[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kawasaki-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kawasaki-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,46,96,120,144,173,194,225,275,301,325,731,758,780],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100633742","phase-3-statins-study-in-children-of-acute-kawasaki-disease-with-coronary-artery-abnormalities-100633742",false,"NCT07530640","Statins Study in Children of Acute Kawasaki Disease With Coronary Artery Abnormalities","Clinical Study of Atorvastatin in the Treatment of Acute Kawasaki Disease Complicated With Coronary Artery Abnormalities in Children","Inclusion Criteria:\n\n* KD complicated with CAA, less than 20 days after the onset of KD, or more than 20 days after onset but the KD inflammation has not been controled.\n* IVIG and\u002For other anti-inflammatory treatments have been used\u002Fare being used.\n* The guardians agree to atorvastatin treatment and sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients with history of family hypercholesterolemia\u002Ftaking statins\u002Fsevere chronic diseases.\n* Patients with abnormal laboratory data including CK≥500U\u002FL, total cholesterol\\\u003C3.1mmol\u002FL, ALT or AST≥ 2 times the upper limit of normal.\n* The guardians do not agree to atorvastatin treatment.","ALL","2 Years","18 Years",{"count":20,"type":21},9,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this observational study is to learn about the safety and effects of atorvastatin in treatment of Chinese Kawasaki disease (KD) children complicated with coronary artery abnormalities (CAA) in acute phase. The main questions it aims to answer are: Is atorvastatin safe in Chinese children of acute KD? Does atorvastatin contribute to control the acute inflammation in KD and improve the CAA?",[27,28],"Kawasaki Disease","Coronary Artery Abnormalities",[27,30,31,32],"Coronary artery abnormalities","Atorvastatin","Acute","RECRUITING","2026-06-14",{"date":36,"type":37},"2026-06-16","ACTUAL",{"date":39,"type":37},"2026-06-08",{"date":41,"type":21},"2027-09-30",{"name":43,"class":44},"Children's Hospital of Fudan University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100383878","pharmacokinetics-pharmacodynamics-and-safety-profile-of-understudied-drugs-administered-to-children-per-standard-of-care-pops-100383878","NCT04278404","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs","POPS or POP02","Inclusion Criteria:\n\n1. Participant is \\\u003C 21 years of age\n2. Parent\u002F Legal Guardian\u002F Adult Participant can understand the consent process and is willing to provide informed consent\u002FHIPAA:\n3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment\n\nExclusion Criteria:\n\n1. Participant has a known pregnancy\n\n   Below exclusion criteria apply only to:\n\n   Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)\n2. Has had intermittent dialysis within previous 24 hours\n3. Has had a kidney transplant within previous 30 days\n4. Has had a liver transplant within previous 1 year\n5. Has had a stem cell transplant within previous 1 year\n6. Has had therapeutic hypothermia within previous 24 hours\n7. Has had plasmapheresis within the previous 24 hours\n8. Has a Ventricular Assist Device\n9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study",true,"0 Years","20 Years",{"count":58,"type":21},5000,"OBSERVATIONAL","The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.",[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,27,84,85],"Coronavirus Infection (COVID-19)","Pulmonary Arterial Hypertension","Urinary Tract Infections in Children","Hypertension","Pain","Hyperphosphatemia","Primary Hyperaldosteronism","Edema","Hypokalemia","Heart Failure","Hemophilia","Menorrhagia","Insomnia","Pneumonia","Skin Infection","Arrythmia","Asthma in Children","Bronchopulmonary Dysplasia","Adrenal Insufficiency","Fibrinolysis; Hemorrhage","Attention Deficit Hyperactivity Disorder","Multisystem Inflammatory Syndrome in Children (MIS-C)","Coagulation Disorder","Down Syndrome","2026-03-31",{"date":88,"type":37},"2026-04-06",{"date":90,"type":37},"2020-03-05",{"date":92,"type":21},"2027-07",{"name":94,"class":44},"Duke University",51,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":45},"100630765","maskd-a-study-on-kawasaki-disease-kd-complicated-by-macrophage-activation-syndrome-mas-100630765","NCT07491926","MASKd: a Study on Kawasaki Disease (KD) Complicated by Macrophage Activation Syndrome (MAS)","MACROPHAGE ACTIVATION SYNDROME IN KAWASAKI DISEASE: Features, Treatment, Outcome, Predictive and Diagnostic Factors (The MASKd Study)","Inclusion Criteria:\n\n* Age between 4 weeks and under 18 years at the time of KD diagnosis\n* Diagnosis of KD made according to the 2024 AHA guidelines\n* Diagnosis of MAS made by the attending physician within 30 days from the onset of KD.\n\nExclusion Criteria:\n\n* Unconfirmed diagnosis of KD (e.g., mimicking conditions)\n* Primary (genetic) HLH\n* Lack of informed consent\n* MAS diagnosed more than 30 days after or more than 15 days before the onset of KD","4 Weeks","17 Years",{"count":106,"type":21},150,"Kawasaki Disease (KD) is one of the most common vasculitides in childhood and represents a leading cause of acquired heart disease in developed countries. Macrophage Activation Syndrome (MAS) is a potentially life threatening hyperinflammatory condition belonging to the spectrum of hemophagocytic lymphohistiocytosis (HLH), and it can complicate various rheumatologic diseases. Awareness of MAS in the context of KD has recently increased, supporting the hypothesis that it is an underdiagnosed complication. The study aims to define the epidemiology, clinical characteristics, management, and therapeutic strategies of MAS in patients with KD, through a multicenter data collection in Europe.",[27,109],"Macrophage Activation Syndrome (MAS)","NOT_YET_RECRUITING","2026-03-18",{"date":113,"type":37},"2026-03-25",{"date":115,"type":21},"2026-02",{"date":117,"type":21},"2029-02",{"name":119,"class":44},"Meyer Children's Hospital IRCCS",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":54,"sex":16,"minAge":55,"maxAge":18,"enrollmentInfo":126,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":45},"100624132","clinical-study-on-an-artificial-intelligence-assisted-chest-radiograph-model-based-on-big-data-and-deep-learning-for-early-detection-of-kawasaki-disease-100624132","NCT07405658","Clinical Study on an Artificial Intelligence-Assisted Chest Radiograph Model Based on Big Data and Deep Learning for Early Detection of Kawasaki Disease","Inclusion Criteria:\n\n1. Case group\n\n   * The age of seeking medical treatment is less than or equal to 18 years old; ·The medical record system diagnosis contains the diagnosis of \"Kawasaki Disease\", \"mucocutaneous lymph node syndrome\" or \"IVIG non-response Kawasaki disease\"\n   * At least one complete chest X-ray examination data (images and reports) is available during the same hospitalization\n2. Control group\n\n   * The age of seeking medical treatment is less than or equal to 18 years old\n   * The same period as the case group\n   * Fever lasts for 3 days or more\n   * Rule out the possibility of diagnosing Kawasaki disease\n\nExclusion Criteria:\n\n1. Case group\n\n   * Chest X-ray quality issues: Severe artifacts, overexposure\u002Funderexposure leading to inability to assess key structures\n   * Incomplete clinical information, including lack of chest X-ray examination, laboratory tests, and unclear days of fever Inability to determine the final diagnosis (such as loss to follow-up, diagnosis in doubt)\n2. Control group\n\n   * Chest X-ray quality issues: Severe artifacts, overexposure\u002Funderexposure leading to inability to assess key structures\n   * Incomplete clinical information, including lack of chest X-ray examination, laboratory tests, and unclear days of fever\n   * Inability to make a clear final diagnosis (such as loss to follow-up, questionable diagnosis)",{"count":127,"type":21},20000,"The goal of this observational study is to develop an AI-based early warning system for Kawasaki Disease (KD) using chest X-rays (CXR) in children diagnosed with Kawasaki Disease. The main question\\[s\\] it aims to answer are:\n\n1. Can AI modeling of CXR features help identify high-risk KD patients earlier than current diagnostic methods?\n2. Can the AI system predict the optimal IVIG treatment window and coronary artery risks in KD patients?\n\nParticipants will:\n\nProvide retrospective data on chest X-rays and clinical data (CRP, coronary ultrasound, etc.) Allow analysis of CXR features using deep learning models to extract relevant patterns Have their data incorporated into a federated learning model to ensure privacy and data security",[27,130,131],"Chest X-ray for Clinical Evaluation","Mucocutaneous Lymph Node Syndrome",[27,133,134],"Artificial Intelligence","Mucocutaneous lymph node syndrome","2026-02-10",{"date":137,"type":37},"2026-02-12",{"date":139,"type":21},"2026-02-01",{"date":141,"type":21},"2027-12-31",{"name":143,"class":44},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":152,"maxAge":104,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":157,"conditions":158,"keywords":159,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":45},"100615333","kawasaki-match-trial-100615333","NCT07291245","Kawasaki MATCH Trial","Kawasaki MATCH: A Clinical Decision Support Tool to Detect KD","MATCH","Inclusion Criteria:\n\n* Measured or subjective fever for \\>= 3 calendar days\n* One measured fever \\>= 38.0 C (home or in ED)\n* One or more clinical feature of Kawasaki Disease including:\n* Rash\n* Conjunctival injection\n* Oropharyngeal changes\n* Extremity changes (erythema, edema, desquamation)\n* Cervical adenopathy (\\>=1.5cm)\n* Infants \\\u003C 6 months of age with \\>= 7 days of fever eligible even if none of the above clinical features\n* Requires IV\u002Fphlebotomy for clinical evaluation\n\nExclusion Criteria:\n\n* Congenital or Acquired Immune function\n* Genetic disorders\n* Current systemic steroid, immunosuppression, or chemotherapy treatment (not including inhaled steroids)","30 Days",{"count":154,"type":21},200,[156],"NA","Evaluating the impact of a machine-learning clinical decision support tool on provider practice when evaluating febrile patients with Kawasaki Disease (KD) and non-KD illnesses.",[27],[27,160,161,162,163],"Machine-learning","Artificial Intelligence (AI)","Decision support","Point-of-care","2025-12-04",{"date":166,"type":37},"2025-12-18",{"date":168,"type":37},"2025-03-01",{"date":170,"type":21},"2026-10-31",{"name":172,"class":44},"University of California, San Diego",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":180,"maxAge":104,"enrollmentInfo":181,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},"100539574","european-and-north-indian-cohort-of-kawasaki-disease-100539574","NCT06305611","European and North Indian Cohort of KaWasaki dIsease","Comparison and Performance of Kobayashi and Kawanet IVIg Resistance Scores in a Multi-centric European and North Indian Cohort of KaWasaki dIsease (the KIWI Study)","Inclusion Criteria:\n\n* Patients aged less than 18 years at diagnosis\n* Diagnosis of KD according to the AHA criteria\n\nExclusion Criteria:\n\n* Patients who do not meet the criteria for KD\n* Patients for which an alternative infectious diagnosis was not investigated and\u002For excluded.","1 Year",{"count":182,"type":21},103,"Kawasaki disease (KD) is currently the leading cause of acquired heart diseases in children in developed countries. Cardiac involvement is the main determinant of the long-term prognosis of these patients, as coronary aneurisms (CAAs) may lead to ischemic heart disease and even sudden death. The current standard of care for KD has consistently reduced CAAs frequency from 25-30% to about 5%. Unfortunately, 10-20% of KD patients results resistant to standard treatment leading to a major risk of cardiac complications. Thus, scoring systems have been constructed in order to identify patients likely to be resistant to IVIG and who may benefit from more aggressive initial therapy. Different scoring scales developed by Kobayashi, Egami et Sano had shown a good sensitivity (77-86%) and specificity (67-86%) in predicting IVIG unresponsiveness in Japanese populations. However, their predictive value was not confirmed by subsequent studies in different ethnic populations. Recently, the French Kawanet group have proposed a IVIG unresponsiveness score that provided good sensitivity and acceptable specificity in a non-Asian KD population even if it was not subsequent validated by an external study. In our study population, the achievement of specificity and sensitivity values for both scores consistent with those reported by the original studies (sensitivity 70% and specificity 80% for Kobayashi and sensitivity 77% and specificity 60% for Kawanet), will be considered a success.",[27],"2025-09-23",{"date":187,"type":37},"2025-09-29",{"date":189,"type":37},"2021-07-13",{"date":191,"type":21},"2026-10-30",{"name":119,"class":44},27,{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":201,"maxAge":18,"enrollmentInfo":202,"targetDuration":4,"studyType":22,"phases":204,"briefSummary":206,"conditions":207,"keywords":211,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":45},"100591285","phase-4-model-informed-dose-optimization-for-rivaroxaban-in-children-with-giant-coronary-artery-aneurysm-after-kawasaki-disease-100591285","NCT06978439","Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease","Rivaroxaban in Chinese Children With Giant Coronary Artery Aneurysm After Kawasaki Disease: a Pilot Study","Inclusion Criteria:\n\n1. Giant coronary artery aneurysm(s) in any coronary artery after acute stage of Kawasaki disease. Giant coronary artery aneurysm(s) should be confirmed by two-dimensional echocardiography and meet the diagnostic criteria of Z-score ≥10 or coronary artery internal diameter ≥8mm;\n2. Anticoagulant with antiplatelet drug therapy for anti-thromboprophylaxis is recommended for the next 6 months;\n3. Participant should be able to tolerate oral feeding, nasogastric or gastric feeding;\n4. Children aged 1 Month to\\\u003C18 years, bodyweight ≥ 2600g.