Kristianstad

Researchers are exploring the differences in clinical, molecular, and genetic features among cutaneous melanoma, melanoma in situ, dysplastic nevi, and benign nevi. The study also seeks to understand biological aggressiveness and find objective diagnostic markers for both primary and secondary melanoma. It includes patients suspected of having primary melanoma or metastatic melanoma and collects detailed information to support this research. Participants are adults receiving routine dermatological, surgical, or oncological care who are scheduled for surgical excision or cytological diagnostics of pigmented skin lesions or metastatic melanoma. Before surgery, imaging and blood samples are collected. During surgery, skin punch biopsies of the lesion and nearby normal skin are taken and stored frozen. Tissue samples from metastatic melanoma are also collected through biopsies during treatment and follow-up. Participants complete questionnaires about risk factors, medical history, lifestyle, and quality of life. Researchers document lesions with imaging and collect histology and molecular data stored securely. The study measures genomic and transcriptomic differences across melanoma types and tracks these findings over time. The total participation period spans from initial inclusion through follow-up, with samples and data collected before, during, and after treatments.

Researchers are evaluating new disease descriptions and management guidelines for breath-holding spells in children under 5 years old in southern Sweden. The study aims to determine if these guidelines reduce unnecessary diagnostic procedures and are safe to use. It also investigates whether iron supplements decrease the frequency and severity of these spells and explores what information and support parents need for managing their childrens condition. Children diagnosed with typical breath-holding spells will be managed according to the new guidelines, which include cardiac evaluations like ECG for those with relevant family history or symptoms, and blood tests for anemia and iron deficiency if the child has multiple spells. Children with non-typical spells will be assessed individually using current practices. If iron deficiency is identified, supplementation is recommended. Some parents of children with frequent spells may participate in interviews as part of a sub-study. Participants will be evaluated by medical doctors and monitored through digital surveys over time. Researchers will assess the safety and usability of the guidelines, the effectiveness of iron treatment, and the support needs of parents. The study includes follow-up for up to 36 months to monitor outcomes and uses interviews and surveys to gather detailed information from families. The total participation duration varies, with specific assessments scheduled within weeks to months after inclusion.

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.

This research aims to describe and evaluate the Cognitive Orientation to Daily Occupational Performance CO-OP approach for adolescents aged 13 to 17 with mild intellectual disability ID. Intellectual disability affects daily life management and problem-solving related to everyday tasks, and current treatment options with strong evidence to improve occupational performance are limited. CO-OP is a person-centered method where participants set their own goals and develop strategies to achieve them, showing promise in other groups like adolescents with cerebral palsy but requiring more evidence for use in adolescents with mild ID. Participants will undergo the CO-OP intervention over 10 weeks, where they will be guided to use meta-cognitive strategies to improve daily activities, self-efficacy, occupational performance, and independence. The study collects data at baseline, immediately after, and six months post-intervention. The project includes qualitative, quantitative, and mixed methods data collection, such as filmed sessions, field notes on therapy fidelity, and comparisons with policy documents. During the study, adolescents and their parents will participate in assessments including the Canadian Occupational Performance Measure and Performance Quality Rating Scale to evaluate changes in occupational performance and satisfaction. Self-efficacy and qualitative experiences of CO-OP will also be measured at multiple time points. Participants will meet weekly for ten weeks, and interviews with adolescents and parents will be conducted post-intervention and six months later to understand their perceptions and experiences.

Researchers are investigating the management of febrile infants aged 60 days or younger who visit pediatric emergency departments PEDs in Sweden. The study evaluates a new clinical guideline compared to current standard practices across 11 PEDs. This observational study aims to improve care by reducing unnecessary diagnostic tests, hospitalizations, and broad-spectrum antibiotic use, which have implications for patient comfort, healthcare resources, and environmental impact. The study will implement the new guideline in 7 PEDs while 4 PEDs will continue their usual care as a control group. All febrile infants aged 60 days or younger with a body temperature of 38.0C or higher, measured at home or in the PED, will be included. The research collects clinical data including fever details, gestational age, birth weight, symptoms, lab results, and diagnoses to refine and personalize management recommendations. Participants will be observed during their visit to the PED, with data gathered on investigations, treatments, and hospitalizations. The primary measure is how effectively the new guideline identifies cases of meningitis, bacteremia, and urinary tract infections, including any delays in treatment, tracked over 10 days. Secondary measures include prevalence of infections, clinical signs, and adherence to the guideline. The study plans to enroll at least 2,500 infants over approximately two years, with careful monitoring of outcomes and resource use.

Spontaneous intracerebral hemorrhage ICH is a serious type of stroke with high death and disability rates. Researchers are investigating whether a structured treatment package called a Care Bundle can improve the 3-month outcomes for patients with acute ICH compared to standard care. The study is an international, multicenter, parallel, cluster-randomized clinical trial focusing on implementing this Care Bundle in high-income countries, building on results from previous trials mostly done in low- and middle-income countries. The Care Bundle includes early intensive blood pressure lowering, treatment of fever and high blood sugar, rapid reversal of oral anticoagulation, and timely referrals to intensive care or neurosurgery when needed. Hospitals are randomized in batches through three phases usual care, randomized evaluation of the Care Bundle versus usual care, and a post-implementation follow-up where all hospitals apply the Care Bundle. Each batch lasts 18 months, with 6 months per phase, and the overall study rollout spans 2.5 years. Participants are adults aged 18 or older diagnosed with spontaneous ICH confirmed by imaging within 24 hours of symptom onset. During the study, patient management details and outcomes will be closely monitored, including brain imaging, blood pressure, glucose levels, and functional status. The primary outcome is functional recovery measured by a utility-weighted modified Rankin Scale score at 180 days. Secondary outcomes include disability, death, and health-related quality of life. The study also collects data on treatments and care decisions to evaluate the Care Bundles effectiveness and sustainability.

