[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hvidovre University Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":455},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,50,85,106,136,167,192,215,239,260,284,301,322,348,373,398,430],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100639806","nutritional-status-in-adults-with-diabetic-foot-ulcers-100639806",false,"NCT07621770","Nutritional Status in Adults With Diabetic Foot Ulcers","Nutritional Status in Adults With Diabetic Foot in an Outpatient Wound Clinic: A Feasibility and Pilot Study","NutriDFU-P","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosed with diabetes type 1 or type 2\n* Presence of one or more DFUs\n* Receiving treatment in a participating outpatient wound clinic\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Above ankle amputation of the contralateral leg\n* Current treatment with intravenous antibiotics for acute infection.\n* Current hospitalisation for acute surgical management of the foot ulcer\n* Declining or unable to participate in a telephone follow-up interview.\n* Current long-term enteral (tube feeding) or parenteral nutritional support.\n\nExclusion criteria for bioelectrical impedance analysis (BIA)\n\n\\- Presence of a cardiac pacemaker or other implanted electronic device","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","OBSERVATIONAL","This feasibility and pilot study has two aims. The primary aim is to assess the feasibility of collecting clinical, nutritional, and functional data among adults with diabetic foot ulcers (DFUs) who are treated at an outpatient wound clinic. Specifically, the study will evaluate recruitment and inclusion rates, the relevance and clinical utility of selected variables, and assess the completeness and reliability of data collection.\n\nThe secondary aim is to provide a preliminary characterisation of nutritional status, dietary intake, body composition, muscle strength, mobility, and wound-related quality of life, to inform the design and methodology of a future full-scale national study.\n\nDFUs are associated with delayed healing, recurrent infections, reduced quality of life, and increased risk of hospitalization and amputation. These conditions are frequently accompanied by systemic inflammation, impaired circulation, and metabolic disturbances, which may increase nutritional requirements and negatively affect wound healing.\n\nDespite nutrition being recognized as a modifiable factor of ulcer healing, the nutritional status of individuals with DFUs remains insufficiently characterised, and evidence regarding clinically relevant nutritional deficiencies in this population is limited.\n\nParticipants will undergo assessment of height, weight, body composition, handgrip strength, and a 24-hour dietary recall interview during an outpatient clinic visit. Nutritional screening questionnaires and patient-reported measures of appetite, nutritional impact symptoms, mobility, and quality of life will be collected through telephone interviews within one week of the clinical visit.\n\nEligible participants are adults (\\>18 years) who are referred to the outpatient wound clinic with a hard-to-heal foot ulcer. Participants must be able to communicate in Danish or English.",[25,26,27,28,29,30,31],"Diabetic Foot Ulcers (DFU)","Nutrition Assessment","Malnutrition (Calorie)","Ulcer Foot","Dietary Intake Assessment","Bio-Impedance Measurements","Wound Healing",[33,34,35,36,37,38],"DFU","Malnutrition","Wound healing","Nutritional assessment","outpatient","hard-to-heal ulcer","NOT_YET_RECRUITING","2026-05-29",{"date":42,"type":43},"2026-06-02","ACTUAL",{"date":42,"type":21},{"date":46,"type":21},"2026-10-30",{"name":48,"class":49},"Hvidovre University Hospital","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100636090","feasibility-of-a-co-designed-mobility-intervention-after-hip-fracture-surgery-100636090","NCT07561164","Feasibility of a Co-designed Mobility Intervention After Hip Fracture Surgery","Feasibility, Fidelity, and Acceptability of a Co-designed Intervention to Promote Mobility in Patients After Hip Fracture Surgery","HIP-ME-UP","Inclusion Criteria:\n\n* Age ≥ 60 years.\n* Admitted to one of the two acute orthopedic wards at Copenhagen University Hospital Hvidovre (CUHH) following hip fracture surgery.\n* Pre-fracture Cumulated Ambulation Score (CAS) (by recall) ≥ 3 points, indicating independence or assisted independence in basic mobility activities such as bed transfer, chair transfer, and indoor walking.\n* Participants may be included if they are able to provide informed consent independently or if informed consent is obtained from a legally authorized proxy (e.g., caregiver or close relative) in cases of cognitive impairment. This applies to both Danish- and non-Danish speaking patients. Non-Danish speakers may be included with support from translated study materials and assistance from relatives or interpreters, where appropriate.\n* Inclusion the latest on postoperative day three.\n\nExclusion Criteria:\n\n* Non-ambulatory before the fracture, e.g. permanently bedbound or wheelchair-dependent.\n* Terminal illness with limited expected survival.\n* Post-operative weight-bearing restrictions precluding mobility activities.\n* Multiple fractures or suspected pathological fractures (e.g. related to malignancy).