[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":327},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,48,83,105,129,157,179,205,226,253,277,305],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100324933","natural-history-genetics-and-pathophysiology-of-systemic-juvenile-idiopathic-arthritis-adult-onset-stills-disease-and-related-conditions-100324933",false,"NCT03510442","Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease, and Related Conditions","Investigation of the Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease and Related Inflammatory Conditions","* INCLUSION CRITERIA:\n\nSubjects with known or suspected sJIA, AOSD or a similar inflammatory phenotype will provide informed consent and then be evaluated either in the outpatient or inpatient unit of the NIH Clinical Center. To be eligible for follow-up visits patients must meet the Inclusion Criteria, but not the Exclusion Criteria. Subjects determined to not have known or suspected sJIA or AOSD, or a related\n\ninflammatory phenotype, will not be followed.\n\nPatients with signs and symptoms of sJIA will be classified as outlined in #1, #2 and #3 below:\n\n1. Patients less than 16 years of age will be considered to have sJIA if they meet the ILAR criteria for sJIA.\n2. Patients 16 years of age and older will be considered to have sJIA if they have previously met ILAR criteria for sJIA.\n3. Family members of individuals included under items 1 and 2.\n4. Controls for clinical, cellular, molecular, and biochemical assays, and genetic evaluation will be enrolled. Individuals who undergo phlebotomy specifically to provide a control specimen will include both pediatric and adult patients and will not be pregnant.\n\nPatients with signs and symptoms of AOSD will be classified as outlined in #1, #2 and #3 below:\n\n1. Patients 16 years of age and older will be considered to have AOSD if they meet the Yamaguchi criteria for AOSD (including a negative ANA and RF).\n2. Patients may be considered to have a diagnosis of AOSD if they met criteria for diagnosis in the past but do not still have present evidence of disease.\n3. Family members of individuals included under items 1 and 2.\n4. Controls for clinical, cellular, molecular, and biochemical assays, and genetic evaluation will be enrolled. Individuals who undergo phlebotomy specifically to provide a control specimen will include both pediatric and adult patients and will not be pregnant.\n\nPatients with suspected sJIA, AOSD or a related inflammatory condition, as indicated by the presence of episodic fever and\u002For arthritis, may also be included.\n\nEXCLUSION CRITERIA:\n\n1. In adults, inability to provide informed consent and unavailability of a legally authorized representative to provide surrogate consent. In the case of minors, unavailability of a parent or guardian.\n2. Presence of any medical condition that would, in the opinion of the investigators, confuse the interpretation of the study.\n3. Unavailability, or inability to adhere with the schedule for follow-up visits.\n4. Pregnancy",true,"ALL","1 Day","100 Years",{"count":21,"type":22},2000,"ESTIMATED","OBSERVATIONAL","Background:\n\nInflammatory conditions can cause symptoms like fevers, arthritis, and rash. Systemic juvenile idiopathic arthritis (sJIA) is one of these conditions. So is adult-onset Still s disease (AOSD). Their causes are unknown. Researchers want to learn more about these conditions. This includes genetic changes and environmental factors.\n\nObjective:\n\nTo study sJIA and AOSD in children and adults over time.\n\nEligibility:\n\nPeople with known or suspected sJIA, AOSD, or similar inflammatory condition\n\nDesign:\n\nParticipants will be screened with a phone call.\n\nParticipants will have 1 visit. It may be outpatient or they may be admitted to the clinic. The visit may last up to 5 days. Participants will have:\n\n* Medical history\n* Physical exam\n* Musculoskeletal exam\n* Questions about overall health and quality of life, disease activity, functional status, and cognitive ability.\n\nParticipants may also have:\n\n* Pictures taken of their skin, joints, or spine\n* Blood, urine, and stool tests\n* Scans or X-rays of joints with arthritis\n* Chest X-ray\n* Heart tests\n* Skin biopsy. The skin will be numbed. The top layers of a small area will be scraped off.\n\nParticipants who have a joint aspiration may provide a fluid sample. The joint will be prepared, then fluid is removed by needle. A corticosteroid may be injected.\n\nParticipants who have a bone marrow biopsy may provide sample cells.\n\nParticipants may be seen by NIH specialists.\n\nMembers of the participant s family and healthy volunteers may give blood or saliva samples for genetic testing.\n\nParticipants may repeat some study tests every 6 months.",[26,27,28,29],"Still's Disease, Adult-Onset","Systemic Inflammation","Arthritis","Autoinflammatory Syndrome",[31,32,28,33,34],"Inflammation","Fever","Sequencing","Natural History","RECRUITING","2026-07-01",{"date":38,"type":39},"2026-07-02","ACTUAL",{"date":41,"type":39},"2018-05-21",{"date":43,"type":22},"2050-01-01",{"name":45,"class":46},"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","NIH",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":16,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":69,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":47},"100181078","phase-2-effects-of-treatments-on-atopic-dermatitis-100181078","NCT01631617","Effects of Treatments on Atopic Dermatitis","Effects of Treatments on the Microbiome in Healthy Volunteers and Patients With Atopic Dermatitis","* INCLUSION CRITERIA:\n\nCohorts 1 \\[NO FURTHER ACCRUAL\\], 2 \\[INACTIVE\\], 4 \\[NO FURTHER ACCRUAL\\] and 5 \\[INACTIVE\\]: Healthy Volunteers\n\n* Males and females aged 18-50 years at time of initial protocol sampling\n* Subjects must participate fully and be willing to comply with the procedures of the protocol\n* Subjects must be co-enrolled in NIH protocol 08-HG-0059\n* Ability of subject to understand and provide written informed consent\n* Access to bathing facilities (Cohort 2 \\[INACTIVE\\])\n* Ability to swallow capsules or tablets\n\nCohort 3 \\[INACTIVE\\]: Atopic Dermatitis Patients\n\n* Subjects must be aged 2-50 years\n* Subjects must be co-enrolled in NIH protocol 08-HG-0059\n* Subjects must have a diagnosis of atopic dermatitis on the basis of the criteria defined by UK Working Party s Diagnostic Criteria for Atopic Dermatitis\n* Subjects must have a primary care provider\n* Subjects must have an Objective SCORAD (SCORing Atopic Dermatitis) of greater than or equal to 15 indicating AD severity of moderate to severe\n* Prior to initiation of randomized treatment, subjects must have signs of bacterial skin infections (skin weeping, crusting, and\u002For pustules)\n* Access to bathing facilities\n* All subjects and\u002For their Legally Authorized Representative (LAR) must have the ability and agree to participate fully and comply with\n\nthe procedures of the protocol and provide informed consent. Pediatric patients will be included in age appropriate discussions and\n\nage appropriate assent will be obtained in accordance with NIH guidelines.