\n\nExclusion Criteria:\n\n1. Active bleeding or bleeding risk contraindicating anticoagulant therapy\n2. With history of venous thromboembolism or risk factors related with venous thromboembolism, like congenital heart disease, carcinoma, central venous catheter or long-term immobilization.\n3. Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment\n4. An eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2 (For children younger than 1 year, serum creatinine results above 97.5th percentile)\n5. Platelet count \\\u003C 100 x 109\u002FL\n6. Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase \\> 5x ULN or total bilirubin \\> 2x ULN with direct bilirubin \\> 20% of the total\n7. Sustained uncontrolled hypertension defined as systolic and\u002For diastolic blood pressure \\>95 th age percentile\n8. Concomitant use of strong inhibitors of both CYP3A4 and P-glycoprotein, including but not limited to all human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically (fluconazole is allowed)\n9. Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine\n10. Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment\n11. Inability to cooperate with the study procedures and follow-up visits\n12. Refuse to provide informed consent\n\neGFR, estimated glomerular filtration rate; ULN, upper level of normal; TB, total bilirubin (TB); CYP3A4, cytochrome P450 isoenzyme 3A4","1 Month",{"count":203,"type":21},10,[205],"PHASE4","Based on a population pharmacokinetic model-based dose optimization study, a 15 mg-equivalent, age-, and bodyweight-adjusted dosing regimen for Chinese children with giant coronary artery aneurysms after Kawasaki disease was proposed. This single-center, single-arm, pilot study aims to evaluate the feasibility of the 15 mg-equivalent dosing regimen within a limited sample size.\n\nPatients will be followed for more than 6 months. Clinical outcomes, including coronary artery thrombosis, major adverse cardiovascular events, and bleeding events, will be recorded. Rivaroxaban levels will be measured to assess the robustness of the model-informed dose optimization.",[27,208,209,210],"Pilot Study","Coronary Artery Aneurysm","Rivaroxaban",[212,213,214,215,216],"kawasaki disease","giant coronary artery aneurysm","rivaroxaban","model-informed dose optimization","anticoagulant","2025-09-01",{"date":219,"type":37},"2025-09-08",{"date":221,"type":37},"2024-01-10",{"date":223,"type":21},"2025-12-31",{"name":43,"class":44},{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":16,"minAge":232,"maxAge":233,"enrollmentInfo":234,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":236,"conditions":237,"keywords":261,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":274},"100599630","cardiovascular-risk-in-children-with-chronic-conditions-study-100599630","NCT07086989","Cardiovascular Risk in Children With Chronic Conditions Study","CR3C","Inclusion criteria:\n\n1. Individuals aged between 6 and 25 years;\n2. Diagnosed with a chronic childhood condition\u002Fdisease associated with an increased risk of early cardiovascular disease;\n3. Provided informed consent (if over 18 years old) or had informed consent provided by their legal guardian (if under 18 years old) following appropriate information about the study.\n\nChronic childhood conditions\u002Fdiseases associated with increased risk of early cardiovascular disease are defined according to the 2019 American Heart Association recommendations (https:\u002F\u002Fdoi.org\u002F10.1161\u002FCIR.0000000000000618), as well as other conditions\u002Fdiseases for which at least two large-scale epidemiological studies have demonstrated an increased risk of cardiovascular disease.\n\nExclusion criteria:\n\n1. Severe intellectual and developmental disability;\n2. Decompensated heart failure;\n3. Severe primary immunodeficiency;\n4. Ongoing intravenous chemotherapy;\n5. Infectious diseases posing a public health risk; or\n6. History of regular alcohol or drug use.","6 Years","25 Years",{"count":235,"type":21},300,"Children living with chronic health conditions face a higher risk of developing cardiovascular diseases than their peers, largely due to the accelerated aging of the heart and blood vessels. Although experts recognize this elevated risk and recommend close monitoring and early intervention, the underlying mechanisms driving this phenomenon remain poorly understood. At present, no effective interventions specifically target its root causes.\n\nRecent research shows that both large blood vessels (such as the carotid artery) and small vessels (such as those in the retina) can display early signs of damage decades before clinically apparent heart or vascular disease emerges. This accelerated vascular aging can result from multiple factors - including disease-related processes such as persistent inflammation and metabolic disturbances, treatment-related effects such as chemotherapy or long-term steroid use, and lifestyle changes associated with chronic illness, such as reduced physical activity and altered eating habits. However, it is still unclear how these factors influence the development and progression of vascular changes in children as they grow. Importantly, these changes can be monitored through non-invasive methods, offering a unique opportunity to study at-risk patients many years before overt cardiovascular disease develops.\n\nIdentifying these early changes may enable us to detect and track individuals at heightened risk well in advance of clinical disease. This study aims to deepen our understanding of the causes of increased cardiovascular risk in children with chronic conditions and to lay the groundwork for earlier, more targeted prevention strategies.",[238,239,240,241,242,27,243,244,65,245,246,247,248,249,250,251,252,253,254,255,256,257,258,259,260],"Kidney Transplant","Familial Hypercholesterolaemia","Type 1 Diabetes Mellitus (T1DM)","Type 2 Diabetes Mellitus (T2DM)","Chronic Kidney Disease","Liver Transplant","Obesity and Overweight","Coarctation of Aorta","Bone Marrow Transplant","Cancer (Solid Tumors)","Leukemia","Lymphoma","Lipoprotein(a)","Aorta Stenosis","Non Alcoholic Fatty Liver Disease","Dyslipaemia","White Coat Hypertension","Pulmonary Hypertension","Juvenile Idiopahtic Arthritis","Systemic Lupus Erthematosus","Inflammatory Bowel Disease (IBD)","HIV Infection","Transposition of Great Arteries",[262,263,264],"cardiovascular risk","vasculature","children with chronic conditions","2025-08-04",{"date":267,"type":37},"2025-08-08",{"date":269,"type":37},"2025-04-01",{"date":271,"type":21},"2029-01-31",{"name":273,"class":44},"Semmelweis