Bergen

Researchers are studying whether calderasib alone or combined with cetuximab can treat advanced solid tumors in people who have the KRAS G12C mutation. This phase 2, open-label trial aims to find out how many participants respond to these treatments and to compare their safety and tolerability. Participants receive calderasib by mouth and cetuximab through intravenous infusion. The study includes people with locally advanced or metastatic solid tumors other than colorectal cancer, who have already undergone standard treatments. The trial monitors response and side effects over time as participants receive either calderasib alone or in combination with cetuximab. During the study, participants undergo regular assessments to measure tumor response and track any side effects or adverse events. Researchers record how many people experience treatment-related side effects and how many stop treatment due to these effects. The study follows participants for up to approximately 76 months to assess long-term outcomes and safety.

Patients with Chronic Obstructive Pulmonary Disease (COPD) often experience symptoms such as difficulty breathing, cough, and excessive mucus production. These symptoms can increase the risk of infections and flare-ups, often leading to hospital stays and disease progression. Managing COPD requires ongoing care, and this research is exploring a mobile application called "Pust Deg Bedre" (PDB), designed to support patients in following tailored breathing and airway clearance techniques to improve self-management. The study aims to assess how feasible it is to use the app and to understand the experiences of patients and physiotherapists with the app in treating COPD symptoms. The study includes a digital health intervention where physiotherapists train patients to use the PDB app and provide customized treatment plans within the app based on clinical assessments. Patients will follow their tailored treatment using the app for 8 weeks, with adjustments made as needed during this period. Follow-up assessments will occur both digitally and in person. In addition to the intervention, qualitative interviews and focus groups with patients and physiotherapists will explore their experiences. Video-recorded therapy sessions and special interview techniques will help gather detailed feedback. A long-term follow-up with physiotherapists will be conducted 6 months after the intervention to learn about the lasting impact on their clinical practice. Participants will be involved for a total of 8 weeks of treatment with a follow-up at 6 months, during which researchers will collect both quantitative data like recruitment rates, adherence, adverse events, dropout rates, physical functioning, and health outcomes, and qualitative data from interviews and focus groups. The study will also measure patient satisfaction and health literacy. Safety and satisfaction will be carefully monitored throughout. The overall goal is to evaluate the app's feasibility and gather insights that may help improve self-management for people living with COPD.

This research aims to evaluate a personalized digital treatment designed for adolescents aged 15 to 18 with eating disorders. The study investigates the feasibility, preliminary clinical outcomes, and cost-effectiveness of this digital approach within a child and adolescent psychiatric outpatient setting. It uses both qualitative and quantitative methods, including semi-structured interviews, to understand the treatment's acceptability, adherence, and impact on symptoms of eating disorders. Participants will undergo a 10-week therapist-guided digital treatment program focused on reducing eating disorder symptoms and improving life-coping skills. The treatment helps adolescents gain knowledge about eating disorders, manage food and activity balance, regulate emotions, build self-esteem, and cope with social challenges. Weekly therapist contact supports participants throughout the intervention. Throughout the study, participants complete self-report questionnaires at multiple time points: before treatment, during, after the 10-week program, and at 3- and 6-month follow-ups. Measures include treatment credibility, adherence, satisfaction, eating disorder symptoms, clinical impairment, and quality of life. Researchers will also evaluate recruitment success and gather detailed patient experiences through interviews. The study aims to identify who benefits most and understand the treatment's overall utility and cost-effectiveness.

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

Researchers are evaluating the use of a handheld device called Grasp to reduce pain and distress in children and adolescents aged 8 to 15 during minor medical procedures involving needle pricks. These procedures include venous puncture, peripheral venous cannula insertion, and local anesthetic injections before dental treatments. The study aims to compare the effects of using the Grasp device with standard care to see if it helps lower self-reported pain and distress levels. The Grasp device consists of a soft silicone ball with pressure sensors connected to an iPad application. When participants squeeze the ball repeatedly before and during the procedure, musical feedback and visual cues are provided in real time through the app. Participants in the intervention group will squeeze the ball every 1 to 2 seconds starting at least 10 seconds before the procedure until it is finished. The control group will receive standard care without the device. The study plans to enroll children and adolescents from several clinics, including a dental center and pediatric clinics. Participants will report their pain and distress levels on paper forms before and immediately after the needle prick procedure. Parents or legal guardians will also provide their assessments of their child's pain and distress. Some participants with prior experience using Grasp during venous cannulation will be interviewed about their experiences. The main outcome measured is self-reported pain right after the procedure. The study includes questionnaires and interviews to gather information on the device's impact during and after the procedures.

