Lillehammer

Amyotrophic lateral sclerosis (ALS) is a serious, fast-progressing nervous system disease with an average survival of 2.5 years after diagnosis. Currently, effective treatments are limited to Riluzole. Research suggests that increasing cell access to Nicotinamide Adenine Dinucleotide (NAD) and stimulating enzymes called sirtuins may slow disease progression. This study aims to evaluate whether a combination of Nicotinamide Riboside (NR) and Pterostilbene, called EH301, can slow neurodegeneration, delay disease progression, improve survival, and enhance quality of life in ALS patients. The NO-ALS extension study follows patients who completed the original NO-ALS trial. All participants receive the active treatment EH301, which combines Nicotinamide Riboside and Pterostilbene, as an open-label extension. This study provides patients the option for compassionate use of the supplement while assessing its effects on motor symptoms, lung function, and survival. Participants will be monitored for adverse events throughout the study, which lasts up to 1 year. Researchers will track safety, progression of motor symptoms, changes in vital capacity, and overall survival. This extension allows long-term observation of EH301's impact on ALS progression and patient well-being.

Vitamin B12 deficiency is a common micronutrient deficiency worldwide, including in developed countries like Norway. It is essential for normal cell division, brain development, and the growth of infants. This research aims to study the effects of daily oral vitamin B12 supplements on the brain development of breastfed infants and evaluate other health outcomes related to vitamin B12 status. The study is a randomized, double-blind, placebo-controlled trial involving breastfed infants. Pregnant women will be informed about the study during their first antenatal visit, and infants will be assigned to either a screening group or a control group. Infants showing signs of vitamin B12 deficiency will receive intramuscular injections of 400 micrograms of cyanocobalamin. Those in the control group will not receive an intervention, but their blood samples will be stored and analyzed after one year. Participants will be followed up to assess neurodevelopment and growth at 12 months of age. Researchers will measure vitamin B12 and other vitamin deficiencies at 1 to 3 months and monitor cognitive function later in childhood. The study includes safety monitoring and treatment of deficient infants, with a total participation period of at least one year.

Mental health problems affect about one in five working-age adults in OECD countries, posing a significant challenge for public health and work productivity. Common mental disorders (CMD), such as major depression and anxiety, are leading causes of work absenteeism, accounting for 30% of all sick leave in Norway in 2024. This research investigates a digital, transdiagnostic work-focused cognitive behavioral therapy (CBT) program designed to help patients with CMD who are on sick leave or work assessment allowance, focusing on improving return to work and user experience with the program. The treatment being studied is a digital CBT program that addresses core mechanisms maintaining depression and anxiety, such as avoidance and suppression of unwanted thoughts, and promotes cognitive flexibility under stress. The program consists of seven modules with psychoeducational materials and therapist-tailored tasks. Trained eTherapists provide guidance mainly through asynchronous messaging, with phone or face-to-face contact as needed. After 12 weeks of treatment, participants have a concluding session to decide next steps, and then retain access to the program without therapist support for six additional months. Participants will be assessed at multiple time points including baseline, 6 weeks, 12 weeks, 6 months, and 12 months for outcomes such as degree of sick leave and return to work self-efficacy. Data collection includes self-reported questionnaires on symptoms and functioning, system data on program use, and qualitative interviews with a subset of participants. Safety monitoring includes weekly suicide risk assessments. The study plans to enroll 390 participants over 18 months from specialized outpatient mental health care in Norway.