University",3,{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":283,"targetDuration":4,"studyType":22,"phases":285,"briefSummary":286,"conditions":287,"keywords":288,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":45},"100488710","phase-4-rivaroxaban-for-children-aged-over-2-years-with-giant-coronary-artery-aneurysms-after-kawasaki-disease-100488710","NCT05643651","Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease","Rivaroxaban Versus Warfarin for Thromboprophylaxis in Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease: a Multicenter, Open-label, Parallel, Exploratory, Randomized Controlled Trial","RIVA-KG","Inclusion Criteria:\n\n1. Giant coronary artery aneurysm(s) in any coronary artery after acute stage of Kawasaki disease. Giant coronary artery aneurysm(s) should be confirmed by two-dimensional echocardiography and meet the diagnostic criteria of Z-score ≥10 or coronary artery internal diameter ≥8mm;\n2. Anticoagulant with antiplatelet drug therapy for anti-thromboprophylaxis is recommended for the next 3 months;\n3. Participant should be able to tolerate oral feeding, nasogastric or gastric feeding;\n4. Children aged ≥ 2 years\n\nExclusion Criteria:\n\n1. Active bleeding or bleeding risk contraindicating anticoagulant therapy\n2. With history of venous thromboembolism or risk factors related with venous thromboembolism, like congenital heart disease, carcinoma, central venous catheter or long-term immobilization.\n3. Thrombus within giant coronary aneurysm was confirmed by previous imaging examinations, including two-dimensional echocardiography, computed tomography angiography in coronary artery or coronary angiography\n4. An eGFR \\\u003C30mL\u002Fmin\u002F1.73 m2 (For children younger than 1 year, serum creatinine results above 97.5th percentile)\n5. Platelet count \\\u003C 100 x 109\u002FL\n6. Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase \\> 5x ULN or total bilirubin \\> 2x ULN with direct bilirubin \\> 20% of the total\n7. Sustained uncontrolled hypertension defined as systolic and\u002For diastolic blood pressure \\>95 th age percentile\n8. Concomitant use of strong inhibitors of both CYP3A4 and P-glycoprotein, including but not limited to all human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically (fluconazole is allowed)\n9. Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine\n10. Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment\n11. Inability to cooperate with the study procedures and follow-up visits\n12. Refuse to provide informed consent eGFR, estimated glomerular filtration rate; ULN, upper level of normal; TB, total bilirubin; CYP3A4, cytochrome P450 isoenzyme 3A4",{"count":284,"type":21},100,[205],"Based on population pharmacokinetic model-based simulation, a 15 mg-equivalent, age-, and bodyweight-adjusted dosing regimen for Chinese children with giant coronary artery aneurysms after acute Kawasaki disease was proposed. This exploratory trial aims to evaluate the feasibility, safety and effectiveness of rivaroxaban compared to warfarin for thromboprophylaxis in children aged over 2 years with giant coronary artery aneurysms after Kawasaki disease",[27,209],[289,290,210,291,292],"Kawasaki disease","Giant coronary artery aneurysm","Warfarin","Anticoagulation","2025-06-29",{"date":295,"type":37},"2025-07-02",{"date":297,"type":37},"2025-06-01",{"date":299,"type":21},"2027-09-01",{"name":43,"class":44},{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":308,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":310,"conditions":311,"keywords":314,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":45},"100592454","pharmacometrics-analysis-of-rivaroxaban-in-chinese-children-aged-over-2-years-100592454","NCT06993636","Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years","Population Pharmacokinetic\u002FPharmacodynamic Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years With Giant Coronary Artery Aneurysm After Kawasaki Disease","Inclusion Criteria:\n\n1. Giant coronary artery aneurysm(s) in any coronary artery after acute stage of Kawasaki disease. Giant coronary artery aneurysm(s) should be confirmed by two-dimensional echocardiography and meet the diagnostic criteria of Z-score ≥10 or coronary artery internal diameter ≥8mm;\n2. Anticoagulant with antiplatelet drug therapy for anti-thromboprophylaxis is recommended for the next 6 months;\n3. Children aged 2 years to \\\u003C18 years\n\nExclusion Criteria:\n\n1. Active bleeding or bleeding risk contraindicating anticoagulant therapy\n2. Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment\n3. Patients participating in clinical trials of other drugs at the same time",{"count":309,"type":21},60,"Based on an established Kawasaki disease cohort database, this prospective, single-center, single-arm, observational study will collect clinical data from children aged 2 years and older with giant coronary artery aneurysms after Kawasaki disease who received rivaroxaban treatment. Rivaroxaban plasma concentrations, anti-factor Xa activity levels, and genetic polymorphisms will be measured and analyzed to support the population pharmacokinetic\u002Fpharmacodynamic analysis",[27,209,210,312,313],"Anticoagulant Drugs","Pharmacokinetics and Pharmacodynamics",[289,315,316,214,216],"Coronary artery aneurysm","Population pharmacokinetic and pharmacodynamic","2025-05-25",{"date":319,"type":37},"2025-05-29",{"date":321,"type":37},"2023-01-01",{"date":323,"type":21},"2026-12-31",{"name":43,"class":44},{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":333,"targetDuration":334,"studyType":59,"phases":4,"briefSummary":335,"conditions":336,"keywords":679,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":722,"lastUpdatePostDateStruct":723,"startDateStruct":724,"completionDateStruct":726,"leadSponsor":728,"locationsCount":730},"100193378","rare-disease-patient-registry--natural-history-study---coordination-of-rare-diseases-at-sanford-100193378","NCT01793168","Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford","Coordination of Rare Diseases at Sanford","CoRDS","Inclusion Criteria:\n\n* Diagnosis of a rare disease, a disease of unknown prevalence, undiagnosed or an unaffected carrier of a rare\u002Funcommon disease\n\nExclusion Criteria:\n\n* Diagnosis of a disease which is not rare",{"count":127,"type":21},"100 Years","CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases. This program allows patients and researchers to connect as easily as possible to help advance treatments and cures for rare diseases. The CoRDS team works with patient advocacy groups, individuals and researchers to help in the advancement of research in over 7,000 rare diseases. The registry is free for patients to enroll and researchers to access. Visit sanfordresearch.org\u002FCoRDS to