[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Institute of Environmental Health Sciences (NIEHS)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":501},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,48,73,93,119,131,140,150,159,189,216,240,266,294,316,337,362,384,408,430,453,476],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100054161","phase-2-fast-for-dm---fatty-acid-supplementation-trial-fast-for-dermatomyositis-dm-100054161",false,"NCT07111065","FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)","Phase II, Randomized, Double-Blind, Placebo-Controlled Trial of Omega-3 Fatty Acid (O3FA) Supplementation for Adult and Juvenile Dermatomyositis (DM\u002FJDM)","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Adults 18-60 years of age with probable or definite EULAR-ACR criteria for adult or juvenile dermatomyositis (DM, JDM).\n* Willingness to adhere to the general healthy diet pattern regimen, undergo dietary coaching on weekly to biweekly basis (10 sessions), and to complete online random reporting of dietary intake over a 6-month period.\n* Ability and willingness to comply with taking 4 study pills twice a day for 6 months.\n* Ability and willingness to wear ActiGraph device at home for 7 continuous days, twice in the study.\n* Willingness and ability to complete and consent to study testing, including blood, stool, and urine samples, and imaging studies.\n* Ability and willingness to complete a total of 5 study visits (screening, weeks -6, 0, 12, 24) onsite at NIH Clinical Center in Bethesda, Maryland.\n* Has the ability\u002Ftransportation methods to attend on-site visits. Willing to pay for travel and out-of-pocket expenses.\n* Own or have reliable access to a computer, laptop or smart phone device (iPhone or Android) with internet access, and an active email address, to complete study consent form, online questionnaires, telehealth visits, and review online dietary education materials and videos.\n* Ambulatory\n* Must live within the United States.\n* Must be proficient in the English language and complete questionnaires in English (forms validated in English). Ability and willingness to complete forms online.\n* Moderately active DM\u002FJDM defined by:\n\n  * MD global VAS with a \\>= 2.0 cm on a 10 cm scale and maximum value of 7.0 cm, and\n  * At least 2 of the following criteria:\n\n    * Patient global activity \\>= 2 cm out of 10 cm visual analog scale (VAS).\n    * MMT-8 score of \\\u003C=138 out of 150.\n    * Health Assessment Questionnaire disability index with a minimum value of \\>= 0.50 out of 3.0\n    * Elevation of at least one of the muscle enzymes (which includes creatine kinase (CK), aldolase, lactate dehydrogenase (LDH), ALT and AST) at a minimum level of 1.3X the upper limit of normal.\n    * Global Extramuscular disease activity score with a minimum value of \\>= 1.0 cm on a 10 cm VAS scale (this measure is the physician s composite evaluation and is based on assessments of activity scores on the constitutional, cutaneous, skeletal, gastrointestinal, pulmonary and cardiac scales of the Myositis Disease Activity Assessment Tool (MDAAT).\n* Physician global damage and muscle damage both \\\u003C= 5.0 cm\u002F10 cm VAS\n* If receiving prednisone and methotrexate, the dose must be stable for at least 4 weeks prior to the Week 6 visit, and daily prednisone \\\u003C= 20 mg\u002Fday.\n* Background therapy with other non-corticosteroid immunosuppressive agent, if required, must be at a stable dose for at least 6 weeks prior to the Week 6 visit, except with IVIG regimen should be stable 90 days prior to the Week 6 visit and for rituximab, stable regimen for 4 months prior to Week 6.\n* If an immunosuppressive agent was discontinued prior to the screening visit, then there must be a washout period before week -6 visit:\n\n  * 4-week washout for prednisone, methotrexate, and IV methylprednisolone (IV pulse therapy)\n  * 8-week washout for other immunosuppressive drugs, including azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, cyclophosphamide, colchicine, and hydroxychloroquine\n  * 8-week washout for IVIG\n  * For discontinuation of biologic or targeted drug therapies or dietary supplements, a washout prior to visit 1 (week 6) is required of 4 terminal half-lives.\n\n    * Half-lives of most common biologics and targeted drug therapies used in the treatment of DM\u002FJDM:\n\n      * Etanercept Half-life 70 hours, Waiting period before enrollment (4 Half-lives) 12 days\n      * Adalimumab, Half-life, 14 days, Waiting period before enrollment (4 Half-lives) 60 days\n      * Rituximab, Half-life 32 days, Waiting period before enrollment (4 Half-lives) 130 days\n      * Infliximab, Half-life 9 days, Waiting period before enrollment (4 Half-lives) 36 days\n      * Abatacept, Half-life 17 days, Waiting period before enrollment (4 Half-lives) 68 days\n      * Anakinra, Half-life 6 hours, Waiting period before enrollment (4 Half-lives) 1 day\n      * Tofacitinib, Half-life 3 hours, Waiting period before enrollment (4 Half-lives) 1 day\n      * Baricitinib, Half-life 12hours, Waiting period before enrollment (4 Half-lives) 2 days\n* Negative pregnancy test (urine or blood sample) if born female.\n* Body Mass Index (BMI) \\> 18 and \\\u003C= 35 kg\u002Fm\\^2\n* Fish intake of less than 2 servings per week on average for the past 3 months.\n* Intake of meat products (beef, lamb, pork, venison, rabbit, cow s milk or dairy products) within 2 months of screening visit and of week 0 and have no reaction (no shortness of breath, hives, rash, or diarrhea) within 6 hours of ingestion of these meat products.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Polymyositis; inclusion body myositis; cancer-associated myositis, defined as the diagnosis of myositis within 3 years of the diagnosis of cancer, except basal or squamous cell skin cancer or carcinoma in situ of the cervix if at least 5 years since excision.\n* Myositis in overlap with another autoimmune disease will be excluded under the following conditions:\n\n  i. Myositis overlapping with another autoimmune disease that precludes accurate assessment of treatment response (e.g., difficulty assessing muscle strength in a patient with scleroderma and associated myositis).\n\nii. Myositis overlapping with inflammatory bowel disease, including Crohn s disease, ulcerative colitis, or celiac disease.\n\niii. Myositis overlapping with autoimmune thyroid disease (e.g., Hashimoto s disease or Graves disease), unless the thyroid disease is\n\nstable and well controlled with no changes in thyroid-related medications for at least 3 months prior to enrollment, in which case the\n\npatient may be included.\n\n* Drug- or toxin-induced myositis, including known HMG-CoA reductase autoantibody-positive necrotizing myopathy following statin use.\n* Moderate to severely active myositis that would require initiation of another immunosuppressive treatment.\n* Joint disease, severe calcinosis, or other musculoskeletal condition, which precludes the ability to assess\u002Fquantitate muscle strength and function.\n* Concomitant illness that would prevent adequate patient assessment or in the investigators opinion pose an added risk for study participants. The investigator may consider further evaluation or consultation if clinically indicated prior to study enrollment:\n\n  * Recurrent or chronic infections, including HIV, hepatitis B and C, Epstein Barr virus, active coronavirus infection, active or recurrent gastrointestinal infection (including Helicobacter pylori), active or recurrent skin infections with calcinosis.\n  * Disorders that would preclude accurate assessment of neuromuscular function.\n  * Severe swallowing dysfunction with inability to swallow pills.\n  * Patients with generalized lipodystrophy.\n  * Severe cardiomyopathy or arrhythmias, including atrial fibrillation or atrial flutter, New York Heart Association Classification III or IV for congestive heart failure, severe interstitial lung requiring oxygen therapy, gastrointestinal vasculopathy\u002Fulceration or gastroparesis, renal failure requiring dialysis, that in the investigators opinion poses an additional risk for study participants.\n  * Subjects with any acute and life-threatening condition unrelated to myositis, such as prior sudden cardiac arrest, acute myocardial infarction, stroke, embolism in last 3 months.\n  * History of malignancy, except basal or squamous cell skin cancer or carcinoma in situ of the cervix if at least 5 years since excision.\n  * Uncontrolled hypertension with average blood pressure \\>= 140\u002F90, requiring a new anti-hypertensive medication in the past 8 weeks.\n  * Psychiatric illness that precludes compliance or neuromuscular assessment, including major psychiatric illness requiring hospitalization within the past year and\u002For has had a change in depression or anxiety prescription medications within the past 3 months (by discretion of study physician).\n  * Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, irritable bowel syndrome, symptomatic gallstones, or other conditions that could affect intestinal fat absorption.\n  * Subjects with clinically diagnosed hepatic disease, including but not limited to hepatitis, steatosis, cirrhosis.\n  * Osteoporotic fracture under therapy for pain control or impacting ambulation.\n  * Serum creatinine \\> 2.0mg\u002Fdl or eGFR less than 50 mL\u002Fmin per 1.73 m\\^2.\n  * Subjects with coagulation or bleeding disorders (such as hemophilia) or receiving anti-platelet or anti-coagulant medications, including daily aspirin, warfarin, or Plavix.\n  * Life-threatening non-myositis illness that would interfere with the patient s ability to complete the study.\n* Known contraindications to O3FAs, excipients or placebo contents (e.g., allergy or known hypersensitivity to that drug or its excipients, including porcine gelatin, allergies to fish or shellfish, tocopherols, glycerin, or corn). Religious or ethical reasons to not consume fish, corn and\u002For porcine (pork) products.\n* Participants with any of the following:\n\n  * Idiopathic anaphylaxis\n  * Alpha-gal reaction\n  * Known food allergies to beef, pork, lamb or other meat products, including cow s milk and dairy products, with a history of shortness of breath, rash, or hives within 6 hours of eating these foods.\n* Currently using O3FAs or consuming EPA\u002FDHA in any form for the past 6 months.\n* Currently taking supplements or medications that affect lipoproteins for the past 6 months, including fish oil supplements, bile-acid sequestrants, plant sterol supplements, PCSK9 inhibitors, fibrates, statins, or niacin.\n* Use of medications or dietary supplements that interact with O3FA per pharmacy evaluation. A PharmD will evaluate the patient's current medication list for medications\u002Fsupplements with the potential for significant interactions with O3FA.\n* No antibiotic usage in past 3 months, as well as no usage of anti-virals, antifungals, anti-parasitics in past 3 months (except antimalarials and Paxlovid or other COVID-19 anti-viral therapy allowed).\n* Subjects being treated with tamoxifen, estrogens or progestins that have not been stable for \\> 4 weeks.\n* Uncontrolled diabetes with HgbA1C \\> 8 or hospitalization in past 6 months for diabetes.\n* Uncontrolled hyperlipidemia with TC \\> 400 mg\u002FdL, TG \\>150mg\u002FdL.\n* Currently on a weight-loss program\n* Has experienced a weight change (gain or loss) of greater than 15 pounds or greater than 20 percent in the past 3 months\n* Currently taking a GLP-1 receptor agonist medication\n* No restrictive dietary habits per discretion of the study team.\n* Current use of medications or dietary supplements for weight or appetite control, including laxatives or diarrheal inhibitors within the past 4 weeks.\n* History of eating disorder.\n* Initiation of an exercise program within 4 weeks of screening visit.\n* Known or suspected history of drug or alcohol abuse within the past 6 months as determined by the medical record or patient interview.\n* Blood donation in the last 6 weeks or planned blood donation during study or requiring regular blood transfusion.\n* Pregnant females or nursing mothers within past 3 months, or those planning to get pregnant during the next 9 months.\n* Low total WBC \\\u003C 2000, platelets \\\u003C 100,000\u002Fmm\\^3; hemoglobin \\\u003C 9.5 gm\u002Fdl.\n* Vitamin D level \\\u003C 20 ng\u002Fml (at screening visit - necessitates addition of supplement and re-screen after minimum of 8 weeks).\n* Subjects with TSH levels greater than 1.5X upper limit of normal or clinical evidence of hypothyroidism (at screening visit- necessitates addition of supplement and re-screen after minimum of 8 weeks).\n* Participants with severe claustrophobia.\n* History of or anticipated poor non-cooperation with study requirements.\n* Participation in another clinical experimental therapeutic study within 30 days of screening visit or during the study.