Levanger

Researchers are evaluating a medicine called nerandomilast for adults with systemic sclerosis, a condition affecting the skin and internal organs. The study focuses on people with limited or diffuse cutaneous systemic sclerosis who have had symptoms for less than 7 years. The goal is to see if nerandomilast helps improve symptoms and slows disease progression while assessing how well the medicine is tolerated. Participants are randomly assigned to one of two groups one takes nerandomilast tablets, and the other takes placebo tablets that look identical but do not contain medicine. Tablets are taken twice daily. The study lasts from 1 to about 4 years, with regular visits to the study site and phone check-ins. During visits, participants have blood tests and assessments of skin thickening, lung function, and organ health to monitor changes and treatment effects. Throughout the study, doctors monitor participants overall health and any side effects. They regularly assess safety and tolerability of the treatment. The main outcome measured is the time to disease progression or death over up to 4 years. Other outcomes include changes in skin scores, lung capacity, physical function, and disease impact questionnaires. Participants health is closely followed during the study period.

Researchers are exploring the use of a Deep Neural Network DNN to assist in evaluating mediastinal and hilar lymph nodes during Endobronchial Ultrasound EBUS procedures. The study aims to determine how well the DNN can identify lymph nodes and blood vessels in patients with undiagnosed enlarged lymph nodes, using ultrasound images. This study is conducted across multiple centers and focuses on lung cancer-related imaging. The study involves training the DNN with annotated ultrasound images to recognize and segment lymph nodes and blood vessels. Initially, the DNNs performance will be assessed using postoperative processed images and static EBUS images. In a later phase, the DNN will be applied in real time during EBUS procedures. The intervention includes a machine learning algorithm running on EBUS images to label mediastinal lymph nodes and their levels during the procedure. Participants referred to thoracic departments with enlarged lymph nodes will be involved. Researchers will evaluate the DNNs capability over 8 months, along with measures of precision, sensitivity, specificity, similarity coefficient, run-time, and monitor adverse events shortly after procedures. The study includes various assessments of the DNNs accuracy and safety, with data collected from ultrasound imaging during and after the EBUS procedure.

Researchers are evaluating the usefulness of circulating tumor DNA ctDNA markers found in blood as a liquid biopsy for diagnosing, predicting outcomes, and monitoring colorectal cancer. The study aims to determine if a panel of ctDNA markers can identify colorectal cancer patients among those scheduled for colonoscopy, and whether the type, number, and level of these markers vary with different colorectal cancer subtypes and their clinical progression. Participants will provide a blood sample and answer a questionnaire at the start of the study. Patients diagnosed with colorectal cancer will be asked to give an additional blood sample during their routine treatment and follow-up visits. This observational study does not involve any experimental treatments but focuses on collecting and analyzing blood samples to assess ctDNA markers. During the study, participants will undergo colonoscopy and be monitored for outcomes such as colorectal cancer, colorectal adenoma, and inflammatory bowel disease within three months after the procedure. Patients with colorectal cancer will be followed for up to five years to track recurrence, treatment response, and survival. The study includes questionnaires and blood tests to gather detailed information and monitor disease progression and response over time.

Researchers are evaluating the effectiveness of approved anti-cancer drugs used outside their usual indication for patients with advanced cancer who have specific molecular changes identified through diagnostic testing. This nationwide, phase 2 clinical trial in Norway uses a combined umbrella and basket design with a Simon two-stage model to study various drug and biomarker combinations across different cancer types. Biological samples will be collected at presentation, during treatment, and upon disease progression to better understand drug response and resistance through advanced genetic analyses, including whole genome sequencing. The study involves patients who have advanced cancers no longer benefiting from standard treatments and who have molecular profiles indicating potential benefit from one of the approved drugs in the trial. Participants will receive treatment with drugs such as atezolizumab, alectinib, and others, used beyond their usual indications based on biomarker profiles. Treatment plans are guided by a national molecular tumor board, and fresh tumor biopsies will be collected before treatment to support biomarker studies. New patient cohorts may be opened as needed based on molecular subgroups and drug availability. Participants will be monitored for tumor response, progression-free survival, overall survival, and treatment duration. Data on treatment toxicity will be collected, and all treatment and outcome information, along with molecular screening results, will be reported to the Cancer Registry of Norway. Long-term follow-up will also use national registries to track patient outcomes. Patients who are screened but not enrolled will be followed for 16 weeks to monitor survival and disease progression.

