Alesund

Breast cancer is the most common cancer diagnosed in women in Europe, representing 29% of cases, with a 5-year survival rate around 90%. Treatment often includes surgery, radiotherapy RT, anthracyclines, aromatase inhibitors, and trastuzumab Herceptin, which have improved survival. However, RT can lead to various cardiovascular diseases, a leading cause of non-cancer death among these patients. New RT techniques have reduced heart radiation exposure, but their impact on cardiovascular risks is not yet known. This observational study follows two groups of breast cancer patients one treated with conventional RT between 2007 and 2012, and another treated with laser-assisted breath-controlled RT between 2015 and 2017. Both groups may have also received anthracyclines andor trastuzumab. The study includes age-matched female controls from the general population to compare cardiovascular outcomes over 15 years. Participants will be monitored for the incidence and prevalence of cardiovascular diseases at 8 and 15 years after RT. Researchers will use cardiac magnetic resonance imaging, coronary fractional flow reserve, ECG, and biomarkers to detect acute heart toxicity and assess its ability to predict later cardiovascular problems. Traditional risk factors like age, hypertension, cholesterol, smoking, and physical activity before RT will also be evaluated throughout the study.

Researchers are studying the effects of antibiotics in children aged 9 to 36 months who have chronic wet cough CWC. This study is a phase 4, double-blind, placebo-controlled, randomized trial conducted across multiple centers nationwide. The goals are to understand how effective antibiotics are in treating CWC, whether the length of antibiotic treatment affects recovery or relapse, and to explore the role of respiratory pathogens, microbiomes, inflammation, immunology, and genetics in these children compared to healthy controls. The study consists of two randomized controlled trials, AMIC 1 and AMIC 2. In AMIC 1, 90 children will be randomly assigned to receive either amoxicillin-clavulanate syrup or a placebo syrup for 14 days. In AMIC 2, 210 children will be randomly assigned to receive either 14 days of amoxicillin-clavulanate with 14 days of placebo or a full 28 days of the antibiotic syrup. Additionally, 50 healthy children will be included for comparison and will have two visits spaced six months apart. During the study, children will be followed for up to 24 months after starting treatment to assess response and relapse of symptoms. Researchers will evaluate treatment response 14 days after antibiotic completion and monitor for any relapse up to two years later. Assessments include cough scoring, microbiome analysis from airway and gut samples, and examination of inflammation, immunology, and genetics. The study also involves regular monitoring to ensure safety and adherence to treatment protocols throughout the trial period.

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.

This research aims to study patients who have undergone surgery for carpal tunnel syndrome CTS at lesund Hospital to identify the presence of ATTR amyloidosis through biopsy. The study focuses on patients with biopsy-confirmed ATTR amyloidosis, assessing whether they have cardiac amyloidosis and monitoring them closely over a long term. The study is observational and plans to follow participants for up to 10 years to understand the frequency of ATTR in CTS and cardiac involvement. Patients with biopsy-proven ATTR amyloidosis will undergo standard examinations recommended by guidelines, including 99mTcDPD SPECT CT, echocardiography, ECG, Holter monitoring, genetic testing for variant and wild type ATTR, laboratory tests, and CMRI when indicated. Light chain disease will be excluded. All patients will be monitored at least annually following established guidelines, and those developing cardiac amyloidosis will receive standard treatments approved by Norwegian authorities. Participants will be followed clinically and with echocardiography yearly for at least 10 years. Assessments include imaging, genetic testing, and laboratory evaluations to track disease progression and cardiac involvement. The primary outcome measures are the frequency of ATTR in CTS within 2 years and cardiac involvement in patients with biopsy-confirmed ATTR over 10 years. This extended follow-up aims to provide comprehensive data on the long-term impact of ATTR amyloidosis in this selected population.

