[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"healthy-volunteer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:healthy-volunteer":505},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,114,0,25,[9,48,71,93,121,146,168,187,199,208,218,227,237,247,277,299,324,347,373,395,403,422,441,463,487],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100054044",false,"NCT05652478","Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study","Early Metabolic Effects of Antiretroviral Drugs in Healthy Volunteers: A Phase 2 Randomized Study","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Aged 18 to 55 years.\n* Able to provide informed consent.\n* Willing to allow samples and data to be stored and shared for future research.\n* Agrees to use a barrier method of contraception or abstain from sexual activity starting at screening though the end of study participation.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Current infection with HIV or hepatitis A, B, or C.\n* Body mass index (BMI) \\\u003C18.5 kg\u002Fm\\^2 or \\>30.0 kg\u002Fm\\^2.\n* Weight change \\>5% in the past 6 months.\n* History of or current cardiovascular disease such as congestive heart failure, heart block, or clinically relevant abnormal ECG as determined by investigators.\n* History of or current liver disease or alanine transaminase serum level \\>2x upper limit of normal.\n* History of or current kidney disease or renal insufficiency, or estimated creatinine clearance \\\u003C=80 mL\u002Fmin (Modification of Diet in Renal Disease equation).\n* Current cancer or history of cancer within 5 years of screening, with the exception of squamous cell carcinoma or basal cell carcinoma that is localized and does not require systemic therapy.\n* History of bariatric surgery.\n* Diabetes mellitus as defined by a prior diagnosis or a hemoglobin A1c of \\>6.4 percent on screening labs.\n* Fasting serum glucose \\>126 mg\u002FdL.\n* History of or current hypo- or hyper-thyroid or abnormal TSH, except minor deviations deemed to be of no clinical significance by the investigator.\n* History of or current asthma or chronic obstructive pulmonary disease.\n* Psychological conditions by self-report, such as (but not limited to) clinical depression, bipolar disorders, which would be incompatible with safe and successful participation in this study.\n* Pregnancy or within 1 year post-partum.\n* Breastfeeding.\n* Blood pressure \\>140\u002F90 mm Hg or current antihypertensive therapy.\n* Hemoglobin that is either 10 percent below the lower limit or 10 percent above the upper limit of the normal range for the Clinical Center Laboratory (acceptable ranges: females 10.08-17.27 g\u002FdL, males 12.33-19.25 g\u002FdL).\n* History of illicit drug, opioid, or alcohol abuse within the last 5 years; current use of illicit drugs or opioids (by history) or excessive alcohol (CAGE assessment score \\>=2).\n* Current use of the following prescription or over-the-counter medications and supplements:\n\n  * Carbamazepine\n  * Oxcarbazepine\n  * Phenobarbital\n  * Phenytoin\n  * Primidone\n  * Rifabutin\n  * Rifampin\n  * Rifapentine\n  * St. John's wort (Hypericum perforatum)\n  * Cation-containing antacids or laxatives\n  * Sucralfate\n  * Buffered medications\n  * Oral calcium, iron, magnesium, or zinc supplements, including multivitamins containing these polyvalent cations\n  * Dalfampridine\n  * Metformin\n  * Dofetilide\n  * Thyroid medications\n  * Corticosteroids\n  * Weight loss medications, including prescription drugs (eg, semaglutide and tirzepatide) and over-the-counter diet pills\n* Use of TAF, TDF, and\u002For FTC for the purpose of HIV PrEP or in a research study within the past 6 months.\n* Any history of exposure to cabotegravir or lenacapavir (eg, as HIV PrEP or as a participant in a research study for these drug).\n* Current use of prescrtiption or nonprescriptive medications that may have interactions with study drugs or confound the study measurements as determined by the investigators.\n* History of adverse or allergic reactions to the study drugs.\n* Daily caffeine intake \\>500 mg (about 4 cups of coffee).\n* Current smoker or user of tobacco products.\n* A change in the participant s diet and\u002For exercise regimen in the past 3 months or during the timeframe of the study period that, in the opinion of the investigator, would compromise the integrity of the data.\n* High-risk sexual activity as determined by the investigators, and\u002For inability or unwillingness to use barrier contraception during the protocol.\n* Any other condition, medication, or dietary pattern that, in the opinion of the investigators, increases risk to the participant, prevents the participant from complying with study procedures, prevents the participant from completing the study, or interferes with the interpretation of study results.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Background:\n\nPeople with HIV take drugs to keep the amount of virus in their body low. One type of these drugs, called integrase strand transfer inhibitors (INSTIs), can cause weight gain over time. Weight gain can cause diabetes, heart disease, and other serious issues. Researchers want to understand how INSTIs cause weight changes.\n\nObjective:\n\nTo characterize the change in plasma metabolite profile that 4 weeks of each treatment may induce in the absence of HIV infection\n\nEligibility:\n\nHealthy people aged 18 to 55.\n\nDesign:\n\nParticipants will be screened in the outpatient clinic. They will have a physical exam and blood tests. They will have a nutritional assessment and tests of their heart function.\n\nParticipants will be randomized to one of four oral treatments: Tenofovir Disoproxil Fumarate TDF\u002FViread, Tenovovir Alafenamide TAF\u002FVemlidy, Dolutegravir DTG\u002FTivicay, or both TAF and DTG taken together for 4 weeks.\n\nParticipants will have a Day 0 visit for the Lead-In Baseline visit for an exam and blood tests and continuous glucose monitor placement.\n\nParticipants will return in 2wks or Day 14\u002FWk 2 for a DEXA (dual-energy X-ray absorptiometry). DEXA is a kind of X-ray that measures body fat and bone density. Optional adiopse (fat) tissue biopsy in the abdomen, and optional microbiome specimen collections. Continuous glucose monitor changed. Oral once a day dose medication will be started with education.\n\nParticipants will return in 2wks or Day 28\u002FWk 4 for exam, labs, and continuous glucose monitor changed.\n\nParticipants will return in 2wks or Day 42\u002FWk 6 for final exam, labs, repeat DEXA scan, repeat adipose tissue biopsy, and microbiome specimen collections.",[28,29,30,31],"Healthy Volunteer","Weight Gain","Metabolic Effects","Integrase Strand Transfer Inhibitors",[33,34,31],"Metabolism","HIV","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":22},"2026-07-16",{"date":43,"type":22},"2030-01-31",{"name":45,"class":46},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":49,"slug":4,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":69,"locationsCount":47},"100053383","NCT06690294","Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism","Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism: A Natural History 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* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* 18-60 years of age.\n* Able to read and understand English proficiently (to be able to complete the multiple study questionnaires and instruments).\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Diabetes\n\n  * Fasting glucose \\>= 126 mg\u002Fdl or HbA1c \\>= 6.5% or\n  * Self-reported history of type 1 or type 2 diabetes.\n* Endocrine disorders, such as\n\n  --Self-reported history of Cushing's disease, pituitary disorders, or hypo- and hyperthyroidism\n* TSH \\\u003C0.1 or \\>= 10 uIU\u002FmL\n* Pulmonary disorders\n\n  --Self-reported history of chronic obstructive pulmonary disease or other lung disease that which would limit ability to follow the protocol (investigator judgment)\n* Cardiovascular diseases,\n\n  --Self-reported history of coronary heart disease, heart failure, arrhythmias, and peripheral artery disease that which would limit ability to follow the protocol (investigator judgment)\n* Liver disease,\n\n  * Advanced liver disease (as determined by history, labs, exams, and patient self-report) that which would limit ability to follow the protocol (investigator judgment)\n  * AST or ALT elevations \\> 3 times upper limit of normal\n* Gastrointestinal Surgery\n\n  --Self-reported history of bariatric surgery\n* Renal disease\n\n  * Self-reported history of renal replacement therapy\n  * Abnormal kidney function (defined as eGFR \\\u003C60 mL\u002Fmin\u002F1.73m\\^2) determined at screening (eGFR values are computed using the 2021 CKD-epi equation)\n* Central nervous system disease:\n\n  --Including self-reported history of previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders\n* Infectious disease:\n\n  --Self-reported history of active tuberculosis, HIV, chronic coccidiomycosis or other chronic or acute infections\n* For Females: pregnancy, \\\u003C=6 months postpartum, currently breastfeeding, or on birth control (i.e., ingested, injected or implanted; non-hormonal methods such as copper IUD will be allowed)\n* Measured weight: greater than or equal to 450 lb. (maximum weight allowed on the DXA scanning tables by the manufacturer)\n* Inability to provide informed consent.\n* Self-reported history of psychological conditions including (but not limited to), active psychosis, schizophrenia, eating disorders, or forms of mental incapacity that would be incompatible with safe and successful participation in this study.\n* Current use of medications\u002Fdietary supplements\u002Falternative therapies known to alter energy metabolism.\n* Inability to consume provided food during ad libitum food intake or snack food test based on a food allergy or intolerances or diet restrictions.\n* Any disorder not covered by any other exclusion criteria which, in the investigator's and\u002For team's opinion jeopardizes the safety of the participant or others or would interfere with adherence to the protocol.\n* Alcohol Abuse as defined by \\>= 8-point score on the Alcohol Use Disorders Identification Test (AUDIT) questionnaire will be an exclusion criterion.\n* Current use of tobacco products that exceed \"Very Low Dependence\" on the Fagerstrom Test for Nicotine Dependence Tool (score greater than 2) will be an exclusion criterion.