Kristianstad

Researchers are investigating the differences in clinical, molecular, and genetic characteristics among cutaneous melanoma, melanoma in situ, dysplastic nevi, and benign nevi. This study also examines metastatic melanoma, aiming to identify objective diagnostic markers and understand biological aggressiveness in both primary and secondary melanoma. The study collects detailed patient information through validated questionnaires covering medical history, UV exposure, family cancer history, skin type, smoking, alcohol use, and quality of life. Participants undergo diagnostic and prognostic imaging, and molecular analyses using omics and machine learning methods. Blood samples are collected before surgical removal of primary lesions and during follow-up treatments for secondary disease. Dermatologists take full-thickness skin punch biopsies from the lesion and nearby normal skin, which are snap-frozen and stored. Tissue from suspected or confirmed secondary melanomas is obtained mainly through surgical and core needle biopsies before, during, and after treatment or disease progression. Throughout the study, participants provide comprehensive questionnaire responses and undergo imaging and histologic examinations documented in a secure database. Researchers analyze molecular and clinical data from tissue and blood samples to explore differences across melanoma types and nevi. The study spans from November 2013 to December 2026 and monitors genomic and transcriptomic variations to improve understanding and diagnosis of melanoma and related skin lesions.

Researchers are evaluating new disease descriptions and management guidelines for breath-holding spells in children under 5 years old living in southern Sweden. The study aims to see if these guidelines reduce unnecessary diagnostic tests, ensure safe clinical management, and assess if iron supplementation lessens the frequency and severity of spells. It also explores the types of information and support parents need for children with these spells. Children diagnosed with typical breath-holding spells will be managed following the new guidelines. Those with a family history or signs of heart disease will receive an ECG, and children with two or more spells will have blood tests to check for anemia and iron deficiency. If iron deficiency is found, iron supplements are recommended. Digital surveys will be given to parents, and children with frequent spells may be invited to participate in interviews. Participants will undergo evaluations by medical doctors, with follow-up lasting up to 36 months to monitor safety and guideline use. The study will measure the safety of the guidelines over this period and usability shortly after inclusion. Researchers will also assess the usability of the disease definition until the doctors complete their assessments. Parents will provide information through surveys, and some may join interviews to share their experiences and support needs.

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.

Intellectual disability (ID) is a lifelong condition that makes it hard for individuals to manage everyday life tasks appropriate for their age, especially in creating strategies and solving problems related to daily activities. Treatment options with strong evidence to improve occupational performance for people with ID are limited. The Cognitive Orientation to Daily Occupational Performance (CO-OP) approach, which has shown benefits in other groups like adolescents with cerebral palsy, uses a person-centered method where individuals choose their own goals and create strategies to achieve them. Early research suggests CO-OP might help adolescents with mild ID, but more evidence on its feasibility and effectiveness is needed. The study evaluates CO-OP in adolescents aged 13 to 17 with mild intellectual disability. CO-OP is a client-centered, performance-based, problem-solving therapy focused on everyday activities. It helps participants use meta-cognitive strategies to develop their own solutions, aiming to boost self-efficacy, occupational performance, and independence. The intervention involves meeting once a week for ten weeks, supported by a parent or significant other. Participants will be assessed using various methods including the Canadian Occupational Performance Measure and the Performance Quality Rating Scale, tracked from before the intervention up to 6 months afterward. Data collection includes qualitative interviews with adolescents and parents, observations comparing therapy sessions to the CO-OP manual, and analysis of therapist notes. The study examines both the effectiveness and how well CO-OP fits this group, with a focus on long-term impact in everyday life.

Researchers are evaluating a new clinical guideline for managing febrile infants aged 60 days or younger who visit pediatric emergency departments. Each year, about one million such infants present with fever in Europe and the United States. Although only a small percentage are diagnosed with serious infections like meningitis, bacteremia, or urinary tract infections, current guidelines recommend extensive testing, hospitalization, and broad antibiotic use. These practices may lead to medical overuse, stress for families, increased healthcare costs, and environmental impact. The study is a prospective observational trial conducted across 11 pediatric emergency departments in Sweden. Seven sites will implement the new guideline as standard care for infants with fever without a known source, while four sites will continue usual practices to serve as controls. The study expects to enroll at least 2,500 febrile infants over approximately two years. Data collected will include clinical signs, laboratory results, and management details to help improve and individualize care guidelines. Participants will undergo assessments including temperature measurement and clinical evaluations to identify serious bacterial infections. Researchers will monitor adherence to the new guideline, compare detection rates of infections between groups, and track any delays in treatment. Outcome measures include the proportion of infants correctly identified with meningitis, bacteremia, or urinary tract infections and those who experienced delayed antibiotic treatment. The study aims to optimize infant care while reducing unnecessary interventions and their consequences.

