Fredrikstad

Researchers are evaluating a preventive intervention called Condensed Internet-delivered Prolonged Exposure CIPE for people experiencing symptoms of post-traumatic stress disorder PTSD about one month after a traumatic event. The goal is to test the effectiveness and cost-effectiveness of CIPE when added to usual treatment provided by psychosocial crisis teams in Norwegian municipalities. This study addresses the lack of evidence-based preventive interventions available for victims after crises and disasters in Norway. Participants are randomly assigned to receive either treatment-as-usual TAU alone or TAU plus the CIPE intervention. CIPE is a therapist-supported, internet-based program consisting of four modules delivered over six weeks. Participants are encouraged to engage daily with their therapist through a secure platform and may have phone sessions. The total therapist contact is generally under 60 minutes, while participants work on intervention tasks about six hours weekly. TAU involves proactive support from interdisciplinary crisis teams following national guidelines. Throughout the one-year study period after trauma, participants undergo assessments including the PTSD Checklist for DSM-5 at 10 to 13 weeks, 6 months, and 12 months post-trauma. Other measures include depression, insomnia, grief symptoms, treatment satisfaction, and quality of life. Researchers will monitor use of specialized mental health services and cost-effectiveness. The study aims to understand how CIPE plus usual care compares to usual care alone in reducing PTSD symptoms and improving overall outcomes.

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.

Helicobacter pylori infection is a common chronic stomach infection linked to serious conditions like gastritis, peptic ulcers, and gastric cancer. This research aims to collect real-world data from European gastroenterologists on how H. pylori infection is diagnosed, treated, and managed over time. The goal is to analyze current clinical practices, evaluate treatment effectiveness and safety, and improve healthcare strategies across Europe. The study uses a non-interventionist, prospective registry design involving up to ten gastroenterologists from 30 European countries. These doctors will record their routine clinical care of H. pylori infected adult patients over ten years using an electronic case report form. Data collected includes patient demographics, diagnosis methods, treatment details, adherence, side effects, and treatment outcomes. Participants will be adults diagnosed with H. pylori infection seen in outpatient digestive clinics. Information on prescribed treatments and eradication confirmation will be gathered systematically. Researchers will monitor treatment prescriptions, adverse events, and treatment success rates during the study. The registry allows future analyses approved by the scientific committee, supporting better understanding and management of H. pylori infection.

This research aims to evaluate how an online education program for clinical staff can improve the use of Hospital-at-Home HaH services in hospitals across Denmark, Norway, and Sweden. The study responds to healthcare pressures like aging populations and staff shortages by assessing if virtual training can overcome barriers to adopting HaH, where acute hospital care is provided at home. The trial uses a randomized design to compare hospitals receiving the education to those continuing usual care. The intervention group will complete the NorDigHE HaH education program, which is delivered online and includes e-learning, simulations, reflection exercises, practical tasks, and tailored implementation tools embedded in the WHO Fast-track Implementation Model. The control group will continue their usual treatment for six months and will be offered access to the education after the study. The intervention also includes workshops, meetings, written guides, and hotline support to help integrate HaH into daily clinical routines. Participants will complete surveys at baseline, three months, and six months to measure HaH activity, staff knowledge, and motivation. The intervention group will also have a 12-month follow-up assessment. Additionally, patients, staff, and management may participate in interviews to share their experiences with HaH. Data collected includes hospital and home care days, readmission rates within 30 days, mortality, and staff attitudes. The study runs from enrollment through six months with extended follow-up for the intervention group.

Researchers are evaluating the effectiveness of approved anti-cancer drugs used outside their usual indication for patients with advanced cancer who have specific molecular changes identified through diagnostic testing. This nationwide, phase 2 clinical trial in Norway uses a combined umbrella and basket design with a Simon two-stage model to study various drug and biomarker combinations across different cancer types. Biological samples will be collected at presentation, during treatment, and upon disease progression to better understand drug response and resistance through advanced genetic analyses, including whole genome sequencing. The study involves patients who have advanced cancers no longer benefiting from standard treatments and who have molecular profiles indicating potential benefit from one of the approved drugs in the trial. Participants will receive treatment with drugs such as atezolizumab, alectinib, and others, used beyond their usual indications based on biomarker profiles. Treatment plans are guided by a national molecular tumor board, and fresh tumor biopsies will be collected before treatment to support biomarker studies. New patient cohorts may be opened as needed based on molecular subgroups and drug availability. Participants will be monitored for tumor response, progression-free survival, overall survival, and treatment duration. Data on treatment toxicity will be collected, and all treatment and outcome information, along with molecular screening results, will be reported to the Cancer Registry of Norway. Long-term follow-up will also use national registries to track patient outcomes. Patients who are screened but not enrolled will be followed for 16 weeks to monitor survival and disease progression.

