[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Aarhus University Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":700},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,63,0,25,[9,41,74,102,130,161,183,206,224,271,296,323,344,373,397,422,451,482,509,545,572,601,628,653,675],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100645309","assessment-of-residual-congestion-in-acute-decompensated-heart-failure-100645309",false,"NCT07682298","Assessment of Residual Congestion in Acute Decompensated Heart Failure","VExUS-AHF","Inclusion Criteria:\n\n1. Adults (≥18 years) admitted with ADHF.\n2. Clinical evidence of congestion during admission, indicated by ≥1 of the following: pitting peripheral edema, ascites, elevated jugular venous pressure, or radiologic\u002Fultrasound evidence of pulmonary congestion.\n3. Treatment with ≥40 mg i.v. furosemide or equivalent dose loop diuretic during admission.\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Moribund\n3. Solitary kidney\n4. Inability to provide written consent","ALL","18 Years",{"count":20,"type":21},580,"ESTIMATED","90 Days","OBSERVATIONAL","DESIGN:\n\nA prospective, multicenter, observational cohort study including 580 patients admitted for acute decompensated heart failure (ADHF).\n\nUltrasound assessment of congestion (VExUS and LUS) will be performed serially during admission: within 48 hours of admission, at the time diuretic therapy is switched from intravenous to oral, and on the day of discharge. The discharge assessment will serve as the primary predictor.\n\nTreating physicians will be blinded to all ultrasound findings. Patients will be followed for 90 days by telephone follow-up and chart review for the primary endpoint, with extended chart review at one year for selected secondary endpoints.\n\nAIMS:\n\nTo determine whether combined ultrasound assessment of venous (VExUS) and pulmonary congestion (LUS) at discharge predicts heart failure readmission and all-cause mortality in patients hospitalized with ADHF.\n\nHYPOTHESIS:\n\nAbnormal VExUS and\u002For LUS findings at discharge are associated with a higher risk of heart failure readmission and all-cause mortality after 90 days.\n\nPRIMARY ENDPOINT:\n\nThe primary endpoint is a composite of heart failure readmission and all-cause mortality (time-to-event analysis) after a 90-day period (chart review). Abnormal VExUS will be defined according to criteria from our ongoing validation study. Abnormal LUS is defined as ≥3 B-lines in ≥2 scanning zones per hemithorax (8-zone method) or ≥15 total B-lines overall.\n\nThe primary analysis will evaluate the association between discharge VExUS and LUS findings and the risk of 90-day heart failure readmission and all-cause mortality using Cox proportional hazards regression. Models will be adjusted for age, sex, and comorbidities.\n\nSECONDARY ENDPOINTS:\n\n1. DAOH within 90 days and one year after discharge\n2. All-cause mortality within 90 days and one year after discharge\n3. Rehospitalization for ADHF within 90 days and one year after discharge\n4. Association between discharge VExUS and markers of congestion, including objective markers (jugular venous pressure, peripheral edema, pulmonary rales, and weight change), NT-proBNP, renal function, and echocardiographic measures of cardiac function.\n5. Incremental prognostic value of discharge VExUS and LUS beyond standard clinical assessment of congestion (jugular venous pressure, peripheral edema, pulmonary rales, and weight change) for predicting 90-day and one-year heart-failure readmission and all-cause mortality.\n6. Post-discharge diuretic use, defined as the change in loop diuretic dose (furosemide-equivalent) from discharge to 30- and 90-day follow-up, and occurrence of diuretic intensification (dose increase or addition of thiazide-type diuretic) within 90 days.\n\nSecondary analyses will employ Cox models for time-to-event outcomes (readmission, mortality, diuretic intensification) and linear regression for continuous outcomes (DAOH, change in diuretic dose). The relationship between discharge VExUS\u002FLUS and post-discharge diuretic use will be evaluated both continuously (dose change) and categorically (intensification vs. no intensification). Incremental prognostic value beyond clinical and biochemical markers (e.g., NT-proBNP) will be assessed using nested model comparisons (likelihood ratio tests, AIC, C-index, NRI, IDI).\n\nINCLUSION CRITERIA:\n\n1. Adults (≥18 years) admitted with ADHF.\n2. Clinical evidence of congestion during admission, indicated by ≥1 of the following: pitting peripheral edema, ascites, elevated jugular venous pressure, or radiologic\u002Fultrasound evidence of pulmonary congestion.\n3. Treatment with ≥40 mg i.v. furosemide or equivalent dose loop diuretic during admission.\n\nEXCLUSION CRITERIA:\n\n1. Pregnancy\n2. Moribund\n3. Solitary kidney\n4. Inability to provide written consent",[26,27],"Acute Heart Failure (AHF)","Decompensated Chronic Heart Failure","RECRUITING","2026-06-26",{"date":31,"type":32},"2026-07-02","ACTUAL",{"date":34,"type":32},"2026-02-15",{"date":36,"type":21},"2028-11-01",{"name":38,"class":39},"Aarhus University Hospital","OTHER",3,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100624883","parathyroidectomy-after-kidney-transplantation-100624883","NCT07415421","Parathyroidectomy After Kidney Transplantation","Subtotal Parathyroidectomy for the Treatment of Persistent Hyperparathyroidism After Kidney Transplantation","Para-KiT","Inclusion criteria\n\n* Age \\> 18 years and legally competent and able to understand spoken and written Danish\n* Kidney transplantation ≥6 months prior (no upper limit of time after transplantation)\n* Stable kidney graft function, defined as estimated GFR ≥ 30 ml\u002Fmin\u002F1.73m3\n* On minimum two separate biochemical measurements:\n\nPTH \\> upper normal limit of assay and\n\n* serum ionized calcium ≥1.33 mmol\u002FL or\n* serum total calcium ≥2.60 mmol\u002FL or\n* serum phosphate ≤0.60 mmol\u002FL despite sufficient dietary intake\n\nwith measurements obtained within\n\n* 3 months in patients 6-12 months post-transplant\n* 6 months in patients \\>12 months post-transplant\n\nand not attributable to calcium supplementation or treatment with thiazide diuretics or lithium.\n\nExclusion criteria\n\n* Inability to provide written, informed consent\n* Current anti-resorptive therapy (bisphosphonate, denosumab)\n* Current bone anabolic therapy (teriparatide, romosozumab)\n* Previous surgical parathyroidectomy\n* Not considered fit for surgery (including pregnancy)\n* Ionized calcium ≥1.50 mmol\u002FL or albumin-corrected calcium ≥3.00 mmol\u002FL despite discontinuation of calcium supplements.",{"count":50,"type":21},85,"INTERVENTIONAL",[53],"NA","This study aims to clarify whether surgical treatment of persistent hyperparathyroidism after kidney transplantation offers clinically meaningful benefits compared with a conservative treatment strategy.\n\nKidney transplant recipients (\\>6 mo after transplantation) with persistent hyperparathyroidism (elevated PTH and either hypercalcemia or hypophosphatemia) will be randomized in a 1:1 ratio to either subtotal parathyroidectomy or conservative management according to standard clinical practice. The study is conducted as an open-label, randomized controlled pilot trial with a 12-month follow-up period.\n\nOutcomes include bone density, physical function, quality of life and symptom burden.",[56,57],"Hyperparathyroidism","Kidney Transplantation Recipients",[59,60,61,62,63,64,65],"Persistent hyperparathyroidism","Kidney transplant recipients","Parathyroidectomy","Bone mineral density","Muscle function","Quality of life","Randomized controlled trial","2026-06-25",{"date":29,"type":32},{"date":69,"type":32},"2026-03-03",{"date":71,"type":21},"2030-12-31",{"name":38,"class":39},1,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":51,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":73},"100596344","phase-4-nicardipine-for-fast-achievement-of-systolic-bp-targets-in-ich-100596344","NCT07044232","NICardipine for Fast Achievement of Systolic BP Targets in ICH","NICardipine for Fast Achievement of Systolic BP Targets in ICH - a Quasi-randomized, Implementation Trial With Stepwise Rollout of Nicardipin Based Treatment of Hypertension.","NICFAST","Inclusion Criteria:\n\n* Age ≥18 years\n* Acute spontaneous Intracerberal Hemorrhage confirmed by imaging\n* Symptom onset to stroke center admission \\\u003C6 hours\n* Elevated systolic blood pressure (\\>140 mmHg) at admission\n\nExclusion Criteria:\n\n* Secondary causes of ICH (e.g., trauma, vascular malformation)\n* Presumed fatal bleeding at admission\n* Short remaining life expectancy (\\\u003C12 month)",{"count":83,"type":21},88,[85],"PHASE4","Quality improvement study with a quasi-randomized design. The study monitors the effect of a gradually implemented treatment algorithm prioritizing intravenous antihypertensives (e.g., nicardipine) over long-acting nitrate patches. It aims to increase the proportion of patients reaching target systolic BP \\\u003C140 mmHg within 1 hour of hospital admission while monitoring safety, clinical outcomes, and healthcare resource utilization.",[88],"Intracerebral Haemorrhage",[88,90,91,92,93],"blood pressure treatment","acute blood pressure treatment","nicardipine","glyceryl trinitrate","2026-06-22",{"date":96,"type":32},"2026-06-24",{"date":98,"type":32},"2025-10-01",{"date":100,"type":21},"2027-09-30",{"name":38,"class":39},{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":51,"phases":112,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100639893","phase-1-safety-and-antiviral-activity-of-a-monoclonal-hepatitis-b-antibody-a-phase-1b-open-label-trial-in-individuals-with-chronic-hepatitis-d-infection-100639893","NCT07610772","Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody: a Phase 1b, Open-label Trial in Individuals With Chronic Hepatitis D Infection","Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody: a Phase 1b, Open-label Trial in Individuals With Chronic Hepatitis D Infection (the SAMBA-D Study)","Inclusion Criteria:\n\n* HDV infection confirmed by positive anti-HDV antibody and detectable HDV RNA\n* HBs antibody negative during screening period\n* Both HBeAg positive and negative participants are included\n* Ability and willingness to provide informed consent\n* Participants who can become pregnant must agree to use two methods of contraception:\n* Participants who can impregnate a partner and who are engaging in sexual activity that could lead to pregnancy must agree to use condoms 10 days prior to study entry and during study follow up to avoid impregnating a partner who can get pregnant.