[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rigshospitalet, Denmark\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":688},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,150,0,25,[9,47,81,105,125,147,173,204,231,262,291,316,340,364,392,417,447,475,502,525,560,583,611,637,666],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100460483","phase-4-optimized-treatment-of-pulmonary-edema-or-congestion-100460483",false,"NCT05276219","DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure","Vasodilation or Loop-diuretics for Initial Treatment of Pulmonary Edema or Congestion Due to Acute Heart Failure - a Randomized Placebo-controlled Trial","DECONGEST-AHF","Inclusion criteria\n\n1. Age ≥ 18 years\n2. Acute (within minutes to days) onset or worsening of subjective dyspnea\\*\n3. Systolic blood pressure ≥100 mmHg\n4. Oxygen saturation \\\u003C94% or need of oxygen\n5. Signs or suspicion of congestion (peripheral edema, rales, and\u002For clinical suspicion of congestion) \\*\n\n   * by the best assessment from a medical doctor. Inclusion must not wait on x-ray or other measures: patients suspected of pulmonary congestion should be included immediately.\n\nExclusion criteria\n\n1. More than 50 mg IV furosemide within the last three hours before randomization including prehospital treatment.\n2. More than 3 hours from hospital-admission to randomization\n3. Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with HR \\> 180 or \\\u003C 40 bpm.\n4. Suspected severe infection or sepsis.\n\nExclusion criteria are purposely liberal, so patients can be included in accordance with everyday clinical practice. However, a safety criterion will be implemented:\n\nIf blood pressure drops below 90 mmHg in 2 measurements with 5 minutes apart and\u002For if urine production is below 50 ml after 1 hour, the intervention will be stopped, and patients can receive furosemide and nitrates freely.\n\nWe purposely chose not to exclude patients with aortic stenosis, since observational studies did not find excess risk of given nitrates to patients with pulmonary edema and aortic stenosis","ALL","18 Years",{"count":21,"type":22},1041,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Background:\n\nIntravenous (IV) loop-diuretics have been a key component in treating pulmonary edema since the nineteen sixties and has a Class 1 recommendation in the 2021 European Society of Cardiology guidelines for heart failure. Conversely, vasodilation was downgraded in the treatment of acute heart failure due to a lack of trials that compare vasodilation with loop-diuretics in a hyperacute clinical setting. This clinical equipoise will be tested in a trial including patients with pulmonary congestion immediately at hospital admission.\n\nPrimary objective:\n\nTo determine the superior strategy of loop-diuretics (furosemide), vasodilation (nitrates) or the combination during emergency treatment.\n\nDesign: Investigator-initiated, randomized, double-blinded, placebo-controlled trial with 1:1:1 allocation.\n\nIntervention:\n\nIntervention-phase will last 6 hours from study-inclusion, and patients will be allocated to one of three groups:\n\n* Boluses of 40 mg IV furosemide + nitrate-placebo as soon as possible and repeated up to 10 times.\n* Boluses of 3 mg IV isosorbide dinitrate + furosemide-placebo as soon as possible.\n* Boluses of both 3 mg IV isosorbide dinitrate + of 40 mg as soon as possible.",[28,29,30],"Pulmonary Edema","Congestive Heart Failure","Acute Heart Failure",[32,33],"acute heart failure","Pulmonary edema","RECRUITING","2026-08-13",{"date":37,"type":38},"2026-08-17","ACTUAL",{"date":40,"type":38},"2023-09-14",{"date":42,"type":22},"2027-06-30",{"name":44,"class":45},"Rigshospitalet, Denmark","OTHER",5,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100622062","back-to-life---early-rehabilitation-therapy-for-patients-undergoing-lumbar-spinal-fusion---a-single-case-experimental-study-100622062","NCT07378735","Back to Life - Early Rehabilitation Therapy for Patients Undergoing Lumbar Spinal Fusion","Back to Life - Early Rehabilitation Therapy for Patients Undergoing Lumbar Spinal Fusion Surgery - A Single-case Experimental Design Study","Back to Life","The investigators will in total include 12 patients undergoing an LSF from the Centre for Rheumatology and Spine Diseases at Rigshospitalet, Denmark.\n\nBefore inclusion, a pilot of three participants will be performed.\n\nInclusion Criteria for all included:\n\n* ≥ 18 years of age\n* Low back pain (LBP) \\> 3 months\n* Read and understand the Danish language\n* The participants should be a part of Frederiksberg Municipality and Copenhagen Municipality (in Denmark)\n\nExclusion Criteria:\n\n* Post-traumatic vertebral compression\u002Fdeformity\n* Patients with the following conditions (infection, neoplasm, metastasis, metabolic bone disease, fractures or other known autoimmune arthropathies)\n* Patients with patient-related circumstances (physical or mental status) that impede their ability to give informed consent and adhere to the study program (e.g., dementia, developmental disorders, or substance-induced cognitive impairment)\n* Other special conditions, where the patient is judged by the surgeon as inappropriate to participate",{"count":56,"type":22},12,[58],"NA","Aim This study aims to assess the effectiveness of an early intervention comprising individually tailored physiotherapy, including dialogue, education, and graded activity, following lumbar spinal fusion surgery. The effectiveness will be evaluated on patient-specific goals, physical activity, pain intensity, pain interference, fear of movement, and pain self-efficacy for patients after a lumbar spinal fusion.",[61,62],"Low Back Pain","Lumbar Spinal Fusion",[64,65,66,67,68,69,70,71],"Physical activity","Low back pain","Lumbar spinal fusion","Exercise","Rehabilitation","Physiotherapy","Single-case experimental study","Cognitive behavioural approach","2026-08-12",{"date":74,"type":38},"2026-08-14",{"date":76,"type":38},"2026-06-01",{"date":78,"type":22},"2028-11",{"name":44,"class":45},1,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":88,"minAge":19,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100611394","automated-insulin-delivery-versus-usual-insulin-treatment-modality-before-and-during-pregnancy-in-women-with-type-1-diabetes-100611394","NCT07240012","Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes","AID-DM","Inclusion criteria during pregnancy planning\n\n* Women, age 18-45 years\n* Duration of type 1 diabetes ≥ 12 months\n* Women who are not pregnant confirmed by a negative pregnancy test on the day of randomization\n* Planning pregnancy within 52 weeks\n\nInclusion during pregnancy:\n\n* Women, age 18-45 years\n* Duration of type 1 diabetes ≥ 12 months\n* Pregnant with an intrauterine singleton living fetus confirmed by an ultrasound scan between 8+0 and 13+6 gestational weeks\n* Accepting participation in the DDBR2 study during pregnancy, delivery and until one month after delivery\n\nExclusion criteria during pregnancy planning and during pregnancy:\n\n* No proficiency in Danish to understand oral and written information\n* Severe mental or psychiatric barriers or concurrent disease on the decision of the principal investigator","FEMALE","45 Years",{"count":91,"type":22},305,[58],"A national multi-center open-label randomized controlled trial that investigates whether the use of the automated insulin delivery system CamAPS FX initiated during pregnancy planning or in early pregnancy improves maternal time in glycemic targets and fetal growth in women with type 1 diabetes compared to usual insulin treatment modality combined with Continuous Glucose Monitoring.",[95,96],"Diabete Type 1","Pregnancy Complications","2026-08-11",{"date":72,"type":38},{"date":100,"type":38},"2025-12-01",{"date":102,"type":22},"2028-10",{"name":44,"class":45},8,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":80},"100575303","phase-4-introduction-of-mycotic-prophylaxis-at-cystectomy-trial-100575303","NCT06770530","Introduction of Mycotic Prophylaxis At Cystectomy Trial.","IMPACT - the Introduction of Mycotic Prophylaxis At Cystectomy