enroll.",[337,338,339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,27,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,393,394,395,396,397,398,399,400,401,402,403,404,405,406,407,408,409,410,411,412,413,414,415,416,417,418,419,420,421,422,423,424,425,426,427,428,429,430,431,432,433,434,435,436,437,438,439,440,441,442,443,444,445,446,447,448,449,450,451,452,453,454,455,456,457,458,459,460,461,462,463,464,465,466,467,468,469,470,471,472,473,474,475,476,477,478,479,480,481,482,483,484,485,486,487,488,489,490,491,492,493,494,495,496,497,498,499,500,501,502,503,504,505,506,507,508,509,510,511,512,513,514,515,516,517,518,519,520,521,522,523,524,525,526,527,528,529,530,531,532,533,534,535,536,537,538,539,540,541,542,543,544,545,546,547,548,549,550,551,552,553,554,555,556,557,558,559,560,561,562,563,564,565,566,567,568,569,570,571,572,573,574,575,576,577,578,579,580,581,582,583,584,585,586,587,588,589,590,591,592,593,594,595,596,597,598,599,600,601,602,603,604,605,606,607,608,609,610,611,612,613,614,615,616,617,618,619,620,621,622,623,624,625,626,627,628,629,630,631,632,633,634,635,636,637,638,639,640,641,642,643,644,645,646,647,648,649,650,651,652,653,654,655,656,657,658,659,660,661,662,663,664,665,666,667,668,669,670,671,672,673,674,675,676,677,678],"Rare Disorders","Undiagnosed Disorders","Disorders of Unknown Prevalence","Cornelia De Lange Syndrome","Prenatal Benign Hypophosphatasia","Perinatal Lethal Hypophosphatasia","Odontohypophosphatasia","Adult Hypophosphatasia","Childhood-onset Hypophosphatasia","Infantile Hypophosphatasia","Hypophosphatasia","Kabuki Syndrome","Bohring-Opitz Syndrome","Narcolepsy Without Cataplexy","Narcolepsy-cataplexy","Hypersomnolence Disorder","Idiopathic Hypersomnia Without Long Sleep Time","Idiopathic Hypersomnia With Long Sleep Time","Idiopathic Hypersomnia","Kleine-Levin Syndrome","Leiomyosarcoma","Leiomyosarcoma of the Corpus Uteri","Leiomyosarcoma of the Cervix Uteri","Leiomyosarcoma of Small Intestine","Acquired Myasthenia Gravis","Addison Disease","Hyperacusis (Hyperacousis)","Juvenile Myasthenia Gravis","Transient Neonatal Myasthenia Gravis","Williams Syndrome","Lyme Disease","Myasthenia Gravis","Marinesco Sjogren Syndrome(Marinesco-Sjogren Syndrome)","Isolated Klippel-Feil Syndrome","Frasier Syndrome","Denys-Drash Syndrome","Beckwith-Wiedemann Syndrome","Emanuel Syndrome","Isolated Aniridia","Axenfeld-Rieger Syndrome","Aniridia-intellectual Disability Syndrome","Aniridia - Renal Agenesis - Psychomotor Retardation","Aniridia - Ptosis - Intellectual Disability - Familial Obesity","Aniridia - Cerebellar Ataxia - Intellectual Disability","Aniridia - Absent Patella","Aniridia","Peters Anomaly - Cataract","Peters Anomaly","Potocki-Shaffer Syndrome","Silver-Russell Syndrome Due to Maternal Uniparental Disomy of Chromosome 11","Silver-Russell Syndrome Due to Imprinting Defect of 11p15","Silver-Russell Syndrome Due to 11p15 Microduplication","Syndromic Aniridia","WAGR Syndrome","Wolf-Hirschhorn Syndrome","4p16.3 Microduplication Syndrome","4p Deletion Syndrome, Non-Wolf-Hirschhorn Syndrome","Autosomal Recessive Stickler Syndrome","Stickler Syndrome Type 2","Stickler Syndrome Type 1","Stickler Syndrome","Mucolipidosis Type 4","X-linked Spinocerebellar Ataxia Type 4","X-linked Spinocerebellar Ataxia Type 3","X-linked Intellectual Disability - Ataxia - Apraxia","X-linked Progressive Cerebellar Ataxia","X-linked Non Progressive Cerebellar Ataxia","X-linked Cerebellar Ataxia","Vitamin B12 Deficiency Ataxia","Toxic Exposure Ataxia","Unclassified Autosomal Dominant Spinocerebellar Ataxia","Thyroid Antibody Ataxia","Sporadic Adult-onset Ataxia of Unknown Etiology","Spinocerebellar Ataxia With Oculomotor Anomaly","Spinocerebellar Ataxia With Epilepsy","Spinocerebellar Ataxia With Axonal Neuropathy Type 2","Spinocerebellar Ataxia Type 8","Spinocerebellar Ataxia Type 7","Spinocerebellar Ataxia Type 6","Spinocerebellar Ataxia Type 5","Spinocerebellar Ataxia Type 4","Spinocerebellar Ataxia Type 37","Spinocerebellar Ataxia Type 36","Spinocerebellar Ataxia Type 35","Spinocerebellar Ataxia Type 34","Spinocerebellar Ataxia Type 32","Spinocerebellar Ataxia Type 31","Spinocerebellar Ataxia Type 30","Spinocerebellar Ataxia Type 3","Spinocerebellar Ataxia Type 29","Spinocerebellar Ataxia Type 28","Spinocerebellar Ataxia Type 27","Spinocerebellar Ataxia Type 26","Spinocerebellar Ataxia Type 25","Spinocerebellar Ataxia Type 23","Spinocerebellar Ataxia Type 22","Spinocerebellar Ataxia Type 21","Spinocerebellar Ataxia Type 20","Spinocerebellar Ataxia Type 2","Spinocerebellar Ataxia Type 19\u002F22","Spinocerebellar Ataxia Type 18","Spinocerebellar Ataxia Type 17","Spinocerebellar Ataxia Type 16","Spinocerebellar Ataxia Type 15\u002F16","Spinocerebellar Ataxia Type 14","Spinocerebellar Ataxia Type 13","Spinocerebellar Ataxia Type 12","Spinocerebellar Ataxia Type 11","Spinocerebellar Ataxia Type 10","Spinocerebellar Ataxia Type 1 With Axonal Neuropathy","Spinocerebellar Ataxia Type 1","Spinocerebellar Ataxia - Unknown","Spinocerebellar Ataxia - Dysmorphism","Non Progressive Epilepsy and\u002For Ataxia With Myoclonus as a Major Feature","Spasticity-ataxia-gait Anomalies Syndrome","Spastic Ataxia With Congenital Miosis","Spastic Ataxia - Corneal Dystrophy","Spastic Ataxia","Rare Hereditary Ataxia","Rare Ataxia","Recessive Mitochondrial Ataxia Syndrome","Progressive Epilepsy and\u002For Ataxia With Myoclonus as a Major Feature","Posterior Column Ataxia - Retinitis Pigmentosa","Post-Stroke Ataxia","Post-Head Injury Ataxia","Post Vaccination Ataxia","Polyneuropathy - Hearing Loss - Ataxia - Retinitis Pigmentosa - Cataract","Muscular Atrophy - Ataxia - Retinitis Pigmentosa - Diabetes Mellitus","Non-hereditary Degenerative Ataxia","Paroxysmal Dystonic Choreathetosis With Episodic Ataxia and Spasticity","Olivopontocerebellar Atrophy - Deafness","NARP Syndrome","Myoclonus - Cerebellar Ataxia - Deafness","Multiple System Atrophy, Parkinsonian Type","Multiple System Atrophy, Cerebellar Type","Multiple System Atrophy","Maternally-inherited Leigh Syndrome","Machado-Joseph Disease Type 3","Machado-Joseph Disease Type 2","Machado-Joseph Disease Type 1","Leigh Syndrome","Late-onset Ataxia With Dementia","Infection or Post Infection Ataxia","GAD Ataxia","Hereditary Episodic Ataxia","Gliadin\u002FGluten Ataxia","Friedreich Ataxia","Fragile X-associated Tremor\u002FAtaxia Syndrome","Familial Paroxysmal Ataxia","Exposure to Medications Ataxia","Episodic Ataxia With Slurred Speech","Episodic Ataxia Unknown Type","Episodic Ataxia Type 7","Episodic Ataxia Type 6","Episodic Ataxia Type 5","Episodic Ataxia Type 4","Episodic Ataxia Type 3","Episodic Ataxia Type 1","Epilepsy and\u002For Ataxia With Myoclonus as Major Feature","Early-onset Spastic Ataxia-neuropathy Syndrome","Early-onset Progressive Neurodegeneration - Blindness - Ataxia - Spasticity","Early-onset Cerebellar Ataxia With Retained Tendon Reflexes","Early-onset Ataxia With Dementia","Childhood-onset Autosomal Recessive Slowly Progressive Spinocerebellar Ataxia","Dilated Cardiomyopathy With Ataxia","Cataract - Ataxia - Deafness","Cerebellar Ataxia, Cayman Type","Cerebellar Ataxia With Peripheral Neuropathy","Cerebellar Ataxia - Hypogonadism","Cerebellar Ataxia - Ectodermal Dysplasia","Cerebellar Ataxia - Areflexia - Pes Cavus - Optic Atrophy - Sensorineural Hearing Loss","Brain Tumor Ataxia","Brachydactyly - Nystagmus - Cerebellar Ataxia","Benign