\n* Clinically unstable or presenting conditions in which early mobilization is contraindicated.\n* Patients who previously participated in HIP-ME-UP Study 4, ensuring that recipients in Study 6 have not been prior HIP-ME-UP study participants or patient partners.","60 Years",{"count":60,"type":21},25,"INTERVENTIONAL",[63],"NA","This clinical study examines whether a co-designed mobility intervention can be delivered in routine hospital care after hip fracture surgery.\n\nHip fracture is a common and serious condition among older adults and is associated with loss of independence, complications, and increased mortality. During hospitalization, many patients remain inactive, even though early and frequent mobility is considered important for recovery.\n\nThe HIP-ME-UP intervention was developed in collaboration with healthcare professionals, patients, caregivers, and hospital management. It aims to support early mobilization, independence in basic mobility activities such as getting in and out of bed and increased physical activity during hospitalization.\n\nThe study will investigate whether the intervention is feasible to deliver in routine clinical practice, whether it is delivered as intended, and whether it is acceptable to patients and healthcare professionals.\n\nParticipants admitted after a hip fracture surgery will receive the intervention during hospitalization. Researchers will collect information on recruitment, retention, fidelity, acceptability, and mobility-related outcomes. Approximately 25 participants will be included.\n\nThe results will help determine whether a larger effectiveness study should be conducted.",[66,67,68],"Hip Fracture Surgery","Mobility Limitation","Postoperative Rehabilitation",[70,71,72,73,74,75],"Early mobility","Physical activity","Feasibility study","Frequent mobility","hospitalization","Fidelity","RECRUITING","2026-05-27",{"date":40,"type":43},{"date":80,"type":43},"2026-05-11",{"date":82,"type":21},"2027-06-30",{"name":48,"class":49},1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":61,"phases":93,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":84},"100585966","progressive-gait-training-after-first-time-deep-venous-thrombosis-clinical-effectiveness-and-involved-mecanisms-the-dvt-cph-rct-100585966","NCT06909240","Progressive Gait Training After First-time Deep Venous Thrombosis: Clinical Effectiveness and Involved Mecanisms (The DVT-Cph RCT)","Inclusion Criteria:\n\n* 18 years or above\n* First time lower extremity DVT\n* Hospitalized at the Emergency Department\n* Can cooperate cognitively and physically (patient reported)\n\nExclusion Criteria:\n\n* Patients without a Danish social security number\n* Terminal patients\n* Patients who do not understand or speak Danish",{"count":92,"type":21},152,[63],"The DVT-Cph RCT aims to investigate:\n\n1. if progressive gait training in combination with standard care is superior to standard care on quality of life in patients with first time lower extremity deep venous thrombosis (clinical effectiveness part).\n2. the association between progressive gait training and disease progression, late complications such as post throbotic syndrome, and severity of venous thromboembolism conditions in patients with first time lower extremity deep venous thrombosis (mechanistic part).",[96],"Deep Vein Thrombosis (DVT)",[71],"2026-01-22",{"date":100,"type":43},"2026-01-23",{"date":102,"type":43},"2025-11-15",{"date":104,"type":21},"2030-02-01",{"name":48,"class":49},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":114,"sex":17,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":61,"phases":119,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},"100597109","probiotic-for-infants-100597109","NCT07054216","Probiotic for Infants","Efficacy of a Probiotic on Gut Health, Immune Maturation, and Well-being in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Study","BABIES II","\"Inclusion Criteria\"\n\nInclusion Criteria for the pregnant person\n\n1. Pregnant person above 18 years of age in gestational week 36+0-38+0 (at Visit 0)\n2. Singleton pregnancy\n3. Ability to read and speak Danish\n4. Plan to breastfeed\n5. Provided voluntary written informed consent.\n\nInclusions Criteria for the newborn\n\n1. Born at full-term ≥37+0\n2. Birth weight ≥ 2500 g\n3. APGAR score of ≥ 7 within the first 5 min of life.\n\n\"Exclusion Criteria\" Exclusion Criteria for the pregnant person\n\n1. Pregnancy at 38 weeks + 0 or later at the time of recruitment\n2. Pregnancy with significant fetal abnormality at ultrasound scan of the fetus at gestational age 19-20 weeks\n3. Alcohol or drug abuse\n4. Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre\n5. Pregnant person with any contraindications for breastfeeding.