Halmstad

Cardiovascular disease CVD is a leading cause of death worldwide and unhealthy lifestyle behaviors are well-known risk factors. This study evaluates whether a digital lifestyle intervention developed within Swedish primary healthcare can improve important cardiovascular health outcomes and promote healthier lifestyle behaviors in patients aged 40 to 60 years. Participants are recruited from multiple centers in Sweden and randomized to either the intervention or control group with standard care. Participants in the intervention group receive support through a digital lifestyle program that includes lectures, home assignments, and group meetings, along with personalized digital feedback from healthcare providers. Both groups receive standard care, which is one structured health dialogue focused on lifestyle habits. The study measures outcomes at 6 months post-randomization, including LDL-cholesterol as the primary outcome, and several secondary outcomes related to cholesterol levels, blood glucose, blood pressure, weight, lifestyle behaviors, and quality of life. Throughout the study, participants undergo assessments of blood lipids, glucose, blood pressure, body measurements, and lifestyle factors such as diet, physical activity, sleep, stress, alcohol, and tobacco use. Researchers also evaluate cardiovascular risk scores and collect participant feedback on using the digital intervention. The total study duration is 6 months post-randomization with data collected to assess the impact of the digital program compared to standard care.

This trial focuses on elderly patients aged 80 years or older, or those 75 years and older who are considered frail, with untreated diffuse large B-cell lymphoma DLBCL and related lymphoma subtypes. The study is a phase III, randomized, open-label, multicenter trial conducted in several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. It aims to compare the standard chemotherapy regimen R-miniCHOP with an experimental treatment R-pola-miniCHP, where vincristine is replaced by polatuzumab vedotin, to assess differences in outcomes for this patient population. Participants will be randomly assigned to one of two treatment groups. One group will receive R-mini-CHOP consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone over six 21-day cycles. The other group will receive R-pola-mini-CHP, which includes rituximab, cyclophosphamide, doxorubicin, prednisone, and polatuzumab vedotin instead of vincristine, also given over six 21-day cycles. Both treatments last approximately 18 weeks. The study includes a screening period lasting up to 4 weeks before treatment begins. During the study, participants will be followed for up to 36 months after completing treatment to monitor progression-free survival over two years. Researchers will evaluate disease progression and safety outcomes through regular assessments during and after the treatment period. Participants will provide informed consent and undergo evaluations including health status and disease measurements to ensure eligibility and monitor treatment effects throughout the trial.

Researchers are investigating the effects of aerobic group exercise compared to leisure group activities in adolescents aged 13 to 17 with mild to moderate depression. The study aims to measure improvements in depression symptoms using the Childrens Depression Rating Scale - Revised CDRS-R at 13 weeks after starting the interventions. Additional goals include assessing changes in clinical severity, self-reported depressive symptoms, physical fitness, biological markers related to neuroprotection and inflammation, cost-effectiveness, and understanding participants experiences through interviews. Participants will be randomly assigned to one of two groups an aerobic exercise group or a leisure activities group. The aerobic exercise group will engage in 60-minute supervised sessions three times a week for 12 weeks, including aerobic, strength, and mixed training with gradually increased intensity. The leisure group will participate in non-heart rate increasing group activities, such as games and supportive discussions, at the same frequency and schedule. After 26 weeks, those in the leisure group will have the opportunity to join aerobic exercise sessions. During the study, participants will complete assessments at baseline, 13 weeks, 26 weeks, and one year, including video evaluations of depression and functioning, physical fitness tests, body composition analysis, blood sampling for biological markers, and questionnaires on depressive symptoms, quality of life, and costs. Self-reported measures will be collected regularly during the intervention and follow-up periods. Safety monitoring will track adverse events related to depression and exercise. The entire trial spans one year of follow-up after the interventions, with ongoing data collection and evaluation.

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 effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

This research aims to compare the effects of a new low glucose peritoneal dialysis solution called XyloCore against standard glucose-based solutions in patients with End-Stage Renal Disease ESRD who are undergoing Continuous Ambulatory Peritoneal Dialysis CAPD. The study is randomized, controlled, and open-label with blinded assessment of the main outcomes, conducted over a 6-month period. It includes patients already using common glucose peritoneal dialysis solutions and Extraneal for their long-dwell exchange. Participants will be randomly assigned to receive either the experimental XyloCore solution or continue with their current glucose peritoneal dialysis solutions. XyloCore is provided in low, medium, or high strengths matched to the glucose concentration of the patients prior prescription, while the control group maintains their usual glucose-based solutions. Both groups will continue using Extraneal for the nocturnal long-dwell exchange. Dialysis prescriptions may be adjusted by investigators to meet a target dialysis adequacy measure KtV > 1.7 per week. Throughout the study, participants will undergo regular assessments including measurement of dialysis adequacy total weekly KtVurea, blood tests such as HbA1c, cholesterol levels, hemoglobin, and insulin, as well as monitoring of kidney function, fluid removal, fatigue, and adverse events. The study includes follow-up visits for up to 6 months, with careful monitoring of safety and treatment effects. The trial is sponsored by Iperboreal Pharma Srl and uses centralized randomization with blinded evaluation of primary endpoints.