\n\n-Ability of subject to understand and provide written informed consent\n\nCohort 6: Healthy Volunteers\n\n* Subjects previously enrolled in Cohorts 1 \\[NO FURTHER ACCRUAL\\] and 4 \\[INACTIVE\\] who completed on-protocol antibiotic regimen\n* Subjects must participate fully and be willing to comply with the procedures of the protocol\n* Ability of subject to understand and provide written informed consent\n\nEXCLUSION CRITERIA:\n\nCohorts 1 \\[NO FURTHER ACCRUAL\\] and 2 \\[INACTIVE\\]: Healthy Volunteers\n\n* Does not meet inclusion criteria\n* Any female with symptoms and\u002For serum hormone levels consistent with perimenopause or menopause\n* Use of systemic antibiotics in 12 months preceding baseline sampling\n* Use of swimming pools, hot tubs, or whirlpools in 7 days preceding baseline sampling\n* Use of topical or oral complementary\u002Falternative medicine (CAM) agents within 4 weeks of initiation of treatment\n* Known allergic reaction to sulfa, beta-lactam, or tetracycline class drugs; or lidocaine or epinephrine\n* Family history of toxic epidermal necrolysis\n* Known allergy or sensitivity to sodium hypochlorite (NaOCl)\n* History of AD or asthma\n* Inability to comply with the requirements of the protocol\n* Pregnant or lactating\n* Subjects with a primary or acquired immunodeficiency, including HIV seropositiviy\n* Any chronic past or present medical illness, including chronic skin diseases like psoriasis\n* Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants\n* Subjects who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as, assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals\n\nCohort 3 \\[INACTIVE\\]: Atopic Dermatitis Patients\n\n* Does not meet inclusion criteria\n* Any female with symptoms and\u002For serum hormone levels consistent with perimenopause or menopause\n* Known allergic reaction to beta-lactam class drugs, lidocaine, or epinephrine\n* Family history of toxic epidermal necrolysis\n* Known allergic reaction to sodium hypochlorite (NaOCl)\n* Use of systemic antibiotics within 8 weeks, or topical antibiotics on intended sampling sites within 3 weeks, prior to baseline sampling\n* Use of topical corticosteroids on all intended sampling sites within 7 days, prior to baseline sampling\n* Use of topical or oral CAM agents within 4 weeks of initiation of treatment\n* Subjects with known primary or acquired immunodeficiency\n* Subjects with unstable or uncontrolled medical conditions that could require hospitalization during the initial month of the study or who have been hospitalized for treatment of these conditions in the one month prior to baseline sampling\n* Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants within 7 days or 5 half-lives (whichever is the longer time period) of initiating treatment on this protocol\n* Subjects who are currently receiving or have received chemotherapy or radiation for treatment of malignancies within the previous 6 months\n* Pregnancy or lactating\n\nCohorts 4 \\[NO FURTHER ACCRUAL\\] and 5 \\[INACTIVE\\]: Healthy Volunteers\n\n* Does not meet inclusion criteria\n* Any female with symptoms and\u002For serum hormone levels consistent with perimenopause or menopause\n* Use of systemic antibiotics in 12 months preceding baseline sampling\n* Use of swimming pools, hot tubs, or whirlpools in 7 days preceding baseline sampling\n* Use of topical or oral complementary\u002Falternative medicine (CAM) agents within 4 weeks of initiation of treatment\n* (Cohort 4 \\[NO FURTHER ACCRUAL\\]) Known allergic reaction to sulfa class drugs; or lidocaine or epinephrine\n* (Cohort 5 \\[INACTIVE\\]) Known allergic reaction to tetracycline class drugs; or lidocaine or epinephrine\n* Family history of toxic epidermal necrolysis\n* History of AD or asthma\n* Inability to comply with the requirements of the protocol\n* Pregnant or lactating\n* Subjects with a primary or acquired immunodeficiency, including HIV seropositivity\n* Any chronic past or present medical illness, including chronic skin diseases like psoriasis\n* Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants\n* Subjects who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals\n\nCohort 6: Healthy Volunteers\n\n* Does not meet inclusion criteria\n* Use of swimming pools, hot tubs, or whirlpools in 7 days preceding sampling\n* Use of topical or oral CAM agents within 1 week or 4 weeks, respectively, prior to sampling\n* Pregnant or lactating females in all cohorts are excluded from participating due to the potential effects of the above listed antimicrobials on the developing human fetus or nursing infant; listed in Sections 11.1 through 11.5. Females of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Lactating mothers will discontinue breastfeeding prior to study enrollment.\n* Smokers and subjects who use smokeless tobacco products are excluded in all cohorts due to tobacco s unknown impact on human oral mucosa and microflora.","2 Years","50 Years",{"count":58,"type":22},130,"INTERVENTIONAL",[61],"PHASE2","Background:\n\n\\- Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have infections with S. aureus bacteria. Researchers want to study how eczema treatments affect the number and the type of bacteria on the skin.\n\nObjectives:\n\n\\- To study the effect of eczema treatments on skin bacteria.\n\nEligibility:\n\n* Individuals between 2 and 25 years of age who have moderate to severe atopic dermatitis.\n* Healthy volunteers between 18 and 40 years of age with no history of eczema.\n\nDesign:\n\n* Participants will be screened with a physical exam and medical history. Research samples will be collected. Skin biopsies may also be performed.\n* All participants will be assigned to one of several study groups.\n* Healthy volunteers must not have taken antibiotics in the year before the start of the study.\n* All participants will have regular study visits during their 1-year participation. More research samples will be collected at these visits.\n* Healthy volunteers may be asked to come in for a one-time follow up after the 1 year mark.",[64,65,66,67,68],"Eczema","Dermatitis","Skin Diseases, Genetic","Dermatitis, Atopic","Skin Diseases",[70,71,72,73,74],"Investigator-Blinded","Skin Biopsy","Randomized","Antibiotics","Topical","2026-06-27",{"date":77,"type":39},"2026-06-30",{"date":79,"type":39},"2012-09-18",{"date":81,"type":22},"2027-01-01",{"name":45,"class":46},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":16,"sex":17,"minAge":55,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":4,"leadSponsor":104,"locationsCount":47},"100165130","natural-history-and-development-of-spondyloarthritis-100165130","NCT01422694","Natural History and Development of Spondyloarthritis","Studies on the Natural History and Pathogenesis of Spondyloarthritis","* INCLUSION CRITERIA\n\nTo be eligible for follow-up visits, patients must meet the Inclusion Criteria, but not the Exclusion Criteria. Subjects will provide informed consent and then be evaluated either in the outpatient or inpatient unit of the NIH Clinical Center.\n\n* Subjects with known or suspected SpA.\n* Family members of individuals with known or suspected SpA. Family members will not be asked to submit to bone marrow aspiration or interruption of therapy.\n* Controls for clinical, cellular, molecular, and biochemical assays, and genetic evaluation will be enrolled. Individuals who undergo phlebotomy specifically to provide a control specimen will be 6 years of age or older, and not pregnant.\n* Minor healthy volunteers undergoing imaging (SI and\u002For WB MRI) must be old enough to complete the procedure without sedation. Generally this requires that they be at least 6 years of age, so no healthy volunteers under age 6 will be enrolled.