symptoms (PCL-5 and ITQ) and quality of life/function (WHO-5, and WSAS). The measurements will be done before the treatment and one and twelve weeks after treatment.In-depth interviews will also be conducted with up to 30 patients to investigate the outcome and any need for adjustments with focus on patients with minority backgrounds, men and patients with limited benefit. The study uses a mixed methods design, where quantitative measures and information from qualitative interviews are combined to map participants' experience, benefits and feasibility.

Proton therapy is a powerful tool enabling oncologists to spare normal tissue around the target for irradiation much better than what can be achieved with photon irradiation. The infiltrative nature of IDH-mutated grade II and III diffuse glioma, however, renders proton therapy a potential problem. A randomized controlled trial (RCT) is the only option when trying to ensure that chances of long-term survival are not impaired seeking to reduce unwanted late treatment effects. Non-inferiority of proton therapy compared to photon irradiation is the primary endpoint of the RCT. Hence, PRO-GLIO has two main objectives. First, PRO-GLIO will evaluate if proton therapy is safe in patients with IDH-mutated grade II and III diffuse glioma, showing that survival figures at 2 years from radiotherapy are not poorer in the proton arm than in the photon arm. Second, we want to find the true number of patients in need of rehabilitation in both arms, and evaluate if proton therapy conveys a higher QoL than photon irradiation at 2 years from radiotherapy.

The goal of this clinical trial is to evaluate the immune response to gluten in patients with celiac disease (CeD) by comparing different forms of gluten administration. The participant population includes adults diagnosed with CeD, who are adhering to a gluten-free diet (GFD). The main questions it aims to answer are: * Does liquid gluten administration elicit a higher IL-2 cytokine response compared to solid gluten administration? * What is the relationship between serum IL-2 levels and gluten peptide serum concentrations following gluten challenges? Researchers will compare the responses of two groups: participants receiving liquid gluten (shake) to those receiving solid gluten (cookie) to determine if there is a significant difference in the IL-2 response rates between the two forms. Participants will be asked to: * Undergo two gluten challenges (liquid and solid) in a randomized order with at least 4 weeks apart. * Provide blood samples before and after each challenge to measure serum IL-2 levels and gluten peptide concentrations over a period of 6 hours. * Report any symptoms experienced following each gluten challenge.

The goal of this prospective observational cohort study is to provide epidemiological and prognostic data from a defined urban population and to improve understanding of risk factors and long-term outcomes following first-time anterior shoulder dislocation in patients aged 16 years and older presenting to the Oslo Accident and Emergency Outpatient Clinic. The main questions the study aims to answer are: * What is the incidence of first-time anterior shoulder dislocations in the Oslo region? * What is the prevalence and extent of bipolar bone loss and soft tissue injuries measured by CT and MR after a first-time shoulder dislocation? * Does bone loss increase the risk of recurrent shoulder instability? * How do imaging findings and recurrence influence long-term shoulder function and quality of life? Participants will: * Undergo standard clinical evaluation and conventional radiographs as part of routine care and asked to participate and followed longitudinally * Be offered additional CT and MRI imaging to assess glenoid and humeral bone loss and to evaluate soft tissue injuries. * Complete electronic questionnaires (WOSI, EQ-5D-5L, pain score, Rowe score, return to sport/work) at 3 months, 1 year, 5 years, and 10 years. * Be invited to long-term follow-up, including radiographs at 10 years to evaluate signs of osteoarthritis.

This is a prospective, observational study designed to examine the performance of biomarkers, molecular biological methods and other analysis in blood from patient with suspected sepsis in the Emergency department, as well as identidying novel sepsis endotypes. Around 1500 patients will be enrolled.

The goal of this randomized controlled trial is to compare lumbar interbody fusion surgery with multidisciplinary rehabilitation in participants aged 20-65 years with persisting (≥ one year) low back pain. The main question it aims to answer is: • Is lumbar fusion surgery superior to multidisciplinary rehabilitation in alleviating persisting low back pain? Participants will be randomized to either lumbar interbody fusion surgery or a multidisciplinary rehabilitation program. If randomized to lumbar fusion interbody surgery, the participants will: * undergo radiologic examinations, including X-ray, MRI, and MRI spectroscopy * provide blood samples at four intervals including postoperatively * complete PROMs at five intervals * have their activity monitored through the ActivePAL accelerometer * undergo lumbar fusion surgery If randomized to multidisciplinary rehabilitation, the participants will: * undergo radiologic examinations, including X-ray, MRI, and MRI spectroscopy * provide blood samples at three intervals * complete PROMs at five intervals * have their activity monitored through the ActivePAL accelerometer * undergo multidisciplinary rehabilitation

Acute hypoxemic respiratory failure may progress to acute respiratory distress syndrome, a life-threatening condition that often requires mechanical ventilation. The optimal ventilation strategy in this patient population remains uncertain. The SVALBARD trial is a feasibility and pilot study designed to compare spontaneous versus controlled mechanical ventilation in patients with acute hypoxemia respiratory failure. The primary objective is to assess the feasibility of the study procedures and interventions, while also collecting descriptive data on key clinical variables to inform the design of a future randomized controlled trial.