\n\nExclusion Criteria:\n\n* Child-Turcotte-Pugh \\>9 points\n* Severe clinical hepatic decompensation-such as hepatic encephalopathy or variceal hemorrhage-occurring currently or within the past 12 months.\n* Any confirmed significant allergic reactions (urticaria or anaphylaxis) against monoclonal antibody or vaccine, or multiple drug allergies (non-active hay fever is acceptable)\n* Pregnancy or lactation\n* Any vaccination 2 weeks prior to entry\n* Prior receipt of HepB mAb19 therapy\n* Any significant acute infection (e.g. influenza, COVID-19) or any other clinically significant illness 2 weeks prior to entry\n* Active hepatitis C infection\n* Untreated HIV disease\n* Individuals with HIV receiving antiretroviral therapy who have had a measurement of plasma HIV RNA (viral load) \\>50 copies\u002FmL within the past 6 months are excluded. However, a single viral load measurement between \\>50 and \\\u003C500 copies\u002FmL during this period is acceptable.\n* Participation in another clinical study of an investigational product currently or 12 weeks prior to entry, or expected participation during this study\n\nLaboratory abnormalities in the parameters listed below:\n\n* Alpha fetoprotein \\>100 ng\u002FmL\n* Hemoglobin \\\u003C10 gm\u002FdL (6.21 mmol\u002FL)\n* Platelet count \\\u003C25,000 \u002Fmm3\n* Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\n* ALT ≥ x10 upper limit of normal (ULN)\n\nCurrent, or history of:\n\n* Clinical cardiovascular disease (e.g., cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure.\n* Presence of clinically significant ECG abnormalities based on the average of the triplicate ECG recordings (e.g., PR interval \\>210 ms (1st degree AV block only if clinical symptoms are present), QT corrected for heart rate using the Fridericia's correction factor \\[QTcF\\] \\> 450 ms for males and QTcF \\>470 ms for females);\n* Chronic liver disease from another cause, ICD, or autoimmune diseases that in the opinion of the investigator would preclude participation\n* History of hematopoietic stem cell transplant or solid organ transplant","70 Years",{"count":111,"type":21},15,[113],"PHASE1","Hepatitis D virus (HDV) is a major global health issue, with an estimated 12 million people living with the infection worldwide. HDV infection requires the presence of hepatitis B virus (HBV), as it relies on hepatitis B virus for replication within the liver cells. Treatment options for HDV are limited and cannot cure the infection. The combination of concurrent HBV and HDV increases the risk of developing severe liver disease, including cirrhosis and liver cancer. This risk would significantly decrease if HDV is eliminated or reduced. Consequently, there is a need for the development of new treatment options.\n\nColleagues at Rockefeller University in New York have identified the antibody HepB mAb19, which effectively reduces the amount of circulating HBV antigens. Since HDV depends on HBV to replicate, we will test this antibody as a potential treatment for HDV.\n\nThe trial design is a phase 1b open-label aiming at including 15 study participants with chronic hepatitis D infection. All study participants will receive two or three dosis of the antibody, HepB mAB19, and will be followed for 60 weeks after the first HepB mAb19 infusion.\n\nThis study will evaluate the safety and pharmacokinetics of this antibody, as well as its potential effects on viral levels of HDV RNA and antiviral immune responses in individuals living with chronic HDV infection.",[116,117],"Hepatitis D, Chronic","Hepatitis B Chronic Infection",[119,120],"SAMBA-D","2025-522125-36-00 (EU CT no.)","2026-05-27",{"date":123,"type":32},"2026-05-28",{"date":125,"type":32},"2026-04-23",{"date":127,"type":21},"2028-04-01",{"name":38,"class":39},2,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":51,"phases":140,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":160,"locationsCount":73},"100614782","early-phase-1-senicapoc-and-perampanel-for-newly-diagnosed-glioblastoma-100614782","NCT07284069","Senicapoc and Perampanel for Newly Diagnosed Glioblastoma","Phase 0\u002F1 Randomized Clinical Trial of SENIcapoc and PERAmpanel Mono- and Combination Therapy of Newly Diagnosed Glioblastoma","SENIPERA","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Presumed GBM as determined by an expert multidisciplinary neuro-oncological tumor board, including participants from neurosurgery, neuro-oncology, neurology, and neuroradiology. The assessment should be based on a whole-brain MRI according to the consensus recommendations for a standardized brain tumor imaging protocol in clinical trials, not older than 4 weeks from the assessment\n3. Eligibility for surgical resection and planned postoperative concomitant radiochemotherapy and adjuvant chemotherapy according to the Stupp regimen\n4. Eligible for safe postponement of surgery for 14 days from enrollment\n5. Life expectancy \\> 3 months\n6. WHO Performance Status ≤ 2.\n7. Ability to provide written informed consent.\n8. Use of validated anti-conception for fertile female participants in concordance with guidelines provided by the Danish health and medicines authority.\n9. Signed written consent form.\n\nExclusion Criteria:\n\n1. Pregnancy or nursing. Fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy.\n2. Previous treatment with or allergic reaction to perampanel or senicapoc.\n3. Contraindications for senicapoc or perampanel treatment.\n4. Previous malignancy with completion of treatment within five years before inclusion, except for basal cell carcinoma.\n5. Concomitant intake of enzyme-inducing antiepileptic drugs (carbamazepine, phenytoin, phenobarbotal, or primidon).\n6. Significant co-morbidities, i.e.\n\n   1. Significant liver function impairment (ALAT \\> 210 umol\u002FL for men and \\> 135 umol\u002FL for women or total bilirubin \\> 25 umol\u002FL)\n   2. Significant renal impairment (eGFR \\\u003C 60 mL)\n   3. Coagulopathy (INR \\> 1.8 or APTT \\> 57s)\n   4. Thrombocytopenia (platelet count \\\u003C 100 x 103\u002FμL = 100 x 109\u002FL)\n   5. Neutropenia (ANC \\\u003C 1.5 x 103\u002FμL = 1.5 x 109\u002FL)\n   6. Anemia (Hb \\\u003C 10 g\u002FL = 6.0 mmol\u002Fl)\n   7. Severe cognitive impairment.\n7. Active participation in another therapeutic interventional clinical trial.\n8. Any condition that might affect the absorption, distribution, metabolism, or excretion of the trial drugs (including malabsorption states as Whipple's disease, short bowel syndrome, etc.).",{"count":139,"type":21},36,[141],"EARLY_PHASE1","Glioblastoma is the most common and aggressive form of brain cancer in adults. Despite surgery, radiotherapy, and chemotherapy, most patients only live about one year after diagnosis. There is an urgent need for new and better treatments.\n\nRecent research has shown that glioblastoma cancer cells communicate with surrounding brain cells through electrical signals that help the tumor grow and resist treatment. Two existing drugs, perampanel (used for epilepsy) and senicapoc (previously tested for blood disorders), may block these harmful signals. Laboratory studies suggest that combining these two drugs could slow tumor growth and make cancer cells more sensitive to standard therapy.\n\nThe SENIPERA trial will test whether perampanel and senicapoc, alone and in combination, are safe and well tolerated when added to standard treatment for newly diagnosed glioblastoma. The study will also measure how well these drugs reach the brain and tumor, and how they affect tumor biology.\n\nThe study has two parts:\n\nPart A: Tests different doses of senicapoc alone to find the maximum tolerable dose.\n\nPart B: Randomly assigns patients to receive either perampanel alone or perampanel together with senicapoc.\n\nParticipants will all receive standard therapy, including surgery, radiochemotherapy, and adjuvant chemotherapy. During surgery, small samples of tumor and fluid will be collected safely to study how the drugs act in the body and how tumor cells respond. Participants will be closely monitored for side effects and followed with regular clinical visits and MRI scans.\n\nThe trial will take place at Aarhus University Hospital, Denmark, from February 2026 to November 2028 and will enroll 27-36 adult patients. The study aims to identify safe and biologically active treatment combinations that could be tested in larger trials to improve future glioblastoma care.",[144],"Glioblastoma",[146,147,148,149,150,151,152,153],"glioblastoma","senicapoc","perampanel","early-phase","cancer neuroscience","neuro-oncology","window-of-opportunity trial","pacemaker cells","2026-05-06",{"date":156,"type":32},"2026-05-07",{"date":158,"type":32},"2026-03-01",{"date":36,"type":21},{"name":38,"class":39},{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":73},"100635851","cognitive-impairment-in-patients-undergoing-cell--and-antibody-based-immunotherapies-for-haematological-malignancies-the-cognitox-study-100635851","NCT07558057","Cognitive Impairment in Patients Undergoing Cell- and Antibody-based Immunotherapies for Haematological Malignancies: The COGNITOX Study","COGNITOX","Inclusion Criteria:\n\n* Patients must be ≥ 18 years old\n* Able to speak and read Danish\n* Provide informed consent\n\nExclusion Criteria:\n\n* CNS-involvement by the haematological malignancy\n* Cognitive impairment due to pre-existing psychiatric or neurological conditions",{"count":169,"type":21},225,"Cell- and antibody-based therapies, including chimeric antigen receptor T-cell (CAR-T) therapy and bispecific antibodies, represent significant advances in the treatment of hematologic malignancies. These therapies optimise the patient's immune system to target and eliminate malignant cells, achieving profound and durable responses in patients where conventional treatment approaches have failed. However, their mechanism of action-through profound immune activation-introduces a challenging toxicity profile, including cytokine release syndrome and immune effector cell-induced neurotoxicity. Emerging evidence suggests that neurotoxicity associated with these therapies may extend beyond acute symptoms to include persistent cognitive impairments. Such impairments can manifest deficits in memory, attention, executive functioning, and processing speed, potentially compromising patients' quality of life, ability to manage daily activities and return to work.\n\nThe COGNITOX project explores the occurrence, clinical manifestations, and impact on quality of life of neuro-psychologically assessed and patient-reported cognitive impairment. The project's data set is generated through standardized neuropsychological tests (recommended by the International Cognition and Cancer) and validated patient reported outcome measures, to evaluate multiple cognitive domains. The project is developed in close collaboration between the Department of Haematology, Aarhus University Hospital and the Unit for Psychooncology and Health Psychology (EPoS), Department of Psychology and Behavioural Sciences, Aarhus University.