Researchers are studying patients with stage II primary invasive cutaneous melanoma to compare the effects of two different surgical excision margins 1cm versus 2cm. The goal is to determine if narrower margins are as safe as wider margins in preventing melanoma recurrence and if they can improve patients quality of life. This trial also looks at the impact of these excision sizes on health services and society. Participants will be randomly assigned to receive either a 1cm or 2cm wide local excision margin around the primary melanoma lesion. Both groups will undergo sentinel lymph node biopsy and may have reconstruction surgery if needed. The surgery must be done within 120 days of diagnosis and within 28 days of randomization. During the study, participants will be followed for up to 60 months to measure disease-free survival as the primary outcome. Additional assessments include local recurrence, distant disease-free survival, melanoma-specific and overall survival, quality of life questionnaires, neuropathic pain evaluations, adverse event monitoring, and health economic analysis. Follow-up questionnaires and safety checks will occur at multiple time points up to 24 months after surgery, with longer-term monitoring continuing up to 120 months.

Researchers are conducting the BILLIONSTARS study, a prospective, single-arm observational trial focused on patients diagnosed with hepatocellular carcinoma HCC or cholangiocarcinoma CCC who are recommended locoregional interventions such as surgery, ablation, or transarterial chemoembolization, andor antitumoral medical treatments. The study aims to understand how tumor characteristics and individual factors influence treatment response by analyzing blood samples, tumor tissue, and other biological markers. The study plans to enroll 150 patients at specific hospitals and includes research autopsies for patients in late palliative phases. Participants will have blood samples collected before, during, and after systemic treatment to analyze circulating tumor DNA, immune cells, and proteins. Tumor tissue from surgical specimens will be collected mainly as formalin-fixed paraffin-embedded samples, with some fresh tissue stored for future research. Quality of life questionnaires will be completed at the start of the study and at three and six months. Treatments will follow national guidelines and will not be influenced by study participation. Radiological and clinical follow-ups will occur as part of usual care or when clinically necessary. During the study, participants will be monitored through blood sample collections aligned with treatment visits and will complete quality of life assessments. The primary outcome measure is overall survival, assessed up to 60 months. Secondary outcomes include progression-free survival and changes in quality of life using specific questionnaires. The study includes safety and clinical follow-up as per standard protocols, with participation lasting up to several years based on survival and treatment timelines.

Researchers are evaluating if the combination of pivmecillinam and clavulanic acid PAC is not less effective than ciprofloxacin, trimethoprim-sulfamethoxazole, or ertapenem for treating febrile urinary tract infections UTIs caused by extended spectrum beta-lactamase ESBL producing Enterobacterales EPE. This phase 3 clinical trial aims to provide clinical evidence on the safety and efficacy of PAC as a step down oral therapy compared to standard treatments in patients with these resistant infections. Participants will be randomly assigned to receive either the experimental PAC treatment, which includes 400 mg pivmecillinam and 875125 mg amoxicillinclavulanic acid taken three times daily, or one of the standard treatments ciprofloxacin 500 mg twice daily, trimethoprimsulfamethoxazole 800 mg160 mg twice daily, or ertapenem 1 g once daily, based on susceptibility. The treatments are given orally as step down therapy following initial intravenous antibiotics. The trial compares these treatments to assess non-inferiority in clinical cure and other outcomes. During the study, participants will be monitored for clinical cure approximately 10 days after treatment, with follow-up visits up to 28 days to assess recurrence of infection, microbiological cure, treatment tolerability, drug discontinuation rates, additional antibiotic use, hospital readmissions, serious adverse events, and mortality. Data collection includes urine and fecal cultures, patient questionnaires on treatment tolerability, and safety monitoring. The total study duration includes the treatment period and post-treatment follow-up to evaluate outcomes and safety.

Researchers are evaluating two school-based programs designed to improve sleep among teenagers aged 13 to 19 in Swedish high schools and upper secondary schools. The goal is to promote better sleep habits and prevent future depressive symptoms, addressing common issues such as mental health challenges, concentration problems, and lower academic performance linked to insufficient sleep. The study compares two interventions with usual teaching methods. The first program, Sleep on Schedule, involves five lessons over five weeks focusing on sleep knowledge, good routines, time management, and behavioral exercises delivered by school staff. The second program, Technology restriction, includes two lessons over two weeks encouraging students to limit electronic media use before bedtime. Schools are randomly assigned to one of these programs or to a control group receiving no intervention. Participants will complete questionnaires on sleep habits, mental health, and motivation at baseline, three months, and one year. Selected students will wear wrist actigraphs to monitor sleep objectively. The study measures changes in sleep duration as the primary outcome, along with assessments of anxiety, depression, sleep hygiene, insomnia severity, and electronic media use. The project spans from initial lessons through follow-up assessments, aiming to benefit students by teaching preventive sleep strategies.