\n* Hospitalization within past 30 days (other than for routine infusions).\n* Prisoners or subjects who are involuntarily incarcerated.\n* Resident of a nursing home, ward of the state, or institutionalized during any part of the study period.\n* Persons with decisional incapacity\u002Fcognitive impairment.\n* Any history or evidence of severe illness or any other condition that would make the patient, in the opinion of the investigator, unsuitable for the study.\n* Participants who do not complete the ASA24 within 4 calendar days of screening will be excluded from the protocol. Additionally, participants will be excluded if their energy intake from the ASA24 is above or below established cut-off values for age and gender based on the 5th and 95th percentile of energy intakes from National Health and Nutrition Examination Survey (NHANES) data. Cut-off values for exclusion are \\\u003C600 kcal or \\>4400 kcal for women and \\\u003C650 kcal and \\>5700 kcal for men.","ALL","18 Years","60 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Dermatomyositis (DM) is a rare autoimmune disease that causes muscle weakness, skin rashes, and other symptoms. Researchers think both genetic and environmental factors play a role in this disease. They want to find out more about how diet and lifestyle choices affect people with DM\u002FJDM.\n\nObjective:\n\nTo see if omega-3 fatty acid supplements from fish oil, combined with a healthy diet, can help people with DM\u002FJDM.\n\nEligibility:\n\nAdults 18-60 years old, who live in the United States, can read English, and access Internet to complete questionnaires can participate.\n\nDesign:\n\nParticipants will have 5 or 6 inpatient visits. For 5 visits they may need to stay in the Clinical Center for up to 5 days. Participants will be screened. They will have a physical exam with blood, urine and stool tests. They will have tests of their heart and lung function. Their muscle strength will be measured. They may have an imaging scan of their thighs and pelvis. They will complete online questionnaires about their health and lifestyle. They may complete two optional skin biopsies. Participants will take 4 small capsules by mouth twice a day for up to 6 months. The capsules will contain omega-3 fatty acids from fish oil or a placebo. The placebo looks just like the regular capsule but contains no active ingredients. Participants will not know which capsules they are taking. They will follow a healthy diet based on the General Healthy Eating Pattern.\n\nParticipants will receive dietary coaching and will have virtual check-ins throughout the study. For two 7-day periods, they will wear a watch-like device to track their daily activity and sleep patterns. Participants may opt to remain in the study for an additional 12 weeks. All will receive the fish oil supplements during this stage.",[27,28],"Dermatomyositis (DM)","Juvenile Dermatomyositis (JDM)",[30,31,32,33,34],"Fish oil supplements","Omega-3 Fatty Acid","Clinical Trial","Online questionnaires","Diet Study","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":21},"2026-07-16",{"date":43,"type":21},"2031-11-03",{"name":45,"class":46},"National Institute of Environmental Health Sciences (NIEHS)","NIH",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":70,"leadSponsor":72,"locationsCount":47},"100053485","a-natural-history-of-genetic-and-environmental-predictors-of-pubertal-timing-among-youth-with-obesity-100053485","NCT07437976","A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study, including sharing medical records\n2. Male or female, aged 5 to 7 years at the screening visit\n3. Normal weight (defined as BMI \\> 5th percentile and \\\u003C85th percentile for age and sex) or Obese weight (defined as BMI \\> 95th percentile for age and sex)\n4. Ability of parent or guardian to understand and willingness to sign a written informed consent document. And ability of the participant (child) to provide verbal assent and\u002For to sign a written assent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Known diagnosis of syndromic\u002Fgenetic form of obesity\n2. Current use of medications or supplements that affect reproductive hormones (e.g., estrogen, progesterone, testosterone, puberty blockers, regular use of lavender oil or tea tree oil)\n3. Chronic medical conditions (e.g., type 1 or type 2 diabetes, cancer, renal failure, lupus, etc.), at the discretion of the Principal Investigator\n4. Clinically significant abnormal laboratory values, at the discretion of the Principal Investigator\n5. International adoptee (associated with earlier puberty)\n\nIndividuals who do not meet the criteria for participation in this study (screen failure) because of an acute, reversible or transient medical reason may be rescreened upon reversal, improvement or stabilization of their clinical status. Participants who develop an acute, reversible or transient medical condition during the study may return upon reversal, improvement or stabilization of their clinical status.","5 Years","12 Years",{"count":57,"type":21},400,"OBSERVATIONAL","Background:\n\nObesity affects 1 in 5 children in the United States. Childhood obesity often persists into adolescence and adulthood. It can also raise the risk of sleep apnea, fatty liver disease, and fluid buildup in the brain and lead to early-onset puberty. This natural history study will explore how factors such as genes, hormones, diet, and chemical exposures affect puberty in children with obesity.\n\nObjective:\n\nTo learn which factors predict the early start of puberty in children with obesity vs those of normal weight.\n\nEligibility:\n\nChildren aged 5 to 7 years with obesity or of normal weight.\n\nDesign:\n\nParticipants will have clinic visits every 6 months until they reach age 12.\n\nEach clinic visit will include these tests and procedures:\n\nA physical exam.\n\nCollection of blood, urine, and saliva samples. Some samples will be used for genetic tests.\n\nQuestions about medical history and medications and supplements.\n\nA questionnaire about their physical activity over the previous week.\n\nA silicone wrist band. Participants will wear a soft wristband for a week prior to each visit. It will tell researchers what chemicals the children were exposed to during that time.\n\nBreast ultrasound, for girls. A gel will be applied, and a wand will be pressed against the skin. The wand uses sound waves to see the tissue inside the breast.\n\nDXA whole body scan. Once a year, participants will have a DXA (dual energy X-ray absorptiometry) scan. This scan measures the amount of bone, muscle, and fat in the body.\n\nOptional food diary. Parents may record everything the participant eats for two 24-hour periods\n\n...",[61],"Obesity",[63,61,64,65,66],"ADRENARCHE","Reproductive Hormones","Puberty","Environmental predictors","NOT_YET_RECRUITING",{"date":38,"type":39},{"date":41,"type":21},{"date":71,"type":21},"2036-12-23",{"name":45,"class":46},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":92,"locationsCount":47},"100053375","stress-coping-and-sleep-health-study-100053375","NCT07566481","Stress, Coping, and Sleep Health Study","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in a FGD for this study, an individual must meet all of the following criteria:\n\n1. Adult (aged 18 years or older) living in Ohio, US\n2. Self-identify as Bhutanese-Nepali or Bhutanese American\n3. Identify as a refugee\n4. Speak and understand English and\u002For Nepali.\n5. Ability to understand and the willingness to provide informed consent and participate in the FGD\n\nIn order to be eligible to participate in a KII for this study, an individual must meet all of the following criteria:\n\n1. Adult (aged 18 years or older)\n2. Ability to speak and understand English; Familiarity with the lives and experiences of Bhutanese refugees living in Ohio, US\n3. Ability to understand and the willingness to provide informed consent and participate in the virtual KII.\n\nEXCLUSION CRITERIA:\n\nIndividuals who are unable to communicate in either English or Nepali will be excluded from FGD. Since Nepali is the primary language spoken by most Bhutanese refugees before relocation, and English is the dominant language in the United States, participants are expected to have sufficient proficiency in at least one of these languages.\n\nIndividuals who are unable to communicate in English will be excluded from KII. Given their leadership roles and interactions with the healthcare system, educational institutions, local government service providers, and nonprofit organizations in Ohio-where English is the primary language-participants are expected to have sufficient English proficiency. We will not exclude any participants that meet the inclusion criteria from participating in the study overall or in any of the study procedures.\n\nChildren (individuals under 18) are excluded from this study because the knowledge sought is not relevant to this population. This study investigates the relationship between sleep quality and experiences of discrimination among Bhutanese-Nepali refugees in Ohio, as well as the coping mechanisms adults use to manage discrimination-related stress, particularly as it pertains to sleep.\n\nThe constructs under investigation, including perceived discrimination, its psychosocial impact, and adaptive coping strategies, are anchored in the adult experience of resettlement and the stressors associated with adult social and occupational life. Children's experiences of discrimination, sleep patterns, and coping mechanisms differ substantially from those of adults in both nature and context, and findings from an adult sample would not be generalizable to a pediatric population. For these reasons, the inclusion of children would not yield scientifically meaningful data relevant to the study aims.","120 Years",{"count":81,"type":21},70,"Background:\n\nPoor sleep is common among refugee groups worldwide. It can lead to an increased risk of heart disease, diabetes, cancer, and premature death. It can also worsen mental health disorders. Researchers have studied the mental health issues among refugees from Bhutan in the United States. Now they want to understand more about how difficulty sleeping may relate to their other health outcomes.\n\nObjective:\n\nTo learn how the social and environmental conditions Bhutanese refugees affect their sleep health and health outcomes.\n\nEligibility:\n\nRefugees aged 18 years and older of Bhutanese-Nepali or Bhutanese American descent. The participants must live in central Ohio. Also needed are people aged 18 years and older who interact with Bhutanese refugees in this region.\n\nDesign:\n\nParticipants will participate in a focus group discussion. The group will have 8 to 10 participants. It will last 60 to 90 minutes.\n\nThey will talk about their experiences as a refugee and their sleep health. Topics may include adjusting to a new culture; access to housing and health care; and experiences with differential treatment by members inside and outside of their group. The study team will audio record the discussion. They will not share the recording with anyone.\n\nParticipants will complete a short questionnaire. They will answer questions about their age, sex, language preferences, and how long they have lived in the United States.\n\nParticipants who are not refugees will take part in a virtual interview led by a member of the study team. Participants will share their experiences with adapting to a new culture, differential treatment, and other factors have affected refugees sleep. The interview will take about 1 hour.",[84],"Sleep",[86,84,87],"Refugee","Discrimination",{"date":38,"type":39},{"date":41,"type":21},{"date":91,"type":21},"2026-12-31",{"name":45,"class":46},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":116,"leadSponsor":118,"locationsCount":47},"100053215","a-natural-history-of-cardiometabolic-disease-among-us-bhutanese-developing-the-cross-sectional-bhutanese-community-of-central-ohio-health-study-to-understand-acculturation-as-synergizing-socioenvironmental-and-biobehavioral-risk-factors-propagating--100053215","NCT06991751","A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...","A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Bhutanese Community of Central Ohio Health Study to Identify Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating Health Disparities From a Cross-Sectional Study","* INCLUSION CRITERIA:\n\nTo participate in this study all of the following criteria must be met:\n\n* Adults (aged 18 years and older) living in the United States\n* Identify as Bhutanese, which will be defined as those individuals that resided or had\u002Fhave their closest relatives residing in the Kingdom of Bhutan\n* Bhutanese identity will also include those that self-identify as Bhutanese-Nepali or Bhutanese American\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Any South Asian participants that do not identify as Bhutanese.