[{"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":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,104,0,25,[9,44,66,90,121,140,167,192,215,240,261,282,302,328,353,376,397,420,443,465,488,515,535,559,588],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100651137","visual-attention-object-recognition-and-eye-movements-in-healthy-volunteers-100651137",false,"NCT07756853","Visual Attention, Object Recognition, and Eye Movements in Healthy Volunteers","An Observational Study of Visual Attention, Object Recognition, and Eye Movements in Healthy Volunteers","* 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 actively pay attention to visual stimuli and respond as appropriate.\n* Participant has visual acuity of 20\u002F25 or better in both eyes.\n* Participant must be 18 years old or older.\n* Participant must understand and be willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Participant has an ocular, visual, or oculomotor problem that in the opinion of the Principal Investigator (PI) and\u002For clinical associate investigator would interfere with the participant s normal eye movements, visual perception, or required tasks.\n* Participant has a history of eye patching (amblyopia or lazy eye).\n* Participant has a non-ocular condition (e.g., neuropsychological conditions) that in the opinion of the PI and\u002For clinical associate investigator would interfere with the participant s normal eye movements or visual perception.","ALL","18 Years","100 Years",{"count":21,"type":22},40,"ESTIMATED","OBSERVATIONAL","Background:\n\nVision is vital for many of our daily activities. Researchers want to learn more about how we aim our eyes (that is, what images, such as faces, immediately attract our attention) and how we direct our attention (that is, what we see and what we ignore).\n\nObjective:\n\nTo study how healthy adults process and respond to visual images.\n\nEligibility:\n\nHealthy people aged 18 years with no vision problems.\n\nDesign:\n\nParticipants will have 5 to 10 clinic visits over 2 to 4 months. Some participants may have up to 25 visits. Each visit lasts about 1 hour.\n\nParticipants will be screened. They will answer questions about their medical and eye history. They will have a standard eye exam; eye drops will be used to dilate the pupils. (They may skip this exam if they have had an eye exam at the NIH within the past year.)\n\nParticipants will perform eye movement tests. They will sit in front of a computer and view images that appear on the screen. They may be asked to respond to what they see by speaking, moving their hands, looking in a certain direction, or pushing a button. Their eye movements will be tracked.\n\nFor some tests, participants heads may be held steady using a chinrest and head strap. For some tests, they may wear a cap fitted with cameras that use invisible lights in front of their eyes.",[26],"Healthy Volunteer",[28,29,30],"Eye Movement","Visual Attention","Object Recognition","NOT_YET_RECRUITING","2026-08-20",{"date":34,"type":35},"2026-08-21","ACTUAL",{"date":37,"type":22},"2026-08-26",{"date":39,"type":22},"2031-12-30",{"name":41,"class":42},"National Eye Institute (NEI)","NIH",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":62,"leadSponsor":64,"locationsCount":43},"100641549","discovering-determinants-of-food-intake-by-application-of-artificial-intelligence-to-complex-high-dimensional-data-100641549","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","60 Years",{"count":53,"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.",[26],[57,58,59],"Food Intake","Energy Expenditure","Artificial Intelligence",{"date":34,"type":35},{"date":37,"type":22},{"date":63,"type":22},"2037-07-01",{"name":65,"class":42},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)",{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":17,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":86,"leadSponsor":88,"locationsCount":43},"100636498","role-of-theta-frequency-oscillations-in-proactive-and-reactive-control-processes-in-youth-with-attention-deficit-hyperactivity-disorder-adhd-and-obsessive-compulsive-disorder-ocd-100636498","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 cannot tolerate being off their medication for up to 48 hours prior to the study visit and experience an exacerbation of symptoms that necessitates the resumption of medication prior to completion of the study visit.\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":75,"type":22},110,"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 10 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.",[78,79,26],"ADHD","Obsessive Compulsive Disorder (OCD)",[81,82,83],"EEG","MRI","fMRI",{"date":34,"type":35},{"date":37,"type":22},{"date":87,"type":22},"2029-05-31",{"name":89,"class":42},"National Institute of Mental Health (NIMH)",{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":110,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":118,"leadSponsor":120,"locationsCount":43},"100617066","effects-of-meal-macronutrients-on-postprandial-lipids-100617066","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\n   1. BMI \\>30 kg\u002Fm\\^2 (or \\>=27 kg\u002Fm\\^2 in participants of Asian descent), OR\n   2. 