Ostersund

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are studying baricitinib to see if it can help preserve beta-cell function in children and adults aged 1 to 35 years who have been newly diagnosed with type 1 diabetes. This Phase 3 study aims to evaluate the treatments impact on preserving insulin production shortly after diagnosis. Participants will be followed for about 60 weeks to assess changes in key diabetes-related measures. Participants will be randomly assigned to receive either baricitinib or a placebo, both taken orally. The study compares these two groups to evaluate the effects of baricitinib on beta-cell function. The main measurement is the change in C-peptide area under the curve over 52 weeks, which indicates insulin production. Additional outcomes include changes in blood sugar control, insulin use, hypoglycemia events, and other health indicators. During the study, participants will attend visits for assessments and monitoring over approximately 60 weeks. Tests will include blood measurements like C-peptide and hemoglobin A1c, insulin dose tracking, and health surveys. Safety and drug levels will be monitored. Researchers will use these data to understand if baricitinib can help maintain beta-cell function in people newly diagnosed with type 1 diabetes.

Researchers are evaluating optimized pharmacologic treatments for patients with Takotsubo Syndrome, a condition often referred to as broken heart syndrome. This large randomized registry clinical trial aims to include 1000 participants registered in SWEDEHEART to better document effective treatments, as current data from large patient groups are lacking. The trial is a Phase 4 study sponsored by Vastra Gotaland Region and is designed as an open-label, multinational, multicenter trial. Participants are randomly assigned to different treatment groups. One group receives an adenosine infusion for 3 hours followed by oral dipyridamole twice daily until left ventricular function normalizes or up to about one month. Another group receives usual care per European Society of Cardiology recommendations. A separate randomization compares oral apixaban twice daily until normalization of heart function or about one month versus no anticoagulant therapy. The study monitors heart function with echocardiographic assessments at 48-96 hours and possibly later. During the study, participants undergo regular heart ultrasounds to assess wall motion and ejection fraction, along with monitoring for events such as death, cardiac arrest, heart failure, thromboembolic events, and bleeding. The trial collects data up to 30 days after treatment begins. Researchers also track heart rhythm problems and use standardized scoring to evaluate heart muscle movement. Safety and treatment outcomes are closely observed throughout the study period, which lasts until December 2028.

Researchers are investigating the link between lung swelling lung edema and a protein called Heparin-binding Protein HBP in patients in intensive care units ICU. The study focuses on whether the levels of HBP in blood relate to lung blood vessel leakage and the amount of fluid in the lungs. It also looks at how HBP levels connect to the total fluid balance in the body. This observational study involves adult ICU patients monitored with a special device called PiCCO that measures lung fluid and blood flow. The study collects blood samples three times daily over up to three days while patients are monitored with the PiCCO system, which uses a technique called transpulmonary thermodilution to assess lung water and blood volumes. There are no additional treatments given as part of the study it only observes the natural course and measurements in these patients. The PiCCO device requires a central venous line and an arterial catheter and needs regular calibrations during the study period. Participants will have blood samples taken alongside the PiCCO calibrations, and data about lung water, blood volume, and fluid balance will be recorded. Researchers will analyze the relationship between HBP levels and pulmonary vascular permeability index PVPI, which indicates lung vessel leakage, as well as fluid balance. The study lasts while PiCCO monitoring continues, up to three days, with data kept confidential and handled according to privacy regulations. Any clinical findings from monitoring will be managed by the usual ICU care team without influence from the study.

This observational study focuses on women aged 18 and older diagnosed with urgency or mixed urinary incontinence who have received a medical evaluation and first-line treatment recommendation. It evaluates the use and effectiveness of the Te4taeII app following contact with ordinary healthcare. Researchers aim to determine whether treatment via this app is effective and feasible after primary care. Participants will use the Te4taeII app for 15 weeks to manage their urinary incontinence. The app provides education on pelvic floor and urinary incontinence, bladder training, pelvic floor muscle exercises, and psychoeducation. It includes features like reminders, exercise visualization, and feedback on symptom changes. Access to the app requires a one-time activation code provided after study inclusion. Women will complete online questionnaires before starting treatment, after 15 weeks, and one year later to assess symptoms, quality of life, and improvement. These include validated tools like the ICIQ-UI SF and ICIQ-LUTSqol. The study collects data on app usability, satisfaction, and desire for further treatment. Follow-up is conducted digitally, and the primary outcome is the symptom score change from start to 15 weeks.