\n* Pregnant people with SpA are allowed to enrolled. Pregnant people will not be asked to undergo an MRI and will not be asked to submit to skin biopsy or bone marrow aspiration.\n\nEXCLUSION CRITERIA\n\n* Inability to provide informed consent or, in the case of minors, unavailability of a parent or guardian.\n* Presence of any medical condition that would, in the opinion of the investigators, confuse the interpretation of the study.\n* Unavailability, or inability to comply with the schedule for follow-up visits.\n* Children under the age of 2 years old.\n\nThe vast majority of minors with SpA or suspected SpA will be 6 years of age or older. However, it is possible that children younger than age 6 will be evaluated. If children under age 6 are referred for evaluation, we will ensure that they do not have any acute or chronic comorbidity that would preclude them from being safely evaluated at the NIH Clinical Center. Such patients would be referred to other appropriate pediatric hospitals.\n\nBased on estimates of the incidence and prevalence of SpA in the pediatric and adult populations we set the accrual ceiling up to 2000. We hope to enroll up to 100 patients per year.","99 Years",{"count":21,"type":22},"Background:\n\n\\- Spondyloarthritis (SpA) is a group of bone and joint disorders that may cause back and joint pain and stiffness. In some cases, SpA can lead to abnormal bone growth affecting the joints and spine. Some patients have SpA without ever developing these growths, while others develop them after only a few years. Researchers are interested in studying people with SpA and their relatives to determine which people are more likely to develop more severe conditions.\n\nObjectives:\n\n\\- To identify symptoms and medical tests that can help determine whether a person with SpA is at risk for developing more severe forms of the disease.\n\nEligibility:\n\n* Individuals of any age who have been diagnosed with SpA.\n* Healthy volunteer relatives (at least 6 years of age) of the individuals with SpA.\n\nDesign:\n\n* Participants will be screened with medical records and family medical histories, and will be invited to the clinical center for the study.\n* Participants with SpA will have a physical exam and medical history, including a study of joint movement, blood and urine tests, and questionnaires about pain and quality of life.\n* Participants with SpA will have imaging studies, including magnetic resonance imaging (MRI). Other samples such as skin tissue and bone marrow may also be collected for study.\n* Healthy volunteers will provide a blood sample and cheek cell samples.\n* No treatment will be provided, although treatment options will be discussed.",[28,94],"Spondylitis, Ankylosing",[96,97,98,99,100,34],"Sacroiliitis","Ankylosing Spondylitis","Spondyloarthritis","HLA-B27","Enthesitis-Related Arthritis",{"date":77,"type":39},{"date":103,"type":39},"2011-08-12",{"name":45,"class":46},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":16,"sex":17,"minAge":55,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":47},"100496024","natural-history-of-inflammatory-muscle-diseases-100496024","NCT05738824","Natural History of Inflammatory Muscle Diseases","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1\\. Ability of subject, or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent and\u002For assent document.\n\n2a. Patients are adults and minors of age 2 or older, with possible inflammatory myopathy (suspected or confirmed)\n\nOR\n\n2b. Healthy volunteers will be adults aged 18 or older.\n\nEXCLUSION CRITERIA:\n\n1\\. Unwilling to participate in research studies or to provide research samples or data.","120 Years",{"count":113,"type":22},500,"Objective:\n\nTo collect information and biospecimens (such as blood, muscle, and skin samples) that will be used to research causes and treatments of inflammatory muscle diseases.\n\nEligibility:\n\nPeople aged 2 years and older with suspected or confirmed inflammatory muscle disease. Healthy volunteers aged 18 years and older are also needed.\n\nDesign:\n\nParticipants will have at least 1 clinic visit. Each visit will last 4 to 8 hours. Some may return for additional visits.\n\nAll participants will undergo these procedures (unless they are unable to):\n\n* Physical exam, including blood and urine tests.\n* Magnetic resonance imaging (MRI) scan of the thigh. Participants will lie still on a table with padding around 1 thigh. The table will slide into a tube. The scan will last for approximately 40 minutes.\n\nSome procedures are optional:\n\n* Muscle biopsy: An area of skin will be numbed. A quarter-inch cut will be made. Several pieces of muscle tissue, about the size of grains of rice, will be removed.\n* Skin biopsy: An area of skin will be numbed. A piece of skin about a quarter inch in diameter will be removed.\n* Lymph node biopsy: A small sample of fluid or tissue from a lymph node will taken to check for infection.\n* Genetic testing. Some of the samples collected may be used for genetic testing.",[116],"Inflammation In Skeletal Muscle",[118,119,120,34],"Polymyositis","Dermatomyositis","Childhood Dermatomyositis","2026-06-25",{"date":123,"type":39},"2026-06-26",{"date":125,"type":39},"2023-06-01",{"date":127,"type":22},"2032-02-25",{"name":45,"class":46},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":59,"phases":140,"briefSummary":141,"conditions":142,"keywords":146,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":47},"100473094","phase-2-the-role-of-anifrolumab-in-improving-markers-of-vascular-risk-in-patients-with-systemic-lupus-erythematosus-sle---ifn-cvd-100473094","NCT05440422","The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD","The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 18-80 years\n4. In good general health as evidenced by medical history or diagnosed with SLE diagnosed per American College of Rheumatology 1997 revised SLE classification criteria.\n5. Prednisone \\\u003C or equal to 10 mg\u002Fday for at least 2 weeks before screening and maintained throughout randomization (day 1)\n6. Stable standard of care lupus therapies for at least 4 weeks before screening and maintained through randomization (day 1)\n7. Abnormal cardio-ankle vascular index (CAVI) (based on 2 SD above median of healthy controls based on historical data from our own patient cohorts AND\u002FOR\n8. Abnormal Pulse wave velocity (PWV) using Sphygmocor. AND\u002FOR\n9. Abnormal target to background ratio (TBR) in various aortic territories and total aorta using FDG PET CT scan.\n10. Stable medications for diabetes, hypertension and\u002For statins for at least the previous 3 months. No changes of these medications or immunosuppressive drugs will be allowed during trial.\n11. For females and males of reproductive potential: use of highly effective contraception from screening and agreement to use such a method during study participation and for an additional 16 weeks after the end of study medication administration. For the purpose of this study abstinence will be considered as an effective form of contraception.\n12. Subjects must confirm receipt of prior vaccination against COVID-19 and Varicella Zoster. Verbal confirmation of vaccination receipt AND detectable antibodies in serum is acceptable in the absence of vaccine records.