[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Institute of Allergy and Infectious Diseases (NIAID)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":551},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,175,0,25,[9,42,69,97,126,149,174,193,214,243,256,266,276,302,311,321,345,371,392,416,435,461,483,510,530],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":4,"leadSponsor":38,"locationsCount":41},"100054269",false,"NCT00028080","Evaluation, Treatment, and Follow-up of Patients With Lyme Disease","* INCLUSION CRITERIA:\n* Clinical diagnosis of active Lyme disease at the time of the initial NIH evaluation based on the CDC case definition. Study physician will review history to confirm probable cases.\n* Subjects must maintain a private physician for non-protocol related medical complaints and for emergency medical treatment required for these or other of their disorders.\n\nEXCLUSION CRITERIA:\n\n* Post treatment Lyme disease syndrome.\n* Unacceptably poor compliance, which, in the opinion of the investigator, would interfere with one's ability to study or provide quality medical care for the patient.\n\nELIGIBILITY CRITERIA TO BE ASKED TO UNDERGO APHERESIS INCLUDE:\n\n* Age 18 years or above\n* Weight greater than 110 pounds\n* No known heart, lung, kidney disease, or bleeding disorders\n* Negative HIV, HCV and HBsAg serologies\n* Female subjects should not be pregnant or nursing\n* Adequate peripheral venous access\n\nPatients will have a CBC performed up to 2 weeks before the procedure. In order to be able to undergo the procedure, patient must fulfill all of the below:\n\n* Hemoglobin greater than 11 g\u002FdL for males and greater than 10 g\u002FdL for females\n* Platelets greater than 150 k\u002Fmm(3)\n* WBC greater than 3.5 x 10(3) uL\n* MCV above 80\n\nWomen who are able to conceive children must have a negative pregnancy test within 2 weeks before the procedure.","ALL","2 Years","99 Years",{"count":19,"type":20},500,"ESTIMATED","OBSERVATIONAL","This study is designed to establish a population of patients with Lyme disease for evaluation, treatment and follow-up to learn more about the infection.\n\nPatients with active Lyme disease may be eligible for this study.\n\nParticipants will have a medical history and physical examination and diagnostic evaluations as appropriate to their individual condition. Laboratory tests may include routing blood and urine tests, X-rays, or other imaging studies, body fluid or tissue cultures, skin biopsy and tests for allergic or immune responses. Treatment will include only medications approved by the Food and Drug Administration, given according to accepted dose schedules and ways of taking the medicines. All diagnostic tests and treatments will be according to standard medical practice for the disease. No experimental procedures will be offered under this protocol.\n\nPatients will be followed as needed for evaluation and treatment of their condition. In general, they will be asked to return at the end of therapy, then 3, 6 and 12 months later, and then every 6 to 12 months. More frequent visits may be required or less frequent visits may be allowed, depending on the individual s condition.\n\nParticipants may be asked to undergo the following additional procedures for research purposes:\n\n* Extra blood draws to study Lyme disease and other inflammatory conditions. Blood will be drawn from arm veins. The total amount drawn during any 6-week period will not exceed 450 cc (30 tablespoons) for adults and 7 cc (1\u002F2 tablespoon) per kilogram (2.2 pounds) of body weight for children under 18 years of age.\n* Leukapheresis to collect large numbers of white blood cells. Whole blood is collected through a needle in an arm vein, similar to donating blood. The blood circulates through a machine that separates it into its components, and the white cells are removed. The rest of the blood is returned to the body through the same needle. Only adults 18 years of age and older will be asked to undergo leukapheresis.",[24],"Lyme Disease",[26,24,27,28,29,30],"Borrelia Burgdorferi","Infection","Therapy","Natural History","Lyme","RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":35},"2002-01-16",{"name":39,"class":40},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":43,"slug":4,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":15,"minAge":49,"maxAge":17,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":52,"conditions":53,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":4,"leadSponsor":68,"locationsCount":41},"100053339","NCT01386437","Natural History of Individuals With Immune System Problems That Lead to Fungal Infections","The Natural History and Pathogenesis of Human Fungal Infections","* INCLUSION CRITERIA:\n\nPatients:\n\nPatients with or without inherited or acquired abnormalities of immune function manifesting mucocutaneous and\u002For invasive fungal infections are eligible for screening and assessment under this protocol. Specifically, patients must meet all the following inclusion criteria in order to participate in this study:\n\nAdults or children (regardless of age, sex, or ethnicity\u002Frace) with a known or yet uncharacterized inherited immunodeficiency and a definitively diagnosed mucocutaneous or invasive fungal infection.\n\nOR\n\nAdults or children (regardless of age, sex, or ethnicity\u002Frace) with acquired immunodeficiency and a severe, unusual, persistent or treatment-refractory chronic mucocutaneous fungal infection.\n\nOR\n\nAdults or children (regardless of age, sex, or ethnicity\u002Frace) with acquired immunodeficiency and a possible, probable or proven invasive fungal infection (European Organization for Research and Treatment of Cancer \u002F Mycoses Study Group criteria).\n\nOR\n\nAdults or children (regardless of age, sex, or ethnicity\u002Frace) with a well-documented prior, unusual, severe, persistent, or treatment-refractory mucocutaneous or invasive fungal infection(s), who have clinically recovered from the fungal infection.\n\nOR\n\nAdults or children (regardless of age, sex, or ethnicity\u002Frace) with confirmed or suspected autoimmune polyendocrinopathy-candidiasis-ectodermal dystrophy (APECED) who have not yet developed CMC.\n\nOngoing care by a referring\u002Fprimary care physician (inside or outside NIH).\n\nWilling to allow storage of blood and tissue samples for future analyses.\n\nWilling to allow genetic testing from blood, body fluids or tissue specimens.\n\nWilling to have HIV testing\n\nAble to provide informed consent or be accompanied by a parent(s)\u002Flegal guardian(s) or legally authorized representative (LAR) who is able to provide informed consent.\n\nNo children under the age of 2 years will be seen at the Clinical Center, however they will be able to participate via mail-in specimens\n\nPatient Relatives:\n\nIndividuals (regardless of age, sex, or ethnicity\u002Frace) who are genetically related to the patient (e.g., mother, father, siblings, children) may be recruited to establish the genetic origin of immune defects that may be identified in the study patients at the discretion of the PI. Relatives must meet all the following inclusion criteria in order to participate in this study:\n\nWilling to allow storage of blood and tissue samples for future analyses.\n\nWilling to allow genetic testing from blood, body fluids or tissue specimens.\n\nWilling to have HIV testing\n\nAble to provide informed consent or, if younger than 18, be accompanied by a parent(s)\u002Flegal guardian(s) who is able to provide informed consent.\n\nHealthy Volunteers:\n\nHealthy adults regardless of sex, and ethnicity\u002Frace between the ages of 18 and 85 years old may be eligible to participate in this study. Healthy volunteers must meet all the following inclusion criteria in order to participate in this study:\n\nWilling to allow storage of blood and tissue samples for future analyses.\n\nWilling to allow genetic testing from blood, body fluids or tissue specimens.\n\nWilling to have HIV testing\n\nAble to provide informed consent\n\nNIH employees are eligible\n\nEXCLUSION CRITERIA:\n\nPatients:\n\nA patient will not be eligible if he\u002Fshe has any of the following:\n\nAny condition which, in the investigator's opinion, may interfere with the evaluation of a co-existing abnormality of immunity that is the subject of study under this protocol.\n\nAny condition which, in the investigator's opinion, places the patient at undue risk by participating in the study.\n\nUnwillingness to undergo testing or procedures associated with this protocol.\n\nHemoglobin of \\\u003C 7 gm\u002FdL. If a patient is enrolled solely to obtain left-over pathology specimens, saliva, a buccal sample, skin swab, vaginal swab, or a stool sample, this exclusion criteria will not apply as there will be no blood withdrawal.\n\nPatient Relatives:\n\nA genetically related relative will not be eligible for this study if he\u002Fshe has any condition which, in the investigator's opinion, may interfere with the evaluation of an immune system abnormality that is the subject of study under this protocol.\n\nHealthy Volunteers:\n\nA healthy volunteer will not be eligible if he\u002Fshe has any of the following:\n\nHIV infection.\n\nHistory of recurrent or severe infections.\n\nHistory of an underlying malignancy or receipt of cancer chemotherapy within the past 5 years\n\nReceipt of systemic corticosteroids or other systemic immunosuppressants or immunomodulators within the past 30 days\n\nPregnancy or lactating\n\nHistory of heart, lung, kidney disease, or bleeding disorders.\n\nAny condition which, in the investigator's opinion, may interfere with the comparison of clinical specimens against those obtained from affected subjects.",true,"1 Day",{"count":51,"type":20},1200,"Background:\n\n\\- The immune system is made up of special cells, tissues, and organs that fight infections. Problems with this system may lead to frequent, severe, or unusual fungal infections. These infections are often difficult to treat. Researchers want to collect blood and tissue samples from people who have unusual, persistent or severe fungal infections or immune problems that increase the risk of these infections.\n\nObjectives:\n\n\\- To collect medical information and samples for a long-term study of people with immune system problems that lead to fungal infections.\n\nEligibility:\n\n* People with a history of fungal infections caused by immune system problems.\n* Parents, children, and siblings of this group.\n* Healthy volunteers not related to the first two groups.\n\nDesign:\n\n* This long-term study may last for up to 25 years. Those in the study may need to provide new information about every 6 months. The procedures for each person may vary with the particular diagnosis and the extent of fungal infection. Healthy volunteers may have only one or two visits.\n* At the first visit, those in the study will have a full medical history and physical exam. They will also provide blood.\n* Research procedures may include the following:\n* Saliva, urine or stool testing\n* Mouthwash collection for DNA testing\n* Collection of cheek cells, nail clippings, or vaginal fluid\n* Tests of leftover tissue or body fluid from previous medical procedures\n* Skin or oral mucous membrane biopsy\n* Collection of white blood cells\n* Followup visits will involve a physical exam and updated medical history. Blood, saliva, urine, or nail clipping samples may be taken for ongoing studies. Any additional tests or exams required by the study doctors may also be done.\n* Participants may withdraw from the study pool at any time.",[54,55,56,57],"Chronic Mucocutaneous Candidiasis","Invasive Aspergillosis","CARD9","APECED",[59,60,61,62,29,63,64],"Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)","Fungal Infections","Molds","Autoimmune Polyendocrinpathy Syndrome (APS) Type 1","Mucocutaneous Fungal Infection","Invasive Fungal Infection",{"date":34,"type":35},{"date":67,"type":35},"2012-11-05",{"name":39,"class":40},{"id":70,"slug":4,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":48,"sex":15,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":41},"100054044","NCT05652478","Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study","Early Metabolic Effects of Antiretroviral Drugs in Healthy Volunteers: A Phase 2 Randomized Study","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Aged 18 to 55 years.\n* Able to provide informed consent.\n* Willing to allow samples and data to be stored and shared for future research.\n* Agrees to use a barrier method of contraception or abstain from sexual activity starting at screening though the end of study participation.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Current infection with HIV or hepatitis A, B, or C.\n* Body mass index (BMI) \\\u003C18.5 kg\u002Fm\\^2 or \\>30.0 kg\u002Fm\\^2.\n* Weight change \\>5% in the past 6 months.\n* History of or current cardiovascular disease such as congestive heart failure, heart block, or clinically relevant abnormal ECG as determined by investigators.\n* History of or current liver disease or alanine transaminase serum level \\>2x upper limit of normal.\n* History of or current kidney disease or renal insufficiency, or estimated creatinine clearance \\\u003C=80 mL\u002Fmin (Modification of Diet in Renal Disease equation).\n* Current cancer or history of cancer within 5 years of screening, with the exception of squamous cell carcinoma or basal cell carcinoma that is localized and does not require systemic therapy.\n* History of bariatric surgery.\n* Diabetes mellitus as defined by a prior diagnosis or a hemoglobin A1c of \\>6.4 percent on screening labs.\n* Fasting serum glucose \\>126 mg\u002FdL.\n* History of or current hypo- or hyper-thyroid or abnormal TSH, except minor deviations deemed to be of no clinical significance by the investigator.\n* History of or current asthma or chronic obstructive pulmonary disease.\n* Psychological conditions by self-report, such as (but not limited to) clinical depression, bipolar disorders, which would be incompatible with safe and successful participation in this study.\n* Pregnancy or within 1 year post-partum.\n* Breastfeeding.\n* Blood pressure \\>140\u002F90 mm Hg or current antihypertensive therapy.\n* Hemoglobin that is either 10 percent below the lower limit or 10 percent above the upper limit of the normal range for the Clinical Center Laboratory (acceptable ranges: females 10.08-17.27 g\u002FdL, males 12.33-19.25 g\u002FdL).\n* History of illicit drug, opioid, or alcohol abuse within the last 5 years; current use of illicit drugs or opioids (by history) or excessive alcohol (CAGE assessment score \\>=2).\n* Current use of the following prescription or over-the-counter medications and supplements:\n\n  * Carbamazepine\n  * Oxcarbazepine\n  * Phenobarbital\n  * Phenytoin\n  * Primidone\n  * Rifabutin\n  * Rifampin\n  * Rifapentine\n  * St. John's wort (Hypericum perforatum)\n  * Cation-containing antacids or laxatives\n  * Sucralfate\n  * Buffered medications\n  * Oral calcium, iron, magnesium, or zinc supplements, including multivitamins containing these polyvalent cations\n  * Dalfampridine\n  * Metformin\n  * Dofetilide\n  * Thyroid medications\n  * Corticosteroids\n  * Weight loss medications, including prescription drugs (eg, semaglutide and tirzepatide) and over-the-counter diet pills\n* Use of TAF, TDF, and\u002For FTC for the purpose of HIV PrEP or in a research study within the past 6 months.\n* Any history of exposure to cabotegravir or lenacapavir (eg, as HIV PrEP or as a participant in a research study for these drug).\n* Current use of prescrtiption or nonprescriptive medications that may have interactions with study drugs or confound the study measurements as determined by the investigators.\n* History of adverse or allergic reactions to the study drugs.\n* Daily caffeine intake \\>500 mg (about 4 cups of coffee).\n* Current smoker or user of tobacco products.\n* A change in the participant s diet and\u002For exercise regimen in the past 3 months or during the timeframe of the study period that, in the opinion of the investigator, would compromise the integrity of the data.\n* High-risk sexual activity as determined by the investigators, and\u002For inability or unwillingness to use barrier contraception during the protocol.\n* Any other condition, medication, or dietary pattern that, in the opinion of the investigators, increases risk to the participant, prevents the participant from complying with study procedures, prevents the participant from completing the study, or interferes with the interpretation of study results.","18 Years","55 Years",{"count":78,"type":20},120,"INTERVENTIONAL",[81],"PHASE2","Background:\n\nPeople with HIV take drugs to keep the amount of virus in their body low. One type of these drugs, called integrase strand transfer inhibitors (INSTIs), can cause weight gain over time. Weight gain can cause diabetes, heart disease, and other serious issues. Researchers want to understand how INSTIs cause weight changes.