Researchers are evaluating whether proactive therapeutic drug monitoring (TDM) is better than standard care for maintaining steady disease control in adults with rheumatoid arthritis (RA) who are treated with a subcutaneous tumor necrosis factor inhibitor (adalimumab). This Phase 4 study aims to determine if adjusting drug doses based on regular blood tests for drug levels and anti-drug antibodies can prevent disease flare-ups more effectively than standard dosing without such monitoring. Participants will be randomly assigned to one of two groups. The TDM group will have their adalimumab doses adjusted following specific rules based on blood test results to keep drug levels within a therapeutic range. Dose intervals may be shortened, lengthened, or therapy switched depending on antibody levels and drug concentration. The standard care group will continue treatment without these blood test-based adjustments. The study lasts 18 months with visits at baseline, 4, 8, 12, and 18 months, along with digital visits at 2, 6, 10, 14, and 16 months, including blood sampling at each visit. Participants will have regular blood tests to measure drug levels and antibodies every two months. They will attend on-site and digital visits for assessments of disease control and safety. The primary outcome is sustained disease control without flare over the 18-month follow-up. Researchers will monitor adherence, safety, and treatment effectiveness throughout the study period to compare the two treatment approaches.

Researchers are evaluating guided internet-based cognitive behavioural therapy (ICBT) for people with moderate depression, social anxiety disorder, and panic disorder in routine healthcare settings. This observational multicentre study aims to determine the effectiveness and cost-effectiveness of this treatment across different clinics. It also investigates who benefits most, predictors of treatment drop-out, and how user experiences affect adherence and outcomes. Participants receive the eMeistring program, which includes an initial face-to-face visit, followed by eight to nine therapist-guided online therapy sessions or modules depending on the condition. Therapists provide guidance at least once a week via a secure email system. After completing the online sessions, patients have a final face-to-face visit with their therapist. Licensed health personnel such as psychologists, nurses, and social workers provide the therapy. The program is offered at four hospital locations through standard clinical pathways. During the study, participants complete questionnaires about symptom severity, quality of life, work and social ability, user satisfaction, and medication use as part of routine follow-up. Assessments occur at pre-treatment, up to 14 weeks after starting treatment, six months later, and after two years. Researchers also collect administrative data on treatment implementation, personnel, and activity levels. Safety is monitored regularly, with automatic alerts sent to therapists if patients indicate suicidal thoughts. The study lasts over two years, with ongoing evaluation of effectiveness, adherence, drop-out reasons, and cost-effectiveness.

Researchers are investigating the genetic factors that may contribute to the development of Amyotrophic Lateral Sclerosis (ALS) in Norway. The study aims to better understand genetic causes relevant to ALS by analyzing gene frequencies, new ALS genes, and genetic risk factors from 2020 through 2030. Participants will provide written informed consent and complete a brief questionnaire about their family history. A blood sample will be collected for genetic analysis, which is carried out at the Department of Medical Genetics, Telemark Hospital Trust throughout the recruitment period. Participants may opt to receive their genetic results in a diagnostic setting. During the study, participants will be involved in providing clinical information, completing questionnaires, and submitting blood samples. Researchers will monitor genetic characteristics and analyze data related to gene frequency and new ALS genes over time. The study includes adults aged 16 to 100 years and involves continuous genetic analysis from 2020 to 2030.

Researchers are evaluating if a treat-to-target approach that includes structured imaging assessments leads to better long-term outcomes in patients with psoriatic arthritis compared to a conventional treat-to-target strategy. Psoriatic arthritis is a complex disease that can be hard to assess clinically, and imaging techniques like ultrasound and magnetic resonance imaging (MRI) can reveal inflammation not detected through clinical exams. This study specifically aims to see if adding these imaging assessments improves the chances of sustained remission, defined as very low disease activity at 16, 20, and 24 months. The study randomly assigns patients into two groups for a 24-month follow-up. One group receives conventional treat-to-target care based on clinical disease activity assessments alone. The other group follows an imaging informed treat-to-target strategy that includes ultrasound assessments of joints, tendons, and entheses at every visit and MRI scans of the spine and sacroiliac joints at the start and one year. If imaging shows signs of enthesitis or axial inflammation, patients in the imaging group move directly to biological disease modifying antirheumatic drug treatment. Ongoing inflammation detected by ultrasound indicates the treatment target has not been reached. Participants will be monitored regularly with clinical and imaging assessments to track disease activity, inflammation, quality of life, and any adverse events. Outcomes include sustained remission at 16, 20, and 24 months, as well as other disease activity measures and safety. The study follows current European treatment recommendations, and all patients are treated according to a defined algorithm. The total study duration for each participant is 24 months.

