[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hand-foot-and-mouth-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hand-foot-and-mouth-disease":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,73,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100618073","phase-1-phase-i-clinical-trial-of-enterovirus-type71---coxsackievirus-type-a16-bivalent-vaccine-100618073",false,"NCT07326878","Phase I Clinical Trial of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine","A Single-center, Randomized, Double-blind, and Placebo Controlled Phase Ⅰ Clinical Trial of the Safety and Preliminary Immunogenicity of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine in People Aged 6 Months to 59 Years","Inclusion Criteria:\n\n* Age Requirement: volunteers aged 6 months and 59 years.\n* Provision of Legal Identification: volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.\n* Informed Consent: participants, legal guardians, or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.\n* 6\\~23months old: term delivery (gestational week 37 weeks \\~ 42 weeks at birth), 2500g ≤ birth weight ≤ 4000g.\n* Requirements for contraception: agree to take contraception actions in 12 months.\n* Temperature Requirement: axillary body temperature is less than 37.3°C.\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria will be not eligible for enrollment.\n\n* Subjects who have been allergic to any component of the vaccine in the past, or have any history of vaccine allergy or suspected allergy or other serious adverse reactions, such as urticaria, respiratory distress, and angioedema.\n* History of taking administration of a non-SARS-CoV-2 inactivated vaccine or subunit vaccine within 7 days before enrollment, or any live attenuated vaccine or SARS-CoV-2 vaccine within 14 days before enrollment.\n* Subjects with convulsion, epilepsy, encephalopathy, psychiatric history or family history.\n* Known to have serious congenital malformations, developmental disorders, genetic defects or abnormal growth and development, or clinically diagnosed serious chronic diseases, including but not limited to neurological, cardiovascular, blood and lymphatic system, immune system, kidney, liver, gastrointestinal, respiratory system, metabolism and bone diseases and a history of malignant tumors.\n* Subjects are acutely ill or in the acute phase of a chronic illness within 3 days before vaccination.\n* Subjects with a hereditary bleeding tendency or coagulopathy, or a history of bleeding disorders.\n* Subjects who intolerance to venipuncture and with a history of needle- or blood-induced syncope.\n* History of surgical removal of the spleen or other vital organs for any reason.\n* Donation or loss of blood (≥400 mL), receipt of blood products, or receipt of blood transfusion within the 3 months before enrollment.\n* Use of any investigational or unregistered product (drug, vaccine, biological product, or device) other than a study vaccine within 3 months before enrollment or planned for use during the study.\n* Have treatment with immunosuppressive agents within 6 months before enrollment, such as long-term systemic glucocorticoid therapy (e.g., prednisone or a similar drug for more than 2 consecutive weeks within 6 months), but topical use (e.g., ointments, eye drops, inhalers, or nasal sprays) was allowed. Topical use should not exceed the recommended dose on the label or have any signs of systemic exposure.\n* History of any EV71 antigen-containing vaccination, whether commercially available or investigational.\n* Subjects with history of hand, foot, and mouth disease.\n* Subjects with abnormal vital signs with clinical significance.\n* Subjects who do not meet the criteria for good health based on comprehensive physical examination, including: (1) abnormal vital signs with clinical significance; (2) clinical laboratory testing shows laboratory abnormalities and with clinical significance (applicable only to subjects aged 2 years and above).\n* Have been diagnosed with an infectious disease that may interfere with the conduct or completion of the study, such as active tuberculosis, viral hepatitis, human immunodeficiency virus (HIV) infection, etc.\n* Females with positive pregnancy test results.\n* Females who are lactating, or subjects who plan to conceive or to donate sperm or ova from the time of signing the informed consent form until 12 months after completion of the full vaccination schedule (applicable only to subjects aged 18 to 59 years).\n* Subjects with a history of abnormal birth delivery, birth asphyxia, neurological impairment, or clinically diagnosed pathological jaundice (applicable only to subjects aged 6 to 23 months).\n* Subjects deemed by the investigator to be unsuitable for participation in the study.",true,"ALL","6 Months","59 Years",{"count":21,"type":22},144,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a randomized, double-blinded, placebo-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Enterovirus Type71 - Coxsackievirus Type A16 bivalent vaccine in subjects ( aged 6 months to 59 years ).",[28,29,30],"Hand, Foot and Mouth Disease (HFMD)","HFMD","Hand, Foot and Mouth Disease","NOT_YET_RECRUITING","2025-12-26",{"date":34,"type":35},"2026-01-08","ACTUAL",{"date":37,"type":22},"2025-12-30",{"date":39,"type":22},"2027-08-15",{"name":41,"class":42},"Institute of Medical Biology, Chinese Academy of Medical Sciences","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100569837","artificial-intelligence-driven-virtual-standardized-pediatric-patients-trial-100569837","NCT06699433","Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial","Utilizing Artificial Intelligence-driven