Clinical trials

The diet is assumed to contribute to many of our present non-communicable diseases. Vegetarian products are instead considered to be health promoting, However, it is not verified that the modern vegetarian and vegan products are healthier than the ones they are meant to replace. Products based on vegetables are nowadays often produced with advanced techniques and can therefore differ substantially from the original vegetables. The epithelium in the gut is protected by a mucus layer that efficiently prevents bacteria to encounter the epithelium and even to translocate into the gut and the blood stream. In several inflammatory conditions such as e.g., inflammatory bowel disease (IBD) the barrier integrity is disrupted, and translocation will occur. Fibers are important for the gut microbiota enabling the production of short chain fatty acids (SCFA) that is necessary as nutrition for the epithelial cells, Fibers also promote the development of mucus. The aim of the present study is to evaluate components in the diet that is claimed to be health promoting even though they sometimes can be a hazard to your health. Both fibers and antinutrients can be found in these dietary regimens. The health effects of these products will be studied by analysis of the gut microbiota and the barrier integrity as markers of the health status. Gut microbiota will be analyzed with next generation sequencing and q-PCR (polymerase chain reaction). Diversity and the occurrence of different species will be determined. The barrier integrity will be estimated by analysis of bacterial DNA in blood and presence of live bacteria. The study consists of two different parts: 1a. 60 health volunteers are divided into two groups. One group consumes ordinary dairy based yogurt and the other a yogurt based on vegan products for four weeks to enable a change in the gut microbiota. At start and after four weeks fecal samples and questionnaires about the general health and gastrointestinal symptoms will be retrieved. It should be noted that the compounds offered can be bought in the ordinary shops. 1. b. The same design as above but with IBD patients instead. Their disease activity will be monitored by scoring sheets and regular blood tests as a part of their regular check-up. 2. a. The same design as in 1a but with comparison between a regular meat-based diet and a diet with vegetarian meat substitutes instead. 2b. The same design as I 2a but with IBD patients. Healthy volunteers will be invited wit advertisements. The IBD patients will be recruited at the out-patient clinic at the Dept of Gastroenterology at Skåne university hospital, Sweden. Before inclusion their disease activity will be monitored. The study is a prospective non-randomized intervention study including both men and women. Each individual will serve as their own control. The meals based on meat substitutes will be composed in cooperation with a dietitian. The estimated amount of yogurt is 200-250 gram/day, and the amount of meat is 150-200 gram/day.

The purpose of this study is to assess the effect of L-menthol on breathlessness and exercise capacity in patients with Asthma.

The goal of this clinical trial is to learn if psilocybin, given with psychological support, is safe and helps treat anorexia nervosa in young adults. Anorexia nervosa is a serious eating disorder that currently has no approved medicine. Psilocybin is a psychedelic substance that may help the brain form new connections, which could make it easier for people with anorexia nervosa to develop healthier ways of thinking. The main questions this study aims to answer are: * Is psilocybin with psychological support safe and well-tolerated? * Does psilocybin with psychological support help lower symptoms of anorexia nervosa? * How might psilocybin work in the brain to support recovery from anorexia? This study will compare psilocybin with psychological support to Treatment as Usual (TAU). Participants in the study will be randomly placed into one of the two groups. There will be 40 patients with anorexia nervosa included, 20 per group. TAU includes the standard care people receive for anorexia nervosa in a specialized eating disorder clinic in Region Skåne, Sweden. Participants will: * Be between 16 and 35 years old and have anorexia nervosa * Take psilocybin (25 mg) by mouth two times, four weeks apart * Receive psychological support before, during, and after each dosing session (including preparation and integration sessions) * Complete questionnaires, have brain scans (magnetic resonance imaging) and blood tests to learn more about how psilocybin may work * Share their personal experiences as part of a qualitative interview This study hopes to learn if psilocybin, when given with the right support, can be a helpful and safe option for people living with anorexia nervosa.

