Lillehammer

Researchers are evaluating a medicine called nerandomilast for adults with systemic sclerosis, a condition affecting the skin and internal organs. The study focuses on people with limited or diffuse cutaneous systemic sclerosis who have had symptoms for less than 7 years. The goal is to see if nerandomilast helps improve symptoms and slows disease progression while assessing how well the medicine is tolerated. Participants are randomly assigned to one of two groups one takes nerandomilast tablets, and the other takes placebo tablets that look identical but do not contain medicine. Tablets are taken twice daily. The study lasts from 1 to about 4 years, with regular visits to the study site and phone check-ins. During visits, participants have blood tests and assessments of skin thickening, lung function, and organ health to monitor changes and treatment effects. Throughout the study, doctors monitor participants overall health and any side effects. They regularly assess safety and tolerability of the treatment. The main outcome measured is the time to disease progression or death over up to 4 years. Other outcomes include changes in skin scores, lung capacity, physical function, and disease impact questionnaires. Participants health is closely followed during the study period.

Amyotrophic lateral sclerosis ALS is a severe and fast-progressing nervous system disease with a typical survival time of about 2.5 years after diagnosis. Currently, Riluzole is the only treatment available, and the care for advanced ALS is very costly. Research suggests that increasing access to Nicotinamide Adenine Dinucleotide NAD and activating enzymes called sirtuins might slow disease progression. Nicotinamide riboside NR increases NAD, and Pterostilbene stimulates sirtuins. The study aims to evaluate whether a combination of NR and Pterostilbene can slow neurodegeneration, delay disease progression, improve survival, and enhance quality of life in ALS patients. This extension study follows patients who completed the initial NO-ALS trial, where all participants receive the combination supplement EH301 Nicotinamide Riboside and Pterostilbene. It is an open-label study offering compassionate use and monitoring adverse events. The study will assess if this combination can reduce motor symptom progression, preserve lung function, and increase survival over a one-year follow-up. Participants who completed the original NO-ALS trial will be followed for one year with regular assessments. Researchers will monitor adverse events throughout this period and measure disease progression using the ALS Functional Rating Scale Revised and changes in vital lung capacity. The study aims to provide long-term safety and efficacy data while allowing continued access to the supplement. Total participation duration is one year from enrollment in the extension study.

Vitamin B12 deficiency is a common micronutrient shortage worldwide, including in places like Norway. Vitamin B12 is essential for healthy cell growth and brain development, especially in infants. This research investigates the effects of daily oral vitamin B12 supplements on infants brain development and growth. The study is a randomized, controlled trial enrolling breastfed infants to assess neurodevelopment, growth, and other health outcomes related to vitamin B12 status. Infants aged between 1 and 2 months will be screened for high plasma total homocysteine levels. Those with elevated levels will receive a 400 microgram dose of vitamin B12 cyanocobalamin via intramuscular injection. Infants without elevated levels will have their blood samples stored and analyzed after one year without receiving the supplement. Pregnant women are informed about the study early, and infants with confirmed deficiency receive treatment outside the randomized trial. Participants will be monitored with various assessments including neurodevelopmental evaluations at 12 months and later in childhood, growth measurements, and measures of nervous system function. Blood samples will be collected at 1 to 3 months and 12 months to check vitamin levels. Safety is tracked with reports of any adverse events three months after treatment. The study will last at least 12 months with ongoing follow-up to understand the impact of vitamin B12 supplementation on infant health.

Mental health disorders such as major depression and anxiety are common among working-age adults and significantly impact work participation and productivity. These disorders, often called common mental disorders CMD, are a leading cause of sick leave, accounting for 30% of all sick leave in Norway as of 2024. This research evaluates a new digital transdiagnostic work-focused cognitive behavioral therapy CBT program designed specifically for patients with CMD on sick leave or work assessment allowance, aiming to improve return to work and symptom management. The study involves a digital work-focused CBT program consisting of seven modules with psychoeducational content, imagery, and tailored tasks based on traditional CBT principles. Treatment is delivered by trained eTherapists through asynchronous messages, with phone or face-to-face contact if needed. Participants receive a one-day introduction to the program and have access to the treatment platform for six months after completing the 12-week program. Following treatment, a concluding session determines further care needs. Participants undergo assessments at baseline, 6 weeks, 12 weeks, 6 months, and 12 months, including self-reported sick leave, return to work self-efficacy, anxiety, depression, social adjustment, and negative effects. Weekly monitoring of suicidal risk is conducted using specific questionnaires. A subgroup will participate in interviews to explore user experience and treatment impact. The total study duration includes treatment and follow-up periods, with data collected on treatment adherence, user behavior, and clinical outcomes.

This research evaluates the effect and cost-effectiveness of guided internet-based cognitive behavioral therapy ICBT for people with moderate depression, social anxiety disorder, and panic disorder. It is an observational multicenter study conducted in routine healthcare settings to understand who benefits from this treatment, the predictors of drop-out, and how user experience affects adherence and outcomes. Participants receive the eMeistring program, which includes an initial face-to-face visit, followed by eight or nine guided internet-based therapy sessions depending on the condition, with therapist support at least once weekly via secure email. After completing the sessions, a final face-to-face visit with the therapist is offered. Licensed health personnel provide the guidance and the treatment is part of standard care at four hospitals. During the study, participants complete questionnaires on symptom severity, quality of life, work and social ability, satisfaction, and medication use at several points before treatment, up to 14 weeks after starting, six months later, and after two years. Researchers also collect administrative data on treatment implementation and analyze cost-effectiveness and treatment adherence. Safety is monitored through routine outpatient follow-up with alerts sent to therapists if suicidal behavior is reported.