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        * 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   Plus any 2 of the following\n2. Elevated triglycerides defined as EITHER\n\n   1. Fasting triglycerides \\>= 150 mg\u002FdL at screening, OR\n   2. Specific treatment for hypertriglyceridemia\n3. Low HDL cholesterol, defined as EITHER\n\n   1. HDL \\\u003C40 mg\u002FdL (males) or \\\u003C50 mg\u002FdL (females) at screening, OR\n   2. Specific treatment for low HDL\n4. Elevated blood pressure defined as EITHER\n\n   1. Systolic BP \\>= 130 at screening, OR\n   2. Diastolic BP \\>= 85 mm Hg at screening, OR\n   3. Treatment of previously diagnosed hypertension\n5. Elevated glucose defined as EITHER\n\n   1. HbA1c \\>= 5.7% (at screening), OR\n   2. Fasting serum glucose \\>= 100 mg\u002FdL (at screening), OR\n   3. 2-hour post-load glucose levels \\>= 140 mg\u002FdL (by history), OR\n   4. Prior diagnosis of type 2 diabetes\n\nLipodystrophy-specific inclusion criteria:\n\n1. 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 a minimum, the gluteofemoral depot).\n2. 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\nNephrotic syndrome specific inclusion criteria\n\n1. History of biopsy proven non-diabetic glomerular disease (any histology)\n2. Nephrotic range proteinuria defined by ANY of the following:\n\n   1. Protein\u002Fcreatinine ratio uPCR \\>= 3.5 g\u002Fg at screening, OR\n   2. 24 hour protein excretion \\>= 3.5 gr\u002F24hr) at screening, OR\n   3. 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\nEXCLUSION CRITERIA:\n\nCommon exclusion criteria (all groups):\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Consuming extreme macronutrient diet (e.g., very low-carbohydrate, high fat diets such as ketogenic, \"paleo\" or Atkins diets, among others).\n2. 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).\n3. 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.\n4. Body weight \\>450 lbs (upper limit that can be accommodated by DXA scanner).\n5. 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.\n6. Uncontrolled diabetes, defined as HbA1c \\>9% at screening.\n7. Lipemia defined as fasting or non-fasting triglycerides of \\>1000 mg\u002FdL at screening.\n8. Renal dysfunction defined as eGFR \\\u003C50 mL\u002Fmin\u002F1.73 m\\^2 at screening.\n9. 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.\n10. History of hypertriglyceridemia-induced pancreatitis within 3 months prior to screening.\n11. Positive pregnancy test or breastfeeding at screening.\n12. Clinically significant abnormalities in thyroid function, blood counts, as assessed by screening labs.\n13. Acute cardiovascular events within the past 6 months\n14. Anemia (Hgb \\\u003C10 mg\u002FdL in women or \\\u003C12 mg\u002FdL in men) at screening\n15. 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).\n16. Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect intestinal fat absorption.\n17. Subjects treated with tamoxifen, estrogens, or progestins that have not been stable for \\>4 weeks prior to screening.\n18. Blood donation in the last 2 weeks or planned blood donation during the study\n19. Subjects requiring regular transfusions for any reason.\n20. Subjects with known gastroparesis\n21. Inability to adhere to Lifestyle Considerations throughout study duration.\n22. Inability of the subject to understand and the unwillingness to sign a written informed consent document.\n23. Unwillingness to comply with all study procedures and unavailable for the duration of the study\n24. 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":99,"type":22},100,"INTERVENTIONAL",[102],"PHASE2","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....",[105,106,107,26,108,109],"Nephrotic Syndrome","Lipodystrophy","Metabolic Syndrome","Diabetes","Metabolic Associated Steatotic Liver Disease",[111,112,113,114,115],"postprandial lipids","macronutrient","CARBOHYDRATES","FATS","Proteins",{"date":34,"type":35},{"date":37,"type":22},{"date":119,"type":22},"2031-08-01",{"name":65,"class":42},{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":137,"leadSponsor":139,"locationsCount":43},"100569134","assessing-the-impact-of-perceptions-of-unpredictability-on-objective-measures-of-food-consumption-and-metabolism-100569134","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.",{"count":75,"type":22},"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.",[26,131],"Obestity",[26,133,134],"Obesity","Eating