Researchers are investigating a new clinical pathway for managing borderline resectable and locally advanced pancreatic cancer in Norway. This nationwide prospective study aims to evaluate how often surgery can successfully remove tumors and assess survival rates following primary chemotherapy. The goal is to achieve a 50% resection rate for borderline resectable pancreatic cancer and 15% for locally advanced cases, with targeted survival and complication rates after surgery based on national guidelines. Patients receive chemotherapy according to Norwegian standards, preferably with mFOLFIRINOX or gemcitabine-nab-paclitaxel. Surgery is planned within four weeks after completing chemotherapy, involving different types of pancreatic removal procedures, potentially including vascular resections. Diagnostic steps include endoscopic ultrasound biopsy for tumor confirmation and molecular analysis, with optional PET/CT scans at baseline and after at least two months of chemotherapy to assess treatment response. Participants undergo careful evaluations including histological diagnosis, imaging, and monitoring throughout treatment. The main measure of success is the rate of tumor removal by surgery from November 2024 to December 2027. Researchers also track survival, complications, and treatment outcomes to better understand the effectiveness of this personalized approach over time.

Researchers are evaluating the risk of developing pancreatic cancer in adults with type 2 diabetes mellitus (T2DM) who started treatment with exenatide compared to those who began treatment with other glucose-lowering drugs that are not glucagon-like peptide 1 receptor agonists (GLP-1 RA). This non-interventional post-authorization safety study, called EXCEED, will collect data retrospectively from medical and prescription records across seven European countries between 2006 and 2023. Patients included are aged 18 years or older and have a diagnosis of T2DM. The study groups include patients who initiated exenatide treatment and those who started other non-GLP-1 RA based glucose-lowering drugs (GLDs) without prior use of exenatide. Initiators of exenatide will be identified by specific drug codes and included regardless of previous use of other GLDs. The comparator group consists of patients who have not used exenatide or certain other related drugs before or during the study period. Treatment exposure is determined from prescription or insurance claim records. Matching based on patient characteristics and timing will be done to compare groups accurately. Participants' medical histories, prescriptions, and diagnoses will be reviewed for at least 12 months before starting the study drug. The main outcomes measured are the rate of new pancreatic cancer diagnoses and the relative risk of developing pancreatic cancer during an average follow-up of 1.5 years or less. Data from multiple European databases will be analyzed using an intention-to-treat approach to assess safety. Patients with prior cancers (except nonmelanoma skin cancer) or pancreatic diseases will be excluded to ensure accurate results.

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 ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are investigating the long-term safety and tolerability of open-label iptacopan in adults with primary IgA nephropathy who have previously completed specific clinical trials (CLNP023X2203 or CLNP023A2301). This extension study is designed to allow participants continued access to iptacopan until certain conditions are met, such as reaching three years from the last patient first visit, loss of treatment benefit, negative benefit-risk profile, initiation of dialysis or kidney transplant, or commercial availability of the drug. The study will also assess the drug's effects on disease progression every six months. Participants who completed the prior trials and meet inclusion criteria may receive oral iptacopan capsules at a dose of 200 mg twice daily. The study is open-label and non-randomized and will continue treatment under this regimen until one of the study-defined stopping points is reached. Supportive care with ACE inhibitors or ARBs is maintained as per clinical guidelines, and vaccination against certain infections is required before enrollment. During the study, participants will be monitored for safety, including serious adverse events, adverse events of special interest, vital sign abnormalities, ECG changes, and laboratory test abnormalities from the first day of treatment until seven days after the last dose. Efficacy assessments occur every six months to evaluate clinical effects on disease progression. The study aims to collect long-term safety and tolerability data while providing ongoing treatment access until the drug becomes commercially available or other stopping criteria apply.