\n\nObjective:\n\nTo characterize the change in plasma metabolite profile that 4 weeks of each treatment may induce in the absence of HIV infection\n\nEligibility:\n\nHealthy people aged 18 to 55.\n\nDesign:\n\nParticipants will be screened in the outpatient clinic. They will have a physical exam and blood tests. They will have a nutritional assessment and tests of their heart function.\n\nParticipants will be randomized to one of four oral treatments: Tenofovir Disoproxil Fumarate TDF\u002FViread, Tenovovir Alafenamide TAF\u002FVemlidy, Dolutegravir DTG\u002FTivicay, or both TAF and DTG taken together for 4 weeks.\n\nParticipants will have a Day 0 visit for the Lead-In Baseline visit for an exam and blood tests and continuous glucose monitor placement.\n\nParticipants will return in 2wks or Day 14\u002FWk 2 for a DEXA (dual-energy X-ray absorptiometry). DEXA is a kind of X-ray that measures body fat and bone density. Optional adiopse (fat) tissue biopsy in the abdomen, and optional microbiome specimen collections. Continuous glucose monitor changed. Oral once a day dose medication will be started with education.\n\nParticipants will return in 2wks or Day 28\u002FWk 4 for exam, labs, and continuous glucose monitor changed.\n\nParticipants will return in 2wks or Day 42\u002FWk 6 for final exam, labs, repeat DEXA scan, repeat adipose tissue biopsy, and microbiome specimen collections.",[84,85,86,87],"Healthy Volunteer","Weight Gain","Metabolic Effects","Integrase Strand Transfer Inhibitors",[89,90,87],"Metabolism","HIV",{"date":34,"type":35},{"date":93,"type":20},"2026-07-16",{"date":95,"type":20},"2030-01-31",{"name":39,"class":40},{"id":98,"slug":4,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":15,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":79,"phases":107,"briefSummary":109,"conditions":110,"keywords":116,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":123,"leadSponsor":125,"locationsCount":41},"100053852","NCT07262983","Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and\u002For Atopic Dermatitis","A Pilot Study to Evaluate the Safety and Tolerability of Baricitinib in Patients With Job s Syndrome With Lupus-like Disease and\u002For Atopic Dermatitis","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Must be able to understand and provide informed consent or assent.\n2. Aged \\>=12 years.\n3. Documented STAT3 variant causing hyper-IgE syndrome.\n4. Enrollment in NIH protocol 00-I-0159, Natural History, Management, and Genetics of the Hyperimmunoglobulin E Recurrent Infection Syndrome (HIES).\n\n   a. Presence of SLE and\u002For AD as follows: SLE patients should meet either Systemic Lupus International Collaborating Clinics (SLICC) or 2019 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) SLE classification criteria. AD is defined as EASI tool score \\>=16 and body surface area tool score of 10% at screening.\n5. Ability to take oral medication and be willing to adhere to the study intervention regimen.\n6. For individuals on glucocorticoids, the dose must be less than 10 mg daily and stable for the 30 days prior to Day 0.\n7. For individuals on hydroxychloroquine or other antimalarials such as chloroquine or quinacrine, the dose must have been stable for 90 days prior to Day 0. The maximum allowed dose is hydroxychloroquine 400 mg\u002Fday or 6.5 mg\u002Fkg\u002Fday, whichever is greater. The maximum allowed dose for chloroquine phosphate is 500 mg daily, and for quinacrine is 100 mg daily.\n8. Individuals may be on lipid-lowering medications if initiated at least 90 days prior to Day 0, and the dose must be stable for 30 days prior to Day 0.\n9. Individuals of reproductive potential must agree to use at least one highly effective method of contraception when engaging in sexual activities that can result in pregnancy while on study drug. Acceptable methods of contraception include:\n\n   * Intrauterine device (IUD)\n   * Bilateral tubal ligation\n   * Abstinence\n   * Vasectomized partner\n   * Hormonal contraception used in combination with barrier method: progestogen containing (oral, intravaginal, transdermal) or progestogen-only (oral, injectable, implantable) starting 30 days prior to initiation of baricitinib\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Known history of hypersensitivity to baricitinib or other JAK inhibitors.\n2. Current or recent use of any investigational drug\u002Fintervention (within 6 months or 5 half-lives, whichever is longer, prior to Day 0) except for COVID-19 vaccines or therapies that have been granted an FDA emergency authorization.\n3. Scheduled to participate in another clinical study involving an investigational drug during the course of this study.\n4. Use of systemic immunosuppressive or immune-modulating agents within 90 days prior to Day 0, except systemic steroids \\\u003C=10 mg of prednisone equivalent per day.\n5. Current or prior treatment with rituximab in the 6 months prior to Day 0.\n6. Current treatment with methotrexate, mycophenolate mofetil, other less common immunomodulatory drugs such as those falling into the class of disease-modifying antirheumatic drugs (DMARDs), belimumab, and other immunosuppressive biologics not otherwise specified herein. Participants previously on methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or belimumab, other immunosuppressive biologics, or DMARDs should have been withdrawn from the drug for at least 90 days prior to Day 0.\n7. Treatment with cyclophosphamide and pulse methylprednisolone within 6 months prior to Day 0.\n8. Hypercholesterolemia: Values after 8- to 12-hour fasting blood specimen: total cholesterol \\>250 mg\u002FdL or LDL \\>180 mg\u002FdL or hypertriglyceridemia (triglyceride \\>300 mg\u002FdL) within 90 days prior to Day 0.\n9. History of alcohol or drug abuse within 6 months prior to Day 0.\n10. Presence of 1 or more of the following clinically significant laboratory abnormalities:\n\n    1. Serum ALT \\>=3 times ULN.\n    2. Serum total bilirubin \\>=2 times ULN.\n    3. ANC \\\u003C=750 cells\u002FmicroL.\n    4. Hemoglobin \\\u003C=9.0 g\u002FdL.\n    5. Platelet count \\\u003C=100,000\u002FmicroL.\n    6. Serum creatinine \\>=2 times ULN.\n11. Planned or anticipated major surgical procedure during the study.\n12. Plans to receive any live vaccines within 1 month of the anticipated first dose of baricitinib.\n13. Known or suspected immune-dysregulatory disorders besides Job s syndrome, lupus-like disease, and\u002For AD.\n14. Active invasive opportunistic infections (eg, non-TB mycobacterial infections, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis pneumonia, aspergillosis) despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged infections suggesting an immune-compromised status as judged by the investigator.\n15. Known active TB. Participants with treated LTB will be eligible to participate. Participants with untreated LTB will not be excluded but will be evaluated by an infectious disease consultant and may become eligible for trial based on infectious disease consultant recommendations.\n16. Infection with HIV.\n17. Untreated infection with hepatitis B or C.\n18. Unwillingness to receive prophylactic entecavir (or similar), only for individuals with evidence of clearance of hepatitis B with positive hepatitis B core and surface antibody and negative hepatitis B surface antigen and PCR.\n19. BK or JC viremia at screening visit.\n20. Active infection that requires the use of oral or intravenous antimicrobials that remains unresolved at least 14 days prior to the administration of the first dose of study medication.\n21. Individuals with active renal or central nervous system disease or a high activity level in any organ system (except articular) that requires immediate immunosuppressive therapy as determined by the investigator.\n22. History of cancer, with the exceptions of basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix, provided the participant is in remission and curative therapy was completed at least 12 months prior to screening. History of other malignancies are also permitted provided that the individual is in remission and curative therapy was completed at least 5 years prior to screening.\n23. Planned or anticipated use of any prohibited medications and procedures during the study.\n24. Pregnancy or current breastfeeding.\n25. Currently receiving hemodialysis or peritoneal dialysis.\n26. Past or current medical problems or findings from physical examination, electrocardiogram, or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risk from participation in the study, may interfere with the individual s ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. These may include, but are not limited to:\n\n    1. Known coronary artery aneurysm.\n    2. Known history of arterial or venous thrombosis or at high risk for clotting disorder.\n    3. Known history of PE or DVT in the past.\n    4. Psychiatric illness or history of medical non-compliance that the study team feels will make the individual unlikely to complete the study.\n    5. Significant impairment of major organ function (lung, heart, liver, kidney) or any condition that, in the opinion of the investigator, would jeopardize the individual s safety following exposure to the study drug.\n27. Individuals with known increased risk factors for MACE including a history of:\n\n    1. Ischemic heart disease (eg, history of acute myocardial infarction).\n    2. Heart failure.\n    3. Cardiomyopathy.\n    4. Severe valvular heart disease.\n    5. Significant arrhythmias.\n    6. Chronic renal failure.\n    7. Cerebrovascular accident or transient ischemic attack.\n    8. Uncontrolled diabetes mellitus.\n    9. Uncontrolled hypertension.\n    10. Current smokers or former smokers with less than 3 years since complete cessation and\u002For \\>20 pack-years of smoking history.\n28. History of idiopathic GI perforation or diverticulitis with high risk of perforation.\n29. Treatment with strong organic anion transporter 3 inhibitors (OAT3) (eg, probenecid) due to drug interactions.\n30. Uncontrolled thyroid disease as per principal investigator or medically responsible investigator.","12 Years","120 Years",{"count":106,"type":20},20,[108],"PHASE1","Background:\n\nAutosomal dominant hyper-IgE syndrome (HIES), also called Job syndrome, is a genetic disorder that affects the immune system. It can cause skin and lung infections and problems with blood vessels, connective tissues, and bones. People with HIES often have lupus-like disease or atopic dermatitis (skin rash). Researchers want to know if a drug approved to treat other immune system diseases (baricitinib) can help people with HIES.\n\nObjective:\n\nTo test baricitinib in people with HIES with lupus-like disease or skin rash.\n\nEligibility:\n\nPeople aged 12 years and older with HIES with lupus-like disease or skin rash.\n\nDesign:\n\nParticipants will have 5 clinic visits, 4 remote visits, and 2 phone visits in 9 months.\n\nParticipants will be screened. They will have a physical exam with blood and urine tests. They will have tests of the speed and pressure of blood flow through their body: Blood pressure cuffs will be placed on each arm and leg; electrodes will be placed on the wrists and a microphone on the chest.\n\nThe study has a 3-month lead-in period. Participants will not take the study drug during this time. They will continue with their usual medical care. They will have 2 phone calls with the study team.\n\nBaricitinib is a tablet taken by mouth. Participants will take 1 or 2 tablets by mouth every day for 6 months. They will start with a low dose and may increase to a higher dose.\n\nBlood and urine tests will be repeated during each study visit. Other tests may also be repeated during some visits. A skin sample may also be taken....",[111,112,113,114,115],"Hyper IgE Syndrome From STAT3 Mutation","Job s Syndrome","HIES","Lupus","Atopic Dermatitis",[111,117,113,114,115,118,119,120],"Job s syndrome","Lupus-like Disease","JAK Inhibition","Janus Kinases",{"date":34,"type":35},{"date":93,"type":20},{"date":124,"type":20},"2030-10-01",{"name":39,"class":40},{"id":127,"slug":4,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":15,"minAge":75,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":79,"phases":135,"briefSummary":137,"conditions":138,"keywords":141,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},"100054223","NCT07027826","The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States","Use of the Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Able to provide informed consent.\n2. Aged 18 to 65 years.\n3. Born in the African continent or their parents were born in Africa,\n4. Exhibiting symptoms of dysphagia and\u002For prior history of food impaction.\n5. Undergoing clinically indicated endoscopy at the NIH Clinical Center (U.S.), Centre Hospitalier Universitaire Gabriel Tour(SqrRoot)(Copyright) (Mali), or other local clinics (Mali) and willing to provide research samples and data.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Recent steroid use (systemic or swallowed\u002Ftopical corticosteroid) within 4 weeks prior to endoscopy.\n2. Recent use of dupilumab (Dupixent) within the last 6 months.\n3. Recent use of other biologic medications (within either 6 months or 5 half-lives, whichever is longer). Examples of biologic medications include:\n\n3a. mepolizumab (Nucala)\n\n3b. reslizumab (Cinqair, Cinqaero)\n\n3c. benralizumab (Fasenra)\n\n3d. cendakimab\n\n3e. tezepelumab (Tezspire)\n\n3f. barzolvolimab\n\n4\\. Individuals suffering from a bleeding diathesis (e.g., hemophilia, severe thrombocytopenia).\n\n5\\. Current use of anticoagulant medications.\n\n6\\. Pregnancy.\n\n7\\. Treatment with another investigational drug or other investigational intervention within 6 months or 5 half-lives whichever is longer.\n\n8\\. Individuals with a known history of any of the following:\n\n8a. eosinophilic esophagitis\n\n8b. esophageal stricture unable to be passed with an upper endoscope\n\n8c. esophageal cancer\n\n8d. esophageal motility disorder (e.g., achalasia)\n\n8e. esophageal varices\n\n8f. esophageal or gastric surgery including fundoplication\n\n8g. neurologic cause of dysphagia (e.g., stroke, Parkinson s disease, etc.)\n\n8h. allergy to gelatin\n\n8i. inability to swallow pills\n\n9\\. Any condition that, in the investigator s opinion, places the individual at undue risk by participating in the study.\n\nCo-enrollment guidelines: Co-enrollment in other trials is restricted, other than enrollment on observational studies. Consideration for co-enrollment in trials evaluating the use of a licensed medication will require the approval of the principal investigator in consultation with the medical monitor. Study staff should be notified of co-enrollment on any other protocol as it may require the approval of the principal investigator.","65 Years",{"count":134,"type":20},70,[136],"NA","Background:\n\nEosinophilic esophagitis (EoE) is a disease that causes inflammation in the esophagus. The esophagus is the tube that moves food from the mouth to the stomach. Diagnosing EoE currently requires a specialized tool called an endoscope. The esophageal string test (EST) is another test; the EST collects fluid from the upper digestive tract. An EST is simpler and cheaper than an endoscopy. Researchers want to know if an EST can diagnose EoE.\n\nObjective:\n\nTo test if the EST can diagnose EoE in people who have trouble swallowing.\n\nEligibility:\n\nAdults aged 18 to 65 years with trouble swallowing. They must have been born in the African continent or their parents were born in Africa.\n\nDesign:\n\nParticipants will be screened. They will give blood, stool, urine, and skin swab samples. They will complete surveys about their medical history, diet, symptoms, and home environment. They will bring a sample of their drinking water for testing.\n\nParticipants will have an EST. They will swallow a pill capsule that contains a nylon string. One end of the string will be taped to their cheek. The string will unravel down the esophagus and into the stomach. It will be pulled out after 1 hour. Fluids that soaked into the string will be tested.\n\nAt a different visit, participants will have an endoscopic exam. An endoscope is a flexible tube that is inserted down the mouth; it can be used to take tissue samples from the esophagus, stomach, and small intestine.\n\nParticipants will have a final visit in person, online, or by phone. They will take a survey and talk about their test results.",[139,140],"Dysphagia","Eosinophilic Esophagitis",[140,139,142],"Esophageal string test",{"date":34,"type":35},{"date":93,"type":20},{"date":146,"type":20},"2027-08-31",{"name":39,"class":40},3,{"id":150,"slug":4,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":15,"minAge":49,"maxAge":17,"enrollmentInfo":154,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":156,"conditions":157,"keywords":161,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":171,"leadSponsor":173,"locationsCount":41},"100053658","NCT07683104","Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet the following criteria:\n\n1. Stated willingness to comply with study requirements.