[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Region Skane\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":705},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,89,0,25,[9,48,76,107,135,162,185,217,250,277,299,326,358,383,404,424,444,474,503,539,576,605,629,650,673],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100569590","fermented-vegan-optimized-diet-in-health-and-colitis-100569590",false,"NCT06696222","Fermented Vegan Optimized Diet in Health and Colitis","FAVORIT","Inclusion Criteria:\n\n* Healthy volunteers in two groups\n* IBD in two groups (ulcerative colitis or Crohn's disease)\n\nExclusion Criteria:\n\n* For healthy any disease requiring medication\n* For IBD previous extensive operation\n* For both antibiotics the past month",true,"ALL","18 Years",{"count":21,"type":22},240,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.\n\nThe 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.\n\nThe 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.\n\nThe study consists of two different parts:\n\n1a. 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.\n\n1. 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.\n2. a. The same design as in 1a but with comparison between a regular meat-based diet and a diet with vegetarian meat substitutes instead.\n\n2b. 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.\n\nThe 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\u002Fday, and the amount of meat is 150-200 gram\u002Fday.",[28,29],"Healthy Volunteers","Inflammatory Bowel Disease (IBD)",[31,32,33,34],"diet","ulcerative colitis","Crohn&#39;s disease","vegetarian diet","RECRUITING","2026-08-20",{"date":38,"type":39},"2026-08-21","ACTUAL",{"date":41,"type":39},"2024-11-18",{"date":43,"type":22},"2027-12-31",{"name":45,"class":46},"Region Skane","OTHER",2,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":47},"100631461","phase-2-efficacy-of-l-menthol-on-breathlessness-in-asthma-100631461","NCT07500974","Efficacy of L-menthol on Breathlessness in Asthma","Effect of L-menthol on Breathlessness and Exercise Capacity in Asthma: a Randomized Crossover Trial","Ment-Astma","Inclusion Criteria:\n\n* the subject has given written consent to participate in the study\n* physician diagnosis of Asthma according to international guidelines\n* mMRC (modified Medical Research Council) score of 1 or above\n* age 18 years or older\n* able to cycle\n* able to understand and talk Swedish to participate in the study procedures, as judged by the Investigators.\n\nExclusion Criteria:\n\n* resting peripheral oxygen saturation (SpO2) \\\u003C 92%\n* hospitalization or clinical instability during the last four weeks\n* treatment with supplementary oxygen at rest or during exercise\n* contraindication to exercise testing in accordance with clinical practice guidelines\n* expected survival shorter than six months as judged by the Investigator\n* medical conditions including congestive heart failure, acute coronary artery disease, neuromuscular diseases, severe psychiatric illness, and olfaction disorder.",{"count":57,"type":22},20,[59],"PHASE2","The purpose of this study is to assess the effect of L-menthol on breathlessness and exercise capacity in patients with Asthma.",[62],"Asthma",[64,65,66,67],"breathlessness","asthma","exercise capacity","CPET","2026-08-17",{"date":70,"type":39},"2026-08-19",{"date":72,"type":39},"2026-05-07",{"date":74,"type":22},"2027-05",{"name":45,"class":46},{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":18,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100605992","phase-2-safety-therapeutic-potential-and-mechanisms-of-two-psilocybin-doses-administered-with-psychological-support-in-young-adults-with-anorexia-nervosa-100605992","NCT07169747","Safety, Therapeutic Potential, and Mechanisms of Two Psilocybin Doses, Administered With Psychological Support in Young Adults With Anorexia Nervosa","The Therapeutic Potential of Psilocybin in Anorexia Nervosa in Young Adults","psiAN","Inclusion Criteria:\n\n* Diagnosis of AN per DSM-5, including anorexia nervosa in partial remission.\n* Have experienced at least one period of weight restoration to a minimum BMI of 17 followed by subsequent weight loss.\n* Age 16-35\n* BMI \\>16\n* Stable contact with a psychiatric unit\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Psychosis, bipolar disorder, substance use disorder, family history of psychosis or bipolar disorder, refusal of birth control, lifetime psychedelic use.\n* Cardiovascular conditions\n* Resting systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mmHg at screening or baseline\n* Clinically significant arrhythmias, tachycardia and QT prolongation\n* History of stroke, myocardial infarction, or other significant cardiovascular events\n* Seizure disorders or history of epilepsy\n* Diabetes mellitus, positive drug tests, suicidal intent, allergy or intolerance to drug content, blood or needle phobia\n* Only for the MRI-part of the study: Metal pieces in the body (contraindicated by fMRI, assessed in each case by MR-technician). Non-compliance to fMRI will not lead to study exclusion\n* Any other clinically significant medical condition that, in the investigator's opinion, may pose a risk to the participant or interfere with study results\n* Care under the Swedish Compulsory Psychiatric Care Act (LPT)\n* Ongoing treatment with medications that have clinically relevant 5-HT2A-receptor antagonistic properties and are therefore expected to directly block or substantially interfere with the pharmacodynamic effects of psilocybin. Such medications require an appropriate washout period prior to psilocybin administration, based on pharmacokinetic properties and clinical judgement. Medications without direct 5-HT2A-antagonistic effects are not excluded on this basis.