\n\nThe current literature on cognitive impairment secondary to cell- and antibody-based therapies is limited, and none of the studies reported so far were conducted within a Danish healthcare context. Understanding the prevalence, severity, and functional impact of cognitive impairments in this patient population is critical. These insights will inform clinical practice, guide patient counseling, and support the development of targeted interventions aimed at mitigating cognitive decline. By generating robust data, this project seeks to improve the knowledge within the field and lay the foundation for an intervention study addressing the needs of patients undergoing these advanced immunotherapies.",[172,173],"Malignant Lymphoma - Lymphoplasmacytic","Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma","NOT_YET_RECRUITING","2026-04-22",{"date":177,"type":32},"2026-04-30",{"date":179,"type":21},"2026-03-31",{"date":181,"type":21},"2034-03-31",{"name":38,"class":39},{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":17,"minAge":190,"maxAge":191,"enrollmentInfo":192,"targetDuration":194,"studyType":23,"phases":4,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":73},"100631336","establishment-of-a-phamacokinetik-model-for-erwinase-pharmacokinetiks-the-aim-of-this-sub-study-is-to-optimize-target-trough-attainment-while-minimizing-high-exposures-that-impose-increased-risk-of-side-effects-such-as-hyperammonemia-100631336","NCT07499349","Establishment of a Phamacokinetik Model for Erwinase Pharmacokinetiks: The Aim of This Sub Study is to Optimize Target Trough Attainment While Minimizing High Exposures That Impose Increased Risk of Side Effects Such as Hyperammonemia","Establishment of a Phamacokinetik Model for Erwinase Pharmacokinetiks","Inclusion Criteria:\n\n* ALL treated with Erwinase\n\nExclusion Criteria:\n\n* not treated with Erwinase","1 Month","45 Years",{"count":193,"type":21},475,"1 Day","The aim of this study is to optimize target trough attainment while minimizing high exposures that impose increased risk of side effects such as hyperammonemia.\n\nClinical pharmacology is based on the principle that plasma drug concentrations are linked to therapeutic effects. Therefore, understanding plasma drug concentrations is critical to balancing efficacy and toxicity in oncology treatment, as shown with Erwinase where elevated activity increases the risk of hyperammonemia. TDM can guide dose adjustments to reduce PK variability and improve outcomes. However, harnessing all information from TDM data can be challenging due to sparse and uneven sampling, and multiple sources of PK variability. Advanced analytical tools, such as pharmacometrics and population PK modelling, can address these complexities by quantifying exposure variability in patients and linking it to dosage, patient characteristics, and biomarkers.\n\nMethods:\n\nThis is a NOPHO study. Within the NOPHO, Erwinase was administered intramuscularly (IM) at a dose of 20,000 IU\u002Fm² on a Mon-Wed-Fri schedule for two weeks. All non-high-risk (non-HR) patients received the same dose. HR-patients received additional Erwinase, with three doses at 2-day intervals in each treatment block. Activity levels are available from \\~150 patients; among these, 20 patients received more than six doses (range: 7-42).\n\nIn the A2G-1, Erwinase was administered intravenously (IV) at 20,000 IU\u002Fm², substituting one PEG-asparaginase dose with seven Erwinase doses every other day. The number of doses received varied depending on the timing of hypersensitivity reactions. Activity levels are already available from \\>90 patients. Measurement of Erwinase enzyme activity levels is performed at the Asparaginase Lab in Aarhus. All samples have been analysed. The data will undergo further cleaning, validation, followed by integration with patient characteristics in a population PK model.\n\nData Management and Security in Uppsala:\n\nAll PK data will be pseudo-anonymized before being securely transferred to Uppsala University through the Allvis data portal. Data handling and formatting will be scripted in R to ensure transparency and reproducibility. Modelling will be performed on the UPPMAX computing cluster via the Swedish National Academic Infrastructure for Supercomputing.\n\nWorkflow, statistics and perspectives:\n\nThe modelling workflow will be performed as follows:\n\n1. A PK model for Erwinase will be established based on asparaginase enzyme activity TDM data obtained from Nordic\u002FBaltic ALL patients treated under the NOPHO and A2G-1. Drug clearance, volume of distribution, absorption, and bioavailability will be derived to describe the PK of both routes of Erwinase administration (IV vs IM). Nonlinear mixed-effects modelling will be applied to obtain both typical population PK parameters as well as patient variability parameters. Potential changes in parameters within patients over time will also be explored.\n\n   Model development and evaluation will be conducted using NONMEM17. Model selection will be based on statistical fit and biological plausibility. Goodness of fit plots and visual predictive checks will ensure the PK model adequately describes the observed data.\n2. The Erwinase PK model will be applied to explore alternative dosing strategies, as simultaneously achieving aimed target attainment (≥100 IU\u002FL).",[197],"Acute Lymphoblastic Leukemia","2026-04-13",{"date":200,"type":32},"2026-04-15",{"date":202,"type":32},"2008-07-01",{"date":204,"type":21},"2028-01-30",{"name":38,"class":39},{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":191,"enrollmentInfo":212,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":214,"conditions":215,"keywords":217,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":221,"leadSponsor":223,"locationsCount":4},"100631335","understanding-the-t-cell-and-b-cell-receptor-repertoire-in-children-and-young-adults-with-anti-drug-antibodies-against-peg-asparaginase-100631335","NCT07499336","UNDERSTANDING THE T-CELL AND B-CELL RECEPTOR REPERTOIRE IN CHILDREN AND YOUNG ADULTS WITH ANTI-DRUG ANTIBODIES AGAINST PEG ASPARAGINASE","Inclusion Criteria:\n\n* ALL treated with Asparaginase, either with or without hypersensitivity reaction\n\nExclusion Criteria:\n\n\\-",{"count":213,"type":21},45,"The aim of this sub study is to identify biomarkers in children and young adults with Acute Lymphoblastic Leukemia with hypersensitivity to PEG-asparaginase.\n\nEvidence strongly implicates humoral immunity in Asparaginase immunogenicity with neutralizing antibodies18. Asparaginase is a bacterial enzyme not naturally present in the human body, and therefore highly immunogenic. Upon administration, antigen-presenting cells internalize and present fragments of the enzyme to naïve T cells, driving their differentiation into T-helper cells signaling differentiation of B-cells. A subset of activated B-cells matures into long-lived plasma cells that home to the bone marrow, where they continuously secrete anti-asparaginase antibodies. Others differentiate into Memory-B-cells that enable rapid antibody responses. This immunological memory means that once sensitization occurs, re-exposure to asparaginase triggers strong hypersensitivity reactions that make further treatment unsafe. Yet, despite the clinical importance, only one study exists on TCR repertoire in response to anti-asparaginase antibodies, but no studies to date have directly profiled the B-cell receptor (BCR) repertoire in children with anti-asparaginase antibodies. The BCR sequencing has recently been developed. By integrating BCR-seq from blood and BM with serum proteomics (Ig-Seq), we can directly link specific plasma cell clones to circulating anti-asparaginase antibodies. This approach will provide mechanistic insight into drug immunogenicity and enable the identification of molecular biomarkers of hypersensitivity risk in children and young adults with ALL.\n\nMethods:\n\nThe investigators will perform a longitudinal Danish cohort study in pediatric and young adult ALL patients receiving PEG-asparaginase as part of induction and post-consolidation therapy treated on the A2G-1. The investigators will include 20 patients with hypersensitivity and 20 without. Biological samples will be collected at baseline, during early post-exposure with PEG-asparaginase, at clinical hypersensitivity, and at follow-up timepoints according to the A2G-1. The investigators will pair these samples with EDTA-plasma samples from the same timepoints. The investigators will perform enrichment of plasma cells together with bulk TCR and BCR repertoire and clonotype sequencing. From plasma the investigators will perform serum proteomics to identify peptide fragments of circulating anti-asparaginase antibodies. Ig-Seq peptides will be aligned with BCR sequences from PBMC and BM to map specific antibodies to their clonal plasma cell origin. This approach yields a direct functional link between repertoire data and pathogenic antibodies.\n\nThe investigators will compare bone marrow repertoires with blood samples to determine whether circulating clones reflect the dominant marrow-resident plasma cells. If anti-asparaginase antibodies-specific BCRs can be reliably detected in blood, this may serve as a non-invasive biomarker, reducing the need for bone marrow sampling.",[216],"Acute Lymphoblastic Leukaemia - Category",[17],"2026-04-07",{"date":198,"type":32},{"date":218,"type":21},{"date":222,"type":21},"2030-01-31",{"name":38,"class":39},{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":231,"targetDuration":233,"studyType":23,"phases":4,"briefSummary":234,"conditions":235,"keywords":250,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":73},"100627888","trace-btc-relation-of-biomarkers-and-patients-reported-quality-of-life-to-outcomes-in-patients-with-biliary-tract-cancer-a-real--world-cohort-100627888","NCT07454486","TRACE-BTC. Relation of Biomarkers and Patients Reported Quality of Life to Outcomes in Patients With Biliary Tract Cancer: a Real- World Cohort","TRACE-BTC","Inclusion Criteria:\n\n* Histopathologically verified biliary tract cancer (BTC) and\u002For Multidisciplinary Team (MDT) conference decision to define the patient as suffering from BTC.\n* Eligible for curative, adjuvant, or palliative oncological treatment.\n* Age ≥ 18 years.\n* Written and oral consent.\n\nExclusion Criteria:\n\n* Other malignant diseases within 5 years of BTC diagnosis, excluding early-stage non-melanoma skin cancer and carcinoma in situ of the cervix.\n* Conditions that prohibit blood sampling.