\n2. Aged \\\u003C= 99 (ability to be seen at NIH vs. remote visit may be determined by age and location).\n3. Willingness to allow storage of data and specimens for future research.\n\nAdditional Inclusion Criteria for Affected Participants\n\n1. Must have one of the following:\n\n   1. Trisomy 8 mosaicism verified by genetic testing (including but not limited to karyotype, fluorescence in situ hybridization \\[FISH\\], whole genome sequencing \\[WGS\\], whole exome sequencing \\[WES\\], or microarray), or\n   2. Inflammatory mucosal ulcerative disease clinically similar to TRIAD at the discretion of the principal investigator.\n2. Ability of participant or LAR to provide informed consent.\n\nAdditional Inclusion Criteria for Biological Relatives\n\n1. Be an unaffected biological relative of an affected participant.\n2. Ability to provide informed consent.\n3. Willingness to provide at least one biospecimen.\n\nEXCLUSION CRITERIA:\n\nIndividuals with any condition or who are taking any medications that, in the opinion of the investigator, contraindicates participation in the study will be excluded.\n\nCo-enrollment guidelines: Enrollment in this protocol does not preclude individuals from enrolling or participating in any other NIH protocols, including studies of investigational agents. Participants will be asked about their participation in other studies to ensure that blood draws do not exceed NIH limits for research protocols.",{"count":155,"type":20},750,"Background:\n\nTrisomy 8 mosaicism is a genetic disorder that can increase inflammation in the body. Symptoms include fevers; sores or ulcers in the mouth, digestive tract, or genital area; skin rashes; problems in organs or tissues; and changes in bone marrow cells. Researchers want to conduct a natural history study to learn more about these symptoms and what causes them.\n\nObjective:\n\nTo gather data and samples from people with and without the trisomy 8 mosaicism.\n\nEligibility:\n\nPeople of any age with the trisomy 8 gene mosaicism. Their healthy relatives are also needed.\n\nDesign:\n\nAffected participants will have visits every 1 to 2 years for 30 years at NIH. Each visit will take 1 to 5 days and may be in-person or remote. With remote visits, participants may have a video call with the study team and samples may be sent to researchers by mail.\n\nParticipants may have these procedures:\n\nPhysical exam, with blood tests.\n\nTests of brain function and motor skills.\n\nSensory tests. Researchers will see how participants respond to sensations such as pinpricks, heat, cold, and pressure.\n\nMagnetic resonance imaging (MRI) scan of the brain and\u002For spine.\n\nX-ray of the spine.\n\nUltrasound test of heart function (echocardiogram).\n\nTissues samples (biopsies) collected from the skin, inside of the mouth, and bone marrow.\n\nSwabs to collect cells from the mouth, skin, and vagina.\n\nCollection of blood, stool, urine, saliva, hair, and fingernail samples.\n\nX-rays, MRI, and heart tests will be done only once. Other procedures may be repeated at each visit. All tests and procedures are voluntary.\n\nHealthy relatives who enroll will have a baseline visit and then follow-up visits as needed. They will have a physical exam. The inside of their mouth may be swabbed. Samples of blood, stool, urine, and saliva may be taken.",[158,159,160],"Trisomy 8 Mosaicism","Trisomy 8 Associated Autoinflammatory Disease","Mucosal Ulcerations",[162,163,164,165,166,167,168],"Genital Ulcers","Myelodysplastic Syndromes","Mucosal ulcerations","Recurrent fever","Oral aphthous ulcers","Autoinflammatory disease","Trisomy 8 mosaicism",{"date":34,"type":35},{"date":93,"type":20},{"date":172,"type":20},"2056-06-01",{"name":39,"class":40},{"id":175,"slug":4,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":104,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":180,"conditions":181,"keywords":183,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},"100054082","NCT06479837","Modeling Host-Pathogen Interaction Using Lymphoid Organoids","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Aged \\>=2 yrs.\n* Undergoing tonsillectomy as part of their clinical care.\n* Able to provide informed consent (for ages \\>=18 years) or has a parent or guardian who can provide informed consent on their behalf (for ages \\\u003C18 yrs).\n* Willing to allow samples and data to be stored and shared for future secondary research.\n* Willing to allow future genetic testing on their biospecimens.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Active infection.\n* Active tonsilitis.\n* Pregnant.\n* Diagnosed with an immunosuppressive condition or currently taking immunosuppressive medications.\n* Current or past intravenous drug use.\n* Any condition that, in the judgment of the investigator, may put the participant at undue risk or make them unsuitable for participation in the study",{"count":19,"type":20},"Background:\n\nStaphylococcus aureus (S.aureus) are bacteria that can make people sick. Sometimes, an S. aureus infection can develop inside the spine; these infections can lead to paralysis and death. Researchers do not know how S. aureus interacts with a person s cells to cause infections in the spine.\n\nObjective:\n\nTo learn how S. aureus interacts with cells in the body using tissues from tonsils discarded after standard surgery to remove them.\n\nEligibility:\n\nPeople aged 2 years and older who are scheduled to have their tonsils removed.\n\nDesign:\n\nResearchers will select participants for the study based on review of their existing medical records, including results of blood tests; any imaging scans, including x-rays; and reports about tissue specimens.\n\nParticipants will answer questionnaires about their health and past infections. They can do this online or on paper.\n\nParticipants will collect a nasal swab 1 week before their surgery. They will be given a tool that looks like a long cotton swab. They will twirl it around inside their nose. The swab will pick up cells and fluids that will be used for research.\n\nAfter their surgery, the participant s surgeon will save samples of tonsil tissue. The surgeon will send these tissue samples and the nasal swab to researchers at the NIH.\n\nThese tissues and the swab will be used in studies to help researchers understand how S. aureus interacts with cells in the body. They hope these studies will help them find better ways to treat S. aureus infections.",[182],"Staphylococcal Infections",[184,185,186],"Organoid","Staphylococcus","Host-pathogen Interactions",{"date":34,"type":35},{"date":93,"type":20},{"date":190,"type":20},"2044-12-01",{"name":39,"class":40},2,{"id":194,"slug":4,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":48,"sex":15,"minAge":75,"maxAge":76,"enrollmentInfo":199,"targetDuration":4,"studyType":79,"phases":201,"briefSummary":202,"conditions":203,"keywords":206,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":211,"leadSponsor":213,"locationsCount":192},"100053229","NCT07215858","BPL-1357 Against H1N1 Influenza Virus Challenge","Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study of the Safety and Efficacy of BPL-1357 Against H1N1 Influenza Virus Challenge","* INCLUSION CRITERIA:\n\nIndividuals must meet all of the following criteria to be eligible for study participation:\n\n1. Adults \\>=18 and \\\u003C= 55 years of age at the time of consent.\n2. Able to provide written informed consent.\n3. Non-smoker (i.e., tobacco and cannabis) and does not use vape or e-cigarette products currently. Also, must not have used any of these products extensively in the past (regular use more than 5 times per week, more than 6 months lifetime total).\n4. Has not received influenza vaccination of any type within 6 months prior to enrollment and consents to not receive influenza vaccination of any type until after the end of study participation (PBD63).\n5. Has not received any other vaccination of any type within 4 weeks prior to enrollment and consents to not receive any unlicensed vaccine until after the end of the study (PBD63).\n6. Has not received any broadly protective influenza vaccine in the past.\n7. Participants of childbearing potential must meet one of the following criteria through the end of study participation (PBD63):\n\n   1. Is infertile, including postmenopausal status (as defined by age .45 years plus no menses for \\>= 1 year without an alternative medical cause) or history of hysterectomy or bilateral oophorectomy.\n   2. Agrees that, when engaging in intercourse that can result in pregnancy, they will use an acceptable or highly effective form of contraception, and their male partner will use a condom with spermicide. Acceptable methods of female contraception include\n\n   the following:\n   * Bilateral tubal ligation\n   * Implant of levonorgestrel\n   * Injectable progestogen\n   * Oral contraceptive pills\n   * Diaphragm with spermicide\n   * Intrauterine device (IUD)\n   * Sexual abstinence\n   * Vasectomized partner\n8. Able to speak and understand English (NIH).\n9. Able to speak and understand English and\u002For Spanish (UTMB).\n10. A negative HIV test within 6 months before enrollment.\n11. Has not used IN medications (including but not limited to nasal sprays, sinus rinses), and has not routinely used over-the-counter medications (including but not limited to aspirin, decongestants, antihistamines, and other nonsteroidal anti-inflammatory drugs), and herbal medications (including but not limited to herbal tea or St. John's Wort) within 14 days (about 2 weeks) prior to study enrollment and agrees not to use these medications until after the end of study participation (PBD63), unless approved by the investigator.\n12. Agrees not to donate blood or blood products from enrollment through the final study visit (PBD63).\n13. Not planning on cohabitating with any high-risk individuals (e.g., infants, elderly, those with high-risk conditions (e.g., pregnancy, medical conditions such as those outlined in exclusion criterion 1) for at least 2 weeks after discharge from the inpatient portion of this study.\n14. Participant is willing and able to comply with all trial procedures.\n\nEXCLUSION CRITERIA\n\nIndividuals meeting any of the following criteria will be excluded from study participation:\n\n1. Current medical conditions (self-reported or medically documented) including but not limited to:\n\n   1. Chronic pulmonary disease (e.g., asthma, emphysema).\n   2. Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).\n   3. Chronic medical conditions requiring close medical follow-up or hospitalization (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).\n   4. Immunosuppression, immune deficiency, or ongoing malignancy.\n   5. Neurological and neurodevelopmental condition (e.g., Bell s palsy, cerebral palsy, epilepsy, seizures).\n2. Body mass index (BMI) \\\u003C18 and \\>35.\n3. Pregnant or breastfeeding.\n4. History of postinfectious or postvaccine neurological sequelae including GBS.\n5. History of stroke within the past 5 years.\n6. Acute illness within 7 days prior to enrollment (PAD0).\n7. Known allergy to influenza vaccination or components contained in the influenza vaccine being used.\n8. Known allergy to influenza treatments (including oseltamivir or nonsteroidal anti-inflammatory medications).\n9. Known allergy to 2 or more classes of antibiotics (e.g., penicillins, cephalosporins, fluoroquinolones, or glycopeptides).\n10. Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment.\n11. Receipt of any unlicensed drug or investigational agent within 3 months or 5.5 half-life (whichever is greater) prior to enrollment.\n12. Receipt of any unlicensed vaccine within 6 months prior to enrollment.\n13. Self-reported or known history of alcoholism or drug abuse or use within 6 months prior to enrollment, or positive urine test for illicit drugs (i.e., amphetamines, cocaine metabolites, benzodiazepines, opiates, but not tetrahydrocannabinol) prior to vaccination on PAD0.\n14. Self-reported or known history of psychiatric or psychological issues that require treatment and are deemed by the PI to be a contraindication to protocol participation.\n15. History of angioedema or anaphylaxis.\n16. Study site staff who directly report to the study or site PI are excluded from participation.\n17. Any condition, event or lab value that, in the judgment of the investigator, is a contraindication to protocol participation or would place the participant at increased risk for participation.\n18. Any condition or event that, in the judgment of the investigator, impairs the participant's ability to give informed consent.\n\nIndividuals meeting any of the following criteria will be excluded from participation in Phase B:\n\n1. Positive urine test for illicit drugs (i.e., amphetamines, cocaine metabolites, benzodiazepines, opiates, but not tetrahydrocannabinol) prior to inoculation (PBD0).\n2. Acute illness within 7 days prior to inoculation with the human challenge virus (PBD0).\n3. Grade 3 or greater sign, symptom, or lab abnormality that is clinically significant and (in the opinion of the site PI) puts the participant at higher risk of adverse effects with influenza challenge.\n4. Pregnant or breastfeeding.\n5. Positive test for influenza within 8 weeks prior to challenge.",{"count":200,"type":20},129,[81],"Background:\n\nInfluenza (flu) infections are a serious global health threat. Each year, between 3 and 5 million people get the flu, and up to 500,000 die from it. Current vaccines protect against seasonal flus, but broader vaccines are needed to protect against potential flu pandemics.\n\nObjective:\n\nTo test an experimental flu vaccine.\n\nEligibility:\n\nHealthy people aged 18 to 55 years.\n\nDesign:\n\nThe study will last 5 to 8 months and has 2 phases, A and B.\n\nThe study vaccine will be given either as a shot in the arm or as a nasal spray. Participants will receive 1 of 3 combinations: (1) study vaccine in the nose and placebo in the arm; (2) placebo in the nose and study vaccine in the arm; or (3) placebo in the nose and placebo in the arm. A placebo is just like the real vaccine but contains no active ingredients.\n\nPhase A: Participants will have 5 clinic visits over 56 days. They will receive a shot and a nasal spray at 2 of the visits, 28 days apart. At each visit, they will have a physical exam, with tests of their blood, urine, and nasal secretions. They will check their temperature at home and record any symptoms for 7 days after each vaccine.\n\nPhase B: Participants will stay in the hospital for at least 9 days. They will be infected with a flu virus. They will provide blood, urine, and nasal fluid samples. They will have tests of their heart function. They will remain in the hospital until they test negative for the flu 2 days in a row.\n\nThey will have 2 follow-up visits, 4 and 8 weeks after leaving the hospital.\n\n...",[204,205],"Influenza","Human",[204,207,208],"Vaccine","Human Challenge",{"date":34,"type":35},{"date":93,"type":20},{"date":212,"type":20},"2028-03-01",{"name":39,"class":40},{"id":215,"slug":4,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":48,"sex":15,"minAge":75,"maxAge":220,"enrollmentInfo":221,"targetDuration":4,"studyType":79,"phases":223,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":242},"100054120","NCT07536308","A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults","A Phase 1 Open-Label Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike, A Next-Generation SARS-CoV-2 Booster Vaccine Via Intranasal and Inhalational Routes, in Previously Vaccinated Adults","Inclusion Criteria:\n\n1. Provides written informed consent before initiation of any study procedures.\n2. Able to understand and agree to comply with planned study procedures and be available for all study visits.\n3. Non-pregnant adults, 18 through 64 years of age at the time of study product administration.\n4. Participants of childbearing potential\\* must agree to use or have practiced true abstinence\\*\\* or use at least one acceptable primary form of contraception.\\*\\*\\*\n\n   \\*These criteria apply to females who are in a heterosexual relationship and are of childbearing potential. Not of childbearing potential include post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation\u002Fsalpingectomy).\n\n   \\*\\*True abstinence is 100 percent of the time, no sexual intercourse (penis enters the vagina). Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post-ovulation methods\\] and withdrawal are not acceptable methods.\n\n   \\*\\*\\*Acceptable forms of primary contraception include a monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more before the participant's study product administration, a copper intrauterine device, a levonorgestrel-releasing intrauterine device, a progestin-only oral contraceptive pill, a depot medroxyprogesterone injection, or a progestin implant. Combined hormonal contraceptives containing estrogen, including combined oral contraceptive pills, transdermal patches, and vaginal rings, are not acceptable for this trial. Must have used at least one acceptable primary form of contraception for at least 30 days before study product administration and agree to continue at least one acceptable primary form of contraception through 60 days after study product administration.