Virtual Standardized Pediatric Patients to Enhance the Capabilities of Primary Healthcare Doctors in China for Managing Common Pediatric Diseases: a Randomized Controlled Trial","1. Inclusion and Exclusion Criteria for Research Institutions\n\n   Inclusion Criteria:\n   * Primary and secondary hospitals\n   * Community health centers (stations) and clinics, as well as township health centers and village health clinics\n\n   Exclusion Criteria:\n   * Specialized medical institutions (such as specialized hospitals and dental clinics)\n   * Public health prevention and treatment institutions (such as tuberculosis prevention centers)\n   * Ethnic medicine institutions (such as Mongolian and Tibetan hospitals)\n   * Hospitals above the secondary level\n   * Hospitals that have not yet been graded (due to their short establishment time and potentially unstable operations)\n2. Inclusion and exclusion criteria for research subjects\n\nInclusion Criteria:\n\n* Practicing (assistant) doctors and rural doctors working in medical institutions that meet the above conditions\n* With a scope of practice only including general practice, internal medicine, surgery, and pediatrics\n\nExclusion Criteria:\n\n-None",{"count":52,"type":22},459,[54],"NA","Background: China's healthcare system for children faces significant challenges, particularly due to the limited pediatric service capacity of primary healthcare institutions. A shortage of effective and accessible training tools for primary care doctors further hinders progress in addressing this gap. Technological advancements, especially in artificial intelligence, offer a potential solution to improve pediatric care. Artificial intelligence-driven virtual standardized patients (VSPs), leveraging internet and virtual simulation technologies, simulate clinical cases with specific disease characteristics, providing an innovative, efficient, and flexible training method. VSPs are increasingly utilized in medical education, clinical reasoning, and licensure exams. This study focuses on using VSPs to improve the management of common pediatric conditions, which are major health concerns for children and impose significant psychological and financial burdens on families.\n\nMethods: This study will involve a three-arm randomized controlled trial to evaluate the effectiveness of a virtual pediatric standardized patient platform in enhancing primary care doctors' management of common pediatric diseases. At least 459 participants, including general practitioners, internal medicine practitioners, surgeons, and pediatricians from more than 10 provinces across China, will be randomly assigned to one of three groups: the virtual patient platform group, the case teaching manual group, or the case teaching video group. Five virtual patient cases covering pneumococcal pneumonia, rotavirus enteritis with hypovolemic shock, hand-foot-and-mouth disease, acute appendicitis, and respiratory failure will be developed, along with corresponding case teaching materials. After a two-week learning period, participants' disease management abilities will be assessed using clinical vignettes. The primary outcome is adherence to best clinical practice guidelines, categorized into full adherence, partial adherence, and nonadherence.\n\nDiscussion: This study aims to leverage artificial intelligence for capacity enhancement, targeting the shortcomings of primary care pediatrics and using VSP to help enhance primary care pediatrics capacity. It is a randomized controlled trial involving over 300 primary healthcare institutions across more than 10 provinces in China, ensuring broad and representative participation from both developed and underdeveloped regions.",[57,58,59,60,61],"Pneumococcal Pneumonia","Rotavirus Enteritis With Hypovolemic Shock","Hand-foot-and-mouth Disease","Acute Appendicitis","Respiratory Failure (Pediatric Patients)","RECRUITING","2024-12-15",{"date":65,"type":35},"2024-12-19",{"date":67,"type":22},"2024-12",{"date":69,"type":22},"2025-01",{"name":71,"class":42},"Southern Medical University, China",3,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":43},"100536331","surveillance-of-hfmd-in-pediatric-outpatients-100536331","NCT06263439","Surveillance of HFMD in Pediatric Outpatients","Prospective Clinico-virological Surveillance of Diseases Foot-hand-mouth\u002FHerpangina Associated With Enteroviruses in Pediatric Outpatients","PMB","Inclusion Criteria:\n\n* Children aged 0 to 10 years presenting with HFMD or herpangina\n\nExclusion Criteria:\n\n* Refusal to participate by holders of parental authority\n* Refusal to participate for children over 3 years of age","10 Years",{"count":83,"type":22},3000,"OBSERVATIONAL","The aims of this prospective multicentric study is to determine the types of enteroviruses (EVs) responsible for hand, foot and mouth disease (HFMD) or herpangina in children seen within an ambulatory setting :\n\n* to detect an EV-A71 epidemic or another type associated with atypical forms of the disease at an early stage\n* to describe and compare the epidemiological, demographic, clinical and virological characteristics of these infections between the different types of EV.",[30,87,88],"Herpangina","Enterovirus Infections",[90,91,92,87,93],"Hand, foot and mouth disease","Enterovirus A71","Coxsackievirus A6","Primary care in paediatrics","2024-02-15",{"date":96,"type":35},"2024-02-16",{"date":98,"type":35},"2023-06-20",{"date":100,"type":22},"2028-06-20",{"name":102,"class":42},"University Hospital, Clermont-Ferrand",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":5},"100527309","phase-4-lot-to-lot-consistency-study-of-three-commercial-batches-of-enterovirus-71-vaccine-100527309","NCT06146088","Lot-to-lot Consistency Study of Three Commercial Batches of Enterovirus 71 Vaccine","To Evaluate the Lot-to-lot Consistency of Immunogenicity, Safety, and Immune Persistence of Three Consecutive Commercial Manufacturing Batches of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell) in Children Aged 6-35 Months in a Randomized, Blinded Study","Inclusion Criteria:\n\n* Age Requirement: Children aged 6 to 35 months at the time of enrollment.