The menisci of the knee joint are structures composed of cartilage and connective tissue, whose primary functions are to stabilize the joint and distribute weight across joint surfaces. In doing so, it helps protect the joint from osteoarthritis - a form of joint failure commonly referred to as "joint wear". Meniscal surgeries are among the most common orthopaedic procedures performed both in Sweden and globally. Historically, damaged menisci were treated by removing the injured part. However, this approach is linked to early-onset osteoarthritis. Osteoarthritis affects approximately one-third of individuals over the age of 45 and ranks among the ten most common diagnoses in Europe based on years lived with disability. The knee is the most frequently affected joint, and the importance of the menisci in preserving knee function has become increasingly recognized. In recent years, advances in surgical techniques have led to a shift towards meniscus-preserving procedures. A typical injury is the displaced meniscus, in which a large portion of the meniscus becomes detached from the joint capsule and wedges itself inside the joint, causing mechanical locking and preventing full extension. A displaced meniscus often loses its blood supply and suffers mechanical damage from being compressed between the joint surfaces. To preserve the meniscus and prevent irreversible damage, early surgical intervention is required. If the injury is too old or the tissue too damaged, the injured part of the meniscus must be removed, which significantly increases the risk of developing early knee osteoarthritis. It remains unclear how soon surgery must be performed to successfully preserve the meniscus, and this likely depends on various other factors, including patient age, presence of additional joint injuries, and surgical technique. There is currently no reliable data on the proportion of displaced menisci that heal after meniscus-preserving surgery. However, studies suggest that 20-30% of repaired menisci require reoperation due to failed healing. Given that displaced menisci are considered surgical emergencies, they pose a significant burden on healthcare systems already strained by limited access to urgent surgery. Meanwhile, ongoing development of surgical techniques raise ethical and logistical questions for health providers - especially as the scientific evidence for the benefits of some advanced treatments remains inconclusive. Therefore, more research is needed to guide the optimal management of displaced bucket-handle lesions across a diverse patient population, taking into account age, activity level, and concurrent injuries. A key priority is to identify predictors of healing potential, particularly the time window during which surgical repair remains a viable option. With better knowledge, more menisci could potentially be preserved - reducing both the number of unnecessary re-operations and the long-term incidence of knee osteoarthritis.

Adenosine is a commonly used pharmaceutical stressor at cardiac magnetic resonance examinations to assess suspected chronic coronary syndrome (CCS). However, several studies have reported that the current use of adenosine does not induce adequate hyperemic response in a substantial number of patients, leading to false diagnostics. The aim of this trial is to investigate the hyperemic effect of the standard dose of adenosine (140 microgram/kg/min) to the high dose of adenosine (210 microgram/kg/min) to improve the diagnostic methods using adenosine as a stressor and ultimately improve treatment decisions and patient prognosis in CCS.

The County Council of Region Skåne, Sweden, has recently initiated Targeted Health Dialogues in primary care. The prevention program includes health dialogues provided by specially trained personnel, collection of clinical and laboratory data as well as questionnaire data on, e.g., individual health and health behaviors. So far, it enrolls all 40-year old Swedish and foreign-born inhabitants in the county and it will also include all 50- and 60-year old persons within a near future. A research project will be integrated within the program where the collected data will be linked, on the individual level, to national and regional data on hospital admissions, clinical diagnoses from specialist clinics and primary care, causes of death, and prescriptions. The individual linkages will also include population data on sociodemographic characteristics, neighborhood of residence and family relations. Blood samples will be collected for analyses of molecular biomarkers. The research project will examine associations between potential predictors and future risk of cardiovascular diseases and other serious diseases, such as cancer, and also whether the effect of the prevention program is modified by these potential predictors. The effect of the intervention will be examined, and whether the protocol needs to be modified in order to develop more precise and personalized medicine.

