Skien

This research aims to evaluate how the medicine nerandomilast affects lung fibrosis in adults with systemic autoimmune rheumatic diseases who have lung fibrosis. The study includes adults 18 years and older who have not shown improvement in lung function after standard immunosuppressant treatment. Participants have interstitial lung disease related to rheumatic diseases such as rheumatoid arthritis, systemic sclerosis, idiopathic inflammatory myopathy, Sjgrens disease, or mixed connective tissue disease. Participants are randomly divided into two groups one group receives nerandomilast tablets and the other receives placebo tablets that look identical but contain no medicine. Tablets are taken twice daily for at least 26 weeks and up to 1 year. Participants continue their usual immunosuppressant treatments during the study. Participants stay in the study for about 7.5 to 13 months and visit the study site 9 to 10 times. During visits, lung function tests and chest imaging are performed, and participants complete questionnaires about symptoms and quality of life. Researchers compare results between the groups to assess the effects of nerandomilast while monitoring health and any side effects throughout the study.

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 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 conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

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.

Researchers are comparing two types of reverse shoulder replacements to see which provides better shoulder function after two years. This study focuses on patients who need shoulder replacement due to conditions like osteoarthritis or rotator cuff issues. The study aims to find out if a bone transplant method, called BIO-RSA, improves outcomes compared to the conventional reverse shoulder arthroplasty RSA. The trial involves 130 patients randomly assigned to receive either the BIO-RSA or the conventional RSA procedure. BIO-RSA includes placing a bone graft under the shoulder implant to increase joint stability and range of motion, potentially reducing complications like scapular notching. The study is blinded and conducted across multiple hospitals to compare these two surgical methods over a two-year period. Participants will have their shoulder function evaluated before surgery and at 3, 12, and 24 months afterward using patient questionnaires, physical exams by physiotherapists, and CT scans reviewed by radiologists. The main measure is the change in the Western Ontario Osteoarthritis Shoulder WOOS score after 24 months. Other assessments include quality of life, shoulder motion, and pain. The study will monitor participants for two years to gather comprehensive data on outcomes and complications.

This research aims to explore the genetic causes related to the development of Amyotrophic Lateral Sclerosis ALS in Norway. The study focuses on individuals diagnosed with probable or definite ALS according to the El-Escorial criteria. Understanding genetic factors may help in better characterizing the disease and its risk factors over time. Participants diagnosed with ALS will be followed through the Norwegian health-care system. After giving informed consent, they will complete a brief questionnaire about their family history and provide a blood sample. These samples, along with clinical information and consent forms, are sent to the Department of Medical Genetics at Telemark Hospital Trust for ongoing genetic analysis throughout the recruitment period. Participants may choose to receive their genetic results as part of a diagnostic process. During the study, participants will be involved in providing blood samples and completing questionnaires. Researchers will analyze genetic data to identify gene frequency, new ALS genes, and genetic risk factors between 2020 and 2030. The study involves observation only, with no additional treatments. Participation includes genetic testing and data collection to better understand ALS genetics, with the study continuing until 2035.

Researchers are investigating the best treatment approach for older men aged 75 years and above with high-risk, non-metastatic prostate cancer. This trial aims to determine whether immediate curative treatments like radiotherapy or surgery provide the same survival and quality of life benefits as seen in younger patients, or if the risks and side effects might outweigh these benefits. The study also evaluates if early side effects from immediate treatment are balanced by better long-term cancer control and quality of life. Participants are randomly assigned to one of two groups. One group receives immediate curative therapy, which includes radiotherapy combined with hormone therapy or, for some, surgery called radical prostatectomy. The other group receives conservative treatment involving observation or hormone therapy, with further treatment as needed based on disease progression. This open-label, multicenter study compares these two approaches over a long-term period. During the study, participants will undergo regular assessments including quality of life questionnaires and evaluations of urinary, bowel, and prostate cancer-related symptoms. The primary outcomes measured are overall survival and disease burden over up to 10 years. Secondary outcomes include role functioning, symptom-free survival, metastasis-free survival, and the need for additional treatments. The study monitors participants health status and quality of life throughout this extended follow-up period.

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 investigating palliative radiotherapy for patients with symptomatic pelvic soft tissue tumors from gastrointestinal, urological, or gynecological cancers. This national, randomized, open-label phase III trial aims to determine if a short-course radiotherapy schedule 1-2 fractions of 8 Gy provides symptom relief that is not worse than a longer schedule 5 fractions of 5 Gy. The study also evaluates health-related quality of life, toxicities, survival, and biomarkers related to tumor hypoxia as secondary and exploratory goals. Participants will receive either a short-course radiotherapy treatment of 8 Gy in 1-2 sessions or a longer course of 5 Gy in 5 sessions. Both schedules are delivered as palliative care to relieve symptoms such as pain, bleeding, or dysfunction in bowel, urinary, or vaginal areas. Patients will choose a main symptom to track during the study. The trial specifically excludes curative treatments and focuses on symptom control with radiation therapy. During the study, patients are monitored through patient-reported symptom intensity assessments, physician-reported toxicities up to 52 weeks, and survival evaluations over two years. Researchers will also collect quality of life data and explore biomarkers to better understand treatment effects. Participation involves regular symptom reporting and clinical follow-up, with the primary outcome measured 12 weeks after treatment.