Kristiansand

Amyotrophic lateral sclerosis (ALS) is a serious, fast-progressing nervous system disease with an average survival of 2.5 years after diagnosis. Currently, effective treatments are limited to Riluzole. Research suggests that increasing cell access to Nicotinamide Adenine Dinucleotide (NAD) and stimulating enzymes called sirtuins may slow disease progression. This study aims to evaluate whether a combination of Nicotinamide Riboside (NR) and Pterostilbene, called EH301, can slow neurodegeneration, delay disease progression, improve survival, and enhance quality of life in ALS patients. The NO-ALS extension study follows patients who completed the original NO-ALS trial. All participants receive the active treatment EH301, which combines Nicotinamide Riboside and Pterostilbene, as an open-label extension. This study provides patients the option for compassionate use of the supplement while assessing its effects on motor symptoms, lung function, and survival. Participants will be monitored for adverse events throughout the study, which lasts up to 1 year. Researchers will track safety, progression of motor symptoms, changes in vital capacity, and overall survival. This extension allows long-term observation of EH301's impact on ALS progression and patient well-being.

Researchers are evaluating a complex intervention aimed at implementing advance care planning (ACP) for severely ill elderly patients who live at home and are acutely admitted to hospital. The study uses a cluster randomized design involving twelve Norwegian hospital units specializing in geriatric care. It seeks to understand current ACP implementation, identify barriers and facilitators at multiple levels, explore ethical dilemmas, and assess the benefits and challenges experienced by patients, relatives, and healthcare staff. The project also aims to measure the impact of an implementation support program on communication quality, decision-making, and healthcare outcomes, as well as its cost-effectiveness. The intervention includes a comprehensive implementation support program featuring leadership commitment, responsive evaluation, a whole ward approach, and a train-the-trainer model to ensure sustainability. This program provides an implementation team and ACP coordinators, along with training, supervision, network conferences, and shared resources such as guidelines and teaching materials. The clinical intervention involves routine information and invitation to ACP for eligible patients, written materials for patients and relatives, and documentation with collaboration across healthcare levels. Half of the hospital units receive this support immediately, while the others receive it after the intervention period. Participants are involved through questionnaires to staff, clinicians, patients, and relatives, as well as patient record reviews and qualitative interviews. The study measures fidelity to the ACP model at multiple time points and evaluates patient-reported, relative-reported, and clinician outcomes during the intervention period, which spans 10 to 18 months after starting the support. Researchers also assess barriers and facilitators in wider healthcare contexts and perform economic analyses. The total involvement includes baseline and follow-up assessments up to 18 months.

Researchers are evaluating the safety and effectiveness of stopping antibiotic treatment early in adult patients hospitalized with respiratory virus infections. This study addresses concerns about antibiotic overuse in community-acquired pneumonia, which can lead to resistance. The trial focuses on patients with moderately severe disease who test positive for respiratory viruses like influenza, RSV, and others, aiming to see if stopping antibiotics early is as safe and effective as continuing them. Participants are adults 18 years or older who are already on antibiotics started by their admitting doctor. They will be randomly assigned to either stop antibiotic therapy or continue it as usual. The main goal is to compare early clinical response at 120 hours after randomization, defined by survival with symptom improvement without needing additional antibiotics. The study also looks at mortality rates, length of hospital stay, and total antibiotic use. During the study, researchers will monitor symptoms, treatment needs, and patient outcomes closely. They will track improvements or worsening of symptoms and record any additional treatments required. The involvement period includes hospitalization and follow-up through the early clinical response time point. Safety and treatment effects will be assessed carefully to determine if early antibiotic discontinuation is a viable option.

Researchers are investigating whether a shorter duration of immunotherapy is as effective as the current standard for patients with high-risk malignant skin melanoma who have undergone radical surgery. This phase 3 international study focuses on patients aged 18 and older with stage IIb-c, III, or IV melanoma. The goal is to compare six months versus twelve months of immunotherapy to determine if the shorter treatment can prevent cancer recurrence as well as the longer one, potentially reducing side effects, hospital visits, and healthcare costs. The study treatment involves immunotherapy using drugs nivolumab or pembrolizumab given intravenously according to routine clinical practice. Patients are randomized to receive either six months (experimental group) or twelve months (standard group) of treatment. For those who received neoadjuvant immunotherapy before surgery, treatment durations are adjusted accordingly to total six or twelve months. Follow-up includes imaging scans at baseline, six months, and thirty-six months, along with medical examinations at multiple time points up to three years. If relapse occurs, further evaluations and treatment decisions are made by a multidisciplinary team. Participants will have regular visits for physical exams, imaging tests, and blood work to monitor their health and treatment response. The main outcomes measured are relapse-free survival and distant metastatic-free survival at two years. Overall survival and health economic effects will also be assessed. Patients are followed for up to five years to track survival and any disease recurrence, ensuring close monitoring of safety and effectiveness throughout the study period.