Paroxysmal Tonic Upgaze of Childhood With Ataxia","Autosomal Recessive Syndromic Cerebellar Ataxia","Autosomal Recessive Spastic Ataxia With Leukoencephalopathy","Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay","Autosomal Recessive Spastic Ataxia - Optic Atrophy - Dysarthria","Autosomal Recessive Spastic Ataxia","Autosomal Recessive Metabolic Cerebellar Ataxia","Autosomal Dominant Spinocerebellar Ataxia Due to Repeat Expansions That do Not Encode Polyglutamine","Autosomal Recessive Ataxia, Beauce Type","Autosomal Recessive Ataxia Due to Ubiquinone Deficiency","Autosomal Recessive Ataxia Due to PEX10 Deficiency","Autosomal Recessive Degenerative and Progressive Cerebellar Ataxia","Autosomal Recessive Congenital Cerebellar Ataxia Due to MGLUR1 Deficiency","Autosomal Recessive Congenital Cerebellar Ataxia Due to GRID2 Deficiency","Autosomal Recessive Congenital Cerebellar Ataxia","Autosomal Recessive Cerebellar Ataxia-pyramidal Signs-nystagmus-oculomotor Apraxia Syndrome","Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome Due to WWOX Deficiency","Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome Due to TUD Deficiency","Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome Due to KIAA0226 Deficiency","Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome","Autosomal Recessive Cerebellar Ataxia With Late-onset Spasticity","Autosomal Recessive Cerebellar Ataxia Due to STUB1 Deficiency","Autosomal Recessive Cerebellar Ataxia Due to a DNA Repair Defect","Autosomal Recessive Cerebellar Ataxia - Saccadic Intrusion","Autosomal Recessive Cerebellar Ataxia - Psychomotor Retardation","Autosomal Recessive Cerebellar Ataxia - Blindness - Deafness","Autosomal Recessive Cerebellar Ataxia","Autosomal Dominant Spinocerebellar Ataxia Due to a Polyglutamine Anomaly","Autosomal Dominant Spinocerebellar Ataxia Due to a Point Mutation","Autosomal Dominant Spinocerebellar Ataxia Due to a Channelopathy","Autosomal Dominant Spastic Ataxia Type 1","Autosomal Dominant Spastic Ataxia","Autosomal Dominant Optic Atrophy","Ataxia-telangiectasia Variant","Ataxia-telangiectasia","Autosomal Dominant Cerebellar Ataxia, Deafness and Narcolepsy","Autosomal Dominant Cerebellar Ataxia Type 4","Autosomal Dominant Cerebellar Ataxia Type 3","Autosomal Dominant Cerebellar Ataxia Type 2","Autosomal Dominant Cerebellar Ataxia Type 1","Autosomal Dominant Cerebellar Ataxia","Ataxia-telangiectasia-like Disorder","Ataxia With Vitamin E Deficiency","Ataxia With Dementia","Ataxia - Oculomotor Apraxia Type 1","Ataxia - Other","Ataxia - Genetic Diagnosis - Unknown","Acquired Ataxia","Adult-onset Autosomal Recessive Cerebellar Ataxia","Alcohol Related Ataxia","Multiple Endocrine Neoplasia","Multiple Endocrine Neoplasia Type II","Multiple Endocrine Neoplasia Type 1","Multiple Endocrine Neoplasia Type 2","Multiple Endocrine Neoplasia, Type IV","Multiple Endocrine Neoplasia, Type 3","Multiple Endocrine Neoplasia (MEN) Syndrome","Multiple Endocrine Neoplasia Type 2B","Multiple Endocrine Neoplasia Type 2A","Atypical Hemolytic Uremic Syndrome","Atypical HUS","Wiedemann-Steiner Syndrome","Breast Implant-Associated Anaplastic Large Cell Lymphoma","Autoimmune\u002FInflammatory Syndrome Induced by Adjuvants (ASIA)","Hemophagocytic Lymphohistiocytosis","Behcet's Disease","Alagille Syndrome","Inclusion Body Myopathy With Early-onset Paget Disease and Frontotemporal Dementia (IBMPFD)","Lowe Syndrome","Pitt Hopkins Syndrome","1p36 Deletion Syndrome","Jansen Type Metaphyseal Chondrodysplasia","Cockayne Syndrome","Chronic Recurrent Multifocal Osteomyelitis","CRMO","Malan Syndrome","Hereditary Sensory and Autonomic Neuropathy Type Ie","VCP Disease","Hypnic Jerking","Sleep Myoclonus","Mollaret Meningitis","Recurrent Viral Meningitis","CRB1","Leber Congenital Amaurosis","Retinitis Pigmentosa","Rare Retinal Disorder","KCNMA1-Channelopathy","Primary Biliary Cirrhosis","ZMYND11","Transient Global Amnesia","Glycogen Storage Disease","Alstrom Syndrome","White Sutton Syndrome","DNM1","EIEE31","Myhre Syndrome","Recurrent Respiratory Papillomatosis","Laryngeal Papillomatosis","Tracheal Papillomatosis","Refsum Disease","Nicolaides Baraitser Syndrome","Leukodystrophy","Tango2","Cauda Equina Syndrome","Rare Gastrointestinal Disorders","Achalasia-Addisonian Syndrome","Achalasia Cardia","Achalasia Icrocephaly Syndrome","Anal Fistula","Congenital Sucrase-Isomaltase Deficiency","Eosinophilic Gastroenteritis","Idiopathic Gastroparesis","Hirschsprung Disease","Rare Inflammatory Bowel Disease","Intestinal Pseudo-Obstruction","Scleroderma","Short Bowel Syndrome","Sacral Agenesis","Sacral Agenesis Syndrome","Caudal Regression","Scheuermann Disease","SMC1A Truncated Mutations (Causing Loss of Gene Function)","Cystinosis","Juvenile Nephropathic Cystinosis","Nephropathic Cystinosis","Kennedy Disease","Spinal Bulbar Muscular Atrophy","Warburg Micro Syndrome","Mucolipidoses","Mitochondrial Diseases","Mitochondrial Aminoacyl-tRNA Synthetases","Mt-aaRS Disorders","Hypertrophic Olivary Degeneration","Non-Ketotic Hyperglycinemia","Fish Odor Syndrome","Halitosis","Isolated Congenital Asplenia","Lambert Eaton (LEMS)","Biliary Atresia","STAG1 Gene Mutation","Coffin Lowry Syndrome","Borjeson-Forssman-Lehman Syndrome","Blau Syndrome","Arginase 1 Deficiency","HSPB8 Myopathy","Beta-Mannosidosis","TBX4 Syndrome","DHDDS Gene Mutations","MAND-MBD5-Associated Neurodevelopmental Disorder","Constitutional Mismatch Repair Deficiency (CMMRD)","SPATA5 Disorder","SPATA5L1 Related Disorder","Acrodysostosis","Multi-systematic Smooth Muscle Dysfunction Syndrome","CRELD1 (Cysteine Rich With EGF Like Domains 1)","GNB1 Syndrome","Pyruvate Dehydrogenase Complex Deficiency Disease","Beta Mannosidosis","Kbg Syndrome","Labrune Syndrome","Metachromatic Leukodystrophy (MLD)","Moyamoya Disease","OPHN1 Syndrome","Oculopharyngeal Muscular Dystrophy (OPMD)","TUBB3 Mutation","WOREE (WWOX-related Epileptic Encephalopathy","SCAR12","Skraban-Deardorff Syndrome","Hereditary Myopathy With Early Respiratory Failure",[680,681,682,683,684,390,685,686,397,687,27,688,689,690,560,569,691,692,348,693,694,356,695,357,696,347,697,698,572,699,700,575,576,701,578,579,702,703,582,704,705,706,632,707,708,709,710,711,712,713,637,714,715,716,642,643,717,718,719,720,721],"Rare Diseases","Neglected Diseases","Orphan Diseases","Rare Disease Research","Registries","Ataxia","Cornelia de Lange Syndrome","Ataxia Telangiectasia","Batten Disease","Mucolipidosis IV","Klippel-Feil Syndrome","Undiagnosed","Uncommon Disease","Hypersomnia","Hyperacusis","Marinesco-Sjogren Syndrome","4p-\u002FWolf-Hirschhorn Syndrome","Narcolepsy","Wiedermann-Steiner Syndrome","Autoimmune\u002Finflammatory Syndrome Induced by Adjuvants (ASIA)","Hemophagocytic Lymphohistiocytosis (HLH)","Inclusion body myopathy with early-onset Paget disease and frontotemporal dementia (IBMPFD)","1p36 deletion syndrome","Jansen metaphyseal chondrodysplasia","Chronic recurrent multifocal osteomyelitis (CRMO)","Malan syndrome","Hereditary Sensory and Autonomic Neuropathy","Juvenile nephropathic