Researchers are evaluating if patients with acute heart failure can achieve the same level of heart failure medication management through digital follow-up at home compared to traditional hospital visits, based on the STRONG-HF strategy. This study addresses the challenge of low use of recommended heart failure therapies despite evidence showing they reduce mortality, aiming to improve care delivery by testing remote medication up-titration and follow-up. The trial builds on the STRONG-HF trials success, which showed better outcomes with early medication adjustment and follow-up in specialized clinics but faced barriers due to frequent hospital visits. Participants will be randomly assigned to one of two groups one receiving follow-up and heart failure medication management at home via telecommunication led by specialized nurses, including home visits at 1, 2, 3, and 6 weeks plus a primary care physician visit around week 2 the other group receiving follow-up and medication management at hospital outpatient clinics on the same schedule. Both groups follow the STRONG-HF intensive care strategy with early and rapid medication up-titration to at least half the maximum tolerated doses at discharge and then to maximum tolerated doses after 2 weeks, with safety visits at weeks 1, 3, and 6. During the 90-day study period, participants will be monitored for medication doses, heart function via echocardiography, blood tests including NT-proBNP, quality of life assessments, self-care, and patient satisfaction. Readmissions and survival will be tracked for up to 24 months. Follow-up visits occur weekly during the first 6 weeks, and researchers will assess treatment adherence, adverse events, and healthcare costs. This approach aims to reduce the burden on patients and healthcare systems while maintaining effective heart failure care.

Researchers are evaluating whether using risk stratification tools based on machine learning can detect clinically significant prostate cancer as well as the current standard practice of performing MRI scans for men suspected of having prostate cancer. The study focuses on men aged 50 to 75 who have elevated prostate-specific antigen PSA levels or suspicious digital rectal exam results. The goal is to find out if these tools can reduce unnecessary MRIs and biopsies, lower health anxiety, and improve cost-effectiveness while maintaining cancer detection rates. In this study, all participants undergo risk assessment using the European Randomised Study of Screening for Prostate Cancer ERSPC risk calculators to decide if further testing with MRI and biopsy is needed. This approach is compared to the usual care where most men with elevated PSA receive an MRI and, if necessary, a prostate biopsy. The study evaluates whether risk stratification can safely reduce the number of MRIs and biopsies without missing significant cancers. The study is interventional with a single group design. Participants will be followed during the initial diagnostic work-up lasting up to six weeks to measure detection of clinically significant prostate cancer. Additional outcomes include detection of insignificant cancer, number of biopsies and MRIs performed, quality of life impacts related to biopsy decisions, and cost-effectiveness assessed one year after inclusion. Researchers will monitor participants health-related quality of life and assess the efficiency of diagnostic procedures over time.

This research aims to evaluate a psychoeducational course designed to help patients who have a history of increased suicide risk. The study compares this group intervention to a control group receiving a single individual session focused on safety planning. Both groups will continue to receive treatment as usual during acute care and follow-up. The study is conducted as a randomized controlled trial involving patients admitted to acute psychiatric wards or those in contact with outpatient emergency psychiatry teams. Participants randomized to the psychoeducational course will attend group sessions that include three meetings for patients and one session for their next of kin. The sessions cover topics such as understanding suicidal thoughts and behaviors, recognizing triggers and early warning signs, and creating personalized safety plans to prevent future suicide risk. The control group receives one individual therapy session focused on suicide risk and safety planning with a psychologist or physician. Both groups continue treatment as usual, which may include medication and occupational therapy. During the study, participants will complete assessments measuring self-efficacy, mental pain, depression, and anxiety immediately after intervention and at 6, 12, 24, and 60 months post-intervention. Researchers will also track suicide attempts, suicide deaths, psychiatric hospital admissions, and other related outcomes over the same follow-up periods. The study includes blinded data collection and rating to reduce bias, with a total participation duration extending up to five years after the intervention.