\n\nNon-English-speaking subjects as a population will be excluded from participation in this protocol. Primary and secondary hypotheses of the protocol relate to a battery of psychological questionnaires and performances tests which are administered throughout the study. There are currently no validated, translated forms of these questionnaires and tests available; therefore, we will restrict enrollment to English speaking subjects only.","60 Years",{"count":56,"type":22},110,"OBSERVATIONAL","Background:\n\nMany people in the United States are overweight or obese. This natural history study will look into how life events during childhood can impact eating behaviors and weight gain as adults.\n\nObjective:\n\nTo explore how childhood experiences affect adult eating behaviors.\n\nEligibility:\n\nHealthy people aged 18 to 60 years.\n\nDesign:\n\nParticipants will have 3 clinic visits.\n\nThey will be screened with blood tests. They will answer questions about their alcohol and tobacco use.\n\nAt the next visit, participants will undergo these activities:\n\nParts of their body (such as waist, neck, and thighs) will be measured with a tape.\n\nThey will have an imaging scan to find out how much body fat they have.\n\nThey will start wearing a device like a wristwatch that measures their physical activity. They will wear this device for up to 10 days.\n\nThey will wear a device on their upper arm or belly that measures blood glucose (sugar) levels. Participants will wear this for 7-10 days.\n\nThey will answer questions about their education, childhood, and routines.\n\nThey will receive a kit to collect a stool sample at home.\n\nAt the last visit, participants will have these tests:\n\nParticipants will relax and breathe normally while wearing a clear, plastic canopy that fits over their entire head.\n\nBlood samples will be taken before and after participants drink a sugary drink.\n\nParticipants will be offered a large selection of foods for lunch. They will eat as much as they want. Then they will answer questions about how they feel about food and themselves.",[28,60],"Obestity",[28,62,63],"Obesity","Eating Behavior","NOT_YET_RECRUITING",{"date":38,"type":39},{"date":41,"type":22},{"date":68,"type":22},"2027-01-30",{"name":70,"class":46},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)",{"id":72,"slug":4,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":89,"leadSponsor":91,"locationsCount":47},"100054278","NCT07566468","Role of Theta Frequency Oscillations in Proactive and Reactive Control Processes in Youth With Attention Deficit Hyperactivity Disorder (ADHD) and Obsessive Compulsive Disorder (OCD)","* INCLUSION CRITERIA\n\n  1. Ability to provide informed assent and parent consent\n  2. Age: 10-17 years\n  3. ADHD Group: Diagnosis of ADHD based on DSM-5 criteria\n\n     OCD Group: Diagnosis of OCD based on DSM-5 criteria\n\n     HV Group: No Neurological or Psychiatric diagnosis based on DSM-5 criteria\n  4. Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II). WASI-II will be used as a measure of intellectual function. Children will be included when FSIQ \\> 70.\n  5. Normal or corrected to normal vision\n\nEXCLUSION CRITERIA\n\nParticipants will be screened to exclude participants in whom MRI or EEG might result in increased risk of side effects or complications or whose data would not be scientifically valid.\n\n1. Non-English Speakers\n2. Pregnancy\n3. Any implant, prosthesis or alteration of the body that, in the opinion of the investigator, would be unsafe with MRI or EEG or that would produce an artifact that would compromise the integrity of data;\n4. Active or History of psychosis, bipolar I disorder, Level 2 or 3 autism spectrum disorder, active severe substance use disorders (within the last month), have active suicidal intent or plan as detected on screening instruments;\n5. Individuals currently taking Stimulant medications who are unwilling or unable to not take the medication during study visit days.\n6. Past or present medical or neurological condition, disease, disorder, genetic finding, or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject s ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data.\n7. For the HV group, any impairing current psychiatric diagnosis.","10 Years","17 Years",{"count":56,"type":22},"Background:\n\nAttention deficit hyperactivity disorder (ADHD) is common in children. It can cause problems with attention and the ability to control actions and impulses. Obsessive compulsive disorder (OCD) is less common in children but not rare. It involves ongoing thoughts, urges, impulses, and repeated behaviors. Researchers want to study differences in brain activity between healthy children, those with ADHD, and those with OCD.\n\nObjective:\n\nTo learn more about how the brain controls thinking and behavior.\n\nEligibility:\n\nPeople aged 12 to 17 years with ADHD, OCD, or neither.\n\nDesign:\n\nParticipants will have 3 to 10 clinic visits in up to 1 year. Each visit will last 2 to 3 hours.\n\nThree visits are required:\n\nBehavioral. Participants will complete a computer task. Their mood, memory, attention, and thinking skills will be tested.\n\nEEG. Participants will undergo electroencephalography (EEG) to measure signals in their brain. Small electrodes will be placed on the scalp. A cap will be stretched over the head. Signals will be recorded while participants rest or do tasks on a computer.\n\nMRI. Participants will have a magnetic resonance imaging scan (MRI). They will lie on a table that rolls into a tube. The MRI will take pictures of their brain while they do tasks on a computer.\n\nSeven more visits are optional. These include 2 more EEG visits and 2 more MRI visits.\n\nThree will be magnetoencephalography (MEG) visits: MEG measures small magnetic field changes in the brain. A helmet with sensors will be placed on the head. Brain changes will be recorded while participants rest or do tasks on a computer.",[81,82,28],"ADHD","Obsessive Compulsive Disorder (OCD)",[84,85,86],"EEG","MRI","fMRI",{"date":38,"type":39},{"date":41,"type":22},{"date":90,"type":22},"2029-05-31",{"name":92,"class":46},"National Institute of Mental Health (NIMH)",{"id":94,"slug":4,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":103,"conditions":104,"keywords":110,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":118,"leadSponsor":120,"locationsCount":47},"100054144","NCT07313787","Effects of Meal Macronutrients on Postprandial Lipids","Prospective Cross-Over Study of the Effects of Meal Macronutrients on Postprandial Lipids","* INCLUSION CRITERIA:\n\nCommon inclusion criteria (all groups):\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Age \\>= 18 years\n2. Average alcohol intake in the past 6 months \\\u003C 3 drinks (approximately 30g) per day (male) or \\\u003C 2 drinks (approximately 20 g) per day (female)\n\nHealthy control specific inclusion criteria:\n\n1. In good general health with no known active medical conditions as evidenced by medical history\n2. Fasting glucose \\\u003C100 mg\u002FdL\n3. HbA1c \\\u003C5.7%\n4. Fasting triglycerides \\\u003C150 mg\u002FdL\n5. ALT and AST within normal limits\n6. BMI \\>=18.5 to \\\u003C25 kg\u002Fm\\^2 (or \\\u003C23 kg\u002Fm\\^2 in participants of Asian descent)\n7. Not taking any medications or supplements that, in the opinion of the investigator, would interfere with interpretation of study data.\n\nMetabolic syndrome specific inclusion criteria\n\n1\\. Obesity defined as either\n\n1. BMI \\>30 kg\u002Fm\\^2 (or \\>=27 kg\u002Fm\\^2 in participants of Asian descent), OR\n2. Elevated waist circumference as defined below:\n\n   * Country\u002FEthnic group - Europid, Sub-Saharan African, Eastern Mediterranean and Middle East (Arab):\n\n     --Sex: Male - Waist circumference: \\>=94cm\n\n     --Sex: Female - Waist circumference: \\>=80cm\n   * Country\u002FEthnic group - South Asian, Chinese, Japanese, Ethnic South and Central American:\n\n     * Sex: Male - Waist circumference: \\>=90cm\n     * Sex: Female - Waist circumference: \\>=80cm\n\n       2\\. Elevated triglycerides defined as EITHER\n\n       2a. Fasting triglycerides \\>= 150 mg\u002FdL at screening, OR\n\n       2b. Specific treatment for hypertriglyceridemia\n\n       3\\. Low HDL cholesterol, defined as EITHER\n\n       3a. HDL \\\u003C40 mg\u002FdL (males) or \\\u003C50 mg\u002FdL (females) at screening, OR\n\n       3b. Specific treatment for low HDL\n\n       4\\. Elevated blood pressure defined as EITHER\n\n       4a. Systolic BP \\>= 130 at screening, OR\n\n       4b. Diastolic BP \\>= 85 mm Hg at screening, OR\n\n       4c. Treatment of previously diagnosed hypertension\n\n       5\\. Elevated glucose defined as EITHER\n\n       5a. HbA1c \\>= 5.7% (at screening), OR\n\n       5b. Fasting serum glucose \\>= 100 mg\u002FdL (at screening), OR\n\n       5c. 2-hour post-load glucose levels \\>= 140 mg\u002FdL (by history), OR\n\n       5d. Prior diagnosis of type 2 diabetes\n\n   Lipodystrophy-specific inclusion criteria:\n   1. Clinical diagnosis of generalized or partial lipodystrophy based on reduction in adipose tissue outside the normal range in some or all adipose depots (including, at aminimum, the gluteofemoral depot).\n   2. Insulin resistance as defined by fasting insulin \\>22.5 or high exogenous insulin requirement (\\> 2 units per kg per day or \\> 200 units total per day) at screening.\n\n   Nephrotic syndrome specific inclusion criteria\n   1. History of biopsy proven non-diabetic glomerular disease (any histology)\n   2. Nephrotic range proteinuria defined by ANY of the following:\n\n   2a. Protein\u002Fcreatinine ratio uPCR \\>= 3.5 g\u002Fg at screening, OR\n\n   2b. 24 hour protein excretion \\>= 3.5 gr\u002F24hr) at screening, OR\n\n   2c. History of nephrotic range proteinuria (as defined above) within the past 5 years but in complete (defined as proteinuria \\\u003C= 0.3 g\u002Fday or partial remission (defined as a 50% or greater decrease in proteinuria compared to baseline and proteinuria \\\u003C 3.5 g\u002Fday) based on 24 hr urine or uPCR at time of screening\n\n   EXCLUSION CRITERIA:\n\n   Common exclusion criteria (all groups):\n\n   An individual who meets any of the following criteria will be excluded from participation in this study:\n   1. Consuming extreme macronutrient diet (e.g., very low-carbohydrate, high fat diets such as ketogenic, paleo or Atkins diets, among others).\n   2. Plans to actively gain or lose weight during the study period (other than changes in water balance as clinically needed in subjects with nephrotic syndrome).