Skin color, how easily a person burns or tans in the sun (skin phototype), and the amount of chronic sun damage in the skin are important factors in skin health. These characteristics influence a person's risk of skin cancer, how skin diseases appear, how well treatments work, and how accurately doctors and artificial intelligence (AI) systems can diagnose skin conditions. However, current methods for classifying these characteristics are often imprecise and rely heavily on subjective assessments. As a result, both healthcare professionals and patients may incorrectly classify skin type, which can lead to inaccurate risk assessments and less personalized care. This study aims to develop and validate AI algorithms that can accurately classify skin pigmentation, skin phototype, and accumulated sun damage using photographs of the skin. Unlike existing approaches, the study combines several different methods to create a more objective "ground truth" for training the AI. These methods include skin color measurements using spectrophotometry or colorimetry, assessments using the Monk Skin Tone Scale, questionnaires about sun sensitivity, and clinical evaluations by trained observers. By combining these data sources, the researchers hope to create a more reliable and scientifically robust classification system. The study will recruit adults aged 18 years and older from several countries, including countries from all continents. Participants will complete a questionnaire about their skin, propensity to burn and sun exposure history. Researchers will then take standardized close-up and dermoscopic images of the skin on the arm and forearm, measure skin pigmentation using objective instruments when available, and assess skin phototype and sun damage. No invasive procedures will be performed, and no personally identifiable information will be collected. The collected images and measurements will be used to train deep learning AI models. The researchers aim to develop algorithms that can classify skin pigmentation with at least 85% accuracy, skin phototype with at least 75% accuracy, and sun damage with at least 80% accuracy compared with the combined reference assessments. The algorithms will then be tested in independent datasets, including large dermatology image databases from Sweden, to evaluate how well they perform in different populations. The study has several potential benefits. More accurate classification of skin characteristics could improve personalized skin cancer risk assessments and allow prevention advice to be tailored to individual needs. This may help identify people who would benefit from closer surveillance and stronger sun protection recommendations while avoiding unnecessary restrictions for people at lower risk. Improved classification could also enhance the diagnosis and management of inflammatory skin diseases and skin cancers, which can appear differently in people with different skin tones. An additional goal is to address known biases in dermatology AI systems, which often perform less accurately in individuals with darker skin. By including participants with a wide range of skin tones and backgrounds, the researchers aim to contribute to the benchmarking of AI-driven medical devices wich hopefully can result in the development of fairer and more equitable AI tools. The study involves minimal risk. Only photographs of the arm and forearm will be taken, and researchers will avoid capturing tattoos, prominent scars, or other identifying features. All data will be stored securely and only accessible to authorized researchers. The potential benefits of improving skin disease diagnosis, skin cancer prevention, and fairness in medical AI are considered to outweigh the small privacy risks associated with participation.

The BILLIONSTARS study is a prospective, single arm observational study inviting patients diagnosed with hepatocellular carcinoma (HCC) or cholangiocarcinoma (CCC) who are to be recommended locoregional intervention by surgery, ablation or transarterial chemoembolization and/or antitumoral medical treatment. The aim is to investigate how tumor- and individual-related factors affect response to treatment. To this end, circulating tumor DNA, immune cells and various proteins will be analyzed in repeated blood samples taken before, during and after completion of systemic treatment. When applicable, analyses will also be performed on tumor tissue from resected tumors and biopsies, and in some cases also from autopsies

Surgical left atrial appendage closure (LAAC) has been associated with reduced rates of stroke in patients with atrial fibrillation (AF) who have undergone cardiac surgery. In recent time, procedures with catheter-based devices for LAAC have failed to achieve results that would make them considered a safe alternative to oral anticoagulation. Several concerns regarding catheter-based devices have been raised due to their contact with circulating blood, device migration and periprocedural complications. LAAC using an externally placed clip via thoracoscopy would elude some of these concerns and may therefore be a feasible alternative to oral anticoagulation in patients with AF. This study aims to assess whether thoracoscopic left atrial appendage closure (TLAAC) is noninferior to medical treatment in patients with AF and an elevated bleeding risk using or being planned to initiate OAC and in those patients with clinical contraindications to oral anticoagulants.

