Ostersund

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are studying whether baricitinib can help preserve beta-cell function in children and adults newly diagnosed with type 1 diabetes. This Phase 3 trial focuses on participants aged 1 to less than 36 years who have recently been diagnosed with this condition. The goal is to understand if baricitinib, compared to a placebo, can maintain insulin-producing cell activity. Participants will be randomly assigned to receive either baricitinib or a placebo, both given orally. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. Treatment and observation will continue for about 60 weeks. During the study, participants will undergo evaluations including measuring C-peptide levels to assess beta-cell function at the start and after 52 weeks. Researchers will monitor health status, collect laboratory tests, and track any side effects or changes in diabetes-related markers to determine the effects of baricitinib over the study period.

Researchers are evaluating optimized drug treatments for patients with Takotsubo Syndrome, also known as Broken Heart Syndrome. This large Phase 4 trial aims to include 1000 patients registered in SWEDEHEART to provide documented evidence for effective pharmacologic care, as current data is limited. The study is a multinational, multicenter, registry-based, open-label, randomized controlled trial focused on improving treatment outcomes for this heart condition. Participants may receive one of several treatments: an infusion of Adenosine at 70 g/kg/min for 3 hours, oral Dipyridamole 200 mg twice daily, oral Apixaban 5 mg twice daily, or care guided by recommendations from the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology, which may vary by local practice. The trial includes two randomizations with specific treatment options and criteria. During the study, researchers will assess heart function using wall motion scores and monitor for serious events such as death, cardiac arrest, heart failure hospitalization, or reduced heart ejection fraction up to 30 days after treatment. They will also track thromboembolic events and cardiac thrombus via echocardiography within the first few days and through day 30. Safety and treatment adherence will be monitored throughout, with detailed follow-up to understand treatment effects and patient outcomes.

The trial investigates the relationship between lung edema and a protein called Heparin-binding Protein (HBP) in intensive care patients. Researchers aim to find out if HBP levels in the blood correlate with lung vascular permeability and the amount of fluid in the lungs, as well as the patient's total fluid balance. This study focuses on patients monitored with a special device called PiCCO that measures lung fluid and blood volume. Patients included in the study are those admitted to the ICU and monitored with the PiCCO device, which uses a technique combining transpulmonary thermodilution and pulse contour analysis. Blood samples are collected three times a day during device calibration for up to three days, or until the PiCCO device is removed. No new treatments are given as part of the study, and patient care continues as usual. Participants will have blood samples taken regularly, along with measurements of lung vascular permeability and extravascular lung water using the PiCCO system. Researchers will analyze these data for correlations with HBP levels. The study includes close monitoring without extra risks from study procedures. Collected health information will be kept securely and confidentially, and patients or their representatives will provide consent before participation.

Researchers are evaluating the use and effectiveness of the Tät®II app for treating urgency and mixed urinary incontinence in women aged 18 and older who have already seen a healthcare provider for their condition. The study aims to determine if treatment via this app is effective and feasible after primary care contact. Women diagnosed with urgency or mixed urinary incontinence and recommended first-line treatment including pelvic floor muscle training or bladder training are invited to participate. Participants will use the Tät®II app for 15 weeks. The app provides information on the pelvic floor and urinary incontinence, bladder training exercises, pelvic floor muscle training, and psychoeducation related to incontinence. It also includes features like reminders, exercise visualization, statistics on exercise performance, and feedback on symptom changes. After signing consent and verifying medical evaluation, participants receive an activation code to access the app and complete treatment independently. Women will complete online questionnaires before starting treatment, after 15 weeks, and one year later. These questionnaires assess urinary symptoms, quality of life, and perceived improvement using validated tools. Researchers will analyze changes in symptom scores to measure treatment effects. Additional data on user experience, satisfaction, and desire for further treatment will also be collected. The study includes safety monitoring and follow-up, with an expected enrollment of about 60 women.