\n\n    EXCLUSION CRITERIA:\n\n    An individual who meets any of the following criteria will be excluded from participation in this\n\n    study:\n    * Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.\n    * Concurrent enrolment in another clinical study with an investigational product\n    * Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period.\n    * Any of the following found at Screening:\n\n      * Aspartate aminotransferase (AST) \\>2.5 x upper limit of normal (ULN).\n      * Alanine aminotransferase (ALT) \\>2.0 x ULN.\n      * Total bilirubin \\>ULN (unless due to Gilbert's syndrome)\n      * Serum creatinine \\>2.5 mg\u002FdL (or \\>181 micromol\u002FL)\n      * Urine protein\u002Fcreatinine ratio \\>2.0 mg\u002Fmg (or \\>226.30 mg\u002Fmmol)\n      * Neutrophil count \\\u003C1000\u002FmicroL (or \\\u003C1.0 x 109\u002FL)\n      * Platelet count \\\u003C25000\u002FmicroL (or \\\u003C25 x 109\u002FL)\n      * Hemoglobin \\\u003C8 g\u002FdL (or \\\u003C80 g\u002FL), or \\\u003C7 g\u002FdL (or \\\u003C70 g\u002FL) if related to subject's SLE such as in active hemolytic anemia\n      * Glycosylated hemoglobin (HbA1c) \\>8% (or \\>0.08) at screening (diabetic subjects only)\n      * Positive SARS\u002FFlu A\u002FB\u002FRSV (Panther), PCR\n\n    Note: Abnormal screening test(s) which exclude the patient may be repeated once within 4 weeks of the Screening Visit. If the repeat test(s) does not meet the above criteria, then the patient may be included in the study and will not be considered a screen failure.\n    * Receipt of any of the following:\n\n      1. Azathioprine \\>200 mg\u002Fday\n      2. Mycophenolate mofetil \\> 3 g\u002Fday or mycophenolic acid \\>2.16 g\u002Fday\n      3. Oral, SC, or intramuscular methotrexate \\>25 mg\u002Fweek\n      4. Mizoribine \\>150 mg\u002Fday. Leflunomide more than 20 mg and any other immunosuppressant usage at the discretion of the PI.\n    * Receipt of any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives prior to week 0 (day 1), whichever is greater.\n    * Receipt of any commercially available biologic agent within 5 half-lives prior to signing of the ICF\n    * Receipt of B cell depleting therapy (including but not limited to belimumab, ocrelizumab, ofatumumab, atacicept, Obinutuzumab, or rituximab), \\\u003C26 weeks prior to the signing of the consent for all B-cell depleting therapy or \\\u003C40 weeks prior to the signing of the ICF for atacicept.\n    * Receipt of any of the following: (a) Intra-articular, intramuscular or IV corticosteroids within 4 weeks prior to Day 1 (b) Any live or attenuated vaccine within 8 weeks prior to signing the ICF (administration of killed vaccines is acceptable)\n    * History or evidence of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months based on screening or at baseline.\n    * Recent cardiac or stroke event (with in the last year prior to week 0 (day 1))\n    * Active SLE disease with SLEDAI 2K \\>6 at the time of screening.\n    * Active severe or unstable neuropsychiatric SLE including, but not limited to: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; status epilepticus; cerebellar ataxia; and mononeuritis multiplex:\n\n      1. That would make the subject unable to fully understand the ICF OR\n      2. Where, in the opinion of the Principal Investigator (PI), protocol specified SOC is insufficient and utilization of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and\u002For high dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated\n    * Active severe SLE-driven renal disease where, in the opinion of the PI, protocol specified standard of care (SOC) is insufficient and utilization of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and\u002For high dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated.\n    * History of or current diagnosis of catastrophic or severe anti-phospholipid syndrome within 1 year prior to signing the ICF. Antiphospholipid syndrome adequately controlled by anticoagulant therapy for at least 3 months is acceptable.\n    * Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at screening. Subjects refusing HIV testing during the screening period will not be eligible for study participation.\n    * Confirmed positive test for hepatitis B serology for:\n\n      1. Hepatitis B surface antigen (HBsAg), OR\n      2. Hepatitis B core antibody (HBcAb)\n      3. If positive for HBcAb, hepatitis B virus (HBV) DNA will be checked. If HBV DNA is detected above the lower limit of quantitation (LLOQ) at screening subject will be excluded\n\n    Note: Subjects who are only HBcAb positive at screening will be tested every month for HBV DNA. To remain eligible for the study, the subject s HBV DNA levels must remain below the LLOQ as per the central laboratory.\n    * Positive test for hepatitis C antibody along with detectable Hepatitis C viral RNA.\n    * Any severe herpes infection at any time prior to Week 0 (Day 1), including, but not limited to, disseminated herpes (ever), herpes encephalitis (ever), recurrent herpes zoster (defined as 2 episodes within 2 years) or ophthalmic herpes (ever)\n    * Any herpes zoster, cytomegalovirus (CMV) or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.\n    * Any of the following:\n\n      1. Clinically significant chronic infection (i.e., osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to week 0 (day1) (chronic nail infections are allowed)\n      2. Any infection requiring hospitalization or treatment with IV antibiotics not completed at least 4 weeks prior to week 0 (day1)\n    * Any infection requiring oral antimicrobials (including antivirals) within 2 weeks prior to Day 1, except if taking antivirals\u002Fantimicrobials prophylactically.\n    * History of cancer, apart from:\n\n      1. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy \\>=3 months prior to Week 0 (Day 1)\n      2. Cervical cancer in situ treated with apparent success with curative therapy \\>=1 year prior to Week 0 (Day 1).\n    * Pregnancy or lactation or intend to become pregnant anytime from initiation of Screening until completion of study.\n    * Spontaneous or induced abortion, still or live birth, or pregnancy \\\u003C= 4 weeks prior to week 0 (day1)\n    * Known allergic reactions to any component of the investigational product formulation or history of anaphylaxis to any human gamma globulin therapy.\n    * Tested positive for COVID-19 infection on the day of screening or up to 21 days prior to screening.","18 Years","80 Years",{"count":139,"type":22},45,[61],"Background:\n\nPeople with systemic lupus erythematosus (SLE) are at risk of developing complications in their blood vessels. This can increase the risk of heart attacks or stroke. No medications have been effective at reducing this risk in people with lupus.\n\nObjective:\n\nTo test whether a drug (anifrolumab) can improve blood vessel function and reduce blood vessel inflammation in people with SLE.\n\nEligibility:\n\nPeople aged 18 to 80 years with SLE.\n\nDesign:\n\nParticipants will undergo screening. They will have a physical exam. They will have blood and urine tests. They will have a test of their heart function and a chest X-ray. They will answer questions about their SLE symptoms.\n\nParticipants will visit the clinic 9 times in 8 months. After screening, visits will be 4 weeks apart. Each visit may take up to 4 hours.\n\nParticipants will receive infusions from a tube attached to a needle inserted into a vein in the arm (IV). Some will receive anifrolumab. Others will receive a placebo treatment. They will not know which one they are getting.