This study will evaluate whether HbA1c screening can be performed in dental care to detect elevated blood glucose in patients with advanced periodontitis and support referral to primary care. Periodontitis is a common chronic inflammatory disease affecting the supporting tissues of the teeth. Advanced periodontitis is associated with prediabetes, type 2 diabetes and cardiovascular disease. The relationship between periodontitis and diabetes is bidirectional: diabetes increases the risk and severity of periodontitis, while periodontal inflammation may contribute to impaired glucose regulation. Patients with advanced periodontitis may therefore represent a group at increased risk of undetected elevated blood glucose. Many of these patients visit dental care regularly but may not otherwise be reached by structured medical prevention. This is a cross-sectional observational feasibility study conducted in public dental clinics in Skåne, Sweden, in collaboration with primary care. Adult patients aged 18 years or older with advanced periodontitis, defined as periodontitis stage 3-4 or grade B/C, will be invited to participate during a routine dental visit. Patients with previously diagnosed diabetes will not be included. After informed consent, participants will complete or update a health declaration and undergo capillary HbA1c testing at the dental clinic using a validated point-of-care instrument. Participants will receive their test result. Those with HbA1c ≥42 mmol/mol will receive standardized information and be referred to their listed primary care centre for further diagnostic assessment and preventive follow-up according to routine clinical practice. The study will assess how feasible this pathway is in routine dental care. Outcomes include participation rate, successful HbA1c testing, time required for study procedures, prevalence of elevated HbA1c, proportion referred to primary care, completed primary care follow-up within six months, dropout and costs. Follow-up data will be collected from medical records and regional registers. The study may provide a practical model for collaboration between dental care and primary care, with the long-term aim of improving early detection of prediabetes and diabetes and strengthening preventive care for patients with advanced periodontitis.

The aim of this study is to test the efficacy of the CE-marked wearable system Stroke Alarm to identify the onset of a stroke with unilateral arm motor deficit within 3 hours of onset. This is a multicenter, prospective observational single-arm trial with a registry-based propensity matched control population. A total of 500 patients will be included in the trial. An interim analysis will determine if the stroke onset frequency is sufficient to determine the main outcome. Should the number of stroke events differ from what is expected at interim analysis, study enrollment will continue to increase cohort size. Patients who meet the criteria for participation will, after signing consent, be included and receive the Stroke Alarm bracelets that are used for 3 months. Study data will be collected as baseline at inclusion, at follow-up 3 months after inclusion and by using national Swedish registry data after completion of the study. Patients with elevated stroke risk according assessed by presence of specific criteria associated with elevated risk caused by: 1. recent TIA with an ABCD2 score of ≥6, large artery atherosclerosis or atrial fibrillation, OR 2. recent ischemic stroke with large artery atherosclerosis or atrial fibrillation, without persisting arm motor deficit, OR 3. atrial fibrillation with an CHA2DS2-Vasc score ≥ 4 without adequate anticoagulation OR 4. recent hemorrhagic stroke with atrial fibrillation, without persisting arm motor deficit The combined efficacy goal is at least 60% sensitivity for Stroke Alarm b of stroke with unilateral arm motor deficit within 3 hours of onset (with a 95% confidence interval above 30%) and a specificity of at least 80% using a clinical stroke diagnosis as gold standard. A control population matched for calendar year, age (± 5 years), sex, healthcare region, baseline stroke severity according to the National Institutes of Health Stroke Scale (NIHSS, ± 5 points), unilateral arm motor deficit (NIHSS item 5a/5b 1-4), presence of neglect/inattention (NIHSS item 11 1-2), atrial fibrillation, cohabitation status and pre-stroke functional level twill be identified in the Swedish national stroke registry, Riksstroke, and used for comparison.

This randomized controlled trial will evaluate whether a brief preoperative virtual reality intervention reduces anxiety and improves early recovery in adults undergoing elective gynecological surgery. Approximately 140 participants will be randomly assigned in a 1:1 ratio to either virtual reality in addition to usual care or usual care alone. The virtual reality intervention will consist of approximately 10-20 minutes of an immersive relaxation experience before surgery. The primary outcome is the change in preoperative anxiety measured before and after the intervention. Secondary outcomes include postoperative quality of recovery, pain, opioid consumption, postoperative nausea and vomiting, and early recovery-related healthcare outcomes.