\n   3. Change in body weight of \\>5% or \\>3 kg (whichever is larger) in the 3 months prior to screening (by participant report) in participants who do NOT have nephrotic syndrome.\n   4. Body weight \\>450 lbs (upper limit that can be accommodated by DXA scanner).\n   5. Participating in a regular strenuous exercise program (\\> 2h\u002Fweek of vigorous activity) as determined by volunteer report or evidence of vigorous exercising in order to lose weight, change body shape, or to counteract the effects of eating.\n   6. Uncontrolled diabetes, defined as HbA1c \\>9% at screening.\n   7. Lipemia defined as fasting or non-fasting triglycerides of \\>1000 mg\u002FdL at screening.\n   8. Renal dysfunction defined as eGFR \\\u003C50 mL\u002Fmin\u002F1.73 m\\^2 at screening.\n   9. In participants with liver disease, history of decompensated advanced liver disease, defined as direct bilirubin \\> 0.5 g\u002FdL, PT \\> 18 seconds, albumin \\\u003C 3 g\u002FdL, MELD score \\> 12, or history of ascites, encephalopathy, variceal bleeding, spontaneous bacterial\n\n      peritonitis or liver transplant.\n   10. History of hypertriglyceridemia-induced pancreatitis within 3 months prior to screening.\n   11. Positive pregnancy test or breastfeeding at screening.\n   12. Clinically significant abnormalities in thyroid function, blood counts, as assessed by screening labs.\n   13. Acute cardiovascular events within the past 6 months\n   14. Anemia (Hgb \\\u003C10 mg\u002FdL in women or \\\u003C12 mg\u002FdL in men) at screening\n   15. Food allergies or other dietary restrictions that could increase risk associated with test meals or cause the subject to be unwilling to consume test meals (i.e. celiac disease, vegan diets).\n   16. Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect intestinal fat absorption.\n   17. Subjects treated with tamoxifen, estrogens, or progestins that have not been stable for \\>4 weeks prior to screening.\n   18. Blood donation in the last 2 weeks or planned blood donation during the study\n   19. Subjects requiring regular transfusions for any reason.\n   20. Subjects with known gastroparesis\n   21. Inability to adhere to Lifestyle Considerations throughout study duration.\n   22. Inability of the subject to understand and the unwillingness to sign a written informed consent document.\n   23. Unwillingness to comply with all study procedures and unavailable for the duration of the study\n   24. Any other condition or medication which, in the opinion of the investigator, increases risk to the subject, prevents the subject from complying with study procedures, prevents the subject from completing the study, or interferes with the interpretation of study results.","120 Years",{"count":101,"type":22},100,[25],"Background:\n\nAbnormal fats in the blood can lead to many problems, including heart disease. Researchers want to learn more about how eating meals with different levels of nutrients affects fats in the blood. Specifically, they want to study people with too much body fat, too little body fat, and a kidney problem called nephrotic syndrome.\n\nObjective:\n\nTo learn more about how different types of foods affect fat levels in the blood.\n\nEligibility:\n\nPeople aged 18 years or older with a health condition that affects how their body handles fats. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have 2 overnight stays in the clinic within 6 months. At each visit, after staying overnight, they will eat a breakfast casserole. At 1 visit, breakfast will be a high-fat, low carbohydrate meal. At the other, it will be a high-carbohydrate, low-fat meal.\n\nParticipants will have a tube inserted into a vein in their arm. They will have blood drawn via the tube 12 times in 8 hours: 2 times before they eat the breakfast and 10 times after.\n\nParticipants will have other tests during their stays:\n\n* A resting metabolic test captures the air they exhale and measures how much energy they use at rest.\n* A dual energy X-ray absorptiometry (DXA) scan measures how much fat and muscle they have.\n* A Fibroscan is a special type of ultrasound of the liver.\n* A body surface scan uses lasers to measure the total area of the body.\n* A bioelectric impedance (BIS) exam measures how fast small electric currents move through their body.\n\nParticipants may opt to have a third visit. At this visit, the breakfast will be high in protein....",[105,106,107,28,108,109],"Nephrotic Syndrome","Lipodystrophy","Metabolic Syndrome","Diabetes","Metabolic Associated Steatotic Liver Disease",[111,112,113,114,115],"postprandial lipids","macronutrient","CARBOHYDRATES","FATS","Proteins",{"date":38,"type":39},{"date":41,"type":22},{"date":119,"type":22},"2031-08-01",{"name":70,"class":46},{"id":122,"slug":4,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":130,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":142,"leadSponsor":144,"locationsCount":47},"100053744","NCT06274749","Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial","The Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults >= 55 Years Old. A Randomized Triple-Masked Controlled Clinical Trial","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Provision of signed and dated informed consent form.\n* Stated willingness to comply with all study procedures and availably for the duration of the study.\n* Male or female, age \\>= 55 years.\n* Able to speak and read English. (We do not have ready access to interpreters of different languages at the NIA Clinical Unit).\n* BMI \\>= 27.\n* Ability to take oral medication and be willing to adhere to the daily regimen.\n* Ability to perform walking and treadmill tests without physical limitations.\n* In good general health, as evidenced by medical history\u002Fphysical exam\u002Flaboratory results.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* History of diabetes requiring treatment with any glucose lowering drug(s).\n* Fasting glucose \\>= 126 on screening visit.\n* Is on treatment with an investigational drug or other intervention within 8 weeks of enrollment.\n* Hospitalization within 12 months for myocardial infarction, coronary revascularization or bypass surgery or stroke.\n* History of autoimmune disease, e.g., Hashimoto s thyroiditis, Myasthenia Gravis or Rheumatoid Arthritis.\n* Uncontrolled thyroid disease.\n* Chronic liver disease indicated by medical history or one of the liver enzymes greater than 2 times the normal range.\n* History of chronic kidney disease or GFR \\\u003C60 mL\u002Fmin\u002F1.73 m\\^2.\n* Anemia (defined as hemoglobin level \\\u003C12 g\u002Fdl for men or \\\u003C 11 g\u002Fdl for women).\n* Poor venous access.\n* Uncontrolled hypertension as judged by the Investigator.\n* History of significant GI disease, e.g., IBS, Crohn s disease.\n* Active cancer or has had treatment for cancer in the last 1 year.\n* Medical condition requiring absolute and continuous need for long-term treatment with antibiotics, corticosteroids, immunosuppressors.\n* Currently pregnant or a nursing mother due to possible changes in hormones and metabolism.\n* History of, or laboratory evidence of HIV virus infection at Screening Visit.\n* History of, or laboratory evidence of Hepatitis B or C at Screening Visit.\n* Positive urine drug screen at Screening Visit (unless taking prescribed medication and at the discretion of the PI).\n* Reports claustrophobia and\u002For is not eligible to have an MRI as per the MRI eligibility form.\n* Weight \\>= 300 lbs (MRI scanner weight limit).\n* Hip or knee replacement or other medical condition that prevents MRI research scans from being performed.\n* Diagnosed with cognitive impairment that clearly prevents the participant from providing informed consent.\n* Current smoker or tobacco use in the past year.\n* History of substance abuse, including marijuana use in the past year.\n* On average, consumes more than 1 alcoholic drink per day.\n* Any other condition which in the investigator s opinion may adversely affect the subject s ability to complete the study or its measures or which may pose significant risk to the subject.","100 Years",{"count":129,"type":22},180,[131],"NA","Background:\n\nAs people age, the cells in the pancreas that produce insulin begin to release less of this hormone, and levels of blood glucose (sugar) rise. This can lead to illnesses such as diabetes. Urolithin A (UA) is a natural nutritional supplement that may improve how the body controls blood glucose.\n\nObjective:\n\nTo learn if UA improves levels of insulin and other hormones that help control blood glucose.\n\nEligibility:\n\nPeople aged 55 years and older with a body mass index of 27 or higher.\n\nDesign:\n\nParticipants will have 6 clinic visits over 8 weeks.\n\nParticipants will be screened. They will have a physical exam with blood and urine tests and a test of their heart function.\n\nUA gelcaps are taken by mouth every morning at home. Half of participants will take UA. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking.\n\nParticipants will have tests during the study including:\n\nOral glucose tolerance: Participants will drink a sweet liquid. Blood will be drawn at intervals over the next 3 hours.\n\nContinuous glucose monitor: A sensor with a needle that goes just under the skin will be placed on the upper arm. Participants will wear this sensor throughout the study.\n\nExercise. Participants will walk on a treadmill while their heart rate, hearth rhythm, and blood pressure are monitored. They will walk in a hallway at normal and fast paces.\n\nImaging scans of the thigh; scans of the brain are optional....",[28],[135,136,137,138,139],"Urolithin A","GLUCOSE METABOLISM","Insulin","Muscle Strength","Microbiomes",{"date":38,"type":39},{"date":41,"type":22},{"date":143,"type":22},"2027-03-31",{"name":145,"class":46},"National Institute on Aging (NIA)",{"id":147,"slug":4,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":4,"leadSponsor":167,"locationsCount":47},"100053685","NCT00001360","Studies of Blood Flow to the Brain During Thought","Regional Cerebral Blood Flow Studies of Object Perception, Identification, Localization, and Memory","* INCLUSION CRITERIA:\n* Healthy adults, with at least a high school education, aged 18 to 65 years, will be recruited to participate in the study.\n* Able to read and write in English to guarantee understanding of all written and spoken instructions, which are in English.