Halmstad

Unhealthy lifestyle habits are major risk factors for cardiovascular disease (CVD), which is the leading cause of death worldwide and in Sweden. This research evaluates a digital lifestyle program developed within Swedish primary healthcare to see if it can improve important heart health outcomes and encourage healthier habits in adults aged 40 to 60. The study is a multi-center randomized trial comparing standard care alone to standard care plus the digital intervention. The main goal is to measure LDL-cholesterol levels six months after starting the study, along with other health and lifestyle factors. Participants receive standard care consisting of one structured health dialogue focused on lifestyle habits. Those in the intervention group also get access to the digital lifestyle program, which includes digital lectures, home assignments, and group meetings online. Healthcare providers can offer personalized digital support and feedback to help patients improve diet, physical activity, alcohol use, tobacco use, sleep, and stress management. The intervention is delivered entirely through digital means alongside regular primary care. During the study, participants will be monitored for changes in cholesterol levels, blood sugar, blood pressure, weight, body measurements, cardiovascular risk scores, diet, physical activity, sleep, stress, alcohol and tobacco use, and quality of life. These assessments happen six months after randomization to evaluate the effects of the intervention. The study uses these measures to understand how well the digital program supports healthier lifestyle changes and reduces cardiovascular risk.

Researchers are conducting a phase III randomized, open-label, multicenter trial across several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. The study focuses on elderly patients with untreated diffuse large B-cell lymphoma (DLBCL), defined as patients aged 80 years or older, or those aged 75 years or older who are considered frail based on a simplified Comprehensive Geriatric Assessment. The trial aims to compare the effectiveness of two treatment regimens in this population. Participants are randomly assigned to receive either the standard R-miniCHOP treatment or an experimental R-pola-miniCHP regimen where vincristine is replaced with an immunoconjugate, polatuzumab vedotin. Both treatments involve cycles of drugs including rituximab, cyclophosphamide, doxorubicin, and prednisone, administered over 18 weeks. The trial includes a screening period lasting up to 4 weeks, followed by the active treatment phase, and then a follow-up period lasting up to 36 months after treatment completion. Throughout the study, participants will be monitored to measure progression-free survival over 2 years as the primary outcome. The study involves regular assessments including clinical evaluations and safety monitoring. Enrollment began in the first quarter of 2020, with the last patient visit expected by the first quarter of 2027, allowing for long-term observation of treatment effects and patient outcomes.

Researchers are evaluating the effects of aerobic group exercise compared to leisure group activities in adolescents aged 13 to 17 years with mild to moderate depression. This study aims to measure changes in depression symptoms using the Children's Depression Rating Scale-Revised (CDRS-R) after 13 weeks of intervention, with additional assessments at 26 weeks and one year. The study also examines secondary outcomes like global impressions of severity and improvement, self-reported depressive symptoms, functional assessments, physical fitness measures, body composition, biological markers related to neuroprotection and inflammation, and cost-effectiveness. Participants will be randomly assigned to either a 12-week aerobic group exercise program or a leisure activity group, both held three times a week for one hour. The aerobic exercise includes strength, conditioning, and mixed sessions with increasing intensity over time, while the leisure group engages in non-heart rate increasing activities like games and supportive social interaction. After 26 weeks, those in the leisure group are offered the opportunity to participate in the aerobic exercise program. The study is conducted at specialized child and adolescent psychiatric clinics in Sweden. During the study, participants will complete regular assessments through video calls and web-based questionnaires, including depression scales, quality of life measures, and cost evaluations. Physical fitness tests and blood samples will be collected at multiple time points. Safety and adherence are monitored throughout, with participants able to withdraw at any time. The total study duration includes baseline, 13-week, 26-week, and one-year follow-up assessments to evaluate both short- and long-term effects of the interventions.

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 investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

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.

