Hamar

Researchers are evaluating a preventive intervention called Condensed Internet-delivered Prolonged Exposure (CIPE) for people who have symptoms of post-traumatic stress disorder (PTSD) about one month after experiencing a traumatic event. The study aims to test the effectiveness and cost-effectiveness of CIPE in Norwegian municipal psychosocial crisis services, comparing it to usual treatment. This research addresses the lack of evidence-based preventive options available for trauma victims in Norway and explores how CIPE may reduce PTSD symptoms, depression, insomnia, prolonged grief, and the need for specialized mental health care. CIPE is a therapist-supported program delivered online through four modules. It includes education about normal trauma reactions, exposure techniques to confront reminders of trauma both in real life and imagination, and a breathing exercise. Participants receive CIPE alongside treatment as usual (TAU), which varies but generally involves psychological first aid, psychoeducation, social support activation, and practical help. The study compares outcomes between those receiving CIPE plus TAU and those receiving only TAU. Participants are involved for at least 6 weeks after starting treatment, with follow-ups at 6 and 12 months post-trauma. Researchers assess symptoms using the PTSD Checklist for DSM-5 (PCL-5) and measure depression, insomnia, prolonged grief, treatment satisfaction, and referrals to specialized care. The study also evaluates quality of life and cost-effectiveness of adding CIPE to usual care. Participants must complete questionnaires and provide informed consent, with language requirements for English or Norwegian speakers aged 16 to 99 years.

This research focuses on parastomal hernia, a condition requiring surgical repair. It evaluates an endoscopic approach called endoscopic trans-abdominal preperitoneal plasty (TAPP), which uses a specialized technique called transversus abdominis release (TAR) along with mesh reinforcement following the Sugarbaker principle. The study includes both laparoscopic and robotic surgery methods and also addresses repair of any accompanying midline hernias using an enhanced-view Rives-Stoppa technique. Participants undergo a procedure involving endoscopic preperitoneal repair of the parastomal hernia. This repair follows the Sugarbaker principle combined with TAR and uses mesh reinforcement placed extraabdominally, anterior to the transversalis fascia. The interventions include minimally invasive laparoscopic or robotic techniques to perform this repair. During the study, researchers monitor participants for any adverse events over a one-month period after surgery. The study involves procedural assessments and observation of outcomes related to safety and effectiveness of the repair method. Participant involvement is centered around the surgical intervention and follow-up for one month to track any complications or adverse events.

This research aims to determine if a home-based exercise program called "five plus training" can improve walking ability more than the usual recommendation of walking daily for patients with intermittent claudication, a condition causing pain in the calf muscles due to reduced blood flow. The study focuses on patients who experience calf pain after walking short distances and evaluates the impact of different exercise approaches on their walking capacity and quality of life. Participants will be randomly assigned to one of two exercise groups: one group will follow the "five plus training," which involves standing and lifting the body onto tiptoes repeatedly until calf pain begins, then performing five additional lifts; the other group will walk for at least 30 minutes three times per week. The "five plus training" is done three times a day using a wall for balance support. These exercises aim to induce muscle ischemia followed by reperfusion to maximize training effects. During the 12-week study, researchers will assess participants' walking distance on a treadmill and use questionnaires to measure quality of life. They will also monitor blood flow using the Ankle-Brachial index. The study includes regular follow-ups to evaluate how each exercise program affects walking ability and overall well-being in patients with intermittent claudication.

Researchers are investigating the best treatment approach for older men aged 75 years and above with high-risk, non-metastatic prostate cancer. This study aims to determine whether immediate curative therapy, such as radiotherapy or surgery, offers survival benefits and improves quality of life compared to conservative treatment strategies. The trial also evaluates whether the side effects of immediate treatment are balanced by better long-term tumor control and overall survival in this older population. Participants are randomly assigned to one of two groups: one receiving immediate curative therapy including radiotherapy or surgery, and the other receiving conservative treatment, which includes hormone therapy or observation. The hormone therapy involves androgen deprivation using either LHRH agonists, antagonists, or androgen monotherapy. The study is a phase 3, open-label, multicenter trial with parallel groups, designed to compare these treatment approaches over time. During the study, participants undergo medical and geriatric evaluations to assess their health status and ability to participate. They complete health-related quality of life questionnaires and are monitored through clinical assessments and imaging to evaluate tumor status. The primary outcomes measured are overall survival over 10 years following recruitment and the burden of disease during the same period. Researchers also track side effects, functional status, and cost-effectiveness of treatments throughout the study.

Researchers are investigating the effectiveness of approved anti-cancer drugs used outside their usual indications for patients with advanced cancer who have specific molecular changes identified through genetic testing. This nationwide, phase 2 study in Norway uses a combined umbrella and basket design to explore drug and biomarker combinations across different cancer types. Biological samples will be collected at diagnosis, during treatment, and if the disease progresses to better understand factors affecting drug response and resistance. Patients eligible for this study have advanced cancer that has been previously treated with standard therapies and have acceptable organ function and performance status. Treatment is guided by molecular testing results and recommendations from a national tumor board. Patients receive drugs matched to their tumor's molecular profile, with treatment eligibility confirmed before starting. New patient groups may be opened if no suitable cohort exists. The drug Atezolizumab is among those evaluated, administered according to protocol-specific criteria. Participants will be closely monitored for tumor response, survival, treatment duration, and side effects including serious toxicities. They will undergo molecular testing including whole genome sequencing from tumor biopsies and liquid biopsies. Data on treatment outcomes and molecular markers will be collected and reported to national cancer registries. Patients not enrolled in treatment cohorts will be followed for 16 weeks to track disease progression and survival, with long-term follow-up planned through national health databases.