Osteoarthritis affecting the joint between the forearm bones at the wrist, called the distal radioulnar joint (DRUJ), often results from fractures, ligament injuries, or degenerative wrist diseases. This condition causes pain and limits the ability to lift and rotate the forearm. The intact DRUJ is important for normal load transfer from the hand to the forearm. Two surgical treatments are used for painful DRUJ osteoarthritis: removal of the ulnar head (Darrach procedure) and replacement with an ulnar head implant. Although both methods have shown good long-term results, they have not been directly compared to determine which provides better outcomes and fewer complications. This study is a prospective, randomized multicenter trial conducted in several hand surgery centers across Norway, coordinated from Østfold Hospital Trust and other major hospitals. Participants with stable but painful DRUJ osteoarthritis will be randomly assigned to receive either the Darrach procedure or ulnar head replacement using the Herbert UHP implant. The surgeries will follow standardized procedures at each center, and postoperative care and follow-up will be the same for both groups. Participants will be evaluated before surgery, and then again after 3 months, 1 year, and 5 years. Assessments include measuring range of motion, grip strength, and functional scores by an independent hand therapist. Researchers will also record any complications or additional surgeries. The main outcome measured at 5 years is the Norwegian version of the Quick Disability Arm Shoulder Hand (Quick DASH) score, which assesses arm and hand function. The study aims to compare the clinical results and safety of the two surgical methods over a long-term period.

Researchers are comparing physical therapy to surgical decompression in patients with lumbar spinal stenosis (LSS) to determine if physical therapy can be an effective nonsurgical alternative. This randomized controlled multicenter trial aims to evaluate whether structured physical therapy is as effective as surgical decompression for patients whose symptoms suggest the need for surgery. The study focuses on patients experiencing intermittent neurogenic claudication confirmed by MRI showing stenosis at one or two lumbar levels, with symptoms lasting more than six months. Participants are assigned to either a standard decompression surgery group or a physical therapy group. The physical therapy treatment lasts three months and includes a well-defined program of home activities along with 4 to 6 visits to a physical therapy intervention center. The surgical group undergoes the standard decompression surgery procedure. This study compares these two approaches to assess their effectiveness in improving patient disability related to LSS. During the study, researchers will measure the proportion of patients who achieve a 30% or more improvement from their baseline Oswestry Disability Index 2.1 (ODI) score six months after treatment. Participants will be monitored to evaluate changes in their symptoms and functional ability. The trial includes adults aged 50 to 80 years who are candidates for surgery and capable of physical exercise. Outcomes will help determine if physical therapy can provide a viable alternative to surgery for lumbar spinal stenosis.

Researchers are studying cancer patients who have completed treatment to compare two ways of doing resistance exercise. The goal is to see if a 12-week digital home-based resistance exercise program can improve exercise adherence and health outcomes as well as the same exercise program done in person at a studio with an instructor. Exercise has been shown to benefit health after cancer, but many patients face barriers such as inconvenient locations, timing, and lack of tailored support. This study aims to offer an alternative approach that can reach more patients regardless of where they live. Participants will follow a resistance exercise program either digitally from home or on-site with supervision at a hospital exercise location. The digital group will access exercise sessions using technology like a computer or tablet, while the on-site group will exercise under direct guidance. Both programs last 12 weeks and focus on improving physical strength. The study compares exercise adherence between the two groups and also looks at effects on functional health, mental well-being, and metabolic markers. During the study, participants will be monitored from the start until the 12-week pre-test. Researchers will assess how well participants stick to the exercise program and measure various health outcomes related to physical function, mental health, and metabolism. Participants need access to digital tools and must understand Norwegian to take part. The study carefully tracks safety and eligibility to ensure participants can safely complete the program.