Haukeland

Researchers are conducting an international, multicenter, open-label, phase III trial to evaluate the effectiveness of induction and consolidation chemotherapies and radiotherapy in patients with high-risk neuroblastoma. The study includes three sequential randomizations to compare different treatment regimens and assess their impact on event-free survival over three years. This trial also examines the role of local treatment based on the presence of residual disease after surgery and high-dose chemotherapy. The first randomization compares two induction chemotherapy regimens: RAPID COJEC and GPOH. The second randomization evaluates single high-dose chemotherapy with Busulfan-Melphalan versus tandem high-dose chemotherapy with Thiotepa followed by Busulfan-Melphalan. For patients with macroscopic residual tumor after surgery and high-dose chemotherapy, the third randomization compares radiotherapy alone (21.6 Gy) to radiotherapy plus an additional boost of 14.4 Gy. Patients without residual disease receive standard radiotherapy to the preoperative tumor bed. Participants will undergo multiple assessments including disease evaluation after induction chemotherapy and surgery, laboratory tests, and monitoring of organ function and performance status. Researchers will measure event-free survival at the end of each randomization sequence up to one year and longer-term outcomes. Safety monitoring and consent procedures are integral, and participants are expected to comply with study visits and procedures throughout the treatment and follow-up periods.

Researchers are evaluating if oral treatment with pivmecillinam is effective for adults hospitalized with febrile urinary tract infections (fUTI) caused by Escherichia coli. This Phase 4, open-label randomized clinical trial compares oral pivmecillinam to standard oral or intravenous antibiotic treatments following 2-4 days of intravenous therapy. The study aims to determine whether pivmecillinam is as effective as standard care by assessing clinical and microbiological responses after treatment. Participants will be randomly assigned to receive either pivmecillinam tablets (400 mg four times daily) for 7 or 10 days depending on patient factors, or standard care antibiotics chosen by their physician for 7 to 14 days. The control treatments include various intravenous and oral antibiotics guided by laboratory susceptibility testing. Some participants will provide additional samples to study changes in the gut microbiome and the pharmacokinetics of pivmecillinam. During the study, patients will keep a diary recording medication use, body temperature, urinary symptoms, and side effects until 7 days after treatment ends. Phone interviews will be conducted 7 and 28 days after treatment to assess clinical response. Urine samples will be collected at these times to evaluate bacterial growth. Subgroups will provide fecal samples over three months and blood and urine samples to study drug effects and metabolism. The main outcome is clinical response measured about one week after treatment ends.

Researchers are evaluating the Scandinavian guidelines designed to manage children with mild and moderate head injuries who visit emergency departments in Sweden and Norway. The study aims to determine how sensitive these guidelines are in identifying important patient outcomes, such as serious brain injuries, without introducing any new treatments. This observational study includes children under 18 years old who have suffered blunt head trauma within 24 hours and seeks to improve the accuracy of decision-making tools used in emergency care. Participants will be managed according to their hospital's usual care practices without any changes or experimental treatments. Doctors and nurses will collect detailed information about each child's injury, symptoms, and treatment in a web-based case report form. In some centers, a sub-study will collect blood and saliva samples within 12 hours of injury to analyze biomarkers that might predict brain injury. CT scans, when performed, will be reviewed by certified radiologists. During the study, follow-up information will be gathered from medical records and questionnaires sent to guardians at 1, 3, and 4 months after the injury, with additional long-term follow-up after 6 months. Researchers will track outcomes like the number of children with serious brain injuries within one week of trauma. Data will be analyzed statistically to assess how well the guidelines predict important outcomes and to explore the potential of biomarkers to reduce unnecessary CT scans. The study plans to enroll up to 5,300 children over about four years.