This research aims to understand how health develops after Infective Endocarditis IE and whether physical exercise training within a cardiac rehabilitation program can improve patients health. IE is a serious infection of the heart that requires long hospital treatment and causes lasting physical and mental challenges, including fatigue, anxiety, depression, and difficulties returning to work. The study will explore quality of life, mental health, and fatigue symptoms over one year following IE treatment. Participants will receive a physical exercise training program within cardiac rehabilitation based on SEPHIA and SWEDEHEART protocols. The program includes individualized physical evaluations by a physiotherapist before and after the training period, and group exercises led by a physiotherapist twice weekly for 12 weeks. Digital surveys and interviews will be used to gather patient experiences and self-reported health outcomes during the year. During the study, participants will answer digital surveys on perceived health four times over one year and attend three interviews to discuss their health and rehabilitation experience. Physiotherapeutic evaluations will occur before and after the exercise training program. The study measures changes in physical capacity, fatigue, and health-related quality of life, along with patient adherence to the program. The total participation lasts one year, with ongoing assessments to understand health restoration after IE.

Researchers are studying the effects of high-intensity interval training HIIT on adults diagnosed with axial spondyloarthritis SpA, a group of inflammatory diseases affecting the spine and joints. This randomized controlled trial aims to compare HIIT with usual exercise routines to understand its impact on physiological health, inflammation, and self-reported disease activity. The study also explores adherence to exercise recommendations and how digital coaching may support sustainable high-intensity training. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will do three training sessions per week for three months, including two HIIT sessions with coaching from a physiotherapist and digital support via a fitness watch and app. After this, they will continue with self-selected high-intensity training for nine months with monthly coaching contacts. The control group will maintain their usual exercise habits over 12 months. Throughout the study, participants will undergo assessments at the start, after three months, and after one year. These include physical fitness tests like aerobic capacity and grip strength, blood tests for inflammatory biomarkers, body composition measurements, and self-reported questionnaires on health status, pain, fatigue, and confidence in managing their condition. Continuous monitoring of heart rate during training and coaching support will help track adherence and intensity. The primary outcomes focus on disease activity and inflammatory markers, while secondary outcomes include physical function and well-being.

Researchers are evaluating the use of weighted blankets as a sleep intervention for children aged 6 to 14 years with ADHD and sleep problems. The study compares the short- and long-term effects of weighted blankets to the standard treatment with melatonin. It also explores the barriers and facilitators to using weighted blankets in daily clinical practice and assesses related health-economic outcomes. Participants receive either a weighted blanket or standard melatonin treatment as part of the study. The trial is non-randomized and compares these two active treatments to understand their impact on sleep and health over time. The treatments are assessed at multiple time points including baseline, 1 month, 3 months, 6 months, 1 year, and then yearly for up to 10 years. During the study, children will complete several assessments including the Insomnia Severity Index, Pediatric Insomnia Severity Index, Childrens Sleep Habits Questionnaire, and Sleep Self Report, among others. Secondary outcomes include measures of child and family well-being, anxiety, ADHD symptoms, quality of life, pain, costs related to psychiatric care, school attendance, and healthcare visits. These evaluations occur regularly from baseline through long-term follow-up to monitor effects and safety.

Researchers are investigating pain levels in adults who have experienced out-of-hospital cardiac arrest and are receiving intensive care. This observational substudy, PAINCARE, is part of the larger international STEPCARE trial that looks at sedation, temperature, and blood pressure strategies after cardiac arrest. The study aims to understand how much pain patients experience early in intensive care and how this pain relates to outcomes like delirium, ventilator-free days, and long-term pain reports. The study collects detailed pain assessments during the first 168 hours after patients are randomized, using validated self-report or behavioral pain tools. Participants are adults who have had cardiac arrest outside the hospital, have returned spontaneous circulation, and are comatose upon enrollment. The substudy includes both retrospective and prospective participants depending on local approvals. Analyses will focus on the time patients spend in moderate to severe pain while in the ICU, as well as associations between early pain and various health outcomes. Participants pain levels will be closely monitored along with other health factors like delirium and ventilator use during their ICU stay. Researchers will also assess pain one month after the cardiac arrest. Data completeness and quality will be carefully reported and analyzed. The study does not test treatments but observes pain and outcomes to generate hypotheses for future research. Participation duration varies but involves monitoring through ICU stay and follow-up at one month.