\n* Known or suspected non-compliance.",{"count":232,"type":21},300,"5 Years","Purpose of the Study:\n\nBile duct cancers are rare and aggressive. About 250 new cases are diagnosed each year in Denmark. These cancers are difficult to detect early, so only about 20% of patients can have surgery when diagnosed. Even after surgery, the cancer often returns, and chemotherapy only slightly reduces the risk of relapse.\n\nFor patients who cannot have surgery, treatments such as chemotherapy (sometimes combined with immunotherapy) can relieve symptoms and extend life, but their effect is limited. A small number of patients have specific genetic changes in their cancer that can be treated with targeted medicines.\n\nCurrently, doctors cannot predict which patients will benefit from treatment. Standard monitoring methods like CT scans are expensive, inconvenient, and sometimes unreliable because bile ducts are hard to see clearly on scans.\n\nBlood tests that detect cancer DNA in the blood (called circulating tumor DNA or ctDNA) and other biological markers may be a better way to monitor the disease and adjust treatment. These tests could help detect cancer recurrence earlier and determine whether treatment is working. Measuring patients' quality of life and symptoms over time may also help predict treatment benefit and evaluate effectiveness.\n\nThe goal of this study is to:\n\n* Investigate how biomarkers, including ctDNA, can predict disease course, detect relapse, and monitor treatment response.\n* Identify the best way to measure ctDNA in patients with bile duct cancer.\n* Examine whether patients' own reports of quality of life and symptoms can help assess treatment effect and prognosis.\n\nStudy Design and Procedures:\n\nThis is a prospective cohort study focusing on blood biomarkers and patient-reported symptoms and quality of life.\n\nParticipants agree to provide blood samples:\n\n* Before treatment\n* During treatment\n* During follow-up\n\nEach sample involves up to 40 ml of blood, with a maximum of 20 samples per patient.\n\nThe blood will be analyzed for:\n\n* ctDNA and genetic changes\n* Cancer-related markers\n* Inflammation markers\n* Immune system markers\n\nTumor tissue samples will also be examined to compare blood and tissue results. Full genome or exome sequencing will not be performed. Samples will be stored in a research biobank.\n\nFor patients with incurable disease, quality of life and symptom burden will be monitored repeatedly using Danish questionnaires.\n\nParticipants:\n\nThe study will include:\n\n* Up to 100 patients with potentially curable disease\n* Up to 200 patients with incurable disease\n\nTo participate, patients must:\n\n* Have confirmed bile duct cancer\n* Be eligible for curative, additional (adjuvant), or palliative treatment\n* Be over 18 years old\n* Provide written and verbal consent\n\nPatients cannot participate if they:\n\n* Had another cancer within the past 5 years (except early skin cancer or very early cervical cancer)\n* Cannot safely provide blood samples\n* Are unable to cooperate with study procedures\n\nRisks and Inconveniences:\n\nParticipants will have extra blood samples taken, usually during regular hospital visits. Possible side effects include mild soreness or small bruises at the needle site. The extra blood amount (40 ml per sample) is considered medically insignificant.\n\nParticipants will also spend time filling out questionnaires. The number and frequency of questions have been kept as low as possible while still providing meaningful data.\n\nFinancial Information:\n\nExtra costs for blood sampling, laboratory analysis, and data collection will be covered by external research funding managed by Aarhus University Hospital.\n\nThe researchers have no financial interest in the project. Patients will not receive financial compensation for participating.\n\nRecruitment and Consent:\n\nPotential participants are identified during routine clinical care. During a planned meeting with a doctor, patients receive written and verbal information about the study, including its purpose, risks, advantages, and disadvantages.\n\nThe conversation takes place in a calm and private setting. Patients may bring a support person. They have time to ask questions and at least 24 hours to consider participation.\n\nPatients can withdraw their consent at any time without affecting their treatment. Consent must be given before any study-related procedures begin.\n\nPublication of Results:\n\nThe results - whether positive or negative - will be presented at national and international conferences and submitted to peer-reviewed scientific journals.\n\nEthical Considerations:\n\nAll participants receive standard medical treatment. The risks and disadvantages are limited, and participants are unlikely to benefit directly from the study. However, the research may improve how biomarkers and patient-reported outcomes are used to predict prognosis and treatment response, potentially leading to better treatment for future patients with bile duct cancer.",[236,237,238,239,240,241,242,243,244,245,246,247,248,249],"Biliary Tract Cancer (BTC)","Biliary Tract Cancer (CCA)","Gall Bladder Cancer","Biliary Tract Cancers (BTC)","Cholangiocarcinoma","Cholangiocarcinoma Non-resectable","Cholangiocarcinoma Resectable","Cholangiocarcinoma Metastatic","Cholangiocarcinoma of the Bile Duct","Cholangiocarcinoma, Extrahepatic","Cholangiocarcinoma, Hilar","Cholangiocarcinoma, Intrahepatic","Cholangiocarcinoma, Perihilar","Cholangiocarcinoma; Liver",[251,240,252,253,254,255,256,257,258,259,260,261,262],"Biliary Tract Neoplasms","Intrahepatic Cholangiocarcinoma","Extrahepatic Cholangiocarcinoma","Gallbladder Neoplasms","Circulating Tumor DNA","Liquid Biopsy","Minimal Residual Disease","Biomarkers, Tumor","Observational Study","Biobanking","DNA Methylation","Precision Oncology","2026-03-02",{"date":265,"type":32},"2026-03-06",{"date":267,"type":21},"2026-03-15",{"date":269,"type":21},"2031-12-30",{"name":38,"class":39},{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":17,"minAge":278,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":51,"phases":281,"briefSummary":282,"conditions":283,"keywords":285,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":73},"100491471","comprehensive-geriatric-assessment-for-perioperative-optimization-in-cystectomy-100491471","NCT05679557","Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy","COMPETENCE","Inclusion Criteria:\n\n1. Patients with muscle-invasive bladder cancer and scheduled radical cystectomy.\n2. Planned urinary diversion with an ileal conduit\n3. Age ≥ 65 years.\n4. Patients considered frail by G8 screening tool (total score ≤14).\n\nExclusion Criteria:\n\n1. Patients who refuse or are not able to provide informed consent.\n2. Patients who do not speak or understand Danish.\n3. Planned concomitant nephroureterectomy or other major surgical intervention at the same time as RC","65 Years",{"count":280,"type":21},140,[53],"Patients with muscle-invasive bladder cancer are often older and multimorbid, thus in an increased risk of perioperative mortality and morbidity in relation to radical cystectomy (RC). The aim of the study is to investigate the effect of perioperative Comprehensive Geriatric Assessment (CGA) and tailored intervention in older, frail patients with bladder cancer undergoing RC.",[284],"Bladder Cancer",[286,287],"Frailty","Comprehensive Geriatric Assessment","2026-02-26",{"date":290,"type":32},"2026-02-27",{"date":292,"type":32},"2023-02-01",{"date":294,"type":21},"2027-04-01",{"name":38,"class":39},{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":51,"phases":306,"briefSummary":307,"conditions":308,"keywords":310,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":322},"100626220","sublobar-wedge-resection-or-stereotactic-radiotherapy-treatment-of-high-risk-patients-with-early-stage-lung-cancer-100626220","NCT07432802","Sublobar Wedge Resection or Stereotactic Radiotherapy Treatment of High-risk Patients With Early-stage Lung Cancer","Sublobar Wedge Resection or Stereotactic Radiotherapy Treatment of High-risk Patients With Early-stage Lung Cancer - a Randomized, Controlled Trial The STRADOS Trial","STRADOS","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Biopsy-proven NSCLC\n* Diagnostic codes: DC34, DC 34.1, DC 34.2, DC 34.3 or DC 34.9\n* Clinical stage I NSCLC according to the 9th edition of TNM\n* Performed diagnostic PET-CT and supplementary invasive procedures for staging purposes in accordance with the Danish national reference program for the staging and treatment of lung cancer (30)\n* 9th edition TNM staging: cT1aN0M0, cT1b-cN0M0, cT1cN0M0 and cT2aN0M0 (clinical stage I)\n* Tumor is localized in the outer third of the lung and considered technically resectable by SWR, as well as treatable with peripheral SBRT when assessed during MDT conference\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0-2.\n* Preoperative pulmonary function test according to national guidelines performed within 6 weeks before the MDT conference\n* Patient fulfills the \"high-risk patient\" criteria outlined:\n\nA high-risk patient is a patient that fulfills at minimum one of the main-risk criteria and\u002For two of the secondary criteria:\n\nMain criteria:\n\n* FEV-1 ≤ 50% and\u002For\n* DLCO ≤ 50%\n\nSecondary criteria:\n\n* Age ≥ 80\n* FEV-1 = 51-60% and\u002For DLCO = 51-60%\n* Known pulmonary hypertension with PAP ≥40 mm Hg diagnosed \\\u003C 6 months before inclusion\n* Known LVEF ≤ 40% diagnosed \\\u003C 6 months before inclusion\n\nExclusion Criteria:\n\n* Declared terminally ill or life expectancy shorter than one year.\n* Multifocal disease\n* PS ≥ 3\n* Centrally located tumors not eligible to SBRT\n* Previous ipsilateral lung surgery\n* Pregnancy or breastfeeding.\n* Inability to understand oral and written informed consent\n* Intravenous substance abuse or severe alcohol abuse (\\> 25 units per week)\n* Not amendable for surgery in general anesthetic\n* Previous radiotherapy to the thorax, which may limit the feasibility or increase the risk of stereotactic reirradiation due to cumulative dose constraints and potential toxicity\n* Diagnosed with Interstitial lung disease (ILD)",{"count":305,"type":21},182,[53],"In low-risk patients with stage I non-small cell lung cancer (NSCLC) surgical treatment with an anatomical resection is currently the standard of care.\n\nFor medically inoperable patients with stage I NSCLC, radiation therapy is currently the standard treatment. The latest generation of radiation therapy modalities is Stereotactic Body Radiation Therapy (SBRT).