Kristiansand

Researchers are evaluating new treatments for advanced ovarian cancer in women who have completed initial surgery and chemotherapy. The study focuses on non-HRD positive ovarian cancer, comparing a targeted therapy called sacituzumab tirumotecan sac-TMT given alone or with bevacizumab, against standard care options such as bevacizumab maintenance or observation. The goal is to see if sac-TMT with or without bevacizumab can help patients live longer without their cancer worsening. Participants in the experimental group will receive sac-TMT through intravenous infusion on days 1, 15, and 29 of every 6-week cycle until the cancer progresses, side effects become prohibitive, or other reasons for stopping arise. They may optionally receive bevacizumab on days 1 and 22 of each cycle. The comparator group will either receive bevacizumab alone every 3 weeks for up to 22 courses or be monitored without active treatment. Supportive medications like steroid mouthwash and other rescue drugs are recommended before sac-TMT infusions. Throughout the study, participants will be regularly monitored for how long they live without their disease progressing, overall survival, side effects, and quality of life using specialized questionnaires. These assessments will continue for up to approximately 78 months. The study is randomized, with single masking, and led by Merck Sharp & Dohme LLC. Participants can expect regular visits for treatment and monitoring during this period.

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.

Amyotrophic lateral sclerosis ALS is a severe and fast-progressing nervous system disease with a typical survival time of about 2.5 years after diagnosis. Currently, Riluzole is the only treatment available, and the care for advanced ALS is very costly. Research suggests that increasing access to Nicotinamide Adenine Dinucleotide NAD and activating enzymes called sirtuins might slow disease progression. Nicotinamide riboside NR increases NAD, and Pterostilbene stimulates sirtuins. The study aims to evaluate whether a combination of NR and Pterostilbene can slow neurodegeneration, delay disease progression, improve survival, and enhance quality of life in ALS patients. This extension study follows patients who completed the initial NO-ALS trial, where all participants receive the combination supplement EH301 Nicotinamide Riboside and Pterostilbene. It is an open-label study offering compassionate use and monitoring adverse events. The study will assess if this combination can reduce motor symptom progression, preserve lung function, and increase survival over a one-year follow-up. Participants who completed the original NO-ALS trial will be followed for one year with regular assessments. Researchers will monitor adverse events throughout this period and measure disease progression using the ALS Functional Rating Scale Revised and changes in vital lung capacity. The study aims to provide long-term safety and efficacy data while allowing continued access to the supplement. Total participation duration is one year from enrollment in the extension study.

Researchers are evaluating a complex intervention to improve advance care planning ACP for severely ill elderly people living at home who are acutely admitted to hospital. This cluster randomized study involves twelve Norwegian geriatric hospital units and aims to enhance patient and family involvement in treatment decisions, improve quality of life, and support ethical and legal care planning. The project also explores barriers and facilitators to implementing ACP at clinical, health service, and governmental levels, including economic analyses. The intervention group receives a comprehensive support program that includes leadership commitment, training for staff, implementation teams, ACP coordinators, and practical tools such as guidelines and documentation templates. The control group receives no implementation support during the trial but will be offered the program afterward. The study period includes baseline, 9-month, and 18-month assessments for the intervention group and baseline and 18-month assessments for the control group. Participants will undergo questionnaires and interviews with patients, relatives, clinicians, and staff at multiple time points before, during, and after the implementation. Data from patient records and national health registers will be collected to assess the fidelity of ACP implementation, clinical outcomes, communication quality, and cost-effectiveness. The trial runs until December 2026 and includes various measures to evaluate the impact of the support program on ACP delivery and related outcomes.

Researchers are evaluating the safety and effectiveness of stopping antibiotic treatment early in adults hospitalized with respiratory viral infections. This study focuses on patients with moderately severe disease who test positive for respiratory viruses such as influenza, respiratory syncytial virus, parainfluenza virus, or human metapneumovirus. The goal is to determine if early discontinuation of antibiotics leads to similar clinical outcomes compared to continuing antibiotic therapy, aiming to reduce unnecessary antibiotic use and combat antimicrobial resistance. Participants are randomly assigned to either stop antibiotic therapy as started by their admitting physician or to continue antibiotic therapy without changes. The study monitors early clinical response at 120 hours after randomization, defined by survival with symptom improvement and no need for rescue antibiotics. Secondary assessments include mortality rates, hospital stay duration, antibiotic use, and readmission rates, all measured during hospital admission and up to 30 days after discharge. During the trial, participants undergo nasopharyngeal swab testing to confirm viral infection and are monitored closely for symptoms, survival, and antibiotic use. Researchers evaluate clinical response at 120 hours and track outcomes such as mortality, hospital stay length, and antibiotic doses until discharge and 30 days later. The study aims to gather detailed safety and efficacy data over the hospital stay and follow-up period, supporting more targeted antibiotic use in viral respiratory infections.