\n\nEXCLUSION CRITERIA:\n\nSubjects will be excluded if they:\n\n* have evidence of, or a history of:\n* major medical, neurological or psychiatric illness\n* serious head injury\n* learning disability-drug or alcohol abuse or dependence in the past 3 months, except nicotine\n\n-are taking prescription drugs or supplements that may affect brain function-\n\n-have serious vision or hearing problems\n\nIn addition to the above, additional exclusion criteria apply for all MRI studies:\n\n* Female subjects who are pregnant or have a positive pregnancy test 24 hours prior to an experiment will be excluded from neuroimaging studies.\n* All subjects will be questioned prior to MRI scanning for possible occupational exposure to metal slivers or shavings, which may have become accidentally lodged in the tissues of the head or neck. Subjects with surgical clips or shrapnel in or near the brain or blood vessels, subjects with cochlear implants, subjects with any metallic body in the eye or CNS, and subjects with any form of implant wire or metal device which may concentrate radiofrequency fields will be excluded from MRI scanning experiments because of possible risks during MRI scanning. Those whose history is suggestive of such a problem will also be excluded from the MRI portion of the experiments. They may still participate in the behavioral and MEG experiments.\n* Subjects unable to lie flat on their back for up to 3 hours may not be eligible to participate in MRI scans.","65 Years",{"count":154,"type":22},4100,"The purpose of this study is to use brain imaging technology to measure changes in blood flow to areas in the brain as individuals perform intellectual tasks.\n\nThis study will use functional magnetic resonance imaging (fMRI) to examine blood flow to areas of the brain as participants engage in tasks associated with visual perception, visual recognition, and memory.",[28],[158,159,160,161,162,163],"Cognition","Vision","Cortex","Visual Processing","Magnetic Resonance Imaging","Natural History",{"date":38,"type":39},{"date":166,"type":39},"1993-09-17",{"name":92,"class":46},{"id":169,"slug":4,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":174,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":176,"conditions":177,"keywords":178,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":184,"leadSponsor":186,"locationsCount":47},"100054147","NCT07637656","Discovering Determinants of Food Intake by Application of Artificial Intelligence to Complex, High-Dimensional Data","Discovering Determinants of Food Intake by Application of Machine Learning to Complex, High-Dimensional Data","* INCLUSION CRITERIA:\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. Age 18 to 60\n3. In good general health as evidenced by medical history and physical exam\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Weight \\>=204 kg (\\>=450 pounds, maximum weight of the iDXA machine as per manufacturer s manual), or weight \\\u003C45.4 kg (\\\u003C100 pounds, minimum weight allowed based on the NIH guidelines of blood drawing for research purposes)\n2. Unstable weight (+\u002F-5%) within past 6 months as determined by volunteer self-report.\n3. Current use of medications, dietary supplements, or alternative therapies known to alter energy metabolism\n4. Inability to consume provided food based on food allergy or intolerance or other food restrictions (e.g., kosher, vegan, or vegetarian)\n5. Current pregnancy, or recent pregnancy within past 6 months or currently lactating\n6. History or clinical manifestation of:\n\n6i. Diabetes, including fasting glucose \\>= 126 mg\u002Fdl or HbA1c \\>= 6.5%, or history\n\n6ii. Surgery for treatment of obesity\n\n6iii. Endocrine disorders, such as Cushing s disease, pituitary disorders, or hypo- and hyperthyroidism (TSH \\\u003C0.1 or \\>= 10 uIU\u002FmL)\n\n6iv. Pulmonary disorders including chronic obstructive pulmonary disease or other lung disease that which would limit ability to follow the protocol\n\n6v. History of coronary artery disease, heart failure, arrhythmias, and peripheral artery disease that which would limit ability to follow the protocol\n\n6vi. Liver disease, including cirrhosis, active hepatitis B or C based on history, and AST or ALT \\>= 3x normal\n\n6vii. Gastrointestinal disease including Crohn's disease, ulcerative colitis, celiac disease, or other malabsorptive disorders by history\n\n6viii. Hematologic disorders including significant anemia (male hemoglobin \\\u003C 13.0 g\u002FdL or female hemoglobin \\\u003C 11.0 g\u002FdL)\n\n6ix. Renal disease including abnormal kidney function (eGFR \\\u003C60 mL\u002Fmin\u002F1.73m\\^2)\n\n6x. Central nervous system disease, including cerebrovascular accidents, dementia, and neurodegenerative disorders by history\n\n6xi. Cancer requiring treatment in the past 5 years, except for nonmelanoma skin cancers or cancers that have clearly been cured\n\n6xii. Infectious disease such as active tuberculosis, HIV (by self-report), chronic coccidiomycosis or other chronic infections that might influence appetite\n\n6xiii. Diagnosis of binge eating disorder, anorexia, or major psychiatric disorders including depression, schizophrenia, and psychosis\n\n6xiv. Menopausal transition (late) to early postmenopause (e.g., \\>= 2 skipped cycles and an interval of amenorrhea \\>= 60 days and \\\u003C12 months)\n\n7\\. Alcohol abuse as defined by \\>= 8-point score on the Alcohol Use Disorders Identification Test (AUDIT) questionnaire interview\n\n8\\. Inability to provide informed consent\n\n9\\. Any disorder, unwillingness, or inability not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators, such as those that jeopardize the safety of the participant or others, or would interfere with completion of study procedures",{"count":175,"type":22},800,"Background:\n\nMany people in the United States are overweight or obese. Researchers want to learn why some people can overeat and not gain weight, whereas others who do not overeat still gain weight.\n\nObjective:\n\nTo study factors related to food intake that can lead to weight gain over time.\n\nEligibility:\n\nHealthy adults aged 18 to 60 years.\n\nDesign:\n\nParticipants will have 6 to 8 clinic visits over 2 years. The first 3 or 4 study visits will be 1 week apart.\n\nProcedures during visits may include the following:\n\nCollection of blood, hair, urine, and stool samples.\n\nMeasurement of the waist, neck, thighs, and other parts of the body.\n\nDual energy x-ray absorption (DXA) scan: Participants will lie still on a padded table while they are scanned to measure body fat.\n\nPhysical activity monitor: Participants will wear a monitor on the wrist for 2 weeks.\n\nCognitive tests: Participants will perform tasks to measure attention, memory, and brain function.\n\nContinuous glucose monitor. Participants will wear a device that measures their blood glucose for 1 week.\n\nMixed meal test and stomach emptying test. Participants will drink a breakfast shake and swallow a dose of acetaminophen. Blood will be drawn over the next 4 hours.\n\nResting metabolic rate: Participants will wear a clear hood over their head while they rest for 20 minutes. The hood will measure the gases they breathe.\n\nBreakfast and lunch test. Participants will eat a standard breakfast. They will be allowed to select from foods and eat as much as they like at lunch. They will be asked how hungry or full they are.\n\nQuestionnaires. Participants will answer questions about their health, sleep, physical activity, and eating.",[28],[179,180,181],"Food Intake","Energy Expenditure","Artificial Intelligence",{"date":38,"type":39},{"date":41,"type":22},{"date":185,"type":22},"2037-07-01",{"name":70,"class":46},{"id":188,"slug":4,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":189,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":176,"conditions":190,"keywords":191,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":198,"locationsCount":47},"100641549",{"count":175,"type":22},[28],[179,180,181],"2026-07-01",{"date":194,"type":39},"2026-07-02",{"date":196,"type":22},"2026-07-07",{"date":185,"type":22},{"name":70,"class":46},{"id":200,"slug":4,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":76,"maxAge":77,"enrollmentInfo":201,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":79,"conditions":202,"keywords":203,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":206,"leadSponsor":207,"locationsCount":47},"100636498",{"count":56,"type":22},[81,82,28],[84,85,86],{"date":194,"type":39},{"date":196,"type":22},{"date":90,"type":22},{"name":92,"class":46},{"id":209,"slug":4,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":99,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":103,"conditions":212,"keywords":213,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":216,"leadSponsor":217,"locationsCount":47},"100617066",{"count":101,"type":22},[25],[105,106,107,28,108,109],[111,112,113,114,115],{"date":194,"type":39},{"date":196,"type":22},{"date":119,"type":22},{"name":70,"class":46},{"id":219,"slug":4,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":220,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":221,"keywords":222,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":225,"leadSponsor":226,"locationsCount":47},"100569134",{"count":56,"type":22},[28,60],[28,62,63],{"date":194,"type":39},{"date":196,"type":22},{"date":68,"type":22},{"name":70,"class":46},{"id":228,"slug":4,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":127,"enrollmentInfo":229,"targetDuration":4,"studyType":23,"phases":230,"briefSummary":132,"conditions":231,"keywords":232,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":235,"leadSponsor":236,"locationsCount":47},"100537201",{"count":129,"type":22},[131],[28],[135,136,137,138,139],{"date":194,"type":39},{"date":196,"type":22},{"date":143,"type":22},{"name":145,"class":46},{"id":238,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":239,"targetDuration":4,"studyType":23,"phases":240,"briefSummary":26,"conditions":241,"keywords":242,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":245,"leadSponsor":246,"locationsCount":47},"100489389",{"count":21,"type":22},[25],[28,29,30,31],[33,34,31],{"date":194,"type":39},{"date":196,"type":22},{"date":43,"type":22},{"name":45,"class":46},{"id":248,"slug":4,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":16,"sex":17,"minAge":152,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":23,"phases":257,"briefSummary":259,"conditions":260,"keywords":262,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":276},"100632647","NCT07516405","Safety and Tolerability Trial of Psilocybin in Healthy