\n\nAt some visits they will have additional tests:\n\nCAVI (cardio-ankle vascular index) tests blood vessel function. Participants will lie still for 20 minutes. Small electrodes will be placed on both wrists with stickers. A microphone will be placed on their chest. Blood pressure cuffs will be wrapped around their ankles and arms.\n\nFDG-PET\u002FCT is an imaging procedure. Participants will receive a substance through an IV line. They will lie on a table for 110 minutes while a machine captures images of their body.",[143,144,145],"Systemic Lupus Erythematosus","Cardiovascular Disease","Premature Atherosclerosis",[147,148,149],"Vascular Inflammation","Interferons","Vascular Function","2026-06-24",{"date":121,"type":39},{"date":153,"type":39},"2023-12-07",{"date":155,"type":22},"2027-08-02",{"name":45,"class":46},{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":136,"maxAge":19,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":176,"completionDateStruct":4,"leadSponsor":178,"locationsCount":47},"100059944","studies-of-the-natural-history-of-rheumatic-diseases-100059944","NCT00024479","Studies of the Natural History of Rheumatic Diseases","* INCLUSION CRITERIA:\n\nKnown or suspected rheumatic disease\n\nAge greater than or equal to 18 years\n\nWillingness and capacity to provide informed consent.\n\nEXCLUSION CRITERIA:\n\nPatients will be excluded if any of the inclusion criteria cannot be met.\n\nWomen who are pregnant or breastfeeding at the time of enrollment.",{"count":164,"type":22},7500,"This study will explore the causes of rheumatic diseases and why many of them affect certain minority communities more severely. Rheumatic diseases may cause joint pain, stiffness or swelling. Some can involve bones, muscles, tendons or ligaments. Some cause abnormalities of the immune system-the body s defense against disease. Some rheumatic diseases are painful or deforming and some can be life threatening. Information obtained from this study will be used to learn about the disparities in rheumatic disease in the minority community and to design further, more targeted, research studies to address this issue.\n\nPatients with known or suspected rheumatic disease 18 years of age or older may be eligible for this study. Candidates will undergo a medical history and physical examination to confirm the diagnosis of rheumatic disease and determine what is needed for evaluation and treatment.\n\nParticipants will receive standard medical care for rheumatic disease and arthritis. No experimental treatments, medications or procedures will be included in this study. Procedures may include routine blood tests for blood chemistries, cell counts, and antibodies commonly found in patients with rheumatic disease; a urine test for proteins and cells; and X-rays and other imaging tests to check for abnormalities in the lungs or other organs. All medical information will be kept confidential.\n\nPatients who are found to be eligible for other current NIH research studies will be offered an opportunity to participate in these studies.",[167,28],"Rheumatic Diseases",[169,170,171,34,172,173],"Minorities","Rheumatic Disease","Community Based","Ethnicity","Health Disparities","2026-06-23",{"date":150,"type":39},{"date":177,"type":39},"2001-10-03",{"name":45,"class":46},{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":186,"minAge":136,"maxAge":111,"enrollmentInfo":187,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":189,"conditions":190,"keywords":193,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":47},"100482835","gonadotropin-releasing-hormone-agonist-gnrha-in-ovarian-preservation-in-sle-subjects-receiving-cyclophosphamide-as-determined-by-questionnaires-100482835","NCT05567198","Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires","Efficacy of Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires","* ELIGIBILITY CRITERIA:\n* INCLUSION CRITERIA: Group 1: SLE patients receiving CYC alone\n\nSLE females \\\u003C40 years at the beginning of CYC treatment without GnRH-a cotreatment.\n\n-EXCLUSION CRITERIA: Group 1: SLE patients receiving CYC alone\n\nFemales \\>40 years at the beginning of CYC treatment; any females with a prior history of reproductive disorders, infertility, or untreated sexually transmitted infections (STIs).\n\n-INCLUSION CRITERIA: Group 2: SLE patients receiving both CYC and leuprolide acetate (GnRH-a). Leuprolide acetate was injected at a dose of either 3.75 mg\u002Fmonth or 11.25mg\u002Fevery 3 months.\n\nSLE females \\\u003C40 years at the beginning of CYC treatment with GnRH-a cotreatment.\n\n-EXCLUSION CRITERIA: Group 2: SLE patients receiving both CYC and leuprolide acetate (GnRH-a). Leuprolide acetate was injected at a dose of either 3.75 mg\u002Fmonth or 11.25mg\u002Fevery 3 months.\n\nFemales \\>40 years at the beginning of CYC treatment; any females with a prior history of reproductive disorders, infertility, or untreated STIs.\n\n-Group: Control subjects.\n\nAge-matched female SLE patients without a history of reproductive disorders, infertility, or untreated STIs, who have not received CYC either with or without GnRH-a.","FEMALE",{"count":188,"type":22},100,"Background:\n\nSystemic lupus erythematosus (SLE) is a disease that affects females nine times more often than males. People with SLE are often treated with cyclophosphamide (CYC). But CYC can damage a woman s ovaries; it may cause infertility. A drug called GnRHa is sometimes given to protect the ovaries during CYC therapy. But no one really knows how effective GnRHa treatment is. This natural history survey will compare women who received GnRHa during CYC therapy with those who did not.\n\nObjective:\n\nTo find out whether GnRHa can help protect women s ovaries during CYC.\n\nEligibility:\n\nWomen under age 40 years starting CYC treatment with or without GnRHa.\n\nDesign:\n\nThis study will do 2 things: It will conduct patient surveys. It will collect data from medical records.\n\nParticipants will complete a one-time survey. They will answer questions about their menstrual cycle. They will be asked about their history of pregnancy or infertility.\n\nParticipants can take the survey in 4 ways:\n\nOn paper, sent through the mail.\n\nOnline, in a secure web page managed by the NIH.\n\nBy phone.\n\nIn person, during a routine visit to the NIH clinic.\n\nThe survey will take about 30 minutes.\n\nParticipants medical records will be reviewed. Researchers will look for data about the participants SLE disease. This may include their symptoms and the results of their blood tests. It may also include the details of prior treatments.\n\nResearchers will also collect data about participants reproductive history. This may include their personal or family history of infertility. It may include any fertility treatments and any sexually transmitted infections.",[191,192],"Systemic Lupus Erythematosus (Sle)","Primary Ovarian Insufficiency (Poi)",[192,194,195,196,34],"Nephritis","Neuro-Psychiatric Lupus","Anti-Mullerian Hormone (Amh)","2026-06-17",{"date":199,"type":39},"2026-06-18",{"date":201,"type":39},"2023-03-03",{"date":203,"type":22},"2027-05-31",{"name":45,"class":46},{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":17,"minAge":136,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":215,"conditions":216,"keywords":217,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":220,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":47},"100247845","natural-history-pathogenesis-and-outcome-of-melorheostosis-a-rare-osteosclerotic-disease-100247845","NCT02504879","Natural History, Pathogenesis and Outcome of Melorheostosis A Rare Osteosclerotic Disease","Study of the Natural History, Pathogenesis and Outcome of Melorheostosis - a Rare Osteosclerotic Disease","* INCLUSION CRITERIA:\n\nAll eligible patients are invited to participate in this protocol. Patients are adults aged \\> 18 years with possible melorheostosis (suspected or confirmed). Since both men and women are affected with the disease, both sexes will be studied. All ethnic and racial groups are at risk and will be included.