\n* Provision of legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.\n* Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the study's requirements and complete relevant visits on time.\n* Temperature Requirement: Axillary body temperature prior to vaccination is less than 37.3°C.\n\nExclusion Criteria:\n\n\\[First Dose Exclusion Criterions\\] Subjects meeting any of the following exclusion criteria will not be eligible for enrollment\n\n* Allergic History: Subjects have a previous history of allergies to any component of the vaccine (e.g., aluminum hydroxide, glycine), or previous or suspected allergy to any vaccine or other serious adverse reaction (e.g., anaphylactic shock, laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local anaphylactic necrosis reaction, dyspnea, angioedema, systemic rash and\u002For urticaria, etc.).\n* Vaccination History: Subjects received any inactivated vaccine or subunit vaccine within 7 days prior to the first dose of the investigational vaccine or any live attenuated vaccine within 14 days prior to the first dose of the investigational vaccine.\n* Neurological and Mental Health: Subjects with a history or family history of convulsion, epilepsy, encephalopathy, and psychosis.\n* Health Conditions: Subjects with known severe congenital malformation or developmental disorder (e.g., Down syndrome, sickle cell anemia, congenital neurological disorders).\n* Acute Illness: Subjects have experienced acute illness (e.g., fever) or acute onset of chronic illness within 3 days before the first dose of investigational vaccine, or use of antipyretic, analgesic, or antiallergic drugs within 3 days before the first dose of the investigational vaccine.\n* Coagulation Abnormalities: Subjects with genetic bleeding tendency, coagulopathy, or a history of bleeding disorders.\n* Organ Removal History: Subjects have a history of surgical removal of the spleen or other vital immune organs for any reason.\n* Blood Conditions: Subjects with blood loss (≥400mL) or receipt of blood transfusion, immune globulin (other than hepatitis B immune globulin), or blood products within 3 months prior to the first dose of the investigational vaccine.\n* Drug Administration: Subjects use any investigational or unregistered product (drug, biological product, or device) within 3 months prior to the first dose of the investigational vaccine, or planned use during the study, except the investigational vaccine.\n* Immune Therapy: Subjects have a treatment with immunosuppressive agents within 6 months before the first dose of the investigational vaccine, such as long-term treatment with systemic glucocorticoids (e.g., prednisone or a similar agent for more than 2 consecutive weeks within 6 months), but topical use (e.g., ointments, eye drops, inhalers, or nasal sprays) would be allowed.\n* Previous history of receipt of other EV71 vaccines.\n* Previous history of hand-foot-mouth disease.\n* Immune-related Disease: Subjects have been diagnosed with an infectious disease that may interfere with the conduct or completion of the study (e.g., tuberculosis, viral hepatitis, human immunodeficiency virus infection, etc.).\n* Investigators' Discretion: The final exclusion criterion is the investigator's discretion to determine whether a subject is suitable for participation in the study.\n\n\\[Contraindication of the second dose of vaccine\\] Subjects meeting any of the following exclusion criteria will not be eligible for the second dose of the investigational vaccine\n\n* Meeting allergic conditions that are mentioned in the First Dose Exclusion Criteria after the first dose.\n* Severe Adverse Reactions: Subjects experienced serious adverse reactions after receiving the previous vaccine dose.\n* Other Exclusion Reasons as Determined by the Investigator: The investigator determines other reasons for exclusion.","35 Months",{"count":112,"type":22},1500,[114],"PHASE4","This study is a randomized, blinded study to evaluate the lot-to-lot consistency of immunogenicity, safety, and immune persistence of three consecutive manufacturing lots of EV71 vaccine, in 1500 children aged 6-35 months. The primary immunogenicity endpoint is the anti-EV71 neutralizing antibody geometric mean titer (GMT) 30 days after the final dose. The secondary immunogenicity endpoints are the geometric mean fold increases and seroconversion rates of anti-EV71 neutralizing antibodies 30 days after the final dose. The immune persistence endpoints are the seropositive rates as well as GMT of anti-EV71 neutralizing antibodies 12 and 24 months after the final dose. The safety endpoints are the number of adverse events\u002Freactions within 30 minutes after each dose, the number of solicited adverse events\u002Freactions within 7 days after each dose, the number of unsolicited adverse events\u002Freactions within 30 days after each dose, and the number of serious adverse events (SAE) from the first dose to 6 months post the final dose.",[30],[118,119],"Enterovirus 71","Inactivated enterovirus 71 vaccine","2024-01-01",{"date":122,"type":35},"2024-01-03",{"date":124,"type":35},"2023-11-25",{"date":126,"type":22},"2026-07-15",{"name":41,"class":42}]