\n\nIn high-risk patients, minimal invasive surgery in terms of sublobar resection (wedge resection) with lymph node sampling is currently the recommended treatment approach for these patients, even though the evidence is limited. Additionally, SBRT is an alternative treatment option but the use in these patients is also based on weak evidence. So, it is highly warranted to compare these two treatment options in this group of patients in a randomized, controlled trial where selection bias can be eliminated. It is the specific aim of this study to provide such a trial allowing an evidence-based approach when deciding between surgery and SBRT as treatment for NSCLC in high-risk patients.\n\nThe STRADOS study (STereotactic RADiotherapy Or Surgery) is an open randomized, controlled national multicenter study in which high-risk patients with stage I non-small-cell lung cancer (NSCLC) are randomized to receive either surgical treatment with minimal invasive wedge resection with lymph node sampling, or SBRT.\n\nThe overall purpose of the study is to investigate the disease-free survival (DFS) after surgical treatment when compared to SBRT. The primary endpoint is DFS after 3 years. Secondary endpoint is quality of life after 1, 3, 6, 12 and 36 months. Tertiary endpoints are overall survival (OS) after 3 and 5 years; DFS after 5 years; re-admission adverse events and complications after 1, 3, 6, 12 and 36 months; health-care related costs within 12 and 36 months; PRO data - other than quality of life (QoL) (health condition, symptoms and functional level) after 1, 3, 6, 12 and 36 months and lung function test after 12 month.",[309],"Lung Cancer (NSCLC)",[311,312,313,314],"lung cancer","surgery","Stereotactic radiotherapy treatment","randomized","2026-02-25",{"date":290,"type":32},{"date":318,"type":21},"2026-09-01",{"date":320,"type":21},"2031-08-30",{"name":38,"class":39},4,{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":332,"conditions":333,"keywords":335,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":341,"leadSponsor":343,"locationsCount":73},"100625716","clinical-utility-of-ctdna-in-the-treatment-of-oligometastatic-disease-100625716","NCT07426250","Clinical Utility of ctDNA in the Treatment of Oligometastatic Disease","Clinical Utility of ctDNA in the Treatment of Oligometastatic Disease - A Prospective Observational Clinical Study - A Part of the POB-project","Inclusion Criteria:\n\n* Metastatic spread from histopathological diagnosed solid cancer\n* Planned for LAT (local ablative therapy) for OMD (oligometastatic disease)\n* ≥ 18 years\n* Written and oral consent\n\nExclusion Criteria:\n\n* Other cancer disease within 5 years\n* Conditions that will contraindicate blood samples",{"count":331,"type":21},500,"This prospective observational study investigates the clinical utility of circulating tumor DNA (ctDNA) in patients with oligometastatic disease (OMD) undergoing definitive-intent local ablative treatment (LAT). The study aims to evaluate ctDNA as a prognostic and response biomarker before, during, and after LAT across cancer types and treatment modalities. Serial plasma samples and archival tumor tissue will be analyzed to assess ctDNA detection rates, elimination patterns, minimal residual disease, and association with recurrence, progression, and survival outcomes.",[334],"Oligometastatic Cancer",[336],"Local Ablative Treatment of Oligometastatic Disease","2026-02-16",{"date":339,"type":32},"2026-02-23",{"date":158,"type":21},{"date":342,"type":21},"2030-09-01",{"name":38,"class":39},{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":352,"sex":353,"minAge":354,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":51,"phases":357,"briefSummary":358,"conditions":359,"keywords":4,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":73},"100625202","burden-of-tuberculosis-among-pregnant-and-postpartum-women-in-guinea-bissau-100625202","NCT07419568","Burden of Tuberculosis Among Pregnant and Postpartum Women in Guinea-Bissau","Assessing the Burden of Tuberculosis Among Pregnant and Postpartum Women: Implications for Integrating Tuberculosis Screening Into Routine Antenatal Care in Guinea-Bissau","TIPP","Inclusion Criteria:\n\n* Pregnant women ≥ 15 years of age\n* Residing in the study\n* Attending ANC consultations at health centre in Bandim, Belem or Cuntum\n* Must provide informed consent\n\nExclusion Criteria:\n\n* Pregnant women ≤ 15 years of age\n* Inability to provide informed consent\n* Residing outside of the study area\n* Receives TB treatment at the time of, or a year prior to, enrolment",true,"FEMALE","15 Years",{"count":356,"type":21},720,[53],"This study aims to address critical diagnostic and data gaps in tuberculosis (TB) care among pregnant and postpartum women in Guinea-Bissau, a high-burden, resource-limited setting. Recognising that current TB screening during antenatal care (ANC) relies largely on unstructured symptom questions, the study will integrate more systematic and innovative approaches into routine maternal health services.\n\nThe project will implement the Bandim TBscore II as a structured triage tool to classify symptom severity and guide referrals. To strengthen diagnostic capacity, two novel tools will be evaluated: stool-based GeneXpert testing (a method recommended in children and explored here as a feasible alternative for pregnant women) and artificial intelligence-powered chest X-ray interpretation software designed to enhance TB detection where radiological expertise is lacking.\n\nThe study will also generate comprehensive, population-based data on TB and TB infection (TBI) among pregnant, postpartum women and women of reproductive age in Guinea-Bissau. The results are intended to inform health policy, both locally and in high-income countries, by providing evidence to improve TB screening protocols and care for this vulnerable group. Ultimately, the study seeks to develop scalable strategies that can be replicated across low- and middle-income countries to advance maternal and child health and support global TB eradication efforts.",[360,361,362,363,364],"Tuberculosis (TB)","Tuberculosis Infection, Latent","Pregnancy","Tuberculosis Diagnosis","Maternal Health","2026-02-14",{"date":367,"type":32},"2026-02-19",{"date":369,"type":21},"2026-02",{"date":371,"type":21},"2027-11",{"name":38,"class":39},{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":382,"conditions":383,"keywords":386,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":394,"leadSponsor":396,"locationsCount":129},"100622983","artificial-intelligence-assisted-magnetic-resonance-imaging-diagnostic-strategy-in-a-tertiary-stroke-center-100622983","NCT07390708","Artificial Intelligence-Assisted Magnetic Resonance Imaging Diagnostic Strategy in a Tertiary Stroke Center","An Artificial Intelligence-Assisted Magnetic Resonance Imaging Diagnostic Strategy in a Tertiary Stroke Center-a Diagnostic Accuracy Study","AID-STROKE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Stroke team activation\n* Thrombolysis candidate\n* Known symptom onset\n* MRI candidate\n\nExclusion Criteria:\n\n* Prior inclusion\n* Previous MRI in the same course of hospitalization\n* No resident radiologist on call\n\nParticipation in the neurologists' sub-study is limited to participants enrolled at one of the two participating sites at Gødstrup Regional Hospital.",{"count":331,"type":21},"Quality improvement study with prospective observational design. The study monitors the diagnostic accuracy of an AI-assisted resident radiologist-termed the AI-ResRad diagnostic strategy-compared to an on-call specialist neuroradiologist-termed the SpecNeuroRad strategy-in interpreting stroke MRIs in patients with known onset.\n\nThe study includes a pre-planned sub-study evaluating the diagnostic accuracy of neurologists and AI-assisted neurologists.",[384,385],"Stroke","Stroke Assessment",[387,388,389],"stroke","MRI","Artificial Intelligence","2026-02-05",{"date":392,"type":32},"2026-02-09",{"date":337,"type":21},{"date":395,"type":21},"2027-07-01",{"name":38,"class":39},{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":403,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":407,"conditions":408,"keywords":410,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":73},"100400261","selective-internal-radiation-therapy-with-90y-resin-micropheres-for-refractory-colorectal-cancer-liver-metastases-100400261","NCT04491929","Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases","Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases - SIRT - A Translational Feasibility Study","SIRT","Inclusion Criteria:\n\n* Diagnosis of metastatic colorectal adenocarcinoma with liver dominant disease\n* Diagnosis of liver metastasis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.\n* The Liver metastasis are not eligible for resection, RFA or SBRT\n* All patients must be off all chemotherapeutic regimens for 14 days prior to SIRT treatment\n* All patients must be off vascular endothelial growth factor inhibitors for 6 weeks prior to SIRT treatment\n* Progressive disease, severe intolerance during or following all standard lines of chemo-therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Age 18 years or older\n* Able to understand written information\n* Consent to samples for translational research\n\nExclusion Criteria:\n\n* Pretherapeutic work-up procedure with Tc-99m macroaggregated albumin (MAA) scintigraphy showing extrahepatic foci in GI-tract\n* Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach or duodenum, after application of established angiographic techniques to stop such deposition\n* Previous radiation therapy to the lungs and\u002For to the upper abdomen overlapping with dose to the liver at interventionist´s decision\n* Lung shunt greater than 20% or \\> 30 Gray radiation absorbed dose to the lungs, at estimated by Tc-99m-MAA\n* Pregnancy\n* Symptomatic lung disease precluding SIRT at interventionist´s decision\n* Active uncontrolled infection\n* Any pre-treatment laboratory findings within 30 days of treatment demonstrating: alanine aminotransferase level greater than 5 times upper normal limit and\u002For serum bilirubin greater than 2 mg\u002Fdl (\\>34 umol\u002Fl)\n* Current or previously evidence of ascites on CT-scan or physical examination\n* Tumour volume greater than 50% of liver volume\n* Conditions precluding translational samples",{"count":406,"type":21},30,"Observational, feasibility study investigating biological aspects in patients with liver metastasis from colorectal cancer undergoing treatment with SIRT, by translational analysis of biological samples.",[409],"Liver Metastasis Colon Cancer",[411,412,413],"Liver metastasis Colon Cancer","Circulating Tumour DNA","Selective Internal Radiation Therapy","2026-01-12",{"date":416,"type":32},"2026-01-13",{"date":418,"type":32},"2020-11-01",{"date":420,"type":21},"2028-09-30",{"name":38,"class":39},{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":429,"maxAge":18,"enrollmentInfo":430,"targetDuration":4,"studyType":51,"phases":432,"briefSummary":433,"conditions":434,"keywords":439,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":73},"100619826","hypnotherapy-for-needle-related-procedural-pain-and-anxiety-management-in-a-pediatric-setting-100619826","NCT07349667","Hypnotherapy