\n\nRelatives of patients with melorheostosis may be included for genetic testing only.\n\nEXCLUSION CRITERIA:\n\n* Pregnant or lactating women. A pregnancy test is performed in women of childbearing potential (up to age 55) unless they have a history of hysterectomy or tubal ligation.\n* Children (age less than 18 years) are excluded.\n* Subjects with severe active infection or other co-morbidities that in the opinion of the investigator would warrant exclusion.\n* Subjects unable to provide informed consent.","90 Years",{"count":214,"type":22},350,"Background:\n\n\\- The rare disease melorheostosis causes bones to thicken. This may lead to pain, and can affect bones, joints, and muscles. Researchers want to learn more about the disease and how it progresses.\n\nObjective:\n\n-To see what happens to people with melorheostosis over time and understand the causes of the disease.\n\nEligibility:\n\n* People 18 and over with melorheostosis.\n* Their unaffected relatives.\n\nDesign:\n\n* All participants will have a medical history and physical exam.\n* Participants who are relatives will give samples of blood or cheek cells.\n* Other participants will be in the study for about 1 week.\n* They will have blood and urine collected.\n* Strength, walking, and range of motion will be measured.\n* Participants may also have\n* X-rays and scans.\n* A pain and neurological evaluation.\n* Their skin evaluated by a dermatologist.\n* A small sample of bone taken.\n* Nerve conduction studies. Small electrodes with to wires will be put on the skin. A metal probe will give a small electrical shock.\n* Electromyography. A thin needle will be placed into the muscles.\n* An ultrasound, which uses sound waves to examine the muscles and nerves. An ultrasound probe will be placed over the skin.\n* A bone scan. They will get a small amount of radioactive fluid through a needle in an arm vein. This fluid travels to the bones. The bones will be photographed in a machine.\n* Bone Densitometry, a low-level x-ray.\n* Photographs taken.\n* A small circle of skin removed with a surgical instrument.\n* Questionnaires about their quality of life.\n* Participants will be asked to return about every 2 years. At these visits, participants may have blood and urine tests and x-rays.",[170],[218,219,34],"Osteosclerosis","Hyperostosis",{"date":199,"type":39},{"date":222,"type":39},"2015-08-16",{"date":224,"type":22},"2030-07-01",{"name":45,"class":46},{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":16,"sex":17,"minAge":232,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":235,"conditions":236,"keywords":242,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":252,"locationsCount":47},"100228924","studies-of-the-natural-history-pathogenesis-and-outcome-of-idiopathic-systemic-vasculitis-100228924","NCT02257866","Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis","* INCLUSION CRITERIA:\n\nSUBJECTS WITH VASCULITIS\n\n* Subjects who fulfill modified versions of the 1990 American College of Rheumatology (ACR) Classification Criteria for GPA31 and PAN\n* Subjects who fulfill the 1990 ACR Classification Criteria for EGPA, GCA, and TAK\n* Subjects who fulfill the 2012 Chapel Hill Nomenclature definition for MPA\n* Subjects with other suspected systemic or single-organ vasculitides\n\nHEALTHY VOLUNTEERS\n\n-Volunteers able to provide consent, or in the case of minors, assent\n\nEXCLUSION CRITERIA:\n\nSUBJECTS WITH VASCULITIS:\n\n* Subjects less than 3 years of age\n* Active malignancy, infection, or any medical condition that in the opinion of the investigator would warrant exclusion\n* Inability to provide consent, or in the case of minors, assent\n* Subjects with bleeding diathesis or on anticoagulant medications (e.g. coumadin, heparin, clopidogrel but not including aspirin or NSAIDs) are excluded from participation in nasal brushing or biopsy studies\n\nHEALTHY VOLUNTEERS\n\n* Volunteers less than 3 years of age\n* Diagnosis of vasculitis or other autoimmune\u002Fautoinflamamtory disease, including systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, mixed connective tissue disease or any overlap autoimmune syndrome\n* Active malignancy, infection, or any medical condition that in the opinion of the investigator would warrant exclusion\n* Pregnant (by history of last menstrual period) or breast feeding subjects\n* Subjects with bleeding diathesis or taking anticoagulant medications (eg coumadin, heparin, clopidogrel but not including aspirin or NSAIDs) are excluded from participating in nasal brushing studies","3 Years",{"count":234,"type":22},4000,"Background:\n\n\\- Vasculitis is a group of diseases that inflame and damage blood vessels and tissue. It can cause many medical problems. Few tests can diagnose the disease, and none can reliably predict a relapse. Researchers want to study people s genes and follow people over time to see how the disease affects them.\n\nObjective:\n\n\\- To learn the signs, symptoms, imaging tests, genetic markers, and blood tests that can help identify people with vasculitis and predict what will happen to them over time.\n\nEligibility:\n\n* People age 3 and older who have or are thought to have vasculitis, or are related to someone with it.\n* Healthy volunteers.\n\nDesign:\n\n* Participants will be evaluated by a doctor who has expertise caring for patients with vasculitis.\n* Participants will give a blood sample. Some will give a urine sample.\n* Some participants may have brushings or biopsies taken from the inside lining of the nose.\n* Images of participants blood vessels may be taken using scans. For some scans, participants will lie on a table that moves in and out of a cylinder that takes pictures. For some scans, a contrast agent may be injected into an arm vein. Other scans may use a radioactive form of sugar. Healthy minors will not have scans.\n* Some participants will answer questionnaires. - Some participants will have their tests done at NIH. Others will have their doctor take the blood, saliva, or cheek swab samples and send them to NIH.\n* Some participants will have one visit lasting 1-2 (but sometimes up to 4) days. Some participants may have follow-up visits every 3 - 6 months, indefinitely.",[237,238,239,240,241],"Takayasu's Arteritis","Giant Cell Arteritis","Polyarteritis Nodosa","Relapsing Polychondritis","ANCA-Associated Vasculitis",[239,243,244,240,245,34],"Takayasu's Arthritis","Giant Cell Arthritis","Antineutrophil Cytoplasmic Antibodies","2026-06-13",{"date":248,"type":39},"2026-06-16",{"date":250,"type":39},"2014-09-29",{"date":43,"type":22},{"name":45,"class":46},{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":19,"enrollmentInfo":260,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":262,"conditions":263,"keywords":266,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":4,"leadSponsor":276,"locationsCount":47},"100062399","studies-of-the-natural-history-pathogenesis-and-outcome-of-autoinflammatory-diseases-including-juvenile-dermatomyositis-100062399","NCT00059748","Studies of the Natural History, Pathogenesis, and Outcome of Autoinflammatory Diseases Including Juvenile Dermatomyositis","Studies of Natural History, Pathogenesis, and Outcomes in Autoimmune and Inflammatory Diseases Including Juvenile Dermatomyositis","* INCLUSION CRITERIA:\n* Patients with CANDLE, SAVI, and JDM who are mutation positive for the disease or fulfill clinical criteria of the disease.