Behavior",{"date":34,"type":35},{"date":37,"type":22},{"date":138,"type":22},"2027-01-30",{"name":65,"class":42},{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":17,"minAge":147,"maxAge":19,"enrollmentInfo":148,"targetDuration":4,"studyType":100,"phases":150,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":163,"leadSponsor":165,"locationsCount":43},"100537201","effects-of-urolithin-a-supplementation-on-glucose-metabolism-in-healthy-adults-55--years-old-a-randomized-triple-masked-controlled-clinical-trial-100537201","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.","55 Years",{"count":149,"type":22},180,[151],"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....",[26],[155,156,157,158,159],"Urolithin A","GLUCOSE METABOLISM","Insulin","Muscle Strength","Microbiomes","RECRUITING",{"date":34,"type":35},{"date":37,"type":22},{"date":164,"type":22},"2027-03-31",{"name":166,"class":42},"National Institute on Aging (NIA)",{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":174,"sex":17,"minAge":18,"maxAge":147,"enrollmentInfo":175,"targetDuration":4,"studyType":100,"phases":177,"briefSummary":178,"conditions":179,"keywords":183,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":188,"leadSponsor":190,"locationsCount":43},"100489389","early-metabolic-effects-of-antiretroviral-drugs-in-healthy-volunteers-a-phase-2-randomized-study-100489389","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 chronic obstructive pulmonary disease.\n* Psychological conditions by self-report, such as (but not limited to) clinical depression, or 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 drugs).\n* Current use of prescription 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,{"count":176,"type":22},120,[102],"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, 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.",[26,180,181,182],"Weight Gain","Metabolic Effects","Integrase Strand Transfer Inhibitors",[184,185,182],"Metabolism","HIV",{"date":34,"type":35},{"date":37,"type":22},{"date":189,"type":22},"2030-01-31",{"name":191,"class":42},"National Institute of Allergy and Infectious Diseases (NIAID)",{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":174,"sex":17,"minAge":18,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":202,"conditions":203,"keywords":204,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":4,"leadSponsor":214,"locationsCount":43},"100054408","studies-of-blood-flow-to-the-brain-during-thought-100054408","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":201,"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....",[26],[205,206,207,208,209,210],"Cognition","Vision","Cortex","Visual Processing","Magnetic Resonance Imaging","Natural History",{"date":34,"type":35},{"date":213,"type":35},"1993-09-17",{"name":89,"class":42},{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":174,"sex":17,"minAge":222,"maxAge":147,"enrollmentInfo":223,"targetDuration":4,"studyType":100,"phases":224,"briefSummary":226,"conditions":227,"keywords":228,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":43},"100652711","phase-1-a-phase-1-single-dose-study-of-mt-201-and-concomitant-infliximab-in-healthy-participants-100652711","NCT07776782","A Single-Dose Study of MT-201 and Concomitant Infliximab in Healthy Participants","A Phase 1, Open-Label, Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MT-201 Administered With Concomitant Infliximab in Healthy Participants","Inclusion Criteria:\n\n1. Male or female (of non-childbearing potential only) between 19 and 55 years of age inclusive, at the time of signing informed consent.\n2. Females must be of non-childbearing potential and must have undergone sterilization procedures, and have official documentation, at least 6 months prior to the first dose.\n3. Male subjects must use highly effective forms of contraception during sexual intercourse with female partners of childbearing potential.\n4. Good general health.\n5. Able to provide written informed consent and understand and comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. History or presence of any clinically significant organ system disease.\n2. Abnormal laboratory assessments, physical exam of ECG outside the normal range that is judged by the Investigator to be clinically significant.\n3. History of alcohol or drug abuse within the past 24 months.\n4. Current use or history of regular tobacco, or nicotine-containing products within 3 months prior to screening.\n5. Administration of any prescription drug within 21 days or 5 half-lives (whichever is longer) of study drug administration; or over-the-counter drug within 7 days or 5 half-lives (whichever is longer) of study drug administration.\n6. Administration or use of any investigational drug or device within 30 days preceding the first does of study drug administration.