Trial. Perioperative Mycotic Prophylaxis to Reduce Postoperative Complications Following Cystectomy - a Double-blinded, Placebo-controlled, Randomized Trial","IMPACT","Inclusion Criteria:\n\n* Patients 18 years and older\n* Willingness to participate in the study and the ability to understand and sign an informed consent\n* Indication for performing cystectomy\n* The urinary diversion is limited to the ileal conduit\n\nExclusion Criteria:\n\n* Patients with contraindications to Fluconazole. This includes allergies and treatment with non-pausable medication that in combination is contraindicated\n* Patients in active treatment for mycotic infections",{"count":114,"type":22},420,[25],"This study aims to introduce a perioperative antifungal prophylaxis for patients undergoing cystectomy: surgically removal of the urinary bladder with construction of a urinary diversion. We wish to investigate the effect of antifungal prophylaxis on complications after the operation.",[118],"Cystectomy",{"date":72,"type":38},{"date":121,"type":38},"2024-06-24",{"date":123,"type":22},"2027-09",{"name":44,"class":45},{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":135,"conditions":136,"keywords":139,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":80},"100493586","petct-follow-up-for-head-and-neck-squamous-cell-carcinoma-100493586","NCT05707078","PET\u002FCT Follow up for Head and Neck Squamous Cell Carcinoma","PET Follow","Inclusion Criteria:\n\n* Informed consent\n* Age above 18\n* Completed curative treatment for HNSCC of the oral cavity, nasopharynx, oropharynx, hypopharynx or larynx\n\nExclusion Criteria:\n\n* Patient refusal\n* Patients with clinical N0 neck\n* Patients who had neck dissections prior to radiotherapy\n* Patients who are clinical inoperable for any reason",{"count":133,"type":22},600,[58],"PET\u002FCT follow up for Head and Neck Squamous Cell Carcinoma The following is a presentation of a prospective protocol, named PET\u002FCT follow up for Head and Neck Squamous Cell Carcinoma (PET Follow), including patients who have completed radiotherapy treatment for squamous cell carcinoma of the head and neck (HNSCC).\n\nThe purpose of this study is to investigate the diagnostic performance of 18F-fluorodeoxy-D-glucose (FDG) Positron Emission Tomography\u002F Computed Tomography (PET\u002FCT) in patients with HNSCC after curative intended treatment.",[137,138],"Head and Neck Squamous Cell Carcinoma","PET\u002FCT",[138,140],"HNSCC",{"date":72,"type":38},{"date":143,"type":38},"2023-03-07",{"date":145,"type":22},"2030-12-30",{"name":44,"class":45},{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":158,"conditions":159,"keywords":162,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":80},"100450419","copenhagen-master-observational-trial-100450419","NCT05145244","Copenhagen Master Observational Trial","Copenhagen Master Observational Trial (C-MOT): A Prospective Investigator-initiated Observational Study to Study Biomarkers in Relation to Clinical Outcome in Patients With Non-Small Cell Lung Cancer or Breast Cancer","C-MOT","Inclusion Criteria:\n\n* Patients (≥ 18 years of age) with diagnosis of NSCLC or breast cancer amenable to medical or radiation therapy with curative or palliative intent\n* Evidence of a personally signed and dated informed consent form document indicating that the patient has been informed of all pertinent aspects of the study\n* Able to read and understand Danish\n* Willing and able to complete collection of data including WGS\n\nExclusion Criteria:\n\n* Patient with breast cancer initiating adjuvant systemic therapy\n* In the judgment of the investigator, the patient's life expectancy is fewer than 3 months at the time of diagnosis of NSCLC or breast cancer",{"count":156,"type":22},2400,"OBSERVATIONAL","The primary objectives of this prospective non-interventional study (NIS) are to assess and describe outcomes in relation to biomarkers, including whole-genome sequencing (WGS) in patients with non- small cell lung cancer (NSCLC) or breast cancer receiving treatment offered in the clinic (standard of care or included in clinical trials).",[160,161],"Non-small Cell Lung Cancer","Breast Cancer",[163,164,165,166],"Real world data","Observational trial","WGS, whole genome sequencing","Patient Reported Outcomes, PRO",{"date":72,"type":38},{"date":169,"type":38},"2021-08-01",{"date":171,"type":22},"2027-12-31",{"name":44,"class":45},{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":18,"minAge":179,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},"100446269","phase-2-the-prevent-agitation-trial-ii---children-1-year-100446269","NCT05091242","The PREVENT AGITATION Trial II - Children ≤1 Year","Inclusion Criteria:\n\n* Paediatric patients (male and female), aged 3- ≤ 12 months\n* Scheduled general anaesthesia with sevoflurane and opioid. Induction with propofol is optional\n* The legally acceptable representative for the study participant provides written informed consent\u002Fassent for the trial\n\nExclusion Criteria:\n\n* ASA \\>2\n* Cardiac, neuro and trauma surgery\n* Ex-premature (\\\u003C37 weeks) • Premedication with clonidine\n* Intubated prior to scheduled anaesthesia or is expected to require intubation after the procedure\n* Critical illness incl. hemodynamic instability (inotropic drugs needed)\n* Bleeding requiring transfusion prior to scheduled anaesthesia\n* Planned for a postoperative nurse-controlled analgesia pump including a continuous infusion of opioid\n* Malignant disease\n* Cardiac disease incl. arrhythmia\n* Chronic lung disease that may influence study results or study participation in the opinion of the Investigator or may comprise safety and well-being of the patient\n* Mental retardation\n* Neurological disease including symptoms similar to emergence agitation\n* Has or is suspected of having a family or personal history of malignant hyperthermia\n* Has or is suspected of having an allergy to study treatment or its excipients\n* Any condition that can in opinion of the Investigator, deteriorate safety and well-being of the patients or interfere with pharmacokinetic data\n* Positive Covid-19 test or clinical suspicion of Covid-19 (according to current local guidelines)","3 Months","12 Months",{"count":182,"type":22},336,[184,185],"PHASE2","PHASE3","Emergence agitation is a clinical condition in which the child experiences a variety of behavioural disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. Emergence agitation is a common challenge in children with a reported incidence of approximately 25% ranging from 10 to 80 %. Clonidine is often used off-label in paediatric anaesthesia e.g. sedation in the intensive care unit, prevention of withdrawal symptoms after long-term sedation, as premedication before induction of anaesthesia or as treatment\u002Fprevention of emergence agitation. The study is designed as a randomised, placebo-controlled clinical trial evaluating efficacy and safety of a single dose of intraoperative clonidine in children 3-12 months, including pharmacokinetics.",[188],"Emergence Delirium",[190,191,192,193,194,195,196],"Anesthesia","Clonidine","Sevoflurane","Pharmacokinetics","Postoperative Nausea and Vomiting","Postoperative Pain","Infant",{"date":72,"type":38},{"date":199,"type":38},"2021-10-25",{"date":201,"type":22},"2028-01-31",{"name":44,"class":45},2,{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":211,"targetDuration":213,"studyType":157,"phases":4,"briefSummary":214,"conditions":215,"keywords":218,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":230},"100232215","cerebellar-mutism-syndrome-study-100232215","NCT02300766","Cerebellar Mutism Syndrome Study","Nordic Study of the Cerebellar Mutism Syndrome in Children With Brain Tumours of the Posterior Fossa","Inclusion Criteria:\n\n* Age \\\u003C 18 years at the date of first imaging showing this tumour\n* Tumour in the cerebellum\u002F4th ventricle\u002Fbrainstem with intention to treat with surgical resection or open biopsy. Second and further surgeries are also included.