\n* Pregnant at time of study or screening","100 Years",{"count":102,"type":21},50,"Background:\n\nAs of 2021, almost 45 million people in the United States were foreign-born immigrants. South Asians, including people from Bhutan, are the fastest-growing immigrant subgroup in the US. Their income and education levels are higher than the US average. Yet they have worse physical and mental health outcomes than their White US-born counterparts. These risks include type 2 diabetes and obesity.\n\nObjective:\n\nThis natural history study will explore how life experiences and environmental factors affect heart health and metabolism among Bhutanese people living in the US.\n\nEligibility:\n\nAdults aged 18 years or older who identify as Bhutanese and live in the US.\n\nDesign:\n\nParticipants will be recruited and screened by the Bhutanese Community of Central Ohio (BCCO). They will have 1 visit to the BCCO s Arogya Clinic in Reynoldsburg. The visit will last 2 hours.\n\nParticipants will take a survey; they may use either English or Nepali. They will answer questions about their background; their experiences living in the US; and how their customs and habits might have changed. They will also be asked about their experiences with discrimination; their mental health and well-being; their community; quality of life; and overall physical health. The survey will take 60 minutes.\n\nParticipants will also speak with a researcher. They will be asked how they feel about providing biological samples; these may include saliva, blood, and urine. Their answers will be audio recorded.",[105,106],"Cardiometabolic Risk Factors","Mental Health",[108,109,110,111,112,113],"Bhutanese","South Asian","Community engaged","Biospecimen perceptions","Epidemiology","Syndemic",{"date":38,"type":39},{"date":41,"type":21},{"date":117,"type":21},"2026-08-31",{"name":45,"class":46},{"id":120,"slug":4,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":121,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":82,"conditions":122,"keywords":123,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":130,"locationsCount":47},"100636499",{"count":81,"type":21},[84],[86,84,87],"2026-07-01",{"date":126,"type":39},"2026-07-02",{"date":128,"type":21},"2026-07-07",{"date":91,"type":21},{"name":45,"class":46},{"id":132,"slug":4,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":133,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":134,"keywords":135,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":138,"leadSponsor":139,"locationsCount":47},"100626618",{"count":57,"type":21},[61],[63,61,64,65,66],{"date":126,"type":39},{"date":128,"type":21},{"date":71,"type":21},{"name":45,"class":46},{"id":141,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":25,"conditions":144,"keywords":145,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":148,"leadSponsor":149,"locationsCount":47},"100601482",{"count":20,"type":21},[24],[27,28],[30,31,32,33,34],{"date":126,"type":39},{"date":128,"type":21},{"date":43,"type":21},{"name":45,"class":46},{"id":151,"slug":4,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":100,"enrollmentInfo":152,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":103,"conditions":153,"keywords":154,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":157,"leadSponsor":158,"locationsCount":47},"100592309",{"count":102,"type":21},[105,106],[108,109,110,111,112,113],{"date":126,"type":39},{"date":128,"type":21},{"date":117,"type":21},{"name":45,"class":46},{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":166,"sex":167,"minAge":168,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":171,"conditions":172,"keywords":177,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":47},"100361428","reproductive-axis-maturation-in-the-early-post-menarchal-years-100361428","NCT03986021","Reproductive Axis Maturation in the Early Post-Menarchal Years","Reproductive Axis Maturation in the Early Post-Menarchal Years: A Pilot Study","* Part 1 - Pre-menarche monitoring (\"holding pattern\"):\n\nInclusion Criteria:\n\n* Age 8-14.5 years old\n* Healthy weight, defined as having a body weight \\>85% of expected (EBW) and a body mass index (BMI) \\\u003C99th percentile\n* Some breast development\n* Pre-menarche\n\nExclusion Criteria:\n\n* Taking or planning to take medications that affect reproductive hormones in the next 2 to 3 years (e.g. birth control pills, biotin supplements).\n* Planning to move more than 60 miles from the CRU within the next 2 to 3 years\n* Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.\n* First-degree relative with polycystic ovarian syndrome, premature ovarian insufficiency, hypogonadotropic hypogonadism, or other pubertal development disorder\n* Excessive exercise (defined as running \\>20 miles per week or its equivalent)\n* Pregnancy\n\nPart 2 - Post-menarche cycle tracking:\n\nInclusion Criteria:\n\n* Age at menarche 10-14.5 years old\n* Healthy weight, defined as having a body weight \\>85% of expected (EBW) and a body mass index (BMI) \\\u003C99th percentile\n* Approximately \\\u003C 6 months post-menarchal (will typically have completed 4 or fewer menstrual cycles)\n* Biochemical criteria: normal thyroid hormone, prolactin, and testosterone levels\n\nExclusion Criteria:\n\n* Taking or planning to take medications that affect reproductive hormones in the next 2 to 3 years (e.g. birth control pills, biotin supplements).\n* Planning to move more than 60 miles from the CRU within the next 2 to 3 years\n* Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.\n* First-degree relative with polycystic ovarian syndrome, premature ovarian insufficiency, hypogonadotropic hypogonadism, or other pubertal development disorder\n* Excessive exercise (defined as running \\>20 miles per week or its equivalent)\n* Anemia (defined as hemoglobin \\\u003C12.0 g\u002Fdl)\n\n  --Participants with hemoglobin between 11.5 g\u002Fdl and 12.0 g\u002Fdl may still participate by providing dried blood spots, or no more than 18 ml of blood during any given interval.\n* Pregnancy\n\nPart 3 - Intensive monitoring of ovarian follicle growth\n\nInclusion Criteria:\n\n* Age at menarche 10-14.5 years old\n* Healthy weight, defined as having a body weight \\>85% of expected (EBW) and a body mass index (BMI) \\\u003C99th percentile\n* Within 1 year of menarche\n* Biochemical criteria: normal thyroid hormone, prolactin, and testosterone levels\n\nExclusion Criteria:\n\n* Taking or planning to take medications that affect reproductive hormones in the next 1-2 years (e.g. birth control pills, biotin supplements).\n* Planning to move more than 60 miles from the CRU within the next year\n* Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.\n* First-degree relative with polycystic ovarian syndrome, premature ovarian insufficiency, hypogonadotropic hypogonadism, or other pubertal development disorder\n* Excessive exercise (defined as running \\>20 miles per week or its equivalent)\n* Anemia (defined as hemoglobin \\\u003C12.0 g\u002Fdl)\n\n  --Participants with hemoglobin between 11.5 g\u002Fdl and 12.0 g\u002Fdl may still participate by providing dried blood spots, or no more than 18 ml of blood during any given interval.\n* Pregnancy\n\nPart 4 - Late Post-menarche cycle tracking:\n\nInclusion Criteria:\n\n* Age 11-17.5 years old\n* Approximately 2-5 years post-menarchal\n* Biochemical criteria: normal thyroid hormone and prolactin\n\nExclusion Criteria:\n\n* Taking or planning to take medications that affect reproductive hormones in the next 2 to 3 years (e.g. birth control pills, biotin supplements).\n* Planning to move more than 60 miles from the CRU within the next 6 months\n* Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.\n* Anemia (defined as hemoglobin \\\u003C12.0 g\u002Fdl)\n\n  --Participants with hemoglobin between 11.5 g\u002Fdl and 12.0 g\u002Fdl may still participate by providing dried blood spots, or no more than 18 ml of blood during any given interval.\n* Pregnancy\n\nAdolescent girls, at-risk daughters, or sisters of women with PCOS\n\nThe girls with mothers or sisters with PCOS group will complete the Screening Visit and Parts 1-3. The same inclusion and exclusion criteria apply for Parts 1, 2, and 3 as stated above except that these individuals must have a first-degree relative with PCOS and they can have high androgen levels, excess body hair, and severe acne at screening.\n\nWomen with known PCOS (activities for 8 weeks only)\n\nInclusion Criteria:\n\n* Age \\>=18-34 years old\n* PCOS diagnosis\n* at least 3-years post-menarchal with irregular menstrual cycles\n* Biochemical (blood) or clinical signs of high androgen levels\n\nExclusion Criteria:\n\n* Cannot be taking any medications that affect reproductive or metabolic hormones (e.g. birth control pill, biotin supplements, spironolactone, metformin).\n* Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.\n* Pregnancy\n\nHealthy control women (Activities x 2 menstrual cycles)\n\nInclusion Criteria:\n\n* Age \\>=18-34 years old\n* at least 3-years post-menarchal with regular menstrual cycles every 21-35 days\n\nExclusion Criteria:\n\n* Cannot be taking any medications that affect reproductive or metabolic hormones (e.g. birth control pill, biotin supplements, spironolactone, metformin).\n* Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.\n* PCOS diagnosis or first-degree relative with disorder\n* Pregnancy\n\nMothers of pediatric participants (Activities for 8 weeks \u002F 2 menstrual cycles)\n\nInclusion Criteria:\n\n* Age \\>=18-65 years old\n* Biological mother of A Girl's First Period participant\n\nExclusion Criteria:\n\n* Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus.\n* Pregnancy",true,"FEMALE","8 Years","65 Years",{"count":57,"type":21},"Background:\n\nMost adult women with irregular periods of unknown cause report symptoms dating back to early adolescence. This study aims to learn how girls' periods change in the 2 years after their first period. We are also looking at girls who may have a condition called PCOS. This will help researchers learn what healthy puberty looks like and how they can spot signs of hormone problems early on.\n\nObjective:\n\nTo learn how long it takes girls to develop regular menstrual cycles after their first period.\n\nEligibility:\n\nHealthy girls ages 8-14 who either (1) haven't had their first period but show signs of puberty, such as breast development and hair in the genital area; or (2) had their first period in the past 6 months\n\nGirls at risk for PCOS age 8-14 who have a mom or sister with PCOS\n\nGirls with irregular menstrual cycles age 11-17.5\n\nTo compare with the girls, we are looking at women \\>=18-34 years old with PCOS,\n\nHealthy women \\>= 18-34 years old without PCOS,\n\nand Mothers of pediatric participants age 18-65\n\nDesign:\n\nBoth parents or guardians must allow their daughter to participate. They must attend all study visits with her.\n\nParticipants will first be screened by phone. Those who qualify will be screened in person. They will have a physical exam. They will give blood and urine samples. They will have an ultrasound of their abdomen. They will fill out questionnaires. They will sit in a BOD POD for 6 minutes: This is an egg- shaped machine that takes body measurements. They have the option to provide DNA samples.\n\nParticipants will have sets of visits at home or at the clinic about every 6 months. The number of visits in each set will depend on their menstrual cycle. Then they will have a final visit. Visits will include repeats of the screening tests. There are additional parts that participants may choose to be involved in depending on how involved they want to be.\n\nAt home, participants will collect their urine daily to measure hormones. They will keep a diary of their periods.\n\nAdults: Women with known PCOS will complete the same Screening Visit as the girls and will collect dried urine specimens at home for 8 weeks;\n\nThe Healthy control women group will complete the same Screening Visit as the girls and collect dried urine specimens at home for 2 menstrual cycles;\n\nThe Mothers of pediatric participants group will complete a Screening Visit (informed consent, urine pregnancy test) and collect vaginal swab specimens at home for 2 menstrual cycles (approx. 