\n5. Participants of childbearing potential must have a negative urine pregnancy test at screening and within 24 hours before study product administration.\n6. In general, good health.\\*\n\n   \\*As determined by medical history and physical examination, including vital signs, to evaluate acute or ongoing chronic medical diagnoses\u002Fconditions that have been present for at least 90 days, which would affect the assessment of participant safety. Chronic medical diagnoses\u002F conditions should be stable for the last 30 days (i.e., no hospitalization, ER, or urgent care for the condition). This includes no change in chronic prescription medication, dose, or frequency due to deterioration of the chronic medical diagnosis or condition within the 30 days preceding the study product administration. Any prescription change that is due to a change of health care provider, insurance company, etc., or done for financial reasons, and in the same class of medication, will not be considered a deviation of this inclusion criterion. Participants may be on chronic or as-needed (prn) medications if, in the opinion of the participating site PI or appropriate sub-investigator, they pose no additional risk to participant safety or assessment of reactogenicity and immunogenicity.\n7. Receipt of a complete primary COVID-19 vaccine series and at least one booster\\* with last vaccination at least 16 weeks before study product administration.\n\n   \\*Booster may be either homologous or heterologous to the primary vaccine series. It must be an FDA-authorized\u002Flicensed vaccine, though doses may have been received as part of a clinical trial.\n8. Clinical screening laboratory evaluations are within normal reference ranges or grade 1 with no clinical significance (NCS) per investigator discretion.\\*\n\n   \\*(White Blood Cells \\[WBCs\\] with differential \\[diff\\], hemoglobin \\[Hgb\\], platelets \\[PLTs\\], PTT, PT, Alanine Transaminase \\[ALT\\], Aspartate Transaminase \\[AST\\], Creatinine \\[Cr\\], Alkaline Phosphatase \\[ALP\\], Total Bilirubin \\[T. Bili\\]). ALT, AST, ALP, T. Bili, and creatinine values that are below the reference range will not be exclusionary, as these values below the reference range are clinically insignificant.\n9. Must agree to have samples stored for secondary research.\n10. Must complete a Test of Understanding (ToU) before enrollment by answering 90 percent of questions correctly at least once in 3 attempts.\n\nExclusion Criteria:\n\n1. Positive SARS-CoV-2 PCR at screening.\n2. Abnormal vital signs (Grade 1 or higher).\\*\n\n   \\*Grade 1 or higher is equivalent to: Systolic blood pressure (SBP) = 141 mmHg or = 89 mmHg Diastolic blood pressure (DBP) = 91 mmHg Heart rate (HR) is = 101 beats per minute or = 54 beats per minute Oral temperature = 38.0 degrees Celsius (100.4 degrees Fahrenheit)\n3. History of SARS-CoV-2 infection within the prior 16 weeks OR receipt of any COVID-19 vaccine within the prior 16 weeks before study product administration.\n4. Participant who is pregnant or breastfeeding or less than 12 weeks post partum at the time of study product administration.\n5. Participant has donated blood or plasma within 4 weeks prior to study product administration, or does not agree to refrain from blood or plasma donation until Day 181.\n6. Receipt of antibody or blood-derived products within 90 days before study product administration.\n7. Any significant medical or psychiatric diseases or any other condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation.\\*\n\n   \\*Significant self-reported or medically reported medical or psychiatric conditions include, but are not limited to drug or alcohol abuse within 6 months of enrollment, significant kidney disease, liver disease, history of hematologic malignancies, ongoing malignancy or recent diagnosis of malignancy in the last five years, excluding treated basal cell and squamous cell carcinoma of the skin, and cervical carcinoma in situ, which are allowed.\n8. Any respiratory disease, including but not limited to chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease, bronchiectasis, etc.\n9. Neurological or neurodevelopmental conditions.\\*\n\n   \\*These conditions include: history of Bell's palsy, history of four or more migraine headaches in the past 12 months that interfered with normal daily activity or any migraine headache in the past 5 years that required emergency or inpatient medical care, epilepsy, seizures in the last 5 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, myelopathy, peripheral neuropathy, encephalomyelitis, transverse myelitis, stroke or transient ischemic attack, multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, or Alzheimer's disease.\n10. Cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), including any history of myocarditis or pericarditis, or uncontrolled cardiac arrhythmia.\n11. Any autoimmune disease, including hypothyroidism without a defined non-autoimmune cause.\n12. Any significant nasal or upper airway disease.\\*\n\n    \\*Including, but not limited to, being prone to epistaxis, a history of inflammatory rhinitis (including allergic rhinitis) that requires daily medications, cochlear implants, head\u002Fneck radiation history, anosmia\u002Fdysosmia, conditions that require prescription or over the counter intranasal medication (intermittent use will be allowed if no use occurred for 30 days before study product administration and participant agrees to not use intranasal medication (other than steroids) for 30 days after study product administration and to not use intranasal steroids for 6 months after study product administration), and certain ear, nose and throat (ENT) conditions, including significant upper airway\u002Fnasopharyngeal disease or abnormal anatomy such as CSF leak.\n13. Has an acute illness, as determined by the site Principal Investigator or appropriate sub-investigator within 72 hours before study product administration.\\*\n\n    \\*An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.\n14. Has a positive test result for hepatitis B surface antigen, hepatitis C virus RNA (by reflex testing), or human immunodeficiency virus (HIV) antigen\u002Fantibody test at screening.\n15. Has any confirmed or suspected immunosuppressive or immunodeficient state, such as asplenia, recurrent severe infections, and chronic\\* immunosuppressant medication within the past 6 months.\\*\\*\n\n    \\*Chronic meaning more than 14 continuous days.\n\n    \\*\\*Ophthalmic and topical steroids are allowed, see exclusions 12 and 21 for intranasal steroids.\n16. Has received any investigational product within 60 days, or 5 half-lives, whichever is longer, before study product administration; or is planning to receive one during the study.\n17. Has a history of hypersensitivity or severe allergic reaction\\* to any previous licensed or unlicensed vaccine or to the candidate vaccine components.\n\n    \\*e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction\n18. History of chronic idiopathic urticaria.\n19. Received or plans to receive licensed inactivated\u002Fsubunit vaccine within 14 days of study product administration or live vaccine within 28 days of study product administration.\n20. Plan to receive a COVID-19 vaccine within the 180 days following study product administration.\n21. Regular use of intranasal medications, including steroids.\\*\n\n    \\*Participant must have had no intranasal medication use for 30 days before study product administration and plans not to use intranasal medications for 30 days after study product administration for medications other than steroids, and for 6 months after study product administration for intranasal steroids (including over-the-counter fluticasone).\n22. History of smoking within three months before enrollment.\\*\n\n    \\*Including cigarettes, smokeless and other tobacco products, e-cigarettes (to include vaping and Juuling products), marijuana, nicotine gum, and nicotine lozenges.\n23. Use of intranasal illicit drugs in the 5 years before study product administration or plans to use during the study.\n24. Planned international travel between study product administration and Day 29.\n25. Previous receipt of any adenovirus-vector vaccine by the intranasal or aerosol routes.\n26. Bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following Intramuscular injections or venipuncture.\n27. Recent (within 3 months of study product administration): major surgery, \\>=3 days immobility, chronic infection, or head trauma that may increase thrombosis risk.\\*\n\n    \\*Major surgery is either abdominal or vascular, or orthopedic surgery, and immobility implies bed rest.\n28. History of venous or arterial thrombosis or any known thrombophilic condition, including heparin-induced thrombocytopenia (HIT) or thrombosis.\n29. BMI \\>\u002F= 40kg\u002Fm\\^2\n30. Current\u002Fplanned systemic estrogen therapy, except stable transdermal estradiol, from 30 days pre-dose through end of study participation. Low-dose vaginal estrogen is permitted.","64 Years",{"count":222,"type":20},80,[108],"This phase 1 randomized, open-label, dose-escalation clinical trial evaluates the safety and immunogenicity of OCU500, a ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine, in healthy adults aged 18-64 who previously completed a primary COVID-19 vaccination series and at least one booster. The study evaluates two dose levels (1×10\\^10 viral particles (VP) and 5×10\\^10 VP) and two routes of administration (intranasal and inhaled). The trial includes 80 participants across four study arms (20 per arm). The primary objective is to evaluate the safety and reactogenicity of a single dose of OCU500 administered in previously vaccinated healthy adults.",[226],"COVID-19",[228,229,230,231,232,233,234],"coronavirus","COVID","Next Generation","OCU500","Open-label","Phase I","vaccine","2026-07-09",{"date":34,"type":35},{"date":238,"type":35},"2026-05-26",{"date":240,"type":20},"2027-11-01",{"name":39,"class":40},6,{"id":244,"slug":4,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":15,"minAge":103,"maxAge":104,"enrollmentInfo":245,"targetDuration":4,"studyType":79,"phases":246,"briefSummary":109,"conditions":247,"keywords":248,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":255,"locationsCount":41},"100613161",{"count":106,"type":20},[108],[111,112,113,114,115],[111,117,113,114,115,118,119,120],"2026-07-01",{"date":251,"type":35},"2026-07-02",{"date":253,"type":20},"2026-07-07",{"date":124,"type":20},{"name":39,"class":40},{"id":257,"slug":4,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":48,"sex":15,"minAge":75,"maxAge":76,"enrollmentInfo":258,"targetDuration":4,"studyType":79,"phases":259,"briefSummary":202,"conditions":260,"keywords":261,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":264,"leadSponsor":265,"locationsCount":192},"100609536",{"count":200,"type":20},[81],[204,205],[204,207,208],{"date":251,"type":35},{"date":253,"type":20},{"date":212,"type":20},{"name":39,"class":40},{"id":267,"slug":4,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":15,"minAge":75,"maxAge":132,"enrollmentInfo":268,"targetDuration":4,"studyType":79,"phases":269,"briefSummary":137,"conditions":270,"keywords":271,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":274,"leadSponsor":275,"locationsCount":148},"100595082",{"count":134,"type":20},[136],[139,140],[140,139,142],{"date":251,"type":35},{"date":253,"type":20},{"date":146,"type":20},{"name":39,"class":40},{"id":277,"slug":4,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":15,"minAge":282,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":79,"phases":285,"briefSummary":286,"conditions":287,"keywords":288,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":301},"100554828","NCT06504160","Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2)","Safety and Efficacy of Topical Bacteriotherapy for Atopic Dermatitis Using Staphylococcus Hominis A9","Inclusion Criteria:\n\nEach individual must meet all of the following criteria at Screening to be eligible for enrollment as a study participant:\n\n1. Participant and\u002For parent\u002Flegal guardian must be able to understand and provide informed consent and assent (if applicable).\n2. Male or female participant 6 years of age or older.\n3. Meet ADRN Standard Diagnostic Criteria for active AD.\n\n   Each individual must meet all of the following criteria at Baseline to be eligible for enrollment as a study participant:\n4. Have at least 7 cm2 of lesional skin within the upper extremities, lower extremities, and\u002For trunk. Lesions on the face, neck, hands, feet, and intertriginous areas do not count toward the required area, as samples may not be taken from these areas. The required area may be one contiguous area or may be comprised of multiple areas with a compliant total area.\n5. Have at least 3% body surface area of AD involvement as indicated by derived total area of involvement score during SCORAD assessment.\n6. Have an IGA score of two or greater.\n7. Each potential participant who can become pregnant must meet either of the following criteria prior to randomization to be eligible for enrollment as a study participant.\n\n   1. Willing to remain abstinent from intercourse that may result in a pregnancy.\n   2. Willing to use an FDA-approved method of contraception for the duration of study participation. Acceptable methods include the following:\n\n      * Permanent sterilization of partner\n      * Long-acting reversible contraceptives (e.g., intrauterine devices or systems, implantable rods, contraceptive injections) when used as directed for at least 7 days prior to Baseline.\n      * Short-acting hormonal contraceptives (e.g., oral contraceptive pills, patch, vaginal ring) when used as directed for at least 30 days prior to Baseline\n      * Barrier methods (e.g., condoms; diaphragm, sponge, or cervical cap with spermicide)\n8. Have obtained negative pregnancy test results during both the Screening and Baseline Visits.\n\nExclusion Criteria:\n\nIndividuals who meet any of the following criteria at Screening or Baseline are not eligible for enrollment as study participants:\n\n1. Inability or unwillingness to give written informed consent or comply with study protocol.\n2. Has self-reported as pregnant or lactating during the Screening or Baseline Visit, or is pregnant as indicated by a positive pregnancy test result obtained at the Screening or Baseline Visit.\n3. Sensitivity to or difficulty tolerating Dove® fragrance-free bar soap, Cetaphil® lotion, alcohol-based cleaners, clobetasol and fluocinonide ointments, triamcinolone ointment, hydrocortisone ointment, glycerol, hydroxyethylcellulose or soy products.\n4. Known recalcitrance to topical steroids, including class 1 steroids, within 6 months of the Screening Visit.\n5. History of serious life-threatening reaction to tape or adhesives.\n6. Known allergy to all antibiotics to which S. hominis A9 is sensitive. These include ampicillin-sulbactam, cefazolin, cefoxitin, clindamycin, daptomycin, doxycycline, levofloxacin, linezolid, minocycline, moxifloxacin, mupirocin, nitrofurantoin, oxacillin, rifampin, trimethoprim-sulfamethoxazole, and vancomycin.\n7. Has a major defect in the epidermal barrier such as open wounds or genodermatoses (e.g., Netherton's syndrome).\n8. Is immunocompromised (e.g., Human Immunodeficiency Virus (HIV)\u002FAcquired Immunodeficiency Syndrome (AIDS), Wiskott-Aldrich Syndrome) or has an immune system disorder (e.g., autoimmune disease).\n9. Has current malignant disease (except non-melanoma skin cancer in an area not affected by treatment).\n10. Has a history of psychiatric disease or history of alcohol or drug abuse that, in the opinion of the study investigator, would interfere with the ability to comply with the study protocol.\n11. Ongoing participation in another investigational trial or use of investigational drugs within 8 weeks, or five half-lives (if known), whichever is longer, of the Screening Visit.\n12. Treatment with non-steroid systemic immunosuppressant within 6 months of the Screening Visit.\n13. Treatment with any biologic, including dupilumab, within 16 weeks of the Screening Visit.\n14. Treatment with oral or injectable therapy for AD (excluding oral steroids) within five half-lives (if known) or 16 weeks before the Screening Visit, whichever is longer.\n15. Treatment with oral retinoids (e.g., isotretinoin) within 60 days of the Screening Visit.\n16. Treatment with allergen immunotherapy within 30 days of Screening Visit.\n17. Has close contacts (e.g., spouse, children, or members in the same household) who have severe barrier defects or are immunocompromised.\n18. May, in the opinion of the investigator, have difficulty tolerating the medication washout requirements for topical AD treatments, prescription moisturizers, antibiotics, oral steroid therapies, and phototherapy ahead of Baseline.