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Found 3 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
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.
Actively Recruiting
Researchers are studying patients with self-harm behaviors and borderline personality disorder who are receiving Dialectical Behaviour Therapy (DBT) in clinical units across Norway. The goal is to identify factors that predict how patients respond to treatment and their clinical progress, including the impact of patient characteristics like psychiatric diagnoses, previous behaviors, and treatment history. This project is a collaboration between the National Centre for Suicide Research and Prevention and clinical DBT programs, using a standardized system to collect and compare treatment data across different settings. The study includes two types of DBT treatments: one adapted for adolescents (DBT-A), which involves 20 weeks of weekly individual therapy, multifamily skills training, family therapy as needed, and telephone coaching; and the standard DBT version for adults, which consists of weekly individual therapy, weekly skills training, and telephone coaching as needed. Treatments are delivered by clinical units that use a uniform protocol for psychiatric diagnosis and clinical assessment, tailored for either children/adolescents or adults. Participants will undergo baseline assessments before treatment, multiple evaluations during therapy, at treatment end, and during follow-up. Data collection includes interviews and ratings by therapists plus self-reports by patients using tablets and a mobile app for frequent emotional and behavioral tracking. Researchers will measure outcomes such as self-harm behavior, suicidal thoughts, depressive symptoms, emotional regulation, coping skills, social and occupational functioning, and use of emergency services to better understand treatment response and clinical changes over time.