Skovde

Researchers are investigating whether regular radiological assessments during follow-up after surgery for high-risk malignant melanoma improve patient survival. The study addresses concerns about the resource demands, potential radiation exposure, and anxiety caused by such imaging, especially given the recent introduction of effective medical treatments for melanoma. There is currently no clear evidence supporting routine imaging in this context. Participants are randomly assigned to one of two groups. One group follows national guidelines with regular doctor appointments for 3 years, while the other group receives the same follow-up plus additional whole-body CT or PET scans and blood tests at baseline, 6, 12, 24, and 36 months. An interim analysis will be done after 1,000 patients enroll. During the study, researchers will monitor overall survival at 5 years as the primary outcome. They will also assess quality of life through questionnaires over the 3-year follow-up. Participants will attend scheduled visits for clinical evaluations, imaging, and blood tests, with the study aiming to provide clear evidence about the role of imaging in post-surgical melanoma care.

Researchers are studying patients who experience out-of-hospital cardiac arrest OHCA with ventricular fibrillation VF or ventricular tachycardia VT that do not respond to initial defibrillation. The study aims to evaluate whether using double sequential defibrillation DSD earlier, after the first failed standard defibrillation, can improve 30-day survival compared to continuing with standard defibrillation. This trial addresses important gaps in knowledge about optimal defibrillation strategies to increase survival in this critical condition. The trial compares two treatment groups one using early double sequential defibrillation, where a second defibrillator with pads placed in the anterior-posterior position is applied as soon as possible, delivering rapid sequential shocks from two devices and the other continuing with standard single defibrillation using one defibrillator with anterior-lateral pad placement. Both groups receive resuscitation until return of spontaneous circulation, resuscitation is stopped, or the patient is transported to the hospital. The study is randomized and open-label, involving ambulance units equipped with two study-specific defibrillators. Participants are adult OHCA patients with an initial shockable rhythm and at least one failed standard defibrillation. During the study, ambulance teams perform screening, randomization, treatment according to assigned group, and initial follow-up. The main outcome measured is survival at 30 days. Secondary outcomes include return of spontaneous circulation, survival to hospital admission and discharge, and neurological function at discharge. The study will continue monitoring these outcomes to assess the effectiveness of early DSD compared to standard defibrillation strategies.

Researchers are evaluating the use of oral cortisone prednisolone treatment in children aged 1 to 17 years who have acute peripheral unilateral facial nerve palsy. This condition affects about 10 to 20 children per 100,000 annually in Sweden, with 20% experiencing lasting symptoms such as excessive tearing, drooling, and facial asymmetry. The study is a double-blind, randomized, placebo-controlled multicenter trial aimed at assessing whether prednisolone improves recovery compared to placebo over 12 months. Participants will be randomly assigned to receive either prednisolone tablets dosed at 1 mg per kg of body weight daily for 10 days up to a maximum of 50 mg per day or placebo tablets that look identical. The treatment will start upon admission, and clinical data will be collected during follow-up visits. The primary outcome is full recovery of facial nerve function measured by the House-Brackmann scale at 12 months, with additional facial function and disability assessments also conducted. During the study, children will undergo clinical evaluations at regular intervals up to 12 months to monitor nerve recovery and facial function using several scales and questionnaires. Researchers will track adherence to treatment and monitor for any side effects or complications. The total participation time for each child will be approximately one year, allowing detailed observation of long-term outcomes and treatment effects.

Gestational diabetes mellitus GDM is a common metabolic problem during pregnancy, affecting 2-10% of pregnant women in Sweden depending on screening methods. Women with GDM face about a 50% chance of developing type 2 diabetes T2DM within 20 years. This research evaluates a lifestyle intervention model using both personal and technical support to help prevent T2DM after pregnancy, aiming for an inexpensive and easy-to-implement approach within regular primary care. Participants will be randomly assigned to receive either the lifestyle intervention or usual care. The intervention includes support at every visit to the Child Health Care Centre with blood tests, measurements, and guidance on diet and physical activity. Participants also get access to a digital platform called MyMOWO, which offers personalized exercise programs and health coaching. Women in the usual care group continue with standard follow-up at health care units. A control group of women with normal glucose tolerance will also be studied. Throughout the study, women will have physical examinations, blood tests including oral glucose tolerance tests, questionnaires on lifestyle and diet, and fitness tests like VO2max. Measurements will take place at baseline, one year, 18 months, four years, and five years after delivery. Data on insulin resistance, blood sugar control, fitness, wellbeing, and glucose tolerance will be collected. Women who become pregnant again during the study will be excluded from final analysis but encouraged to stay involved. The total participation duration is up to five years, with ongoing monitoring and support.

Researchers are investigating whether reducing wheat gluten or certain amino acids commonly found in wheat gluten can improve blood sugar control and reduce inflammation in healthy volunteers, parents, children, adolescents, and adults, including those with diabetes. The study also seeks to identify individuals who have an inflammatory response leading to poor blood sugar control. It explores the connections between diabetes, inflammation, and severe COVID-19 infection. Participants will follow a diet with four different phases over four weeks their usual diet, a gluten-free diet, a diet containing wheat gluten, and a diet including gluten combined with probiotics. During these periods, participants will consume gluten-free or regular gluten-containing pasta meals and take probiotics as described. The study uses a crossover design where each participant serves as their own control. Continuous glucose monitors and activity trackers will be used to assess glucose uptake during the study. Participants will attend four clinical visits at baseline and weekly intervals for blood sampling. They will also collect samples at home, including capillary blood, feces, urine, buccal swabs, and saliva, and complete questionnaires about diet, diabetes risk factors, and COVID-19. The main outcomes include stabilizing blood sugar levels and amino acid metabolism. Secondary outcomes include blood lipids, glutathione S transferases, and fibrinogen. Total study duration for each participant is four weeks.