\n\nExclusion Criteria for the newborn\n\n1. Congenital disorders that could affect their safety or the study outcome\n2. Admission to Neonatal Intensive Care Unit for more than 24 hours\n3. Participation in another clinical intervention study which can interfere with this probiotic intervention\n4. Probiotics other than the study product.",true,"0 Days","1 Day",{"count":118,"type":21},378,[63],"The BABIES II study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with an 8½ months intervention period from 14 days of age to 9 months of age followed by a 3-months short-term follow-up period until 1 year of age and a possible long-term follow-up until 18 years of age. The study will evaluate the effect of supplementation with a probiotic strain on different health outcomes.",[122],"Healthy Infants",[124,125,126],"Infant","Gastrointestinal Microbiome","Diet, Food, and Nutrition","2025-08-27",{"date":129,"type":43},"2025-08-28",{"date":131,"type":43},"2025-08-25",{"date":133,"type":21},"2028-07-01",{"name":48,"class":49},2,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":61,"phases":147,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":84},"100465570","optimizing-graft-selection-for-acl-reconstruction-100465570","NCT05342441","Optimizing Graft Selection for ACL Reconstruction","Optimizing GRAft SElection for ACL Reconstruction (GRASE-ACL Trial) - a Three-armed Randomized Controlled Trial","GRASE-ACL","List of Inclusion criteria\n\n* clinically confirmed first-time ACL rupture\n* Current injury sustai´ned within 2 years\n* high activity level prior to ACL rupture (Tegner score ≥ 3) and personal goal of returning to physical activity.\n\nList of preoperative exclusion criteria\n\n* Inadequate Danish language skills to answer questionnaires.\n* Prior ligament surgery in the injured knee\n* Prior ligament surgery in the non-injured knee\n* Instability of the non-injured knee\n* Known osteoarthritis (Kelgren Lawrence score ≥ 2)\n* Prior open surgery to either knee\n* Prior severe fracture involving knee joint surfaces\n* Prior severe injury to thigh muscles in either leg (e.g. tear or compartment)\n* Prior severe injury to the patella tendon of either knee (e.g. subluxation)\n* Medical condition preventing full participation (e.g. active cancer, - rheumatoid arthritis)\n* Psychiatric condition preventing full participation\n* Pregnancy\n* Obesity (BMI \\> 30)\n\nList of Perioperative exclusion criteria (Arthroscopy)\n\n* Medial meniscus lesion \\> 50%\n* Lateral meniscus lesion \\> 50%\n* Treated Meniscal root lesion or radial meniscal tear that require restrictive regimen\n* Cartilage lesion \\>2cm2, Articular cartilage injury classification (ICRS) grade 3\n* Concurrent ligament injury (except medial collateral ligament (MCL) lesion grade 1-2)","40 Years",{"count":146,"type":21},150,[63],"Purpose:\n\nTo investigate the differences between the three most common methods for reconstruction of the anterior cruciate ligament (ACL), to support the development of the best method for the individual patient.\n\nMain research area: ¨ Sports Orthopedic Surgical research.\n\nState of the art:\n\nEvery year in Denmark 2500 patients receive surgical reconstruction surgery to replace a ruptured ACL. Many patients experience a decline in knee function and 4-12% suffer a new ACL rupture within 5 years. According to data from the Danish ACL register, three methods of reconstruction are most prevalent, but with large variation between hospitals. This indicates lack of consensus on optimal surgical procedure.\n\nDesign:\n\nAssessor-blinded randomized controlled study. 150 patients aged 18-40 with ruptured ACL are allocated to reconstruction with tendon(s) harvested from either the semitendinosus and gracilis, or the patella tendon, or the quadriceps tendon. Patient follow-up will be conducted preoperatively and 1, 6, 12, 24 months postoperatively.\n\nPrimary technologies and outcomes:\n\n* Patient-reported knee-joint function, quality of life and donor-site morbidity is obtained with standardized questionnaires. Primary outcome is subjective knee function with the International Knee Documentation Committee evaluation form (IKDC)\n* Instrumented analysis of knee-joint coordination and neuromuscular control including 3-D motion capture and electromyography (EMG) during single leg jumps, landings and change-of-direction. Measurement of maximal explosive muscle power in knee extension and flexion. Primary outcome is relative difference between injured and healthy leg in rate of force development (RFD-LSI).\n* Standard clinical knee examination of range of motion and instrumented examination of knee-joint stability.\n* Magnetic Resonance Imaging (MRI) of the thigh muscles for examination of muscle morphology.\n\nThe trial is designed for publication in three primary publications\n\n1. \\- Patient reported effect of graft choice in ACL reconstruction\n2. \\- Biomechanical effect of graft choice in ACL reconstruction\n3. \\- Clinical effect of graft choice in ACL reconstruction\n\nAdditional secondary publications are in the pipeline. Reference to primary protocol and results will always be emphasized in secondary publication to ensure methodological transparency.",[150],"ACL - Anterior Cruciate Ligament Rupture",[152,153,154,155,156,157,158,159],"ACL reconstruction","Graft choice","Quadriceps graft","Semitendinosus\u002Fgracilis graft","Muscle morphology","Neuromuscular control","BPTB graft","Patient reported function","2025-08-24",{"date":129,"type":43},{"date":163,"type":43},"2022-05-09",{"date":165,"type":21},"2028-05-31",{"name":48,"class":49},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":174,"targetDuration":176,"studyType":22,"phases":4,"briefSummary":177,"conditions":178,"keywords":181,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":84},"100595198","effectiveness-evaluation-of-social-prescribing-100595198","NCT07029334","Effectiveness