\n* BMI \\> 21.0 for ≥ 6 consecutive months within the 12 months prior to screening, as documented in medical records.","16 Years","35 Years",{"count":87,"type":22},40,[59],"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.\n\nThe main questions this study aims to answer are:\n\n* Is psilocybin with psychological support safe and well-tolerated?\n* Does psilocybin with psychological support help lower symptoms of anorexia nervosa?\n* How might psilocybin work in the brain to support recovery from anorexia?\n\nThis 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.\n\nParticipants will:\n\n* Be between 16 and 35 years old and have anorexia nervosa\n* Take psilocybin (25 mg) by mouth two times, four weeks apart\n* Receive psychological support before, during, and after each dosing session (including preparation and integration sessions)\n* Complete questionnaires, have brain scans (magnetic resonance imaging) and blood tests to learn more about how psilocybin may work\n* Share their personal experiences as part of a qualitative interview\n\nThis 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.",[91],"Anorexia Nervosa",[93,91,94,95,96,97],"Psilocybin","Young adults","fMRI","BDNF","Adolescents","2026-08-12",{"date":100,"type":39},"2026-08-14",{"date":102,"type":22},"2026-07-20",{"date":104,"type":22},"2027-10-01",{"name":45,"class":46},1,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":18,"minAge":114,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":47},"100599035","surgical-outcome-after-displaced-bucket-handle-meniscal-lesions---repair-versus-partial-meniscectomy-100599035","NCT07079254","Surgical Outcome After Displaced Bucket-handle Meniscal Lesions - Repair Versus Partial Meniscectomy","Surgical Outcome After Displaced Bucket-handle Meniscal Lesions - Repair Versus Partial Meniscectomy: A 10-year Observational Study","Inclusion Criteria:\n\n* 15 years or above.\n* Displaced longitudinal bucket-handle tear including the posterior horn on MRI and a knee extension deficit.\n\nExclusion Criteria:\n\n* Patient younger than 15 years.\n* Insufficient knowledge of the Swedish language.\n* Per-operative findings including a bucket-handle rupture in combination with a complete radial rupture","15 Years",{"count":116,"type":22},300,"OBSERVATIONAL","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.\n\nIn 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.\n\nIt 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.\n\nGiven 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.\n\nTherefore, 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.",[120,121,122],"Meniscus Rupture","Meniscus Injury","Osteoarthritis of Knee",[124,125,126,127],"Meniscus","Re-operation","Bucket-handle","Osteoarthritis",{"date":129,"type":39},"2026-08-13",{"date":131,"type":39},"2023-10-07",{"date":133,"type":22},"2045-12",{"name":45,"class":46},{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":17,"sex":18,"minAge":142,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":147,"conditions":148,"keywords":152,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":106},"100560521","phase-4-hyperemic-myocardial-perfusion-by-adenosine-at-different-doses-100560521","NCT06578234","Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses","HYPER","Inclusion Criteria:\n\nPatients:\n\n1. The subject has given their written consent to participate in the trial.\n2. Are referred to Department of Clinical Physiology, Skåne University Hospital, for suspected or known CCS or heart failure\n3. Matches the inclusion criteria for sex and age (6 females and 6 males from each group in each age decade from 40 to \\>80 years old)\n4. Matches the inclusion criteria for no known heart failure (group b) or known heart failure (group c)\n5. No caffein intake \\\u003C24h prior to the examination\n\nHealthy volunteers:\n\n1. The subject has given their written consent to participate in the trial.\n2. Matches the inclusion criteria for sex and age (6 females and 6 males from each group in each age decade from 40 to \\>80 years old)\n3. No caffein intake \\\u003C24h prior to the examination\n\nExclusion Criteria:\n\nPatients:\n\n1. Acute referral (in-house patients)\n2. Clinically unstable\n3. Acute chest pain\n4. Severe or decompensated heart failure\n5. Non sinus rhythm (e.g. atrial fibrillation)\n6. Asthma or severe chronic obstructive pulmonary disease\n7. Known chronic renal failure (eGFR \\\u003C45mL\u002Fmin\u002F1.73m2)\n8. AV-block II or III\n9. Left Bundle Branch Block\n10. Systolic blood pressure \\\u003C90 mmHg or \\>230 mmHg at rest\n11. Increased intracranial pressure\n12. Known allergy or adverse reaction to adenosine or mannitol\n13. Known allergy or adverse reaction to gadolinium contrast agents\n14. Treatment with medication containing dipyradimol or teofyllamin\u002Fteofyllin\n15. Claustrophobia\n16. Devices contraindicated to CMR imaging (pacemaker, implants, intracranial clips etc)\n17. Pregnancy or breast feeding (screened by question only)\n18. Inability to give informed consent due to mental state, language difficulties etc\n\nHealthy volunteers:\n\n1. Any of the exclusion criteria for patients\n2. Blood pressure \\> 140\u002F90 measured according to clinical routine\n3. Known systemic disease\n4. Known cardiac disease\n5. Cardiovascular medication\n6. Medication that might influence cardiovascular health\n7. Smoking","40 Years",{"count":144,"type":22},180,[146],"PHASE4","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\u002Fkg\u002Fmin) to the high dose of adenosine (210 microgram\u002Fkg\u002Fmin) to improve the diagnostic methods using adenosine as a stressor and ultimately improve treatment decisions and patient prognosis in CCS.",[149,150,151],"Chronic Coronary Syndrome","Coronary Artery Disease","Ischemic Heart Disease",[153,154,155],"Myocardial perfusion","Cardiac Magnetic