Sodertalje

Researchers are evaluating the impact of two different guidelines for monitoring labor progress on neonatal and maternal outcomes. The study compares the World Health Organizations Labour Care Guide LCG with standard delivery care in Sweden. The goal is to see if using the LCG can reduce adverse neonatal outcomes and lower the rate of intrapartum Cesarean sections. This study uses a multicenter, stepped-wedge cluster randomized design to explore these effects along with economic considerations and experiences related to childbirth. Participants will receive labor monitoring either according to the WHOs LCG guidelines or standard care. The study will involve multiple delivery units in Sweden, and women in active labor will be randomly assigned to either group as the new guidelines are gradually introduced. Alongside the main study periods, researchers will examine perinatal interventions, labor complications, and collect qualitative data through questionnaires, focus groups, and interviews with women, their partners, and healthcare providers. During participation, women and their partners will be asked about their childbirth experiences, while providers compliance and views on using the LCG will also be assessed. The study will track outcomes such as perinatal mortality, neonatal morbidity, cesarean section rates, and obstetric events like postpartum hemorrhage and labor duration. Data collection and follow-up will occur from 12 weeks up to 18 months after delivery, including economic evaluations and provider experiences to fully understand the effects of the labor monitoring methods.

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.

Researchers are studying ATTR amyloidosis to better understand the diseases course before and after diagnosis. This observational study focuses on patient characteristics, treatment patterns, and key outcomes, including clinical, economic, and quality of life measures. The goal is to gather real-world evidence on how ATTR amyloidosis presents and progresses in patients. Participants are grouped based on different subtypes of ATTR amyloidosis, such as cardiomyopathy, polyneuropathy, wild type, hereditary, and mixed phenotypes. The study collects data retrospectively and longitudinally across multiple countries. It does not involve any interventions but analyzes existing patient data, including treatments and healthcare utilization over time. During the study, researchers review healthcare resource use such as outpatient visits, hospitalizations, and emergency department visits from diagnosis and up to 12 years following. Clinical assessments like neuropathy impairment scores and activities of daily living are also examined. The study measures outcomes including mortality, transplant events, and disease manifestations to better characterize ATTR amyloidosis and its impact on patients.

This research aims to evaluate ways to prevent hernia after loop ileostomy reversal in patients who have undergone rectal cancer surgery. A loop ileostomy is a temporary opening created during rectal cancer surgery that is later closed in a separate operation. Hernia, a weakening of the abdominal wall at the stoma site, can cause pain, discomfort, and serious complications, and its frequency after ileostomy reversal varies widely. This study compares the use of a protective mesh to standard closure methods to see if hernia rates can be reduced. Participants will be randomly assigned to one of two groups one group will receive reinforcement of the abdominal wall with a mesh called Ultrapro Advanced, placed behind the muscles the other group will have the stoma site closed using standard suturing without mesh. The study is double-blinded, meaning neither patients nor surgeons recording follow-up data know which treatment was given. Procedures and outcomes such as operation time, complications, hospital stay, pain, and infections will be carefully recorded. Participants will be monitored before and after surgery, including a 30-day follow-up visit with questionnaires and complication assessments by a doctor not involved in the surgery. One year after the cancer operationwhich generally occurs 6 to 9 months after ileostomy reversalpatients will have a CT scan with straining to check for hernia and complete questionnaires. Further follow-up with questionnaires and imaging will occur at three years. The study involves detailed tracking of post-surgical recovery and hernia development over several years.

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 the effect of spironolactone combined with standard care compared to standard care alone in patients with Heart Failure with Preserved Ejection Fraction HFPEF. This condition is common and serious, but currently lacks effective treatment. The trial is a phase 3 Registry-Randomized Clinical Trial RRCT involving patients from the Swedish Heart Failure Registry and the US. HFPEF is defined by heart failure symptoms, elevated NT-proBNP levels, and an ejection fraction of 40% or higher. Participants will be randomly assigned to receive either spironolactone added to their usual care or usual care alone. Spironolactone will be given as 25 mg tablets, starting at 25 mg per day with a possible increase to 50 mg daily if tolerated. If spironolactone is not tolerated, eplerenone may be prescribed instead. The control group will continue with their standard care without spironolactone. The study duration is planned for 9 years, with enrollment lasting 7 years. During the study, researchers will collect data on cardiovascular death and hospitalizations due to heart failure as the primary outcomes. Secondary outcomes include hospitalizations for various causes, adverse events, and treatment adherence. In Sweden, outcomes will be obtained by linking national registries, while in the US, sites and call centers will report outcomes. The trial aims to enroll approximately 2000 patients, with follow-up continuing for at least 5 years after study start to monitor these outcomes.

This research focuses on pregnancies exposed to anifrolumab, a drug used for treating systemic lupus erythematosus SLE. The program collects and analyzes data to understand pregnancy and infant outcomes when exposed to anifrolumab during pregnancy or shortly before conception. It aims to evaluate the safety of this exposure by gathering detailed information from patient reports and healthcare professionals. The study gathers initial pregnancy data through reports submitted to AstraZenecas pharmacovigilance system. Pregnancy outcome details are collected close to delivery, with additional follow-up data on infant health obtained 12 months after birth. For pregnancies already concluded at the time of reporting, retrospective data including pregnancy outcomes and infant health are collected. The main group studied includes pregnancies with anifrolumab exposure from 16 weeks before conception through pregnancy. Participants contribute information through reports and follow-ups, with data collected using targeted checklists to ensure completeness. Researchers measure major and minor congenital malformations, adverse pregnancy outcomes, and the frequency of these events from conception through 12 months of infant age. The studys observation period extends to 12 months after birth to gather comprehensive safety data regarding anifrolumab exposure in pregnancy.