Evaluation of Social Prescribing","Effectiveness Evaluation in the SHINE Research Programme - Social Prescribing for Adults and Elderly: The Path to Effective Implementation","All participants in the SP intervention are invited consecutively to participate in the effectiveness evaluation by the Link Worker. There are no exclusion or inclusion criteria in the effectiveness evaluation of the SP intervention.",{"count":175,"type":21},350,"9 Months","Social Prescribing (SP), or Social Henvisning (SH) in Denmark, integrates healthcare with social and cultural services to address social determinants of health. The 'Social Prescribing Vesterbro-Sydhavnen' initiative, launched in fall 2024 as part of usual care, aims to involve general practitioners (GP) as primary prescribers to social services through a dedicated link worker, enhancing early intervention and connecting healthcare with community support.\n\nThis evaluation aims to assess the effectiveness of the 'Social Prescribing Vesterbro-Sydhavnen' project as part of the Implementation Research Programme SHINE.\n\nThe primary outcomes are: changes in contacts with general practice, unplanned hospital contacts and emergency calls (1813) as well as change in patients' perception of loneliness and health-related Quality of life.",[179,180],"Loneliness","Health Related Quality of Life",[182,183],"Social Prescribing","Public Health","2025-07-23",{"date":186,"type":43},"2025-07-24",{"date":188,"type":43},"2025-07-04",{"date":190,"type":21},"2027-03-01",{"name":48,"class":49},{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":61,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":84},"100411937","the-effect-of-arthroscopic-subacromial-decompression-in-patients-who-are-non-responders-to-non-operative-treatment-100411937","NCT04644042","The Effect of Arthroscopic Subacromial Decompression in Patients Who Are Non-responders to Non-operative Treatment.","The Effect of Arthroscopic Subacromial Decompression in Patients With Subacromial Impingement Syndrome Who Are Non-responders to Non-operative Treatment. A Double-blinded, Randomized, Controlled Trial.","SELECT","Inclusion Criteria:\n\n* SIS diagnosis (Consultant's clinical diagnosis of SIS + at least 3 out of 5 positive tests from the following: Hawkin's, Neer's, Jobe's, Painful arc and external rotation resistance test)\n* Positive subacromial injection test\n* Insidious onset of shoulder pain\n* Considered a surgical candidate by an orthopedic shoulder specialist.\n* Symptoms for at least 6 months\n* Completion of at least 3 months supervised shoulder training\n* No improvement in symptoms for at least 3 months\n* The patient must be expected to be able to attend rehabilitation and post-examinations.\n\nExclusion Criteria:\n\n* Terminal illness or severe medical illness (ASA score higher than or equal to 4), systemic musculoskeletal disease, inflammatory joint disease (e.g. rheumatoid arthritis), symptomatic cervical spine pathology or thoracic outlet syndrome.\n* Full-thickness rotator cuff tear, calcified tendonitis, labral tear, frozen shoulder, biceps tendon pathology, acromioclavicular osteoarthrosis, glenohumeral osteoarthrosis or other concomitant shoulder pathology.\n* Previous surgery or radiotherapy on the affected shoulder.\n* Pregnancy\n* Ongoing workers compensation case or job rehabilitation process","99 Years",{"count":202,"type":21},160,[63],"To investigate if glenohumeral arthroscopy and arthroscopic subacromial decompression is more effective than glenohumeral arthroscopy alone in improving patient-reported outcome at 12 months in patients with subacromial impingement syndrome (SIS) who are non-responders to non-operative treatment.",[206],"Subacromial Impingement Syndrome","2025-04-26",{"date":209,"type":43},"2025-04-30",{"date":211,"type":43},"2021-09-01",{"date":213,"type":21},"2029-06-01",{"name":48,"class":49},{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":114,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":61,"phases":224,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":84},"100587254","early-phase-1-metabolic-effects-of-endogenous-bile-acids-after-gastric-bypass-surgery-100587254","NCT06925997","Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery","Bile-bar","Inclusion Criteria:\n\nIntervention group\n\n* RYGB-operated ≥ 18 months prior to inclusion\n* History of diabetes prior to RYGB (HbA1c ≥48 mmol\u002Fmol or use of antidiabetic medication)\n* HbA1c \\\u003C58 mmol\u002Fmol on no antidiabetic medication or metformin alone\n* Weight change \\\u003C ±3 kg for \\>3 months at time of inclusion\n\nControl group A\n\n* No history of diabetes\n* HbA1c \\\u003C48 mmol\u002Fmol at time of inclusion\n* Fasting plasma glucose \\\u003C 7.0 mmol\u002FL at time of inclusion\n* Weight change \\\u003C ±3 kg for \\>3 months at time of inclusion Control group B\n* Type 2 diabetes (HbA1c ≥48 mmol\u002Fmol or use of antidiabetic medication at time of inclusion)\n* Weight change \\\u003C ±3 kg for \\>3 months at time of inclusion\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Haemoglobin \\\u003C 6.5 mmol\u002FL at time of inclusion\n* Fasting plasma glucose \\> 10.0 mmol\u002FL at time of inclusion\n* Prior cholecystectomy\n* Chronic or tendency to diarrhoea",{"count":223,"type":21},18,[225],"EARLY_PHASE1","Non-randomized, open-label, parallel-group