Researchers are studying the use of molecular biomarkers to personalize treatment for patients with endometrial cancer. This includes evaluating biomarkers identified in prior studies to improve surgical treatment decisions and chemotherapy response predictions. The trial is divided into two parts: first, testing biomarker-guided lymphadenectomy during surgery; second, assessing the biomarker stathmin to predict response to taxane chemotherapy in endometrial and ovarian cancer patients. In the first part, patients with low-risk tumors defined by hormone receptor status will avoid pelvic and para-aortic lymphadenectomy, while high-risk patients will undergo this surgical procedure. In the second part, patients receiving weekly taxane treatment will have tissue biopsies and urine samples collected to measure stathmin levels, with imaging performed every eight treatment cycles until disease progression. Stathmin levels are analyzed centrally to guide treatment decisions. Participants will be followed clinically for five years, with ongoing collection of survival and recurrence data. They will complete quality of life questionnaires during follow-up. For the chemotherapy group, urine and blood samples are collected weekly during treatment cycles and imaging is done periodically. The main outcomes include the number of cancer recurrences five years after diagnosis and the duration of treatment response in metastatic disease as related to stathmin levels.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

Researchers are evaluating whether proactive therapeutic drug monitoring (TDM) is better than standard care for maintaining steady disease control in adults with rheumatoid arthritis (RA) who are treated with a subcutaneous tumor necrosis factor inhibitor (adalimumab). This Phase 4 study aims to determine if adjusting drug doses based on regular blood tests for drug levels and anti-drug antibodies can prevent disease flare-ups more effectively than standard dosing without such monitoring. Participants will be randomly assigned to one of two groups. The TDM group will have their adalimumab doses adjusted following specific rules based on blood test results to keep drug levels within a therapeutic range. Dose intervals may be shortened, lengthened, or therapy switched depending on antibody levels and drug concentration. The standard care group will continue treatment without these blood test-based adjustments. The study lasts 18 months with visits at baseline, 4, 8, 12, and 18 months, along with digital visits at 2, 6, 10, 14, and 16 months, including blood sampling at each visit. Participants will have regular blood tests to measure drug levels and antibodies every two months. They will attend on-site and digital visits for assessments of disease control and safety. The primary outcome is sustained disease control without flare over the 18-month follow-up. Researchers will monitor adherence, safety, and treatment effectiveness throughout the study period to compare the two treatment approaches.

Amyotrophic lateral sclerosis (ALS) is a serious and rapidly progressing nervous system disease with an average survival of two to three years after diagnosis. Patients experience significant physical and psychological suffering, and apart from the drug Riluzole, no effective treatment exists. The care for advanced ALS is costly, and one major challenge is deciding whether to extend ventilation support as the disease progresses, which can maintain quality of life but also imposes a heavy caregiving burden on family and healthcare workers. This study evaluates the impact of long-term mechanical ventilation support on the quality of life of ALS patients and their families. Patients either choose life-prolonging treatment with long-term mechanical ventilation support or decline it. The study involves using questionnaires to measure overall quality of life, health-related quality of life, and disease-specific quality of life before and after starting ventilation support. Participants include ALS patients, their partners, and children aged 8 and older. The study collects data at inclusion and at 3, 9, 15, and 21 months after inclusion using the Quality of Life Scale. Researchers aim to provide valuable information to help patients and clinicians make shared decisions about ventilation support by understanding its effects on patients and their families over time.

This research focuses on acute ischemic stroke patients with large vessel occlusion, evaluating the introduction of mechanical thrombectomy at a limited-volume stroke center in South-East Norway. The study aims to assess whether implementing this treatment, guided by a simulation-based quality assurance program, can reduce patient morbidity and mortality. The hospital's limited patient volume poses challenges, so the quality program includes systematic skill training and continuous guideline updates to support treatment quality. Patients receive care under a simulation-based quality program involving stroke team simulation and virtual reality task training. This program supports the introduction of mechanical thrombectomy to improve treatment timelines and outcomes. The study tracks important time periods from stroke onset through treatment, documents technical outcomes like reperfusion levels, and monitors complications during thrombectomy procedures. Participants are observed for mortality, morbidity, and symptomatic intracranial hemorrhage within specified time frames, including 24 hours and 3 months after treatment. The research includes monitoring technical and clinical outcomes, adverse events, and performance in simulation training over time. The total participant involvement covers acute treatment and follow-up assessments to evaluate the effects of thrombectomy introduction at this hospital.

This research aims to determine if a home-based exercise program called "five plus training" can improve walking ability more than the usual recommendation of walking daily for patients with intermittent claudication, a condition causing pain in the calf muscles due to reduced blood flow. The study focuses on patients who experience calf pain after walking short distances and evaluates the impact of different exercise approaches on their walking capacity and quality of life. Participants will be randomly assigned to one of two exercise groups: one group will follow the "five plus training," which involves standing and lifting the body onto tiptoes repeatedly until calf pain begins, then performing five additional lifts; the other group will walk for at least 30 minutes three times per week. The "five plus training" is done three times a day using a wall for balance support. These exercises aim to induce muscle ischemia followed by reperfusion to maximize training effects. During the 12-week study, researchers will assess participants' walking distance on a treadmill and use questionnaires to measure quality of life. They will also monitor blood flow using the Ankle-Brachial index. The study includes regular follow-ups to evaluate how each exercise program affects walking ability and overall well-being in patients with intermittent claudication.