\n19. Past or current medical conditions or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.\n\n    Individuals who meet any of the following criteria at Baseline are not eligible for enrollment as study participants:\n20. Have more than 30% body surface area of AD involvement, as indicated by the derived total area of involvement score during SCORAD assessment.\n21. Active bacterial, viral, or fungal skin infections, except for onychomycosis and tinea pedis.\n22. Any noticeable breaks or cracks in the skin on the target areas of investigational product application, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection.\n\n    a. At the investigator's discretion, participants with minor breaks, cracks, or excoriations on body areas not eligible for sampling during the trial may be enrolled, provided there is no evidence of infection and investigational product is not applied to these areas until healed.\n23. Use of topical AD treatments - including steroids and calcineurin inhibitors - on the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), or trunk within seven days of the Baseline Visit.\n24. Treatment with prescription moisturizers classified as medical device (e.g., Atopiclair®, MimyX®, Epiceram®, etc.) on the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), or trunk within seven days of the Baseline Visit.\n25. Use of any systemic microbialª within fourteen days of the Baseline Visit, or use of any topical antimicrobial on the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), or trunk within fourteen days of the Baseline Visit.\n\n    a. Antimicrobials include antibiotics, antifungals, antiparasitics, and antivirals. Certain systemic antivirals that do not exhibit systemic anti-inflammatory effects may be permitted with prior approval from a protocol co-chair).\n26. Within the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), and trunk, use of topical products - prescription or over-the-counter, all formulations - not specified per protocol, within seven days of the Baseline Visit.\n27. Use of systemic corticosteroid therapies for any indication within 28 days of the Baseline Visit.\n28. Use of systemic corticosteroid therapies for treatment of an asthma exacerbation within 3 months of the Baseline Visit.\n29. Require a dose greater than 880 mcg\u002Fday of fluticasone propionate or equivalent inhaled corticosteroid to maintain asthma control, at the time of the Baseline Visit.\n30. Any phototherapy for skin disease (such as narrow band ultraviolet B \\[NBUVB\\], ultraviolet B \\[UVB\\], ultraviolet A1 \\[UVA1\\], psoralen + UVA \\[PUVA\\]) or regular use (more than 2 visits per week) of a tanning bed within 28 days of the Baseline Visit.","6 Years",{"count":284,"type":20},86,[108],"This is a Phase 1b, randomized, placebo\u002Fvehicle-controlled, double-blinded, multi-center trial. It is designed to assess the safety and efficacy of S. hominis A9 (ShA9) topical application as a treatment for atopic dermatitis (AD). The trial will enroll adults and pediatric participants with atopic dermatitis.\n\nThe primary safety objective of this study is to compare the safety profile of ShA9 to placebo (vehicle) over 14 weeks of application, which includes an initial two-week period of co-treatment with topical corticosteroids (TCS). The primary efficacy objective of this study is to assess the ability of ShA9, compared to placebo (vehicle), to prolong the period of atopic dermatitis control over 12 weeks after conclusion of an initial two-week period of co-treatment with TCS.",[115],[289,290,291,292,293,294],"atopic dermatitis","eczema","ADRN","TIME-2","microbiome","Staphylococcus hominis",{"date":251,"type":35},{"date":297,"type":35},"2025-05-22",{"date":299,"type":20},"2027-02-05",{"name":39,"class":40},8,{"id":303,"slug":4,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":104,"enrollmentInfo":304,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":180,"conditions":305,"keywords":306,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":307,"startDateStruct":308,"completionDateStruct":309,"leadSponsor":310,"locationsCount":192},"100552957",{"count":19,"type":20},[182],[184,185,186],{"date":251,"type":35},{"date":253,"type":20},{"date":190,"type":20},{"name":39,"class":40},{"id":312,"slug":4,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":48,"sex":15,"minAge":75,"maxAge":76,"enrollmentInfo":313,"targetDuration":4,"studyType":79,"phases":314,"briefSummary":82,"conditions":315,"keywords":316,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":317,"startDateStruct":318,"completionDateStruct":319,"leadSponsor":320,"locationsCount":41},"100489389",{"count":78,"type":20},[81],[84,85,86,87],[89,90,87],{"date":251,"type":35},{"date":253,"type":20},{"date":95,"type":20},{"name":39,"class":40},{"id":322,"slug":4,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":48,"sex":15,"minAge":326,"maxAge":327,"enrollmentInfo":328,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":330,"conditions":331,"keywords":333,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":41},"100327094","NCT03538600","Sample Collection From Healthy Volunteers for Assay Optimization","* INCLUSION CRITERIA:\n\n  1. Aged 3-80 years.\n  2. Able to provide informed consent (for ages \\>=18 years) or has a parent or guardian who can provide informed consent on their behalf (for ages \\\u003C18 years).\n  3. Agree to allow biological samples to be stored for future research.\n  4. Willing to provide blood, stool, saliva, skin\u002Fmucosal\u002Ftonsil swabs, and\u002For skin punch biopsy specimens.\n\nEXCLUSION CRITERIA:\n\nIndividuals meeting any of the following criteria will be excluded from study participation:\n\n1. Pregnancy.\n2. History of autoimmune or autoinflammatory disease.\n3. Diabetes mellitus.\n4. Cancer chemotherapy within the past 5 years.\n5. Currently receiving treatment for an active malignancy.\n6. Surgery within the past 8 weeks.\n7. History of recent (within the past 30 days) infection.\n8. History of significant, active parasitic, amebic, fungal, or mycobacterial infections within the past 5 years (as determined by the PI).\n9. Infected with HIV and\u002For hepatitis B and\u002For C.\n10. Use of an oral or inhaled glucocorticoid within the past 30 days.\n11. History of a bleeding disorder.\n12. Screening lab values are both outside of the NIH Department of Laboratory Medicine normal reference range and deemed clinically significant by the PI.\n13. Receipt of an immunosuppressant or immunomodulatory drug within the past 30 days.\n14. Receipt of a live-attenuated vaccine within the past 30 days.\n15. Receipt of any other type of vaccine within the past 14 days.\n16. Current or past use (within the past 90 days) of immunoglobulin therapy.\n17. Current use of illicit drugs (per subject report).\n18. Current use of nicotine-containing products, including cigarettes and chewing tobacco, nicotine patches, gum, electronic cigarettes, etc.\n19. Current alcohol use disorders (criteria per Diagnostic and Statistical Manual of Mental Disorders, fifth edition).\n20. Any condition that requires active medical intervention or monitoring to avert serious danger to the individual s health or wellbeing.\n21. Any condition that, in the opinion of the PI, contraindicates participation in this study or would significantly affect immune profile.\n\nCo-enrollment guidelines: Participants may be co-enrolled in other studies. The PI may withdraw them from this study for any reason that may contraindicate participation.","3 Years","80 Years",{"count":329,"type":20},600,"Background:\n\nThe Laboratory of Immune System Biology (LISB) works with other labs at the National Institutes of Health. They study how parts of living things come together to make a whole. LISB designs and improves research tests on human samples like blood and cells. In order to do its work, LISB needs to have a lot of these samples available.\n\nObjective:\n\nTo collect biological specimens to use for designing and improving research tests. Specimens include blood, stool, saliva, and skin\u002Fmucosal swabs.\n\nEligibility:\n\nHealthy people ages 3-80\n\nDesign:\n\nParticipants will be screened with an interview about their general health and their medical history. They will have a physical exam and blood tests.\n\nIf the results of the screening are normal, participants will be asked to give one or more of these samples:\n\nBlood will be drawn from an arm vein with a needle and syringe.\n\nMucus and skin will be collected by rubbing the area with a cotton swab. The areas may include the top of the tongue, inside the cheek, nostrils, behind the ear, elbow pit, or vagina.\n\nParticipants will spit into a tube to collect saliva.\n\nParticipants will pass stool into a plastic container that fits in the toilet under the seat. They will get sampling kits and instructions.\n\nOver the next 5 years, if more samples are needed, participants will be contacted to set up another visit to the NIH. These visits will each take about 1 hour.\n\nAbout every 2 years, when participants come to NIH for a visit, extra blood will be collected. It will be tested for HIV and hepatitis B and C.\n\n...",[332],"Healthy Volunteers",[334,335,336,337,338,29],"Blood","Microbiome Analysis","Stool","Saliva","Skin",{"date":251,"type":35},{"date":341,"type":35},"2018-06-28",{"date":343,"type":20},"2043-06-30",{"name":39,"class":40},{"id":346,"slug":4,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":48,"sex":15,"minAge":49,"maxAge":350,"enrollmentInfo":351,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":353,"conditions":354,"keywords":359,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":192},"100301592","NCT03206099","NIAID Centralized Sequencing Protocol","* PARTICIPANT INCLUSION CRITERIA:\n* Must fulfill one of the following criteria:\n\n  * Proband participants: must be individuals under investigation by another NIH protocol on which they are co-enrolled, or are referred from the GDMCC protocol \"Defining the Genetic Etiology of Suppurative Lung Disease in Children and Adults\" (NCT04702243). Probands may have a disease under investigation or be healthy volunteers\n  * Biological relatives: biologically related to a proband participant.\n* Aged 0-99 years.\n* Participants must be willing to undergo genetic testing.\n* Participants must be willing to allow samples to be stored for future research.\n* Participants must be willing to have their de-identified genomic data shared, for example in a controlled access databases like the Database of Genotypes and Phenotypes (dbGaP).\n* To complete surveys and interviews:\n\n  * Proficient with the English language.\n  * Able to provide informed consent.\n* Adult healthy volunteers must be able to provide informed consent.\n\nPARTICIPANT EXCLUSION CRITERIA:\n\nAny condition that, in the opinion of the investigator, contraindicates participation in this study is a reason for exclusion.","100 Years",{"count":352,"type":20},20000,"Background:\n\nGenetic testing called \"sequencing\" helps researchers look at DNA. Genes are made of DNA and are the instructions for our bodies to function. We all have thousands of genes. DNA variants are differences in genes between two people. We all have lots of variants. Most are harmless and some cause differences like blue or brown eyes. A few variants can cause health problems.\n\nObjective:\n\nTo understand the genetics of immune disorders various health conditions, as well as outcomes of clinical genomics and genetic counseling services performed under this protocol.\n\nEligibility:\n\nParticipants in other NIH human subjects research protocols - either at the NIH Clinical Center (CC) or at Children s National Health System (CNHS) - (aged 0-99 years), and, in select cases, their biological relatives\n\nDesign:\n\nResearchers will study participant s DNA extracted from blood, saliva, or another tissue sample, including previously collected samples we may have stored at the NIH. Researchers will look at participant s DNA in great detail. We are looking for differences in the DNA sequence or structure between participants and other people.\n\nParticipants will receive results that:\n\n* Are important to their health\n* Have been confirmed in a clinical lab\n* Suggest that they could be at risk for serious disease that may affect your current or future medical management.\n\nSome genetic information we return to participants may be of uncertain importance.\n\nIf genetic test results are unrelated to the participant s NIH evaluations, then we will not typically report:\n\n* Normal variants\n* Information about progressive, fatal conditions that have no effective treatment\n* Carrier status (conditions you don t have but could pass on)\n\nThe samples and data will be saved for future research.\n\nPersonal data will be kept as private as possible.\n\nIf future studies need new information, participants may be contacted.",[355,356,357,358],"Atopy","Primary Immunodeficiency","Autoimmunity","Autoinflammation",[360,361,362,363,364,29],"Phenotyping","Genetics","Sequencing","Inborn Errors of Immunity","Genomics",{"date":251,"type":35},{"date":367,"type":35},"2017-07-31",{"date":369,"type":20},"2029-12-31",{"name":39,"class":40},{"id":372,"slug":4,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":11,"sex":15,"minAge":75,"maxAge":132,"enrollmentInfo":377,"targetDuration":4,"studyType":79,"phases":379,"briefSummary":380,"conditions":381,"keywords":383,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":386,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":41},"100298622","NCT03167437","An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab","An Open-Label, Proof of Concept Study of Vorinostat for the Treatment of Moderate-to-Severe Crohn's Disease, Ulcerative Colitis, and Chronic Granulomatous Disease Colitis Patients and Maintenance Therapy With Ustekinumab","* INCLUSION CRITERIA:\n\nIndividuals with moderate-to-severe CD, UC, and CGD colitis who are not controlled by and refractory to standard therapy will be eligible for inclusion into this study if they meet the following criteria:\n\n1. Are 18 to 65 years of age, inclusive, at enrollment date.\n2. Have a diagnosis of CD, UC, or CGD colitis that has been endoscopically or radiographically confirmed. A colonoscopy will be required at baseline to document mucosal disease activity. SES-CD for CD and CGD colitis will be obtained with minimum score of 7 and MES for UC patients will be obtained with minimum score of 2.\n3. Have active CD symptoms as defined by a CDAI score between 220 and 350, UC symptoms defined by a Mayo score of 6 to 10 (moderate) or 10 to 12 (severe), or CGD colitis symptoms defined as an HBI score of 8-16 (moderate) or \\> 16 (severe), and demonstrate active symptoms as defined by continued weight loss, abdominal pain and\u002For diarrhea not controlled by standard therapy.\n4. The participant must have active CD and UC symptoms (as noted above) and therefore have had an inadequate response to, loss of response to, or intolerance to at least 1 of the following agent groups in control of their disease (as defined below for each individual agent group: Corticosteroids or Immunomodulators or TNF-alpha antagonists or Anti-integrin antibodies or JAK inhibitors or IL-12p19 (IL-23) antagonists). No specific induction therapy or long-term treatment for CGD colitis patients has been defined; therefore all symptomatic patients will be evaluated for inclusion on individual basis.\n\n   a. Corticosteroids\n\n   i. Signs and symptoms of persistently active disease despite a history of at least one 4-week induction regimen that included a dose equivalent to prednisone \\>=30 mg PO once daily (QD) for 2 weeks or intravenously (IV) for 1 week OR\n\n   ii. One failed attempt to taper corticosteroids to below a dose equivalent to prednisone 10 mg PO QD or to taper to below a dose of 9 mg of budesonide\n\n   OR\n\n   iii. History of intolerance of corticosteroids at the discretion of the principal investigator (PI) (including but not limited to Cushing s syndrome, osteopenia\u002Fosteoporosis, hyperglycemia, insomnia, or infection)\n\n   b. Immunomodulators\n\n   i. Signs and symptoms of persistently active disease despite a history of at least one 12-week regimen of oral azathioprine (AZA) (\\>= 2.5 mg\u002Fkg\u002FDay) or 6-MP (\\>= 1.5 mg\u002Fkg\u002FDay) OR\n\n   ii. Signs and symptoms of persistently active disease despite a history of at least one 12-week regimen of MTX (\\>= 25 mg\u002Fweek) OR\n\n   iii. History of intolerance of at least one immunomodulator (including but not limited to nausea\u002Fvomiting leading to discontinuation, abdominal pain, pancreatitis, liver function test abnormalities, lymphopenia, thiopurine methyltransferase genetic mutation, or serious infection)\n\n   c. TNF-alpha antagonists with signs and symptoms of persistently active disease despite a history of receiving infliximab, adalimumab, or certolizumab at a dose approved for the treatment of CD or UC and:\n\n   i. Patient had an inadequate response after completing the full induction regimen, per approved product labeling\n\n   ii. Responded initially but then lost response with continued therapy\n\n   iii. Patient had a significant adverse event response which precluded further use including but not exclusion of infusion reaction, serum sickness and\u002For lupus-like rash.