\n* Patients who fulfill criteria for definite or probable JDM\n* Patients with other suspected autoinflammatory diseases\n* There is:\n\n  * 2 years old or older\n  * Patients or their legal guardians need to be able and willing to give informed consent and a pediatric patient needs to be willing to assent to the protocol whenever possible.\n\nRelatives of patients with autoinflammatory diseases or healthy volunteers may be included for genetic testing. The genetic evaluations will be conducted in collaboration with Dr. Fleisher's laboratory at the Clinical Center laboratory and other groups. We may also collect blood for serum and RNA analyses to establish a cohort of healthy controls that is matched in age, gender and ethnicity to the study patients. Skin biopsies for research may be requested from patients, patient relatives and healthy volunteers\n\nEXCLUSION CRITERIA:\n\n* Active malignancy or any medical condition that in the opinion of the investigator would warrant exclusion\n* Inability to return for follow up visits\n* Pregnancy\n* Adults without the capacity to consent",{"count":261,"type":22},5000,"Purpose:\n\nThe purpose of this protocol is 1. To comprehensively evaluate patients with autoinflammatory diseases clinically, genetically and immunologically at the autoinflammatory disease clinic at the NIH. 2. To follow patients with autoinflammatory Diseases that are genetically defined including Neonatal-Onset Multisystem Inflammatory Disease (NOMID), the most severe clinical phenotype of Cryopyrin-Associated Periodic Syndromes (CAPS), Deficiency of IL-1 Receptor Antagonist (DIRA), Chronic Atypical Neutrophilic Dermatosis with Lipodystrophy and Elevated temperatures (CANDLE), and STING-Associated Vasculopathy with onset in Infancy (SAVI), and those with genetically undefined autoinflammatory disorders to determine long-term disease outcomes. 3. To develop biomarkers that help us assess disease activity and response to treatment. 4. To assess the eligibility of affected patients for inclusion in ongoing and planned treatment protocols.\n\nGoal: The goals of our studies are to understand the underlying immune dysregulation, to identify the genetic cause and to translate our findings into novel treatments that improve patients disease outcome.\n\nEligibility:\n\n* Patients with known NOMID\u002FCAPS, DIRA, CANDLE, SAVI, CRMO, Still's Disease, and with other yet undifferentiated autoinflammatory diseases.\n* Healthy adult and pediatric relatives.\n* Volunteers\n\nDesign:\n\nParticipants will be evaluated at the NIH for 2-5 days. All participants will have a detailed medical history, physical exam, blood tests and other evaluations depending on the extend of their autoinflammatory disease.\n\nParticipants may also expect the following assessments:\n\n1. Clinical test that help assess organ damage and functional impact such as hearing vision, memory and learning tests.\n2. Imaging studies to characterize the organ involvement of the inflammatory disease including: X-rays, CT scans, special MRIs, bone scans.\n3. Laboratory evaluations including clinical markers of disease activity, research samples for genetic studies, and blood samples for cytokine\u002Fbiomarker assessment, and gene expression profiling.\\\u003CTAB\\>\n4. Completion of questionnaires to assess disease activity and quality of life.\n5. If indicated, other procedures may be administered that include: a lumbar puncture if CNS inflammation is suspected and a skin biopsy if skin inflammation is present. other gastrointestinal procedures as they are clinically indicated.\n6. Patients my have a research skin biopsy taken.\n\nParticipants may return for a single follow-up visits or for long term-follow up depending on their disease and willingness to be followed long-term.",[264,265],"Autoinflammatory Disease","Juvenile Dermatomyositis",[267,268,269,270,31,34],"Myositis","JDM","Immune Dysregulation","Skin Rash","2026-06-04",{"date":273,"type":39},"2026-06-05",{"date":275,"type":39},"2003-05-09",{"name":45,"class":46},{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":284,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":286,"conditions":287,"keywords":292,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":47},"100245278","studies-of-dermatologic-diseases-biospecimen-acquisition-protocol-100245278","NCT02471352","Studies of Dermatologic Diseases Biospecimen Acquisition Protocol","Studies of Dermatologic Diseases-Biospecimen Acquisition Protocol","* INCLUSION CRITERIA:\n* Eligible participants must:\n\n  * Have a dermatologic condition, as determined by the PI or AIs, OR --be at risk for developing a dermatologic condition, as determined by the PI or AIs, OR\n  * be a family member of a person with a dermatologic condition OR\n  * be a healthy volunteer, as defined as a person with no known significant health problems.\n  * Be willing to provide biospecimens for research and clinical studies, and for storage to be used for future research.\n  * Subjects of age greater than 0 years old (including only viable neonates) are eligible.\n\nEXCLUSION CRITERIA:\n\n* Presence of conditions that, in the judgment of the investigator, may put the subject at undue risk or make them unsuitable for participation in the study.\n* Inability to comply with the requirements of the protocol.",{"count":285,"type":22},700,"Background:\n\n\\- Skin disease can have many causes. It can have widespread consequences, and in rare cases can lead to death. Researchers want to determine the causes of various types of skin diseases and find a way to treat them.\n\nObjectives:\n\n\\- To determine the causes of various skin diseases and find ways to treat them.\n\nEligibility:\n\n* People ages 2 and older who have:\n\n  * A skin disease or at risk of developing a skin disease OR\n  * A family member of persons with a skin disease\n* Healthy volunteers ages 2 and older\n\nDesign:\n\n* Participants will be screened under a separate protocol.\n* Participants may take a survey about how their skin condition affects their quality of life.\n* Participants will have a medical history and a physical exam including a detailed skin exam. Pictures will be taken of their skin to document any skin disease.\n* Participants will have specimens collected. This may include:\n\n  * Several teaspoons of blood taken at each visit\n  * Stool samples\n  * Nail and body fluid (like saliva) samples\n  * Cheek swabs. The inside of the cheek will be scraped for about a minute in each direction to collect cells.\n  * Collection of skin samples with:\n\n    * A swab (like a Q-tip)\n    * Gently scraping skin to remove the outer layers of cells\n    * Applying and removing 1-inch pieces of tape\n* Participants may have up to 4 skin biopsies in 12 months, with 4 separate biopsies taken each time.