clinical study evaluating the effects of endogenous bile acids on changes in plasma fibroblast growth factor-19 (FGF-19) and glucose metabolism by extended depletion of circulating bile acids using colesevelam as an experimental tool in subjects operated with gastric by-pass (RYGB).",[228,229,230],"Bariatric Surgery Candidate","Bile Acid, Elevated Serum","Glucose Metabolism Disorders","2025-04-11",{"date":233,"type":43},"2025-04-13",{"date":235,"type":43},"2024-05-02",{"date":237,"type":21},"2028-12",{"name":48,"class":49},{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":114,"sex":17,"minAge":4,"maxAge":116,"enrollmentInfo":247,"targetDuration":4,"studyType":61,"phases":249,"briefSummary":250,"conditions":251,"keywords":252,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":84},"100576760","characterization-of-the-gastrointestinal-microbiota-in-newborn-infants-100576760","NCT06789484","Characterization of the Gastrointestinal Microbiota in Newborn Infants","Recovery of a Probiotic in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Proof-of-concept Study","BABIES I","Inclusion Criteria:\n\n* Inclusion Criteria for the pregnant person:\n\n  1. Healthy pregnant person in gestational week 36+0-38+0\n  2. Age ≥ 18 years\n  3. Normal singleton pregnancy\n  4. Ability to read and speak Danish\n  5. Normal ultrasound scan of the fetus at gestational age 19-20 weeks\n  6. Plan to exclusively breastfeed\n  7. Provided voluntary written informed consent.\n* Inclusions Criteria for the newborn:\n\n  1. Born at full-term ≥37+0\n  2. Birth weight above 2500 g\n  3. APGAR score of at least 7 within the first 5 min of life.\n\n     Exclusion Criteria:\n* Exclusion Criteria for the pregnant person:\n\n  1. Pregnancy at over 38+0 weeks' gestation at recruitment\n  2. Multiple pregnancy\n  3. Pregnancy with any fetal abnormality\n  4. Alcohol or drug abuse\n  5. Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre\n  6. Any contraindications for breastfeeding.\n\nExclusion Criteria for the newborn :\n\n1. Congenital disorders that could affect their safety or the study outcome\n2. Admission to Neonatal Intensive Care Unit for more than 24 hours\n3. Participation in another clinical intervention study which can interfere with this probiotic intervention\n4. No other probiotics than the study product.",{"count":248,"type":21},40,[63],"The BABIES study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period (Figure 1). The study will evaluate the seeding ability of supplementation with a probiotic strain.\n\nThe aim is to investigate the recovery and engraftment of the probiotic strain in infant fecal samples after 4 weeks supplementation using a strain specific quantitative Polymerase Chain Reaction (qPCR).",[122],[124,125,126],"2025-04-10",{"date":233,"type":43},{"date":256,"type":43},"2025-03-04",{"date":258,"type":21},"2025-12-31",{"name":48,"class":49},{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":17,"minAge":144,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":271,"conditions":272,"keywords":274,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":84},"100504308","pulmonary-immune-cell-microbiome-interactions-in-the-healthy-lung-100504308","NCT05846620","Pulmonary Immune Cell-microbiome Interactions in the Healthy Lung","Pulmonary Immune Cell-microbiome Interactions in the Healthy Lung: the ILLUMINA-2 Study","ILLUMINA-2","Inclusion Criteria:\n\n* Men and women\n* Age 40 to 75\n\nExclusion Criteria:\n\n* Immune deficiency\n* Lung disease\n* Active cancer or infection\n* Absolute contraindications for bronchoscopy\n\n  * Untreated malignant arrhythmia\n  * Documented or suspected intracranial hypertension (intracranial pressure ≥ \\> 15 mmHg)\n  * One-lung ventilation\n  * Severe coagulopathy","75 Years",{"count":270,"type":21},50,"The overall aim is to to provide a normal material for the composition and spatial heterogeneity of the following in the healthy lung: i) immune cell populations and their activation patterns, ii) the surrounding cytokine-chemokine milieu, including trans-compartmental fluxes of these mediators between the lung and bloodstream, and iii) the lung microbiome.\n\nMain hypotheses:\n\n* Absolute and relative immune cell counts in bronchoalveolar lavage fluid (BALF) are similar to those previously reported by other methods6,7.\n* No trans-compartmental flux of cytokines between the lungs and bloodstream is present, but cytokine concentrations (notably IL-6 and IL-8) vary with the immune-cell-microbiome composition.\n* Immune cell (mainly T cell) activation, differentiation, and gene expression patterns are expected to differ between blood and BALF in a manner that depends on the regional diversity of the pulmonary microbiome.",[273],"Healthy",[275],"healthy lung, lung microbiota, microbiome","2025-03-13",{"date":278,"type":43},"2025-03-17",{"date":280,"type":43},"2023-04-17",{"date":282,"type":21},"2028-11-30",{"name":48,"class":49},{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":290,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":300,"locationsCount":84},"100500361","pulmonary-immune-cell-microbiome-interactions-in-ards-100500361","NCT05795257","Pulmonary Immune Cell-microbiome Interactions in ARDS","Pulmonary Immune Cell-microbiome Interactions in Acute Respiratory Distress Syndrome: the