Resonance","Adenosine",{"date":129,"type":39},{"date":158,"type":39},"2024-10-23",{"date":160,"type":22},"2026-12-31",{"name":45,"class":46},{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":18,"minAge":142,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":106},"100432563","targeted-health-dialogues-in-primary-care-100432563","NCT04912739","Targeted Health Dialogues in Primary Care","Targeted Health Dialogues in Primary Care: Lifestyle Screening and Molecular Profiling for a Healthier Life","Inclusion Criteria:\n\n* 40-, 50-, 60-, and 70-year old men and women\n* Listed at a healthcare center in Skåne county\n\nExclusion Criteria:\n\n\\* Inability to understand the written study information and give informed consent","70 Years",{"count":171,"type":22},18000,"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.",[174,175,176,177,178],"Health Behaviors","Risk Factors","Cardiovascular Diseases","Cancer","Serious Diseases",{"date":129,"type":39},{"date":181,"type":39},"2020-10-01",{"date":183,"type":22},"2040-12-31",{"name":45,"class":46},{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":193,"targetDuration":195,"studyType":117,"phases":4,"briefSummary":196,"conditions":197,"keywords":200,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},"100651900","skin-type-determination-using-image-artificial-intelligence-100651900","NCT07765303","Skin Type Determination Using Image Artificial Intelligence","Skin Pigment Type, Phototype and Photodamage Determination Using Image Analyses Powered by Artificial Intelligence - SPAI Study","SPAI","Inclusion Criteria:\n\n* Aged 18 years or older\n* Able and willing to provide informed consent (oral or written, according to local regulations)\n* Willing to complete the study questionnaire\n* Willing to undergo non-invasive skin imaging and skin characteristic assessments of predefined sites on the upper arm and forearm\n\nExclusion Criteria:\n\n* Younger than 18 years of age\n* Unable to provide informed consent\n* Unable to complete study procedures\n* Tattoos, prominent scars, wounds, skin lesions, dressings, or other identifiable features at the predefined imaging sites that may interfere with image acquisition, assessment quality, or participant anonymity",{"count":194,"type":22},1500,"1 Day","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.\n\nThis 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.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nAn 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.\n\nThe 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.",[198,199],"Skin Ageing","Skin",[201,202,203,204,205,206,207,208],"skin tone","pigmentation","skin color","chronic sun damage","photodamage","sun sensitivity","phototype","Fitzpatrick type","2026-08-10",{"date":100,"type":39},{"date":212,"type":39},"2025-04-28",{"date":214,"type":22},"2028-12-31",{"name":45,"class":46},11,{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":225,"targetDuration":227,"studyType":117,"phases":4,"briefSummary":228,"conditions":229,"keywords":232,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":249},"100583539","on-treatment-surveillance-of-tumor-evolution-and-response-to-systemic-treatment-in-bile-duct-and-liver-cancer-100583539","NCT06877637","On-treatment Surveillance of Tumor Evolution and Response to Systemic Treatment in Bile Duct and Liver Cancer","BILe Duct and LIver Cancer: ON-treatment Surveillance of Tumor Evolution And Response to Systemic Treatment","BILLIONSTARS","Inclusion Criteria:\n\n* \\> 18 years of age\n* Clinically diagnosed intrahepatic Cholangiocarcinoma (iCCC), perihilar Cholangiocarcinoma (pCCC), distal Cholangiocarcinoma (dCCC), gall bladder carcinoma (GBC) or mixed Hepatocellular carcinoma\u002FCholangiocarcinoma planned to undergo surgery\n* Histologically or cytologically confirmed Cholangiocarcinoma (iCCC, pCCC, dCCC, GBC, mixed HCC\u002FCCC) for patients planned to receive palliative systemic treatment or\n* Clinically diagnosed Hepatocellular carcinoma (HCC) planned for surgery, ablation or transarterial chemo-embolization. For patients planned to receive systemic treatment histological or cytological confirmation is required except for patients with LI-RADS 5 lesions.\n\nExclusion Criteria:\n\n* \\\u003C 18 years of age\n* Severe comorbidities\n* Inability to comprehend study information",{"count":226,"type":22},150,"2 Years","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\u002For 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",[230,231],"Hepatocellular Carcinoma (HCC)","Cholangiocarcinoma",[233,234,235,236,237,238,239,240],"cholangiocarcinoma","hepatocellular carcinoma","bile duct cancer","liver cell cancer","circulating tumor DNA","targeted therapy","tumor heterogeneity","tumor evolution","2026-07-31",{"date":243,"type":39},"2026-08-03",{"date":245,"type":39},"2025-05-15",{"date":247,"type":22},"2029-12-31",{"name":45,"class":46},3,{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":23,"phases":259,"briefSummary":260,"conditions":261,"keywords":265,"overallStatus":268,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":106},"100647171","standalone-thoracoscopic-left-atrial-appendage-closure-versus-medical-therapy-in-atrial-fibrillation-100647171","NCT07705282","Standalone Thoracoscopic Left Atrial Appendage Closure Versus Medical Therapy in Atrial Fibrillation","STELLA-AF","Inclusion Criteria:\n\n1. Age ≥ 18 years and any of criteria 2-3\n2. AF with a CHA2DS2-VA score ≥2 and a HAS-BLED score ≥3 or other clinically significant bleeding condition and ongoing OAC treatment\n3. AF with a CHA2DS2-VA score ≥2 but deemed unfit for OAC by responsible physician due to clinical contraindications (e.g. amyloid angiopathy, previous intracranial haemorrhage or severe gastrointestinal bleeding).