Skovde

Researchers are investigating whether adding regular radiological scans during follow-up after surgery for high-risk malignant melanoma improves patient survival. This study focuses on patients who have undergone radical surgery for stage IIb-c and III cutaneous malignant melanoma. Since radiological exams can be costly, cause anxiety, and expose patients to radiation, the study aims to determine their value especially given the availability of effective medical treatments for melanoma. Participants are randomly assigned to one of two groups for a 3-year follow-up period. One group receives routine follow-up with regular doctor visits according to national guidelines. The other group receives the same follow-up plus whole body CT or PET scans and blood tests at baseline, 6, 12, 24, and 36 months. An interim analysis will be done after 1000 patients have enrolled. Throughout the study, researchers will monitor overall survival over a 5-year period. Participants will have scheduled assessments including scans and blood tests if assigned to the imaging group. The study also tracks adherence to follow-up visits and any health changes. This approach aims to provide clear evidence on the benefit and impact of imaging during follow-up after melanoma surgery.

Out-of-hospital cardiac arrest (OHCA) often involves dangerous heart rhythms like ventricular fibrillation (VF) or ventricular tachycardia (VT), which require defibrillation to restore a normal heartbeat. Survival chances decrease the more defibrillations are needed. Recent research suggested that using Double Sequential Defibrillation (DSD), which applies two defibrillators sequentially, may improve survival in patients with refractory VF. This trial aims to evaluate if applying DSD earlier, right after the first failed defibrillation in patients with shockable rhythms, improves 30-day survival compared to standard single defibrillation. Participants will receive either the early DSD strategy, where a second defibrillator is added with electrodes placed on the chest and back (anterior-posterior position) and shocks are delivered sequentially, or the usual care involving standard defibrillation with one defibrillator and pads placed in the anterior-lateral position. The study is an open-label, randomized controlled trial with equal allocation to each group, conducted by emergency medical services equipped with two defibrillators on site. During the trial, emergency teams will screen eligible adult OHCA patients with shockable rhythms who have had at least one unsuccessful defibrillation. The main outcome measured is survival 30 days after the cardiac arrest. The trial involves initial rhythm analysis, delivery of assigned defibrillation methods, and follow-up to assess outcomes. This study could influence future advanced cardiac life support guidelines if early DSD proves beneficial for a wider group of patients.

Researchers are evaluating the effects of three different treatments on major adverse kidney events (MAKE) in adults who are unconscious after being resuscitated from out-of-hospital cardiac arrest. This sub-study is part of the larger STEPCARE trial and involves 3,500 participants. The study focuses on kidney-related outcomes, including death within 30 days, need for kidney replacement therapy, and kidney function changes measured by creatinine levels at hospital discharge. The main trial randomly assigns patients to one of three treatments: continuous deep sedation for 36 hours versus minimal sedation; fever control using a feedback-controlled device if body temperature rises above 37.7°C versus fever control without a device; and two blood pressure targets with mean arterial pressure (MAP) set to either ≥65 mmHg or ≥85 mmHg maintained by vasopressors for 36 hours. The feedback-controlled temperature device is set to maintain temperature at 37.5°C when used. Participants will be closely monitored during their hospital stay with data collected prospectively according to the main trial protocol. Researchers will assess major adverse kidney events within 30 days and examine creatinine changes during the hospital stay and within 72 hours after resuscitation. The study aims to understand how these treatments affect kidney outcomes after cardiac arrest, with analyses following a predefined statistical plan.

Acute facial nerve palsy affects 10 to 20 children per 100,000 each year in Sweden, with about 20% experiencing lasting symptoms like excessive tearing, drooling, and facial asymmetry that can impact social interactions. This research aims to evaluate the benefit of cortisone treatment (prednisolone) in children aged 1 to 17 with acute facial nerve palsy by conducting a randomized, double-blind, placebo-controlled multicenter trial. Although cortisone has shown benefits in adults with this condition, strong evidence in children is lacking, prompting this study to assess if prednisolone improves recovery rates. Participants will receive either oral prednisolone at a dose of 1 mg per kilogram of body weight once daily for 10 days (up to a maximum of 50 mg per day) or matching placebo tablets. Treatment will begin shortly after admission at one of 9-12 study centers across Sweden during 2019-2020. The study will follow participants closely to monitor their progress and response to treatment over time. Children will be assessed regularly with clinical evaluations and recovery measurements, with the main outcome being total recovery of facial nerve function measured by the House-Brackmann scale at 12 months after inclusion. Researchers will track clinical data and recovery during the study period to determine the effectiveness of prednisolone compared to placebo. This long-term follow-up aims to provide clear evidence to guide future treatment for children with acute facial nerve palsy.

Gestational diabetes mellitus (GDM) is a common metabolic condition during pregnancy, affecting 2-10% of pregnant women in Sweden depending on screening methods. Women with GDM face a significantly higher risk of developing type 2 diabetes (T2DM) later, with about half developing it within 20 years. This study aims to test a lifestyle intervention model that combines personal support and technical tools within primary care to prevent postpartum diabetes, while also exploring metabolic factors linked to diabetes development in women with GDM. Participants are randomized into two groups: an intervention group receiving support from Child Health Care units during visits, including blood tests and measurements, alongside access to a digital lifestyle tool called MyMOWO; and a usual care group following standard healthcare routines. The intervention includes personalized coaching, reminders about physical activity and diet, and regular monitoring of health markers such as blood glucose and waist circumference. Assessments occur at baseline, one year, and four years postpartum. Throughout the study, women undergo detailed evaluations including physical exams, blood tests, questionnaires on lifestyle and diet, fitness testing, and continuous activity monitoring. Data collection includes glucose tolerance tests and metabolic markers to assess diabetes development. Safety and progress are monitored via regular visits at the Child Health Care Centre, with follow-up planned for up to four years after delivery to observe long-term outcomes.