Researchers are evaluating a virtual reality (VR) technology designed to improve social functioning among adults with substance use and mental health disorders. This multi-center, pragmatic randomized controlled trial compares VR training to usual treatment for patients receiving long-term addiction care. The study aims to assess whether VR can enhance resilience, quality of life, practical and social skills, and social participation over a six-month period, as well as evaluate the cost-effectiveness of this VR intervention. Participants will receive VR training focused on social cognition, communication, and competence using realistic scenarios. The VR setup includes a Meta Quest Pro headset connected to a PC running Windows 11 with Unreal Engine 5.4, operating entirely offline without storing session data. The VR sessions occur twice weekly for five weeks. The comparison group will receive standard addiction treatment without VR. Throughout the study, participants will be monitored from enrollment through about six months for health and disability outcomes. Researchers will collect information on social functioning and quality of life. The study includes adult patients aged 18 to 70 years undergoing inpatient substance use disorder treatment in specialized units in South-East Norway. Safety during VR sessions is ensured by excluding individuals with conditions like epilepsy or severe sensory impairments.

This research aims to compare two techniques for closing midline laparotomy incisions to prevent incisional hernias, a common complication where abdominal contents protrude through a surgical scar. The trial focuses on patients undergoing midline laparotomy at three Norwegian hospitals. It evaluates the use of the small-bite suture technique alone against the same technique combined with an added onlay polypropylene mesh to strengthen the closure. Participants will be randomly divided into two groups. One group will receive the standard small-bite suture closure, while the other will have the closure reinforced with an onlay polypropylene mesh. Both treatments are performed during the midline laparotomy surgery. The study is conducted across three Norwegian hospitals: Hamar Hospital, Gjøvik Hospital, and Lillehammer Hospital. Throughout the study, participants will be monitored for incisional hernias through clinical exams and CT scans one year after surgery. Additional evaluations at four to six weeks and one year will assess surgical site complications like infections or wound problems, as well as participants' quality of life and pain levels. The primary goal is to determine the incidence of incisional hernia at 12 months post-surgery.

Researchers are evaluating the outcomes and patient experiences of two surgical methods, bipolar enucleation of the prostate (BEEP) and transurethral resection of the prostate (TURP), in men with urinary voiding problems caused by enlarged prostate (benign prostate obstruction). This multi-center randomized controlled trial aims to compare the effectiveness of BEEP and TURP, explore the relationship between symptom relief and the amount of prostate tissue removed, assess patient experiences, and evaluate the cost-effectiveness of BEEP compared to TURP. The study focuses on men with prostate sizes between 30mL and 80mL who require surgery for lower urinary tract symptoms (LUTS). Participants will be randomly assigned to receive either BEEP or TURP, both transurethral surgical procedures but differing in tissue removal technique. TURP removes central prostate tissue starting from the bladder neck, while BEEP removes tissue starting in the peripheral zone towards the bladder. Treatments will be performed at two hospital urology departments, with surgeons using bipolar techniques. The study includes a 12-month follow-up period after surgery to assess outcomes. During the study, participants will complete assessments including the International Prostate Symptom Score (IPSS) at baseline and 12 months to measure urinary symptoms. Patient experiences will be gathered using the Nordic Patients Experience Questionnaire (NORPEQ) at baseline, 3, and 12 months. Additional evaluations include urinary flow measures, residual urine volume, adverse effects questionnaires, health-related quality of life surveys, and healthcare resource use. Safety data such as complications, catheter use, and hospital readmissions will also be collected. The study plans to enroll 120 men and will analyze the data to compare symptom improvement, patient satisfaction, and cost-effectiveness of the two surgical methods.

Researchers are evaluating screen delivery as an alternative to office delivery for cognitive therapy in youth aged 14 to 18 years with social anxiety disorder (SAD). The study aims to compare the effectiveness, acceptability, and sustainability of screen delivery against traditional office-based therapy. It also seeks to identify factors that influence therapy outcomes, including the credibility of the treatment and the therapeutic alliance between youth and therapists. The study involves a randomized controlled trial where 200 youth with SAD are assigned to either screen delivery or office delivery of cognitive therapy based on the CT-SAD-A manual. Participants attend 14 weekly therapy sessions, each lasting 90 minutes, with an additional booster session offered six months after treatment. Therapists deliver therapy either via video communication or in-person at clinics across four regional sites in Norway. Participants complete an initial screening questionnaire and a diagnostic interview online before starting therapy. During treatment, they fill out weekly questionnaires, and researchers conduct interviews and assessments at the end of therapy, as well as at 6 months, 2 years, and 4 years post-treatment. Parents are also interviewed and informed. Outcomes are measured using scales for social anxiety symptoms, and therapy sessions are monitored for adherence and competence. Safety monitoring includes reports of anxiety, depression, and suicidality, with procedures in place for any signs of deterioration.