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 evaluating the benefits and risks of using furosemide, a diuretic, compared to a placebo in critically ill adult patients who experience fluid overload in the intensive care unit ICU. Fluid overload, a common complication in ICU patients, can worsen outcomes especially in those with acute kidney injury. The study aims to determine if reducing excess fluid with furosemide improves patient health or if fluid overload is simply a marker of severe illness. Participants are randomly assigned to receive either furosemide or a placebo isotonic saline through intravenous infusion. The furosemide group receives a bolus dose followed by an infusion adjusted to target a negative fluid balance of 1 ml per kg per hour, with fluid balance monitored three times daily. The placebo group receives saline dosed and adjusted by the same protocol. Treatment continues until the excess fluid is removed and fluid balance is neutral. During the study, participants will be closely monitored for fluid balance and clinical stability. Researchers will assess outcomes including days alive and out of hospital within 90 days, mortality rates up to one year, serious adverse events, quality of life, and cognitive function. The study involves a randomized, blinded design to compare the effects of furosemide versus placebo over a one-year follow-up period.

Researchers are studying the best approach for patients with synchronous metastatic renal cell carcinoma RCC, a type of kidney cancer that has spread to other parts of the body. This trial compares the effects of delaying surgery to remove the primary kidney tumor until after initial immunotherapy treatment versus not having surgery at all. The trial focuses on patients with intermediate or poor risk features according to a cancer risk scoring system and aims to understand how these approaches affect overall survival. Participants will begin with induction immunotherapy using either a combination of nivolumab and ipilimumab or a combination of tyrosine kinase inhibitor TKI and immunotherapy. After about three months, their eligibility for surgery is assessed by a local team of specialists. Those suitable and with certain risk features may be randomized to either have deferred surgery followed by maintenance therapy or continue with maintenance therapy without surgery. Patients not suitable for surgery continue systemic therapy and are re-evaluated later. Tissue, blood, and stool samples are collected at baseline and during follow-up for research. During the study, participants receive regular evaluations including tumor measurements and sample collections at baseline, 3 months, and 6 months. Researchers monitor overall survival as the primary outcome over at least three years, along with other measures like progression-free survival, response rate, and treatment-related side effects. Safety and surgical outcomes are tracked, and immunological and genetic markers are studied to understand treatment effects. Treatment with nivolumab may continue for up to two years unless side effects occur.

Researchers are investigating whether a home-based exercise program called five plus training improves walking ability better than the current recommendation of walking for at least 30 minutes three times per week in patients with intermittent claudication. This condition causes pain in the calves due to poor blood flow during walking, and the study aims to determine which exercise method enhances walking distance and quality of life. The trial is sponsored by the Norwegian University of Science and Technology and includes randomized, double-blind assignment to exercise groups. Participants are randomly assigned to either the five plus training group or a walking group. The five plus training involves standing in front of a wall for balance support and repeatedly lifting the body onto tiptoes with the calf muscles until pain starts, then performing five additional calf raises to promote muscle blood flow. The walking group is instructed to walk for at least 30 minutes three times weekly. This training continues over a 12-week period to compare effects. During the study, participants walking distance is measured using a treadmill test, and their quality of life is assessed through questionnaires. The ankle-brachial index, a test comparing blood pressure at the ankle and arm, is also monitored. These assessments help evaluate changes in walking capability and symptoms. The study follows participants for 12 weeks, with ongoing monitoring to assess the safety and impact of the exercise programs.

Researchers are investigating whether a treat-to-target strategy that includes structured imaging assessments improves patient outcomes in psoriatic arthritis compared to a conventional treat-to-target approach. The study focuses on sustained remission, defined as very low disease activity at 16, 20, and 24 months. This two-arm, parallel-group study randomizes patients to either conventional clinical assessments or additional imaging assessments using ultrasound and MRI to guide treatment decisions. Participants receive treatment following European recommendations, with the conventional arm targeting disease activity based on clinical measures such as DAPSA remission, enthesitis, and psoriasis body surface area. The imaging-informed arm adds ultrasound assessments of joints, tendons, and entheses at every visit, plus MRI of the spine and sacroiliac joints at baseline and one year. Imaging results influence treatment progression, including advancing to biologic disease-modifying drugs if inflammation is detected. During the 24-month follow-up, patients undergo clinical and imaging assessments, including joint counts, enthesitis indices, and skin evaluations. Researchers measure disease activity, inflammation, health-related quality of life, and adverse events throughout the study. The primary outcome is sustained remission, while secondary outcomes include various disease activity scores and safety monitoring. The study aims to provide insights into the benefits of incorporating imaging in psoriatic arthritis management.

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.