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This trial studies adults aged 18 years and older with lung fibrosis caused by systemic autoimmune rheumatic diseases who have not shown lung function improvement after standard immunosuppressant treatment. It evaluates how the medicine nerandomilast affects lung disease associated with these conditions. The study is a phase 3, double-blind, randomized, placebo-controlled trial designed to test nerandomilast's safety and efficacy over at least 26 weeks. Participants are randomly assigned to receive either nerandomilast tablets or placebo tablets twice daily for a period of at least 26 weeks and up to 1 year. Alongside this, participants continue their ongoing immunosuppressant treatments for their rheumatic disease. The study involves two groups receiving either the active drug or placebo to compare outcomes between them. During the 7.5 to 13 months of participation, individuals visit the study site about 9 to 10 times for lung function tests, chest imaging at select visits, and to complete questionnaires about symptoms and quality of life. Researchers monitor changes in lung disease using high-resolution CT scans and assess safety by recording any side effects. The main outcome is the change in lung fibrosis score after 26 weeks of treatment.

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 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 conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

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 comparing two types of reverse shoulder replacements: the conventional reverse shoulder arthroplasty (RSA) and the bony increased offset-reversed shoulder arthroplasty (BIO-RSA). This study aims to find out if the lateralized BIO-RSA offers better shoulder function and fewer complications than the conventional RSA after two years. The study addresses issues like limited range of motion, prosthesis dislocation, and scapular notching that may occur with the traditional RSA. The study involves 130 patients across four hospitals who are scheduled for primary reverse shoulder arthroplasty due to conditions like osteoarthritis or rotator cuff problems. Participants will be randomly assigned to receive either the BIO-RSA or the conventional RSA. BIO-RSA includes a bone transplant under the glenoid component to lateralize the joint center and potentially improve movement and stability. The research is conducted as a blinded randomized controlled trial. Participants will be followed for two years, with shoulder function evaluated through patient-reported outcomes using the Western Ontario Osteoarthritis Shoulder (WOOS) index at baseline, 3, 12, and 24 months after surgery. Additional assessments include physiotherapist examinations and CT scans reviewed by radiologists. The main outcome measured is the change in WOOS score from before surgery to 24 months after surgery to determine which procedure provides better clinical results.

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.

Researchers are investigating the genetic factors that may contribute to the development of Amyotrophic Lateral Sclerosis (ALS) in Norway. The study aims to better understand genetic causes relevant to ALS by analyzing gene frequencies, new ALS genes, and genetic risk factors from 2020 through 2030. Participants will provide written informed consent and complete a brief questionnaire about their family history. A blood sample will be collected for genetic analysis, which is carried out at the Department of Medical Genetics, Telemark Hospital Trust throughout the recruitment period. Participants may opt to receive their genetic results in a diagnostic setting. During the study, participants will be involved in providing clinical information, completing questionnaires, and submitting blood samples. Researchers will monitor genetic characteristics and analyze data related to gene frequency and new ALS genes over time. The study includes adults aged 16 to 100 years and involves continuous genetic analysis from 2020 to 2030.

Researchers are investigating the best treatment approach for older men aged 75 years and above with high-risk, non-metastatic prostate cancer. This study aims to determine whether immediate curative therapy, such as radiotherapy or surgery, offers survival benefits and improves quality of life compared to conservative treatment strategies. The trial also evaluates whether the side effects of immediate treatment are balanced by better long-term tumor control and overall survival in this older population. Participants are randomly assigned to one of two groups: one receiving immediate curative therapy including radiotherapy or surgery, and the other receiving conservative treatment, which includes hormone therapy or observation. The hormone therapy involves androgen deprivation using either LHRH agonists, antagonists, or androgen monotherapy. The study is a phase 3, open-label, multicenter trial with parallel groups, designed to compare these treatment approaches over time. During the study, participants undergo medical and geriatric evaluations to assess their health status and ability to participate. They complete health-related quality of life questionnaires and are monitored through clinical assessments and imaging to evaluate tumor status. The primary outcomes measured are overall survival over 10 years following recruitment and the burden of disease during the same period. Researchers also track side effects, functional status, and cost-effectiveness of treatments throughout the study.

Researchers are investigating the effectiveness of approved anti-cancer drugs used outside their usual indications for patients with advanced cancer who have specific molecular changes identified through genetic testing. This nationwide, phase 2 study in Norway uses a combined umbrella and basket design to explore drug and biomarker combinations across different cancer types. Biological samples will be collected at diagnosis, during treatment, and if the disease progresses to better understand factors affecting drug response and resistance. Patients eligible for this study have advanced cancer that has been previously treated with standard therapies and have acceptable organ function and performance status. Treatment is guided by molecular testing results and recommendations from a national tumor board. Patients receive drugs matched to their tumor's molecular profile, with treatment eligibility confirmed before starting. New patient groups may be opened if no suitable cohort exists. The drug Atezolizumab is among those evaluated, administered according to protocol-specific criteria. Participants will be closely monitored for tumor response, survival, treatment duration, and side effects including serious toxicities. They will undergo molecular testing including whole genome sequencing from tumor biopsies and liquid biopsies. Data on treatment outcomes and molecular markers will be collected and reported to national cancer registries. Patients not enrolled in treatment cohorts will be followed for 16 weeks to track disease progression and survival, with long-term follow-up planned through national health databases.