\n* Informed consent from custodial parent(s)\n\nExclusion Criteria:\n\n* None",{"count":212,"type":22},2000,"1 Year","The purpose of this study is to determine why up to 25% of the pediatric patients who have surgery for a tumor in the posterior fossa develops the Cerebellar Mutism Syndrome (CMS). Furthermore the purpose is to explore the clinical course and the best treatment of the syndrome.",[216,217],"Infratentorial Neoplasms","Mutism",[219,220,221,222],"Cerebellar Mutism Syndrome","Posterior Fossa Tumor","Pediatric cancer","Neurosurgical techniques","2026-08-10",{"date":72,"type":38},{"date":226,"type":4},"2014-10",{"date":228,"type":22},"2028-12-31",{"name":44,"class":45},32,{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":239,"enrollmentInfo":240,"targetDuration":4,"studyType":23,"phases":242,"briefSummary":243,"conditions":244,"keywords":248,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":46},"100630846","conduction-system-pacing-vs-biventricular-pacing-for-cardiac-resynchronization-therapy-100630846","NCT07492979","Conduction System Pacing vs. Biventricular Pacing for Cardiac Resynchronization Therapy","Nordic-CSP - a Randomized Nordic Study - Is Conduction System Pacing Superior Compared to Conventional BIV-CRT in Reducing the Death or Heart Failure-related Hospitalization in Patients With Heart Failure and Bundle Branch Block?","Nordic-CSP","Inclusion Criteria:\n\n* ≥18 years of age,\n* LVEF ≤ 35%,\n* NYHA Class II-IV (IV only outpatients),\n* optimized in medical treatment (OMT)\n\nAND one of the following:\n\n. LBBB according to AHA\u002FACC\u002FHRS Scientific Statement from 2009 and ≥130ms or\n\n* LBBB-like intraventricular conduction delay (IVCD) \\> 150ms or RV paced QRS and indication for upgrade to CRT (\\> 40% RV pacing) OR\n* ≥18 years of age,\n* LVEF ≤ 40 %\n* pacing indicated by AV-block and, thus, expected large percentage of ventricular pacing.\n\nExclusion Criteria:\n\n* recent acute myocardial infarction (AMI)\n* coronary artery bypass graft (CABG) (\\\u003C3 months)\n* life expectancy \\\u003C2 years, patients in hemodialysis\n* treatment with a cardiac implantable electronic device (CIED) is contraindicated.\n* Patients are excluded with regards to the MRI sub study if eGFR \\> 35 ml\u002Fmin, in case or contrast allergy or certain metal implants.","99 Years",{"count":241,"type":22},1100,[58],"The NORDIC-CSP trial is an investigator-initiated, blinded, nordic RCT aimed at evaluating whether using direct pacing of the HIS bundle (HIS)-pacing or left bundle branch (LBB) pacing is superior to conventional biventricular pacing in reducing the incidence of the composite endpoint of death and non-planned HF hospitalization. The study will be conducted in the 4 CRT-centres in Denmark and 6-8 centres from countries Sweden, Norway and Finland.",[245,246,247],"Cardiac Resynchronisation Therapy (CRT)","Heart Failure","Conduction System Pacing",[237,249,250,251,252,253],"conduction system pacing","His-pacing","LBB-pacing","Biventricular pacing","Cardiac Resynchronization Therapy","2026-07-24",{"date":256,"type":38},"2026-07-28",{"date":258,"type":38},"2026-06-17",{"date":260,"type":22},"2031-07-01",{"name":44,"class":45},{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":269,"enrollmentInfo":270,"targetDuration":4,"studyType":23,"phases":272,"briefSummary":273,"conditions":274,"keywords":276,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":80},"100649143","unilateral-vs-bilateral-lung-volume-reduction-surgery-100649143","NCT07731958","Unilateral vs. Bilateral Lung Volume Reduction Surgery","Unilateral Versus Bilateral Lung Volume Reduction Surgery for Patients With Severe COPD","Inclusion Criteria:\n\n* Suitable target areas in both lungs\n* Age ≥ 18 years.\n* Speaks and understands Danish or English\n* Informed consent obtained\n* Usual inclusion criteria in LVRS:\n\nModerate to severe COPD with MRC score \\> 2 \\\u003C 75 years old 17 \\\u003C BMI \\> 30 FEV1 \\> 20% and \\\u003C 45% of predicted RV \\> 200% of predicted as a sign of relevant hyperinflation DLCO \\> 20% of predicted The patient should be in ideal medical treatment and have completed rehabilitation A high-resolution CT \\\u003C 3 months old should follow the referral to MDT Absence of nodules suspicious of malignancy on CT scan Absence of significant comorbidity including severe cardiovascular disease LVEF normal Absence of pulmonary hypertension, TI-gradient \\\u003C 40 mmHg Absence of chronic or frequent lung infections Smoking abstinence six months prior to surgery Assessed as sufficiently physically fit to undergo surgery and rehabilitation\n\nExclusion Criteria:\n\n* Dependent on wheelchair\n* Living in nursery home\n* Dependent on walker device\n* Psychiatric disorder (anxiety, depression, schizophrenia)\n* Simultaneous lung cancer surgery\n* Massive adhesions during surgery assessed by the surgeon indicating problems postoperatively\n* Increased risk of post-operative bleeding assessed perioperatively by the surgeon.\n* Perioperative decision on not doing operation on the other side (medical, surgical or anaesthesiologic problems that favours a fast termination of the surgery, decided by the team in OR).\n* Previous cardiothoracic surgery\n* Increased bleeding risk (e.g., preoperative INR \\>2, overdue discontinuation of anticoagulants according to guidelines by the Danish Society for Thrombosis and Haemostasis, known coagulopathy).","75 Years",{"count":271,"type":22},146,[58],"This study compares two surgical approaches for patients with severe Chronic Obstructive Pulmonary Disease (COPD) and severe emphysema: unilateral (operating on one lung) versus bilateral (operating on both lungs) lung volume reduction surgery (LVRS).",[275],"Emphysema, Pulmonary",[277,278,279,280,281,282,283],"Thoracic surgery","VATS","LVRS","Lung volume reduction surgery","Lung function","Mortality","Dyspnea","2026-07-22",{"date":256,"type":38},{"date":287,"type":38},"2025-03-21",{"date":289,"type":22},"2032-07",{"name":44,"class":45},{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":23,"phases":299,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":315,"locationsCount":80},"100543067","preventive-interventions-for-chronic-pain-worsening-100543067","NCT06351046","Preventive Interventions for Chronic Pain Worsening","Inclusion Criteria:\n\n* At least 18 years old\n* Fluent in the Danish language\n* Complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10)\n* Access to internet\n* Willing and available to participate in the study.\n\nExclusion Criteria:\n\n* Specialized or multidisciplinary pain treatment at baseline\n* History of epilepsy\n* Seizure disorder\n* History of nausea or dizziness\n* Hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment.\n* Injury to eyes, face or neck that impedes comfortable use of virtual reality equipment.\n* Current cancer disease\n* Medical diagnosis of depression\n* Cognitive dysfunction that interferers with compliance to the study,\n* Currently pregnant or planning to become pregnant during the study period\n* No access to the internet during the study period.",{"count":298,"type":22},44,[58],"This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has two arms (1:1): A Virtual Reality based Pain Self-management (VRPS) program group, and a control group (usual care). Included will be 44 patients at least 18 years old; fluent in the Danish language; complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10); access to internet; and willing and available to participate in the study. Excluded will be specialized or multidisciplinary pain treatment at baseline; history of epilepsy, seizure disorder, nausea or dizziness, hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment; injury to eyes, face or neck.",[302],"Chronic Non-Cancer Pain",[304,305,306,307,308],"Patient Reported Outcome","Virtual Reality","Pain Intensity","Randomized Controlled Trial","Non-pharmacological treatment","2026-07-08",{"date":311,"type":38},"2026-07-09",{"date":313,"type":38},"2025-05-14",{"date":171,"type":22},{"name":44,"class":45},{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":23,"phases":323,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":80},"100601030","feasibility-of-wireless-continuous-vital-sign-monitoring-and-impact-on-patients-undergoing-adult-spinal-surgery-in-a-general-ward-100601030","NCT07105189","Feasibility of Wireless Continuous Vital Sign Monitoring and Impact on Patients Undergoing Adult Spinal Surgery in a General Ward","Inclusion Criteria:\n\n* Included are adult patients (\\>=18 years) scheduled for ASD surgery with estimated a \\>3 day expected post-operative stay. ASD-surgery is defined as a posterior instrumented fusion of at least five spinal levels including instrumentation to the pelvis, caused by a degenerative condition of the spine.