Researchers are evaluating whether a shorter period of immunotherapy after radical surgery is as effective as the standard longer treatment for patients with high-risk malignant skin melanoma. This study focuses on people aged 18 and older who have undergone surgery for stage IIb-c, III, or IV melanoma. The goal is to see if six months of immunotherapy can prevent cancer recurrence as well as the current 12-month treatment, potentially reducing side effects, hospital visits, and healthcare costs. The study is a randomized phase 3 trial conducted internationally with patients followed for up to five years. Participants will receive immunotherapy drugs, currently nivolumab or pembrolizumab, given intravenously. They are randomly assigned to either six months experimental group or 12 months standard group of treatment. Patients who had immunotherapy before surgery neoadjuvant treatment can also join, with their pre-surgery treatment time added to the post-surgery treatment. Medical exams and imaging scans CT or PET-CT are done at the start, six months, and 36 months, along with regular check-ups over three years. If cancer returns, additional tests and treatments are planned based on medical team decisions. During the study, participants will have scheduled visits for physical exams, blood tests, and scans to monitor their health and detect any recurrence. Researchers will measure relapse-free survival and distant metastatic-free survival at two years as primary outcomes, with overall survival and health economic effects also assessed over five years. Safety monitoring includes standard care practices and follow-up for up to five years. The study aims to confirm if shorter immunotherapy duration maintains the same outcomes while benefiting patients and healthcare systems.

Researchers are evaluating the use of specific molecular biomarkers to personalize treatment for patients with endometrial cancer. This study focuses mainly on biomarkers found promising in previous research and aims to improve surgical and medical treatment decisions. The trial has two parts one tests the use of biomarkers to guide lymphadenectomy during surgery, and the other assesses the biomarker stathmins potential to predict response to taxane chemotherapy in endometrial and ovarian cancer. The study includes an implementation phase where lymphadenectomy is performed based on hormone receptor status ER and PR to define patient risk and guide surgery. Patients considered low risk based on tumor grade and receptor status may avoid lymphadenectomy, while higher-risk patients undergo pelvic and para-aortic lymphadenectomy. In the second phase, patients receiving weekly taxane treatment have tissue biopsies and urine samples analyzed for stathmin levels before and during treatment. Imaging scans and blood tests are conducted regularly to monitor disease progression. Participants will receive routine clinical follow-up for five years, including quality of life questionnaires. Researchers will collect data on survival, disease recurrence, and quality of life over this period. For patients in the taxane treatment phase, urine and blood samples will be collected weekly, with imaging every eight treatment cycles. The studys main outcomes include the number of cancer recurrences after five years and the duration of treatment response in metastatic disease, along with correlations of stathmin levels in various samples.

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

Amyotrophic lateral sclerosis ALS is a severe and rapidly progressing nervous system disease with an average survival of two to three years after diagnosis. Patients experience significant physical and psychological challenges, and apart from the drug Riluzole, effective treatments are lacking. This study aims to understand how life-sustaining ventilation support, either non-invasive or with tracheostomy, impacts the quality of life of ALS patients, their partners, and children, addressing a difficult ethical issue in ALS care. Participants are divided into two groups those who choose life-prolonging treatment with long-term mechanical ventilation support and those who decline such treatment. The study involves a longitudinal questionnaire approach conducted in Norway, measuring overall, health-related, and disease-specific quality of life over time. Assessments occur at inclusion and then every three months up to 21 months. Throughout the study, ALS patients, their partners, and children complete various quality of life questionnaires, including the Quality of Life Scale, EQ-5D-5L, ALS-specific scales, and caregiver burden surveys. Researchers monitor changes in these assessments to understand the effects of ventilation support. The study is sponsored by Haukeland University Hospital and includes participants aged 8 years and older, with data collection planned until 2032.

Researchers are evaluating the effects of introducing mechanical thrombectomy at a limited-volume stroke center in South-East Norway. This observational study focuses on patients with large vessel occlusion acute ischemic stroke and aims to assess whether the new local thrombectomy service reduces patient morbidity and mortality. The study is guided by a national quality assurance program that includes simulation-based training to maintain high standards despite the centers smaller patient volume. The intervention involves comparing stroke patients who receive thrombectomy either at the local hospital or at a more distant comprehensive center. The local center uses a simulation-based quality program involving stroke team simulation and virtual reality task training to support skill development and procedural quality. The study will monitor timelines related to stroke onset, hospital arrival, and thrombectomy procedure, as well as technical outcomes and complication rates associated with the treatment. Participants will be observed for outcomes including mortality, morbidity, and symptomatic intracranial hemorrhage within specific time frames after treatment. The primary outcomes are measured at three months post-treatment, while secondary outcomes include time intervals and technical success measured up to 24 hours, and simulation training performance tracked over five years. This study provides ongoing quality monitoring and aims to share results that may benefit stroke care practices globally. Overall participation and follow-up can last up to five years for training observations.