Hamar

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.

This observational study focuses on parastomal hernia repair using endoscopic methods. It evaluates laparoscopic and robotic extraperitoneal mesh repair techniques that include transversus abdominis release TAR and mesh reinforcement following the Sugarbaker principle. The study aims to assess these surgical approaches and their outcomes over time. The repair involves an endoscopic trans-abdominal preperitoneal plasty TAPP method placing mesh extraabdominally, anterior to the transversalis fascia. Both laparoscopic and robotic procedures are used, with additional repair of any midline hernias through an enhanced-view Rives-Stoppa technique. This approach is studied for safety and effectiveness in reinforcing hernia repair. Participants will be monitored for adverse events within one month after the procedure, with further follow-up over two years to observe late complications and hernia recurrence. The study collects data through clinical evaluations during this period. Participation duration varies with follow-up assessments scheduled up to two years after surgery to ensure comprehensive monitoring of outcomes.

Researchers are investigating whether a home-based exercise program called five plus training improves walking ability better than the current recommendation of walking for at least 30 minutes three times per week in patients with intermittent claudication. This condition causes pain in the calves due to poor blood flow during walking, and the study aims to determine which exercise method enhances walking distance and quality of life. The trial is sponsored by the Norwegian University of Science and Technology and includes randomized, double-blind assignment to exercise groups. Participants are randomly assigned to either the five plus training group or a walking group. The five plus training involves standing in front of a wall for balance support and repeatedly lifting the body onto tiptoes with the calf muscles until pain starts, then performing five additional calf raises to promote muscle blood flow. The walking group is instructed to walk for at least 30 minutes three times weekly. This training continues over a 12-week period to compare effects. During the study, participants walking distance is measured using a treadmill test, and their quality of life is assessed through questionnaires. The ankle-brachial index, a test comparing blood pressure at the ankle and arm, is also monitored. These assessments help evaluate changes in walking capability and symptoms. The study follows participants for 12 weeks, with ongoing monitoring to assess the safety and impact of the exercise programs.

Researchers are investigating the best treatment approach for older men aged 75 years and above with high-risk, non-metastatic prostate cancer. This trial aims to determine whether immediate curative treatments like radiotherapy or surgery provide the same survival and quality of life benefits as seen in younger patients, or if the risks and side effects might outweigh these benefits. The study also evaluates if early side effects from immediate treatment are balanced by better long-term cancer control and quality of life. Participants are randomly assigned to one of two groups. One group receives immediate curative therapy, which includes radiotherapy combined with hormone therapy or, for some, surgery called radical prostatectomy. The other group receives conservative treatment involving observation or hormone therapy, with further treatment as needed based on disease progression. This open-label, multicenter study compares these two approaches over a long-term period. During the study, participants will undergo regular assessments including quality of life questionnaires and evaluations of urinary, bowel, and prostate cancer-related symptoms. The primary outcomes measured are overall survival and disease burden over up to 10 years. Secondary outcomes include role functioning, symptom-free survival, metastasis-free survival, and the need for additional treatments. The study monitors participants health status and quality of life throughout this extended follow-up period.

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 a virtual reality VR technology designed to help people with substance use disorders and mental health conditions improve their social functioning. This multi-center, pragmatic randomized controlled trial RCT compares VR training to usual treatment in patients receiving long-term addiction therapy. The study aims to measure improvements in resilience, quality of life, practical and social functioning, social participation over six months, and assess the cost-effectiveness of VR training over twelve months. Participants assigned to the VR group will attend two VR sessions per week for five weeks, totaling ten sessions. During these sessions, they will experience various virtual city environments with increasing complexity, facing everyday social situations. Initial sessions include instructions on using the VR equipment and navigating scenarios, with some sessions involving observation and others allowing participants to select responses presented both visually and verbally. The control group will continue receiving standard addiction treatment, which includes individual and group therapies, physical exercise, and social activities led by healthcare professionals. Throughout the study, participants will be monitored for changes in health, disability, social and practical functioning, social participation, and resilience from enrollment until about six months. Cost-effectiveness will be evaluated up to twelve months. Assessments include questionnaires and clinical observations. The study runs until December 2026, with participants expected to attend regular VR sessions if assigned and continue their usual care during and after the trial.