\n* Registered nurses and nurses' assistants employed at the orthopedic ward during the study period will be included if they have experience working with wCVSM during the study period. The study includes both sexes, variation of level of education and years of work experience. Included nurses and nurses' assistants should be proficient in the Danish language.\n\nExclusion Criteria:\n\n* Exclusion criteria are patients who are unable to wear continuous monitoring due to a pacemaker or allergy.\n* Patients who are not proficient in the Danish language will be excluded.",{"count":5,"type":22},[58],"The goal of this feasibility study is to explore the use of wireless continuous vital sign monitoring in an orthopaedic setting among orthopaedic nurses and patients undergoing adult spinal deformity surgery. In addition to the standard care National Early Warning Score the participants in this study will be monitored by CPC12S a wearable sensor that is worn on the chest using electrodes measuring electrocardiography single lead (ECG), Heart rate, respiratory rate, SpO2, blood pressure and temperature.\n\nMain hypotheses:\n\nThe use of wireless continuous vital sign monitoring in daily clinical practice for patients undergoing ASD surgery is feasible in terms of increased acceptability among orthopeadic surgical nurses measured over 12 months with a response rate of at least 80% with an average score of ≥5 at the last measurement in each of the four dimensions of the USE questionnaire: Usefulness, ease of use, ease of learning and satisfaction.\n\nThe following parameters will be evaluated:\n\nPrimary outcome:\n\n1. The feasibility in terms of acceptability of the concept of wCVSM among orthopedic surgical ward nurses.\n\n   Secondary outcomes:\n2. The feasibility in terms of acceptability of the concept of wCVSM in patients undergoing ASD surgery.\n3. The technical fidelity of wCVSM, assessed by data collected of vital signs, display of alerts to staff nurses and response to the alerts.\n4. The frequency of vital sign deviations in patients after ASD surgery using wCVSM compared to NEWS2.\n5. Clinical outcomes of patients undergoing ASD surgery including surgical complications, reinterventions, ICU admissions, unplanned ward transfer, and admissions to another department.",[326,327,328,329,330,331,332],"Adult Spinal Deformity","Wireless Continuous Vital Signs Monitoring","Wireless Vital Signs Monitoring System","Acceptability","ASD Surgery","Remote Monitoring","Feasibility Studies","2026-07-07",{"date":311,"type":38},{"date":336,"type":38},"2025-12-10",{"date":338,"type":22},"2027-01-31",{"name":44,"class":45},{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":347,"sex":88,"minAge":19,"maxAge":348,"enrollmentInfo":349,"targetDuration":4,"studyType":23,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":80},"100632265","phase-4-reversible-effects-of-oral-contraceptive-removal-on-serotonergic-neurotransmission-100632265","NCT07511439","Reversible Effects of Oral Contraceptive Removal on Serotonergic Neurotransmission","REVERSE","Inclusion Criteria:\n\n1. Healthy women (assigned female at birth) at 18-39 years of age\n2. Currently using a second-generation combined oral contraceptive containing 150 ug levonorgestrel and 30 ug ethinylestradiol for at least 3 months\n\nExclusion Criteria:\n\n1. Current or previous neurological or psychiatric disease, severe somatic disease, or consumption of medical drugs (including psychoactive medication) likely to influence the test results\n2. Non-fluent in Danish or pronounced visual or auditory impairments\n3. Current or past learning disability\n4. Pregnancy within the last year or previous pregnancy lasting into second or third trimester\n5. A wish to become pregnant within the following 12 months\n6. Participation in experiments with exposure to radioactivity (\\> 10 mSv) within the last year or significant occupational exposure to radioactivity\n7. Contraindications for MRI (pacemaker, metal implants, claustrophobia)\n8. A history of head injury or concussion resulting in loss of consciousness for more than 2 min\n9. Alcohol or drug abuse\n10. Drug use other than tobacco and alcohol within the last 30 days\n11. Cannabis \\> 50 x lifetime\n12. Recreational drugs other than cannabis \\> 10 x lifetime (for each substance)\n13. Nicotine addiction\n14. Non-compliance to COC within the last 3 months (i.e., \\> 2 missed pills in a cycle)\n15. Contraindication for use of combined oral contraception",true,"39 Years",{"count":350,"type":22},60,[25],"The goal of this study is to learn about potential reversible effects of combined oral contraceptive (COC) use on the serotonergic brain system. The main question it aims to answer is:\n\n\\- If COC discontinuation results in an increase in serotonin 4 receptor binding in caudate, putamen, and hippocampus measured with Positron Emission Tomography from baseline to follow-up ≥ week 8 after discontinuation.\n\nThe secondary question it aims to answer is:\n\n\\- Over what timeframe the serotonin 4 receptor binding is restored after COC discontinuation to the level previously seen in a group of premenopausal women who had not used hormonal contraception before.\n\nResearchers will compare discontinuation with continuation of a 2nd generation COC containing 150 ug levonorgestrel and 30 microgram to see if COC discontinuation results in an increased serotonin 4 receptor level in the brain.\n\n\\-\n\nParticipants will:\n\n* Be randomized to discontinue or continue their COC use for 1-52 weeks.\n* Undergo an investigational program including brain scans, biological sampling, and neuropsychological testing at baseline and at follow-up.\n\nThe study uses a group sequential design with two sequential analyses planned, including an interim analysis after 60% of the brain scans have been acquired, which will be used to decide the timing of the last 40% of the scans - this is performed to best determine when the recovery of the serotonin 4 receptor level occurs.",[354,355],"The Focus of the Study is to Investigate Reversible Effects of Combined Oral Contraceptive Use on Serotonergic Neurotransmission","Healthy Adult Females","2026-06-30",{"date":358,"type":38},"2026-07-02",{"date":360,"type":38},"2026-04-23",{"date":362,"type":22},"2030-12-31",{"name":44,"class":45},{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":347,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":23,"phases":372,"briefSummary":373,"conditions":374,"keywords":377,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":391},"100623902","does-ai-make-clinicians-more-appropriately-confident-a-randomized-study-in-preterm-birth-prediction-100623902","NCT07402668","Does AI Make Clinicians More Appropriately Confident? A Randomized Study in Preterm Birth Prediction","Inclusion Criteria:\n\n* Medical doctors currently working in or training within the field of obstetrics and gynecology.\n* Experience performing transvaginal cervical ultrasound examinations.\n\nExclusion Criteria:\n\n\\- No prior experience performing transvaginal cervical ultrasound examinations.",{"count":371,"type":22},125,[58],"The goal of this randomized questionnaire-based study is to evaluate how different presentations of artificial intelligence (AI) decision support influence clinical judgment among medical doctors working in obstetrics and gynecology when assessing the risk of spontaneous preterm birth using clinical case vignettes with cervical ultrasound images. The study specifically compares two AI presentation formats: a binary classification (preterm vs term birth) and an individualized risk estimate of preterm birth.