\n\nExclusion Criteria:\n\n1. Clinical frailty score ≥5\n2. Indication for OAC other than AF\n3. Indication for dual antiplatelet therapy, if OAC is discontinued\n4. Previous open-heart surgery\n5. Present indication for cardiac surgery\n6. Present indication for ablation for atrial fibrillation\n7. Previous radiation therapy of the chest, due to malignancy\n8. Previous pericarditis or myocarditis\n9. Previous surgery including access to the left pleural space\n10. Documented FEV1\\\u003C70% or other significant pulmonary disease (including but not restricted to fibrosis, pulmonary post-covid syndrome, cystic fibrosis)\n11. Ongoing treatment with corticosteroids or previous treatment for more than 3 consecutive months.\n12. Allergy to contrast media\n13. Patient already included in another interventional clinical trial\n14. Patient listed abroad, which would render them to be lost to follow-up after discharge\n15. Patient does not understand study information given in the local language or, for other reasons, is deemed unfit to participate according to the investigators",{"count":258,"type":22},936,[25],"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.\n\nThis 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.",[262,263,264],"ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION","Oral Anticoagulation","Thoracotomy",[266,267],"Left atrial appendage closure","Atrial fibrillation","NOT_YET_RECRUITING","2026-07-10",{"date":271,"type":39},"2026-07-15",{"date":273,"type":22},"2028-01-01",{"date":275,"type":22},"2032-12-31",{"name":45,"class":46},{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":23,"phases":287,"briefSummary":288,"conditions":289,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":298,"locationsCount":106},"100646662","hba1c-screening-in-dental-care-and-primary-care-referral-in-patients-with-advanced-periodontitis-100646662","NCT07688278","HbA1c Screening in Dental Care and Primary Care Referral in Patients With Advanced Periodontitis","Early Detection of Elevated Blood Sugar in Patients With Advanced Periodontitis: a Feasibility Study","DENT-PC","Inclusion Criteria:\n\n* Age 18 years or older.\n* Advanced periodontitis, defined as stage 3-4 periodontitis or grade B\u002FC periodontitis according to clinical and radiographic assessment during routine dental care.\n* Ability to understand study information and provide informed consent.\n\nExclusion Criteria:\n\n* Previously diagnosed diabetes mellitus.\n* Inability to provide informed consent, for example due to severe mental disorder or markedly impaired health status as judged by the clinical staff.",{"count":286,"type":22},600,[25],"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.\n\nPeriodontitis 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.\n\nThis 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\u002FC, will be invited to participate during a routine dental visit. Patients with previously diagnosed diabetes will not be included.\n\nAfter 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\u002Fmol 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.\n\nThe 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.\n\nThe 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.",[290,291],"Periodontitis, Adult","Prediabetes \u002F Type 2 Diabetes","2026-06-30",{"date":294,"type":39},"2026-07-07",{"date":296,"type":22},"2026-07-01",{"date":43,"type":22},{"name":45,"class":46},{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":309,"conditions":310,"keywords":314,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":324,"locationsCount":325},"100540311","stroke-alarm-efficacy-trial-100540311","NCT06315192","Stroke Alarm Efficacy Trial","StrokeAlarmEFF","INCLUSION CRITERIA\n\n1. Age 50 years or older\n2. Modified Rankin scale of 0-2.\n3. Diagnosed with either:\n\n   A. Recent\\* transient ischemic attack (TIA, G45.9), AND:\n   * ABCD2 score of ≥6, OR:\n   * Atrial fibrillation OR:\n   * Large artery atherosclerosis\\*\\*.\n\n   B. Recent\\* acute ischemic stroke (I63), AND:\n\n   • Atrial fibrillation, OR:\n   * Large artery atherosclerosis\\*\\*. C. Atrial fibrillation\u002Fflutter (I48), AND\n   * None, or reduced dose of, oral anticoagulation medication\\*\\*\\*, AND\n   * CHA2DS2-VASC score ≥4.\n\n   D. Recent\\* intracerebral hemorrhage (I61.9), AND:\n\n   • Atrial fibrillation.\n4. The patient has received the required information about the study and agrees in writing to participate.\n5. Smartphone user since at least 1 year.\n\n   * Within the last 2 weeks \\*\\*Atherosclerosis in carotid, vertebral aortic arch or major intracerebral arteries according to CTA or ultrasound.\n\n     * Including all oral anticoagulation medication such as Warfarin and NOACs. Patients with reduced dose of a NOAC can be included, regardless if this is within the approved label, or if reduced dose is chosen off-label for other reasons. Treatment with antiplatelet medication is permissible.\n\nEXCLUSION CRITERIA\n\n1. Previous inclusion in this study.\n2. Arm motor deficit from any previous medical condition.\n3. Unable to give informed consent to participate in the study.\n4. Does not master any of the languages available within the Stroke Alarm smartphone app in speech and writing.\n5. Does not have access to a Stroke Alarm compatible smartphone.\n6. Deemed unable to handle the Stroke Alarm smartphone app, or participate in planned follow-up within the framework of the study due to other diseases or circumstances.\n7. Does not want to participate.",{"count":307,"type":22},500,[25],"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.\n\nThis is a multicenter, prospective observational single-arm trial with a registry-based propensity matched control population.\n\nA 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.\n\nPatients 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.