Trondheim

Researchers are investigating new treatment options for meningiomas that continue to grow despite local therapies like surgery or radiotherapy. This trial focuses on evaluating a precision medicine approach that combines PET-based imaging to select patients with tumors expressing somatostatin receptors and a targeted radioligand therapy called 177Lu-DOTATATE. This is the first randomized clinical trial studying this therapy in patients with meningiomas that have not responded to other treatments. Participants will be randomly assigned to one of two groups. One group receives 177Lu-DOTATATE through intravenous infusions every four weeks for a total of four cycles. The other group receives local standard care, which may include treatments like hydroxyurea, bevacizumab, sunitinib, octreotide, everolimus, or observation with supportive care, based on the investigators choice. This study is designed to compare the effects of 177Lu-DOTATATE against various standard treatments in this patient population. During the study, participants will undergo regular MRI scans to measure tumor size and progression. Researchers will also assess overall survival, neurological function, quality of life, and treatment side effects over a period extending up to two years after enrollment. Monitoring includes imaging, laboratory tests, and health questionnaires to evaluate how the disease and treatments affect participants over time.

Researchers are evaluating the potential effects of a 3-day course called the Lightning Process LP for adults with Chronic Fatigue SyndromeMyalgic Encephalomyelitis CFSME. CFSME is a serious condition causing heavy symptoms, low function, and significant impact on work and social life. The study aims to explore both positive and negative effects on symptoms, disability, quality of life, and long-term work participation, addressing a challenging health and societal problem in Norway. The study randomly assigns about 100 adults with CFSME to either participate in the 3-day LP course or receive treatment as usual initially. The LP course includes teaching on stress theory, Positive Psychology, and techniques to regulate thoughts, feelings, and behavior to influence physiology positively. Those initially on the waiting list receive the LP course after 10 weeks. Adverse events during or after the course are monitored and managed according to protocol. Participants will be followed up with assessments including physical function at 10 weeks after the course and fatigue, pain, post-exertional malaise, mental wellbeing, overall improvement at 6 months. Work participation and sick leave are tracked at 24 months. The study involves questionnaires and evaluations to measure these outcomes, aiming to provide evidence-based knowledge for better CFSME care. The study runs until December 2028.

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Researchers are evaluating the efficacy and safety of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced Stage III, unresectable non-small cell lung cancer NSCLC whose disease has not progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

Researchers are evaluating the long-term effects of mirikizumab treatment in children and teenagers aged 2 to 19 years with moderate-to-severe ulcerative colitis or Crohns disease. This phase 3 study aims to assess the clinical remission rates and other health outcomes related to these conditions over an extended period. The study is sponsored by Eli Lilly and Company and follows a treatment focus for pediatric participants with these inflammatory bowel diseases. Participants receive mirikizumab administered by subcutaneous injections, with doses adjusted based on their weight. There are up to six planned doses, and if needed, intravenous rescue dosing is available if a participants condition worsens. The study may include a continued access period providing additional treatment beyond the main study duration. Participants are involved for about 172 weeks, attending up to 44 visits throughout the study. Regular assessments include evaluating clinical remission using the Modified Mayo Score for ulcerative colitis and the Pediatric Crohns Disease Activity Index for Crohns disease, along with other response and remission measures. Researchers monitor laboratory tests such as C-reactive protein levels and track corticosteroid use. Safety and health status are closely observed during the study and any continued treatment periods.

Childhood obesity is a growing global health concern linked to serious health problems such as type 2 diabetes, high blood pressure, certain cancers, and mental health challenges. Researchers are evaluating a digital support system called Evira to help improve treatment outcomes for children with obesity. This randomized controlled study aims to assess the effects of adding Evira to the usual lifestyle treatment for childhood obesity in children aged 4 to 17 years. The study compares two groups one receiving Evira Care combined with standard lifestyle treatment, and the other receiving standard lifestyle care alone. Evira Care involves daily weight monitoring at home using a special scale connected to a mobile app and website, allowing parents and clinicians to track weight changes and communicate easily. The intervention group will receive guidance on how to use the system and make feasible lifestyle changes, with weight targets set for the first three months. The control group continues with standard care without restrictions on visits or clinical support. Participants will be involved for 12 months, undergoing clinical exams including puberty assessment, cardio-respiratory, thyroid, skin, and abdominal checks, along with measurements of weight, height, and blood pressure. Blood tests may be done as needed. All participants will complete questionnaires about quality of life, eating disorders, and treatment satisfaction. Researchers will monitor weight change as the primary outcome, along with treatment compliance and psychosocial health measures, while collecting information on any side effects.