\n\nThe main questions it aims to answer are:\n\n* Which AI presentation format leads to better alignment between clinicians' confidence and decision accuracy (diagnostic calibration)?\n* Do different AI presentation formats lead to helpful or harmful changes in clinical decisions?\n\nParticipants will complete an online questionnaire in which they review clinical cases, make diagnostic and management decisions, rate their diagnostic confidence before and after seeing the AI output, and report their trust in the AI.",[375,376],"Preterm Birth","Artificial Intelligence (AI) in Diagnosis",[378,379,380,381,382,383],"Preterm birth","Premature birth","Diagnostic calibration","Diagnostic accuracy","Diagnostic confidence","Artificial intelligence",{"date":385,"type":38},"2026-07-01",{"date":387,"type":38},"2026-02-03",{"date":389,"type":22},"2026-07",{"name":44,"class":45},18,{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":347,"sex":18,"minAge":398,"maxAge":399,"enrollmentInfo":400,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":203},"100643095","protein-biomarkers-and-host-rna-expression-profiles-in-congenital-cytomegalovirus-infection-100643095","NCT07635368","Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection","Inclusion Criteria:\n\n1. Children born between 1 January 2010 and 31 December 2025 with an available neonatal dried blood spot sample collected through the Danish National Newborn Screening Program.\n2. Cases: children with verified congenital CMV infection, defined as a positive CMV PCR result on neonatal dried blood spot, blood, or urine collected within the neonatal period.\n3. Controls: children without evidence of congenital CMV infection selected from the same newborn screening population and matched to cases on sex, gestational age, birthweight, and age at DBS sampling.\n\nExclusion Criteria:\n\n1. DBS samples not approved for research use.\n2. DBS samples with insufficient blood material for RNA expression profiling and\u002For proteomic analyses.\n3. Samples with inadequate analytical quality for molecular or proteomic analyses.","0 Days","28 Days",{"count":401,"type":22},630,"This study seeks to identify and test host protein biomarkers and RNA expression profiles in dried blood spot samples as novel diagnostic markers of congenital cytomegalovirus sequelae and to improve the understanding of the pathogenesis of the disease.",[404,405,406,407,408],"Congenital Cytomegalovirus","Cytomegalovirus Infections","Neonatal Infection","Sensorineural Hearing Loss","Viral Infection","2026-06-04",{"date":411,"type":38},"2026-06-09",{"date":413,"type":38},"2026-04-21",{"date":415,"type":22},"2026-12-31",{"name":44,"class":45},{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":347,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":23,"phases":426,"briefSummary":428,"conditions":429,"keywords":433,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":80},"100643757","phase-1-scar-remodeling-after-burn-injury-using-allogeneic-adipose-derived-stromal-cells-100643757","NCT07635875","Scar Remodeling After Burn Injury Using Allogeneic Adipose-derived Stromal Cells","ScarASC","Inclusion Criteria:\n\n* Adults ≥ 18 years of age\n* Males and females\n* Hypertrophic scars (age of scar \\> 2 years) after burn injuries on the front thorax or extremities.\n* Two uniform 6 cm x 6 cm areas of burn scar tissue on the front thorax or extremities. The scar should be large enough to separate the areas by a minimum of two centimeters.\n* Ability to understand information about the project.\n\nExclusion Criteria:\n\n* Significant comorbidities or lack of cognitive abilities to follow instructions.\n* Not being able to participate due to language or other personal issues.\n* Pregnancy or breastfeeding\n* Current or previous steroid therapy (systemic or local) within one year.\n* Scar revision surgery within one year in the affected areas.\n* Keloids.\n* Active cancer or previous cancer within two years (skin cancers do not apply)\n* Penicillin and Streptomycin allergy.",{"count":425,"type":22},39,[427,184],"PHASE1","The present project serves to test whether stem cell therapy offers a new treatment option for the scars of burn survivors. In Denmark, 12.000 people seek medical assistance every year for burn injuries leaving thousands of people with the devastating condition of hypertrophic scarring. Affected patients experience pain, itching, numbness, and reduced range of motion, which profoundly impact their quality of life. We hypothesize that adipose-derived stem cells can improve scar quality. To test this, we have conducted an integrated phase I + II trial (the ScarASC trials). ScarASC will be the first randomized controlled trial to use stem cells in burn patients. Two scar areas in each patient will be randomly injected with A) allogeneic adipose-derived stem cells and B) the control medium (placebo). We maintain a patient-centered scope, with our primary endpoint being a patient-reported outcome measure. However, we also obtain objective scar assessments using three-dimensional photographs, the scar elevation index, and gene\u002Fprotein expression regulation.",[430,431,432],"Scar Conditions and Fibrosis of Skin","Scar Quality Assessment and Safety","Scar Tissue",[434,435,436,437,438,439],"Mesenchymal stromal cell therapy","Cell therapy","Regenerative medicine","Scar tissue","Clinical trial","ATMP","2026-06-03",{"date":411,"type":38},{"date":443,"type":38},"2026-04-16",{"date":445,"type":22},"2028-05-31",{"name":44,"class":45},{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":453,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":455,"enrollmentInfo":456,"targetDuration":4,"studyType":23,"phases":458,"briefSummary":459,"conditions":460,"keywords":462,"overallStatus":467,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":468,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":474},"100477981","the-hycore1-trial-hybrid-revascularization-versus-coronary-artery-bypass-grafting-100477981","NCT05504031","The HYCORE1 Trial: Hybrid Revascularization Versus Coronary Artery Bypass Grafting","The HYCORE1 Trial: Hybrid Revascularization Versus Coronary Artery Bypass Grafting in Patients With Multi-vessel Coronary Artery Disease. A Randomized Clinical Trial.","HYCORE1","Inclusion Criteria:\n\n* Written informed consent\n* ≥ 18 years of age\n* Functionally significant MVD, defined as ≥ 70% diameter stenosis by visual estimation or functionally significant stenosis (FFR \\\u003C 0.80, non-hyperaemic index (iFR) \\\u003C 0.89) in at least two of the major epicardial vessels or major side branches\n* Patient history reviewed by both cardiac surgeon and cardiologist who in agreement find both CABG and hybrid revascularisation indicated and technically feasible with an expectation of complete revascularisation of all functionally significant stenoses in the LAD and at least one other coronary artery ≥ 2.5mm in diameter or left main bifurcation stenosis with functionally significant stenoses in both the LAD and left circumflex artery.