The BILNOR study is a prospective multicenter observational study evaluating how common bile duct stones are best managed in patients undergoing cholecystectomy. The study focuses particularly on transcystic laparoscopic common bile duct exploration (LCBDE) and assesses stone clearance, technical success, complications, and health-economic outcomes in routine clinical practice. A secondary aim is to compare LCBDE with intraoperative ERCP regarding efficacy, complication rates, and costs. Approximately 340 patients from several Norwegian centers are planned to be included starting in March 2026.

Heart failure and atrial fibrillation are two of the most common heart diseases globally. Nearly half of all patients with heart failure also have atrial fibrillation. When heart failure and atrial fibrillation occur together, the risk of hospitalization and premature death increases significantly. However, there is a lack of reliable tools to assess how severely the heart is affected in these patients. This makes it difficult both to establish the correct diagnosis, tailor treatment, and predict who is at greatest risk of hospital admission or death from the disease. One of the most important targets in heart failure is the filling pressure in the left ventricle. When this pressure is high, it means that the heart has difficulty receiving blood, leading to shortness of breath and fluid retention in the body. Today, filling pressure is usually estimated using ultrasound (echocardiography), but the available methods are primarily developed for patients without atrial fibrillation. In patients with both heart failure and atrial fibrillation, the measurements are so uncertain that they cannot be used as a reliable basis for clinical decision-making. In this study, entitled Heart Failure combined with Atrial Fibrillation (HFcAF), the investigators will test new ultrasound methods that combine novel measures of cardiac chamber function with established techniques. Artificial intelligence will be used to identify the most useful combinations of parameters, select cardiac cycles that are best suited for analysis in atrial fibrillation, and automate and optimize the measurements. This approach may provide both more accurate and faster assessments, while also making the methods easier to implement in clinical practice. The aim is to improve the estimation of filling pressure so that it becomes more precise also in patients with atrial fibrillation. The investigators will then examine whether these improved methods can be used to predict which patients are at highest risk of hospitalization or death due to heart failure. The study is designed as a prospective multicenter study, in which patients are recruited from several hospitals in different countries. This will make the results robust and generalizable to a wide range of patient populations. The investigators anticipate that the project will pave the way for better diagnostics and risk stratification in heart failure combined with atrial fibrillation and, in the longer term, contribute to improved guidelines and treatment for a large number of patients. If successful, the project will provide a new tool that can contribute to earlier and more targeted treatment, thereby improving quality of life and prognosis for a large group of patients.

The main aim of this project is to determine the short and long-term effectiveness of an out-patient treatment for patients with anorexia nervosa. Specifically, we will measure whether TBT-S in addition to treatment as usual (TAU) will be more effective than TAU alone in reducing eating disorder psychopathology. Assessments will be conducted at four timepoints; pre and post TBT-S, and at 3 and 12 months follow-up. Primary outcome measure is eating disorder psychopathology, with the hypothesis that patients receiving TBT-S in addition to TAU will show significantly greater reduction in eating disorder psychopathology from TBT-S treatment admission to 3 month follow-up, compared to controls.

Children born prematurely may develop a characteristic retinal disease named retinopathy of prematurity (ROP). This disease could lead to retinal detachment and blindness. ROP was traditionally treated with laser, but injection with a medication (A-VEGF) has become more common. In this study, the researchers will explore whether treatment of ROP affects visual function and retinal development. To explore this, the study group will examine children with ROP (but not treated) with children treated with either laser or injection. The researchers will compare the children's visual functions (e.g. visual acuity and visual field) and their retinas (e.g. central and peripheral retina).

Patients with intrahepatic cholangiocarcinoma (IHC) have relatively aggressive tumors, and the prognosis for most of these patients is dismal. Surgery is the only option that can offer potential cure, but only an estimated 20-25 % are amenable to resection. Down-staging conventional chemotherapy has a relatively low response rate (\< 50 %). Patients will be included into the respective treatment arms based on their tumour characteristics and disease stage, but also based on their ability/preferences, as HAI-FUDR/DEX requires going to Oslo every fortnight for the duration of the treatment and SIRT has some limitations regarding tumour distribution. Data from the MSKCC has suggested a clinically relevant benefit from adding intrahepatic chemotherapy to systemic therapy. HAI-FUDR/DEX is not approved in Norway and can only be evaluated in a protocolized trial. Given the risk of distant disease progression with IHC, the addition of conventional systemic chemotherapy makes good clinical sense, and data from MSKCC supports this approach. SIRT is another modality also applied trans-arterially and directly into the tumour. This treatment is approved in Norway and available in Bergen and in Oslo. It is far less cumbersome to deliver and maintain than HAI-FUDR/DEX. The efficacy and safety of the two treatment groups, HAI-FUDR/DEX and SIRT, will be compared in a parallel cohort (non-randomized) design