Researchers are comparing the effects of a new low glucose peritoneal dialysis solution called XyloCore to traditional glucose-based solutions in patients with End-Stage Renal Disease (ESRD) who are undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD). This Phase 3, randomized, controlled, open-label, multicenter study aims to assess the efficacy and safety of XyloCore over a 6-month period while maintaining blinded evaluation of key outcomes. Participants will be randomly assigned to receive either the investigational XyloCore solution—available in Low, Medium, or High Strength formulations based on glucose concentration—or to continue their standard glucose-based peritoneal dialysis treatments such as Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova, or Equibalance. All patients will continue using Extraneal (7.5% Icodextrin) for their long-dwell nocturnal exchange. The number and osmotic strength of daily short dwell exchanges can be adjusted by investigators as needed, with the goal of achieving a weekly total Kt/V urea clearance above 1.7. During the study, participants will be monitored for dialysis effectiveness, mainly by measuring total weekly Kt/V urea at 24 weeks. Clinical status will be regularly assessed, including evaluation of safety and tolerability. Randomization is stratified to balance patients with diabetes and those treated with only one daily exchange. The study's open-label design includes blinded assessment of primary endpoints to reduce bias, and treatment adjustments will be tailored to each patient's clinical situation throughout the trial.

This research investigates how health evolves after Infective Endocarditis (IE) and whether participating in a physical exercise training program within cardiac rehabilitation can improve health for patients with IE. IE is a serious infection of the heart requiring weeks of hospital treatment, followed by long-lasting physical and mental challenges such as fatigue, anxiety, depression, and difficulties returning to work. The study aims to understand patients' quality of life, mental health, and overall recovery during the year after IE treatment through both surveys and interviews. Participants will engage in a physical exercise program guided by specialized physiotherapists twice a week for 12 weeks, following established cardiac rehabilitation protocols (SEPHIA and SWEDEHEART). They will have individualized physical evaluations before starting and after completing the exercise training. The program focuses on improving physical capacity and reducing fatigue symptoms through group exercises and personalized assessments. During the 18-month study, participants will complete digital surveys on health-related quality of life and fatigue symptoms four times within one year. They will also take part in three interviews about their experiences with health and rehabilitation before and after the training program. Physiotherapists will conduct physical tests before and after the rehabilitation period. The study measures include changes in physical capacity, patient adherence to the program, and patient-reported experiences of cardiac rehabilitation and post-infection health over time.

Researchers are evaluating the effects of high-intensity interval training (HIIT) on people diagnosed with axial spondyloarthritis (SpA), a group of inflammatory diseases affecting the spine and pelvic joints. The study aims to investigate how HIIT influences physiological health, inflammation, and self-reported disease activity compared to regular exercise, focusing on both short-term and long-term effects. This randomized controlled trial includes 100 adults with confirmed axial SpA recruited from rheumatology clinics in southern Sweden. Participants in the intervention group will perform three exercise sessions per week for 12 weeks: two HIIT sessions and one moderate or high-intensity session, all using self-selected activities like cycling or walking. Coaching is provided by physiotherapists and through digital tools such as a fitness watch and app to monitor heart rate and training intensity. After the initial 12 weeks, a 9-month period of customized coaching and monthly follow-up calls will support continued training. The control group will continue their usual exercise routines for 12 months. During the study, participants will undergo baseline, 3-month, and 12-month assessments including physiological tests, body composition measurements, blood tests for inflammatory biomarkers, and self-reported questionnaires on health, pain, fatigue, and exercise adherence. Researchers will monitor disease activity through standardized scores and inflammatory proteins, as well as physical fitness and confidence in managing symptoms. Safety monitoring and data confidentiality are maintained throughout the study.

Researchers are studying the effects of weighted blankets on children aged 6 to 14 years who have ADHD and sleep problems. The study compares the short- and long-term impacts of weighted blankets with the standard treatment using melatonin. It also explores how easy or difficult it is to use weighted blankets in regular clinical care and examines the cost-effectiveness of this intervention. Participants will be divided into two groups: one group will use a weighted blanket, and the other will receive melatonin as their treatment. The study will monitor outcomes over time to assess differences between these approaches and how they affect sleep and overall health. Children will be assessed using several sleep-related questionnaires, including the Insomnia Severity Index and Pediatric Insomnia Severity Index, at multiple time points: baseline, 1 month, 3 months, 6 months, 1 year, and then yearly for up to 9 additional years. These assessments help track changes in sleep patterns and related health outcomes throughout the study period.