for Needle-related Procedural Pain and Anxiety Management in a Pediatric Setting","Hypnotherapy for Needle-related Procedural Pain and Anxiety Management in a Pediatric Setting: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Children aged 6 to 18 years\n* Scheduled for a painful medical procedure (injections or blood sampling)\n* Informed consent obtained from parents or legal guardians\n\nExclusion Criteria:\n\n* Children with a history of psychiatric disorders or cognitive impairment\n* Children unable to understand and participate in hypnotherapy sessions\n* Any contraindication to hypnotherapy\n* Children with diagnosed cancer","6 Years",{"count":431,"type":21},70,[53],"The proposed study aims to evaluate the effectiveness of hypnotherapy as a non-pharmacological intervention for managing pain and anxiety during needle-related medical procedures in children aged 5 to 17 years. This research addresses a significant gap in pediatric healthcare, where painful procedures often induce distress and long-term anxiety, leading to avoidance of necessary medical care. Conventional pain management strategies primarily rely on pharmacological methods, which may pose risks and side effects. Thus, exploring safe and effective alternatives, such as hypnotherapy, is crucial.The target group for this randomized controlled trial includes children scheduled for painful procedures, such as injections or blood sampling. Participants will be randomly assigned to either the hypnotherapy group, receiving tailored sessions conducted by trained hypnotherapists, or the standard of care group, which will involve conventional pain management techniques. The study will assess primary outcomes, including anxiety levels and pain perception, before, during, and after the procedures using validated scales.\n\nKey activities of the project include conducting individualized hypnotherapy sessions, monitoring anxiety and pain levels through structured assessments, and analyzing the data to determine the effectiveness and feasibility of hypnotherapy. Secondary objectives will explore potential long-term benefits and safety concerns associated with hypnotherapy. If successful, this study could significantly enhance pediatric pain management practices, reduce reliance on pharmacological interventions, and improve the overall healthcare experience for children. The findings may also inform broader healthcare policies regarding non-pharmacological pain management strategies in pediatric settings.",[435,436,437,438],"Arthritis, Juvenile","Arthritis, Juvenile Idiopathic","Lupus Erythematosus, Systemic","Dermatomyositis, Juvenile",[440,441,442],"Hypnotherapy","pediatric","needle fear","2026-01-09",{"date":445,"type":32},"2026-01-20",{"date":447,"type":21},"2026-03",{"date":449,"type":21},"2029-12",{"name":38,"class":39},{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":17,"minAge":458,"maxAge":459,"enrollmentInfo":460,"targetDuration":4,"studyType":51,"phases":462,"briefSummary":463,"conditions":464,"keywords":467,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":73},"100614832","mrgfus-for-parkinsons-tremor-100614832","NCT07284719","MRgFUS for Parkinson's Tremor","Predictors and Mechanisms of Tremor Relapse After MR-Guided Focused Ultrasound Thalamotomy in Parkinson's Disease","Inclusion Criteria:\n\n* Established diagnosis of idiopathic Parkinson's disease\n* Tremor not manageable with optimal medication\n* Clinical Indication for MRgFUSth\n* Able to understand study requirements and provide consent\n* HOEHN and YAHR \\\u003C3\n\nExclusion Criteria:\n\n* Dementia or severe cognitive impairment\n* The presence of another significant neurological\u002Fpsychiatric disorder or significant disease\n* Severe psychopathology, not medically managed\n* Poor balance and gait function based on neurological examination\n* Epilepsy\n* Active drug abuse\n* History of stroke or structural lesions on MRI that could interfere with image analysis.\n* Contraindications for MRI\n* Cardiac pacemaker\n* Pregnancy or breast-feeding\n* Claustrophobia\n* Patients unable to lie on the back for 2-4 hours in the MR-scanner-setting\n* Patients who do not want information about findings of unknown disease during the trial\n* SDR (Skull density rate) lower than 0.35","50 Years","80 Years",{"count":461,"type":21},20,[53],"This study investigates magnetic resonance-guided focused ultrasound thalamotomy (MRgFUSth) for people with Parkinson's disease (PD) and tremor not responding to conventional standard doses of dopamine replacement therapy. The aim is to identify clinical and imaging biomarkers predictive of sustained tremor control up to 24 months after MRgFUSth treatment. Participants will undergo a suprathreshold levodopa test and ¹⁸F-DOPA PET imaging to evaluate dopaminergic and serotonergic involvement in tremor. All participants will receive MRgFUSth and be followed for 24 months with standardized clinical, cognitive, and quality-of-life assessments. The study seeks to improve understanding the possible mechanisms of tremor relapse and inform patient selection for MRgFUSth in PD.",[465,466],"Parkinson s Disease","Tremor",[468,469,470,471,472,473],"MRgFUS","MR-guided focused ultrasound","Parkinson's disease","tremor","Parkinson's tremor","Relapse","2026-01-05",{"date":476,"type":32},"2026-01-07",{"date":478,"type":32},"2025-12-01",{"date":480,"type":21},"2029-02",{"name":38,"class":39},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":353,"minAge":18,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":492,"conditions":493,"keywords":495,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":508,"locationsCount":40},"100615717","beyond-survival-addressing-gynecological-and-sexual-health-in-women-after-radiotherapy-for-anal-cancer-100615717","NCT07296237","Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer","DACG VI. Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer","DACG VI","Inclusion Criteria:\n\n* Women aged 18 years or older\n* Diagnosed with anal cancer\n* Treated with chemoradiotherapy with curative intent\n* Between 6 and 36 months since completion of radiotherapy\n* Able and willing to give written informed consent\n\nExclusion Criteria:\n\n* Previous pelvic radiotherapy for another disease\n* Treated with electron beam radiotherapy\n* Unable to speak or understand Danish",{"count":491,"type":21},80,"The goal of this observational study is to learn how radiotherapy for anal cancer affects the vaginal and sexual health of women after treatment. The study will also look at whether the radiation dose to the vagina is linked to the level of vaginal problems.\n\nThe main questions this study aims to answer are:\n\n* How many women develop moderate or severe narrowing of the vagina after radiotherapy?\n* Is there a link between the radiation dose and vaginal problems?\n* How do vaginal changes affect sexual health and daily life?\n* What care and support do women receive, and how satisfied are they with this support?\n\nParticipants are women aged 18 years or older who were treated with chemotherapy and radiotherapy for anal cancer and are 6 to 36 months after treatment.\n\nParticipants will:\n\nHave a gynaecological examination to check the vagina for changes such as narrowing, stiffness, bleeding, or scarring Complete online questionnaires about quality of life and sexual health Answer questions about use of vaginal dilators, hormone treatment, and sexual counselling Allow researchers to analyse their radiotherapy scans to measure how much radiation the vagina received Some participants will also take part in a telephone interview about their experience with guidance and support after treatment\n\nThe study will include about 80 participants across three Danish hospitals. About 20 participants will take part in the interview part of the study.\n\nThe results from this study may help improve how doctors and nurses prevent, detect, and treat vaginal and sexual problems after radiotherapy for anal cancer. This may lead to better support and quality of life for future patients.",[494],"Anal Cancer",[496,497,498,499,500,501],"anal cancer","Radiotherapy","Sexual dysfunction","Female sexual health","Gynecological side effects","Patient-reported outcomes","2025-12-09",{"date":504,"type":32},"2025-12-22",{"date":506,"type":32},"2025-11-13",{"date":318,"type":21},{"name":38,"class":39},{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":17,"minAge":516,"maxAge":517,"enrollmentInfo":518,"targetDuration":4,"studyType":51,"phases":520,"briefSummary":521,"conditions":522,"keywords":525,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":73},"100606901","sleep-and-blankets-100606901","NCT07181577","Sleep and Blankets","SWAN","Inclusion Criteria:\n\n* Participants must be between 16 and 24 years old\n* Participants must have a score on the Insomnia Severity Index (ISI) above 10.\n\nExclusion Criteria:\n\n* Presence of neurological disorders known to influence or be related to poor sleep including affective disorders and diagnosed medical sleep disorders (e.g., sleep apnea, narcolepsy)\n* Circulatory or respiratory disease\n* Pregnancy, shift or night work\n* Prior use of special blanket (within the past five years)\n* Insufficient Danish proficiency.","16 Years","24 Years",{"count":519,"type":21},672,[53],"Purpose\n\nThe primary aim of this research project is to evaluate whether a special blanket is an effective intervention for improving sleep among young people aged 16-24 with sleep disturbances. Sleep problems are increasingly common among Danish youth, with approximately one in five reporting significant sleep difficulties in the past 14 days. This trend has been rising steadily since 2010 and is mirrored internationally. Sleep disturbances are linked to a wide range of physical and mental health problems, including stress, anxiety, and depression, as well as negative effects on academic performance and social relationships. Early intervention is crucial to prevent chronic insomnia and poor mental health outcomes in adulthood.\n\nCurrent treatments include specialized psychological therapies and medication. However, psychological therapies require extensive time and commitment, and medication carries risks of side effects, tolerance, and dependency, making non-pharmacological, safe, and accessible alternatives necessary. The special blanket is believed to promote relaxation through stimulation of the tactile and proprioceptive systems. Although promising in clinical and pedagogical contexts for certain populations (e.g., children with developmental disorders and adults with neurological conditions), there is limited scientific evidence regarding its efficacy and underlying mechanisms, particularly among youth with sleep disturbances.