Bergen

Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.

Researchers are evaluating calderasib alone or combined with cetuximab to treat people with advanced solid tumors that have the KRAS G12C mutation, excluding colorectal cancer. This study aims to measure how many participants experience tumor shrinkage or disappearance and compare the responses between the two treatments. It is a phase 2, open-label trial focused on treatment safety and tolerability. Participants will receive calderasib orally with no set limit on treatment cycles. Some participants will also receive cetuximab via intravenous infusion every two weeks. Treatment continues until criteria for stopping the study intervention are met. The trial uses a randomized, parallel design to compare the two experimental arms. Throughout the study, participants will be monitored for tumor response, adverse events, and treatment discontinuations related to side effects. Researchers will also assess progression-free survival, duration of response, and overall survival up to about 76 months. The trial lasts until April 2032, with ongoing safety and efficacy evaluations during this period.

Many patients receiving radiation therapy for head and neck cancer develop painful mouth sores called oral mucositis, causing severe pain that lasts through and beyond treatment. This study evaluates whether BupiZenge, a lozenge containing the long-acting pain reliever bupivacaine, provides better pain control than lidocaine solution. The trial aims to see if improved pain management with BupiZenge enhances quality of life and reduces opioid use in adults aged 18 to 80 with head and neck cancer undergoing radiotherapy. Participants are randomly assigned to receive either BupiZenge lozenges or lidocaine oral solution. BupiZenge is taken as one lozenge that dissolves slowly in the mouth with a dosing interval of at least 3 hours, up to 8 lozenges per day. Lidocaine is used as an oral solution held in the mouth, also every 3 hours as needed, with a maximum daily dose of 120 mL. The study includes a combined screening and run-in period up to five weeks, followed by treatment during radiotherapy and for up to six weeks total if pain and sores persist after radiotherapy. Participants will record their mouth pain daily using a 0 to 10 scale, with primary measurement focusing on pain reduction over 3 hours after taking the study treatment on the last day of radiotherapy. Additional assessments include pain at other time points, opioid use, quality of life questionnaires, laboratory tests, and safety monitoring. After treatment, there is a 30-day follow-up period to evaluate lasting effects and safety outcomes.

Researchers are evaluating a digital health intervention using a mobile application called Pust Deg Bedre PDB to support self-management in patients with Chronic Obstructive Pulmonary Disease COPD. COPD patients often experience symptoms like dyspnea, cough, and chronic mucus hypersecretion, which increase infection risks and exacerbate the disease. This study aims to explore the feasibility, patient and physiotherapist experiences, and implementation of the PDB app in managing these symptoms. The intervention involves physiotherapists providing patients with training on how to use the PDB app, which offers tailored breathing and airway clearance techniques based on clinical assessment. Patients will engage with the apps treatment plan over an 8-week period, with follow-up at 6 months. Adjustments to the treatment plan may be made during the intervention. The study includes qualitative interviews and video-recorded physiotherapy sessions to gain deeper insights into the interactions and experiences of patients and physiotherapists. Participants will be assessed through questionnaires and interviews at the end of the 8-week treatment and at the 6-month follow-up. Researchers will collect both quantitative and qualitative data, including health-related outcomes, adherence, adverse events, and patient satisfaction. Physiotherapists will also be followed up to explore the impact of participation on their clinical practice. The total study duration includes the initial intervention and a long-term follow-up, aiming to gather comprehensive information on the apps usefulness and acceptability.