\n7. Blood donation within 60 days prior to dosing or plasma donation within 14 days prior to dosing.\n8. Sensitivity to any of the study drugs, or components thereof, or drug or other allergy that in the opinion of the Investigator or Sponsor Medical Monitor, contraindicates participation in the study.","19 Years",{"count":7,"type":22},[225],"PHASE1","A Phase 1, Open-Label, Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MT-201 Administered with Concomitant Infliximab in Healthy Participants",[26],[229,230],"Phase 1","MT-201","2026-08-19",{"date":34,"type":35},{"date":234,"type":35},"2026-07-16",{"date":236,"type":22},"2026-11-12",{"name":238,"class":239},"Mirador Therapeutics, Inc.","INDUSTRY",{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":174,"sex":17,"minAge":18,"maxAge":247,"enrollmentInfo":248,"targetDuration":4,"studyType":100,"phases":250,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":43},"100594243","mri-assessment-of-knee-kinematics-from-extension-to-flexion---exploratory-study-100594243","NCT07016906","MRI Assessment of Knee Kinematics From Extension to Flexion - Exploratory Study","FLEXIGEN","Inclusion Criteria:\n\n* Healthy volunteers (no damage to either knee)\n* Male or female, aged between 18 and 40\n* Healthy volunteer affiliated to or benefiting from a social security scheme\n* A healthy French-speaking volunteer who has signed an informed consent form.\n\nExclusion Criteria:\n\n* Contraindication to MRI\n* Joint osteoarthritis\n* BMI \\> 30\n* Previous trauma or surgery to the knee\n* Recurrence of sprains\n* Knee trauma other than sprain\n* Protected person: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.\n* Pregnant or breast-feeding woman","40 Years",{"count":249,"type":22},36,[151],"During flexion of the knee, internal rotation of the tibia associated with translation of the tibial plateaus in relation to the femoral condyles is automatically induced. This mechanism combines a sliding phenomenon and a rolling phenomenon of the condyles on the plate, the latter being known as 'roll-back'. In 2024, imaging analyses of the knee, and in particular MRI, are carried out with the leg in extension.\n\nMRI of the knee at different degrees of flexion would enable to assess the sliding and roll-back phenomena, in order to gain a better understanding of knee kinematics.\n\nHowever, MRI of the knee at different degrees of flexion is limited by the size of the MRI machines and especially by the knee antennae, which are narrow and do not allow flexion beyond 30°. In this context, the only solution for carrying out an MRI study on knees in flexion would be to carry out this examination with an antenna that allows the knee to be positioned at different angles of flexion. This particular type of antenna only exists in veterinary schools, where they are used in particular for horses.\n\nConsequently, this study is based on the assumption that the kinematics of the knee can be assessed using MRI with an antenna for veterinary use.",[26],{"date":32,"type":35},{"date":255,"type":35},"2025-07-08",{"date":257,"type":22},"2026-09-30",{"name":259,"class":260},"GCS Ramsay Santé pour l'Enseignement et la Recherche","OTHER",{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":174,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":268,"targetDuration":4,"studyType":100,"phases":270,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":43},"100652372","early-phase-1-a-study-of-the-pharmacokinetics-biodistribution-and-dosimetry-of-granzyme-b-targeted-cu-64-labeled-pet-radiotracers-in-adult-healthy-volunteers-100652372","NCT07774650","A Study of the Pharmacokinetics, Biodistribution and Dosimetry of Granzyme-B Targeted [Cu-64]-Labeled PET Radiotracers in Adult Healthy Volunteers","A Phase 0 Study of the Pharmacokinetics, Biodistribution and Radiation Dosimetry of Granzyme-B Targeted [Cu-64]-Labeled Positron Emission Tomography (PET) Radiotracers in Adult Healthy Volunteers","Inclusion Criteria:\n\n1. Adult male or female participants 18-60 years of age judged to be in good health by the Investigator\n2. No clinically significant laboratory abnormalities; all tests of liver and kidney function within normal limits\n3. Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the ICF and this protocol\n4. Female participants of childbearing potential and male participants who are fertile and have female partners of childbearing potential must agree to use adequate birth control throughout the study to the conclusion of follow-up.