\n\n   d. Anti-integrin antibodies:\n\n   with signs and symptoms of persistently active disease despite a history of receiving an anti-integrin antibody agent (natalizumab or vedolizumab) at a dose approved for the treatment of CD or UC and:\n\n   i. Patient had an inadequate response after completing the full induction regimen, per approved product labeling\n\n   ii. Responded initially but then lost response with continued therapy\n\n   iii. Patient had a significant adverse event response which precluded further use including but not exclusion of infusion reaction, serum sickness and\u002For lupus-like reaction.\n\n   e. JAK inhibitor:\n\n   with signs and symptoms of persistently active disease despite a history of receiving a JAK inhibitor (tofacitinib and ruxolitinib) at a dose approved for the treatment of CD or UC and:\n\n   i. Patient had an inadequate response after completing the full induction regimen, per approved product labeling\n\n   ii. Responded initially but then lost response with continued therapy\n\n   iii. Patient had a significant adverse event response which precluded further use including but not exclusion of infusion reaction, serum sickness and\u002For lupus-like reaction.\n\n   f. Anti-IL-12 p19 (IL-23) antibodies:\n\n   with signs and symptoms of persistently active disease despite a history of receiving an anti-IL-12p19 (IL-23) antibody agent (Skyrizi and Tremfya) at a dose approved for the treatment of CD or UC and:\n\n   i. Patient had an inadequate response after completing the full induction regimen, per approved product labeling\n\n   ii. Responded initially but then lost response with continued therapy\n\n   iii. Patient had a significant adverse event response which precluded further use including but not exclusion of infusion reaction, serum sickness and\u002For lupus-like reaction.\n5. At the discretion of the PI, concomitant medications will be permitted if the following conditions are met prior to baseline assessment (Day-1):\n\n   a. 5-aminosalicylic acid (ASA)-based compounds are permissible if:\n\n   i. Oral 5-ASA-based compounds must be at a stable dose for at least 3 weeks prior to baseline or\n\n   ii. Recently discontinued oral 5-ASA-based compounds must have been discontinued at least 3 weeks prior to baseline or\n\n   iii. Rectal 5-ASA-based compounds are not permissible during the study and must have been discontinued at least 3 weeks prior to baseline.\n\n   b. Corticosteroids (e.g., prednisone, budesonide) are permissible if:\n\n   i. Oral corticosteroids must be at a prednisone-equivalent dose of \\\u003C= 40 mg\u002Fday, or 9 mg\u002Fday of budesonide, and have been at a stable dose for at least 3 weeks prior to baseline or\n\n   ii. Discontinuation of oral corticosteroids must have been completed at least\n\n3 weeks prior to baseline or\n\niii. Parenteral (subcutaneous, intramuscular, or IV) or rectal corticosteroids are not permitted during the study and must not have been used within a 3- week period prior to baseline\n\nc. CD, UC, or CGD colitis-specific antibiotics are permissible if using an antibiotic for treatment of CD,UC, or CGD colitis (i.e., metronidazole, ciprofloxacin, rifaximin, ampicillin, sulfonamide and tetracycline)\n\ni. Participants must have been using the antibiotic for at least 3 weeks before baseline at a stable dose or\n\nii. If not currently using a CD, UC, or CGD colitis-specific antibiotic, the stop date must have been at least 3 weeks prior to baseline.\n\nd. Immunomodulators are permissible if:\n\ni. Participants receiving chronic (i.e., \\>= 12 weeks) treatment with AZA, 6- MP, or MTX prior to baseline must be on a stable dose for at least 6-8 weeks prior to baseline and must continue on this same dose during the study. OR\n\nii. Participants who have discontinued therapy with AZA, 6-MP, or MTX must have stopped the medication at least 4 weeks prior to baseline. OR\n\niii. Participants must not have received therapy with other known immunomodulators (e.g. cyclosporine, tacrolimus, sirolimus, pentoxifylline, or mycophenolate mofetil) or experimental agents (e.g. granulocyte- or macrophage colony stimulating factor) for at least 8 weeks or 5 half-lives of agent from baseline, whichever is longer.\n\ne. The use of Anti-TNF, Anti-integrin, JAK inhibitors, Anti-IL-12p19 (IL-23) therapy or other biological therapy listed below will not be permitted and the following washout period will be required in order for participant to be eligible:\n\ni. Three months washout prior to baseline for certolizumab or natalizumab.\n\nii. Two months washout prior to baseline for adalimumab, infliximab, and vedolizumab, tofacitinib, ruxolitinib, Skyrizi and Tremfya.\n\niii. 8-week washout prior to baseline for cyclosporine, pimecrolimus, tacrolimus, and any other systemic immunosuppressant.\n\n6\\. Participants must have a primary medical care provider.\n\n7\\. Male participants must agree to employ birth control measures to prevent pregnancy in female partners from start of treatment and continuing through 3 months post treatment.\n\n8\\. Females of childbearing potential must not be breast-feeding, possibly or actually pregnant, must not have had unprotected intercourse for one month prior to dosing, and must agree not to become pregnant beginning from enrollment in the study to at least 6 months after the end of treatment. Participants must remain completely abstinent of potentially reproductive sexual intercourse (e.g. due to a committed lifestyle) or to consistently use BOTH a barrier method with a spermicide (male or female condom) AND ALSO one of the below listed methods of birth control:\n\n1. Continuous\u002Fdaily hormonal methods including oral contraceptive pills, patch, implant\u002Finjection, etc.\n2. Surgical sterilization of either partner, of sufficient duration to be effective, and NOT known to have failed.\n3. Intrauterine device.\n\n   EXCLUSION CRITERIA:\n\n   Individuals who meet ANY of the following criteria will be excluded from participation in this\n\n   study:\n   1. Presence of clinically significant systemic infection (e.g., chronic or acute infection, urinary tract infection, or upper respiratory tract infection) within three months of screening.\n   2. History or presence of recurrent or chronic infection (e.g., viral infection \\[including hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV)\\], bacterial infection, systemic fungal infection, or syphilis).\n   3. Positive for tuberculosis (TB) via QuantiFERON-Gold (QFT-G). Individuals who are known to have received the tuberculosis vaccine will be administered the QFT-G. Patients cannot have received tuberculosis vaccine within 12 months prior to start of study and cannot receive tuberculosis vaccine while on study or within 12 months from the time of conclusion of study participation.\n   4. Has a history of active tuberculosis (TB) or a chest x-ray (CXR) with findings suggestive of old TB infection including calcified nodular lesions, apical fibrosis, or pleural scarring), acute or chronic HBV, HCV, HIV, or opportunistic infections.\n   5. A conduction abnormality on baseline electrocardiogram (ECG) that in the opinion of a cardiologist, is deemed significant.\n   6. At the discretion of the principal investigator, off-label use of any small molecule therapeutics that are immune modulators (e.g., naltrexone) within 90 days of beginning screening or at any time during the last 30-days of the screening window.\n   7. Presence of abnormal hematological and biochemical parameters, including:\n\n      * Neutrophil count \\\u003C 1500 cells\u002Fmm3\n      * Hemoglobin \\\u003C 9 g\u002FdL\n      * Platelet count \\\u003C= 150,000 cells\u002Fmm3\n      * Creatinine \\>= 1.2 times the upper limit of normal (ULN)\n      * Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\>= 1.5 times\n\n      ULN\n      * Prothrombin time-international normalized ratio (PT-INR) \\> 1.0 ULN\n      * Serum bilirubin level \\> 1.0 times ULN\n   8. Individuals on chronic anticoagulation medications.\n   9. Stool sample positive for GI pathogens potentially causing disease (as assessed by FilmArray GI panel for 22 viral, bacterial, and parasitic organisms that can cause infectious diarrhea \\[GI pathogen panel\\]). The principal investigator will consult with an infectious disease specialist to review results and decide whether treatment is warranted.\n   10. Presence of cytomegalovirus (CMV) infection as defined by positive immunohistochemical staining on tissue intestine biopsy.\n   11. History of low-grade or high-grade colonic mucosal dysplasia.\n   12. History of bowel surgery other than perianal (e.g., fistulotomy, seton placement, or abscess drainage) within 6 months prior to beginning the CDAI screening diary, Mayo scoring, or Harvey Bradshaw index or drawing screening blood samples.\n   13. Presence of surgical changes to gut anatomy that preclude administration of clinical activity indices; this includes but is not limited to ileostomy, colostomy, or subtotal colectomy with ileorectal anastomosis.\n   14. Known or suspected short bowel syndrome.\n   15. Requirement of parenteral, total parenteral, elemental oral, or nasogastric nutrition.\n   16. History or current evidence of cancer, other than non-melanomatous cancer of the skin, or participants that have undergone excision of basal cell carcinoma, squamous cell carcinoma of the skin. All patients receiving ustekinumab will be monitored for the appearance of non-melanoma skin cancer. Patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment will be followed closely.\n   17. Unwillingness or inability to comply with study requirements.\n   18. Presence of only small bowel disease that is inaccessible by standard colonoscopy for harvest of research biopsies. Individuals with only upper gastrointestinal disease or only perianal fistulizing disease are also excluded for this reason.\n   19. Refusal to abstain from using COX-2 inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) throughout the study agent administration period.\n   20. Has uncontrolled diabetes\n   21. Is taking anti-seizure medication, such as valproic acid or its derivative (i.e., Depakote).\n   22. Presence of any condition that, in the opinion of the principal investigator, contraindicates participation in this study.\n   23. Has participated in another investigational trial within 8 weeks (or 5 half-lives of any investigational study agent), whichever is greater, prior to the pre-trial (screening) visit. The window will be derived from the last date of treatment on the previous trial.",{"count":378,"type":20},35,[108,81],"Background:\n\nCrohn s disease (CD) is an inflammatory bowel disease. It causes inflammation of the gut. Symptoms may include diarrhea, abdominal pain, fatigue, weight loss and malnutrition. CD has no cure, but symptoms can sometimes be controlled with medicine. Researchers want to see if it is safe to treat CD with the medicine vorinostat. It is thought that vorinostat may reduce the inflammation process of CD. This may then help to relieve symptoms of CD. Participants who respond to Vorinostat will be invited to an extension phase of treatment with Vorinostat and possibly a maintenance treatment using Ustekinumab.\n\nObjectives:\n\nTo see if vorinostat is safe for people with moderate-to-severe CD. To see if it is safe for people with moderate-to-sever CD to receive maintenance therapy using Ustekinumab after successful treatment of Vorinostat.\n\nEligibility:\n\nAdults 18-65 with moderate-to-severe CD that medicine is not controlling.\n\nDesign:\n\nPhase I is screening. It may last 120 days. Participants will have:\n\nPhysical exam\n\nMedical history\n\nTests of blood, urine, and stool samples\n\nHeart test\n\nQuestionnaires\n\nTuberculosis skin test\n\nThey may have a colonoscopy and lymphapheresis collection. These will be explained in a separate consent.\n\nThey will keep a diary of symptoms.\n\nPhase II is treatment using Vorinostat. It will take 12-13 weeks. Participants will take the study drug by mouth twice daily for 12 weeks. They will get a weekly phone call to talk about how the drug makes them feel. They will have blood taken regularly. Every 4 weeks, they will have a check-up that will repeat some screening tests.\n\nPhase III extension treatment of Vorinostat for an additional 6 months for those who respond to vorinostat and it is safe for them to continue treatment. Participants will continue to receive weekly calls to talk about how the drug makes them feel. They will have blood taken regularly. Every 3 months, they will have a check-up that will repeat some screening tests.\n\nPhase IV: is maintenance therapy for 2 years with Ustekinumab. Participants will receive a one time loading dose of ustekinumab, and then will receive the approved maintenance dose once every 8 weeks, at which time they will return to the NIH Clinical Center for evaluation. The participant will get a phone call 3 days after each dose and again 2 weeks later to see how the drug makes them feel. After two years of receiving treatment with ustekinumab the participant will have an end of study visit, where some of the screening tests, including a colonoscopy, will be repeated....",[382],"Crohn's Disease",[384,385],"Reduce Symptoms of Crohn's Disease","HDAC Inhibitors",{"date":251,"type":35},{"date":388,"type":35},"2017-10-30",{"date":390,"type":20},"2035-06-30",{"name":39,"class":40},{"id":393,"slug":4,"hasResults":11,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":397,"eligibilityCriteria":398,"healthyVolunteers":11,"sex":15,"minAge":75,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":79,"phases":401,"briefSummary":402,"conditions":403,"keywords":405,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":415},"100521911","NCT06075745","Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates","Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates (CTOT-44)","COLT","Inclusion Criteria:\n\n1. Subject must be able to understand and provide informed consent\n2. Negative for Cytomegalovirus (CMV) IgG antibody as assessed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory within 12 months of enrollment, and no history of prior positive CMV serology (IgG antibody)\n3. Negative human immunodeficiency virus (HIV) testing and no clinical suspicion of HIV infection\n4. Planned for a first living donor liver transplant or listed\u002Fanticipated to be listed for a first deceased donor liver transplant.\n5. Anticipated to receive a liver transplant within 1-12 months\n6. For individuals of reproductive potential, a negative serum or urine pregnancy test within 72 hours prior to enrollment. NOTE: Individuals of reproductive potential are defined as individuals who have reached menarche and who have not been post-menopausal for at least 12 consecutive months with follicle-stimulating hormone (FSH) \\>=40 IU\u002FmL or 24 consecutive months if an FSH is not available, i.e., who have had menses within the preceding 24 months, and have not undergone a sterilization procedure (e.g., hysterectomy, bilateral oophorectomy, or salpingectomy)\n7. Participants who are able to impregnate or become pregnant (i.e., of reproductive potential) and are participating in sexual activity that could lead to pregnancy must agree to practice contraception\u002Fbirth control (hormonal or barrier method) or agree to not participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) for at least 1 month following the last vaccine\u002Fplacebo dose. For acceptable contraception methods that are more than 80 percent effective, see Food and Drug Administration (FDA) Office of Women's Health (http:\u002F\u002Fwww.fda.gov\u002Fbirthcontrol)\n8. The most recent platelet count is \\>= 20,000 cells\u002Fmm\\^3 within 3 months prior to enrollment and in the opinion of the investigator, has not decreased \\\u003C 20,000 cells\u002Fmm\\^3 at time of study IP administration.\n\nEligibility criteria required: Dose 2:\n\n1. Most recent platelet count \\>= 20,000 cells\u002Fmm\\^3 within 3 months prior to enrollment and in the opinion of the investigator, has not decreased \\\u003C 20,000 cells\u002Fmm\\^3 since last result\n2. For women of reproductive potential as defined previously, a negative serum or urine pregnancy test (performed within 72 hours)\n\nExclusion Criteria:\n\n1. Women who are breastfeeding or planning to breastfeed\n2. Prior Cytomegalovirus (CMV) vaccination\n3. Receipt of immunoglobulin or CMV-specific immunoglobulin within the last 3 months (this includes coronavirus disease (COVID) convalescent plasma)\n4. Currently enrolled in another interventional study that, in the investigator's opinion, could affect the evaluation of safety and\u002For vaccine effect outcomes\n5. Prior (ever) receipt of a stem cell transplant (Peripheral blood stem cell (PBSC), marrow, cord blood, etc.)