\n\nPatients with elevated stroke risk according assessed by presence of specific criteria associated with elevated risk caused by:\n\n1. recent TIA with an ABCD2 score of ≥6, large artery atherosclerosis or atrial fibrillation, OR\n2. recent ischemic stroke with large artery atherosclerosis or atrial fibrillation, without persisting arm motor deficit, OR\n3. atrial fibrillation with an CHA2DS2-Vasc score ≥ 4 without adequate anticoagulation OR\n4. 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.\n\nA 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\u002F5b 1-4), presence of neglect\u002Finattention (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.",[311,312,313],"Stroke Acute","Atrial Fibrillation","TIA",[315,316,317,318],"Stroke","wearable","indication","sensor","2026-06-29",{"date":292,"type":39},{"date":322,"type":39},"2024-09-05",{"date":43,"type":22},{"name":45,"class":46},10,{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":23,"phases":336,"briefSummary":337,"conditions":338,"keywords":342,"overallStatus":268,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":4},"100645168","recovery-with-virtual-reality-for-stress-and-pain-100645168","NCT07679022","Recovery With Virtual Reality for Stress and Pain","Recovery With Virtual Reality for Stress & Pain (ReVRS)","ReVRS","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Scheduled to undergo elective gynecological surgery according to the study protocol at a participating center where virtual reality can be provided.\n* Able and willing to provide informed consent for study participation, 1:1 randomization, and use of virtual reality.\n\nExclusion Criteria:\n\n* Increased risk of adverse effects related to virtual reality, including pronounced motion sickness, claustrophobia, or photosensitive epilepsy.\n* Active substance use disorder or active misuse of alcohol or illicit drugs.\n* Severe chronic pain and\u002For regular preoperative opioid treatment, as defined in the study protocol.",{"count":335,"type":22},140,[25],"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.",[339,340,341],"Preoperative Anxiety","Postoperative Pain","Postoperative Recovery",[343,344,345,346,347,339,340,348,349,350],"Virtual Reality","Perioperative Care","Gynecologic Surgery","Quality of Recovery","QoR-15","Opioid Consumption","Postoperative Nausea and Vomiting","Nonpharmacologic Intervention","2026-06-25",{"date":296,"type":39},{"date":354,"type":22},"2026-09-30",{"date":356,"type":22},"2029-02-28",{"name":45,"class":46},{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":368,"conditions":369,"keywords":372,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":382},"100611846","clustervap-multicentre-proteomic-endotyping-of-ventilator-associated-pneumonia-100611846","NCT07245888","ClusterVAP: Multicentre Proteomic Endotyping of Ventilator-associated Pneumonia","Endotyping of Ventilator-associated Pneumonia With Proteomics on Bronchoalveolar Lavage for Improved Diagnosis, the ClusterVAP Study","ClusterVAP","Inclusion Criteria:\n\nAdult patients (≥18 years) admitted to an intensive care unit (ICU). Receiving invasive mechanical ventilation. Undergoing bronchoalveolar lavage (BAL) or mini-BAL on clinical indication for suspected lower respiratory tract infection.\n\nNew or worsening clinical signs compatible with lower respiratory tract infection within the preceding 24 hours, defined as the treating clinician's suspicion plus at least one of:\n\nBody temperature \\>38 °C or \\\u003C36 °C. Visually purulent tracheal secretions. Signs of reduced oxygenation (e.g., increased FiO₂ and\u002For decreased arterial pO₂, increased positive end-expiratory pressure or driving pressure).\n\nRequest for chest radiograph to investigate infection or new infiltrate. Initiation of antibiotic therapy targeting lower respiratory tract infection.\n\nExclusion Criteria:\n\nBAL or mini-BAL performed solely for screening without suspicion of infection. Concurrent enrolment in the VAPmarkers study (reserved for external validation).\n\nAge \\\u003C18 years. Any condition that, in the opinion of the investigator, would preclude safe participation or confound study objectives.",{"count":367,"type":22},400,"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.",[370,371],"Ventilator Acquired Pneumonia","Mechanical Ventilation Complication",[373,374,375],"VAP","endotyping","mini-BAL",{"date":292,"type":39},{"date":378,"type":39},"2026-05-01",{"date":380,"type":22},"2027-12",{"name":45,"class":46},4,{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":393,"conditions":394,"keywords":396,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":402,"locationsCount":403},"100448259","biomarkers-for-ventilator-associated-pneumonia-100448259","NCT05117125","Biomarkers for Ventilator-associated Pneumonia","Biomarkers for Prediction of and Diagnosis of Ventilator-associated Pneumonia","VAPmarkers","Inclusion Criteria:\n\n* Admission to an intensive care unit\n* Intubation within last 24 hours\n* Anticipated mechanical ventilation of at least 48 hours\n\nExclusion Criteria:\n\n* FiO2 above 70% or PEEP above 15\n* Severe coagulopathy (spontaneous PK(INR) \\>1.8 or thrombocytes \\\u003C50). Prophylaxis treatment dose of LMWH or factor Xa inhibitors\u002FNOAC is not an exclusion criteria. If higher doses of these substances are administered, the responsible clinician should be consulted before sample collection.\n* Ongoing infection of the lungs at admission to the ICU.