[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100087476":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":26,"responsibleParty":44,"collaborators":10,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":10,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":10,"studyType":60,"phases":10,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":10,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"1",null,"Any healthy donors meeting inclusion\u002Fexclusion criteria",[13],{"name":14,"affiliation":15,"role":16},"Michael B Fessler, M.D.","National Institute of Environmental Health Sciences (NIEHS)","PRINCIPAL_INVESTIGATOR",[18,23],{"name":19,"role":20,"phone":21,"phoneExt":10,"email":22},"NIEHS Join A Study Recruitment Group","CONTACT","(855) 696-4347","myniehs@nih.gov",{"name":14,"role":20,"phone":24,"phoneExt":10,"email":25},"(984) 287-4081","fesslerm@niehs.nih.gov",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"NIEHS Clinical Research Unit (CRU)","RECRUITING","Research Triangle Park","North Carolina","27709","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-78.86029,35.89709,{"lat":39,"lon":38},[42],{"name":19,"role":20,"phone":43,"phoneExt":10,"email":22},"855-696-4347",{"type":45,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100087476","immune-cell-response-to-stimuli-100087476",false,"NCT00397280","Immune Cell Response to Stimuli","Innate Immunity Signal Transduction in Human Leukocytes","* INCLUSION CRITERIA:\n* Normal, healthy adult donors as judged by screening questionnaire\n* Nonpregnant\n* Weighing at least 110 lbs\n* 18-65 years of age\n* HIV negative (proof required every 6 months we will conduct test)\\*\n* Hepatitis B surface antigen and hepatitis C serology negative (checked every 6 months we will conduct test)\\*\n\n  * The rationale for HIV and hepatitis viral testing is that chronic viral infection may alter and possibly invalidate our experimental results. HIV and hepatitis results will be confidentially obtained. Testing will be contracted to an external certified laboratory and will be paid for by the study group. Results will be available only to the study doctor\u002FPI (Fessler), the study coordinator, the CRU Director (Garantziotis, LAI), and the donor, with the few caveats that follow\n\nAll positive HIV, hepatitis B, and hepatitis C results will be promptly communicated to the donor by the study doctor\u002FPI or the CRU Director. The participant will be referred to their physician and\u002For to the N.C. Department of Health for confirmatory testing and counseling. As explained in detail in the attached Supplement describing N.C. State Department of Health code will be followed. The state code mandates reporting of positive results along with the participant s name and identifying information to the N.C. Department of Public Health. Upon contracting with the testing laboratory, clarification will be obtained and documented as to whether the contracted laboratory or the study MD will be responsible for reporting positive results to the state to avoid duplication of reporting. Upon receipt of the test results, the N.C. Department of Health will contact the participant to inform them of the positive result, how to find care, how to avoid infecting others, how the newly diagnosed HIV and\u002For hepatitis infection is reported, and the importance of informing their partners at possible risk because of their HIV and\u002For hepatitis infection. If the HIV, hepatitis B, and hepatitis C results are negative, the participant will be not be notified. However, the participant may contact the research study nurse for their results.\n\nHIV and hepatitis B\u002FC test results, non-reactive and reactive, will be documented confidentially by the PI or study coordinator in the subject s file, and kept in a locked file cabinet in the CRU Medical Records Room.In order to document the reporting procedure and the time associated with the reporting process, a document has been created and placed in the study specific manual (Hepatitis B\u002FC and HIV Notification Process for Reactive Results Form)\n\nEXCLUSION CRITERIA:\n\nBy questionnaire:\n\nFeeling ill within the last 24 hours.\n\nAlcohol consumption in the last 24 hours.\n\nVisit to the dentist in the last 24 hours.\n\nA doctor visit for illness or vaccination in the last 2 weeks.\n\nDiarrhea in the last 2 weeks.\n\nRecurrent fever (4 weeks).\n\nPregnant or suspected pregnancy in the last 6 weeks.\n\nBlood or plasma donation that will cause the participant to exceed 550ml of blood in the last 8 weeks.\n\nReceiving a blood donation in the past 12 months.\n\nBleeding disorder.\n\nAnemia.\n\nHeart problems.\n\nInsulin dependent diabetes.\n\nProblems with blood donation.\n\nRisk of or evidence of Creutzfeldt-Jacob Disease in the family.\n\nHIV-positive status, Hepatitis B\u002FC-positive status or other confirmed or suspected immunosuppressive or immunodeficient conditions.\n\nUse of immunosuppressants or other immune-modifying drugs.\n\nUse of selected medications within the preceding 5 days unless the PI or AI receiving the samples states otherwise (NSAIDS\u002Faspirin\u002Ftylenol, antidepressants, antihistamines , corticosteroids, HMG CoA reductase inhibitors, and antihypertensives).\n\nBy exam:\n\nTemperature over 99.5 F.\n\nBlood pressure less than 90\u002F50.\n\nBlood pressure higher than 170\u002F95 mm Hg.\n\nPulse rate less than 50 or greater than 100 beats\u002Fminute.\n\nIf blood donation exceeds 200ml:\n\n* Hematocrit less than 34% for women or less than 36% for men, or greater than 56% for either gender.\n* Patients will be informed of disqualifying vital signs and hematocrit values and advised by trained staff, as appropriate, to seek assistance from their physician.",true,"ALL","18 Years","65 Years",{"count":58,"type":59},750,"ESTIMATED","OBSERVATIONAL","This study will investigate the response of immune cells (neutrophils, monocytes) to various signals in the test tube to determine how they sense the signals in the body and what substances they produce in response to them. It will determine how the cells may, under certain circumstances, contribute to inflammation, and will measure substances in the blood plasma (the liquid, non-cellular part of the blood) that might stimulate white blood cells, in order to understand how the blood responds to possible disease-related conditions.\n\nHealthy normal volunteers 18 years of age and older who weigh at least 110 pounds may be eligible for this study. Participants give about 320 milliliters (mL) of blood (about 1 1\u002F3 cups) or less at each donation. They donate no more than once every 8 weeks and no more than six times a year. On some occasions, less than 320 mL of blood may be drawn. The collected blood is separated into its components and specific cells are exposed to substances to examine their response.",[63],"Inflammation",[65,66,67],"Inflammatory Response","Lipopolysaccharide","Natural History","2026-06-13",{"date":70,"type":71},"2026-06-16","ACTUAL",{"date":73,"type":71},"2009-07-13",{"name":15,"class":6},1]