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 a new e-health program called INSPIRE designed to support the brain development of very preterm infants born before 32 weeks or with low birth weight. The program focuses on helping parents develop responsive caregiving behaviors to improve multiple areas of the child's development such as cognitive, motor, feeding, language, and social-emotional skills. The study aims to see if this intervention improves child development up to 2 years of age, as well as examining parental stress, parent-child emotional connection, health inequalities, and gender effects. The INSPIRE intervention involves digital e-health sessions delivered to parents after hospital discharge, with a total of 18 sessions over two years. It uses video interaction to guide parents in strengthening their interactions with their infants and empowering them to respond to their child's needs in positive ways. Families will be randomly assigned to receive either the INSPIRE program or standard care, with the goal of assessing the program's impact compared to usual support. Participants and their families will be followed and assessed regularly up to the child's corrected age of 24 months. Researchers will measure the child's development using the Bayley Scales of Infant Development and evaluate parental experiences and stress. The study includes ongoing monitoring of child and parent outcomes to understand the intervention's effects and aims to establish a sustainable nationwide program to support preterm infants and their families, especially benefiting those far from specialized healthcare.

This research aims to explore complications following the closure of a temporary loop ileostomy in patients who have undergone rectal cancer surgery. The study focuses on two main questions: whether the choice of anastomotic method affects the postoperative recovery, and whether using a prophylactic mesh during stoma site closure reduces the occurrence of hernias. The study is a prospective randomized multicenter trial involving patients with rectal neoplasm. Participants will be randomly assigned to receive either a stapled or hand-sewn anastomosis after ileostomy closure. Additionally, they may be randomized to have the stoma site closed using either a lightweight mesh placed under the muscle (retromuscular) or a long-lasting suture. The anterior fascia and skin are closed with running monofilament sutures, with the skin closure performed using a pursestring technique. During the study, researchers will monitor participants for postoperative complications including small bowel obstruction within 30 days and stoma site hernia formation over two years. The assessments will gather data on healing and complications to evaluate the impact of the different surgical techniques. Participant involvement includes follow-up for safety and effectiveness outcomes over the specified periods.

This trial evaluates the effects of a restrictive approach to giving non-resuscitation fluids in adults with septic shock, a serious condition caused by infection leading to dangerously low blood pressure. The study aims to assess both the potential benefits and harms of limiting these fluids compared to usual care. The trial focuses on adult patients diagnosed within 12 hours of intensive care unit (ICU) admission who require medication to support blood pressure. Participants are randomly assigned to one of two groups. The first group follows a protocol to reduce non-resuscitation fluids, where maintenance fluids are stopped if the patient has a positive fluid balance and is not dehydrated. Fluids and nutrition are carefully managed according to specific guidelines, including concentrated intravenous medications and nutrition support if needed. The second group receives usual care with fluids and medications given according to local routines, including maintenance fluids at a set dose unless otherwise specified. During the study, researchers monitor participants closely, focusing on mortality within 90 days after enrollment as the primary outcome. Fluid balance, medication use, nutrition, and patient condition are assessed to compare the two approaches. The study includes adult patients admitted to the ICU with septic shock and requires monitoring during their stay and follow-up to understand the effects of fluid management strategies on survival and safety.

Researchers are evaluating whether remote video exercise-based cardiac rehabilitation (exCR) can increase participation in rehabilitation sessions after a myocardial infarction (heart attack), compared to traditional center-based exCR. The study is designed as a national multicenter registry-based cluster randomized crossover clinical trial, preceded by a feasibility and safety study conducted during the COVID-19 pandemic. Patients diagnosed with type 1 myocardial infarction and aged 18 to 79 years are included, with long-term follow-up planned at 1 and 3 years after the cardiac event. The study involves two phases: first, a feasibility study offering remote exCR at participating sites until the pandemic peak subsides, ending in August 2022; second, a randomized trial where cardiac rehabilitation centers are assigned to provide either remote exCR, usual center-based exCR, or a combination based on patient preference at intervention sites, while control sites offer only center-based exCR. The exercise program is standardized, requiring at least 24 supervised sessions over 3 to 4 months, each session including aerobic exercise and strength training at specified intensity levels. Success is defined as attending at least 75% of sessions within four months. Participants will be monitored through their attendance and adherence to the exercise sessions. Researchers will assess the average number of exCR sessions completed over 3 to 4 months. Additional evaluations include safety monitoring and long-term follow-up at 1 and 3 years to observe outcomes after the initial cardiac event. The study also considers patient access to internet for remote participation and evaluates exercise test results to ensure safety during rehabilitation.