\n\nMethods and Study Design\n\nThis project is a Phase 1 randomized controlled trial (RCT) assessing the effect of 4 weeks of using a special blanket on sleep problems among young people aged 16-24, as well as the impact on participants' mental and physical health. Additionally, the study investigates possible stress-related mechanisms involved in the use of the special blanket. Following the 4-week intervention, an open-label extension phase of 8 weeks (Phase 2) will explore continued use and acceptability of the blanket.\n\nEligible participants, screened for sleep problems, will be randomly assigned to one of three groups:\n\nGroup 1: receives a special blanket (Blanket A) for home use over 4 weeks.\n\nGroup 2: receives another special blanket (Blanket B) for 4 weeks.\n\nGroup 3 (observation group): no blanket provided but followed for 4 weeks to monitor changes in sleep problems.\n\nThe 4-week intervention phase (Phase 1) includes baseline (T1, week 0), mid-intervention (T2, week 2), and post-intervention (T3, week 4) online assessments. Sleep disturbances, physical and mental health, and stress-related mechanisms will be measured using validated questionnaires administered through REDCap. The first 40 participants in Groups 1 and 2 will additionally provide saliva samples and wear a circadian rhythm monitor (activity watch).\n\nIn Phase 2, participants in Groups 1 and 2 may continue using the blanket or revert to their usual bedding. At the end of Phase 2 (T4, week 12), follow-up questionnaires will assess sleep and user experience, including satisfaction, perceived benefits, barriers, and drawbacks of the blanket. Group 3 will then be offered a special blanket for an 8-week trial.\n\nParticipants The investigators aim to recruit 672 young people aged 16-24 with sleep problems.\n\nInclusion criteria are age 16-24 years and sleep problems measured by Insomnia Severity Index (score \\>10). Exclusion criteria are any underlying somatic, psychological, or neurological condition significantly affecting sleep quality; use of medications affecting sleep; pregnancy; shift work or night work; previous use of special blankets for sleep improvement and insufficient Danish language skills (questionnaires in Danish).\n\nSignificance and Relevance\n\nThe investigators anticipate that the findings will contribute to the current understanding of the non-pharmacological management of sleep problems, related mental and physical health outcomes, and underlying stress-related mechanisms of special blanket interventions. The results will be relevant to health professionals working with sleep problems, but also to adolescents and younger adults with sleep problems and their parents. New clinical guidelines on sleep problems in children and adolescents recommend non-pharmacological treatments as the first choice, specifically mentioning the potential efficacy of special blankets. The proposed project will help inform further development of such guidelines and related clinical practice. If special blankets are found to be effective in reducing insomnia, they could serve as an inexpensive, easily disseminated, and administered treatment with no known side effects, with the potential to greatly reduce the personal, as well as societal costs of insomnia.",[523,524],"Sleep Problems","Insomnia",[526,527,528,529,530,531,532,533,534,535,536,537],"insomnia","sleep","RCT","blankets","actigraphy","sleep problems","sleep quality","young adults","sleep interventions","sleep disturbances","saliva","adolescents",{"date":539,"type":32},"2025-12-17",{"date":541,"type":32},"2025-10-15",{"date":543,"type":21},"2027-02-01",{"name":38,"class":39},{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":353,"minAge":552,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":51,"phases":555,"briefSummary":556,"conditions":557,"keywords":559,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":73},"100613836","phase-4-the-effect-of-denosumab-on-muscle-and-strength-and-insulin-sensitivity-100613836","NCT07271771","The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity","DENMUSIN","Inclusion Criteria:\n\n* Postmenopausal women (postmenopausal for at least two years)\n* Age ≥ 40 years\n* BMD T-score ≥ -2.0 (lumbar spine, total hip or femoral neck)\n* At least 2 lumbar vertebrae that can be evaluated by dual-energy x-ray absorptiometry (DXA)\n* Diabetes Mellitus type 2\n* Treatment with metformin as monotherapy\n\nExclusion Criteria:\n\n* Treatment for osteoporosis at any time\n* Other antidiabetic medication than metformin\n* Low-energy vertebral fractures at any time\n* Low-energy hip fracture at any time\n* Ongoing treatment with systemic glucocorticoids\n* Metabolic bone disease (for example osteogenesis imperfecta, Paget's disease of bone, hyperparathyroidism)\n* Treatment affecting bone, calcium metabolism or muscle\n* Active cancer within the last 5 years with the exception of basal cell skin cancer\n* Estimated glomerular filtration rate (eGFR) ≤ 35 mL\u002Fmin\n* Unable to read and understand Danish\n* Immobility","40 Years",{"count":554,"type":21},40,[85],"Randomized, placebo controlled prospective trial evaluating the effect of denosumab on insulin sensitivity and muscle strength.",[558],"Osteoporosis",[560,561,562,563],"muscle","insulin sensitivity","denosumab","bone mineral density","2025-12-08",{"date":566,"type":32},"2025-12-15",{"date":568,"type":32},"2024-05-21",{"date":570,"type":21},"2027-03-01",{"name":38,"class":39},{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":17,"minAge":458,"maxAge":4,"enrollmentInfo":580,"targetDuration":4,"studyType":51,"phases":582,"briefSummary":584,"conditions":585,"keywords":587,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":600},"100593914","phase-3-a-european-randomized-study-on-blood-thinners-and-cholesterol-lowering-treatments-to-prevent-future-vascular-events-in-people-with-covert-brain-infarcts-cbi-100593914","NCT07012629","A EUROpean Randomized Study on Blood-thinners and Cholesterol-lowering Treatments to Prevent Future Vascular Events in People With Covert Brain Infarcts (CBI)","A EUROpean Pragmatic Multicenter Randomized Trial on Platelet Inhibition and\u002For Lipid Lowering Treatment in Covert Brain Infarction (CBI)","EURO-CBI","Inclusion Criteria:\n\n* MRI demonstrating a lacunar infarct (acute\u002Fsubacute\u002Fchronic) without prior stroke\u002FTIA symptoms. (A round or ovoid, subcortical, fluid-filled cavity (signal similar to cerebrospinal fluid (CSF)) between 3 and 15 mm in diameter and demonstrating a peripheral T2\u002FFLAIR hyperintense rim of marginal gliosis. For infratentorial lesions the hyperintense rim may be less marked and a complete ring is not required) OR\n* MRI demonstrating a cortical infarct (acute\u002Fsubacute\u002Fchronic) without prior stroke\u002FTIA symptoms (A cortical infarct is defined as a fluid-filled cavity (signal similar to CSF) in the cortex, juxtacortical region or cerebellar cortex and with a ring of T2\u002FFLAIR hyperintense lesions or as cortical T2\u002FFLAIR lesions without a fluid-filled cavity with presumed vascular origin. Both supra- and infratentorial lesion will be included) AND Life expectancy \\> 12 months AND Predominantly independent in actives of daily living (mRS score ≤ 3) AND Age ≥ 50 years\n\nExclusion Criteria:\n\n* History of stroke\u002FTIA\n* High risk of bleeding (e.g., recent or recurrent gastrointestinal or genitourinary bleeding associated with a decrease in hemoglobin levels of at least 1 mmol\u002FL, active peptic ulcer disease, MRI with cortical siderosis and\u002For prior lobar hemorrhage)\n* Indication for long-term use of anticoagulants (e.g. deep vein thrombosis, pulmonary embolism, atrial fibrillation, and rarer indications; such as mechanical heart valve, antiphospholipid antibody syndrome etc.)\n* Concurrent indication for lipid-lowering treatment and\u002For platelet-inhibitors for secondary cardiovascular prevention (ischemic heart disease, recent stenting, ischemic stroke, revascularization surgeries, lower-extremity atherosclerotic arterial disease etc.)\n* Co-existing progressive neurodegenerative disease including dementia or Parkinson's disease.\n* Neoplastic condition that is uncontrolled or associated with an increased risk of bleeding\n* Patient already on antiplatelet or anticoagulation agent, regardless of indication\n* Women with a history of menopause below 12 months are only included after negative pregnancy test",{"count":581,"type":21},1652,[583],"PHASE3","Magnetic resonance imaging (MRI) is commonly used in healthcare, and sometimes it shows small areas of brain damage called Covert Brain Infarcts (CBIs). These are usually found by chance when people have scans for things like headaches or dizziness. Although CBIs don't cause symptoms at the time, they are linked to a higher risk of future stroke and death.\n\nThere is currently no standard treatment for CBIs, and doctors have different approaches-some give stroke-preventing medication (like antiplatelets or statins), while others don't treat at all. This is mostly because there isn't enough research yet.