8 weeks)....",[173,174,175,176],"Reproductive Physiological Processes","Pediatrics","Adolescent Health","Adolescent Development",[178,179,180,181,182],"Menarche","Adolescent","Physiology","Hormones","Natural History",{"date":126,"type":39},{"date":185,"type":39},"2019-12-19",{"date":187,"type":21},"2029-07-01",{"name":45,"class":46},{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":100,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":204,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":47},"100541118","phase-2-h01-in-adults-with-interstitial-lung-disease-the-solis-study-100541118","NCT06325696","H01 in Adults With Interstitial Lung Disease (The SOLIS Study)","Phase IIa Investigation of H01 in Adults With Interstitial Lung Disease (The SOLIS 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* Ability of subject to understand, and the willingness to sign a written informed consent document and comply with requirements of the study\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or Female participants ages \\>18 years\n* MD diagnosis of Idiopathic Pulmonary Fibrosis or other progressive ILD as defined previously\n* DLCO\\>30% and FVC\\>45%\n* Subjects in reproductive age who are heterosexually active must use an acceptable method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, IUD, or Hormone-based contraceptive\n* Agreement to adhere to Lifestyle Considerations throughout study duration\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Active on lung transplantation list\n* On supplemental oxygen at rest\n* Evidence of an acute respiratory infection or exacerbation of pulmonary fibrosis\n* Known diagnosis of celiac disease or wheat or gluten allergies\n* Cirrhosis or active viral or non-viral hepatitis: Bilirubin, AST and ALT values higher than twice the upper range of normal, or a Child-Pugh score of 7 or more\n* Subjects with history of active Inflammatory Bowel Disease, dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills\n* Subjects with significant renal impairment defined as eGFR lower than 40 ml\u002Fmin.\n* Subjects with a baseline corrected Fridericia's QT interval (QTcF) \\>450ms or baseline ECG abnormalities which, in the opinion of the study physician, are clinically significant and would place the participant at increased risk for adverse effects.\n* Subjects with ongoing alcohol or illegal drug use disorder\n* Subjects who are pregnant, lactating or attempting to conceive\n\n  * Participants able to become pregnant (have not completed menopause, had a hysterectomy and\u002For both tubes and\u002For both ovaries removed) must use effective birth control methods to try and not become pregnant while participant in this study. Methods include (a) partner vasectomy, (b) bilateral tubal ligation, (c) intrauterine devices (IUDs), (d) hormonal implants (such as Implanon), or (e) other hormonal methods (birth control pills, injections, patches, vaginal rings).\n  * Male participants able to father children with a partner able to become pregnant must agree to use effective birth control (listed above) to participate in this study.\n* Known allergy to hymecromone or any component thereof\n* Chronic therapy with medications that are known potent human UDP-glucuronosyltransferase inhibitors: canagliflozin, temazepam, tacrolimus.\n* Physician concern that participant may not adhere to the study protocol\n* Current participation in another clinical treatment trial for ILD. May participate after 12 weeks from conclusion of another treatment trial.\n* Changing dose of other ILD medications over the 3 months prior to baseline\n* Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that place the participant at increased risk for adverse effects, as determined by the study physician.",{"count":197,"type":21},37,[24],"Background:\n\nInterstitial lung disease affects the tissues that aid the transfer of oxygen and carbon dioxide between the air and the bloodstream. The disease can cause fibrosis, a thickening and scarring of lung tissue. Fibrosis often continues getting worse, and most people with this disease die in 3 to 5 years.\n\nObjective:\n\nTo test a study drug (hymecromone) in people with interstitial lung disease or lung fibrosis.\n\nEligibility:\n\nPeople aged 18 years and older with interstitial lung disease or lung fibrosis.\n\nDesign:\n\nParticipants will have at least 7 clinic visits over 5 months.\n\nParticipants will have screening and baseline visits. They will have blood tests and tests of their heart function. They will give a sputum sample. Other tests will include:\n\nSpirometry: Participants will breathe in and out through a mouthpiece to measure how much air they can hold in their lungs and how hard they can breathe.\n\nDiffusion capacity of lungs for carbon monoxide: Participants will breathe in a gas that contains a small amount of carbon monoxide. Then they will breathe through a mouthpiece. This test measures how well oxygen moves from the air into the blood.\n\nResting energy expenditure. Participants will lie still for 30 minutes with a clear dome over their head. This test measures the calories their body burns at rest.\n\n6-minute walk test. Participants will walk at their normal pace for 6 minutes. Their vital signs and blood oxygen levels will be checked.\n\nHymecromone is a tablet taken by mouth. Participants will take 2 tablets every morning and 2 tablets every night for 12 weeks. Tests will be repeated at study visits.",[201,202,203],"Interstitial Lung Disease","Idiopathic Pulmonary Fibrosis","Lung Diseases, Interstitial",[205,206,207,208],"Pulmonary Fibrosis","Lung disease","Hyaluronan","Drug","2026-06-30",{"date":124,"type":39},{"date":212,"type":39},"2025-05-05",{"date":214,"type":21},"2027-12-31",{"name":45,"class":46},{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":166,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":222,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":224,"conditions":225,"keywords":229,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":4,"leadSponsor":238,"locationsCount":239},"100083273","personalized-environment-and-genes-study-100083273","NCT00341237","Personalized Environment and Genes Study","* INCLUSION CRITERIA\n\nIn order to be eligible for participation in this study, an individual must meet all of the following criteria:\n\n* Adults greater than or equal to 18 years of age\n* If female, must not be (self-reported as) pregnant. At the time of enrollment, a pregnancy test will only be done at the PI s discretion.\n* Able to understand and provide written informed consent\n* Able to come to the NIEHS Clinical Research Unit (CRU) for enrollment and study-related visits\u002Fprocedures.\n\nEXCLUSION CRITERIA\n\nAn individual who does not meet the inclusion criteria listed above is excluded from participation in this study.",{"count":223,"type":21},25000,"Despite the overwhelming focus on genetic and genomic causes of human disease over the past two decades, it has been estimated that genetics is currently known to explain only 20% and 40% of the etiology of common disease. Thus, it is becoming increasingly apparent that human disease is a consequence of both genetic susceptibility and environmental exposures. Importantly, while individuals cannot change their genetic composition, we do have the ability both personally and as a society, to influence our environment, promoting health and decreasing the risk of disease. The Personalized Environment and Genes Study (PEGS) aims to determine how the environment and gene-environment interactions can inform our understanding of human health and disease. As science has evolved, so too has the science of this project. This evolution was reflected in a change in the title of this project from the Environmental Polymorphisms Registry (EPR) to the Personalized Environment and Genes Study (PEGS) to more accurately reflect the science that can be conducted. PEGS is a unique resource because of the depth of environmental phenotyping which includes extensive information from exposome surveys, as well as whole genome sequencing on a significant number of participants in the cohort. While it is small relative to genomic cohorts, none of these have the extensive environmental data that is present in PEGS. In addition, other cohorts with deep environmental data lack the depth of genomic data that is present in PEGS. Importantly, PEGS has already provided important analytic advances that are of great interest to and can be confirmed in larger cohorts such as All of Us.\n\nThe Personalized Environment and Genes Study (PEGS) aims to provide a resource for environmental health translational research by examining gene-environment interactions in health and disease. PEGS is an extension of two previous efforts where it began as a pilot study, the Environmental Polymorphisms Study (EPS; IRB# 02E9004) and was approved subsequently as a full protocol titled the Environmental Polymorphisms Registry (EPR) (IRB #04-E-N0053 and transitioned to its current ID# 04-E-0053). The EPR was envisioned as a phenotype-by-genotype registry of participants who had donated DNA samples, and who had agreed to be contacted for follow-up clinical translational studies based on their DNA genotypes. At the time, the only information available was a participant s age, sex, race, and ethnicity. Further phenotyping of a participant and\u002For any biospecimens obtained were investigated during a follow-up translational clinical study on participants recruited based on their genotype (hence phenotype-by-genotype) and the PEGS was the first recruit-by- genotype study at the NIH. Following a period focused on recruiting approximately 15,000 participants to enable genotyping of rare (approximately 1% minor allele frequency) single nucleotide polymorphisms (SNPs), the PEGS Consortium Project was undertaken in 2010- 2011 to examine, using the DNA of nearly 4,000 participants, approximately 700 SNPs in approximately 80 environmental response genes that work in concert with environmental exposures to elicit a phenotype. Several clinical follow-up studies, genotype-phenotype association studies, and publications have resulted from the PEGS Consortium Project.\n\nTo expand phenotype information available to researchers, the Health and Exposure Questionnaire was administered between 2013-2014. In 2017, a more detailed Exposome Questionnaire which includes questions relating to the external and internal exposome was administered. This was an important resource through which to integrate exposures with genotype-phenotype association studies.\n\nWhole genome sequencing has now been performed on approximately 4700 participants who were reconsented for this purpose, as indicated above. Questionnaire data was fully adjudicated and combined in a robust and searchable database. With the increased power of the data available, the project was renamed as the Personalized Environment and Genes Study (PEGS) and rolled out in Sept. 2021.",[226,227,228],"Diabetes","Heart Disease","Asthma",[230,231,232,233,182],"Genotype","Phenotype","Environmental Factor","Single Nucleotide Polymorphism","2026-06-27",{"date":209,"type":39},{"date":237,"type":39},"2010-05-26",{"name":45,"class":46},2,{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":166,"sex":16,"minAge":247,"maxAge":100,"enrollmentInfo":248,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":250,"conditions":251,"keywords":255,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":4,"leadSponsor":264,"locationsCount":265},"100059503","adult-and-juvenile-myositis-100059503","NCT00017914","Adult and Juvenile Myositis","Studies in the Natural History and Pathogenesis of Childhood-Onset and Adult-Onset Idiopathic Inflammatory Myopathies","* ELIGIBILITY CRITERIA:\n\nPatients with Myositis:\n\nInclusion Criteria:\n\nAll patients should have age range 2-100 years.\n\nAll Patients admitted to the study must satisfy at least one of the following criteria among item 1 (A or B or C) OR item 2 (A or B or C) AND item 3:\n\n1. Patient has documented evidence that he\u002Fshe meets criteria for an idiopathic inflammatory myopathy\n\n   A. Possible, probable or definite adult or juvenile polymyositis or dermatomyositis by Bohan and Peter criteria\n\n   B. Possible, probable or definite inclusion body myositis by Griggs and\u002For ENMC criteria\n\n   C. Has an idiopathic inflammatory myopathy that does not meet these criteria, including common or rarer forms of myositis such as cancer- associated, focal, orbital, eosinophilic myositis, macrophagic, proliferative, etc.\n2. Has one of the following conditions:\n\n2A. Have a disorder that is related to an idiopathic inflammatory myopathy, that may include:\n\n* Inflammatory and non-inflammatory myopathies:\n* Mimicking and related skin disorders:\n* Disorders of the complications of myositis (including interstitial lung disease, calcifying disorders, cardiomyopathies, etc.):\n* Overlapping autoimmune diseases that may be associated with myositis\n* Patients with muscle and\u002For skin inflammation and documented environmental exposures:\n* Patients with myositis or complications of myositis and suspected genetic disorders:\n* Patients with undifferentiated connective tissue disease\n* Patients with signs or symptoms of myositis (such as weakness, skin rashes, interstitial lung disease) or laboratory abnormalities (such as elevated CK or muscle biopsy with myopathic features) who do not have an established diagnosis of myositis for them to be evaluated to establish a diagnosis\n\n  3\\. Ability of patient or parent\u002Fguardian to give informed consent to all or part of the study after full information has been provided.