Older Adults","A Multicenter Phase 1 Safety and Tolerability Trial of Psilocybin in Healthy Older Adults","Psil-Pk","Inclusion Criteria:\n\n* Aged 65-85 years \\& be male, female, or non-binary\n* Generally healthy\n* Have an identified support person\n* Capacity to Consent\n\nExclusion Criteria:\n\n* Unstable medical condition\n* Risk for hypertensive crisis (screening blood pressure \\>140\u002F90 mmHg)\n* Significant central nervous system (CNS) pathology\n* Primary psychotic or affective psychotic disorders\n* Family history of psychotic or serious bipolar spectrum illnesses\n* High risk of adverse emotional or behavioral reaction\n* Active substance use disorders (SUDs)\n* Extensive use of serotonergic hallucinogens\n* High risk of completed suicide\n* History of hallucinogen persisting perception disorder (HPPD)\n* Concurrent Medications: centrally-acting serotonergic agents; antipsychotics; certain mood stabilizers, aldehyde dehydrogenase inhibitors; significant inhibitors of UGT 1A9 or UGT 1A10\n* Certain psychiatric conditions\n* Presence of relevant finding (psychological, physical symptom, medication) prior to dosing that would make a participant unsuitable for the study","85 Years",{"count":256,"type":22},40,[258],"PHASE1","This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.",[28,261],"Older Adults (65-85 Years)",[263,264,265],"healthy older adults ages 65-85","psilocybin safety","psilocybin tolerability","2026-06-29",{"date":268,"type":39},"2026-06-30",{"date":270,"type":39},"2026-04-01",{"date":272,"type":22},"2028-03",{"name":274,"class":275},"University of Colorado, Denver","OTHER",6,{"id":278,"slug":4,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":152,"enrollmentInfo":283,"targetDuration":4,"studyType":23,"phases":285,"briefSummary":286,"conditions":287,"keywords":288,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":298},"100628815","NCT07466550","A Study to Assess How Intravenous and Subcutaneous Administrations of Risankizumab Moves Through the Body of Healthy Adult Participants","A Phase 1 Study in Healthy Subjects to Assess Pharmacokinetics Following Intravenous and Subcutaneous Administration of Risankizumab","Inclusion Criteria:\n\n* Body weight between 40 kg and 100 kg inclusive at screening and upon initial confinement.\n* BMI is ≥ 18.0 to ≤ 32.0 kg\u002Fm2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.\n\nExclusion Criteria:\n\n* Exposure to any anti-interleukin-12\u002F23 or anti interleukin-23 treatment for at least one year prior to Screening.\n* Intention to perform strenuous exercise to which the subject is unaccustomed within one week prior to administration of first dose of study treatment or during the study.",{"count":284,"type":22},60,[258],"The purpose of this study is to compare how the drug moves through the body following risankizumab subcutaneous (SC) and risankizumab intravenous (IV) doses.",[28],[28,289],"Risankizumab",{"date":192,"type":39},{"date":292,"type":39},"2026-06-04",{"date":294,"type":22},"2027-01",{"name":296,"class":297},"AbbVie","INDUSTRY",2,{"id":300,"slug":4,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":16,"sex":17,"minAge":304,"maxAge":127,"enrollmentInfo":305,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":307,"conditions":308,"keywords":311,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":47},"100234290","NCT02327884","Characterization of Diseases With Salivary Gland Involvement","* INCLUSION CRITERIA:\n* Persons older than 4 years of age, affected with or suspected of being affected with a disease\u002Fdisorder involving the salivary glands or who is a relative of a person who is affected with these diseases\u002Fdisorders.\n\nOr,\n\n\\- Persons 18 years or older with active hepatitis with or without sicca symptoms and patients undergoing immunotherapy with an immune checkpoint inhibitor for oral cancer.\n\nSpecific to patients undergoing immunotherapy with an immune checkpoint inhibitor for threatment of oral cancer, these patients will be seen before and after check point inhibitor therapy which will coincide with 4 weeks (+\u002F-2 weeks) before and again immediately before (+\u002F- 2 weeks) definitive oral cancer treatment initiation (e.g., surgical resection, etc.).\n\nOr,\n\n\\- Healthy persons age 18 or older, who agree to have blood, urine, saliva or tissue samples collected and studied.\n\nEXCLUSION CRITERIA:\n\n* Anyone not able to give consent\u002Fassent or parental\u002Fguardian consent\n* NIH employees who report directly to the principal investigator\n* Significant concurrent medical condition or other circumstances that may affect the participant s ability to tolerate or complete the study, such as concurrent chemotherapy or bleeding disorders.\n\n  * Specific only to the immune checkpoint inhibitor patients, oral cancer as a serious concurrent medical condition, will not serve as an exclusion criteria.\n  * Moreover, these immune checkpoint inhibitor subjects, if unable to tolerate the study procedures, such as salivary gland biopsies, saliva collections, and\u002For oral exams, will be excluded as determined by the Principal Investigator.\n* Additional exclusion criteria for Healthy Volunteers (HV):\n\n  * Pregnancy\n  * Sicca Symptoms\n  * HIV, hepatitis B or C infection\n  * Chronic medical illness, other than well-controlled hypertension or hyperlipidemia\n  * Chronic use of medications, with the exception of oral contraception, hormone replacement therapy, aspirin, antihypertensives and antilipemics","4 Years",{"count":306,"type":22},1150,"Background:\n\n\\- Salivary glands in and around the mouth and throat make saliva. Salivary gland disorders can affect a person s quality of life. Studying people who have a disease that affects their salivary gland(s) may teach researchers about the disorders and their genetics.\n\nObjectives:\n\n\\- To study salivary gland diseases and disorders. To collect data and samples from people with salivary gland problems and their relatives.\n\nEligibility:\n\n* People more than 4 years old who have or are suspected to have a disease involving salivary glands.\n* Their relatives more than 4 years old.\n* Healthy volunteers 18 years or older.\n\nDesign:\n\n* Participants may be screened with:\n* Medical history\n* Physical exam\n* Blood and urine tests\n* General oral and dental history and exam\n* Saliva collection\n* Eye exam and test for dry eyes\n* Health questionnaires (adults)\n* Biopsy of some minor salivary glands. A small incision will be made on the inside of the lower lip and several tiny salivary glands will be removed.\n* Participants will have 2-3 visits. These may include:\n* Repeats of some screening tests\n* Ultrasounds of some glands. Researchers will put some gel on the face, then press on it with a smooth wand.\n* Adults may have other biopsies\n* A small catheter inserted into the opening of the parotid gland duct on the inside of the cheek. A saline solution (in a syringe) will fill the duct.\n* Swishing a saltwater solution in the mouth for 10 seconds and then spitting into a cup\n* Scrapings collected from teeth, tongue, and cheeks",[28,309,310],"Sjogren's Syndrome","Salivary Gland Disease",[312,313,309,314,315],"Genetics","Dry Mouth","Gland dysfunction","Induced Pluripotent Stem (iPS) Cell Lines","2026-06-27",{"date":268,"type":39},{"date":319,"type":39},"2015-04-03",{"date":321,"type":22},"2032-04-01",{"name":323,"class":46},"National Institute of Dental and Craniofacial Research (NIDCR)",{"id":325,"slug":4,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":16,"sex":17,"minAge":330,"maxAge":331,"enrollmentInfo":332,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":334,"conditions":335,"keywords":336,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":4,"leadSponsor":345,"locationsCount":47},"100180885","NCT01629108","Normal Values in Hearing and Balance Testing","Normative Values in Audiovestibular Testing","* INCLUSION CRITERIA:\n\nHealthy adult volunteers:\n\n* Healthy adults, aged 18-80 years\n* Able to provide informed consent\n* Normal hearing sensitivity, defined as pure-tone thresholds less than or equal to 25 dB HL, or when the pure-tone threshold exceeds 25 dB HL, it must be less than or equal to the median threshold for the appropriate gender- and age-based group, for 250-8000 Hz (Morrell et al, 1996, ISO-7029, 2000).\n* No air-bone gaps in excess of 10 dB for 500-4000 Hz.\n* Normal middle ear function as indicated by normal 226 Hz tympanograms bilaterally, defined as middle ear pressure between more or less 100 decaPascals, and peak compensated static compliance between 0.3-1.5 milliliters\n* American English as a first language for those participating in study tasks evaluating auditory processing.\n* Able to refrain from caffeine and alcohol for 48 hours before vestibular study sessions because both agents may modify the test results.\n\nEXCLUSION CRITERIA:\n\n* History of auditory and\u002For vestibular disorders (e.g., Meniere s syndrome, labyrinthitis).\n* Evidence of active outer or middle ear disease or anomaly (e.g. otitis media, stenotic ear canal, otorrhea)\n* History of chronic (fluid in middle ear for more than 4 months) or recurrent otitis media (more than 4 episodes of acute otitis media in one year)\n* History of ear surgery other than PE tubes\n* Current PE tubes\n* History of treatment with ototoxic medications (e.g. cisplatin, aminoglycoside antibiotics)\n* Unable to discontinue medications that can interfere with vestibular test results for the 48 hours immediately preceding a vestibular study session. These include any and all anti-dizziness medications (such as Antivert), prescription pain medications (such as Percocet), prescription headache medications (such as Imitrex), sleeping pills (such as Ambien), anti-seizure medications (such as Topamax), and\u002For antihistamines (such as Benadryl).\n* Current diagnosis from the Diagnostic and Statistical Manual of Mental Disorders (DSM IV) of a psychiatric disorder or on medications for a psychiatric disorder in the past two years, including any or all antidepressants, anxiolytics, or psychostimulant drugs.\n* Cognitive impairment as evidenced by a score \\\u003C26 on the Montreal Cognitive Assessment (MoCA).\n* Attention deficit hyperactivity disorder (ADHD) as evidenced by a score of greater than or equal than or equal to 4 on the Adult ADHD Self Report Scale (Kessler et al., 2005).