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 a new e-health program designed to improve the neurodevelopment of very preterm infants, born before 32 weeks or with low birth weight, by supporting parents in responsive caregiving. The study aims to see if this program, called INSPIRE, can enhance cognitive, motor, feeding, language, and socio-emotional development up to 2 years of age. Additional goals include assessing parental stress, emotional availability, health inequalities, and gender differences. This trial is conducted by Ume University with a multi-professional team and builds on a pilot study involving nine families. The intervention group will receive the INSPIRE program, which consists of 18 sessions delivered digitally over two years, starting at hospital discharge. This program focuses on strengthening parent-child interactions and empowering parents with responsive parenting skills. Families in the control group will receive standard care without the INSPIRE intervention. The study randomly assigns families to either group and follows up with assessments over time. Participants will be involved from discharge through at least 2 years corrected age, with evaluations including neurodevelopmental tests such as the Bayley Scales of Infant Development at 24 months. Additional assessments cover motor skills, language, feeding, emotional availability, parental stress, and mental health using various standardized tools at multiple time points up to 5.5 years of age. Researchers will monitor child development, parent well-being, and other outcomes to understand the interventions impact and safety over the study period.

Researchers are studying complications after closing a temporary loop ileostomy in patients who had surgery for rectal cancer. The study aims to answer two main questions whether the choice of anastomotic method affects recovery after surgery, and if using a mesh to close the stoma site can reduce hernias. This is a prospective randomized trial involving multiple centers to explore these surgical techniques. Participants are randomly assigned to receive either a stapled anastomosis using a linear staple device or a hand-sewn anastomosis with a running monofilament suture. Additionally, there is an optional randomization to close the stoma site either with a lightweight mesh placed under the muscle or with a long-lasting suture. The skin and fascia are closed with running monofilament sutures, including a pursestring technique for the skin. During the study, researchers will monitor participants for postoperative bowel obstruction within 30 days and for stoma site hernias over 2 years. They will also assess other complications and hospital stay length within 30 days. Participants will undergo follow-up visits to evaluate these outcomes and ensure proper recovery. The total participation timeline includes short-term and long-term monitoring to capture relevant surgical results.

Researchers are evaluating the effects of a restrictive approach to giving non-resuscitation fluids compared to usual care in adult patients with septic shock. The goal is to understand both the beneficial and harmful impacts of limiting these fluids in this critical condition. This trial is led by Region Skane and involves adult patients diagnosed with septic shock under specific clinical criteria. Participants are assigned randomly to one of two groups. One group receives non-resuscitation fluids following a strict protocol that starts within two hours of randomization and continues during their ICU stay, up to 90 days. This protocol includes stopping maintenance fluids if fluid balance is positive and the patient is not dehydrated, adjusting intravenous and enteral fluids to correct electrolyte disturbances, and using concentrated intravenous medications. The other group receives fluids according to usual local care routines, which involve maintenance fluids at about 1 mlkgh unless otherwise specified and glucose at a maximum concentration of 10%, with medications concentrated per local protocol. Participants are monitored during their ICU stay and followed for up to 90 days to assess mortality, complications, and days free from mechanical ventilation. Cognitive function and health-related quality of life are evaluated six months after inclusion. The study uses a triple-blind randomized design to compare outcomes between the protocolized fluid reduction and usual care. Regular assessments and follow-up visits will track participant status and safety throughout the study period.

Researchers are evaluating surgical treatments for adult acquired flatfoot deformity AAFD, a condition causing foot pain and changes in walking. This trial compares the standard medial displacement calcaneal osteotomy MDCO alone with MDCO combined with a sinus tarsi implant STI, which may provide better correction by supporting soft tissues and improving foot alignment. The study is a randomized controlled trial involving patients aged 16 to 75 with mobile AAFD stage II who have not improved after physiotherapy. Participants will be randomly assigned to receive either MDCO with STI or MDCO without STI. Both groups may also receive additional procedures like Strayers gastrocnemius recession, flexor digitorum longus tendon transfer, spring ligament repair, and possibly a Cotton osteotomy if needed. Surgery will be performed by experienced foot and ankle surgeons at multiple orthopedic centers. Postoperative care includes casting and weight-bearing instructions tailored to the procedures performed. Patients will be assessed before surgery and at 4-5 months, 1 year, and 2 years after surgery through clinical exams, questionnaires measuring foot function and quality of life SEFAS and EQ-5D, and weight-bearing foot X-rays to measure angles like Mearys angle. Researchers will also evaluate pain, satisfaction, heel-rise endurance, sick-leave duration, and complications. Follow-up involves blinded examiners and radiologists to ensure unbiased assessments, with patients encouraged to complete all visits and questionnaires over the two-year period.