\n\nExclusion Criteria:\n\n* Chronic kidney disease with estimated glomerular filtration rate \\\u003C 20 mL\u002Fmin\u002Fkg\n* Pregnancy\n* Left main stenosis without additional functionally significant stenoses in both the LAD and the LCX\n* Contraindications to the use of dual antiplatelet therapy\n* STEMI within 1 month\n* Indication for acute revascularization","80 Years",{"count":457,"type":22},1048,[58],"Coronary artery disease often necessitates complex interventions like coronary artery bypass surgery (CABG) or percutaneous coronary intervention (PCI) with stents. Hybrid coronary revascularization, a minimally invasive approach, integrates both methods for complete revascularization. This multicenter randomized trial involves 1200 patients, comparing hybrid coronary revascularization to CABG in a 1:1 ratio. Eligible participants have multi-vessel coronary disease and are referred for elective or sub-acute CABG. Inclusion criteria include age 18 or older, significant multi-vessel disease, and potential complete revascularization with both methods. Exclusion criteria include chronic kidney disease, pregnancy, contradiction to dual antiplatelet therapy, recent myocardial infarction, and acute revascularization. The hybrid group undergoes staged revascularization, combining minimally invasive grafting of the left interior mammary artery to the left anterior descending artery with PCI-stenting of remaining lesions. The control group undergoes conventional CABG with sternotomy. The primary outcome is a composite of all-cause mortality, myocardial infarction, stroke, or unplanned hospitalization, while secondary outcomes include periprocedural complications, cardiovascular mortality, hospital-free days within 90 days, angina frequency, and quality of life. Evaluation occurs 12 months after randomization. The trial commences in 2024, with inclusion expected to conclude in 5 years.",[461],"Coronary Artery Disease",[463,464,465,466],"Coronary artery disease","Hybrid coronary revascularization","PCI","CABG","NOT_YET_RECRUITING",{"date":440,"type":38},{"date":470,"type":22},"2026-07-15",{"date":472,"type":22},"2044-01",{"name":44,"class":45},3,{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":23,"phases":485,"briefSummary":486,"conditions":487,"keywords":490,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":80},"100633204","phase-4-anemia-therapy-in-patients-with-infective-endocarditis-100633204","NCT07523646","Anemia Therapy in Patients With Infective Endocarditis","Anemia Therapy in Patients With Infective Endocarditis (POET-IRON)","POET-IRON","Inclusion Criteria:\n\n* 18 years or older\n* Confirmed bacterial endocarditis.\n* Hb ≤6.0 mmol\u002Fl\n* Stabilization criteria:\n\n  * Stable condition (patients with satisfactory clinical response to initial treatment)\n  * At least 10 days with IV administered antibiotic treatment and at least 7 days after surgery in cases of valve surgery.\n  * Transesophageal echocardiography (TEE) performed prior to randomization with no signs of abscess formation or valve abnormalities, which would require surgery.\n  * No fever for at least 48 hours prior to enrollment.No positive blood cultures within last 4 days prior to randomization.\n  * CRP \\\u003C 25 mg\u002FL OR \\> 25% reduction from peak value.\n  * Leucocytes \\\u003C15 mia.\u002FL OR \\> 25% reduction from peak value.\n\nExclusion Criteria:\n\n* Known or suspected immunocompromise (e.g., HIV infection, ongoing chemotherapy, systemic corti-costeroid treatment \\>20 mg prednisolone equivalent\u002Fday)\n* Inability to provide informed consent for participation\n* Relapsing infective endocarditis (endocarditis caused by the same microorganism within 6 months)\n* Allergy \u002F intolerance to EPO or iron therapy\n* Inability to complete a 6MWT\n* Hematological conditions, that contradicts use of IV iron therapy\n* Death prior to clinical stabilization\n* Failure to fulfill criteria of clinical stabilization",{"count":484,"type":22},74,[25],"Infective endocarditis (IE) is a bacterial infection of the heart valves, inserted material or surrounding struc-tures and is associated with a high morbidity and mortality. In patients with IE, anemia is considered to result from the underlying infection, prolonged sustained inflammatory response due to the often slow natural course of the disease, and coexisting comorbidities.\n\nPrevious studies have found that moderate to severe anemia is associated with a markedly higher risk of mortality in the 6-months recovery phase following treatment for IE. In many cardiac patients and patients with chronic inflammation, randomized trials have shown benefit of treatment of anemia with adjunctive therapy i.e., vitamins (vitamin B12\u002Ffolic acid), intravenous iron, and erythropoiesis stimulating agents in alleviating anemia, without increased risk of infection. Despite these findings, anemia screening and management are not addressed in current endocarditis guidelines. Thus, in patients with IE and anemia, adjunctive treatment of the anemia might be beneficial for recovery and improve outcomes.\n\nThe aim of POET-IRON is to assess the efficacy of adjunctive anemia treatment in patients with IE, using intravenous iron supplementation, erythropoietin-stimulated erythropoiesis, and dietary optimization including vitamins if necessary, and its effect on hemoglobin levels compared to standard care.\n\nThe investigators hypothesize that this intervention is safe and will increase hemoglobin concentration, thereby alleviating symptoms of anemia and improving clinical outcomes through enhanced oxygen-carrying capacity, tissue oxygenation, and functional status.",[488,489],"Infective Endocarditis (IE)","Severe Anemia",[491,492,493],"Anemia","Infective Endocarditis","Inflammation","2026-05-26",{"date":496,"type":38},"2026-05-29",{"date":498,"type":38},"2026-05-15",{"date":500,"type":22},"2028-08",{"name":44,"class":45},{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":88,"minAge":19,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":510,"conditions":511,"keywords":512,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":80},"100640988","the-impact-of-image-acquisition-in-cervical-ultrasound-on-ai-based-prediction-of-preterm-birth-in-clinical-practice-100640988","NCT07598097","The Impact of Image Acquisition in Cervical Ultrasound on AI-Based Prediction of Preterm Birth in Clinical Practice","The Impact of Image Acquisition in Cervical Ultrasound on AI-Based Prediction of Preterm Birth in Clinical Practice: A Prospective Observational Study","Inclusion Criteria:\n\n* Pregnant women aged ≥18 years\n* Attending routine second-trimester scan (and scheduled transvaginal cervical assessment per local protocol\u002Fworkflow)\n\nExclusion Criteria:\n\n* Absence of transvaginal cervical assessment at the second-trimester scan\n* Missing follow-up data on pregnancy outcome (gestational age at delivery)\n* Inadequate image quality or missing required cervical ultrasound image",{"count":212,"type":22},"This study prospectively evaluates whether the performance of an already-developed artificial intelligence (AI) model for predicting spontaneous preterm birth changes when cervical ultrasound images are obtained using different ultrasound image settings.\n\nThe primary research question is whether the AI model performs differently across images acquired with different imaging settings.",[375,376],[378,379,383,513,514,381,515,516],"Deep learning","Image acquisition","Cervical ultrasound","Prospective validation","2026-05-19",{"date":519,"type":38},"2026-05-20",{"date":521,"type":38},"2026-03-11",{"date":523,"type":22},"2027-02",{"name":44,"class":45},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":529,"acronym":530,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":534,"briefSummary":535,"conditions":536,"keywords":544,"overallStatus":467,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":554,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":80},"100638098","pire-20-a-stepped-care-model-for-involving-relatives-across-sectors-100638098","NCT07590726","PIRe 2.0: A Stepped-Care Model for Involving Relatives Across Sectors","PIRe","Inclusion Criteria\n\n* Primary relative of an adult diagnosed with acquired brain injury (ABI) or malignant brain tumor (MBT), admitted to a participating hospital department.\n* Formally identified as the primary relative by the patient.\n* Aged ≥18 years.\n* Ability to read, understand, and complete questionnaires in Danish.\n\nExclusion Criteria\n\n* Insufficient proficiency in Danish to complete questionnaires and participate in structured conversations.\n* Concurrent participation in another interventional study with a similar aim that may interfere with the present study.",{"count":533,"type":22},160,[58],"Serious brain diseases and injuries affect not only the person who becomes ill or injured, but also their family. Relatives of people with acquired brain injury (ABI) or malignant brain tumor (MBT) often take on a major role in daily care, decision-making, and coordination across healthcare services. This role can include managing information, supporting rehabilitation, and acting as a link between hospital care and community rehabilitation. Many relatives report high levels of stress, uncertainty, and emotional burden, especially during transitions between care settings.