This research aims to determine if hip replacement surgery arthroplasty can reduce the need for additional operations compared to internal fixation in elderly patients with an undisplaced femoral neck fracture. Patients aged 75 years and older with this type of fracture will be included and randomly assigned to one of two treatments through the Swedish Fracture Register platform. The study focuses on combining reoperation rates and mortality into a single main outcome measure to evaluate which treatment offers better results. Participants will receive either arthroplasty, which may be hemi or total hip replacement depending on the patients condition and surgeons decision, or internal fixation using screws, pins, or a sliding hip screw device based on hospital routine. The study is a randomized controlled trial without blinding, comparing these two device-based treatments for hip fractures in elderly patients. During the study, researchers will monitor the combined rate of reoperations and mortality for 1 to 2 years after surgery. Additional outcomes include reoperation rates, short- and long-term mortality, and patient-reported physical function one year after surgery. Participants will be followed up to assess these outcomes, with care taken to track their progress and safety over the study period.

Spontaneous intracerebral hemorrhage ICH is a serious type of stroke with high death and disability rates. Researchers are investigating whether a structured treatment package called a Care Bundle can improve the 3-month outcomes for patients with acute ICH compared to standard care. The study is an international, multicenter, parallel, cluster-randomized clinical trial focusing on implementing this Care Bundle in high-income countries, building on results from previous trials mostly done in low- and middle-income countries. The Care Bundle includes early intensive blood pressure lowering, treatment of fever and high blood sugar, rapid reversal of oral anticoagulation, and timely referrals to intensive care or neurosurgery when needed. Hospitals are randomized in batches through three phases usual care, randomized evaluation of the Care Bundle versus usual care, and a post-implementation follow-up where all hospitals apply the Care Bundle. Each batch lasts 18 months, with 6 months per phase, and the overall study rollout spans 2.5 years. Participants are adults aged 18 or older diagnosed with spontaneous ICH confirmed by imaging within 24 hours of symptom onset. During the study, patient management details and outcomes will be closely monitored, including brain imaging, blood pressure, glucose levels, and functional status. The primary outcome is functional recovery measured by a utility-weighted modified Rankin Scale score at 180 days. Secondary outcomes include disability, death, and health-related quality of life. The study also collects data on treatments and care decisions to evaluate the Care Bundles effectiveness and sustainability.

Researchers are evaluating the long-term performance and reliability of Medtronics market-released cardiac rhythm therapy products, including leads and devices used for pacing, sensing, or defibrillation. This observational study aims to analyze how well these cardiac devices function over time by measuring survival probabilities and tracking device-related complications. The study applies to patients with conditions such as arrhythmia, bradycardia, heart failure, and sinus tachycardia. The study includes all Medtronic market-released cardiac leads and implantable devices such as pacemakers IPG, implantable cardioverter defibrillators ICD, and cardiac resynchronization therapy CRT devices. Participants either have a new implant or are within 30 days post-implantation. Data from prior qualifying Medtronic studies with complete follow-up may also be included. The study continuously monitors these products from the time of implant until the lead is no longer in use due to patient exit, death, or device deactivation. Participants provide consent for data access and use, and their health information is tracked over the long term. Researchers evaluate lead-related complications and product survival throughout the study period, which began in 1983 and is ongoing until 2040. The study does not involve additional treatments but collects follow-up data to assess device performance and safety over time.

This registry study is designed to continuously evaluate and periodically report the safety and effectiveness of Medtronic medical products that are already available on the market. It aims to support patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying clinical surveillance and promoting advanced performance assessments with minimal burden. Participants include patients who have or are planned to receive an eligible Medtronic product. Enrollment can occur at any time relative to therapy start or retrospectively. The study involves ongoing data collection related to the use of these products in routine clinical care. Throughout participation, patients are monitored for safety and effectiveness outcomes approximately every 6 to 12 months, depending on the therapy. Data gathered helps assess product performance over time while minimizing additional visits or procedures. Follow-up continues until the studys completion, which extends to the year 2040.

This research aims to evaluate whether specific abdominal muscle exercises can reduce the risk of developing parastomal hernias in patients receiving a permanent sigmoidostomy after surgery for colon cancer. Parastomal hernias affect about half of these patients and can significantly impact stoma function, physical ability, and quality of life. The study also explores patients experiences living with parastomal hernias to better understand daily challenges. Participants will be randomly assigned to one of two groups one group will receive usual care advice to prevent hernias, while the other will receive the same advice plus specific abdominal muscle training. This training starts before surgery and continues for the first year afterward. The study includes clinical assessments, manual and electronic measurements of hernia size, and computed tomography CT scans to track hernia development at 6, 12, and 36 months post-surgery. Throughout the study, participants will report on stoma function, discomfort, and quality of life using tailored questionnaires. Researchers will record the type of ostomy bandage used and assess physical activity and back pain from before surgery up to 36 months afterward. A subgroup will participate in interviews to share their experiences living with hernias. The studys results aim to improve methods for assessing hernias and inform future patient care after stoma surgery.