\n* History or diagnosis of a central nervous system disorder, including but not limited to:\n\n  * Intracranial tumors\n  * Cerebrovascular disease\n  * Degenerative CNS disorder\n  * CNS trauma\n  * Encephalitis\n  * Meningitis\n* Current diagnosis of speech and\u002For language disorders, autism, auditory neuropathy, or auditory processing disorder; or in therapy for these disorders in past 2 years.\n* Reduced visual acuity preventing ability to see the visual targets used for vestibular and balance testing as evidenced by corrected visual acuity worse than 20\u002F25 on a Snellen chart for those participating in vestibular tasks.\n* Ocular motor impairment preventing ability accurately follow the visual target used for calibration and\u002For ocular motor tasks for those participating in the vestibular tasks.\n* Employees and staff of the Audiology Unit, Otolaryngology Branch, NIDCD.\n* Reduced balance or postural instability as evidenced by a Timed Up and Go score greater than or equal to 11.1 seconds (Whitney et al., 2004) for adults \\\u003C65 years of age and \\>12.6 seconds for adults 65-80 years of age (Shumway-Cook et al.,2000) and\u002For Activities-specific Balance Confidence Score \\\u003C67% for those participating in vestibular study tasks.\n\nHealthy children volunteers:\n\nINCLUSION CRITERIA:\n\n* Healthy children, aged 5 years-0 months to 17 years-11 months\n* Normal hearing sensitivity, defined as pure-tone thresholds of 15 dB HL or better for 250-8000 Hz\n* Normal middle ear function as indicated by normal 226 Hz tympanograms bilaterally, defined as middle ear pressure between more or less 100 decaPascals, and peak compensated static compliance between 0.2-1.5 milliliters\n* American English as a first language for those participating in study tasks evaluating auditory processing.\n* Ability to follow the verbal instructions and commands for study tests\n* Able to refrain from alcohol and caffeine intake for 48 hours before vestibular study sessions because caffeine may modify the test results\n* Weight greater than 40 pounds for those participating in vestibular tasks that include CDDP\n\nEXCLUSION CRITERIA:\n\n* History of auditory and\u002For vestibular disorders (e.g. Meniere syndrome, enlarged vestibular aqueduct).\n* Evidence of active outer or middle ear disease or anomaly (e.g. otitis media, stenotic ear canal, otorrhea)\n* History of chronic (fluid in middle ear for more than 4 months) or recurrent otitis media (more than 4 episodes of acute otitis media in one year)\n* History of ear surgery other than PE tubes\n* Current PE tubes\n* History of treatment with ototoxic medications (e.g. cisplatin, aminoglycoside antibiotics)\n* Unable to discontinue medications that can interfere with vestibular test results for the 48 hours immediately preceding a vestibular study session. These include any and all anti-dizziness medications (such as Antivert), prescription pain medications (such as Percocet), prescription headache medications (such as Imitrex), sleeping pills (such as Ambien), anti-seizure medications (such as Topamax), and\u002For antihistamines (such as Benadryl).\n* Current diagnosis from the Diagnostic and Statistical Manual of Mental Disorders (DSM IV) of a psychiatric disorder or on medications for psychiatric disorder in the past two years, including any or all antidepressants, anxiolytics, or psychostimulant drugs.\n* Cognitive impairment as evidenced by a standard score less than 85 on the Peabody Picture Vocabulary Test (Fourth Edition)\n* Attention deficit hyperactivity disorder (ADHD) as evidenced by a score of greater than or equal to 6 on the SNAP IV\n* History or previous diagnosis of a central nervous system disorder, including but not limited to:\n\n  * Intracranial tumors\n  * Cerebrovascular disease\n  * Degenerative CNS disorder\n  * CNS trauma\n  * Encephalitis\n  * Meningitis\n* Current diagnosis of speech and\u002For language disorders or delays, autism, auditory neuropathy, or auditory processing disorder; or in therapy of these disorders in past 2 years.\n* Reduced visual acuity preventing ability to see the visual targets used for vestibular and balance testing as evidenced by corrected visual acuity worse than 20\u002F25 on a Snellen chart for those participating in vestibular study tasks.\n* Ocular motor impairment preventing ability to see or accurately follow the visual target used for ocular motor tasks for those participating in the vestibular study tasks.\n* Reduced balance or postural instability as evidenced by a Timed Up and Go score of greater than or equal to 9.4 seconds for those participating in vestibular study tasks.","5 Years","80 Years",{"count":333,"type":22},500,"Background:\n\n\\- Researchers at the National Institutes of Health give many tests of hearing and balance. These tests can help detect problems that affect hearing or balance. It is important to know exactly how healthy people perform on each of these tests. This information will indicate when a test result is normal and when a test result shows a problem. Researchers also want to determine the best methods for each test.\n\nObjectives:\n\n\\- To test different types of hearing and balance tests, and collect information on normal values for each test.\n\nEligibility:\n\n\\- Healthy volunteers between 5 and 80 years of age.\n\nDesign:\n\n* This study will require a single visit to the National Institutes of Health Clinical Center. It will include both screening tests and study tests of hearing and balance. Sometimes, a second visit may be required if a test is designed to measure the same thing on 2 different days. Each visit will last between 2 and 5 hours, depending on the number of tests scheduled per visit.\n* Participants will have a physical exam and medical history. They will also have basic tests to check for normal hearing and balance.\n* Participants may have different hearing tests, including the following:\n* Auditory Evoked Potentials to study how the ears and brain handle sound information.\n* Auditory Processing Tests to study how a person processes complex sounds like speech in background noise.\n* Tests of middle ear and inner ear function.\n* Participants may have different balance and inner ear tests, including the following:\n* Balance test on a tilting platform.\n* Different tests to measure how well the eyes, ears, and brain work together to help maintain balance.\n* Treatment will not be needed as part of this study.",[28],[337,338,339,340,341,163],"Normative Data","Vestibular","Auditory","Healthy Volunteers","Hearing",{"date":268,"type":39},{"date":344,"type":39},"2012-09-21",{"name":346,"class":46},"National Institute on Deafness and Other Communication Disorders (NIDCD)",{"id":348,"slug":4,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":16,"sex":17,"minAge":353,"maxAge":127,"enrollmentInfo":354,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":356,"conditions":357,"keywords":361,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":369,"startDateStruct":370,"completionDateStruct":4,"leadSponsor":372,"locationsCount":47},"100176270","NCT01568697","Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)","Oral Microbial and Immunological Characterization of Patients With Immune Dysfunction","* INCLUSION CRITERIA:\n\nSubjects with Genetic Immune Defects:\n\nPatients with a known genetic immune defect will be eligible for screening inclusion under this protocol.\n\n* Diagnosed with a genetic immune defect\n* Willing to allow genetic testing\n\n  * 7 years old\n\nSubjects with Severe Periodontitis of Suspected Genetic Etiology:\n\n* History of severe periodontitis prior to age \\\u003C30\n* Willing to allow genetic testing\n\n  -\\>=7 years old\n* In good general health\n\nFamily members of Subjects with Severe Periodontitis of Suspected Genetic Etiology:\n\n-Willing to allow genetic testing\n\n-\\>=7 years old\n\nHealthy Volunteer Subjects (with\u002Fwithout periodontitis):\n\n* In good general health\n\n  -\\>=18 years old\n* Willing to allow genetic testing\n* Have a minimum of 20 natural teeth\n\nInclusion Criteria for Natural History phase, all subjects:\n\n* Diagnosis of genetic immune defect\n* Presence of oral manifestation (primarily periodontitis)\n\nCriteria for standard of care treatment:\n\n* Active untreated disease (visible signs of tissue inflammation including erythema\u002Fedema, generalized bleeding upon probing)\n* Periodontal disease defined as bone loss of \\>=5mm as measured on periodontal exam.\n\nEXCLUSION CRITERIA:\n\nAll Subjects:\n\n* History of Hepatitis B or C\n* History of HIV\n* Prior radiation therapy to the head or neck\n* Have an active malignancy except localized basal or squamous cell carcinoma of the skin\n* Have been treated with systemic chemotherapeutics or radiation therapy within 5 years of screening\n* Pregnant or lactating\n* If participation in the protocol would not be safe or in the subject s best interest in the opinion of either the PI or the primary medical team.\n\nAdditional Exclusions for Healthy Volunteers:\n\n* Diagnosis of diabetes and\u002For HbA1C level \\>6%\n* More than 3 hospitalizations in the last 3years\n* Have an autoimmune disorder such as Lupus, Rheumatoid arthritis, etc.\n* In the 3 months before study enrollment, have used any of the following:\n\n  * Systemic (intravenous, intramuscular, or oral) antibiotics\n  * Oral, intravenous, intramuscular, intranasal, or inhaled corticosteroids or other immunosuppressants (e.g., cyclosporine)\n  * Cytokine therapy\n  * Methotrexate or immunosuppressive chemotherapeutic agents\n  * Large doses of commercial probiotics (\\>=10\\^8 colony-forming units or organisms per day); includes tablets, capsules, lozenges, chewing gum, or powders in which a probiotic is a primary component; ordinary dietary components such as fermented beverages\u002Fmilks, yogurts, and foods do not apply\n* Have used tobacco products (including e-cigarettes) within 1 year of screening\n* Unwillingness to consent to oral biopsy\n* NIH employees working in the Oral Immunity and Inflammation Unit and members of the Clinical Research Core Team will not be eligible for enrollment.\n\nAdditional Exclusions for Standard of Care Treatment at NIH:\n\n* Mild\u002Fmoderate non-active disease (absence of active inflammatory lesions)\n* Subjects with urgent\u002Fcomplex restorative needs (ex. severe active carious lesions\u002Ffractured dentition)\n* Subjects in need for advanced prosthetic needs (including implants and restorations)","7 Years",{"count":355,"type":22},700,"Background:\n\n\\- Gum disease is a condition in which the tissue around the tooth root becomes swollen and infected. This condition can cause tooth loss if it is not treated. Who gets gum disease and how bad it will be depends on (1) the different bacteria in the mouth and (2) how the immune system of an individual handles these bacteria. Researchers want to look at the oral bacteria and genetic immune problems of different people to learn how these affect gum disease and other conditions of the mouth.