cystinosis","Nephropathic infantile cystinosis","Ocular cystinosis","Kennedy disease","Spinal Bulbar Muscular Atrophy (SBMA)","SMC1A Truncated Mutations (causing loss of gene function)","Leigh syndrome","Mucolipidosis","Mitochondrial aminoacyl-tRNA synthetases (Mt-aaRS Disorders)","Shine Syndrome","Intestinal Bromhidrosis Syndrome","Fish odor syndrome","Autosomal recessive extra oral halitosis","CACNA1H mutation","Dimethylglycine dehydrogenase deficiency","2025-05-22",{"date":319,"type":37},{"date":725,"type":37},"2010-07",{"date":727,"type":21},"2100-12",{"name":729,"class":44},"Sanford Health",2,{"id":732,"slug":733,"hasResults":11,"nctId":734,"briefTitle":735,"officialTitle":736,"acronym":737,"eligibilityCriteria":738,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":18,"enrollmentInfo":739,"targetDuration":4,"studyType":22,"phases":741,"briefSummary":742,"conditions":743,"keywords":746,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":749,"lastUpdatePostDateStruct":750,"startDateStruct":752,"completionDateStruct":754,"leadSponsor":755,"locationsCount":757},"100575682","genome-analysis-of-human-endogenous-retroviruses-hervscovid19-100575682","NCT06775457","Genome Analysis of Human Endogenous Retroviruses (HERVs)(COVID19)","Genome Analysis of Human Endogenous Retroviruses (HERVs) and Gut Microbiota in Patients With SARS-CoV-2 Infection, Kawasaki Disease and Other Febrile and Inflammatory Diseases With Systemic Involvement in Pediatric Age.","HERV_COVID","Inclusion Criteria:\n\n* Pediatric patients, newly diagnosed with Kawasaki disease\n* Pediatric patients, newly diagnosed with Vasculitis\n* Pediatric patients, newly diagnosed with SARS-CoV-2 infection\n* Pediatric patients, newly diagnosed with febrile virosis\n* Pediatric patients with inflammatory diseases with systemic involvement\n\nExclusion Criteria:\n\n* None",{"count":740,"type":21},120,[156],"Human Endogenous Retroviruses (HERVs) are ancient sequences that became integrated into our DNA during evolutionary processes.\n\nThe significance of their presence in DNA is still being studied, but HERVs appear to be involved in the regulation of the immune response.\n\nThe gut microbiota is the set of microorganisms that physiologically colonize the gastrointestinal tract. Progressively increasing attention is being paid to the gut microbiota and its potential role in diseases of various kinds. In particular, it has recently been shown how abnormalities in the microbiota can affect immune regulation by determining the occurrence of certain diseases. One objective of the study is to evaluate whether there is an association between the expression of HERVs and clinical manifestations in pediatric age in patients with various diseases such as Kawasaki Disease, IgA Vasculitis\u002FSchonlein-Henoch's Purpura, SARS-CoV-2 infection, or, finally, febrile virosis.\n\nAnother objective of the study is to evaluate whether there is an association between the presence of particular types of bacteria in the gut microbiota and clinical manifestations in pediatric age in patients with Kawasaki Disease, IgA Vasculitis\u002FSchonlein-Henoch purpura, SARS-CoV-2 infection or febrile virosis.\n\nThe results from this may open new perspectives for both the care and therapeutic management of children with these diseases.",[744,27,745],"SARS CoV-2","Retrovirus Infection",[747,27,748],"SARS-COV2","Human Endogenous Retroviruses","2025-01-09",{"date":751,"type":37},"2025-01-15",{"date":753,"type":37},"2021-06-10",{"date":223,"type":21},{"name":756,"class":44},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",5,{"id":759,"slug":760,"hasResults":11,"nctId":761,"briefTitle":762,"officialTitle":763,"acronym":764,"eligibilityCriteria":765,"healthyVolunteers":11,"sex":16,"minAge":201,"maxAge":766,"enrollmentInfo":767,"targetDuration":4,"studyType":22,"phases":769,"briefSummary":770,"conditions":771,"keywords":4,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":773,"lastUpdatePostDateStruct":774,"startDateStruct":776,"completionDateStruct":777,"leadSponsor":779,"locationsCount":4},"100569683","phase-4-non-inferiority-kawasaki-trial-with-anakinra-100569683","NCT06697431","Non Inferiority KawasakI Trial With Anakinra","A Randomized, Controlled, Open-label, Non Inferiority KawasakI Trial With Anakinra","NIKITA","Inclusion Criteria\n\n1. KD defined in at least one of the three following ways as per American Heart Association (AHA) criteria: Fever for at least 5 days in addition to 4 of the following 5 clinical criteria:\n\n   * bilateral non-purulent conjunctivitis\n   * cervical lymphadenopathy\n   * polymorphous skin rash\n   * changes in lips or mucosa (strawberry tongue, red cracked lips, diffuse erythematous oropharynx)\n   * extremity changes (erythema, oedema of palms and soles in initial phase, and at convalescent stage skin peeling)\n2. less than 5 days of fever but all 5 clinical criteria above\n3. incomplete KD cases defined as:\n\n   * children\u002Fadolescents (\\>1 year old) with fever greater than or equal to 5 days AND at least 2 other compatible clinical criteria as listed above;\n   * OR infants ≤ 1 year old with fever greater than or equal to 7 days without other explanation;\n\n   AND for both age groups, CRP ≥30 mg\u002FL or erythrocyte sedimentation rate (ESR) ≥40 mm\u002Fhr (or both) AND for both age groups EITHER the presence of any 3 or more of: anaemia for age (haemoglobin \\\u003C lower limit of normal reference range for local laboratory); platelet count ≥450,000\u002FL or \\\u003C140,000\u002FL; albumin \\\u003C30 g\u002FL; elevated ALT (\\> upper limit of normal reference range for local laboratory); white cell count ≥15,000\u002FL; urine ≥10 white blood cells per high power field iv.\n\n   OR abnormal echocardiogram compatible with KD but without established CAA, with ≥ 3 of the following suggestive features: decreased left ventricular function, mitral regurgitation, pericardial effusion, or dilated but non-aneurysmal coronary arteries (internal diameter 2≤Z\\\u003C2.5; and not meeting the exclusion criteria for aneurysmal change as defined below).\n4. To be enrolled children need to show persistent fever ≤7 days\n5. Written informed consent from an appropriate legal representative(s), and assent from patients older than 7 years\n\nExclusion Criteria\n\n1. Patients with KD and already established coronary artery aneurysms (CAA), as per AHA definition, at screening.