Researchers are evaluating the feasibility and preliminary clinical outcomes of a personalized digital treatment designed for adolescents with eating disorders aged 15 to 18 years. The study aims to understand who benefits from this digital approach, how acceptable and credible it is to participants, and the cost-effectiveness of delivering such treatment in routine child and adolescent psychiatric outpatient care. The intervention includes a therapist-guided digital program consisting of 8 modules delivered over 10 weeks, with weekly therapist contact. Participants will complete self-report questionnaires before, during, and after the treatment, as well as at 3- and 6-month follow-ups. The study also involves semi-structured phone interviews with some participants to explore their experiences with the treatment. Participants will be asked to complete various validated questionnaires assessing eating disorder symptoms, general psychopathology, quality of life, and treatment satisfaction throughout the study period. Adherence to the treatment and participant experiences will be monitored, along with health and social outcomes such as school attendance and emotional regulation. Data collection occurs online, and the total follow-up extends to six months after treatment completion.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are studying whether the handheld device called Grasp can help reduce pain and distress in children and adolescents aged 8 to 15 during small needle procedures. These procedures include venous puncture, insertion of a peripheral venous catheter, and local anesthesia injections before dental treatment. The study aims to compare the effects of using Grasp during these procedures with standard care to see if it helps improve the experience for young patients. Grasp is a soft silicone ball with pressure sensors that detect squeezes of different strengths and durations. When squeezed, it provides real-time visual and auditory feedback through an iPad application, playing melodies and showing dynamic curves. Participants in the intervention group will squeeze the Grasp ball repeatedly, starting at least 10 seconds before and continuing throughout the needle procedure. The control group will receive standard care without Grasp. In addition to the randomized trial, six children with type 1 diabetes will use Grasp during blood sugar measurements or insulin injections as part of exploratory use. During the study, participants will fill out questionnaires about their pain and distress before and after the procedure, as will their parents or guardians. Some participants at the dental clinic will use Grasp during further dental treatment and complete additional forms afterward. The main measure is self-reported pain immediately after the procedure, with secondary measures including distress reported by both children and parents. The study includes interviews with some participants to explore their experiences, and statistical analyses will assess the impact of using Grasp.

Researchers are evaluating resectability rates and survival outcomes in patients with borderline resectable and locally advanced pancreatic cancer who receive primary chemotherapy. This nationwide Norwegian single-arm prospective study follows national guidelines for diagnosis, oncological treatment, surgery, and follow-up. The goal is to achieve a 50% resection rate in borderline resectable pancreatic cancer and 15% in locally advanced cases, aiming for adequate overall survival and controlled morbidity and mortality after surgery. Participants will receive primary chemotherapy according to national guidelines, preferably using mFOLFIRINOX or gemcitabine-nab-paclitaxel regimens. Surgical exploration and resection may follow chemotherapy, with surgery scheduled within four weeks after the last neoadjuvant infusion. Surgical procedures include pancreatoduodenectomy, distal pancreatectomy with splenectomy, or total pancreatectomy with splenectomy, possibly involving venous or arterial resection and reconstruction. Diagnostic procedures include endoscopic ultrasound fine-needle biopsy for diagnosis and molecular pathology and optional PETCT scans at baseline and after two months of chemotherapy. Participants will be assessed regularly with quality of life questionnaires at baseline, 3, 6, and 12 months from diagnosis, then yearly thereafter. Researchers will monitor resection rates, overall survival, mortality and morbidity after surgery, adverse events, and molecular pathology markers. The study collects data from November 2023 through December 2027, with a focus on surgical outcomes and patient well-being following treatment.

Researchers are conducting a large observational safety study called EXCEED to assess the risk of developing pancreatic cancer in adults with type 2 diabetes mellitus T2DM who started treatment with exenatide compared to those who started other glucose lowering drugs not including GLP-1 receptor agonists. This study uses retrospective data from multiple European countries collected from 2006 to 2023. Patients are matched by various factors to compare outcomes using an intention-to-treat approach. The study identifies two groups of patients those who initiated exenatide treatment and those who started other non-GLP-1 RA based glucose lowering drugs. Medication exposure is determined through prescription records or insurance claims available in eight data sources across seven countries. The follow-up period averages about 1.5 years or less, during which the occurrence of a primary diagnosis of pancreatic cancer is recorded and analyzed. Participants are not actively treated as part of the study but are observed through existing healthcare data. The main measurement is the incidence rate and hazard ratio of pancreatic cancer diagnosis during follow-up. Data includes medical histories, prescriptions, and diagnoses collected retrospectively. The study spans from 2024 to 2026 and aims to provide long-term safety information regarding exenatide use in T2DM patients.

Researchers are comparing INCA033989 with the best available therapy for adults who have essential thrombocythemia ET with a CALR mutation and have previously received cytoreductive treatment. The study aims to evaluate the effects of these treatments on this specific patient group. It is a Phase 3 clinical trial sponsored by Incyte Corporation to assess treatment responses and safety. Participants will be randomly assigned to receive either INCA033989 administered intravenously or the best available therapy chosen by their doctor. The treatments are given according to the study protocol. The study focuses on treatment outcomes over a period of weeks, including response durability and symptom changes, with assessments at specified timepoints. During the study, participants will have regular visits to monitor their clinical and hematologic responses, symptoms, and any side effects. Researchers will collect data on mutation levels, symptom questionnaires, and fatigue assessments up to 48 weeks. Safety monitoring will continue for 60 days following the last dose. The total duration of participation may extend up to several months as outlined by the trial schedule.