Haukeland

Researchers are conducting an international, open-label, randomized phase III trial to evaluate the effectiveness of chemotherapy and radiotherapy treatments for patients with high-risk neuroblastoma. The study includes three sequential randomizations to compare different induction chemotherapy regimens, consolidation high-dose chemotherapy HDC approaches, and radiotherapy strategies. The goal is to improve event-free survival EFS over three years among children and young adults diagnosed with this aggressive cancer. The first randomization compares two induction chemotherapy regimens RAPID COJEC versus GPOH. The second randomization assesses single HDC with Busulfan-Melphalan Bu-Mel versus tandem HDC with Thiotepa followed by Bu-Mel. For patients with macroscopic residual disease after surgery and HDC, the third randomization compares standard radiotherapy 21.6 Gy to the tumor bed versus the same radiotherapy plus an additional boost 14.4 Gy. Patients without residual disease receive standard radiotherapy to the tumor bed. Treatments include various chemotherapy drugs, immunotherapy with dinutuximab beta, and radiotherapy delivered according to the assigned groups. Participants will undergo multiple assessments including disease evaluation after induction chemotherapy and surgery, blood tests, and monitoring of organ function. Researchers will measure event-free survival at one year after each randomization sequence. Patients are followed through the different phases of induction, consolidation, and radiotherapy, with adherence to protocol visits and procedures required. Safety and treatment responses are closely monitored throughout the study, which continues until the end date in November 2032.

Researchers are evaluating an optimized expansion strategy for transcatheter aortic valve implantation TAVI in patients without atrial fibrillation who have severe native aortic valve stenosis. The study compares this optimized method, which involves systematic pre- and post-dilatation of the implanted valve, against the standard of care TAVI approach. The goal is to assess whether the optimized technique better reduces hypoattenuating leaflet thickening, a condition measured by cardiac computed tomography CT imaging three months after TAVI. Participants will be randomly assigned to one of two groups the standard of care TAVI group, where pre- and post-dilatation are optional and decided by the operator, or the optimized expansion TAVI group, where systematic pre- and post-dilatation are performed with an optimally sized balloon. The balloon size is based on specific measurements of the native aortic annulus. Both groups undergo the TAVI procedure using either self-expanding or balloon-expandable valves, with post-dilatation encouraged only under certain conditions in the standard care group. During the study, patients will have baseline assessments including medical history, electrocardiogram, echocardiography, and cardiac CT scans. Follow-up visits are scheduled at hospital discharge, and at approximately 3 months, 1 year, and 5 years post-procedure. At these visits, transthoracic echocardiography and various imaging studies like cardiac CT or PET-CT scans will evaluate valve leaflet thickening, valve performance, and other health outcomes. The primary outcome focuses on leaflet thickening at three months, with multiple secondary outcomes assessed up to five years to monitor valve function and patient safety.

Researchers are evaluating the effectiveness of oral pivmecillinam as a step-down treatment for adult patients with febrile urinary tract infections fUTI caused by Escherichia coli. This phase 4, randomized controlled trial compares pivmecillinam to standard antibiotic treatments following initial intravenous therapy. The study aims to see if pivmecillinam, a narrow-spectrum antibiotic, is as effective as the usual care in resolving infection symptoms and preventing bacterial growth in urine. Participants who have received 2 to 4 days of intravenous antibiotics and shown improvement will be randomly assigned to either oral pivmecillinam or standard treatment, which may include various oral or intravenous antibiotics determined by their doctor. Pivmecillinam will be taken as 400 mg tablets four times daily for 7 or 10 days depending on patient factors. The control group will receive standard care antibiotics for 7 to 14 days. Some participants will provide additional samples to study the drugs effects on gut bacteria and how it is processed in the body. During the study, participants will keep a diary to record medication use, symptoms, and side effects, and will have phone interviews 7 and 28 days after treatment ends to assess recovery. Urine samples will be collected at these times to check for bacteria. Subgroups will provide fecal samples over three months to study microbiome changes, and blood and urine samples will be taken from some on pivmecillinam to understand drug levels. The study will monitor clinical and microbiological responses as well as adverse events throughout the follow-up period, which extends up to 28 days post-treatment with some assessments continuing for three months.

Researchers are evaluating a Scandinavian decision support tool designed to help manage children with mild and moderate head injuries who seek care in emergency departments. The study focuses on whether these guidelines can reliably identify children with important complications, such as bleeding in or around the brain, following head trauma. This is a prospective, multicenter observational study including hospitals in Sweden and Norway that routinely treat children with traumatic brain injuries. The study involves no changes to usual care all children receive standard management regardless of participation. Data is collected on patient history, symptoms, and treatment during the emergency visit and entered into electronic case report forms. Follow-up is conducted through medical records and electronic questionnaires sent to guardians at 1, 3, and 4 months after injury, with long-term outcomes assessed beyond 6 months. A sub-study will also explore blood and saliva biomarkers to predict brain injury in certain cases. Participants will be monitored through clinical examinations, CT scan results, and questionnaires about recovery. The study measures outcomes like clinically important brain injury within one week, need for neurosurgery, CT findings, hospital admission, and time to full recovery. Safety and long-term effects are followed for up to four years. Data is analyzed to assess how well the Scandinavian and other international guidelines predict outcomes for children with head trauma.