ILLUMINA-1 Study","ILLUMINA-1","Inclusion Criteria:\n\n* Inclusion criteria - moderate-to-severe ARDS\n* Admitted to the ICU at Hvidovre Hospital\n* Intubated within the past 72 hours\n* Moderate-to-severe ARDS according to the Berlin definition19\n* Age ≥ 18 years\n\nInclusion criteria - none-to-mild ARDS\n\n* Admitted to the ICU at Hvidovre Hospital\n* Intubated within the past 72 hours\n* None-to-mild ARDS according to the Berlin definition19\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* ARDS caused by COVID-19\n* Absolute contraindications for bronchoscopy\n* Untreated malignant arrhythmia\n* Documented or suspected intracranial hypertension (intracranial pressure ≥ \\> 15 mmHg)\n* One-lung ventilation\n* Severe coagulopathy",{"count":248,"type":21},"The overall aim is to compare the composition and spatial heterogeneity of the following in critically ill intensive care unit (ICU) patients: i) immune cell populations and their activation patterns, ii) the surrounding cytokine-chemokine milieu, including trans-compartmental fluxes of these mediators between the lung and bloodstream, and iii) the lung microbiome.\n\nMain hypotheses:\n\n* The immune cell population in bronchoalveolar lavage fluid (BALF) from patients with ARDS is dominated by neutrocytes, while T cells are depleted, and show evidence of hyper-activation and exhaustion\n* T cell hyper-activation and exhaustion is specifically compartmentalised to the lungs, and much more pronounced in moderate-to-severe than none-to-mild ARDS\n* Cyto- and chemokines derived from pulmonary immune cells are higher in moderate-to-severe than none-to-mild ARDS with a greater release from lungs to the bloodstream, notably of IL-6 and IL-8.\n* The differences in T cell profile in BALF, notably the ratio between regulatory T cells and T helper 17 cells, will change with disease severity over time, and can be explained by the presence of tI-IFN antibodies and\u002For a low microbial diversity of the respiratory tract with low enrichment from the oral cavity.",[295],"ARDS, Human",{"date":278,"type":43},{"date":298,"type":43},"2023-03-14",{"date":282,"type":21},{"name":48,"class":49},{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":17,"minAge":308,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":61,"phases":310,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":321,"locationsCount":84},"100511144","occupational-therapy-rehabilitation-for-frail-elders-with-dysphagia-100511144","NCT05935618","Occupational Therapy Rehabilitation for Frail Elders with Dysphagia","No Food or Drink Does Any Good Until It is Swallowed: a Proof-of-concept Study on Occupational Therapy Rehabilitation for Frail Elders with Dysphagia","Inclusion Criteria:\n\n* A score of 5-18 on the Gugging Swallowing Screen.\n* Speaks and understands Danish.\n* Are able to cooperate in the intervention and give written informed consent; i.e. is oriented in time, place and own data, and able to perform four simple oral motor movements on request.\n\n  * Has given written informed consent.\n\nExclusion Criteria:\n\n* Esophageal dysphagia.\n* Progressive neurologenic dysphagia.\n* Psychiatric illness.\n* Delirious.\n* Infections that requires isolation.\n* Need for palliative care.","65 Years",{"count":20,"type":21},[63],"The goal of this proof-of-concept study is to assess the potential of a newly developed intervention with combined skill- and strength-based principles for maximizing swallowing-related outcomes and prevent further weakening of the swallowing muscles in older people with dysphagia (difficulty swallowing).\n\nThe main questions to be answered are:\n\n1. Does the intervention produce clinically significant improvement in ingestive skills during meals in older individuals with dysphagia?\n2. Does the intervention produce clinically significant improvements in tongue strength and orofacial function in older persons with dysphagia?\n3. Does the intervention produce clinically significant improvements in nutritional status and quality of life in older individuals with dysphagia?\n4. Is there an association between perceived autonomy support and intervention engagement when older individuals with dysphagia receive the intervention during hospitalization and continued in community-based rehabilitation after discharge?\n\nParticipants will be asked to perform goal-directed and task-specific swallowing exercises in eating and drinking activities where the intensity variables include advancing steps of an altered bolus volume and consistency according to a 17-level task hierarchy, which are introduced according to predetermined progression rules, as well as increases in swallowing repetitions. The dosage is 2-3 individual, face-to-face therapy sessions per week for up to a maximum of eight weeks. A therapy session lasts up to 45 min. In between therapy sessions, participants integrate the achieved level from therapy into their daily meals as self-training.",[313,314],"Dysphagia, Oropharyngeal","Deglutition Disorders","2025-03-11",{"date":317,"type":43},"2025-03-14",{"date":319,"type":43},"2023-08-07",{"date":258,"type":21},{"name":48,"class":49},{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":114,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":331,"conditions":332,"keywords":335,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":84},"100530785","post-acute-covid-19-sequelae-in-denmark-100530785","NCT06191302","Post-acute