Ventilator-associated pneumonia (VAP) is a common and serious infection in patients receiving mechanical ventilation in intensive care units. Current diagnostic methods are imprecise, leading to unnecessary antibiotic use and delayed treatment. The ClusterVAP study aims to identify biologically and clinically distinct subgroups of patients with suspected VAP by analyzing proteins in bronchoalveolar lavage (BAL) fluid using advanced proteomic techniques. This multicentre observational study will enroll approximately 400 adult patients from intensive care units in Sweden, France, Portugal, Denmark, and the United Kingdom. BAL or mini-BAL samples collected for clinical reasons will be analyzed to define "pneumoclusters" and explore their association with patient outcomes. The study will also identify candidate biomarkers that could support future diagnostic tools. No experimental treatments are given; all patients receive standard care. Results may improve diagnostic accuracy and guide personalized treatment strategies for critically ill patients.

The purpose of this study is to evaluate different peptide biomarkers, variations in the microbiome and patterns in the bacterial transcriptome as prognostic or diagnostic biomarkers of VAP.

The overall aim of the study is to investigate the incidence of type 2 diabetes in individuals who have access to a digital intervention tool as compared with randomized controls during three years. The tool is based on self-affirmation theory and has large emphasis on self-reflection to enable sustainable lifestyle changes. Users get access to expert-written information about relevant health topics and interact with an LLM to promote reflection on the information.

The overall aim of the project is to investigate factors that may influence treatment outcomes in people with difficult-to-treat anorexia nervosa who are enrolled in inpatient care at the Region Skåne Eating Disorders Centre in Lund. Treatment expectations, sense of autonomy, and patient participation, will be investigated, as well as caregivers' attitudes towards, and experiences of working with, autonomy and patient participation in the inpatient setting. The research project is expected to contribute to increased knowledge about the treatment of difficult-to-treat anorexia nervosa, and what part patient participation and autonomy may play when treating severe eating disorders. The overall objectives of the research program are: 1. To contribute to increased knowledge about factors that influence the treatment of people with difficult-to-treat anorexia nervosa 2. To highlight the role of autonomy and patient participation in inpatient care of severe eating disorders 3. To use the research results for clinical improvement work at Region Skåne Eating Disorders Center

Observational retrospective study of patients in need of acute surgical care admitted to Skåne University Hospital between 2009 and 2019.

This is a prospective multicentre randomised controlled trial evaluating whether intraoperative indocyanine green (ICG) fluorescence angiography improves outcomes in head and neck free flap reconstruction compared with standard clinical assessment of flap perfusion. Adult patients undergoing microvascular free flap reconstruction for oncologic, trauma, or benign head and neck defects will be randomised to either intraoperative ICG angiography or conventional clinical perfusion assessment. The primary outcome is partial flap loss requiring intervention within 30 days after surgery. Secondary outcomes include total flap loss, flap-related re-exploration, flap salvage, and postoperative complications.

The goal of this clinical trial is to compare the effect of negative pressure wound therapy (NPWT) versus traditional dressings on the incidence of transplant infection in adult patients undergoing split-thickness skin grafting (STSG) to the lower leg following excision of a skin tumour. The main questions it aims to answer are: Does NPWT reduce the incidence of transplant infection within three months after STSG? Does NPWT improve secondary outcomes such as graft take, reduce reoperations, complications, and resource use? Researchers will compare patients treated with NPWT to patients treated with traditional dressings to see if NPWT results in lower infection rates and better clinical outcomes. Participants will: Undergo excision of a skin tumour on the lower leg followed by STSG. Be randomized to receive either NPWT or traditional dressings applied over the graft. Follow a structured postoperative care and mobilisation schedule. Attend follow-up visits at day 5 and day 14 postoperatively and be monitored through medical record review up to three months after surgery.

