Kristiansund

Researchers are conducting a phase III randomized, open-label, multicenter trial across several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. The study focuses on elderly patients with untreated diffuse large B-cell lymphoma (DLBCL), defined as patients aged 80 years or older, or those aged 75 years or older who are considered frail based on a simplified Comprehensive Geriatric Assessment. The trial aims to compare the effectiveness of two treatment regimens in this population. Participants are randomly assigned to receive either the standard R-miniCHOP treatment or an experimental R-pola-miniCHP regimen where vincristine is replaced with an immunoconjugate, polatuzumab vedotin. Both treatments involve cycles of drugs including rituximab, cyclophosphamide, doxorubicin, and prednisone, administered over 18 weeks. The trial includes a screening period lasting up to 4 weeks, followed by the active treatment phase, and then a follow-up period lasting up to 36 months after treatment completion. Throughout the study, participants will be monitored to measure progression-free survival over 2 years as the primary outcome. The study involves regular assessments including clinical evaluations and safety monitoring. Enrollment began in the first quarter of 2020, with the last patient visit expected by the first quarter of 2027, allowing for long-term observation of treatment effects and patient outcomes.

Researchers are evaluating the long-term effects of music therapy on people with substance use disorder (SUD), a condition linked to significant health burdens worldwide. This large multinational trial involves 600 participants from various European countries, aiming to compare different music therapy methods with usual treatment. The study focuses on whether active or passive music-based interventions can help reduce addiction severity one year after starting the trial. Participants will be randomly assigned to one of three groups: the Active Music Group (AMG), where they actively make and play music in weekly group sessions led by qualified music therapists; the Music Listening Group (MLG), which involves group sessions of music listening also led by professional therapists; or Treatment as Usual (TAU), which includes standard pharmacological or non-pharmacological care offered locally. Each music therapy session lasts up to 90 minutes. During the study, addiction severity will be measured at the start, one year, and two years after randomization using the European Addiction Severity Index. Participants will continue their assigned treatments while researchers monitor their progress and gather information on how music therapy impacts their recovery. The study is designed to be assessor- and statistician-blinded to ensure unbiased results, with the goal of improving rehabilitation options for people living with SUD.

Researchers are developing and evaluating a new model for interaction across health services using welfare technology and telemedicine to improve intravenous antibiotic therapy at home. This innovative model aims to enhance the exchange of patient information, quality systems, and procedures between the municipality and the hospital. The goal is to create knowledge applicable to other diagnostic groups, treatments, and regions beyond this initial focus on infection treatment. In this study, patients receive intravenous antibiotic treatment at home instead of being admitted to the hospital. They are monitored by the municipal regional response center and nurses according to an individualized treatment plan, while hospital physicians remain medically responsible. The approach includes qualitative assessments from interviews and observations with patients, families, and healthcare professionals, as well as quantitative data collection from hospital and municipal records, alarm systems, and infusion pump logs. Participants will be followed for up to 45 months to measure outcomes such as the number of rehospitalizations, patient satisfaction, and healthcare personnel's opinions on patient safety. Assessments include reviewing patient records, conducting interviews, and monitoring device use and communication with the regional response center. This long-term follow-up aims to ensure safety, treatment effectiveness, and overall satisfaction with home-based intravenous antibiotic therapy.

This research aims to compare the effects of using ancillary screws versus no screws in the ACE acetabular cup during total hip replacement surgery for patients aged 65 to 80 with hip osteoarthritis. The study also investigates the migration over time of the Avanteon femoral stem. The purpose is to evaluate implant stability and early fixation using a new CT-based Radiostereometric Analysis (CT-RSA), which may help predict the long-term survival of these implants. Participants will undergo total hip arthroplasty with a hybrid hip replacement, combining an uncemented ACE acetabular component and a cemented Avanteon femoral stem. The study compares implant migration with and without the use of ancillary screws in the acetabular cup. Researchers will use CT-RSA, plain X-rays, and an accelerometer-based activity monitor (ActivePAL) to assess implant stability, migration, and patient activity levels. The study also evaluates the precision of ultra low dose CT-RSA to potentially reduce radiation exposure. During the study, participants will be followed with scheduled clinical and radiographic evaluations including CT-RSA scans and X-rays. Patient-reported outcome measures and activity monitoring will also be collected to assess functional outcomes. The primary outcome is implant migration measured over two years. The study may provide new insights into implant fixation, longevity, and patient recovery following total hip replacement surgery.

Researchers are studying the effectiveness and potential complications of new immunotherapies used to treat multiple myeloma, plasma cell leukemia, and AL amyloidosis in routine care settings in Norway. The goal is to fill gaps in knowledge, support future clinical trials, and help develop guidelines for monitoring and managing side effects to improve patient survival and quality of life. This observational study focuses on patients receiving these treatments as part of regular medical care. The treatments studied include Teclistamab, Elranatamab, Talquetamab, Idecabtagene vicleucel, and Ciltacabtagene autoleucel. The study tracks how these therapies are used and dosed in real-world settings outside clinical trials. Patients receive these immunotherapies as planned by their healthcare providers, and their treatment details and outcomes are observed over time. Participants will be followed for up to ten years from the start of treatment. Researchers will gather data on overall response rates, progression-free survival, time to next treatment, and overall survival. They will also monitor the frequency and severity of adverse events, infection patterns, antibiotic resistance, and use of antimicrobial prevention methods. Data collection includes real-world clinical outcomes to better understand the long-term effects and safety of these immunotherapies.

Researchers are evaluating two different surgical alignment techniques in total knee arthroplasty (TKA) for patients with knee osteoarthritis. The study compares the traditional mechanical alignment (MA), which aims for a neutral knee position, with personalized alignment (PA) techniques such as kinematic or functional alignment that aim to restore the patient's original knee anatomy even if it results in a non-neutral alignment. The study uses robotic assisted surgery to increase accuracy and intends to assess clinical outcomes, implant stability, and postoperative implant positioning. Participants will undergo total knee replacement surgery using the ROSA4 Knee System with the Persona TKA implant. Patients will be randomly assigned to either mechanical alignment or personalized alignment groups. The tibial implant placement will be limited to specific angles in both coronal and sagittal planes. Experienced surgeons trained in both techniques will perform the surgeries, and the study will follow strict infection control practices and monitor for rare complications related to robotic surgery. Participants will be assessed through clinical tests and CT scans to evaluate implant stability and alignment over two years. The study is randomized, double-blinded for patients and some study personnel, and includes 152 patients aged 18 to 80 years. Researchers will monitor patient-reported outcomes, range of motion, strength, activity levels, and implant migration using CT-based radiostereometric analysis to determine which alignment technique may provide better longevity and clinical results.