Researchers are exploring whether reducing wheat gluten or certain amino acids commonly found in wheat gluten can improve blood sugar control and reduce inflammation in healthy individuals, parents, children, adolescents, and adults with or without diabetes. The study also aims to identify people who have an inflammatory response that may cause poor blood sugar control. This research considers the connections between autoimmune diseases like celiac disease, diabetes, and inflammation, and how these may relate to severe COVID-19 infections. Participants will follow different diet phases over four weeks: one week of their usual diet, one week gluten-free, one week with wheat gluten, and one week consuming gluten along with probiotics. They will receive products to support these diets and use continuous glucose monitors and activity tracking devices throughout the study. The study uses a crossover design, meaning each participant acts as their own comparison, and may also compare individuals with and without diabetes. During the study, participants will attend four clinic visits for blood sampling at baseline, after one, two, and three weeks. They will also collect samples like capillary blood, feces, urine, mouth swabs, and saliva at home, and complete questionnaires about diet, diabetes risk factors, and COVID-19. The main outcomes measured are stabilization of blood sugar levels and amino acid metabolism over the four-week period. The study plans to include 60 participants over two years, with a total of 15 sampling occasions per person.

Researchers are evaluating treatments for elderly patients aged 75 and older who have an undisplaced femoral neck fracture (uFNF), classified as Garden I-II. The study compares whether replacing the hip (arthroplasty) reduces the need for further surgeries compared to preserving the hip with internal fixation. The goal is to lower the combined risk of needing reoperation or death within 1 to 2 years after surgery. Participants are randomly assigned to one of two treatment groups using the Swedish Fracture Register. One group receives arthroplasty, which may be either a hemi or total hip replacement depending on hospital routine based on patient age and mobility. The other group undergoes internal fixation, where the fracture is repaired using 2-3 screws, pins, or a sliding hip screw device, again according to hospital routine. Both treatments are devices applied to stabilize or replace the hip after fracture. During the study, participants are monitored for outcomes including the rate of additional surgeries and mortality up to 2 years after their initial operation. The main measure combines these two outcomes into a single variable to evaluate overall treatment success. The entire process is registered and randomized within the Swedish Fracture Register system, ensuring consistent follow-up and data collection.

Spontaneous intracerebral hemorrhage (ICH) is a severe type of stroke accounting for 10-15% of all strokes but causing about half of stroke-related deaths and disabilities. Many patients with ICH have decreased consciousness when admitted, yet intensive care and neurosurgical treatments are not common. Prior studies in low- and middle-income countries showed that a treatment package including early intensive blood pressure lowering and managing fever and high blood sugar improved outcomes. The I-CATCHER study aims to test a similar structured Care Bundle approach in Sweden, Australia, and other high-income countries to improve treatment and prognosis for patients with spontaneous ICH. This study compares a Care Bundle involving early intensive blood pressure control, reversal of oral anticoagulation within 30 minutes, fever management, blood sugar control, and timely referrals to intensive care or neurosurgery against standard care. The Care Bundle targets specific blood pressure levels depending on initial readings and aims to avoid do-not-resuscitate orders or withdrawal of care for 48 hours. Repeat brain imaging is done as needed. Hospitals are randomized in batches over three phases lasting 18 months each: usual care, randomized evaluation, and post-implementation follow-up, with the entire study rolling out over 2.5 years. Participants are adults aged 18 or older with spontaneous ICH confirmed by imaging and admitted within 24 hours of symptom onset. Patient information, treatments, and outcomes are recorded, including functional status measured by the Utility Weighted modified Rankin Scale at 180 days. The study collects data on various treatments, monitoring, and complications to assess if the Care Bundle improves recovery. Safety and sustainability of the Care Bundle are evaluated through continued hospital participation and follow-up.

Researchers are evaluating the long-term reliability and performance of Medtronic cardiac rhythm products, including leads and devices used for pacing, sensing, or defibrillation. The study aims to analyze product survival probabilities to better understand their durability and performance over time. This research includes all Medtronic market-released leads and implantable devices for conditions such as arrhythmia, bradycardia, heart failure, and sinus tachycardia. Participants include those who have been implanted with at least one Medtronic market-released product or those who participated in qualifying Medtronic studies with complete implant and follow-up data. The study monitors these devices from the time of implant, tracking lead-related complications and device performance. If a patient exits the study, passes away, or the device is deactivated, the implant is no longer followed. During the study, researchers collect health information and monitor the devices to assess ongoing performance and complications. Follow-up is essential to confirm device status and ensure accurate data collection. The main outcome measured is lead-related complications for each lead model, with continuous observation from implant until termination due to patient or device status. Participation requires informed consent and authorization for access to health information as per institutional requirements.

This research aims to continuously evaluate and report on the safety and effectiveness of Medtronic products that are already available on the market. It addresses a wide range of conditions including cardiac rhythm disorders, neurological and cardiovascular disorders, digestive issues, respiratory therapy, and various surgical and diagnostic procedures. The registry supports patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying the clinical monitoring process and enhancing performance assessment. Participants in this registry are those who have received or are planned to receive treatment with eligible Medtronic products. Enrollment can occur within a specific time window relative to starting therapy or retrospectively. The study does not involve specific interventions but focuses on the ongoing collection of data related to the products in use. During participation, individuals will be monitored periodically every 6 to 12 months depending on their therapy. Researchers will collect data to assess safety and effectiveness without additional procedures beyond standard care. Follow-up will continue as long as the therapy is ongoing, with the goal of providing long-term surveillance and valuable information to improve patient care and product performance.