\n6. Receipt of immunosuppression:\n\n   * Within the last 3 months prior to randomization:\n\n     * Systemic Chemotherapy or immunotherapy for cancer in the last 3 months (localized therapy for hepatocellular carcinoma \\[HCC\\] such as chemoembolization, Y-90 are not considered \"systemic chemotherapy\" and are not excluded)\n     * Systemic immunosuppressive agents (e.g., cyclophosphamide, methotrexate, mycophenolate, azathioprine, calcineurin inhibitors, mTOR inhibitors, TNF-alpha inhibitors) and\u002For combination immunosuppressive drugs for any autoimmune or other conditions in the last 3 months except corticosteroids as below\n   * Within the last 28 days prior to randomization: averaged daily corticosteroid therapy dose ≥20 mg of prednisone equivalent\n   * Within the last 6 months prior to randomization: receipt of T- or Bcell depleting agents (e.g. ATG, Alemtuzumab, Rituximab)\n7. Transplant status 1A or in the opinion of the investigator is likely to receive a transplant within the next month\n8. At the time of randomization, either listed for, or, in the opinion of the investigator, likely to receive any non-liver organ transplant\n9. Receipt of a clinical vaccine \\\u003C 14 days before or planned to receive a clinical vaccine \\\u003C14 days after the study agent\n10. Known allergy to any component of the study agent\n11. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study\n\nExclusion criteria required: Dose 2:\n\n1. Anaphylaxis or other severe reaction (Grade 4) considered definitely or probably attributable to dose 1\n2. Receipt of liver transplant prior to dose 2\n3. The participant must not have any severe acute illness or other factor, that, in the opinion of the investigator, requires postponement of dose 2 because of safety concerns. The participant can be re-evaluated for eligibility throughout the window of eligibility for the dose 2, once the illness or other factor has improved or resolved\n4. Receipt of a clinical vaccine \\\u003C 14 days before or planned to receive a clinical vaccine \\\u003C14 days after the study agent",{"count":400,"type":20},416,[81],"This is a multi-center clinical trial in Cytomegalovirus (CMV) seronegative prospective liver transplant recipients to determine the efficacy of two doses of Cytomegalovirus-Modified Vaccinia Ankara (CMV-MVA) Triplex CMV vaccine pre-transplant. The primary objective is to assess the effect of pre-transplant (Tx) Triplex vaccination on duration of CMV antiviral therapy (AVT) within the first 100 days post-Tx in CMV seropositive donor (D+) and seronegative (R-) (D+R-) liver transplant recipients (LTxRs). A protocol-mandated preemptive therapy (PET) will be used for CMV disease prevention in D+R- LTxRs.",[404],"Liver Transplant",[406,207,407],"Cytomegalovirus","Orthotopic Liver Transplant","2026-06-30",{"date":251,"type":35},{"date":411,"type":35},"2024-03-05",{"date":413,"type":20},"2028-02-28",{"name":39,"class":40},18,{"id":417,"slug":4,"hasResults":11,"nctId":418,"briefTitle":419,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":48,"sex":15,"minAge":49,"maxAge":17,"enrollmentInfo":421,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":423,"conditions":424,"keywords":427,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":41},"100247843","NCT02504853","Natural History and Genetics of Food Allergy and Related Conditions","* GENERAL INCLUSION CRITERIA:\n\nAll participants must meet the following criteria:\n\n1. Be 2 to 99 years-old at the time of enrollment for participants who will be seen at the NIH CC; be 0 (newborn) to 99 years-old at the time of enrollment for participants who will submit mail-in samples or participate in telehealth visits. Only viable neonates will be enrolled.\n2. Willing to allow storage of blood, buccal swabs, saliva, nasal swabs, stool samples, and other clinically appropriate tissue specimens for future use in medical research\n3. Required to have a primary care or other physician who will manage all health conditions related or unrelated to the study objectives\n\nADDITIONAL INCLUSION CRITERIA FOR AFFECTED PARTICIPANTS\n\nIn addition to the general criteria listed above, affected participants must meet 1 of the following criteria:\n\n1. Have a clinical history of an immediate hypersensitivity reaction to food(s) and be sensitized to food allergen(s) (as evidenced by positive SPT or allergen-specific IgE testing)\n2. Be sensitized (as evidenced by positive SPT or allergen-specific IgE testing) to food allergen(s) but have no overt clinical history of IgE-mediated symptoms when they eat that food(s)\n3. Have a suspected genetic or congenital disorder potentially associated with food allergy or related condition, as determined by the principal investigator (PI) or associate investigators (AIs)\n4. Have a diagnosis of eosinophilic esophagitis (EoE), or clinical suspicion for EoE as determined by the principal investigator (PI) or associate investigators (AIs)\n5. Have a history of atopic dermatitis based on self-report or physician assessment.\n\nADDITIONAL INCLUSION CRITERIA FOR UNAFFECTED RELATIVES:\n\nIn addition to the general criteria listed above, unaffected relatives must meet the following criteria:\n\n1. Be a relative of an affected participant\n2. Be unaffected by food allergy (as determined by clinical history and\u002For allergy testing) or be unaffected by the genetic condition under study\n\nADDITIONAL INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS\n\nIn addition to the general criteria listed above, healthy volunteers must meet the following criteria:\n\n1. Be unrelated to an affected participant\n2. Be unaffected by food allergy (as determined by clinical history and\u002For allergy testing) or be unaffected by the genetic condition under study\n\nADDITIONAL PROCEDURE- SPECIFIC INCLUSION CRITERIA:\n\nThe following additional inclusion criteria apply for participants undergoing leukapheresis:\n\n1. Age \\>= 18 years\n2. Stable hematologic parameters (definition: white blood cell count \\> 2,500\u002FmicroL, hemoglobin \\> 10 g\u002FdL, and platelet count \\> 75,000\u002FmicroL)\n\nGENERAL EXCLUSION CRITERIA:\n\nParticipants will be excluded for any of the following:\n\n* Presence of conditions that, in the judgment of the investigator or the referring physician, may put the participant at undue risk or make them unsuitable for participation in the study.\n* Inability to participate for the duration of the study.\n* The PI deems that participation in the study would not be expected to advance the study goals.\n\nADDITIONAL PROCEDURE- SPECIFIC EXCLUSION CRITERIA\n\nAdditional exclusion criteria apply for unaffected relatives and healthy volunteers who are undergoing endoscopy with biopsies for research purposes. Unaffected relatives and healthy volunteers will be excluded from participating in this procedure if they meet any of the following criteria:\n\n1. uncontrolled asthma or Grade 3 or higher by the American Society of Anesthesiologist s Physical Status Classification System (https:\u002F\u002Fjournals.lww.com\u002Fanesthesiologyopen\u002Ffulltext\u002F2026\u002F04000\u002Famerican\\_society\\_of\\_anesthesiologists\\_statement\\_on.2.aspx)\n2. history of adverse reaction to conscious sedation or general anesthesia required for endoscopy\n3. hemoglobin \\\u003C 11 g\u002FdL\n4. platelet count \\\u003C 100,000 microL\n5. PT INR \\>1.3 or PTT prolonged by \\> 3 seconds\n6. pregnant or breastfeeding\n7. viral screens positive for HIV or hepatitis B or C\n8. severe unstable myocardial ischemia or cardiomyopathy\n9. severe hypoxemia due to chronic pulmonary disease\n10. recent abdominal surgery\n11. anticoagulant therapy that cannot be interrupted\n12. history of reflux disease within the last 3 years or use of acid-suppression medication (including over-the-counter medications such as Tums, Rolaids, Zantac, Prilosec OTC, or Prevacid OTC) within the last 2 months\n13. chronic GI or immunologic disease\n14. clinically indicated EGD or colonoscopy within the past 12 months\n15. use of systemic or inhaled corticosteroids within the past 4 months\n16. have a history of EGID including EoE\n17. younger than 18 years of age",{"count":422,"type":20},1800,"Background:\n\n\\- About 15 million Americans have a food allergy. Because there are no cures or effective prevention or treatment for food allergies, researchers want to learn more about them.\n\nObjective:\n\n\\- To learn more about the causes and effects of food allergy and related conditions.\n\nEligibility:\n\n* People ages 2 99 who have food allergy and\u002For a related genetic or other condition\n* Their relatives\n* Healthy relatives and volunteers\n\nDesign:\n\n* Participants will have at least 3 visits over 1 2 years, and then once a year for up to 12 years. Each may last a day or longer.\n* Participants will be screened with medical history, physical exam, and questionnaires.\n* Participants may have the following:\n* Blood tests\n* Allergy skin prick tests: Drops of allergens are placed on the back or arm. The skin is scratched under each drop.\n* Leukapheresis: blood is taken from a needle in one arm, passed through a machine, and returned through a needle in the other arm.\n* X-rays\n* Esophageal string test: One end of a string is taped to the cheek and the other end is packed into a capsule. When the capsule is swallowed, the string unwinds; it is left in for at least 1 hour.\n* EGD and colonoscopy: Biopsies are taken from the gastrointestinal system.\n* Tiny biopsies of skin\n* Photographs of the body\n* Collection of cells through:\n* Swab of nose, inside of cheek, or skin\n* Gentle skin scrape\n* Tape stripping: piece of tape is put on the skin and pulled off.",[425,426,115,140],"Food Allergy","Loeys-Dietz Syndrome",[140,426,115,428,29],"TGFbeta",{"date":249,"type":35},{"date":431,"type":35},"2015-07-29",{"date":433,"type":20},"2027-06-15",{"name":39,"class":40},{"id":436,"slug":4,"hasResults":11,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":11,"sex":441,"minAge":442,"maxAge":443,"enrollmentInfo":444,"targetDuration":4,"studyType":79,"phases":446,"briefSummary":447,"conditions":448,"keywords":450,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":460},"100596043","NCT07040319","Study of the Pharmacokinetics and Safety of Glecaprevir\u002FPibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV","Phase I\u002FII Study of the Pharmacokinetics and Safety of Glecaprevir\u002FPibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV","Inclusion Criteria:\n\n* Of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with institutional review board\u002Fethics committee (IRB\u002FEC) policies and procedures\n* Willing and able to provide written informed consent for their own and their infant's study participation\n* At entry, 16-45 years of age (inclusive)\n* At entry, gestational age of 14-32 weeks, defined as greater than 13 weeks plus six days and less than or equal to 32 completed weeks gestation, as determined by the site investigator based on best obstetric estimate\n* At screening and at study entry, no evidence of multiple gestation, fetal anomalies, or intrauterine fetal growth restriction, as determined by the site investigator based on ultrasound\n* At screening, detectable HCV RNA test result based on testing of a specimen collected within 30 days prior to entry\n* At screening, negative test results for hepatitis B surface antigen based on testing of a specimen collected within 30 days prior to entry\n* At screening (i.e., from specimens collected within 30 days prior to entry), has normal, grade 1, grade 2, or grade 3 results for the following\n\n  * Aspartate aminotransferase (AST) (\\\u003C10.0 x ULN)\n  * Alanine aminotransferase (ALT) (\\\u003C10.0 x ULN)\n* At screening (i.e., from specimens collected within 30 days prior to entry), has normal, grade 1, or grade 2 results for the following\n\n  * Hemoglobin (≥8.5 g\u002FdL)\n  * Creatinine (≤1.8 x ULN)\n* At screening (i.e., from specimens collected within 30 days prior to entry), has normal or grade 1 results for the following\n\n  * International normalized ratio (INR) (\\\u003C1.5 x ULN)\n  * Platelet count (≥100,000 cells\u002Fmm3)\n  * Total bilirubin (\\\u003C1.6 x ULN)\n* HIV status determined based on testing meeting the requirements specified in protocol\n* For pregnant participants living with HIV: has a suppressed HIV viral load (HIV-1 RNA below the limit of quantification of the assay) on an ARV regimen for at least 30 consecutive days prior to entry that does not include efavirenz, etravirine, cobicistat, or any protease inhibitor (e.g., atazanavir, darunavir, lopinavir, ritonavir), as determined by the site investigator based on available medical records\n* At entry, expects to remain in the geographic area of the study site during pregnancy and for 10 weeks postpartum (or for 20 weeks post-entry, depending on gestational age at entry), as determined by the site investigator based on pregnant participant report\n\nExclusion Criteria:\n\n* Any previous treatment for hepatitis C, including HCV DAAs or interferon-based treatment\n* High risk of preterm delivery, defined as either of the following:\n\n  * History of spontaneous preterm delivery at less than 34 weeks, as determined by the site investigator based on pregnant participant report and available medical records, or\n  * Shortened cervix less than 20 mm if noted on ultrasound during the current pregnancy, as determined by the site investigator based on available medical records\n* Receipt of any prohibited medication, within 14 days prior to entry, as determined by the site investigator based on pregnant participant report and available medical records\n* Any of the following liver-related conditions:\n\n  * Clinical diagnosis of acute hepatitis not otherwise attributable to hepatitis C with AST or ALT ≥2.5 x ULN\n  * Evidence of decompensated cirrhosis including history of or present variceal hemorrhage, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatocellular carcinoma, hepatorenal syndrome, or hepatopulmonary syndrome\n* Has any other documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives","FEMALE","16 Years","45 Years",{"count":445,"type":20},30,[108,81],"This is a Phase I\u002FII, multi-site, open-label, single arm study to describe the pharmacokinetics (PK) and safety of glecaprevir\u002Fpibrentasvir (GLE\u002FPIB) initiated during pregnancy in women with hepatitis C virus (HCV) infection (acute or chronic) with or without HIV and to evaluate safety for their infants through 10 weeks postpartum.",[449],"Hepatitis C",[90,449,451,452],"Pregnancy","Glecaprevir\u002FPibrentasvir","2026-06-29",{"date":249,"type":35},{"date":456,"type":35},"2026-06-25",{"date":458,"type":20},"2027-10-30",{"name":39,"class":40},10,{"id":462,"slug":4,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":48,"sex":15,"minAge":282,"maxAge":468,"enrollmentInfo":469,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":471,"conditions":472,"keywords":474,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":301},"100526542","NCT06136091","Protocol CAUSE-03 \u002F CHEETAH","Mechanisms Underlying Asthma Symptoms and Exacerbations Examined Across T2 Status in Children (CHEETAH) (CAUSE-03)","CHEETAH","Inclusion Criteria:\n\n1. Participant and\u002For parent guardian must be able to understand and provide informed consent and assent\n2. Have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the Protocol CAUSE-03 Manual of Operations (MOP)\n\n   a. Participants who do not live in the pre-selected census tracts but live within the Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have publicly funded health insurance will qualify for inclusion\n3. Either:\n\n   1. Have had a diagnosis of asthma made \\> 1 year prior to recruitment; participants who received an asthma diagnosis by a clinician \\\u003C= 1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment (asthma group), or\n   2. No report of ever being diagnosed with asthma (non-asthma group)\n4. Either:\n\n   1. Require at least Step 2 therapy at the Screening\u002FEnrollment Visit (asthma group), or\n   2. Have not used any asthma medications in the prior year (non-asthma group)\n5. Are able to perform acceptable and repeatable spirometry per American Thoracic Society (ATS) criteria prior to enrollment\n6. Have documentation of current medical insurance with prescription coverage at the Screening\u002FEnrollment Visit\n7. Participant and\u002For parent guardian has a smartphone compatible with the study electronic Patient Reported Outcomes (ePRO) system, Medidata Patient Cloud, and is willing to download one application for study use\n\nExclusion Criteria:\n\n1. Parent or guardian is not able or willing to give written informed consent or comply with study protocol\n2. Have concurrent medical problems that would require systemic corticosteroids or other immunomodulators during the study\n3. Are currently receiving immunotherapy\n4. Are currently receiving treatment with a biologic therapy or have received a biologic therapy within 3 months prior to enrollment\n5. Are currently requiring greater than fluticasone 500 mcg bid plus Long-Acting Beta Agonists (LABA) one puff twice daily or its equivalent plus Long Acting Muscarinic Antagonists (LAMA) and\u002For individuals using oral corticosteroids daily or every other day for more than 14 days at the time of the Screening\u002FEnrollment Visit\n6. Are currently pregnant or lactating, or plan to become pregnant during the time of study participation. Females of child-bearing potential (post-menarche) must be abstinent or use a medically acceptable birth control method throughout the study (i.e., oral subcutaneous, mechanical, or surgical contraception)\n7. Have a known, pre-existing clinically important lung condition other than asthma.