\n\nDespite recommendations for greater involvement of relatives, support for this group is often uneven and poorly coordinated across healthcare sectors. Relatives frequently experience lack of overview, limited guidance, and unclear expectations regarding their role. These challenges may increase caregiver burden and negatively affect both relatives' well-being and the continuity of care.\n\nThe PIRe 2.0 study aims to further test, and implement a structured intervention to support systematic involvement of relatives of people with ABI or MBT across hospital and community rehabilitation services. The intervention is designed as a \"caregiver compass\" that helps relatives understand their role, clarify their needs and wishes for involvement, and gain better overview of the care pathway.\n\nPIRe 2.0 is delivered through a stepped-care model, which allows the level of support to be adjusted over time based on each relative's level of burden and support needs. All relatives receive basic information and screening for caregiver burden using the 4-item Zarit Burden Interview (ZBI-4). Relatives who show signs of increased burden are offered additional support in steps, ranging from structured conversations with nurses to extended cross-sector coordination and specialized support for relatives with high or complex needs. Decisions about stepping up or down are based on both screening results and clinical assessment to ensure flexibility and person-centered care.\n\nThe study includes two groups of relatives: an intervention group receiving support through the PIRe stepped-care model, and a control group receiving usual care only. A total of 160 relatives will participate. Data are collected at baseline, at transitions between hospital and community care, and three to six months after the intervention.\n\nThe primary outcome is change in caregiver burden, measured with the Caregiver Burden Scale (CBS). Secondary outcomes include relatives' roles and responsibilities, perceived support and involvement in care, and mental well-being, assessed using validated patient-reported outcome measures.\n\nIn addition to evaluating the effect of the intervention, the study examines how the PIRe model can be implemented and sustained in everyday practice across healthcare sectors. The results are expected to show whether a structured, stepped-care approach can reduce caregiver burden, improve coordination between hospital and community services, and support more coherent and secure care pathways for people with ABI or malignant brain tumor and their relatives.",[537,538,539,540,541,542,543],"Brain Injuries, Acute","Brain Tumor Adult","Brain (Nervous System) Cancers","Traumatic Brain Injuries","Glioblastom WHO Grade 4","Glioblastoma (GBM)","Stroke",[545,546,547,548,549,550,551,68,552,553],"Acquired brain injury","Malignant brain tumor","Relatives","Caregiver Burden","Involvement","Communication","Care transitions","Implementation","Stepped-care",{"date":517,"type":38},{"date":556,"type":22},"2026-10-01",{"date":558,"type":22},"2029-09-30",{"name":44,"class":45},{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":23,"phases":569,"briefSummary":570,"conditions":571,"keywords":574,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":80},"100545066","early-detection-of-complications-during-immunotherapy-for-haematological-malignancy-100545066","NCT06377059","Early Detection of Complications During Immunotherapy for Haematological Malignancy","Early Detection of Complications During Immunotherapy for Haematological Malignancy - Description of Associated Vital Signs and Immune Responses","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients diagnosed with haematologic malignant disease (e.g. malignant lymphoma)\n* Patients scheduled for treatment with CART or BsAbs\n\nExclusion Criteria:\n\n* Patient is pregnant\n* Patient has a pacemaker\n* Patient is allergic to one or more of the materials that the equipment consists of\n* Investigator deems patient not able to comply with participation in the study",{"count":568,"type":22},100,[58],"Aims\n\n* To identify patients that should remain admitted in hospital for more intense surveillance because of high risk for development of clinical complications\n* Expand the understanding of the interactions between physiology and immunology for the design of future projects and general knowledge Hypothesis Development of a risk model based on a combination of physiological and immunological parameters can contribute to early detection of patients at risk for clinical complications after anti-cancer treatment.",[572,573],"Hematologic Cancer","CRS - Cytokine Release Syndrome",[575],"wireless monitoring","2026-05-12",{"date":498,"type":38},{"date":579,"type":38},"2024-12-02",{"date":581,"type":22},"2027-07-01",{"name":44,"class":45},{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":589,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":591,"targetDuration":4,"studyType":23,"phases":592,"briefSummary":593,"conditions":594,"keywords":596,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":610},"100588251","randomized-controlled-trial-of-the-effects-of-combined-resistance-and-aerobic-exercise-on-health-related-quality-of-life-in-patients-undergoing-first-line-chemotherapy-for-metastatic-colorectal-cancer-reach-100588251","NCT06938971","Randomized Controlled Trial of the Effects of Combined Resistance and AerobiC Exercise on Health-related Quality of Life in Patients Undergoing First-line Chemotherapy for Metastatic Colorectal Cancer (REACH)","Effects of Exercise Training on Health-related Quality of Life in Patients With Unresectable Metastatic Colorectal Cancer: A Multi-center Randomized Controlled Trial","REACH","Inclusion criteria:\n\n\\- Adults (≥18 years of age) schduled to undergo first-line chemotherapy for the treatment of metastatic colorectal cancer.\n\nExclusion criteria :\n\n* Pregnancy.\n* A life expectancy of \\\u003C 6 months.\n* Absolute contraindications to maximal exercise, as per the recommendations by the Danish Society of Cardiology.\n* ECOG (Eastern Cooperative Oncology Group) performance status \\> 2.\n* Inability to understand the Danish or English language.\n* Engagement in structured moderate-to-high aerobic exercise training for \\>30 min \\>1 times\u002Fweek for the past 3 months at the time of inclusion.",{"count":5,"type":22},[58],"The primary objective of this trial is to compare the effects of 18 weeks structured exercise training versus on control on healt-related quality of life in patients with mCRC undergoing first-line chemotherapy.",[595],"Metastatic Colorectal Cancer (mCRC)",[67,64,597,598,599,600,601],"Metastatic colorectal cancer","Colorectal cancer","Endurance training","Oncology","Chemotherapy","2026-05-08",{"date":604,"type":38},"2026-05-13",{"date":606,"type":38},"2025-05-16",{"date":608,"type":22},"2030-05-01",{"name":44,"class":45},4,{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":618,"targetDuration":4,"studyType":23,"phases":620,"briefSummary":621,"conditions":622,"keywords":626,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":636,"locationsCount":474},"100638307","transoral-ultrasound-versus-no-transoral-ultrasound-in-diagnostic-workup-of-peritonsillar-abscess-100638307","NCT07577232","Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess","Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess - Proposal for a Multicenter Cluster Randomized Trial","Inclusion Criteria:\n\n* Patients referred to the ENT outpatient clinic with a suspected PTA.\n* 18 years of age or older.\n\nExclusion Criteria:\n\n* Unable to understand the verbal information, participating in research.\n* Prior surgical interventions (needle aspiration, surgery, incision) during the course of the disease.