Researchers are evaluating RAY121, an inhibitor of the classical complement pathway, in a Phase 1b basket trial involving patients with various immunological diseases including antiphospholipid syndrome, bullous pemphigoid, Behets syndrome, dermatomyositis, immune-mediated necrotizing myopathy, and immune thrombocytopenia. This study aims to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of multiple doses of RAY121 in these patient populations. All enrolled patients will receive multiple doses of RAY121 administered by injection. The study is designed as a single-group trial where participants receive the experimental treatment without comparison to placebo or other interventions. Treatment monitoring and assessments will continue up to 32 weeks following the baseline visit to evaluate the effects and behavior of the drug in the body. Participants will be involved in regular assessments including monitoring for adverse events, measurement of drug concentration and activity, complement pathway activity, and antibody formation against RAY121 from baseline through week 32. The study includes safety evaluations and collection of pharmacokinetic and pharmacodynamic data to understand how the drug works and is tolerated over time. The total participation duration may last up to 32 weeks with ongoing monitoring throughout this period.

Researchers are evaluating whether treating minimal residual disease MRD relapse earlier, after first line treatment for multiple myeloma, can prolong progression-free survival and overall survival compared to treating relapse at progressive disease. This study focuses on patients who become MRD negative after standard first line treatment including autologous stem cell transplantation, aiming to form a uniform group for comparison. The trial is conducted in phases II and III to assess these outcomes over many years. Participants with newly diagnosed multiple myeloma eligible for high-dose therapy will first receive standard Norwegian care bortezomib, lenalidomide, and dexamethasone in 21-day cycles, with four cycles before and after transplant. After induction, patients undergo single or tandem autologous stem cell transplant ASCT based on response and toxicity. Those achieving MRD negativity post consolidation will be randomly assigned to start second-line treatment either at MRD relapse arm A or at progressive disease arm B. Both groups receive the same 28-day cycle treatment of carfilzomib, dexamethasone, and daratumumab until progression, unacceptable side effects, or withdrawal. During the study, patients will have regular MRD assessments every four months in arm A and standard follow-up in arm B, with additional MRD checks scheduled at specific timepoints during second-line treatment. Researchers will measure progression-free survival, overall survival, MRD negativity rates, time to next treatment, and quality of life over 10 to 11 years. Participants will be closely monitored for safety and treatment response throughout their participation, which can last many years depending on outcomes.

Researchers are studying adults aged 18 to 65 with displaced extraarticular lateral clavicle fractures to compare non-surgical treatment with surgical treatment. The goal is to see if non-surgical care is not worse than surgery in improving arm, shoulder, and hand function after one year. This is a multinational, multicenter randomized trial focusing on patient-reported outcomes to guide treatment choices. Participants will be randomly assigned to either non-surgical treatment using a simple sling combined with physiotherapy or surgical treatment involving plates and screws to fix the fracture. Those in the non-surgical group may switch to surgery after six weeks if symptoms persist or worsen. Both treatments follow standardized protocols and are carefully monitored. Throughout the study, participants will complete questionnaires measuring arm and shoulder function, pain levels, and quality of life at multiple time points up to five years after treatment. The main measurement is the Disabilities of the Arm, Shoulder and Hand DASH score at one year. Researchers will also assess other functional scores and pain scales to understand recovery. The total follow-up includes assessments before injury, during recovery, and long-term outcomes.

Researchers are investigating the triggers and causes of eating disorders in athletes by comparing experiences of those who have struggled with these disorders to athletes from the same sports environment without such conditions. The study aims to better understand why some athletes develop eating disorders while others do not, and to gather ideas on how these issues could be prevented and managed in sports. This builds on previous research from over 30 years ago that identified early sports specialization, weight monitoring, high training volume, and traumatic experiences as key factors. Participants include two groups athletes with current or past eating disorders and athletes without eating disorders from the same clubs or teams. Each athlete will take part in individual interviews guided by a structured template to share their experiences and perspectives. The study focuses on self-reported causes, timing of symptoms, knowledge about eating disorders, and ideas for prevention, all collected from August to December 2024. During the study, participants will share background information, family history, current symptoms, and other personal interests related to identity. The research team will analyze these interviews and other background variables to assess factors influencing eating disorders. The study runs from November 2024 to December 2025 and includes ongoing collection of data to develop supportive guidelines and prevention strategies for sports teams and organizations.