\n8. Have a current malignancy or previous history of cancer in remission for less than 12 months prior to enrollment\n9. Have a known immunodeficiency disease\n10. Use of investigational drugs within 4 weeks of enrollment\n11. Have past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study\n12. If in the asthma group, will not allow the study clinician, an asthma specialist, to manage their disease for the duration of the study or who are not willing to change their asthma medications to follow Protocol CAUSE-03 CHEETAH\n13. If in the non-asthma group, having bronchodilator reversibility (improvement in Forced expiratory volume in 1 second (FEV1) with albuterol \\> = 10%) at the Screening\u002FEnrollment visit\n14. Have had a life-threatening asthma exacerbation in the last 2 years requiring intubation, mechanical ventilation or resulting in a hypoxic seizure. Potential participants may be reassessed as outlined in the Protocol CAUSE-03 Manual of Procedures (MOP)","17 Years",{"count":470,"type":20},310,"This is a one-year longitudinal, observational study of 250 urban children and adolescents with asthma and 60 without asthma, ages 6-17 years old.\n\nParticipants with asthma will require daily controller therapy with inhaled corticosteroids ICS (at least Step 2 therapy). Those without asthma cannot have used asthma medications in the year prior to enrollment and cannot demonstrate bronchodilator reversibility at baseline. Phenotypic characteristics will be established at baseline, and the participants will be seen at scheduled visits over 12 months. Each participant will be asked to monitor and self-report cold symptoms and will be asked to complete up to three cold visits",[473],"Asthma",[473,475,476],"Observational study","Children",{"date":249,"type":35},{"date":479,"type":35},"2024-05-08",{"date":481,"type":20},"2027-09-01",{"name":39,"class":40},{"id":484,"slug":4,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":48,"sex":15,"minAge":75,"maxAge":489,"enrollmentInfo":490,"targetDuration":4,"studyType":79,"phases":492,"briefSummary":493,"conditions":494,"keywords":496,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":41},"100562733","NCT06607003","Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays","Phase 1 Study of Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays","* INCLUSION CRITERIA:\n\nAll of the following criteria must be fulfilled for a participant to undergo IBSM:\n\n1. Age \\>=18 and \\\u003C=54 years.\n2. RBCs positive for Duffy antigen\u002Fchemokine receptor.\n3. Malaria comprehension exam passed prior to study activities.\n4. Suitable accommodation and reliable access to the NIHCC for the duration of the study in the opinion of the investigator.\n5. Persons of childbearing potential must be willing to use reliable contraception from 28 days prior to challenge agent administration to the end of study.\n6. Signing of the informed consent form.\n7. Agreement to not live alone from challenge agent administration until the completion of antimalarial treatment.\n8. Agreement to long-term storage of study samples for future research.\n\nEXCLUSION CRITERIA:\n\nA participant will be excluded from participating in this trial if any 1 of the following criteria is fulfilled:\n\n1. Planned travel to a P. vivax-endemic area during the study period (see https:\u002F\u002Fwww.cdc.gov\u002Fmalaria\u002Ftravelers\u002Fcountry\\_table\u002Fa.html).\n2. History of travel to or residence in a P. vivax malaria-endemic region for more than 2 weeks during the past 2 years.\n3. Prior confirmed P. vivax malaria diagnosis or clinical history consistent with likely P. vivax infection. At the investigator's discretion, participants may be enrolled if the exposure was remote, e.g., \\> 5 years ago.\n4. Poor peripheral venous access, at the discretion of the investigator.\n5. For persons of childbearing potential:\n\n   1. Currently pregnant or breastfeeding, or planning on becoming pregnant or breastfeeding until the end of study.\n   2. Rh blood group negative.\n6. Being a current or former study team member or clinical trial staff with direct involvement of the trial, or being an employee supervised by a study team member.\n7. Unwillingness to defer blood donations for at least 3 years.\n8. Use of any of the following within the specified periods:\n\n   1. Investigational P. vivax vaccine within the last 2 years.\n   2. Malaria chemoprophylaxis within 3 months of Day 0.\n   3. Chronic systemic immunosuppressive medications (\\>14 days) within 6 months (e.g., cytotoxic medications, adrenocorticotrophic hormone, or oral\u002Fparental corticosteroids equivalent to \\>0.5 mg\u002Fkg\u002Fday of prednisone). Corticosteroid nasal spray for allergic rhinitis and topical corticosteroids for mild, uncomplicated dermatitis are allowed.\n   4. Prior receipt of packed red cells or other blood products or immunoglobulins within the previous 6 months.\n   5. Systemic antibiotics or medications with potential antimalarial effects less than 28 days before Day 0 (e.g., clindamycin, chloroquine, benzodiazepines, tetracycline, azithromycin, or doxycycline).\n   6. Investigational product or vaccine less than 28 days before Day 0.\n   7. Receipt of any vaccination less than 28 days before Day 0.\n   8. Current or planned use of medications known to significantly prolong the QT interval or otherwise interfere with study agents.\n   9. Smoking more than 5 cigarettes or equivalent per day and unable to stop smoking for the duration of admission. Participants may smoke up to 5 cigarettes or equivalent per day for the rest of the study (by attestation).\n   10. History of alcohol use disorder (exceptions may be made at the investigator's discretion if they have completed treatment or are otherwise currently abstinent) or refusal to agree to refrain from drinking from the day of the challenge agent inoculation until completion of their antimalarial course.\n9. Clinically significant medical condition, physical examination findings, other clinically significant abnormal laboratory results, or past medical history including:\n\n   1. Immunodeficiency including asplenia or functional asplenia or significant autoimmune disease.\n   2. Retinal disease, visual field changes, psoriasis, porphyria, or known allergy to chloroquine or artemether\u002Flumefantrine.\n   3. Cardiac disease including \\>10% cardiovascular risk as determined by the non-laboratory method or an abnormal EKG demonstrating a corrected QT interval by Fridericia's formula of \\>450 msec or other concerning arrhythmia.\n   4. Any other medical condition that may have significant implications for current health status and participation in the study, in the opinion of the investigator.\n10. History of a severe reaction to arthropod bites, or history of anaphylaxis or severe unexpected allergy to any substance.\n11. Screening blood test or urinalysis laboratory parameters outside of local lab normal range (including infectious serologies). Participants may be included at the investigator's discretion for \"not clinically significant\" values outside of normal range.\n12. Any other finding that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participant's ability to give informed consent, or increase the risk of having an adverse outcome from participating in the study.\n\nParticipants who are determined ineligible to participate for any of the reasons above may be rescreened for eligibility at a later time when the disqualifying condition may be resolved.","54 Years",{"count":491,"type":20},300,[108],"Background:\n\nMalaria is a disease caused by parasites transmitted to people by mosquitoes. Around the world, there were 241 million cases and 627,000 deaths from malaria in 2020. Researchers are working to develop vaccines and treatments for this disease.\n\nObjective:\n\nTo learn how malaria develops in people; how the body's immune system reacts to malaria; and how malaria spreads from people to mosquitoes.\n\nEligibility:\n\nHealthy people in the Washington DC area, aged 18 to 54 years. They cannot live alone during parts of the study.\n\nDesign:\n\nParticipants will be infected with a parasite that causes malaria. The parasite will be in donated blood; it will be given through an IV.\n\nParticipants will likely develop symptoms within a week after the injection. Researchers will call daily to check on their health. After about 6 days, participants will come to the NIH clinic each day for blood tests.\n\nParticipants will check in to the NIH clinic around 10 days after the injection. They will stay in the clinic 3 to 6 days. They will have multiple blood tests every day.\n\nParticipants will be bitten by mosquitoes up to 4 times. Cups containing mosquitoes will be held against their skin for 15 minutes.\n\nParticipants will begin taking chloroquine close to the end of their clinic stay. Chloroquine is a pill taken by mouth once or twice a day for 3 days. It is FDA-approved to treat malaria.\n\nParticipants will have follow-up visits 1 and 3 weeks after discharge.",[495],"Malaria",[497,498,499,500,501,502],"IBSM","Challenge","inoculation","Parasitemia","Mosquito Feeding Assay","Malaria Transmission","2026-06-27",{"date":408,"type":35},{"date":506,"type":35},"2024-11-26",{"date":508,"type":20},"2027-11-26",{"name":39,"class":40},{"id":511,"slug":4,"hasResults":11,"nctId":512,"briefTitle":513,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":48,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":516,"conditions":517,"keywords":521,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":524,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":41},"100489688","NCT05656378","A Repository to Study Host-Microbiome Interactions in Health and Disease","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Aged \\>0 years. Only participants \\>3 years old will be seen at the NIH CC.\n* Willing to allow biological samples and data to be stored for future research.\n* Willing to provide at least one of the requested biospecimens.\n\nEXCLUSION CRITERIA:\n\n* An individual who has any condition that, in the judgment of the investigator, may put them at undue risk or make them unsuitable for participation in the study will be excluded.\n* For additional gastrointestinal and skin biopsies only, individuals on blood thinners unless they have already been stopped for the procedure.\n* For additional gastrointestinal biopsies only, individuals who have a history of gastrointestinal perforation with endoscopic biopsies will be excluded from the collection of additional gastrointestinal biopsies for the repository.\n* For additional gastrointestinal biopsies only, healthy children (\\\u003C18 years old).\n* For skin biopsies only, individuals who have a history of keloid formation.\n* For vaginal swabs and vaginal fluid only, individuals who have not started menses.\n* For breast milk only, non-lactating individuals.",{"count":329,"type":20},"Background:\n\nThe microbiome is the bacteria and other microorganisms that live inside and on the body. The microbiome is important for our health. Researchers study how the microbiome help people stay healthy. They study how the microbiome affects the body when people get sick. To do this research, they need samples of the microbiome living on the bodies of many people. The purpose of this natural history study is to collect microbiome samples in a repository. These samples will be used for future research.\n\nObjective:\n\nTo collect microbiome samples from the body that can be used for future research.\n\nEligibility:\n\nPeople of any age. Only those older than 3 years will be seen at the NIH clinic.\n\nDesign:\n\nParticipants will fill out a questionnaire. Topics will include their medical history and foods they eat.\n\nParticipants will be asked to give 1 or more of the following:\n\nStool, urine, saliva, vaginal fluid, and breastmilk. These samples can be collected at home and sent to the researchers.\n\nCells from participants cheek, nose, mouth, skin, rectum, and\u002For vagina. The cells may be collected by rubbing the area with a sterile cotton swab. These procedures can also be done at home.\n\nBlood. Blood may be drawn using a needle inserted into a vein in the arm. For young children, blood may be collected by a prick on the heel or finger.\n\nIntestinal tissue samples. These may be collected from participants who are having an endoscopy or colonoscopy for other reasons.\n\nSkin tissue samples. These may be collected from participants who are having biopsies for other reasons.",[518,451,519,520],"Healthy Controls","Pediatric Illnesses","Inflammatory Diseases",[522,523,476,451,29],"Microbiome","Host Response",{"date":408,"type":35},{"date":526,"type":35},"2023-03-09",{"date":528,"type":20},"2032-01-01",{"name":39,"class":40},{"id":531,"slug":4,"hasResults":11,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":350,"enrollmentInfo":536,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":538,"conditions":539,"keywords":541,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":41},"100223746","NCT02190266","Pathogenesis and Genetics of Disseminated or Refractory Coccidioidomycosis","The Pathogenesis and Genetics of Disseminated or Refractory Coccidioidomycosis","* INCLUSION CRITERIA:\n\nTo be eligible for this study, potential participants must meet the following criteria:\n\n1. Age \\>= 2 years old.\n\n   a. Enrollment of pediatric patients who are acutely ill or likely to become acutely ill will be deferred until a time when they are considered medically stable by the PI.\n2. Have a positive Coccidioides antigen load or culture proven (a) refractory pulmonary coccidioidomycosis or (b) disseminated coccidioidomycosis.\n\n   1. Refractory pulmonary coccidioidomycosis must have occurred for at least 6 months and includes progressive pulmonary involvement without significant pulmonary cavitation.\n   2. Disseminated CM is coccidioidomycosis infection in one or more regions outside of the chest.\n3. Agree to undergo genetic testing.\n4. Allow their samples to be stored for future research.\n\nEXCLUSION CRITERIA:\n\n1. HIV infection\n2. Currently taking more than 20 mg\u002Fday of prednisone or undergoing active immunosuppressive therapy in the opinion of the investigator\n3. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer s ability to give informed consent.",{"count":537,"type":20},400,"Background:\n\n\\- Coccidioidomycosis is caused by a fungus that grows in the southwest United States and parts of Mexico and South America. This disease is caused by breathing dust containing the fungus. It can lead to serious lung and breathing problems. Rarely, the fungus can infect other body parts. This is called disseminated coccidioidomycosis (DCM). If the fungus stays in the lungs for more than 6 months, it is called refractory coccidioidomycosis (RCM). People with DCM or RCM may have difficulty fighting off infection because of immune system problems. Researchers want to study the immune systems of people with DCM or RCM, to learn more about the disease and the best ways to treat it. They also want to learn more about the types of people that get DCM or RCM and about the fungus that causes it.\n\nObjectives:\n\n\\- To learn more about DCM and RCM, the fungus that causes these diseases, and the people who get them.\n\nEligibility:\n\n\\- People over age 2 with DCM or RCM.\n\nDesign:\n\n* Participants will be screened with a review of their medical records.\n* At the initial visit, participants will have:\n* Medical history and physical exam\n* Blood and urine tests. Some blood may be used for genetic testing. The samples will not include participants names. Participants will be notified only if the tests show something urgent about their DCM\u002FRCM. Researchers think this sort of problem will be rare.\n* Questionnaire about their DCM\u002FRCM\n* Sputum (mucus) collection. They will spit into a cup.\n* Participants will have 1 follow-up visit per year. They will have blood tests. They may have other procedures to treat their DCM\u002FRCM.",[540],"Coccidioidomycosis",[542,543,361,27,544,29],"Extrapulmonary","Immunodeficiency","Fungal",{"date":408,"type":35},{"date":547,"type":35},"2014-09-02",{"date":549,"type":20},"2029-07-31",{"name":39,"class":40},""]