Sodertalje

Researchers are evaluating whether using the World Health Organization's Labour Care Guide (LCG) instead of standard care for monitoring labor progress can improve outcomes for newborns and mothers. This study compares these two guidelines to see if the LCG can reduce adverse neonatal outcomes, such as perinatal mortality, neonatal complications, and the need for cesarean sections during labor. The research also looks at other perinatal interventions, complications, and economic factors, using a multicenter, stepped-wedge cluster randomized trial design conducted from 2023 to 2025 in Sweden. Participants will receive care based on either the WHO's LCG or standard labor monitoring guidelines. The LCG is a next-generation partograph designed to follow the latest intrapartum care recommendations. The study involves multiple delivery units where women in active labor receive monitoring according to the assigned guideline. Researchers will compare outcomes such as neonatal morbidity, cesarean section rates, use of oxytocin, postpartum hemorrhage, labor duration, and experiences of women, their partners, and healthcare providers. Throughout the study, participants will be monitored for neonatal complications including low Apgar scores, hypoxic ischemic encephalopathy, intracranial hemorrhage, seizures, meconium aspiration syndrome, and neonatal unit admissions. The study will also assess maternal outcomes and collect feedback via questionnaires and interviews about childbirth experiences and guideline compliance. The primary outcomes are adverse neonatal events and intrapartum cesarean rates, with follow-up from 12 weeks up to 18 months after birth to gather comprehensive data on health and safety.

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 conducting a retrospective, observational, longitudinal study across multiple countries to gather real-world information about patients with ATTR amyloidosis. The study aims to describe patient characteristics such as demographics, family history, key comorbidities, and humanistic outcomes including quality of life, neuropathy impairment, and activities of daily living. It also seeks to understand treatment patterns and disease outcomes, as well as healthcare resource use before and after diagnosis. This study involves analyzing existing data from patients diagnosed with ATTR amyloidosis without introducing any interventions. Patients will be followed from diagnosis throughout the study period to assess various clinical and economic outcomes. No treatments or procedures are administered as part of this study, as it focuses solely on observing and collecting secondary data. Participants' health care use will be evaluated, including outpatient visits, emergency department visits, hospitalizations, and transplants, up to 12 years post-diagnosis. Researchers will also assess clinical measures such as neuropathy impairment scores and new disease manifestations. The study will track mortality and healthcare costs to better understand the disease journey and its impact over time.

Researchers are evaluating ways to prevent hernia formation after loop ileostomy reversal in patients who have undergone rectal cancer surgery. This study is a prospective, double-blinded randomized trial comparing the use of a retro muscular mesh called Ultrapro Advanced against standard treatment without mesh. Hernias at the stoma site can cause pain, discomfort, and more serious complications, but the best method to prevent them after stoma closure is not yet established. Participants will be randomly assigned to receive either mesh reinforcement of the abdominal wall or standard suturing without mesh during their loop ileostomy reversal surgery. The study focuses specifically on patients with low anterior resection for rectal cancer. Surgeons will fill out detailed operation notes, and patients will be closely monitored for complications such as infections, pain, and length of hospital stay. Patients will have follow-up visits at 30 days post-surgery, with a different doctor than the surgeon conducting the visit. They will complete questionnaires about their recovery and complications. At one year and three years after the cancer operation, patients will have CT scans with straining to check for hernia development and will receive further questionnaires. Follow-up doctor visits may be in person or by phone, aligned with routine cancer care. The study aims to see if the mesh reduces hernia incidence and may lead to new treatment recommendations.

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.

Heart failure with preserved ejection fraction (HFPEF) is a common and serious condition without effective treatment options. Researchers are evaluating whether adding spironolactone, a medication, to standard care can reduce the combined risk of cardiovascular death and hospitalizations for heart failure in patients with HFPEF. This study is a Phase 3 trial including patients from the Swedish Heart Failure Registry and the US, all having symptoms of heart failure, elevated heart-related blood markers, and an ejection fraction of 40% or higher. Participants are randomly assigned to one of two groups: one receiving spironolactone along with usual care, and the other receiving usual care alone without spironolactone. The study is designed as a registry-randomized clinical trial and will continue until 721 cardiovascular death or heart failure hospitalization events occur, with an enrollment period of 7 years and a total study duration of 9 years. Data collection in Sweden uses registry linkages, while data in the US comes from site reports and supplemented call center follow-up. During the study, researchers will monitor participants for hospitalizations due to heart failure or cardiovascular death as the primary outcome. Secondary outcomes include other hospitalizations, side effects, and how well patients follow their treatment plans. Outcomes are tracked through national registries and direct reporting, with the main data locked and analyzed five years after the study begins. Approximately 2000 patients aged 50 to 99 years will be included to achieve the event target needed for study conclusions.

Researchers are studying pregnancy and infant outcomes in women exposed to anifrolumab, a drug used to treat moderate to severe systemic lupus erythematosus (SLE). The study collects detailed data on pregnancies from patients treated with anifrolumab, aiming to evaluate the safety of the drug during pregnancy and its impact on infants. This research uses information from AstraZeneca's pharmacovigilance system, focusing on cases reported as part of the PRegnancy outcomes Intensive Monitoring (PRIM) program. The study gathers initial pregnancy information from reports submitted by patients or healthcare providers. Pregnancy outcomes are tracked close to delivery, with additional follow-up data collected 12 months after birth. For pregnancies already completed at the time of reporting, researchers collect retrospective data on pregnancy characteristics, outcomes, and infant health. The program uses targeted checklists and guidance to ensure data completeness and to map variables for analysis. Participants provide data through pregnancy reports and follow-up assessments. Researchers monitor major congenital malformations from conception until the pregnancy outcome or up to 12 months of infant age for live births. The study focuses on collecting comprehensive safety data to understand the effects of anifrolumab exposure during pregnancy and early infancy.