\n* Severely elevated or instable intracranial pressure.",{"count":392,"type":22},1000,"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.",[395],"Pneumonia, Ventilator-Associated",[373],{"date":398,"type":39},"2026-06-26",{"date":400,"type":39},"2021-10-15",{"date":214,"type":22},{"name":45,"class":46},5,{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":17,"sex":18,"minAge":85,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":23,"phases":413,"briefSummary":414,"conditions":415,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":106},"100642231","effect-of-the-digital-livsstilsverktyget-in-conjunction-with-a-large-language-model-on-the-prevention-of-type-2-diabetes-100642231","NCT07659535","Effect of the Digital Livsstilsverktyget in Conjunction With a Large Language Model on the Prevention of Type 2 Diabetes","Personalized Study With the Lifestyle Tool","Inclusion criteria\n\n* Informed consent\n* Age above 35 years\n* Access to Internet and mobile or computer device\n\nExclusion criteria\n\n* diabetes mellitus\n* conditions or treatments that in the judgement of the Investigator could affect the study evaluation\n* connection with the study team, funders, authorities, universities or other public or private bodies in such a way that specific interests in the study outcomes could be suspected.\n* living outside of Sweden\n* inability to read and write in Swedish",{"count":412,"type":22},40000,[25],"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.",[416],"Type 2 Diabetes","2026-06-22",{"date":351,"type":39},{"date":420,"type":22},"2026-06-15",{"date":422,"type":22},"2030-12-31",{"name":45,"class":46},{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":431,"enrollmentInfo":432,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":268,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":4},"100619907","inpatient-care-of-patients-with-difficult-to-treat-anorexia-nervosa---factors-affecting-treatment-outcome-100619907","NCT07350720","Inpatient Care of Patients With Difficult to Treat Anorexia Nervosa - Factors Affecting Treatment Outcome.","Inpatient Care of Patients With Difficult to Treat Eating Disorders - What Affects Treatment Outcome?","Inclusion Criteria:\n\n* Anorexia Nervosa diagnosis (ICD F50.0)\n* Admitted to inpatient care at department 5 at Region Skåne Eating Disorders Center\n\nExclusion Criteria:\n\n* Confidential identity\n* Inability to read or write in Swedish or English\n* Condition or treatment that, according to the study team, makes participation in the study inappropriate","64 Years",{"count":433,"type":22},100,"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:\n\n1. To contribute to increased knowledge about factors that influence the treatment of people with difficult-to-treat anorexia nervosa\n2. To highlight the role of autonomy and patient participation in inpatient care of severe eating disorders\n3. To use the research results for clinical improvement work at Region Skåne Eating Disorders Center",[436,91],"Eating Disorders",{"date":438,"type":39},"2026-06-16",{"date":440,"type":22},"2026-09",{"date":442,"type":22},"2029-12",{"name":45,"class":46},{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":453,"conditions":454,"keywords":460,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":106},"100454296","acute-acute-surgical-care--risk-factors-and-outcomes-for-patients-in-need-of-acute-surgical-care-100454296","NCT05195697","ACUTE-Acute Surgical Care- Risk Factors and Outcomes for Patients in Need of Acute Surgical Care","ACUTE","Inclusion Criteria: Patients admitted to Skåne University hospital in need of acute surgical care -\n\nExclusion Criteria: Below 18 years old\n\n\\-",{"count":452,"type":22},3000,"Observational retrospective study of patients in need of acute surgical care admitted to Skåne University Hospital between 2009 and 2019.",[175,455,456,457,458,459],"Complication of Surgical Procedure","Complication of Treatment","Complication of Anesthesia","Long Term Effects After Emergency Surgery","Long Term Effects After GI Bleeding",[461,462,463,464,465,466],"Emergency surgery","Acute surgery","Complications","Risk factors","Frailty","Ageing",{"date":468,"type":39},"2026-06-17",{"date":470,"type":39},"2020-01-01",{"date":472,"type":22},"2030-12",{"name":45,"class":46},{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":23,"phases":484,"briefSummary":485,"conditions":486,"keywords":4,"overallStatus":268,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":106},"100643524","phase-4-comparing-intraoperative-indocyanine-green-fluorescence-imaging-with-standard-clinical-assessment-for-flap-perfusion-in-head-and-neck-reconstruction-vision-trial-100643524","NCT07635420","Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction (VISION Trial)","Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction: A Randomised Controlled Trial (VISION Trial)","VISION","Inclusion Criteria:\n\n* Age ≥18 years at the time of inclusion\n* Scheduled to undergo microvascular free flap reconstruction as part of oncologic, trauma, or benign surgery in the head and neck area\n* Ability to understand study information and provide written informed consent\n\nExclusion Criteria:\n\n* Known allergy to indocyanine green or iodine\n* Severe hepatic or renal impairment\n* Confirmed or suspected pregnancy\n* Breastfeeding",{"count":483,"type":22},244,[146],"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.",[487,488,489,490,491,492,493,494],"Head and Neck Cancer (H&N)","Free Tissue Flaps","Free Flap","Free Flap Evaluation","Indocyanine Green","Indocyanine Green (ICG)","Microsurgery","Randomised Controlled Trial","2026-06-08",{"date":497,"type":39},"2026-06-09",{"date":499,"type":22},"2026-10-01",{"date":501,"type":22},"2029-08-01",{"name":45,"class":46},{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":23,"phases":513,"briefSummary":514,"conditions":515,"keywords":528,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":106},"100596071","negative-pressure-wound-therapy-for-split-thickness-skin-grafting-to-the-lower-leg-after-excision-of-skin-tumour-a-multicentre-randomised-study-100596071","NCT07040683","Negative Pressure Wound Therapy for Split Thickness Skin Grafting to the Lower Leg After Excision of Skin Tumour: A Multicentre Randomised Study","Negative Pressure Wound Therapy for Split Thickness Skin Grafting to the Lower