COVID-19 Sequelae in Denmark","Investigation of COVID-19 Post-acute Sequelae in Patients From Hvidovre Hospitals Catchment Area, and in a Register of the Danish Population 2000-2026","Inclusion Criteria:\n\n* Has a blood sample in the clinical biobank related to the OBS-COVID index admission\n* Aged above 18 years at time of index-admission\n\nExclusion Criteria:\n\n* Patients without a Danish personal identification number\n* Patients who do not understand or speak Danish",{"count":330,"type":21},800,"Since the first SARS-CoV-2 cases in 2019, over 660 million COVID-19 cases have been reported globally, including 183 million in the EU. Up to 70% of those infected experience reduced organ function four months or more after a COVID-19 diagnosis, potentially increasing the risk of non-communicable diseases (NCDs). The post-acute phase (PAP) after COVID-19 (four months or more after the acute phase) can lead to impaired function in various organ systems, with a focus on the lungs, cardiovascular system, and kidneys. These three NCDs collectively impose a significant burden on individuals and society. Urgently, we need to understand the connection between COVID-19, PAP and NCDs, identifying robust biomarkers for early detection. This study examines PAP and associated risk factors, investigating the link between PAP and the heightened risk of lung, heart, and kidney complications. Utilizing data from a cohort of COVID-19 patients and a control group with respiratory diseases, the study aims to determine prevalence and risk ratios more precisely. The aim is to contribute to minimizing the risk of NCD development or exacerbation in current and future COVID-19 patients, enhancing our understanding of chronic disease development at the population leve",[333,334],"Non-communicable Disease","COVID-19",[336,337,338,339],"Sequelae","Inflammation","Ageing","Non-communicable disease","2025-03-06",{"date":342,"type":43},"2025-03-12",{"date":344,"type":43},"2024-09-10",{"date":346,"type":21},"2026-03-01",{"name":48,"class":49},{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":11,"sex":17,"minAge":355,"maxAge":268,"enrollmentInfo":356,"targetDuration":4,"studyType":61,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":84},"100527194","the-metabolic-impact-of-intermittent-carbohydrate-restriction-in-individuals-with-type-2-diabetes-100527194","NCT06144593","The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With Type 2 Diabetes","INTERCARB","Inclusion Criteria:\n\n* Men or women\n* 35-75 years old\n* BMI \\>27 kg\u002Fm2\n* Known type 2 diabetes in stable glucose lowering therapy (for three months) or with HbA1c \\>48 mmol\u002Fmol if no glucose lowering therapy\n\nExclusion Criteria:\n\n* Anemia (hemoglobin \\\u003C8 mmol\u002FL for men and \\\u003C7 mmol\u002FL for women)\n* TSH outside reference range\n* Treatment with insulin, sulfonylurea, or SGLT2-inhibitors\n* Treatment with systemic corticosteroids\n* HbA1c \\>70 mmol\u002Fmol\n* eGFR \\\u003C60 ml\u002Fmin\u002F1.73 m2\n* Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia\n* Food allergies (including lactose and gluten intolerance)\n* Vegetarian\u002Fvegan diet or following of specific dietary plans\n* Alcohol consumptions \\>84\u002F168 g\u002Fweek (women\u002Fmen)\n* Strenuous activity level \\> 120 minutes per week\n* Weight loss (\\>5 kg) within the last three months or previous bariatric surgery\n* High risk of fibrosis of the liver (estimated by FIB4 score \\> 3.25)","35 Years",{"count":357,"type":21},14,[63],"The primary aim of this randomized cross-over intervention study is to investigate the effect of four weeks of intermittent carbohydrate restriction (alternating between two days of normal dietary intake and two days of carbohydrate restriction to 70-90 grams) on 24-hour average sensor glucose in individuals with type 2 diabetes compared with a four-week control period with normal dietary intake.",[361,362,363,364],"Diabetes Mellitus, Type 2","Overweight and Obesity","Non-Alcoholic Fatty Liver Disease","Metabolic Syndrome","2024-06-05",{"date":367,"type":43},"2024-06-06",{"date":369,"type":43},"2024-01-03",{"date":371,"type":21},"2025-09-01",{"name":48,"class":49},{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":114,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":61,"phases":382,"briefSummary":383,"conditions":384,"keywords":386,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":84},"100490002","copd-at-a-street-level-100490002","NCT05660460","COPD at a Street Level","A Study of the Incidence and Treatment of Impaired Lung Function Among Socially Vulnerable Individuals at a Street Level","Inclusion Criteria:\n\n* 18 years or older\n* Able to speak and understand Danish or English to such an extent that informed consent can be obtained\n\nExclusion Criteria:\n\n\\- Not having a Danish civil registration number, since foreign patients do not have free access to examinations and medical treatment, and cannot be followed up in the national patient registry",{"count":381,"type":21},511,[63],"The trial investigates and describes the prevalence of COPD among socially vulnerable individuals who come in contact with a mobile clinic and investigates the effect of opportunistic screening