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 evaluating an intermittent dosing approach of ibrutinib, a drug used to treat advanced-phase chronic lymphocytic leukemia CLL and small lymphocytic lymphoma SLL. The study explores whether stopping and restarting ibrutinib based on disease progression can maintain disease control while potentially reducing drug costs and side effects. This pilot study focuses on patients who have already received at least six months of ibrutinib and achieved a stable partial remission. Participants will follow an ON-OFF dosing schedule where ibrutinib is stopped after stable partial response and restarted upon clinical progression. The drug is given at the standard daily oral dose of 420 mg during ON periods, and cycles of treatment and off-therapy periods may be repeated until resistance, intolerance, or the need for continuous dosing arises. This approach is being tested to assess the feasibility of intermittent therapy. Throughout the study, participants will be monitored for safety by tracking adverse events over 1 to 24 months. Researchers will also evaluate response rates, time to partial remission, duration off therapy before restarting ibrutinib, cumulative dose, survival, risk of early disease rebound, and time until alternative treatments are needed. Participants will have regular visits for clinical assessments, laboratory tests, and adherence to the study schedule.

Researchers are evaluating how well machine learning ML models can predict the effects of migraine preventive treatments for adults with episodic or chronic migraine. The study aims to identify patient features such as sociodemographic information, headache patterns, and related health conditions to help predict which treatments may work best. This observational trial compares the predicted treatment effects from ML models to the actual observed effects after treatment. Participants will start by providing information through a phone consultation and questionnaire. Headache days are tracked for 4 weeks before beginning a migraine preventive prescribed by their physician. The study then monitors headache days during the first 12 weeks of treatment, divided into 28-day periods, to assess if the preventive reduces headache frequency by 50% or more. Participants may undergo up to two treatment periods, each followed by a phone call to assess outcomes. The total participation time can be up to 28 weeks. During the study, researchers collect sociodemographic, headache, and comorbidity data before treatment starts. Participants will have follow-up phone calls after each treatment period to evaluate outcomes. The main measure is the accuracy of ML models in predicting treatment response based on a 50% reduction in headache days. Secondary measures include time to treatment response and success rates of first-line therapies. The study observes standard care without interfering with treatment decisions and does not include blinding or control groups.

This trial focuses on elderly patients aged 80 years or older, or those 75 years and older who are considered frail, with untreated diffuse large B-cell lymphoma DLBCL and related lymphoma subtypes. The study is a phase III, randomized, open-label, multicenter trial conducted in several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. It aims to compare the standard chemotherapy regimen R-miniCHOP with an experimental treatment R-pola-miniCHP, where vincristine is replaced by polatuzumab vedotin, to assess differences in outcomes for this patient population. Participants will be randomly assigned to one of two treatment groups. One group will receive R-mini-CHOP consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone over six 21-day cycles. The other group will receive R-pola-mini-CHP, which includes rituximab, cyclophosphamide, doxorubicin, prednisone, and polatuzumab vedotin instead of vincristine, also given over six 21-day cycles. Both treatments last approximately 18 weeks. The study includes a screening period lasting up to 4 weeks before treatment begins. During the study, participants will be followed for up to 36 months after completing treatment to monitor progression-free survival over two years. Researchers will evaluate disease progression and safety outcomes through regular assessments during and after the treatment period. Participants will provide informed consent and undergo evaluations including health status and disease measurements to ensure eligibility and monitor treatment effects throughout the trial.