Spontaneous intracerebral haemorrhage (ICH) accounts for approximately 10-15% of all strokes but stands for 50% of stroke-related morbidity and mortality. Approximately half of all patients with ICH have a decreased level of consciousness at hospital admission. Despite this, intensive care and neurosurgical interventions are uncommon. A study conducted in low- and middle-income countries has demonstrated a beneficial effect of a treatment package consisting of early intensive blood pressure lowering, as well as the treatment of pyrexia and elevated blood glucose levels. The I-CATCHER team is now planning to conduct a similar study in Sweden and Australia, as well as in other high-income countries. The study has a clear focus on implementation, aiming to improve treatment and prognosis for patients with ICH within a few years. The purpose of I-CATCHER is to investigate whether a structured treatment package (Care Bundle) improves 3-month prognosis in patients with spontaneous ICH compared to standard care.

This randomized, multicenter, open-label trial evaluates whether preoperative dental screening improves outcomes in patients undergoing surgical or transcatheter cardiac valve intervention. Participants are randomized 1:1 to preoperative dental screening or no screening. The primary outcome is time to first occurrence of all-cause death, redo-intervention of the index valve, or definite infective endocarditis within 2 years. The study uses registry-based follow-up to ensure complete outcome ascertainment.

Gender-Affirming Care and Mental Health (GLOW) investigates the psychological, medical, and social factors that influence the outcomes of gender-affirming care, as well as its impact on mental health, work capacity, and quality of life. Gender dysphoria is defined as the incongruence of a person's experienced gender and sex assigned at birth. In Sweden, the prevalence of gender dysphoria has increased significantly in recent decades. Still there is no consensus on the long-term outcomes ofgender-affirming care. 1. What are the baseline characteristics in individuals seeking gender-affirming care and do any of these predict outcomes of gender-affirmative care?2. Do individuals with gender dysphoria experience improved or reduced quality of life, gender congruence, or functional capacity after gender-affirming care?3. Does gender-affirming care reduce or increase psychiatric symptoms and self-concept clarity?4. What are the effects of gender-affirming care on mortality, work capacity, and healthcare resource utilization as compared to an age and gender matched control group?Data and MethodGLOW targets patients at the Gender Dysphoria Clinic, Region Skåne a National Highly Specialized Care unit (NHV). Mixed methods will be used to analyze data from national registries and self-reported assessments.The NHV status ensures standardized high-quality data collection and clinical follow-up, making this project a unique opportunity to evaluate the care given to individuals with gender dysphoria.Societal Relevance and Utility The growing demand for gender-affirming care underscores the need for research to identify the most effective interventions. The results may also help reduce stigma and improve social integration for individuals with genderdysphoria.GLOW is a longitudinal mixed-methods study based at the NHV Gender Dysphoria Clinic in Region Skåne. It includes registry-based, qualitative interviews and repeated self-report measures up to 5 years after baseline assessment. Quantitative analyses will include regression models and Bayesian methods.

The aim of the study is to evaluate experience of security, accessibility, and avoidable utilization of health care services in patients who have had access to specialized palliative care clinic (SPCC) compared to those who have not, and to evaluate the relatives' experience of the care.

This study aims to develop and evaluate a model for systematic and evidence-based cancer rehabilitation for people with esophageal and gastric cancer to provide conditions for a better quality of life and fewer cancer-related symptoms.

The PAINCARE substudy is an observational cohort substudy nested within the international STEPCARE trial, which evaluates sedation, temperature, and mean arterial pressure strategies after out-of-hospital cardiac arrest. PAINCARE aims to describe the burden of pain during early intensive care after cardiac arrest and to evaluate associations between early pain burden and selected ICU and patient-reported outcomes. Pain is common in critically ill patients but may be difficult to assess in patients who are unconscious, sedated, mechanically ventilated, or unable to self-report. PAINCARE collects structured pain assessments during the first 168 hours after randomization using validated self-report or behavioral pain instruments and relates early pain burden to outcomes including delirium burden, ventilator-free time, ICU-free time, and follow-up pain outcomes. All analyses are observational; PAINCARE is not designed to determine whether modifying pain burden improves outcomes.