\n\nExclusion Criteria:\n\n1. Pregnant or breast-feeding female participants (female participants of childbearing potential must have negative pregnancy tests at Screening and pre-dose Day 0)\n2. Inadequate venous access (at least two distinct access sites allowing for separate test agent administration and PK blood sampling are required)\n3. Inability or unwillingness to undergo serial PET\u002FCT imaging\n4. Active infection or malignancy\n5. Known or suspected inflammatory, autoimmune or fibrotic disease\n6. Major surgery or other intensive medical treatment in the 3 months prior to planned study injection, as assessed by the investigator\n7. Received a radioisotope within 7 physical half-lives of that radioisotope prior to planned study injection\n8. Known allergy\u002Fhypersensitivity to PET\u002FCT tracers or compounds similar to GzmB-Targeted Compounds\n9. Concurrent participation in a clinical trial of investigational product(s)\n10. Participation in other research protocols or clinical care where there was radiation exposure such that the exposure from the last year, in addition to the radiation exposure expected from participation in this clinical study, exceeds the effective dose of 50 mSv, which would be above the acceptable annual limit established by US federal guidelines\n11. Significant intercurrent illness or psychiatric illness\u002Fsocial situation that could place the participant at undue risk during study participation, significantly alter study outcomes, or affect participant compliance with study requirements for dosing and evaluation, as determined by the investigator",{"count":269,"type":22},12,[271],"EARLY_PHASE1","This is an exploratory clinical study of copper-64 \\[Cu-64\\]-labeled granzyme B (GzmB)-targeted compounds for PET\u002FCT imaging. The goal is to determine how GzmB-Targeted \\[Cu-64\\]-labeled compounds are distributed in the body by assessing PET\u002FCT images and blood samples, and to assess the safety profile after a single intravenous dose.\n\nUp to 6 healthy volunteers (3 female, 3 male) will receive one injection of a GzmB-targeted \\[Cu-64\\]-labeled compound, then undergo multiple whole-body PET\u002FCT scans, blood and urine tests over about 24 hours, and a follow-up phone call around Day 7. Up to 2 GzmB-Targeted \\[Cu-64\\]-labeled compounds may be assessed (i.e. maximum of 12 healthy volunteers in total in the study).\n\nResearchers will look at the blood activity of GzmB-Targeted \\[Cu-64\\]-labeled compound and the organ distribution and movement of the product in the body. They will also evaluate any changes in physical examination assessments, vital signs, ECG, and clinical laboratory measurements from pre-administration to post-administration.",[26],"2026-08-17",{"date":231,"type":35},{"date":277,"type":35},"2026-07-08",{"date":279,"type":22},"2026-12",{"name":281,"class":239},"Ratio Therapeutics, Inc.",{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":174,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":289,"targetDuration":4,"studyType":100,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":301},"100639323","phase-1-a-study-testing-the-safety-and-effects-of-fb102-in-healthy-volunteers-100639323","NCT07623057","A Study Testing the Safety and Effects of FB102 in Healthy Volunteers","A Phase 1, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity After Single and Multiple Dose Administration of FB102 Administered in Healthy Participants","Inclusion Criteria:\n\n1. Body mass index (BMI) between 18.0 and 32.0 kg\u002Fm2, inclusive, at Screening.\n2. Weight ≥50 kg and ≤100kg.\n3. Men are required to agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom plus effective contraception for their female partner if of childbearing potential, from Screening and for at least 90 days after the EOT visit and refrain from donating sperm during this period. Effective contraception includes established use of hormonal contraception beginning at least 30 days prior to the Screening visit; or placement of an intrauterine device or intrauterine system. These contraception requirements do not apply if the male participant is in an exclusively same sex relationship; sperm donation prohibitions apply.\n4. Women are eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions apply:\n\n   1. Not of childbearing potential, defined as surgically sterile (hysterectomy, bilateral salpingectomy, tubal ligation or bilateral oophorectomy - verbal confirmation through medical history review is acceptable).\n   2. Postmenopausal (no menses for 12 months and confirmed by follicle-stimulating hormone \\[FSH\\] level ≥40 mlU\u002FmL).\n   3. Of childbearing potential and agree to practice true abstinence or agree to use a highly effective method of contraception consistently from 30 days prior to the Screening visit until the EOT visit and are required to agree not to donate ova during the trial and for 90 days after the EOT visit.\n\nExclusion Criteria:\n\n1. Any clinically significant medical condition malignancy allergy infection or immunosuppressive condition as determined by the Investigator except cured basal or squamous cell skin cancer.