Alesund

Breast cancer is the most common cancer among women in Europe, representing 29% of all cases, with a 5-year survival rate around 90%. Treatment usually involves surgery combined with radiotherapy (RT), anthracyclines, aromatase inhibitors, or trastuzumab. While RT has improved survival, it is linked to a range of cardiovascular diseases such as coronary artery disease, heart valve problems, heart failure, and stroke, which are leading causes of non-cancer deaths in these patients. New RT techniques aim to reduce radiation exposure to the heart, but it is unclear if they lower the risk of cardiovascular disease. This observational study follows two groups of breast cancer patients treated between 2007 and 2012 with different RT methods: conventional RT and laser assisted breath controlled RT. Researchers will track the incidence and prevalence of cardiovascular diseases over 8 and 15 years after treatment in these groups, comparing results with the general female population. The study will also assess early heart damage signs using cardiac MRI, coronary fractional flow reserve, ECG, and blood markers to see if these predict later heart disease. Traditional cardiovascular risk factors such as age, blood pressure, cholesterol, smoking, and physical activity before RT will also be evaluated. Participants will be monitored over 15 years for cardiovascular health outcomes. Assessments include imaging, heart function tests, and blood tests to detect acute heart toxicity and long-term cardiovascular issues. The study aims to better understand heart risks from modern RT in breast cancer patients and identify early indicators of heart damage to improve future care. Total participation duration aligns with the 15-year follow-up period to observe long-term effects.

Researchers are investigating the clinical effectiveness of antibiotics in young children aged 9 to 36 months who have chronic wet cough, a condition often related to protracted bacterial bronchitis. The study aims to compare the impact of different treatment durations on symptom improvement and relapse, while also exploring the role of respiratory bacteria, airway and gut microbiomes, inflammation, immune response, and genetics in this condition. This academic, phase 4, double-blind, placebo-controlled, multicenter trial includes two randomized controlled trials and healthy controls for comparison. The study consists of two parts: AMIC 1 and AMIC 2. In AMIC 1, 90 children will be randomly assigned to receive either amoxicillin-clavulanate syrup or a placebo, both given three times daily for 14 days. In AMIC 2, 210 children will be randomly assigned to receive amoxicillin-clavulanate syrup three times daily for either 14 or 28 days. A group of 50 healthy children will also be included for comparison and will have a follow-up visit six months after enrollment. Participants will be followed for 24 months after the start of the treatment to monitor response to antibiotics, with assessments conducted 14 days after finishing treatment. Researchers will study respiratory pathogens, microbiome changes, inflammation, and immune factors, as well as collect genetic data. The study will include clinical evaluations, cough scoring, and comparisons with healthy controls to better understand the condition and treatment effects over time.

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 patients who have had surgery for carpal tunnel syndrome (CTS) at Ålesund Hospital to find out how often they have a condition called ATTR amyloidosis, which can affect the heart. The study focuses on patients with biopsy-proven ATTR amyloidosis, including both wild type and gene mutation forms. The goal is to understand the prevalence of this condition in this specific group and to monitor any heart involvement over a long period. Patients with a positive biopsy for ATTR amyloidosis will undergo standard examinations recommended by medical guidelines. These include imaging tests like 99mTcDPD SPECT CT, echocardiography, ECG, Holter monitoring, genetic testing, laboratory tests, and cardiac MRI as needed. Patients will be checked yearly for up to 10 years to watch for signs of cardiac amyloidosis. Those who develop heart involvement will receive treatment following national guidelines approved by the Norwegian government. Participants will be followed closely with yearly clinical exams and echocardiography for 10 years. Researchers will measure how often ATTR amyloidosis occurs in this group with CTS and how many develop heart complications. The study also excludes patients with other cardiac diseases at the time of CTS surgery and secondary causes of CTS. This long-term follow-up aims to better understand the condition and improve care for affected patients.

The BAROBS project is a collaberation between three public hospitals in Norway exploring the concequeces ten years or more after undergoing gastric bypass or sleeve gastrectomy for severe obesity. 1400 patients who underwent bariatric surgery at the three hospitals will be invited to a follow up including antrophometric, meassurment of bodily composition by bioimpedance and DXA, blood samples, questionnaires on sosioeconomic topics, symptoms and quality of life, continous glucose monitoring, dental examination, and other clinical evaluation.

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.

Fluid overload is a serious and common problem in adults admitted to the intensive care unit (ICU), often caused by the fluids used during resuscitation. This research aims to understand if removing excess fluid with the drug furosemide improves outcomes compared to a placebo. The study focuses on critically ill adult patients who have gained at least 5% excess fluid relative to their ideal body weight. It is a Phase 4, randomized, blinded, placebo-controlled trial designed to explore the effects of fluid removal on patient health and survival. Participants will be randomly assigned to receive either furosemide, a diuretic drug given by injection or infusion, or a placebo consisting of isotonic saline administered the same way. Treatment will continue until the excess fluid has been removed. The study carefully monitors clinical stability, including blood pressure and medication needs, to ensure safe administration of the treatments. Throughout the study, participants' health will be closely tracked, including days alive and out of hospital within 90 days after randomization. Researchers will assess fluid balance, kidney function, and overall recovery while watching for any side effects or complications. The study also includes strict criteria for patient selection to ensure safety and relevance, with ongoing follow-up to evaluate the impact of fluid removal on critical illness outcomes.

Researchers are evaluating the impact of deferred cytoreductive nephrectomy (surgical removal of the kidney tumor) compared with no surgery in patients with synchronous metastatic renal cell carcinoma (mRCC) who have intermediate or poor risk features according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC). The study focuses on patients receiving initial immunotherapy with nivolumab combined with ipilimumab or a tyrosine kinase inhibitor (TKI)/immuno-oncology combination. This trial aims to clarify whether surgery after initial immunotherapy improves overall survival in this patient group. Participants first receive induction immunotherapy immediately after enrollment. After three months or four treatment cycles, patients are evaluated for tumor removal eligibility by a multidisciplinary team. Those with three or fewer IMDC risk factors and considered suitable for surgery are randomized to either undergo deferred nephrectomy followed by maintenance immunotherapy or receive maintenance immunotherapy without surgery. Patients ineligible for surgery or with more than three risk factors continue systemic therapy and are reevaluated at six months for possible surgery. Treatment with nivolumab can continue up to two years or until unacceptable side effects. Throughout the study, tumor tissue, blood, and stool samples are collected at the start, three months, and six months for biomarker research. Participants undergo disease assessments including measurable tumor evaluation. The main outcome measured is overall survival with a minimum follow-up of three years. This multicenter trial monitors safety, treatment response, and survival to determine the role of deferred surgery after immunotherapy in metastatic kidney cancer.

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.

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.