Leg After Excision of Skin Tumour: The Legs Trial - A Multicentre Randomised Study","LEGS","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Undergoing excision of a skin tumour on the lower leg with planned coverage using split-thickness skin grafting (STSG)\n* Eligible procedures include primary excision, secondary excision, or extended excision performed at the same site as a previous tumour surgery\n* Ability to provide written informed consent\n* Ability to comply with postoperative instructions and follow-up visits\n\nExclusion Criteria:\n\n* Inability to follow postoperative instructions due to cognitive impairment, dementia, or significant language barriers\n* Inability to provide informed consent\n* Severe systemic illness, including:\n* Ongoing sepsis\n* Advanced heart failure\n* End-stage renal or liver disease\n* Active chemotherapy within the previous three months\n* Ongoing treatment with immunosuppressive medications, including:\n* Systemic corticosteroids (e.g., prednisone \\>20 mg\u002Fday or equivalent)\n* Calcineurin inhibitors (e.g., cyclosporine, tacrolimus)\n* Antimetabolites (e.g., methotrexate, azathioprine, mycophenolate mofetil)\n* mTOR inhibitors (e.g., sirolimus, everolimus)\n* Biologic therapies (e.g., rituximab, TNF inhibitors, IL-6 inhibitors, IL-1, IL-17, IL-23 inhibitors)\n* Targeted molecular therapies (e.g., JAK inhibitors such as tofacitinib, baricitinib)\n* Other immunosuppressive drugs\n* Previous radiation therapy to the surgical site\n* Presence of severe skin disease affecting the planned graft recipient site (e.g., advanced psoriasis)",{"count":512,"type":22},242,[25],"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:\n\nDoes NPWT reduce the incidence of transplant infection within three months after STSG?\n\nDoes NPWT improve secondary outcomes such as graft take, reduce reoperations, complications, and resource use?\n\nResearchers 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.\n\nParticipants will:\n\nUndergo excision of a skin tumour on the lower leg followed by STSG.\n\nBe randomized to receive either NPWT or traditional dressings applied over the graft.\n\nFollow a structured postoperative care and mobilisation schedule.\n\nAttend follow-up visits at day 5 and day 14 postoperatively and be monitored through medical record review up to three months after surgery.",[516,517,518,519,520,521,522,523,524,525,526,527],"Skin Transplantation","Skin Grafting","Split Thickness Skin Graft","Negative-Pressure Wound Therapy","Postoperative Complications","Surgical Wound Infection","Lower Extremity","Skin Cancer","Skin Tumour","Wound Healing","Bandages","Leg",[516,517,529,519,520,521,522,525,526,527,530,523],"Split Thickness","Skin Neoplasms","2026-05-27",{"date":533,"type":39},"2026-05-28",{"date":535,"type":39},"2025-11-01",{"date":537,"type":22},"2030-03-31",{"name":45,"class":46},{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":23,"phases":549,"briefSummary":550,"conditions":551,"keywords":556,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":575},"100549078","phase-4-international-care-bundle-evaluation-in-cerebral-hemorrhage-research-100549078","NCT06429332","International Care Bundle Evaluation in Cerebral Hemorrhage Research","International Care Bundle Evaluation in Cerebral Hemorrhage Research - a Batched Parallel Cluster-randomized Trial With a Baseline Period","I-CATCHER","Inclusion Criteria:\n\n* Adults (age ≥18 years)\n* Non-contrast computerized tomography (NCCT) imaging-verified diagnosis of spontaneous intracerebral haemorrhage\n* ≤24 hours from symptom onset or presumed symptom onset (last seen well)\n\nExclusion Criteria:\n\n* Previous care limitation\n* End-stage comorbidity with short life-expectancy (\\\u003C6 m; e.g. terminal cancer)\n* ICH caused by brain tumor or cerebral venous thrombosis\n* Clinical signs of brain herniation at first presentation (unresponsive patient with bilaterally fixed, maximally dilated pupils)\n* Pregnant women beyond 22 weeks gestation may only be included after thorough discussion with an obstetrician to determine risks vs benefit.",{"count":548,"type":22},3500,[146],"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.",[552,553,554,315,555],"Intracerebral Hemorrhage","Intracerebral Haemorrhage","Intraventricular Hemorrhage","Cerebrovascular Disease",[557,558,559,560,561,562,563,564,565,566],"intracerebral hemorrhage","oral anticoagulant","blood pressure lowering","early intensive blood pressure lowering","care bundle","implementation study","reversal treatment","outcome","UW-mRS","Modified Rankin Scale","2026-05-20",{"date":569,"type":39},"2026-05-22",{"date":571,"type":39},"2025-01-07",{"date":573,"type":22},"2027-07",{"name":45,"class":46},54,{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":23,"phases":586,"briefSummary":587,"conditions":588,"keywords":591,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":403},"100632283","the-study-tests-if-preoperative-dental-screening-is-superior-to-no-preoperative-dental-screening-in-improving-the-outcome-of-patients-undergoing-surgical-cardiac-valve-replacement-or-transcatheter-cardiac-valve-implantation-100632283","NCT07511673","The Study Tests if Preoperative Dental Screening is Superior to no Preoperative Dental Screening in Improving the Outcome of Patients Undergoing Surgical Cardiac Valve Replacement or Transcatheter Cardiac Valve Implantation.","SMILE: A Randomized Trial of Preoperative Dental Screening for the Prevention of Endocarditis, Reoperation or Death in Patients Undergoing Surgical or Transcatheter Cardiac Valve Intervention.","SMILE","Inclusion Criteria:\n\n* Age ≥18 years\n* Accepted for cardiac valve intervention\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Previous or ongoing infective endocarditis\n* Urgent surgery\n* Pain from loose tooth\u002Fteeth\n* Immunosuppressive therapy (excluding corticosteroids)\n* Inability to provide informed consent\n* Expected loss to follow-up",{"count":585,"type":22},1300,[25],"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.",[589,590],"Infective Endocarditis (IE)","Heart Valve Disease",[592,593,594,595,596],"Dental screening","valve intervention","endocarditis","TAVI","valve surgery","2026-05-15",{"date":599,"type":39},"2026-05-19",{"date":601,"type":39},"2026-05-06",{"date":603,"type":22},"2036-12-01",{"name":45,"class":46},{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":609,"acronym":610,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":612,"targetDuration":613,"studyType":117,"phases":4,"briefSummary":614,"conditions":615,"keywords":617,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":106},"100629893","glow-gender-affirming-care-and-mental-health-a-longitudinal-study-on-quality-of-life-work-life-and-healthcare-outcomes-100629893","NCT07480590","GLOW: Gender-Affirming Care and Mental Health: A Longitudinal Study On Quality of Life, Work Life, and Healthcare Outcomes","GLOW","Inclusion Criteria:\n\n* All adults (18+) referred to the NHV clinic for gender dysphoria assessment in Region Skåne.\n\nExclusion Criteria:\n\n* Inability to read\u002Fwrite Swedish\n* Protected identity status",{"count":307,"type":22},"5 Years","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.",[616],"Gender Dysphoria, Adult",[618,619,620],"gender dyshoria","longitudinal study","regsiter study","2026-05-13",{"date":623,"type":39},"2026-05-18",{"date":625,"type":39},"2025-12-01",{"date":627,"type":22},"2030-12-01",{"name":45,"class":46},{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":636,"enrollmentInfo":637,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":639,"conditions":640,"keywords":641,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":106},"100546333","sense-of-security-with-access-to-palliative-outpatient-clinic-100546333","NCT06393569","Sense of Security With Access to Palliative Outpatient Clinic","Experience of Security Having Access to Specialized Palliative Care Clinic","Inclusion Criteria:\n\n\\- Patients admitted to included ASiH-unit\n\nExclusion Criteria:\n\n* Patients with cognitive impairment\n* Patients who cannot fill in a questionnaire in Swedish, Arabic or Serbo-Croatian.","120 Years",{"count":638,"type":22},200,"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.",[177],[642],"Palliative care","2026-05-12",{"date":621,"type":39},{"date":646,"type":39},"2024-03-14",{"date":648,"type":22},"2029-03-14",{"name":45,"class":46},{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":4,"eligibilityCriteria":656,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":657,"targetDuration":658,"studyType":117,"phases":4,"briefSummary":659,"conditions":660,"keywords":665,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":668,"startDateStruct":669,"completionDateStruct":671,"leadSponsor":672,"locationsCount":106},"100492964","rehabilitation-and-recovery-for-persons-with-esophageal-or-gastric-cancer-100492964","NCT05698992","Rehabilitation and Recovery for Persons With Esophageal or Gastric Cancer","Rehabilitation and Recovery for Persons With Esophageal or Gastric Cancer - a Clinical Trial Evaluating and Implementing a Model for Evidence-based Cancer Rehabilitation","Inclusion Criteria:\n\n* over 18 years of age\n* esophageal or gastric cancer\n* living in Southern Sweden (Skåne)\n* are planned to undergo curative surgerytreatment at Skåne University Hospital.\n\nExclusion Criteria:\n\n* unable to communicate in the Swedish language\n* suffering from a cognitive impairment that poses a barrier for participating in the study.",{"count":433,"type":22},"15 Months","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.",[661,662,663,664],"Esophageal Cancer","Esophageal Neoplasms","Gastric Cancer","Stomach Neoplasm",[666,667],"Cancer rehabilitation","Recovery",{"date":597,"type":39},{"date":670,"type":39},"2023-02-27",{"date":43,"type":22},{"name":45,"class":46},{"id":674,"slug":675,"hasResults":12,"nctId":676,"briefTitle":677,"officialTitle":678,"acronym":679,"eligibilityCriteria":680,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":681,"targetDuration":682,"studyType":117,"phases":4,"briefSummary":683,"conditions":684,"keywords":687,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":697,"lastUpdatePostDateStruct":698,"startDateStruct":700,"completionDateStruct":702,"leadSponsor":704,"locationsCount":249},"100636368","pain-after-cardiac-arrest-and-resuscitation-paincare-100636368","NCT07564778","Pain After Cardiac Arrest and Resuscitation (PAINCARE)","Characterizing and Quantifying Pain After Cardiac Arrest and Resuscitation: Insights From the PAINCARE Substudy of the STEPCARE Trial","PAINCARE","Inclusion Criteria:\n\n* Out-of-hospital cardiac arrest\n* Adult, age 18 years or older\n* Spontaneous circulation without chest compressions for at least 20 minutes\n* Comatose, defined as not obeying verbal commands\n* Enrolled within 4 hours after return of spontaneous circulation\n\nExclusion Criteria:\n\n* Restrictions or limitations of care\n* On extracorporeal membrane oxygenation before randomization\n* Pregnancy\n* Previously randomized in the STEPCARE trial\n* Trauma or hemorrhage as the presumed cause of arrest\n* Suspected or confirmed intracranial hemorrhage",{"count":116,"type":22},"6 Months","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.",[685,686],"Pain","Out-of-hospital Cardiac Arrest (OHCA)",[688,689,690,691,692,693,694,695,696],"Chest compressions","delirium","quality of life","Cardiopulmonary resuscitation","Mechanical ventilation","ICU length of stay","critical care","cardiac arrest survivors","pain assessment","2026-05-11",{"date":699,"type":39},"2026-05-14",{"date":701,"type":39},"2023-10-15",{"date":703,"type":22},"2028-10-31",{"name":45,"class":46},""]