\n\nThis study will test whether stroke-preventing treatments help people with CBIs. It will also look at whether having a CBI increases the risk of dementia, and whether treatment might lower that risk.",[586],"Covert Brain Infarction",[588,589,590,591],"CBI","Prevention","Asymptomatic brain infarction","Dementia","2025-11-27",{"date":594,"type":32},"2025-12-04",{"date":596,"type":32},"2025-11-26",{"date":598,"type":21},"2040-01-01",{"name":38,"class":39},14,{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":607,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":609,"targetDuration":4,"studyType":51,"phases":611,"briefSummary":613,"conditions":614,"keywords":616,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":73},"100598547","phase-2-cabergoline-for-episodic-migraine-100598547","NCT07072910","Cabergoline for Episodic Migraine","Prevention and Treatment of Episodic Migraine by Cabergoline Therapy (PROTECT). A Randomized, Placebo-controlled, Double-blind, Investigator-initiated Trial","PROTECT","Inclusion Criteria:\n\n* Age ≥18 years\n* Episodic migraine according to ICHD-3 criteria\n* 4-14 monthly migraine days (MMD) in the last 3 months prior to inclusion\n* Stable acute migraine medication use for at least 3 months prior to inclusion\n* Written informed consent\n\nExclusion Criteria:\n\n* \\\u003C 4 MMD or ≥ 15 MMD during the baseline period\n* Chronic migraine (≥15 headache days per month)\n* Trigeminal autonomic cephalalgias and neuralgias\n* Secondary headache conditions\n* Other common primary headache types (e.g. tension-type headache) if attacks are frequent (present on an average of \\>1 day\u002Fmonth and \\>12 days\u002Fyear)\n* Presumed medication-overuse headache\n* Recent changes in preventive migraine treatment (≥3 months prior to study inclusion)\n* History of pulmonary, retroperitoneal, or pericardial disorders, including heart valve disease\n* Severe untreated hypertension\n* Use of drugs with dopamine antagonistic or agonistic properties\n* Psychiatric disorders requiring pharmacological treatment\n* Women of child-bearing potential (i.e. not chemically or surgically sterilized, or not postmeno-pausal) and male participants with partners of child-bearing potential, who are unwilling to use a medically accepted method of contraception, considered reliable by the investigator, from signing of informed consent and throughout the study\n* Women who have a positive pregnancy test at randomization\n* Women who are breast-feeding\n* Allergy or hypersensitivity to cabergoline or similar compounds\n* Concurrent participation in another clinical trial that, in the judgement of the investigator, may interfere with the conduct or outcomes of the present study\n* Inability of the subject, in the opinion of the investigator, to understand and\u002For comply with study medications or procedures, or any conditions that, in the opinion of the investigator, may render the subject unable to complete the study",{"count":610,"type":21},150,[612],"PHASE2","The goal of this randomized, placebo-controlled, double-blind clinical trial is to evaluate the efficacy, safety, and tolerability of cabergoline for the prevention of episodic migraine in adults with 4-14 monthly migraine days (MMD). The main questions it aims to answer are:\n\n1. Does once-weekly cabergoline (0.5 mg or 1.0 mg) reduce MMD compared to placebo?\n2. What are the effects of cabergoline on headache severity, acute medication use, and patient-reported outcomes?\n3. Is cabergoline safe to use in individuals with migraine?\n\nParticipants will:\n\nComplete a 4-week baseline period to document migraine frequency and classify headache days.\n\nBe randomly assigned to one of three treatment arms:\n\n1. Cabergoline 0.5 mg\u002Fweek\n2. Cabergoline 1.0 mg\u002Fweek\n3. Placebo\n\nParticipate in a 12-week double-blind treatment phase, followed by a 12-week open-label treatment phase where all participants receive cabergoline (0.5 mg or 1.0 mg once weekly).\n\nRecord daily headache activity, acute medication use, and severity using an electronic diary.\n\nComplete validated headache questionnaires and provide blood samples for biomarker analysis at baseline, week 12, and week 24.\n\nThe study also includes exploratory analyses of genetic predictors of treatment response and metabolic markers to assess the broader effects of cabergoline.",[615],"Migraine",[615,617,618,619],"Preventive treatment","Cabergoline","Drug repurposing","2025-11-14",{"date":622,"type":32},"2025-11-18",{"date":624,"type":32},"2025-11-12",{"date":626,"type":21},"2028-09-01",{"name":38,"class":39},{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":4,"eligibilityCriteria":634,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":635,"targetDuration":4,"studyType":51,"phases":637,"briefSummary":638,"conditions":639,"keywords":641,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":73},"100533191","surgery-for-thyroid-cancer-with-or-without-autofluorescence-to-prevent-hypoparathyroidism-100533191","NCT06222606","Surgery for Thyroid Cancer With or Without Autofluorescence to Prevent Hypoparathyroidism","Surgery for Thyroid Cancer With or Without Autofluorescence to Prevent Hypoparathyroidism - a Randomized, Controlled Trial","Inclusion Criteria:\n\n* Age\\>18 years and able to give informed consent.\n* Suspicion or diagnosis of thyroid cancer.\n* Planned total thyroidectomy or completion thyroidectomy.\n* Normocalcemia prior to surgery.\n\nExclusion Criteria:\n\n* Planned simultaneous parathyroid surgery.\n* Treatment with active vitamin D analogues.\n* eGFR \\\u003C 30.",{"count":636,"type":21},160,[53],"The study aims to test if use of autofluorescence imaging (AF) reduces the risk of developing hypoparathyroidism (hypoPT) following surgery for thyroid cancer, either total thyroidectomy (TT) or completion hemithyroidectomy (cHT).",[640],"Thyroid Cancer",[640,642,643,644,645],"Surgery","Autofluorescence","Near-Infrared Autofluorescence Imaging","Hypoparathyroidism",{"date":647,"type":32},"2025-10-06",{"date":649,"type":32},"2024-01-01",{"date":651,"type":21},"2027-01",{"name":38,"class":39},{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":659,"eligibilityCriteria":660,"healthyVolunteers":12,"sex":17,"minAge":354,"maxAge":661,"enrollmentInfo":662,"targetDuration":4,"studyType":51,"phases":664,"briefSummary":665,"conditions":666,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":668,"lastUpdatePostDateStruct":669,"startDateStruct":671,"completionDateStruct":673,"leadSponsor":674,"locationsCount":129},"100549680","increased-tuberculosis-case-detection---dioptb-100549680","NCT06437184","Increased Tuberculosis Case Detection - DiOpTB","Increased Tuberculosis Case Detection - a Cluster-randomized Trial Combining Available Resources and Novel Strategies for High Endemic Areas","DiOpTB","Inclusion Criteria:\n\n* ≥15 years old\n* presumed TB with cough, sputum production, and\u002For weight loss of any duration\n\nExclusion Criteria:\n\n* TB treatment within the past year.\n* Cerebral disturbances impairing the ability to give informed consent or follow the treatment regime.","120 Years",{"count":663,"type":21},1584,[53],"As estimated by the WHO 10.6 million new Tuberculosis (TB) cases were identified in 2022- while more than three million went undetected and untreated. The low detection rate illustrates the failure to recognise and diagnose TB in the current cascade of healthcare and is a major obstacle to effective TB control programs. This multi-centre cluster-randomised clinical trial will evaluate the effect (i.e., diagnostic yield) of improving the point-of-care diagnostics already in place in most primary health-care centres in low-resource settings. The present study will be conducted in two different geographical settings in the Western and Eastern African countries of Guinea Bissau and Ethiopia. This improved clinical diagnostic pathway may improve case detection rates at primary healthcare level, ensuring prompt commencement of treatment, thereby diminishing transmission risk in the community and improving treatment outcomes. The Optimized Diagnostic Procedure (ODP) will utilize instructed sputum sampling and pooling as well as computer-aided detection (CAD) chest X-ray (CXR) and additional pooled sputum sample as well as non-sputum sampling (faecal and a buccal\u002Ftongue swab and saliva) for GeneXpert Ultra PCR (Xpert) as state-of-the-art add-ons to the routine diagnostic pathway for TB. This adds to the key components of the WHO \"End TB\" strategy - early diagnosis - and if successful, may be rapidly approved by the WHO and implemented by governments globally with potentially major public health benefits.\n\nThe study will be conducted in close liaison with the national Ministries of Health and TB programs in Guinea-Bissau and Ethiopia. This will facilitate any relevant findings to be taken forward for implementation into policy and practice. Capacity development, training and educational activities will be closely aligned to this study.",[667],"Tuberculosis","2025-09-30",{"date":670,"type":32},"2025-10-03",{"date":672,"type":32},"2024-06-03",{"date":179,"type":21},{"name":38,"class":39},{"id":676,"slug":677,"hasResults":12,"nctId":678,"briefTitle":679,"officialTitle":680,"acronym":681,"eligibilityCriteria":682,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":683,"targetDuration":4,"studyType":51,"phases":685,"briefSummary":686,"conditions":687,"keywords":690,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":668,"lastUpdatePostDateStruct":694,"startDateStruct":695,"completionDateStruct":697,"leadSponsor":699,"locationsCount":73},"100518591","remote-ischemic-conditioning-in-aneurysmal-sah-100518591","NCT06032533","Remote Ischemic Conditioning in Aneurysmal SAH","The Effect of Remote Ischemic Conditioning on Delayed Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage: A Prospective, Randomized, Patient-assessor Blinded, Sham-controlled Pilot Study Investigating Effect on Clinical Outcome.","RESCUE-SAH","Inclusion Criteria:\n\n* Aneurysmal subarachnoid hemorrhage confirmed by computed tomography (CT) with aneurysm origin confirmed by computed tomography angiography (CTA) or digital subtraction angiography (DSA)\n* Aneurysmal subarachnoid hemorrhage symptom-onset ≤ 3 days\n* Aneurysm protected by clipping or coiling\n* Independent in daily living before symptom onset (mRS ≤ 2)\n\nExclusion Criteria:\n\n* Subarachnoid hemorrhage caused by a lesion other than cerebral aneurysm\n* Symptomatic vasospasm at the time of enrollment\n* Previous cerebral lesion e.g. symptomatic cerebral infarction (\\>2cm), multiple sclerosis, symptomatic intracerebral hemorrhage, tumour, prior neurosurgery (excluding prior clipping or coiling of cold aneurysms without complications).\n* History of severe peripheral vascular disease or signs of severe peripheral vascular disease on physical examination\n* History of deep vein thrombosis or signs of deep vein thrombosis on physical examination\n* Kidney involvement or prior kidney disease with an estimated glomerular filtration rate (eGFR) below safe levels for contrast infusion in relation to CT-perfusion.\n* Pregnancy (Women of child-bearing age will have serum-Humane Choriogonadotropine taken prior to final inclusion. If pregnancy cannot be ruled out,the patient can't be included. Women with a safe birth control method will be encouraged to use this method during the entire period of active treatment.)\n* Concomitant other acute life-threatening medical or surgical condition",{"count":684,"type":21},100,[53],"The goal of this clinical trial is to examine the effect of limb occlusion therapy (remote ischemic conditioning, RIC) in subjects with aneurysmal subarachnoid hemorrhage.\n\nThe main question it aims to answer is whether RIC can improve long-term recovery in participants with aneurysmal subarachnoid hemorrhage.\n\nResearchers will compare levels of functional independence in participants in the RIC-group to participants in the sham-group.",[688,689],"Subarachnoid Hemorrhage, Aneurysmal","Delayed Cerebral Ischemia",[691,692,693,689],"Remote Ischemic Conditioning","Subarachnoid Hemorrhage","Aneurysm",{"date":670,"type":32},{"date":696,"type":32},"2023-09-09",{"date":698,"type":21},"2027-11-30",{"name":38,"class":39},""]