Ankle fractures are common injuries occurring in about 1 in 800 people each year. This research evaluates whether repairing the deltoid ligament in unstable ankle fractures improves joint stability, functional outcomes, and may help prevent long-term osteoarthritis. The study focuses on patients with severe ankle fractures, as these injuries can significantly reduce daily function and affect the ability to work, potentially increasing community healthcare costs. Participants will be randomly assigned to one of two groups one receiving standard treatment involving plate and screw fixation of the lateral malleolus only, and the other receiving the same standard treatment plus an additional surgical repair suture of the deep deltoid ligament. The ligament repair involves a specific surgical technique where the ligament is reattached to an anchor in the talus. This multicenter randomized controlled study aims to compare these approaches in unstable Weber B ankle fractures. During the study, participants will be evaluated through patient-reported functional outcomes and radiological stability measurements at 1 and 2 years after injury, with functional outcome data also collected at 5 years. Additional assessments include general health, pain levels, ankle arthritis development, and foot and ankle function scores collected at various intervals up to 5 years. Researchers will monitor the long-term effects of ligament repair on ankle stability and function, with follow-up visits planned to assess recovery and outcomes.

Researchers are conducting an observational study to understand how new immunotherapies are used in treating multiple myeloma and related conditions in Norway. The study aims to fill knowledge gaps, provide evidence for future trials, and help develop guidelines for monitoring and managing side effects to improve patient survival and quality of life. This research focuses on patients with multiple myeloma, primary plasma cell leukemia, and AL amyloidosis. Participants are observed while receiving immunotherapies including Teclistamab, Elranatamab, Talquetamab, Idecabtagene vicleucel, and Ciltacabtagene Autoleucel as part of their routine care outside of clinical trials. The study monitors how these treatments are used in real-world settings, including dosing and administration. There is no assigned treatment group or placebo instead, the study collects data on treatments given during regular healthcare. Throughout the study, participants response to treatment, progression-free survival, time to next treatment, overall survival, and adverse events are tracked for up to ten years. Researchers collect data on infections, antibiotic resistance, airway viruses, and use of antimicrobial prophylaxis during therapy. This long-term monitoring aims to provide comprehensive safety and effectiveness information to guide future care and research.

Researchers are evaluating whether treating minimal residual disease MRD relapse earlier, after first line treatment for multiple myeloma, can prolong progression-free survival and overall survival compared to treating relapse at progressive disease. This study focuses on patients who become MRD negative after standard first line treatment including autologous stem cell transplantation, aiming to form a uniform group for comparison. The trial is conducted in phases II and III to assess these outcomes over many years. Participants with newly diagnosed multiple myeloma eligible for high-dose therapy will first receive standard Norwegian care bortezomib, lenalidomide, and dexamethasone in 21-day cycles, with four cycles before and after transplant. After induction, patients undergo single or tandem autologous stem cell transplant ASCT based on response and toxicity. Those achieving MRD negativity post consolidation will be randomly assigned to start second-line treatment either at MRD relapse arm A or at progressive disease arm B. Both groups receive the same 28-day cycle treatment of carfilzomib, dexamethasone, and daratumumab until progression, unacceptable side effects, or withdrawal. During the study, patients will have regular MRD assessments every four months in arm A and standard follow-up in arm B, with additional MRD checks scheduled at specific timepoints during second-line treatment. Researchers will measure progression-free survival, overall survival, MRD negativity rates, time to next treatment, and quality of life over 10 to 11 years. Participants will be closely monitored for safety and treatment response throughout their participation, which can last many years depending on outcomes.