\n\nExclusion Criteria:\n\n1. Patients \\\u003C2 years or \\>100 years will be excluded.\n2. Any conditions in which the drawing of the amount of blood required or undergoing procedures needed for the study is not deemed medically appropriate by the treating physician or the principal investigator.\n\nFor females of childbearing potential who are pregnant, they will be permitted to enroll, but would be excluded from radiographic procedures involving radiation or greater than minimal risk procedures, including obtaining biopsies.\n\nRelatives of Patients with Myositis:\n\nFor patients with at least one first-degree relative affected with IIIM, all available first-degree relatives (affected and unaffected) are eligible to participate in the genetics portion of the protocol. For patients in which two or more first degree relatives are affected with myositis, any available close relatives (affected or unaffected parents, siblings or children, as well as grandparents and grandchildren, or other close relatives, when available) are eligible to participate in the genetics portion of the protocol.\n\nInclusion criteria:\n\n1. First or more distant relative of a proband with myositis, for genetics studies.\n2. Ability of patient or parent\u002Fguardian to give informed consent to all or part of the study after full information has been provided.\n\nExclusion Criteria:\n\n1. Patients \\\u003C2 years or \\>100 years will be excluded.\n2. Any conditions in which the drawing of the amount of blood required or undergoing procedures needed for the study is not deemed medically appropriate by the treating physician or the principal investigator.\n3. Pregnancy (females of childbearing potential). Verbal confirmation they are not pregnant.\n\nHealthy Volunteers:\n\nInclusion Criteria:\n\n1. Healthy volunteer subjects for biomarker studies will be gender and age-matched (within 5 years) with a myositis patient, as reasonably close as possible.\n2. Volunteer is not related to a myositis patient who is enrolled in the study\n3. Volunteer is in good health, without a recognized systemic rheumatic disorder, autoimmune disease, immune medicated disease, or cancer, and is not taking any anti-inflammatory medicines, including nonsteroidal anti-inflammatory drugs (NSAIDS) or corticosteroids\n4. Volunteer or volunteer s parent\u002Fguardian could give assent\u002Finformed consent to all or part of the study after full information has been provided\n\nExclusion Criteria:\n\nIf Any \"Yes\" answer patient is not eligible for study\n\n1. Volunteer has undergone surgery or had a major trauma within the past 2 months\n2. Volunteer used anti-inflammatory medications within the past 8 weeks of enrollment, including not currently receiving nonsteroidal anti-inflammatory drugs or corticosteroids\n3. Volunteer has been diagnosed with a chronic infectious illness, inflammatory disease, malignancy, cardiac or pulmonary disease, muscle disorder, clotting disorder, metabolic disorder, systemic rheumatic or autoimmune disease, or immune-mediated disease\n4. Volunteer is pregnant (verbally screened for females of childbearing potential)\n5. Volunteer has a medical illness that in the judgement of the investigators does not allow safe blood draws or other clinical evaluations needed for study participation\n6. Volunteer is cognitively impaired\n7. Volunteer and or the volunteer's parents\u002Flegal guardian is unable or unwilling to give informed consent\u002Fassent\n8. Volunteer has functional limitations\n9. Volunteer has joint or muscle problems\n\nIn IMAGE Survey participants must confirm in the survey that they have a medical diagnosis of myositis.\n\nNote that the following screening activities may be performed to determine subject eligibility:\n\n* Email, written, or telephone communications with prospective subjects\n* Review of existing medical records\n* Review of existing imaging studies\n* Review of existing photographs or videos\n* Review of existing pathology specimens\u002Freports from a specimen obtained for diagnostic purposes\n\nIf a participant is ineligible and willing, their contact information- including name, phone numbers, emails, best times to reach, and potential diagnosis- may be shared with other NIH investigators if the participant may be eligible to participate in those studies.","2 Years",{"count":249,"type":21},1200,"This study will evaluate subjects with adult- and childhood-onset myositis to learn more about their cause and the immune system changes and medical problems associated with them. Myositis is an inflammatory muscle disease that can damage muscles and other organs, resulting in significant disability.\n\nChildren or adults with polymyositis or dermatomyositis or a related condition may be evaluated under this study. Healthy children or adults will also be enrolled as \"controls,\" for comparison of test results.\n\nAll patients will undergo a complete history (including completing some questionnaires) and physical examination, review of medical records, and blood and urine tests. Patients may then choose to participate in an additional 1- to 5-day evaluation, which will include some or all of the following diagnostic, treatment or research procedures:\n\n1. Standardized muscle strength testing, range of motion of joints and walking (gait) analysis by a physiotherapist; completion of a questionnaire regarding ability to perform daily tasks\n2. Skin assessment, possibly including photographs of lesions and a skin biopsy (removal of a small skin sample under local anesthetic)\n3. Magnetic resonance imaging (scans that use magnetic fields to visualize tissues) of leg muscles\n4. Swallowing studies, including a physical examination and questionnaire on swallowing ability, studies of tongue strength, and ultrasound imaging during swallowing, and possibly, a modified barium swallow\n5. Voice and speech assessment, possibly including computerized voice analysis and laryngoscopy-analysis of the larynx (voice box) using a small rigid scope with a camera placed in the mouth to view and record vocal cord function\n6. Pulmonary function tests (measurement of air moved into and out of the lungs, using a breathing machine) to evaluate lung function and, possibly, chest X-ray\n7. Electrocardiogram (measurement of the electrical activity of the heart) and, possibly, echocardiogram (ultrasound imaging of the heart)\n8. Endocrine evaluation\n9. Eye examination, in patients with vision loss or other eye symptoms\n10. Nutrition assessment to evaluate muscle mass and muscle wasting, including tape measurements or bioelectric impedance testing, a painless procedure in which wires are attached to the extremities with a sticky paste.\n11. Muscle ultrasound.\n12. Electromyography (record of the electrical activity of muscles)\n13. Muscle or skin biopsy (removal of a small piece of muscle tissue for microscopic examination)\n\nAll patients may have only a one-time evaluation or may return for one follow-up evaluations (either the 1-day or 3- to 5-day evaluation) over a 1-year period.\n\nHealthy children will undergo a medical history and brief physical examination; blood and urine tests; speech and swallowing studies including questionnaires and physical examination, tongue strength, and ultrasound study; and bioelectric impedance testing. Children 8 to 18 years old may also have exercise testing.",[252,253,254],"Dermatomyositis","Polymyositis","Inclusion Body Myositis",[256,257,258,259,260,182],"Adult and Pediatric Disease","Autoimmunity Pathogenesis","Disease Assessment","Genetic and Environmental Risk Factors","Myositis",{"date":209,"type":39},{"date":263,"type":39},"1995-06-07",{"name":45,"class":46},4,{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":16,"minAge":273,"maxAge":79,"enrollmentInfo":274,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":276,"conditions":277,"keywords":282,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":4,"leadSponsor":293,"locationsCount":239},"100171064","inherited-reproductive-disorders-100171064","NCT01500447","Inherited Reproductive Disorders","The Molecular Basis of Inherited Reproductive Disorders","* INCLUSION CRITERIA:\n\nThe essential inclusion criteria include:\n\n1. failure to go through a normal, age-appropriate, spontaneous puberty and low sex steroid levels in the setting of low\u002Fnormal gonadotropins (due to substantial variability among patient presentations, this will be based on the clinical judgement of the Investigator), or\n2. abnormally early development of puberty, or\n3. normal puberty with subsequent development of low gonadotropin levels, or\n4. individuals with features indicating an increased risk of hypogonadotropic hypogonadism.\n5. Family members: both affected and unaffected family members are strongly encouraged to participate.\n\nEXCLUSION CRITERIA:\n\nSince hypogonadotropic hypogonadism is a rare condition, this protocol remains open to enrollment so that we may study all subjects that are both qualified and interested in participating.\n\nBecause HH represents a spectrum, where associated clinical findings may provide phenotypic clues to the assessment of inheritability and underlying physiology, exclusion criteria are very limited:\n\n* Patients who have additional pituitary deficiencies, effectively ruling out isolated GnRH deficiency, whether these deficiencies are congenital or acquired (e.g. secondary to malignancy, infection, or irradiation).\n* Patients who are taking medications known to affect GnRH secretion, such as corticosteroids or continuous opiate administration (or were taking them at the time of diagnosis).","6 Weeks",{"count":275,"type":21},850,"Background:\n\n\\- During puberty, children begin to develop into adults. Problems with the hormones released during puberty can affect the reproductive system. Some people have low hormone levels that severely delay or prevent puberty. Others start puberty abnormally early. Other people may have a normal puberty but develop reproductive disorders later in life. Researchers want to study people with reproductive disorders to learn more about how these disorders may be inherited.\n\nObjectives:\n\n\\- To learn how reproductive system disorders may be inherited.\n\nEligibility:\n\n* People with one of the following problems:\n* Abnormally early puberty\n* Abnormally late or no puberty\n* Normal puberty with hormonal problems that develop later in life\n* People who have not yet had puberty but have symptoms that indicate low hormone levels.\n\nDesign:\n\n* Participants will provide a blood sample for testing. They will complete a questionnaire about their symptoms. They will also have a scratch-and-sniff test to study any problems with their ability to smell.\n* Participant medical records will be reviewed. Participants will also provide a family medical history.\n* Family members of those in the study may be invited to participate.\n* Treatment will not be provided as part of this study.",[278,279,280,281],"Genetic Disorder","Infertility","Hypogonadism","Amenorrhea",[283,284,285,286,287,182],"Hypogonadotropic Hypogonadism","Kallmann Syndrome","Delayed Puberty","Hypothalamic Amenorrhea","Precocious Puberty","2026-06-23",{"date":290,"type":39},"2026-06-24",{"date":292,"type":39},"2012-04-25",{"name":45,"class":46},{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":301,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":302,"conditions":303,"keywords":304,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":47},"100234291","nhales-natural-history-of-asthma-with-longitudinal-environmental-sampling-100234291","NCT02327897","NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)","Natural History of Asthma With Longitudinal Environmental Sampling","* Inclusion Criteria\n\nParticipants must meet all of the following criteria for enrollment:\n\n* Male or female, 18 to 60 years of age\n* Must have clinical evidence of moderate-severe atopic asthma:\n\n  * self-reported symptoms suggestive of asthma (such as wheezing, chest tightness, shortness of breath, cough nocturnal symptoms)\n\nwithin the past year, and\n\n--\\*a positive methacholine test confirming diagnosis \\[provocative concentration causing a 20% fall in forced expiratory volume in 1 second (PC20 FEV1) \\\u003C16 mg\u002FmL for participants on inhaled corticosteroids and \\\u003C8 mg\u002FmL for participants not on inhaled corticosteroids\\] or postbronchodilator FEV1 with at least 12% or 200 mL increase in FEV1 or forced volume vital capacity (FVC) on bronchodilator challenge, and\n\n--no other diagnosis that could explain symptoms.\n\nIf there is documentation of a recent methacholine challenge, those results may be used in lieu of conducting a secondary methacholine challenge.\n\n* Permanently resides within 50 miles of the CRU.