\n2. Clinical picture consistent with Kawasaki Shock Syndrome (KDSS) or Macrophage Activation Syndrome (MAS) OR Multisystem Inflammatory Syndrome in Children (MIS-C)\n3. History or evidence of any previous heart disease\n4. Known hypersensitivity to anakinra, IVIG and ASA or any medical condition that contraindicates the use of these treatments\n5. Patients with KD receiving IVIG, corticosteroids, immunosuppressants, biologic treatments at the time of screening","16 Years",{"count":768,"type":21},38,[205],"This is a multicenter, open-label, randomized, controlled, interventional trial followed by a long-term observational extension period in patients with Kawasaki Disease (KD) to be treated eitherwith endovenous Immunoglobulins (IVIG-standard treatment) versus anakinra\n\nAim of the study: to demonstrate that anakinra is non-inferior to IVIG in KD, in terms of fever control in the acute phase and development of coronary artery dilation\u002Faneurisms (CAA) within one year from the onset.",[27,772],"Anakinra","2024-11-19",{"date":775,"type":37},"2024-11-21",{"date":269,"type":21},{"date":778,"type":21},"2027-04-01",{"name":119,"class":44},{"id":781,"slug":782,"hasResults":11,"nctId":783,"briefTitle":784,"officialTitle":785,"acronym":786,"eligibilityCriteria":787,"healthyVolunteers":11,"sex":16,"minAge":788,"maxAge":104,"enrollmentInfo":789,"targetDuration":4,"studyType":22,"phases":791,"briefSummary":792,"conditions":793,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":794,"lastUpdatePostDateStruct":795,"startDateStruct":797,"completionDateStruct":799,"leadSponsor":801,"locationsCount":45},"100412871","phase-3-a-trial-comparing-the-efficacy-and-safety-of-anakinra-versus-intravenous-immunoglobulin-ivig-retreatment-in-patients-with-kawasaki-disease-who-failed-to-respond-to-initial-standard-ivig-treatment-100412871","NCT04656184","A Trial Comparing the Efficacy and Safety of Anakinra Versus Intravenous Immunoglobulin (IVIG) Retreatment, in Patients With Kawasaki Disease Who Failed to Respond to Initial Standard IVIG Treatment","A Randomized Phase III Multicenter Trial Comparing the Efficacy and Safety of Anakinra Versus Intravenous Immunoglobulin (IVIG) Retreatment, in Patients With Kawasaki Disease Who Failed to Respond to Initial Standard IVIG Treatment","ANACOMP","Inclusion Criteria:\n\n* Children, male and female, from 3 months to \\\u003C18 years old\n* Patient ≥ 5 kg\n* Patient with KD according to the American Heart Association definition for complete or incomplete KD. (Fever ≥ 5 days (or at least 3 days if KD with American Heart Association criteria since the third days of fever) and ≥ 4 of 5 main clinical signs: modification of the extremities, polymorphic exanthema, and bilateral bulbar not exudative conjunctivitis, erythema of the lips or oral cavity, and cervical lymph nodes usually unilateral \\> 1.5 cm in diameter.\n* Patients who failed to respond to the standard therapy of KD, e.g. Persistence or recrudescence of fever ≥ 38°C, 48 hours after the infusion of 2g\u002Fkg of IV Ig. Patients may be screened 24h after the end of the first infusion if they remain febrile 24h after the end of the first infusion.\n* Patient, parents or legal guardian's written informed consent is required\n* Patient with health insurance (SS or CMU).\n* Efficient contraception for the duration of participation in the research for childbearing aged women\n\nExclusion Criteria:\n\n* Preterm and neonates, pregnancy, pregnancy and breast feeding\n* Suspicion of another diagnosis\n* Patient with overt concomitant bacterial, viral or fungal infection\n* Patient previously treated with steroids and\u002For another biotherapy\n* Patient with increased risk of tuberculosis infection\n* Recent tuberculosis infection or with active tuberculosis\n* Patient with any type of immunodeficiency or cancer\n* Patients with severe renal impairment (CLcr \\\u003C 30 ml\u002Fminute)\n* Patients with hepatic insufficiency\n* Patients with neutropenia (ANC\\\u003C1.5 x109\u002Fl)\n* Patients included in another interventional protocol\n* Patient under the following treatments:\n* Preventive Antipyretics (paracetamol, NSAIDs other than aspirin 30-50mg\u002Fkg given for purpose of KD inflammation), as long as the patient receives the study medication\n* Immunosuppressive medications given in a period less than twice of their half-life prior the patient receives the study medication (systemic steroids, cyclosporine, tacrolimus, azathioprine, cyclophosphamide, interferon, mycophenolate, other anti-IL-1, anti IL-6, anti CD20 and anti TNF (Tumor Necrosis Factor)), plasmapheresis)\n* Hypersensitivity to anakinra or excipients (citric acid, sodium chloride, disodium EDTA (Ethylene Diamine Tetra Acetic), polysorbate 80, sodium hydroxide, in water for injection)\n* Hypersensitivity to IV Ig, or excipients (L-proline and water for injection), hypersensitivity to human normal immunoglobulin, in particular if the patient have anti-IgA antibodies (IgA: Immunoglobulin A)\n* Patients with type I or II hyperprolinemia\n* Live vaccines within 1 month prior to enrollment\n* Hypersensitivity to anakinra or to immunoglobulins or to excipients of Kineret® or Privigen® or to E.coli proteins\n* Contraindication for administration of anakinra or IVIG listed in the Summary of Products Characteristics (SmPC) of Kineret® and Privigen®\n* Ongoing or recent use of any other medication Known inhibitors\u002Finducers of cytochrome P450 as listed on the link below: http:\u002F\u002Fmedicine.iupui.edu\u002Fclinpharm\u002Fddis\u002Fmain-table","3 Months",{"count":790,"type":21},84,[24],"Kawasaki disease (KD) is the most frequent vasculitis in younger children \\\u003C5years, and the first cause of acquired ischemic myocardiopathy in childhood. Exceptionally, KD may cause early death during the acute phase by myocardial infarction, but may compromise the long-term cardiovascular outcome by accelerating atherosclerotic disease.\n\nThe incidence of KD is high in far-Eastern countries and Hawaii but KD is relatively rare in other regions (10\u002F100000 children \\\u003C5years in northern Europe) which makes it difficult to develop research on these rare population.\n\nEarly recognition and treatment by intravenous immunoglobulins (IVIG) influences the prognosis positively. IVIG are the standard of care and decrease significantly the risk of coronary aneurysms. However, despite a first infusion of IVIG, 20% of KD patients remain febrile and have high risk of coronary vasculitis. Recent Japanese research group assessed additional cyclosporine treatment in first line KD treatment but failed preventing relapse. To date there is no agreement for a more effective second line treatment.\n\nBased on the auto-inflammatory pattern of KD, the investigators hypothesize that anti IL-1 blocking agents could bring a rapid and sustained effect on systemic and coronary inflammation in patients with KD.\n\nOur hypotheses are:\n\n1. Anakinra treatment may reduce the early and long-term mortality of patients with Kawasaki Disease (KD), by a rapid and sustained effect on vascular inflammation.\n2. The safety of anakinra is good, as the drug has a very short half-life, which allows its rapid withdrawal in case of serious adverse event.\n\nThe use of anakinra is not associated with the risk of contamination by infectious agents, which remain even minimal, a possibility with the use of IVIG.",[27],"2024-02-27",{"date":796,"type":37},"2024-02-28",{"date":798,"type":37},"2023-10-20",{"date":800,"type":21},"2027-03",{"name":802,"class":44},"Assistance Publique - Hôpitaux de Paris"]