\n\n  * An area of skin will be numbed with an injection.\n  * A piece of skin the size of a pencil eraser will be removed using a small instrument.\n  * A flat scar usually develops at the biopsy site.",[288,289,290,291],"Dermatologic Conditions","Healthy Volunteers","Normal Volunteers","Carcinoma, Merkel Cell",[293,294,295,289,296,34],"Dermatologic Condition","Skin Disease","Biospecimen","Merkel Cell Carcinoma","2026-05-28",{"date":299,"type":39},"2026-05-29",{"date":301,"type":39},"2015-06-19",{"date":303,"type":22},"2027-01-31",{"name":45,"class":46},{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":16,"sex":17,"minAge":232,"maxAge":111,"enrollmentInfo":312,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":313,"conditions":314,"keywords":315,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":4,"leadSponsor":326,"locationsCount":47},"100054418","study-of-systemic-lupus-erythematosus-100054418","NCT00001372","Study of Systemic Lupus Erythematosus","Studies of the Pathogenesis and Natural History of Systemic Lupus Erythematosus (SLE)","* INCLUSION CRITERIA:\n\nPatients with known or suspected SLE will be evaluated in either the outpatient or inpatient research ward of the Clinical Center as indicated. Patients will not be selected based on age, race or gender. However, due to the nature of the disease, the patient population will not be expected to be evenly distributed, since SLE is predominantly a disease of young females, with increased prevalence in select racial groups, particularly African Americans and Hispanics. First and second-degree relatives of the patient may be recruited in the study for genetic analysis. We will ask for the patient s permission to contact his\u002Fher relatives.\n\n* SLE or suspected SLE established by ACR\u002FEULAR or ACR criteria\n* Ability to give informed consent\n* Adult and minor relatives (first and second degree) of individuals Included in IV-G (only for genetic studies)\n* Ability of the patient or minor relative s parents to give informed consent\n* Affected individuals age \\>= 3 years with no upper age limit\n* Healthy Volunteers (non-related) age \\>=18 with no upper age limit\n* Healthy Volunteers (first- and second-degree relatives) age \\>=3 with no upper age limit\n* Vascular studies adults only age \\>=18 with no upper age limit\n\nEXCLUSION CRITERIA:\n\n* Concomitant medical problems which would confound the interpretation of studies gathered by this protocol. Included in this is the presence of HIV in the blood, active malignancies, or other significant medical conditions that may interferes with interpretation of some lupus studies.\n* Concomitant medical, surgical or other conditions for which inadequate facilities are available to support their care at NIH\n* Inability or unwillingness to comply with follow up requirements (e.g. distance, social, physical limitations)\n* Any comorbidity of medical or psychological\u002Fpsychiatric condition or treatment after reviewing of patients previous or outside medical records, that in the opinion of the Principal Investigator, would exclude the subjects from the research studies (e.g. Patient requiring urgent and\u002For acute medical care, surgical or other procedures)\n* Unwilling to participate in research studies or to provide research samples or data\n* Any concomitant medical problems or are taking medications which would confound the interpretation of studies they are considered for\n\nEXCLUSION CRITERIA FOR VASCULAR STUDIES ONLY, FOR SLE AND HEALTHY CONTROLS:\n\n* Subjects with a contraindication to MRI scanning will not receive the optional Cardiovascular MRI. These contraindications include subjects with the following devices:\n\n  * Central nervous system aneurysm clips unless it is labeled safe or conditional for MRI\n  * Implanted neural stimulator (e.g.TENS-Unit) unless it is labeled safe or conditional for MRI\n  * Implanted cardiac pacemaker or defibrillator unless it is labeled safe or conditional for MRI\n  * Cochlear or any type of ear implant unless it is labeled safe or conditional for MRI\n  * Ocular foreign body (e.g. metal shavings)\n  * Implanted Insulin pump or drug infusion device unless it is labeled safe or conditional for MRI\n  * Metal shrapnel or bullet unless cleared by plain x-ray as safe for MRI\n* Subjects with renal excretory dysfunction, estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F1.73m\\^2 using the CKD-EPI equation or equivalent (using the CRIS-calculated eGFR to define the threshold) and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications. Subjects meeting this exclusion criterion may still be included in the study but will not be exposed to the cardiac CT angiography, or gadolinium-based contrast agents.\n* Pregnant or lactating women will be excluded from vascular studies.\n* Any clinical instability precluding subject from getting MRI as determined by the enrolling clinician.\n* Healthy controls with known history of coronary artery disease, peripheral vascular disease or atherosclerosis.\n* Individuals younger than 18 years old will be excluded given the radiation exposure as well as the lack of proper validation for the proposed vascular function studies.",{"count":21,"type":22},"This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.\n\nPatients 3 years of age and older with known or suspected SLE and their relatives may be eligible for this study. Patients will be evaluated with a medical history and physical examination, blood and urine tests. Other procedures may include:\n\n1. Electrocardiogram\n2. 24-hour urine collection\n3. Imaging studies, such as chest and joint X-rays, magnetic resonance imaging (MRI) scans, bone scans, and bone densitometry.\n4. Questionnaire about the degree of disease activity, and survey of risk factors for disease complications.\n5. Apheresis-Collection of plasma (fluid portion of blood) or blood cells for analysis. Whole blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components. The required component (plasma or cells) is removed and the rest of the blood is returned to the body through the same needle or through a second needle in the other arm.\n6. Skin biopsy-Removal of a small skin sample for microscopic analysis. An area of skin is numbed with an anesthetic and a small circular portion (about 1\u002F4 inch in diameter) is removed, using a sharp cookie cutter-type instrument.\n7. Kidney, bone marrow or other organ biopsy-Removal of a small sample of organ tissue. These biopsies are done only if they can provide information useful in better understanding the disease or making treatment decisions.\n8. Genetic studies-Collection of a blood sample for gene testing.\n\nPatients will be followed at least once a year with a brief history and physical examination and routine blood and urine tests. Some patients may be seen more often. Treatment recommendations will be offered to patients' physicians, and patients who are eligible for other research treatment studies will be invited to enroll.\n\nParticipating relatives of patients will fill out a brief medical history questionnaire and provide a DNA sample (either a blood sample or tissue swab from the inside of the cheek) for genetic testing.",[143],[316,34,317,318,319,320],"Longitudinal Study","Lupus Nephritis","Lupus","Systemic Lupus","SLE","2026-05-21",{"date":323,"type":39},"2026-05-22",{"date":325,"type":39},"1994-02-10",{"name":45,"class":46},""]