for COPD in these vulnerable persons. The study population is individuals who come in contact with a mobile clinic, that visits home shelters, open drugs scenes etc. in the Capital Region of Denmark during the inclusion period, and monitor them for up to 1 year in order to investigate variables that are significant in terms of the patients' treatment, hospitalizations, and mortality in relation to COPD. Our hypothesis is that there will be a higher incidence of COPD among socially vulnerable individuals who come in contact with the mobile clinic than in the general population.",[385],"COPD",[387,388,389],"screening","socially vulnerable patients","mobile clinic","2024-04-08",{"date":392,"type":43},"2024-04-09",{"date":394,"type":43},"2023-03-15",{"date":396,"type":21},"2029-01-31",{"name":48,"class":49},{"id":399,"slug":400,"hasResults":11,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":114,"sex":17,"minAge":406,"maxAge":407,"enrollmentInfo":408,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":410,"conditions":411,"keywords":416,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":84},"100409134","the-faroese-knee-cohort-etiology-and-long-term-implications-of-trochlear-dysplasia-and-patellar-dislocations-100409134","NCT04607538","The Faroese Knee Cohort: Etiology and Long-term Implications of Trochlear Dysplasia and Patellar Dislocations.","The Faroese Knee Cohort: An Investigation of Etiology and Long-term Implications of Trochlear Dysplasia and Patellar Dislocations","FKC","Inclusion Criteria:\n\n* Age between 15-20 years at the start of patient enrolment.\n* The feeling of patellar instability, or patellar dislocation\u002Fnear-dislocation.\n* The person has to be from the Faroe Islands.\n* All persons under the age of 18 must get written consent by their parents\n\nExclusion Criteria:\n\n* Terminal illness\n* Mental disabilities and illness, meaning that the patient cannot independently answer the PROM´s and cooperate to the clinical investigation.","15 Years","20 Years",{"count":409,"type":21},100,"The investigators intend to establish a national cohort including all persons in the ages from 15-20 years old with patellar instability (PI) or a prior knee injury (ACL-ruptur or meniscus damage) . The cohort will be nicknamed \"The Faroese Knee Cohort\".\n\nThe overall aim is to investigate two groups.\n\n1. The patella instability group, in which we intend to investigate the following.\n\n   * Prevalence of patellar dislocation and trochlear dysplasia in the Faroe Islands.\n   * Risk factors for patellar dislocations-\n   * Heredity of trochlear dysplasia.\n   * If there is a specific gene responsible for the development of trochlear dysplasia.\n   * The development of retropatellar artrhosis, its onset and its impact on quality of life and function,\n2. Knee injury group (ACL-ruptur or meniscus injury)\n\n   * The prevalence of ACL-rupture and\u002For meniscus injury in this specific group in the Faroe Islands.\n   * The impact on quality of life and function.",[412,413,414,415],"Patellar Dislocation","ACL Injury","Meniscus Lesion","Trochlear Dysplasia",[417,418,419,420,421],"Patellar instability","Patellar dislocation","ACL-rupture","Meniscus lesion","Meniscus injury","2023-02-15",{"date":424,"type":43},"2023-02-17",{"date":426,"type":43},"2022-03-01",{"date":428,"type":21},"2051-12-01",{"name":48,"class":49},{"id":431,"slug":432,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":114,"sex":438,"minAge":18,"maxAge":144,"enrollmentInfo":439,"targetDuration":4,"studyType":61,"phases":441,"briefSummary":442,"conditions":443,"keywords":445,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":84},"100481795","the-effect-of-astarte-on-recurrent-urinary-tract-infection-100481795","NCT05553652","The Effect of ASTARTE™ on Recurrent Urinary Tract Infection","The Effect of ASTARTE™; Lactobacillus Crispatus, Lactobacillus Rhamnosus, Lactobacillus Jenesii and Lactobacillus Gasseri on the Reduction of Risk Factors for Recurrent Urinary Tract Infection in Women","rUTI","Inclusion Criteria:\n\n* Women 18-40 years of age\n* Recurrent UTI (2 times UTI within 6 months or \\> 3 times UTI infection within one year).\n* The subjects should be informed about the trial protocol.\n* The subject must be able to follow the protocol, have provided voluntary consent and have signed the declaration of consent.\n\nExclusion Criteria:\n\n* Pregnancy or planning pregnancy\n* Breastfeeding\n* Participation in another trial with probiotic the last 30 days.\n* Hypersensitivity to any ingredient in the study product\n* Patients primarily admitted for a disorder other than UTI\n* Antibiotic treatment for any other condition than UTI at time of recruitment the last 30 days","FEMALE",{"count":440,"type":21},720,[63],"Investigate the effect of dietary supplements\u002Fprobiotic ASTARTE™ ( L. crispatus, L. rhamnosus, L. jensenii, L. gasseri) on the microbiome composition in the intestine and vagina and thereby a reduction of risk factors for the development of rUTI during 6 months of intervention in women aged 18-40 years. This is measured by the incidence of symptomatic UTI.",[444],"Recurrent Urinary Tract Infection",[436,446],"Probiotic","2022-09-21",{"date":449,"type":43},"2022-09-23",{"date":451,"type":43},"2022-09-19",{"date":453,"type":21},"2027-12-01",{"name":48,"class":49},""]