Spontaneous intracerebral hemorrhage (ICH) is a severe type of stroke accounting for 10-15% of all strokes but causing about half of stroke-related deaths and disabilities. Many patients with ICH have decreased consciousness when admitted, yet intensive care and neurosurgical treatments are not common. Prior studies in low- and middle-income countries showed that a treatment package including early intensive blood pressure lowering and managing fever and high blood sugar improved outcomes. The I-CATCHER study aims to test a similar structured Care Bundle approach in Sweden, Australia, and other high-income countries to improve treatment and prognosis for patients with spontaneous ICH. This study compares a Care Bundle involving early intensive blood pressure control, reversal of oral anticoagulation within 30 minutes, fever management, blood sugar control, and timely referrals to intensive care or neurosurgery against standard care. The Care Bundle targets specific blood pressure levels depending on initial readings and aims to avoid do-not-resuscitate orders or withdrawal of care for 48 hours. Repeat brain imaging is done as needed. Hospitals are randomized in batches over three phases lasting 18 months each: usual care, randomized evaluation, and post-implementation follow-up, with the entire study rolling out over 2.5 years. Participants are adults aged 18 or older with spontaneous ICH confirmed by imaging and admitted within 24 hours of symptom onset. Patient information, treatments, and outcomes are recorded, including functional status measured by the Utility Weighted modified Rankin Scale at 180 days. The study collects data on various treatments, monitoring, and complications to assess if the Care Bundle improves recovery. Safety and sustainability of the Care Bundle are evaluated through continued hospital participation and follow-up.

Researchers are evaluating the safety and outcomes of different surgical margin sizes for adults with stage II primary invasive cutaneous melanoma. The trial compares the effects of removing 1 cm versus 2 cm of healthy skin around the melanoma site to see if smaller margins provide similar disease control. This study aims to understand if narrower excision margins can reduce surgery side effects and improve quality of life without increasing the risk of melanoma returning. Participants will be randomly assigned to undergo wide local excision surgery with either a 1 cm or 2 cm margin around the original melanoma scar. Both approaches involve removing an extra margin of skin to eliminate any remaining melanoma cells after the initial biopsy. Surgery is scheduled to be completed within 120 days after diagnosis and within 28 days after randomization. This phase III, multi-center trial will assess if the smaller margin is as effective as the larger one. During the study, patients will be followed for up to 60 months to monitor disease-free survival, which means the length of time without melanoma recurrence. Researchers will also evaluate quality of life, side effects from surgery, and the economic impact on health services. Participants will have regular clinical assessments, and outcomes will be recorded to determine the long-term safety and benefits of the two surgical approaches.

Researchers are evaluating how well tofacitinib works and how patients stick to their treatment for ulcerative colitis in real-life clinical settings in Sweden. This observational study uses data from the ongoing National Swedish registry called SWIBREG and also looks at prescription records to understand treatment adherence. The focus is on measuring clinical disease activity and remission rates over time. Participants in the study receive tofacitinib as prescribed by their doctors according to standard clinical practice and official guidelines. The study does not assign treatments but observes patients who have already been prescribed tofacitinib. Data collection includes records from SWIBREG and the Swedish Prescribed Drug Register to monitor treatment use and clinical outcomes. During the study, researchers track participants' disease activity through clinical assessments and laboratory tests, including fecal calprotectin levels and endoscopic scores. The main outcome measured is the proportion of participants in remission after 52 weeks, as indicated by the Partial Mayo Score. Patients provide informed consent, and their data is collected at baseline and throughout the study to assess treatment effectiveness and adherence over time.

Researchers are investigating how tumor and individual patient factors influence the response to treatment in people diagnosed with hepatocellular carcinoma (HCC) or cholangiocarcinoma (CCC). This prospective observational study takes place at Skåne University Hospital and Central Hospital in Sweden, involving up to 150 patients who are recommended for locoregional treatments such as surgery, ablation, transarterial chemoembolization, and/or systemic antitumoral therapy. Participants will have tumor tissue collected from surgical specimens or biopsies when applicable. Blood samples will be taken before, during, and after systemic treatment to analyze circulating tumor DNA, immune cells, and proteins. Quality of life questionnaires will be completed at the start of the study, and after three and six months. The treatment itself follows standard national guidelines and is not altered by study participation. Research autopsies may also be conducted with patient consent during late palliative phases. During the study, patients will undergo clinical and radiological follow-ups according to routine care. Blood samples will be collected by a research nurse during treatment visits. The main outcome measured is overall survival up to 60 months from inclusion. Secondary outcomes include progression-free survival and changes in quality of life. The study involves informed consent and aims to better understand tumor evolution and treatment response in liver and bile duct cancers.

Researchers are evaluating whether the combination of pivmecillinam and amoxicillin/clavulanic acid (PAC) is not less effective than ciprofloxacin, trimethoprim-sulfamethoxazole, or ertapenem when used as step-down oral treatment for patients with febrile urinary tract infections (UTIs) caused by bacteria producing extended spectrum beta-lactamase (ESBL). This phase 3 trial aims to provide clinical evidence on the safety and efficacy of PAC compared to standard oral therapies for these antibiotic-resistant infections. The study builds on previous observations suggesting beta-lactams may be effective alternatives to fluoroquinolones in such infections. Participants receive either the PAC combination—taking one tablet of pivmecillinam 400 mg plus one tablet of amoxicillin/clavulanic acid 875/125 mg three times daily—or standard treatment with ciprofloxacin 500 mg twice daily, trimethoprim-sulfamethoxazole 800 mg/160 mg twice daily, or ertapenem 1 g once daily, depending on bacterial susceptibility. Eligible patients are those who have already received 1 to 5 days of intravenous antibiotics active against ESBL-producing Enterobacterales and are ready to switch safely to oral antibiotics as determined by their physician. During the study, participants will be monitored for clinical cure about ten days after starting oral therapy. Researchers will assess symptoms, laboratory cultures, and overall response to treatment. The trial includes detailed eligibility screening and safety monitoring, with follow-up assessments to evaluate the treatment outcomes and ensure participant well-being throughout the study period.