Researchers are evaluating if patients with acute heart failure can achieve the same level of heart failure medication management through digital follow-up at home compared to traditional hospital visits, based on the STRONG-HF strategy. This study addresses the challenge of low use of recommended heart failure therapies despite evidence showing they reduce mortality, aiming to improve care delivery by testing remote medication up-titration and follow-up. The trial builds on the STRONG-HF trials success, which showed better outcomes with early medication adjustment and follow-up in specialized clinics but faced barriers due to frequent hospital visits. Participants will be randomly assigned to one of two groups one receiving follow-up and heart failure medication management at home via telecommunication led by specialized nurses, including home visits at 1, 2, 3, and 6 weeks plus a primary care physician visit around week 2 the other group receiving follow-up and medication management at hospital outpatient clinics on the same schedule. Both groups follow the STRONG-HF intensive care strategy with early and rapid medication up-titration to at least half the maximum tolerated doses at discharge and then to maximum tolerated doses after 2 weeks, with safety visits at weeks 1, 3, and 6. During the 90-day study period, participants will be monitored for medication doses, heart function via echocardiography, blood tests including NT-proBNP, quality of life assessments, self-care, and patient satisfaction. Readmissions and survival will be tracked for up to 24 months. Follow-up visits occur weekly during the first 6 weeks, and researchers will assess treatment adherence, adverse events, and healthcare costs. This approach aims to reduce the burden on patients and healthcare systems while maintaining effective heart failure care.

Researchers are evaluating techniques to prevent incisional hernias, a common complication after midline laparotomy surgery, where abdominal contents can protrude through a surgical scar. This trial compares the use of a small-bite suture technique alone versus the same suture technique combined with an additional onlay polypropylene mesh to reinforce the abdominal wall. The study aims to improve understanding and encourage use of mesh in Norway where its use is currently limited. Participants undergoing midline laparotomy at three Norwegian hospitals will be randomly assigned to one of two groups. One group will have their abdomen closed using the small-bite suture method plus an onlay polypropylene mesh, with a subcutaneous drain to help prevent fluid buildup. The other group will receive closure using only the small-bite suture technique. The study will track outcomes after surgery to compare these approaches. Participants will be followed for one year after surgery. Researchers will assess the presence of incisional hernias using clinical exams and CT scans at 12 months. Additional assessments include surgical site complications such as hematoma, infection, seroma, and wound issues at 4 to 6 weeks post-surgery. Quality of life and pain will also be evaluated at both 4 to 6 weeks and one year. This information will help determine which closure method better reduces hernia risk and improves recovery.

Researchers are investigating whether bipolar enucleation of the prostate BEEP leads to better urinary voiding outcomes than transurethral resection of the prostate TURP in men with enlarged prostates experiencing voiding problems. This multi-center randomized controlled trial focuses on men with prostate sizes between 30mL and 80mL who have lower urinary tract symptoms caused by benign prostate obstruction. The study also explores how symptom relief relates to the amount of tissue removed, differences in patient experiences between the two procedures, and the cost-effectiveness of BEEP compared to TURP. Participants will be randomly assigned to receive either TURP or BEEP, both transurethral surgical procedures performed to relieve urinary symptoms by removing prostate tissue. TURP involves removing central prostatic tissue starting from the bladder neck downwards, while BEEP removes tissue starting in the peripheral zone towards the bladder. Outcomes will be assessed at baseline and 12 months after surgery, with additional patient experience questionnaires at 3 and 12 months. Both procedures are performed under standard surgical care by experienced urologists. During the study, participants will complete the International Prostate Symptom Score IPSS to measure urinary symptoms and the Nordic Patients Experience Questionnaire NORPEQ to evaluate patient experience. Additional assessments include urinary flow measurements, residual urine volume, complications, catheter use, quality of life questionnaires, sexual function, and health care resource use. Cost-effectiveness will be analyzed using quality-adjusted life years QALYs over the 12-month follow-up. The study aims to enroll 120 men, with follow-up visits and data collection managed through electronic systems over one year.

Researchers are evaluating screen delivery as an alternative to traditional office delivery for cognitive therapy in youth aged 14 to 18 years with social anxiety disorder SAD. This study aims to compare the effectiveness, acceptability, and sustainability of these two delivery methods and identify factors that influence therapy outcomes. The study is a randomized controlled trial involving 200 youth and addresses important questions about therapy access, economic and climate benefits, and therapeutic alliance. Participants will receive cognitive therapy based on the CT-SAD-A manual, delivered either by video screen or in an office setting. Therapy consists of 14 weekly 90-minute sessions plus a booster session six months after treatment. Therapists involved have specialized training and participate in supervision, with sessions recorded and stored securely. The study also includes a feasibility phase with feedback from therapists, youth, and parents. During the trial, participants complete questionnaires weekly and attend interviews at multiple time points before treatment, after therapy, and at 6 months, 2 years, and 4 years post-treatment. Parents also provide information through interviews. Researchers monitor therapy adherence, therapeutic competence, and safety, including suicidality and mood symptoms. Overall participation spans several years, with data collected to assess therapy effectiveness and long-term outcomes.