\n* Able to present a valid government issued form of identification for entry to the NIEHS campus\n* Able to receive asthma treatment medication(s) via mail\n* Willingness to comply with instructions regarding medication regimen, diet, and life style as directed by the investigator that are required per protocol\n* Access to a vacuum cleaner with a detachable hose component\n\n  * If a woman is found to be pregnant or breastfeeding at the screening or baseline visit, they may continue their participation in the study but will be excluded from participation in the methacholine challenge and bronchoscopy procedures in this study while pregnant.\n\nBronchoscopy Visit Inclusion Criterion\n\nIn addition to the above inclusion criteria, participants must be able to fast for 6 hours (no food or drink, except a small amount of water if needed to take approved medications) prior to the bronchoscopy visit in order to be eligible for enrollment in the bronchoscopy visit.\n\nExclusion Criteria\n\nParticipants meeting any of the following criteria at screening will not be eligible for enrollment or to continue with study visits:\n\n* Current smoker, significant second-hand smoke exposure (defined by urine cotinine \\>200 ng\u002FmL at screening), or a history of smoking greater than 5 pack years. Smoking encompasses all inhaled products, including e-cigarettes.\n* piCO Smokealyzer value of \\>11ppm\n* History of the following comorbidities: chronic obstructive pulmonary disease, cystic fibrosis (CF), emphysema, non-CF bronchiectasis, pulmonary fibrosis, sarcoidosis, unstable angina, pulmonary hypertension\n* Allergy or history of adverse reactions to methacholine\n* Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures\n* Comorbid diseases that affect global health or survival- such as DVT, pulmonary embolism, class III - IV congestive heart failure, or a malignancy under treatment\n\nBronchoscopy Visit Exclusion Criteria\n\nIn addition to the above exclusion criteria, participants meeting any of the following criteria will not be eligible for enrollment into the bronchoscopy visit:\n\n* Pregnancy, as indicated by urine pregnancy test, if of childbearing age and\u002For ability contraindication\n* Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with bronchoscopy\n* Bleeding disorders\n* Facial deformity, major facial surgery\n* Asthma exacerbation or respiratory infection less than or equal to 4 weeks prior to study visit\n* Severe persistent asthma, defined as by ATS-ERS criteria.\n* Allergy or history of adverse reactions to lidocaine\n* Temperature \\>37.6 (Infinite)C; blood pressure \\\u003C90\u002F50 mm Hg or \\>160\u002F100 mm Hg; pulse rate \\\u003C50 or \\>100 beats\u002Fminute\n* Body weight \\\u003C50 kg (\\\u003C110 lbs)\n* The following abnormal lab values (values obtained during clinical assessment):\n\n  * Platelet count \\\u003C100,000 per microliters\n  * White blood cells count \\\u003C3000 per microliters\n  * Absolute neutrophil count \\\u003C1000 per microliters\n  * Hematocrit \\\u003C35% for both female and male\n  * Prothrombin time (PT) \u002F abnormal international normalized ratio (INR) and partial prothromboplastin time (PTT) based on reference laboratory established reference ranges\n  * Serum creatinine \\>1.4 mg\u002FdL\n\nIf a participant is recruited for the Bronchoscopy Visit but does not have current lab values (within 4 weeks), the participant may be asked to return to the CRU for an additional blood draw in order to run the requisite clinical assessments for safety purposes. The participant will be compensated for the additional visit. This is anticipated to be a rare occurrence, as the study team will make all efforts to schedule and complete the bronchoscopy procedure while the lab results are current.\n\nParticipants with active bronchospasm on the day of the bronchoscopy will not undergo bronchoscopy.",{"count":57,"type":21},"Background:\n\n\\- Asthma is a serious clinical and public health problem. Researchers want to collect data to better understand how bacteria and other things in the environment can affect people's asthma.\n\nEligibility:\n\n\\- Nonsmoking adults age 18 - 60 who have moderate to severe asthma.\n\nDesign:\n\n* Participants will complete a medical history form before the first visit.\n* Study visits will include collecting medical history, and conducting physical exam, lung and smoking tests. Participants will give blood, urine, stool, dust, saliva, and sputum samples.\n* Participants will take tests that measure their breathing abilities. They will give saliva samples for DNA study. They will get kits to collect stool and dust samples at home. They will fill out surveys.\n* Participants will have visits every 6 months for 5 years. They can schedule sick visits, if needed, at no cost to the participant. For all visits, they will have asthma check-ups and get treatment, at no cost to the participant.\n* Some participants may take part in a sub-study that includes one 4-hour visit. They will have medical history, physical exam, and lung tests. They will have urine tests to check for pregnancy and tobacco exposure. Then they will have bronchoscopy. For this, an intravenous line will be placed in an arm vein. The nose and throat will be numbed. A flexible fiber-optic tube will be inserted into their airways through the nose. Their airways will be examined and areas of their lung will be washed. A small sample of cells will be taken.",[228],[305,306,307,182],"Atopic Asthma","Exposures","Disease Progression","2026-06-17",{"date":310,"type":39},"2026-06-18",{"date":312,"type":39},"2015-09-10",{"date":314,"type":21},"2030-04-01",{"name":45,"class":46},{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":166,"sex":16,"minAge":17,"maxAge":169,"enrollmentInfo":323,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":325,"conditions":326,"keywords":328,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":4,"leadSponsor":336,"locationsCount":47},"100087476","immune-cell-response-to-stimuli-100087476","NCT00397280","Immune Cell Response to Stimuli","Innate Immunity Signal Transduction in Human Leukocytes","* INCLUSION CRITERIA:\n* Normal, healthy adult donors as judged by screening questionnaire\n* Nonpregnant\n* Weighing at least 110 lbs\n* 18-65 years of age\n* HIV negative (proof required every 6 months we will conduct test)\\*\n* Hepatitis B surface antigen and hepatitis C serology negative (checked every 6 months we will conduct test)\\*\n\n  * The rationale for HIV and hepatitis viral testing is that chronic viral infection may alter and possibly invalidate our experimental results. HIV and hepatitis results will be confidentially obtained. Testing will be contracted to an external certified laboratory and will be paid for by the study group. Results will be available only to the study doctor\u002FPI (Fessler), the study coordinator, the CRU Director (Garantziotis, LAI), and the donor, with the few caveats that follow\n\nAll positive HIV, hepatitis B, and hepatitis C results will be promptly communicated to the donor by the study doctor\u002FPI or the CRU Director. The participant will be referred to their physician and\u002For to the N.C. Department of Health for confirmatory testing and counseling. As explained in detail in the attached Supplement describing N.C. State Department of Health code will be followed. The state code mandates reporting of positive results along with the participant s name and identifying information to the N.C. Department of Public Health. Upon contracting with the testing laboratory, clarification will be obtained and documented as to whether the contracted laboratory or the study MD will be responsible for reporting positive results to the state to avoid duplication of reporting. Upon receipt of the test results, the N.C. Department of Health will contact the participant to inform them of the positive result, how to find care, how to avoid infecting others, how the newly diagnosed HIV and\u002For hepatitis infection is reported, and the importance of informing their partners at possible risk because of their HIV and\u002For hepatitis infection. If the HIV, hepatitis B, and hepatitis C results are negative, the participant will be not be notified. However, the participant may contact the research study nurse for their results.\n\nHIV and hepatitis B\u002FC test results, non-reactive and reactive, will be documented confidentially by the PI or study coordinator in the subject s file, and kept in a locked file cabinet in the CRU Medical Records Room.In order to document the reporting procedure and the time associated with the reporting process, a document has been created and placed in the study specific manual (Hepatitis B\u002FC and HIV Notification Process for Reactive Results Form)\n\nEXCLUSION CRITERIA:\n\nBy questionnaire:\n\nFeeling ill within the last 24 hours.\n\nAlcohol consumption in the last 24 hours.\n\nVisit to the dentist in the last 24 hours.\n\nA doctor visit for illness or vaccination in the last 2 weeks.\n\nDiarrhea in the last 2 weeks.\n\nRecurrent fever (4 weeks).\n\nPregnant or suspected pregnancy in the last 6 weeks.\n\nBlood or plasma donation that will cause the participant to exceed 550ml of blood in the last 8 weeks.\n\nReceiving a blood donation in the past 12 months.\n\nBleeding disorder.\n\nAnemia.\n\nHeart problems.\n\nInsulin dependent diabetes.\n\nProblems with blood donation.\n\nRisk of or evidence of Creutzfeldt-Jacob Disease in the family.\n\nHIV-positive status, Hepatitis B\u002FC-positive status or other confirmed or suspected immunosuppressive or immunodeficient conditions.\n\nUse of immunosuppressants or other immune-modifying drugs.\n\nUse of selected medications within the preceding 5 days unless the PI or AI receiving the samples states otherwise (NSAIDS\u002Faspirin\u002Ftylenol, antidepressants, antihistamines , corticosteroids, HMG CoA reductase inhibitors, and antihypertensives).\n\nBy exam:\n\nTemperature over 99.5 F.\n\nBlood pressure less than 90\u002F50.\n\nBlood pressure higher than 170\u002F95 mm Hg.\n\nPulse rate less than 50 or greater than 100 beats\u002Fminute.\n\nIf blood donation exceeds 200ml:\n\n* Hematocrit less than 34% for women or less than 36% for men, or greater than 56% for either gender.\n* Patients will be informed of disqualifying vital signs and hematocrit values and advised by trained staff, as appropriate, to seek assistance from their physician.",{"count":324,"type":21},750,"This study will investigate the response of immune cells (neutrophils, monocytes) to various signals in the test tube to determine how they sense the signals in the body and what substances they produce in response to them. It will determine how the cells may, under certain circumstances, contribute to inflammation, and will measure substances in the blood plasma (the liquid, non-cellular part of the blood) that might stimulate white blood cells, in order to understand how the blood responds to possible disease-related conditions.\n\nHealthy normal volunteers 18 years of age and older who weigh at least 110 pounds may be eligible for this study. Participants give about 320 milliliters (mL) of blood (about 1 1\u002F3 cups) or less at each donation. They donate no more than once every 8 weeks and no more than six times a year. On some occasions, less than 320 mL of blood may be drawn. The collected blood is separated into its components and specific cells are exposed to substances to examine their response.",[327],"Inflammation",[329,330,182],"Inflammatory Response","Lipopolysaccharide","2026-06-13",{"date":333,"type":39},"2026-06-16",{"date":335,"type":39},"2009-07-13",{"name":45,"class":46},{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":166,"sex":16,"minAge":247,"maxAge":100,"enrollmentInfo":344,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":346,"conditions":347,"keywords":350,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":4,"leadSponsor":360,"locationsCount":361},"100153996","environmental-risk-factors-for-the-anti-synthetase-syndrome-100153996","NCT01276470","Environmental Risk Factors for the Anti-synthetase Syndrome","Environmental Risk Factors for the Anti-Synthetase Syndrome","* INCLUSION CRITERIA:\n\nThere are no gender or ethnic restrictions to enrollment in the study. Age restrictions for children do apply to enrollment in the study.\n\nThe inclusion criteria for enrollment of myositis subjects are:\n\n1. Diagnosis of myositis based on criteria for possible, probable or definite PM or DM, with or without other connective tissue diseases, documented within 24 months of enrollment (using the most recent diagnosis date to define the 24-month period).\n2. CXR to assess possible ILD and assign the subject to the presumptive anti-synthetase positive or negative category if clinically indicated.\n3. Children must be greater than two years of age.\n4. Able and willing to give informed consent, to complete the questionnaires and to donate blood samples (in case of children greater than 2 years of age but \\\u003C18 years of age, parent\u002Flegal guardian must be willing and able to provide informed consent and child will provide assent according to child s maturity level and understanding).