\n* Compromised airways, needing acute airway management.",{"count":619,"type":22},368,[58],"Peritonsillar abscess (PTA) is a collection of pus between the palatine tonsil and the constrictor muscle. PTA is detected by recognizing characteristics during clinical examination: redness, pain, malaise, trismus, and unilateral peritonsillar swelling. Clinical assessment, including inspection and palpation, is the traditional diagnostic method for patients suspected of having PTA. If PTA is suspected, aspiration with a large-gauge needle or incision is performed to drain the abscess . It can be challenging to distinguish PTA and peritonsillar cellulitis (PTC) based on clinical examination alone. Due to the increased availability of point-of-care ultrasound, it is a part of the diagnostic workup of PTA. Several studies have shown that transoral US can improve the diagnostic accuracy of patients with a suspected PTA. However, no large multicenter study has evaluated whether one of these methods is superior to the other. It is therefore very clinician-dependent whether the patient will have a transoral US performed or not. The investigators hypothesize that transoral US will increase the diagnostic accuracy of PTA compared to solely clinical examination, which is a visual and palpatory assessment. This will result in fewer unnecessary aspiration attempts and overlooked PTAs. Additionally, the investigators wish to investigate the number of aspirations of transoral US-guided needle aspirations compared to aspirations without ultrasound.\n\nMethods This is a cluster randomized study. Patients with suspected PTA will be randomized 1:1 to groups A and B. The cluster randomization will happen weekly using an online randomization tool.\n\nParticipants are patients refeered to the outpatient clinic on suspicion of a peritonsillar absces.\n\nThe primary outcome is the diagnostic accuracy\n\nThe investigators aim to determine whether transoral US is a standard part of the clinical examination by comparing clinical examinations with and without US.",[623,624,625],"Peritonsillar Abscess","Peritonsillar Cellulitis","Tonsillitis",[627,628,629],"Transoral ultrasound","peritonsillar abscess","Peritonsillar cellulitis","2026-05-05",{"date":632,"type":38},"2026-05-11",{"date":634,"type":38},"2025-06-09",{"date":385,"type":22},{"name":44,"class":45},{"id":638,"slug":639,"hasResults":12,"nctId":640,"briefTitle":641,"officialTitle":641,"acronym":642,"eligibilityCriteria":643,"healthyVolunteers":12,"sex":18,"minAge":644,"maxAge":4,"enrollmentInfo":645,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":647,"conditions":648,"keywords":652,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":659,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":80},"100608798","orbital-vascular-inflammation-in-ischemic-optic-neuropathy-and-giant-cell-arteritis-100608798","NCT07206238","Orbital Vascular Inflammation in Ischemic Optic Neuropathy and Giant Cell Arteritis","VISION-GCA","Inclusion Criteria:\n\nFor AION group:\n\n* Clinical suspicion of newly onset ischemic optic neuropathy (A-AION or NA-AION), defined by ipsilateral findings of: Papilledema; Relevant visual impairment measured by visual acuity and\u002For visual field; Relative afferent pupillary defect (RAPD), except if mydriatic agents have been administered or if bilateral optic neuropathy is present.\n* Age ≥ 50 years\n\nFor GCA group:\n\n* Clinically- and ultrasound-confirmed, newly diagnosed GCA\n* Absence of visual changes related to GCA in one or both eyes, including: Transient vision loss; permanent vision loss; transient double vision; permanent double vision\n* Age ≥ 50 years\n\nExclusion Criteria:\n\n* Ferromagnetic implants\n* Severe renal impairment with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²\n* Allergy to MRI contrast agents\n* Severe claustrophobia\n* Pregnancy or breastfeeding\n* Previously documented ipsilateral optic neuropathy or giant cell arteritis\n* More than 5 days of treatment with prednisolone prior to inclusion","50 Years",{"count":646,"type":22},122,"Giant cell arteritis (GCA) is an inflammation of the blood vessels. A dangerous complication is sudden vision loss due to insufficient blood supply to the optic nerve. However, it is often difficult to distinguish acute vision loss due to GCA from a similar condition of insufficient blood supply to the optic nerve, called NAION. Quick treatment with anti-inflammatory medication is needed in case of GCA to prevent vision loss on the eye and other serious complications. Patients with NAION have no benefit of the medication, but can have serious side effects, why it is very important to differentiate between these conditions.\n\nIn this project, the investigators will use FDG PET\u002FMRI with Black Blood (BB) sequences and OCT-imaging to study patients with GCA and\u002For ischemic optic nerve disease. The investigators will look for signs of inflammation in and around the small vessels of the orbit using PET\u002FMRI and study subtle retinal changes using OCT images.\n\nThe investigators want to answer the following research questions:\n\nDo patients with ischemic optic nerve disease and GCA show signs of inflammation in the orbital vessel wall on PET\u002FMRI-scans, that are not present in patients with NAION?\n\nDo GCA patients without vision loss, but with signs of orbital vessel wall inflammation on PET\u002FMRI-scans, have a higher risk of later vision loss than GCA patients without?\n\nCan subtle changes in the retina, detectable through OCT, help distinguish between GCA-related vision loss and NAION?\n\nThis will, to our knowledge, be the first study to systematically use FDG PET\u002FMRI BB-scans to illuminate vascular changes in the orbit of patients with GCA and\u002For ischemic optic nerve disease. The results may improve diagnosis and treatment of GCA and NAION in the future. The investigators hope that this will help prevent blindness and other serious complications in patients with GCA, while also avoiding unnecessary treatments for patients with NAION.",[649,650,651],"Giant Cell Arteritis (GCA)","Ischemic Optic Neuropathy","NAION - Non-Arteritic Ischemic Optic Neuropathy",[653,654,655,656,657],"FDG PET\u002FMRI BB","OCT","Retinal biomarkers","Giant cell arteritis","ischemic optic neuropathy","2026-05-02",{"date":660,"type":38},"2026-05-07",{"date":662,"type":38},"2026-01-14",{"date":664,"type":22},"2029-03-30",{"name":44,"class":45},{"id":667,"slug":668,"hasResults":12,"nctId":669,"briefTitle":670,"officialTitle":671,"acronym":672,"eligibilityCriteria":673,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":674,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":676,"conditions":677,"keywords":679,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":682,"startDateStruct":683,"completionDateStruct":685,"leadSponsor":687,"locationsCount":203},"100635122","physical-mobilisation-to-acquired-brain-injury-patients-in-intensive-care-units-a-prospective-cohort-study-100635122","NCT07548580","Physical Mobilisation to Acquired Brain Injury Patients in Intensive Care Units: a Prospective Cohort Study","Describing the Physical Mobilisation Provided to Patients With Acquired Brain Injury in Intensive Care Units: Protocol for a Prospective Cohort Study","FOOBScan2","Inclusion Criteria:\n\n* Adults (age ≥ 18 years)\n* Admitted to a neuro-ICU or to a regular ICU with dedicated beds for severe acquired brain injury patients in Scandinavia\n* Patients with moderate to severe traumatic brain injury (TBI) or stroke\n* Patients must be intubated and expected to require mechanically ventilation for at least 24 hours.\n\nExclusion Criteria:\n\n* Patients that are not likely to survive or for whom a decision has been made on palliative care.\n* Patients allergic to the Sens monitor patch or showing any type of allergic reactions from the patch after inclusion in the study that needs treatments or results in immediately removal of the patch.",{"count":675,"type":22},198,"The objective of this study is to quantify the amount of physical mobilisation provided to patients with moderate to severe acquired brain injury in Scandinavian neuro-ICs, and the association between intensity and duration of mobilisation, physiological data perceived to be related to the safety of high-level mobilisation, and amount of high-level mobilisation during the neuro-ICU stay.",[678],"Acute Brain Injury",[680,681],"Acute brain injury","Mobilisation",{"date":360,"type":38},{"date":684,"type":38},"2025-08-25",{"date":686,"type":22},"2027-01",{"name":44,"class":45},""]