\n\nObjectives:\n\n\\- To study how immune system problems may lead to problems in the mouth, including gum disease.\n\nEligibility:\n\n* Children and adults at least 7 years of age who have genetic problems with their immune system.\n* Healthy adults that have periodontal disease\n* Health adults that do not have periodontal disease\n\nDesign:\n\n* This study will involve a screening visit and a study visit.\n* Participants will be screened with a medical history, blood work and a full oral and dental exam, including dental x-rays and photos.\n* The study visit will involve collection of blood, urine, and other samples, including saliva, plaque, and gum swabs. Any abnormal tissue will sampled for a biopsy. Additional oral and dental exams will be performed. Participants will also answer questions about any current medical or dental problems.",[358,359,360,28],"Immunosuppression","Periodontal Disease","Healthy Subjects",[362,363,364,365,163,366,359,367,28,368],"Microbiome","Periodontitis","Oral Mucosal Immunity","Oral Infection","Immune Disorder","Gum Disease","HV",{"date":268,"type":39},{"date":371,"type":39},"2012-10-05",{"name":323,"class":46},{"id":374,"slug":4,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":152,"enrollmentInfo":378,"targetDuration":4,"studyType":23,"phases":380,"briefSummary":381,"conditions":382,"keywords":384,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":47},"100153235","NCT01266577","Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle","* INCLUSION CRITERIA:\n* 18-65 years of age\n* able to give written informed consent\n* healthy based on medical history and physical exam\n* enrolled in Protocol 01-M-0254 or Protocol 17-M-0181\n\nEXCLUSION CRITERIA:\n\n* Any current Axis 1 diagnosis\n* Clinically significant laboratory abnormalities\n* Positive HIV test\n* Metallic foreign bodies that would be affected by the magnetic resonance imaging (MRI) magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan.\n* History of neurological illness or injury with the potential to affect study data interpretation, such as multiple sclerosis, Parkinson s disease, seizure disorder or traumatic brain injury\n* Inability to lie flat on camera bed for about two and a half hours\n* Pregnant or breastfeeding\n* Current substance use disorder based on DSM-5\n* NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy.",{"count":379,"type":22},300,[131],"Background:\n\n\\- Magnetic resonance imaging (MRI) is a widely used scanning technique to obtain images of the human body and evaluate activity in the brain. A particular MRI method called magnetic resonance spectroscopy (MRS) can be used to study brain chemistry as well, which may help researchers who are studying new treatments for psychiatric illnesses. Researchers are interested in improving current MRI and MRS techniques, as well as developing new MRI and MRS techniques to view and measure brain chemicals and brain activity.\n\nObjectives:\n\n\\- To implement, develop, and optimize brain chemistry imaging techniques using magnetic resonance imaging and magnetic resonance spectroscopy.\n\nEligibility:\n\n\\- Healthy individuals between 18 and 65 years of age.\n\nDesign:\n\n* This study will involve a screening visit and a scanning visit at the National Institutes of Health Clinical Center.\n* Participants will be screened with a full medical and physical examination, blood and urine tests, and neurological testing.\n* During the second visit, participants will have an MRI scan of the brain. (Participants who have received an MRI within the past year will not need to have a second one; the images of the previous scan will be used for this study.) All participants will then have an MRS scan using the same scanning equipment....",[383,28],"Brain Mapping",[385,386,162,387,388],"Brain Metabolism","Neurochemistry","Mental Illness","Magnetic Resonance Spectroscopy",{"date":268,"type":39},{"date":391,"type":39},"2011-01-27",{"date":393,"type":22},"2026-10-23",{"name":92,"class":46},{"id":396,"slug":4,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":152,"enrollmentInfo":397,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":155,"conditions":398,"keywords":399,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":4,"leadSponsor":402,"locationsCount":47},"100054408",{"count":154,"type":22},[28],[158,159,160,161,162,163],{"date":268,"type":39},{"date":166,"type":39},{"name":92,"class":46},{"id":404,"slug":4,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":409,"targetDuration":4,"studyType":23,"phases":411,"briefSummary":412,"conditions":413,"keywords":414,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":419,"leadSponsor":421,"locationsCount":4},"100645339","NCT07680686","Study to Assess How Different Oral Formulations of Ubrogepant Move Through the Body in Healthy Adult Participants","A Two-Part, Phase 1, Open-Label, Randomized Study to Evaluate the Relative Bioavailability (Versus Immediate Release Tablet) and Food Effect of a New Orally Disintegrating Tablet Formulation of Ubrogepant in Healthy Volunteers","Inclusion Criteria:\n\n* BMI is ≥ 18.0 to ≤ 32.0 kg\u002Fm2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.\n\nExclusion Criteria:\n\n* History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, neurologic, or psychiatric disease or disorder, history of Raynaud's Phenomenon, or any uncontrolled medical illness.\n* History of any clinically significant sensitivity or allergy to any medication or food.",{"count":410,"type":22},52,[258],"This study will assess how different oral formulations of ubrogepant move through the body in healthy adult participants under fasting and fed conditions.",[28],[28,415],"Ubrogepant","2026-06-26",{"date":194,"type":39},{"date":268,"type":22},{"date":420,"type":22},"2026-10",{"name":296,"class":297},{"id":423,"slug":4,"hasResults":11,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":152,"enrollmentInfo":428,"targetDuration":4,"studyType":23,"phases":429,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":47},"100644715","NCT07673601","A Study to Assess the Absolute Bioavailability and How Adimanebart SC Moves Through the Body in Healthy Adult Participants","A Phase 1, Open-Label, Randomized, Single Dose, Parallel-Group Study to Assess the Absolute Bioavailability and Evaluate the Effect of Body Weight on the Pharmacokinetics of Adimanebart SC in Healthy Adult Participants","Inclusion Criteria:\n\n* Is at least the local legal age of consent and aged 18 to 65 years, inclusive, when signing the ICF.\n* Has a body weight between 60 and 100 kg and a BMI between 18.5 and 30 kg\u002Fm2, inclusive, at screening and on day -1 for part 1 and part 3, or has a body weight \\\u003C60 kg or between 100 and 130 kg and a BMI between 18.5 and 38.0 kg\u002Fm2, inclusive, at screening and on day -1 for part 2.\n* Discontinues and refrains from using all medications, including nonprescription and prescription medications, for ≥2 weeks before IMP administration, except for hormonal contraceptives and hormone replacement therapy in female participants. The occasional use of acetaminophen or ibuprofen is allowed.\n\nExclusion Criteria:\n\n* Has any current or past clinically meaningful medical or psychiatric condition, including severe hypersensitivity reactions to drugs and\u002For food that, in the investigator's opinion, would confound the study results or put the participant at undue risk.\n* Previously participated in an adimanebart clinical study and received at least 1 dose of IMP.\n* Is currently participating in another interventional clinical study, or has received an IMP in another clinical study within 12 weeks or 5 half-lives (whichever is longer) before screening.",{"count":410,"type":22},[258],"This study aims to find out how much adimanebart gets into the blood circulation of healthy adults. Researchers will measure the amount of adimanebart in blood over time to learn how it moves through the body. The drug's safety will also be assessed.\n\nThe participants will be assigned to one of 3 parts of the study: part 1 investigates the absolute bioavailability; part 2 investigates the effect of different body weights on adimanebart in blood after subcutaneous (SC) dosing; part 3 investigates formulation adaptations.\n\nParticipants will be in the study for approximately up to 24 weeks.",[432,28],"Healthy Volunteers (HV)","2026-06-23",{"date":266,"type":39},{"date":436,"type":39},"2026-06-12",{"date":438,"type":22},"2026-12",{"name":440,"class":297},"argenx",{"id":442,"slug":4,"hasResults":11,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":152,"enrollmentInfo":447,"targetDuration":4,"studyType":23,"phases":449,"briefSummary":450,"conditions":451,"keywords":452,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":47},"100639398","NCT07604558","A Study to Assess the Adverse Events and How Bretisilocin Intramuscular Injection Moves Through the Body of Healthy Adult Participants","An Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Dose of Bretisilocin in Healthy Adult Japanese, Han Chinese, and Non-Asian Volunteers","Inclusion Criteria:\n\n* Group 1: Healthy adult Japanese male or female;\n\n  • Japanese participants must be first-generation Japanese of full Japanese parentage residing outside of Japan for less than 5 years.\n* Group 2: Healthy adult Han Chinese male or female\n\n  • Han Chinese participants must be first-generation Han Chinese of full Chinese parentage residing outside of China for less than 5 years.\n* Group 3: Healthy adult male or female volunteers of African, European, or Latin American descent.\n* A condition of general good health, based upon the results of a medical history, physical and neurological examination, vital signs, laboratory profile and 12-lead ECG.\n\nExclusion Criteria:\n\n* Current diagnosis or history of any clinically significant mental health disorder, cardiovascular disorder, metabolic disorder, or other disorder requiring pharmacologic or other medical treatment. (Previous psychological support without a diagnosed history of a mental health disorder would not be considered exclusionary.)