\n\nThe exclusion criteria for myositis subjects are:\n\n1. Cancer-associated myositis (cancer diagnosed within 2 years of the diagnosis of myositis).\n2. Inclusion body myositis.\n3. Myositis that has clearly developed as the result of a drug, toxin or other exposure and has resolved after discontinuation of the exposure to that agent.\n4. Children less than 2 years of age.\n\nThe inclusion criteria for controls are:\n\n1. Friends or, if friends are not available, cousins of the anti-synthetase-positive myositis patient, or, if friends or cousins are not available, volunteers from the general community (such as the NIH Normal volunteer program), race- gender- and age- (within 5 years for minors and within 10 years for adults) matched, and when possible who is living as close as possible to the geographic area of the myositis patient.\n2. Controls should be without a recognized autoimmune disease or ILD.\n3. Able and willing to give informed consent, to complete the questionnaires and to donate blood samples (in case of children greater than 2 years of age but \\\u003C18 years of age, parent\u002Flegal guardian must be willing and able to provide informed consent) and child will provide assent according to child maturity level and understanding).\n\nThe exclusion criteria for all protocol subjects are:\n\n1. Medical illness that in the judgment of the investigators does not allow safe blood draws or other clinical evaluations needed for study participation.\n2. Cognitive impairment.\n3. Not able or willing to give informed assent or consent.\n4. Children less than 2 years of age.\n5. Patients who at their reference date were not in the US or Canada\n6. Individuals currently incarcerated\n\nHIV considerations:\n\nHIV is not an exclusion for affected participants in this study for the two following reasons:\n\n1. It has no impact on study procedures or tests.\n2. It may be one of the viral risk factors we are investigating.",{"count":345,"type":21},580,"Background:\n\n* Like other complex diseases, autoimmune diseases are the result of numerous causes, including genetic and environmental factors. Some researchers believe that people who are susceptible to autoimmune disorders develop them when the body reacts to environmental or other factors by creating white blood cells that attack the body s own tissues, which then progresses to autoimmune diseases. These immune-triggered disorders can overlap with one another to some extent, but most autoimmune diseases have certain distinct triggers.\n* The autoimmune disorder myositis weakens the muscles and may cause other health problems. Environmental exposures associated with myositis include ultraviolet radiation, stressful life events and muscle overexertion, collagen implants, infections such as retroviruses and streptococci bacteria, and certain drugs and chemicals. Some individuals with myositis also produce proteins in the blood called autoantibodies that react with certain parts of the person s own cells, called synthetases, which are involved in making new proteins. A syndrome called the anti-synthetase syndrome, which includes myositis and lung disease, is associated with having the anti-synthetase autoantibodies. Researchers are interested in studying differences in environmental exposures in individuals with myositis. This study is being conducted to determine if persons with the anti-synthetase syndrome have had different environmental exposures before disease onset compared with other patients with myositis who do not have this syndrome and also compared with healthy volunteers.\n\nObjectives:\n\n\\- To determine whether selected infectious and noninfectious environmental exposures are more common in individuals who have myositis with the anti-synthetase syndrome, compared with healthy volunteers.\n\nEligibility:\n\n\\- Individuals who have been diagnosed with myositis (with or without anti-synthetase autoantibodies), and healthy volunteers without autoimmune disorders.\n\nDesign:\n\n* Participants will be screened with a full medical history and physical examination, and will provide blood, urine and house dust samples.\n* Participants will complete questionnaires about their medical history and the types of exposures they have had at work, at home, and elsewhere. Participants who have myositis will also be asked about certain infections, heavy exercise or physical exertion, sun exposure, tobacco and alcohol use, and stressful events prior to being diagnosed with the disease. Healthy volunteers will be asked about the same exposures before the date of diagnosis of disease of the myositis subject to which they have been matched.\n* Participants will receive a kit that contains instructions and a filter to be put onto their vacuum cleaner to collect house dust in the bedroom. This dust will be kept for possible future analyses of infectious or toxic agents based on the other results from the study.\n* Individuals with myositis will have other tests as clinically indicated, including lung function tests and imaging studies.",[260,252,253,348,349],"Juvenile Dermatomyositis","Juvenile Polymyositis",[351,352,353,257,354,182],"Adult and Pediatric Autoimmune Disease","Antibody","Autoimmune Diseases","Environmental Risk Factors","2026-06-11",{"date":357,"type":39},"2026-06-12",{"date":359,"type":39},"2011-02-09",{"name":45,"class":46},8,{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":166,"sex":16,"minAge":17,"maxAge":100,"enrollmentInfo":368,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":370,"conditions":371,"keywords":373,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":47},"100490485","niehs-repository-of-stored-biological-samples-for-future-use-100490485","NCT05666739","NIEHS Repository of Stored Biological Samples for Future Use","* INCLUSION CRITERIA:\n\nInclusion Criteria for prospective biospecimen collection:\n\nTo be eligible to participate in this study, an individual must meet all the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study.\n2. Ability to provide informed consent.\n3. Male or female, aged \\>=18\n4. Able to travel to the NIEHS CRU for study visits\n\nEXCLUSION CRITERIA:\n\nExclusion Criteria for prospective biospecimen collection:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Not willing to have samples stored for future use.\n2. Any condition that, in the investigator s opinion, places the participant at undue risk for complications associated with required study procedures.",{"count":369,"type":21},2000,"Background:\n\nLaboratory tests that use blood and urine can provide a great deal of information about human health and disease. To develop even better tests and to improve the ways samples are handled for testing researchers need to experiment with samples from healthy people.\n\nObjective:\n\nThis natural history study will collect blood and urine from healthy people. The samples will build a repository that will be used for all kinds of research.\n\nEligibility:\n\nHealthy people aged 18 years or older.\n\nDesign:\n\nParticipants will have 1 study visit. The visit will last up to 2 hours.\n\nParticipants will be screened. They will answer questions about their health history. They will list any medications they take. They will consent to donate samples for research and future use:\n\nBlood: Up to 4.5 tablespoons of blood may be collected from a needle inserted into a vein.\n\nUrine: Participants will be given a sterile container to provide a sample.\n\nSome participants may be asked to provide other types of samples.\n\nSome participants may be asked to provide new samples if their first ones are depleted.",[372],"Normal Physiology",[374,375,376,182],"Blood","Urine","Assay Development","2026-06-10",{"date":355,"type":39},{"date":380,"type":39},"2024-07-15",{"date":382,"type":21},"2032-07-19",{"name":45,"class":46},{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":166,"sex":16,"minAge":17,"maxAge":100,"enrollmentInfo":391,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":393,"conditions":394,"keywords":399,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":4,"leadSponsor":407,"locationsCount":47},"100143840","study-of-the-effect-of-innate-on-the-inflammatory-response-to-endotoxin-100143840","NCT01143480","Study of the Effect of Innate on the Inflammatory Response to Endotoxin","Study of the Effect of Innate Immunity on the Inflammatory Response to Endotoxin","* INCLUSION CRITERIA:\n* Male or female 18 years of age or older\n* Participants must be able to understand and provide written informed consent to participate in the study\n* Participants must be able to travel to the CRU\n* Willing and able to fast after midnight the night prior to their study appointment.\n* Healthy participants as defined by the International Red Cross guidelines (Healthy means that an individual feels well and can perform normal activities. If the individual has a chronic condition such as diabetes or high blood pressure, healthy also means that they are being treated and the condition is under control).\n\nEXCLUSION CRITERIA:\n\n* Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 5 days prior to enrollment visit (e.g., Motrin, ibuprofen, naproxen, and Advil)\n* Use of acetaminophen (Tylenol) within 5 days prior to enrollment visit\n* Use of cholesterol lowering drugs (statins) within 30 days prior to enrollment visit (e.g., Zocor, Mevacor, Lipitor, and Crestor)\n* Use of immunosuppressants or other immune-modifying drugs \\[e.g., Rituxan, Humira, Enbrel, Cyclosporin (Neoral, Sandimmune, and SangCya), and Azathioprine (Imuran)\\], Monoclonal antibodies \\[e.g., infliximab (Remicade)\\], and corticosteroids (e.g., prednisone, prednisolone and dexamethasone)\n* Current treatment for cancer with chemotherapy or radiation\n* Confirmed or suspected immunosuppressive or immunodeficient condition\n* GI or respiratory Illness within 5 days prior to enrollment visit, including cold or allergies\n* Smoked tobacco, chewed tobacco or used electronic cigarettes within 2 weeks prior to enrollment visit (for participants who provide a urine specimen, this will be defined by urine cotinine \\>200 ng\u002FmL at visit)\n* Alcohol consumption greater than 2 standard drinks (1 standard drink contains 15 g of ethanol) per day within the last 24 hours prior to the enrollment visit\n* Body weight \\\u003C 50 kg (\\\u003C110 lbs)\n* Temperature \\> 37.6 C; blood pressure \\\u003C 90\u002F50 mm Hg or \\> 170\u002F95 mm Hg; pulse rate \\\u003C 50 or \\>100 beats\u002Fminute\n* Pregnant or suspected pregnancy\n* Chronic Kidney Disease\n\nThe PI may review medication use on a case by case basis and make a medical determination on the participant s eligibility. In these cases, the PI determination will be documented in the participant s chart.",{"count":392,"type":21},725,"Background:\n\n\\- Innate immunity is the process by which white blood cells and other parts of the immune system sense and respond to potential infections by causing an inflammation. Researchers are interested in studying how the body responds to certain environmental factors, and whether the body s response can contribute to chronic illnesses or diseases such as asthma and certain types of cancers.\n\nObjectives:\n\n\\- To examine how specific genes and proteins in blood cells respond to environmental exposures.\n\nEligibility:\n\n\\- Healthy volunteers between 18 and 45 years of age.\n\nDesign:\n\n* The study will involve one visit of 45 to 60 minutes.\n* Participants will be screened with a brief physical examination and finger stick to determine if they are eligible to donate blood for the study, and will complete a questionnaire about any medications or other drugs (e.g., cigarettes) they may be taking.\n* Participants will provide a blood sample for research purposes.",[228,395,396,397,398],"Atherosclerosis","Metabolic Syndrome","Insulin Resistance","Cancer",[400,401,182,402,403],"Endotoxin","Innate Immunity","Healthy Volunteer","HV",{"date":355,"type":39},{"date":406,"type":39},"2012-07-30",{"name":45,"class":46},{"id":409,"slug":410,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":166,"sex":167,"minAge":168,"maxAge":414,"enrollmentInfo":415,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":417,"conditions":418,"keywords":419,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":47},"100253877","investigating-the-impact-of-obesity-on-pubertal-development-in-girls-100253877","NCT02583646","Investigating the Impact of Obesity on Pubertal Development in Girls","* INCLUSION CRITERIA:\n* Girls without a chronic medical condition\n* Normal weight (BMI 5th-85th%) or overweight\u002Fobese (BMI \\> 85th%)\n* 8-14 years old\n* Some breast development\n* Pre-menarchal\n\nEXCLUSION CRITERIA:\n\n* Treated with medications that may affect reproductive hormones (e.g. birth control pills).