This research aims to explore the genetic causes related to the development of Amyotrophic Lateral Sclerosis ALS in Norway. The study focuses on individuals diagnosed with probable or definite ALS according to the El-Escorial criteria. Understanding genetic factors may help in better characterizing the disease and its risk factors over time. Participants diagnosed with ALS will be followed through the Norwegian health-care system. After giving informed consent, they will complete a brief questionnaire about their family history and provide a blood sample. These samples, along with clinical information and consent forms, are sent to the Department of Medical Genetics at Telemark Hospital Trust for ongoing genetic analysis throughout the recruitment period. Participants may choose to receive their genetic results as part of a diagnostic process. During the study, participants will be involved in providing blood samples and completing questionnaires. Researchers will analyze genetic data to identify gene frequency, new ALS genes, and genetic risk factors between 2020 and 2030. The study involves observation only, with no additional treatments. Participation includes genetic testing and data collection to better understand ALS genetics, with the study continuing until 2035.

Researchers are investigating whether a treat-to-target strategy that includes structured imaging assessments improves patient outcomes in psoriatic arthritis compared to a conventional treat-to-target approach. The study focuses on sustained remission, defined as very low disease activity at 16, 20, and 24 months. This two-arm, parallel-group study randomizes patients to either conventional clinical assessments or additional imaging assessments using ultrasound and MRI to guide treatment decisions. Participants receive treatment following European recommendations, with the conventional arm targeting disease activity based on clinical measures such as DAPSA remission, enthesitis, and psoriasis body surface area. The imaging-informed arm adds ultrasound assessments of joints, tendons, and entheses at every visit, plus MRI of the spine and sacroiliac joints at baseline and one year. Imaging results influence treatment progression, including advancing to biologic disease-modifying drugs if inflammation is detected. During the 24-month follow-up, patients undergo clinical and imaging assessments, including joint counts, enthesitis indices, and skin evaluations. Researchers measure disease activity, inflammation, health-related quality of life, and adverse events throughout the study. The primary outcome is sustained remission, while secondary outcomes include various disease activity scores and safety monitoring. The study aims to provide insights into the benefits of incorporating imaging in psoriatic arthritis management.

Osteoarthritis of the joint between the forearm bones at the wrist, called the distal radioulnar joint DRUJ, can cause pain and reduce the ability to lift and rotate the forearm. This condition often develops after fractures, ligament injuries, or degenerative wrist disease. Researchers are comparing two surgical treatmentsthe Darrach procedure, which removes the ulnar head, and ulnar head replacement with a prosthetic implantto determine which method provides better function and fewer complications in patients with stable but painful DRUJ osteoarthritis. The study involves two groups one undergoing the Darrach procedure and the other receiving a ulnar head replacement using the Herbert Ulnar Head Prosthesis. The surgeries are performed at several hand surgery centers in Norway, following standardized methods. Both groups receive the same postoperative care and follow-up schedule. Participants are randomly assigned to one of the two surgical options to fairly compare outcomes. Participants will be assessed before surgery and then followed up at 3 months, 1 year, and 5 years after the procedure. Evaluations include range of motion, grip strength, functional scores such as the Norwegian version of Quick DASH, patient-related wrist and hand evaluations, pain scales, and monitoring for any complications or additional surgeries. The study aims to gather detailed long-term data on how each surgery affects wrist function and pain over five years.

Researchers are evaluating the effectiveness of physical therapy compared to surgical decompression in patients with lumbar spinal stenosis LSS. The study aims to determine whether structured physical therapy can be a non-surgical alternative to surgery for patients whose symptoms suggest surgery is needed. This randomized controlled multicenter trial tests the hypothesis that there is no difference in efficacy between these two treatments for LSS. Participants are randomly assigned to one of two groups one receiving standard decompression surgery, and the other undergoing a physical therapy program. The physical therapy treatment lasts three months and includes home activities guided by a defined program along with 4 to 6 visits to a physical therapy center. The study compares these interventions to see which better improves patients conditions. During the trial, researchers will assess participants improvements using the Oswestry Disability Index and various pain and walking capacity measures at multiple time points, including 6 months, 1 year, and 2 years after treatment. They will also monitor quality of life and the number of patients who switch from physical therapy to surgery. The total participation time covers these follow-up assessments to evaluate the lasting effects of the treatments.

Researchers are evaluating treatments for chronic migraine, a condition marked by 15 or more headache days per month for over three months, with at least eight days featuring migraine symptoms. This trial aims to assess the effectiveness of combining onabotulinumtoxin A with CGRP monoclonal antibody therapy compared to CGRP therapy alone in preventing chronic migraine attacks. The study also monitors side effects and changes in disease activity, involving about 450 participants in Norway aged 18 to 70 years. Participants will all receive monthly CGRP monoclonal antibody injections as background treatment. They will be randomly assigned to receive either onabotulinumtoxin A injections 155 units at 31 muscle sites or placebo injections following a modified PREEMPT protocol. The treatment period lasts 12 weeks. Before starting treatment, participants will record headache data using an electronic diary app for at least four weeks. The study includes three in-person visits and three telephone visits across a total of 20 weeks. During the study, participants keep detailed headache diaries to track frequency, intensity, medication use, and headache type. Telephone follow-ups at weeks 4 and 8 review treatment adherence and safety. After 12 weeks of treatment, a clinical visit assesses study outcomes, including changes in monthly migraine days and headache severity. Participants continue diary entries for an additional four weeks until the final telephone visit, marking the studys end. The primary outcome is the reduction in monthly migraine days over 12 weeks.