\n* Clinically significant personal or familial history (first degree relative) of epilepsy, seizures, convulsions, or other seizure disorder (excluding febrile seizures as a child), previous head trauma or other risk factor for seizure (e.g., electrolyte disturbances, or structural neurological disorders).\n* Any use of psychoactive substances (including ketamine, esketamine, MDMA, cannabinoids, or nitrous oxide) during the 6 weeks prior to confinement.",{"count":448,"type":22},26,[258],"This study will assess the adverse events, tolerability, and how bretisilocin intramuscular (IM) Injection moves through the body of healthy adult Japanese, Han Chinese, and Non-Asian volunteers participants.",[28],[28,453,454],"Bretisilocin","ABBV-2505","2026-06-22",{"date":457,"type":39},"2026-06-24",{"date":459,"type":39},"2026-05-26",{"date":461,"type":22},"2026-09",{"name":296,"class":297},{"id":464,"slug":4,"hasResults":11,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":468,"eligibilityCriteria":469,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":152,"enrollmentInfo":470,"targetDuration":4,"studyType":23,"phases":472,"briefSummary":473,"conditions":474,"keywords":476,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":47},"100633533","NCT07527923","First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis","A Two-Part Phase 1, Randomized, Double-Blind, Placebo-Controlled First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN20423 in Adult Healthy Participants and Adult Participants With Atopic Dermatitis","AURA-AD","Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis\n\nKey Inclusion Criteria:\n\nPart A:\n\n1. Is judged by the investigator to be in good health based on medical history, physical examination, vital signs, Electrocardiograms (ECGs), and laboratory safety testing at screening and prior to initial dose of study intervention\n2. Has a BMI within 18 to 31 kg\u002Fm² (inclusive) at the screening visit\n\n   Part B:\n3. Has a history of AD for at least 6 months at screening\n4. Has EASI score ≥5 at both the screening and baseline visits\n5. Has IGA score ≥2 at both the screening and baseline visits\n\nKey Exclusion Criteria\n\nPart A:\n\n1. Hospitalized (\\>24 hours) for any reason within 30 days prior to the screening visit\n2. Hypersensitivity to the study treatment or any of its excipients\n3. History of clinical parasite infection, except treated trichomoniasis\n4. Received a live attenuated vaccine within 1 month prior to the first screening visit or anticipates need for a live attenuated vaccine during the study\n5. History of alcohol or drug abuse as determined by the investigator\n\n   Part B:\n6. Known or suspected history of immunosuppression\n7. Presence of skin comorbidities at screening that may interfere with study assessments\n8. Inability to discontinue medications and treatments prior to baseline and during the study per the Excluded Medications and Treatments list\n9. Uncontrolled chronic disease that might require bursts of oral corticosteroids during the study\n\nNote: Other protocol defined Inclusion\u002F Exclusion criteria apply",{"count":471,"type":22},144,[258],"This study will test a study medicine called REGN20423 to see how effective it is in healthy participants (in Part A) and participants with atopic dermatitis (eczema) (in Part B). REGN20423 is a study medicine that is only used in clinical studies. REGN20423 has not previously been studied in humans.\n\nThe study is looking at:\n\n* What side effects REGN20423 might cause\n* How much REGN20423 is in the blood at different times\n* How well REGN20423 works in adults with atopic dermatitis\n* Whether the body makes antibodies against REGN20423\n* How the body changes after having REGN20423, which can help researchers understand why REGN20423 works better in some people than others\n* What the best dose of REGN20423 is",[28,475],"Atopic Dermatitis",[477,478],"Eczema","Inflammatory skin disease",{"date":480,"type":39},"2026-06-25",{"date":482,"type":39},"2026-05-22",{"date":484,"type":22},"2028-06-23",{"name":486,"class":297},"Regeneron Pharmaceuticals",{"id":488,"slug":4,"hasResults":11,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":493,"targetDuration":4,"studyType":23,"phases":494,"briefSummary":495,"conditions":496,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":47},"100640876","NCT07580794","First-in-human Study of HSK56630 in Healthy Subjects","A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HSK56630 in Healthy Participants","Inclusion Criteria:\n\n1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.\n2. Adult males and females between ≥ 18 and ≤ 60 years (inclusive) at Screening.\n3. Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg\u002Fm2 with a body weight ≥ 50 kg (males) or ≥45 kg (females) at Screening.\n4. Participants with normal results or non-clinically significant (NCS) abnormal results in the opinion of the PI or delegate for a comprehensive examination, including physical examination, vital signs examination, laboratory tests (hematology, biochemistry, coagulation and urinalysis), chest X-ray and abdominal ultrasound.\n5. Female participants are eligible to participate if they are not pregnant, not breastfeeding. Male participants must agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior to screening and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom plus effective contraception methods for their female partner.\n6. Able and willing to attend the necessary visits to the study site.\n\nExclusion Criteria:\n\n1. Participants with any clinically significant medical history that may affect the safety evaluation or in vivo process of IP as judged by the PI or delegate, including central nervous, cardiovascular, digestive, respiratory, urinary, blood, immune and endocrine diseases. Participants with childhood asthma (resolved) can be included at the discretion of the PI.\n2. Underlying physical or psychological medical condition that, in the opinion of the PI or delegate, would make the participant unlikely to comply with the protocol or complete the study per protocol.\n3. Participants having special dietary requirements that cannot be accommodated by the unit or that may interfere with study safety or data (e.g. exclusively vegan diet).\n4. Participants who have taken any prescription drugs (excluding contraception) or herbal medicines within 14 days prior to dosing, or have taken any over-the-counter drugs or dietary supplements (including vitamin and calcium supplements) within 7 days prior to dosing; or participants still within 5 half-lives of a drug prior to dosing.\n5. Alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) \\>1.5 × upper limit of normal (ULN) at Screening or Day -1. Repeat testing at Screening is acceptable for out-of-range values following approval by the PI or delegate.\n6. Participants who have been vaccinated 4 weeks prior to first dose or plan to be vaccinated during the study.\n7. Participants who have taken any other investigational product, participated in any other clinical trial, or participated in other medical research activities within 30 days or 5 half-lives whichever is longer prior to first dose and are unsuitable for participating in this study as judged by the PI or delegate.\n8. Ascertained or presumptive hypersensitivity (including allergies) to any ingredient of the IP; history of other significant allergies or anaphylaxis, as determined by the PI or delegate.\n9. Participants who have lost or donated more than 400 mL of blood (excluding menstrual blood loss in females) within 3 months prior to first dose, or plan to donate blood during the study or within 1 month after the end of the study.\n10. Participants who drink excessive tea, coffee or caffeinated beverages (over 8 cups per day on average, 250 mL per cup) within 6 months prior to Screening, or those who cannot abstain from them on Day -1 and during confinement study in the CRU.\n11. Current smoker who smoke more than 5 cigarettes (or equivalent for other nicotine-containing products) per day within 3 months prior to the first dose, or those who cannot abstain from smoking tobacco or the use of nicotine-containing products during the confinement period.\n12. Participants who regularly drink more than 14 standard units of alcohol per week for females and more than 21 standard units of alcohol per week for males; 1 standard unit contains 10 g of alcohol, such as 285 mL of beer, 30 mL of 40% spirits or 100 mL of wine within 6 months prior to Screening or those who cannot abstain from alcohol on Day -1 and during the confinement study; or those with positive alcohol breath test.\n13. Substance abuse-related disorder or a history of drug, and\u002For substance abuse deemed significant by the PI or delegate at Screening or a positive urine drug screen on Screening or Day -1 (including amphetamine, benzodiazepine, cocaine, methamphetamines, opiates, THC, MDMA, tricyclic antidepressants, barbiturates).\n14. Participants with clinically significant abnormal 12-lead electrocardiogram (ECG) results as judged by the PI or delegate or with a corrected QTc (formula: QTcF = QT\u002FRR1\u002F3) interval ≤ 350 msec or greater than 450 msec in males and 470 msec in females.\n15. Participants with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), treponema pallidum antibody (Syphilis TP Ab) or human immunodeficiency virus antibody (HIV Ab) at Screening.\n16. Participants with positive result for quantiFERON gold at Screening.\n17. Participants with estimated glomerular filtration rate (eGFR) \\\u003C 90 mL\u002Fmin\u002F1.73m2 (using the CKD-EPI equation).\n18. History or presence of a condition associated with significant immunosuppression.\n19. Exposure to any drugs that cause significant immunosuppression (including experimental therapies as part of a clinical study) within 4 months or 5 half lives (whichever is longer), prior to Screening.\n20. Participants who may not be able to complete the study for other reasons, cannot comply with the requirements of the study, or are unsuitable to participate in the study as judged by the PI or delegate.",{"count":256,"type":22},[258],"This is a first-in-human, single ascending dose (SAD) study in healthy adult participants. This is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and PK of HSK56630 in healthy adult participants and preliminarily evaluate the PD of HSK56630.",[28],"2026-06-21",{"date":457,"type":39},{"date":500,"type":39},"2026-06-17",{"date":502,"type":22},"2026-12-31",{"name":504,"class":297},"Haisco Pharmaceutical Group Co., Ltd.",""]