\n* Pregnancy\n\nDuring the study, the PI s discretion may be used to determine final eligibility. The PI s discretion may be used at any point in the study (pre-screening, clinical\u002Flab assessments, etc.) to ensure participants are not subjected to unnecessary procedures or visits.","14 Years",{"count":416,"type":21},150,"Background:\n\nStudies suggest that overweight girls may be developing breast tissue, and therefore starting puberty, earlier than normal weight girls. However, it is hard to distinguish breast tissue from fatty tissue. Researchers think that by using breast ultrasound, among other tests, they can do a better job of telling whether an overweight girl has breast tissue. This will help them understand if overweight girls are truly entering puberty before normal weight girls.\n\nObjective:\n\nTo find out if overweight girls go through puberty earlier than normal weight girls.\n\nEligibility:\n\nHealthy girls 8-14 years old who:\n\n* Are normal weight or overweight\n* Have some breast development\n* Have not started their first period\n\nDesign:\n\nParents of participants will be screened over the phone.\n\nMost participants will have 1 visit. However, they can choose to have multiple visits within 4 weeks. The visit will include:\n\n* Physical exam that includes examination of the breasts and genital area\n* Breast ultrasound: A small hand-held device will be passed back and forth over the chest. It uses sound waves to create a picture of the breast tissue.\n* Pelvic ultrasound: A small, handheld device will be passed back and forth over the lower belly. It uses sound waves to create a picture of the ovaries.\n* Urine and blood test\n* A special x-ray called a DXA to measure the amount of fat in the body: The participant will lie still on a table while the x-ray takes pictures of the body.\n\nX-ray of the hand: The picture will tell researchers how mature the participant s bones are.\n\nParticipants may be asked to come back 6 months later to repeat these tests.",[61,65,372],[61,65,420,421,182],"Ultrasound","Pediatric","2026-06-05",{"date":424,"type":39},"2026-06-08",{"date":426,"type":39},"2015-12-15",{"date":428,"type":21},"2026-09-30",{"name":45,"class":46},{"id":431,"slug":432,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":166,"sex":167,"minAge":17,"maxAge":100,"enrollmentInfo":437,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":439,"conditions":440,"keywords":441,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":47},"100437974","women-s-health-awareness-community-resiliency-environmental-action-and-collaborations-for-health-reach-equity-100437974","NCT04983251","Women s Health Awareness Community Resiliency, Environmental Action and Collaborations for Health (REACH) Equity","Women's Health Awareness Community Resiliency, Environmental Action and Collaborations for Health (REACH) Equity","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Females who are African American or Black, Hispanic or Latino, American Indian or Alaska Native, Asian American, Native Hawaiian or other Pacific Islander.\n2. Aged 18 years or older.\n3. Reside in North Carolina.\n4. Be willing to provide photo ID\n5. Able to read and understand English in order to complete surveys (questions validated in English) and logs.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n-Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures.",{"count":438,"type":21},700,"Background:\n\nInequalities in COVID-19 infection, hospitalization, and death in under-studied, under-represented, and under-reported groups of people are severe. A growing number of studies have assessed the impact of individual risk factors. But few studies have assessed which factors are the greatest drivers of COVID-19 disparities from a wider perspective.\n\nObjective:\n\nTo understand the long-term impacts of COVID-19 on minority women and their families to assist in developing community-based programs to help in recovery.\n\nEligibility:\n\nHealthy people aged 18 and older who reside in North Carolina.\n\nDesign:\n\nParticipants will take a 45-minute online survey. The survey will cover their demographics, community, health, lifestyle, household, and environment.\n\nParticipants may choose to have tests. They may visit the Clinical Research Unit. They may also have a home visit for these tests. In some cases, they may mail samples to the study team in prepaid envelopes.\n\nParticipants may take an optional 15 minute survey about their reproductive history.\n\nParticipants may give a blood sample.\n\nParticipants may give a urine sample. They will fill out a log and return with their sample.\n\nParticipants may give saliva samples.\n\nParticipants may give toenail samples from each toe.\n\nParticipants may give dust samples. They will be given 8 alcohol swabs. Two will be for testing. They will be asked to swipe a total of 3 door frames. Each door frame should be in a different room of the house.\n\nParticipants may be given silicone wristbands to wear for 1 week. This is to measure their exposure to air pollutants.\n\nParticipants may be contacted in the future for follow-up. They may be contacted by phone, email, or letter.",[106],[442,443,444,182],"Disparities","Vaccination","COVID-19","2026-04-25",{"date":447,"type":39},"2026-04-28",{"date":449,"type":39},"2023-06-30",{"date":451,"type":21},"2027-09-30",{"name":45,"class":46},{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":166,"sex":16,"minAge":17,"maxAge":460,"enrollmentInfo":461,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":462,"conditions":463,"keywords":466,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":47},"100430733","natural-history-of-the-human-biological-response-to-environmental-exposure-and-injury-100430733","NCT04888923","Natural History of the Human Biological Response to Environmental Exposure and Injury","Natural History of The Human Biological Response to Environmental Exposure and Injury","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study.\n2. Ability to provide informed consent.\n3. Able to read and speak English.\n4. Male or female, aged greater than or equal to 18.\n5. Able to travel to the NIEHS CRU for study visits.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Not willing to have samples stored for future use.\n2. Current pregnancy or lactation, by participant verbal confirmation.\n3. Any condition that, in the investigator s opinion, places the participant at undue risk for complications associated with required study procedures.","90 Years",{"count":369,"type":21},"Background:\n\nEnvironmental exposures like pollution, diet, and stress can help cause human diseases, or make them worse. Researchers want to better understand how injury and inflammation are caused by these exposures. They want to collect biological and environmental samples and other data. They may use the samples to measure a range of factors, like hormones, toxins, and chemicals. This will help them improve their studies.\n\nObjective:\n\nTo identify and understand how environmental exposures contribute to human disease.\n\nEligibility:\n\nHealthy adults ages 18 and older\n\nDesign:\n\nParticipants will be screened with questions about their health history, demographics, and medicines they take.\n\nParticipants may give blood, hair, stool, saliva, and\u002For urine samples. They may have a skin punch biopsy to collect skin cells. They may give fingernail or toenail clippings. They may give a sample of exhaled breath.\n\nParticipants may give a sputum sample. They will inhale a saline mist and cough mucus into a cup.\n\nParticipants may have their nasal passages brushed, scraped, or washed.\n\nParticipants may give cheek cell samples. They will swish mouthwash and spit it into a cup.\n\nParticipants who produce sperm may give samples.\n\nParticipants may have bronchoscopy to collect fluid. A saline solution will be put into their lung and then suctioned out, washing areas of the lung.\n\nParticipants may have a pelvic or transvaginal ultrasound. They may have lung function tests.\n\nParticipants may collect household dust, urine, or stool at home.\n\nParticipants will complete surveys about their health, diet, and exposures.\n\nParticipation will last for one or more study visits.\n\nParticipants may be contacted in the future to take part in other studies.",[327,464,465],"Normal Controls","Metabolic Disease",[467,465,327,182],"Blood Collection","2026-04-17",{"date":470,"type":39},"2026-04-20",{"date":472,"type":39},"2021-11-16",{"date":474,"type":21},"2031-12-31",{"name":45,"class":46},{"id":477,"slug":478,"hasResults":11,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":11,"sex":16,"minAge":168,"maxAge":483,"enrollmentInfo":484,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":485,"conditions":486,"keywords":489,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":47},"100537667","observation-of-environment-and-reproductive-endocrine-effects-100537667","NCT06280807","Observation of Environment and Reproductive-Endocrine Effects","OBServation of Environment and ReproductiVe Endocrine Effects Study (OBSERVE Study)","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Male or female, referring to sex assigned at birth (cis gender)\n2. Age \\> 8 years and weight \\>= 12 kg\n3. A diagnosis of hypogonadism, infertility or other reproductive dysfunction\n\n   Some specific diagnoses (as defined in standard guidelines) will include:\n   * Male or female hypogonadism\n\n     * Obesity\u002Fmetabolic syndrome related to hypogonadism.\n     * Other reproductive dysfunction (e.g., secondary to endocrine dysfunction, thyroid disorders, Cushing syndrome, pharmacotherapy, etc.)\n     * Premature Ovarian Insufficiency\n     * Isolated hypogonadotropic hypogonadism\n   * Polycystic Ovarian Syndrome\n   * Delayed Puberty\n   * Precocious puberty\n   * Perimenopause and post-menopausal states\n   * Androgen Excess States (Nonclassic Congenital Adrenal Hyperplasia, Extreme hyperinsulism, Idiopathic etc.)\n\n   or\n\n   -Exhibiting signs of a diagnosis of hypogonadism, e.g., Bosma arrhinia microphthalmia syndrome (BAMS)\n4. Ability of participant, legal guardian, or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. A diagnosis of a serious medical disorder such as malignancy or heart disease will be grounds for exclusion at the discretion of the PI or AI.\n2. Inability to follow up with the research study and\u002For perform study procedures, at the discretion of the PI or AI.\n3. Pregnant participants, less than 18 years of age, for their safety, since there is not a trained doctor on the study to give proper medical care to pregnant individuals less than 18 years of age.\n\nIndividuals who do not meet the criteria for participation in this study (screen failure) because of an acute, reversible or transient medical reason may be rescreened upon reversal, improvement or stabilization of their clinical status. Participants who develop an acute, reversible or transient medical condition during the study may return upon reversal, improvement or stabilization of their clinical status.","99 Years",{"count":20,"type":21},"Background:\n\nEndocrine disorders occur when the glands that make hormones do not work properly. Hormones levels that are too high or too low can cause problems such as late or early puberty, irregular periods, and infertility. Environmental factors - including pollution; chemical exposure at home and work; foods; medicines; and sleep habits - may cause problems with the endocrine and reproductive systems.\n\nObjective:\n\nTo learn how environmental factors may affect the endocrine and reproductive systems.\n\nEligibility:\n\nMales or females, referring to sex assigned at birth, aged 8 years and older; they must have hypogonadism, infertility, or other reproductive disorders.\n\nDesign:\n\nAdult participants will have 4 to 5 visits in 5 years. Children may have up to 12 visits; they may remain in the study up to the age of 23. Most visits will be less than 3 hours.\n\nParticipants will be screened. They will have a physical exam. They will have blood and urine tests. They will complete questionnaires; they will answer questions about their diet, health, and other topics. Some may be referred for additional tests, such as imaging scans and semen analysis.\n\nSpecific tests conducted during study visits will vary, depending on the participant s diagnosis. In addition to repeated blood and urine tests, these may include:\n\nBody composition measure: Participants will sit in a pod-shaped machine for about 6 minutes. The machines measures the air inside the capsule to record body fat and breathing volume.\n\nResting energy expenditure test: Participants will lie down with a clear dome placed over their head. They will breathe quietly for 30 minutes. This test measures the number of calories their body burns at rest.\n\n...",[280,487,287,488,281],"Hypergonadism","Late Puberty",[490,491,492],"Endocrine","Reproductive Disorders","Hypothalamic-Pituitary-Gonadal Endocrine Axis","2025-12-20",{"date":495,"type":39},"2025-12-23",{"date":497,"type":39},"2024-07-01",{"date":499,"type":21},"2039-03-31",{"name":45,"class":46},""]