[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"host-microbial-interactions\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:host-microbial-interactions":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":27,"conditions":28,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100308670","phase-1-vaginal-microbiome-seeding-and-health-outcomes-in-cesarean-delivered-neonates-100308670",false,"NCT03298334","Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.","Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates: a Randomized Controlled Trial","Inclusion Criteria for Mother:\n\n* Scheduled for cesarean delivery at ≥ 37 weeks\n* Pregnant with single fetus, in good general health, age 18 years or older\n* Negative maternal testing for infections transmitted through vaginal and\u002For other body fluids performed as standard of care tests in early pregnancy\n* Negative testing for Group B strep at 35-37 weeks gestation\n* Vaginal pH ≤ 4.5 indicative of Lactobacillus-dominated vaginal microbiota\n* No maternal or fetal complications that may inhibit the ability to perform microbiome restoration per protocol\n* English or Spanish speaking\n* Negative maternal testing for Gonorrhea, Chlamydia, Hepatitis B, Hepatitis C, Syphilis, and HIV at 35 weeks gestation or later\n* Women aged 18-29 years must have a normal Pap test within 3 years\n* Women aged 30-65 years must have a normal Pap test and an HPV test (co-testing) within 5 years or FDA-approved primary hrHPV testing alone within 5 years or a normal Pap test alone within 3 years\n* Negative maternal testing for SARS-CoV-2 for the delivery admission performed as standard of care test at the Inova Health System.\n\nInclusion Criteria for Infant:\n\n* Infant condition after delivery requires no more than standard neonatal resuscitation\\* or is otherwise medically unable to receive the full VMT procedure\n\n\\[\\*\\] Standard neonatal resuscitation may include: tactile stimulation, bulb suction, oxygen without positive pressure, or drying\n\nExclusion Criteria for Mother:\n\n* Delivery at a hospital other than Inova Health System\n* Cesarean delivery scheduled for active infection that would have interfered with vaginal delivery such as genital herpetic lesions\n* Rupture of membranes prior to scheduled cesarean delivery\n* Bacterial vaginosis within 30 days of cesarean delivery\n* Symptomatic urinary tract infection within 30 days of cesarean delivery\n* Antibiotic therapy within 30 days of cesarean delivery (exclusive of medication use for prophylaxis at the time of surgery)\n* Symptoms on admission suggesting Chorioamnionitis, e.g. maternal fever, fundal tenderness\n* Symptoms on delivery admission of possible vaginal infection such as genital herpetic lesions\n* History of genital HSV\n* History positive testing for Group B strep infection\n* History of a child with a diagnosis of Group B strep sepsis\n* Pregnancy a result of donor egg or surrogacy\n* Preexisting history of Type I or Type II Diabetes\n* Maternal history of documented genital HPV infection, positive HPV testing or genital warts on physician examination\n* Positive maternal testing for SARS-CoV-2 within 30 days of delivery or symptoms on admission suggesting potential Covid-19 infection",true,"ALL","0 Days","50 Years",{"count":21,"type":22},600,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Neonates delivered by scheduled Cesarean Section will be randomized to receive vaginal seeding (exposing the infant to Mother's vaginal flora) or sham. Infants will be followed for three years to examine health outcomes including microbiome development, immune development, metabolic outcomes, and any adverse events.",[29,30,31,32,33,34],"Cesarean Delivery Affecting Newborn","Obesity, Childhood","Intestinal Microbiome","Microbiota","Host Microbial Interactions","Gastrointestinal Microbiome","RECRUITING","2025-06-04",{"date":38,"type":39},"2025-06-08","ACTUAL",{"date":41,"type":39},"2018-07-01",{"date":43,"type":22},"2029-04",{"name":45,"class":46},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":71,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":47},"100581156","host-response-to-infection-by-direct-analysis-of-leukocyte-single-cell-type-gene-expressiontranscript-abundance-direct-ls-ta-a-prospective-study-will-evaluate-the-performance-of-direct-ls-ta-in-triage-febrile-patients-into-major-categories-of-infections-viral-bacterial-or-active-tuberculosis-100581156","NCT06846645","Host Response to Infection by Direct Analysis of Leukocyte Single Cell-type Gene Expression\u002Ftranscript Abundance, Direct LS-TA. a Prospective Study Will Evaluate the Performance of Direct LS-TA in Triage Febrile Patients Into Major Categories of Infections: Viral, Bacterial or Active Tuberculosis.","Peripheral Blood Single Cell-type Expression Profile of Interferon-stimulated and Other Biomarker Genes for Triage of Febrile Patients","Inclusion Criteria:\n\n* Adult patients with fever of acute onset which is defined by a raised body temperature.\n* Patient should understand Chinese word to give informed consent.\n\nExclusion Criteria:\n\n* Patients with a history of any immunodeficiency or immunocompromised condition. Patients received steriod or other immunotherapy.","18 Years","80 Years",{"count":58,"type":22},200,"OBSERVATIONAL","Febrile illness is a common condition and it is crucial to have an early triage of patients according to various aetiologies to enable appropriate treatment. Currently, most screening\u002Fdiagnostic tests target the detection of pathogens, while only a few assays aim to understand the host response, and they are mostly based on a measurement of serum proteins (e.g. CRP or procalcitonin).\n\nRecently, blood transcriptome has been explored to differentiate bacterial and viral infections. However, gene expression in blood represents a composite score of gene expression of all the component cell-types present in the sample. Here, we propose to develop a rapid test that can determine gene expressions of a specified single cell type in peripheral blood (e.g., monocytes or granulocytes) as a host response biomarker to differentiate three major categories of infections that are bacterial, viral, and tuberculosis The assay is called Direct Leukocyte Single cell-type transcript abundance (TA) assay (DIRECT LS-TA) as it can directly determine the gene expression of a specified single cell-type among various other leukocyte populations directly in a peripheral blood sample. Such results signify the nature of host response according to 3 or more axes (Type I or Type II interferon signaling response or pro-inflammatory cytokine signaling) And it can be used to indicate the type of underlying infection (viral, bacterial, or active tuberculosis).",[62,63,64,65,66,67,68,69,33,70],"Single Cell Sequencing Technology","Gene Expression Profiling","Gene Expression","Infection","Viral Diseases","Bacterial Diseases","Active Tuberculosis","Host Defense Mechanisms","Transcriptome",[72,73,74,75,76,77,78,79],"host response","transcriptome","single cell-type gene expression","single cell RNA","triage","fever","febrile patient","Direct LS-TA","NOT_YET_RECRUITING","2025-02-27",{"date":83,"type":39},"2025-03-03",{"date":85,"type":22},"2025-02",{"date":87,"type":22},"2028-12",{"name":89,"class":90},"Chinese University of Hong Kong","OTHER"]