\n2. Alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT), and\u002For total bilirubin \\>1.5× the upper limit of normal (ULN). Participants with bilirubin \\>2× ULN that have a documented diagnosis of Gilbert's syndrome can be enrolled at the Investigator's discretion.\n3. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer considered treated and cured), treated or untreated, within 5 years before Screening, regardless of whether there is no evidence of local recurrence or metastases.\n4. Positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 and 2 antibodies, or interferon-gamma release assay (IGRA) for tuberculosis.",{"count":290,"type":22},48,[225],"The purpose of this Phase 1 trial is to evaluate the safety and effects of FB-102 in healthy volunteers following single and multiple doses.",[26],{"date":231,"type":35},{"date":296,"type":35},"2026-06-23",{"date":298,"type":22},"2027-02",{"name":300,"class":239},"Forte Biosciences, Inc.",2,{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":174,"sex":309,"minAge":18,"maxAge":199,"enrollmentInfo":310,"targetDuration":4,"studyType":100,"phases":312,"briefSummary":313,"conditions":314,"keywords":315,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":4},"100652419","phase-1-a-study-to-learn-how-asp3082-is-processed-in-healthy-men-100652419","NCT07773129","A Study to Learn How ASP3082 is Processed in Healthy Men","A Phase 1, Open-label Study to Evaluate the Metabolism and Excretion of [14C]ASP3082 in Healthy Adult Male Participants","Inclusion Criteria:\n\n* Participant is healthy and has no clinically significant medical conditions based on the physical examination, electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or on day -1.\n* Participant has regular bowel habits (i.e., at least 1 bowel movement per day).\n* Male participant:\n\n  * Must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the investigational period and for 3 months after study intervention administration.\n  * Must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 3 months after study intervention administration.\n  * Must not donate sperm during the investigational period and for 3 months after investigational study intervention administration.\n* Participant agrees not to participate in another interventional study while participating in the present study.\n* Participant has a body mass index (BMI) range of 18.0 to 32.0 kg\u002Fm\\^2, inclusive and weighs at least 50 kg at screening.\n\nExclusion Criteria:\n\n* Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and\u002For other major disease.\n* Participant has a history of malignancy within 2 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence).\n* Participant has had major surgery (e.g., requiring general anesthesia) within 90 days before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 5 half-lives (approximately 8 to 9 days) after the dose of study drug administration or end-of-study visit (ESV), whichever is longer.\n* Participant has previously undergone a cholecystectomy.\n* Participant has\u002Fhad febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day -1.\n* Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria within 2 years before screening.\n* Participant has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease or a family history of long QT syndrome.\n* Participant has used any prescribed or nonprescribed drugs (including vitamins and natural and herbal remedies, e.g., St. John's Wort) in the 28 days prior to day -1, except for occasional use of acetaminophen (up to 2 g\u002Fday) and topical dermatological products (including corticosteroid products).\n* Participant has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 28 days prior to day -1.\n* Participant has received a coronavirus disease 2019 (COVID-19) vaccine within the 14 days prior to day -1 or will have a COVID-19 vaccine dose before the ESV.\n* Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.\n* Participant has participated in more than 2 radiolabeled studies within 12 months prior to day -1 (participation in a previous radiolabeled study has to have been at least 4 months prior to day -1 where exposures are known to the investigator, or 6 months prior to day -1 where exposures are not known to the investigator).\n* Participant has any liver test result (alkaline phosphatase \\[ALP\\], alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\] and total bilirubin \\[TBL\\]) ≥ 1.5 × upper limit of normal (ULN) on day -1.\n* Participant has clinically significant creatinine elevation.\n* Participant has any of the following conditions on day -1: mean pulse \\\u003C 45 or \\> 90 bpm; mean systolic blood pressure (SBP) \\> 140 mmHg; mean diastolic blood pressure (DBP) \\> 90 mmHg (measurements taken in triplicate after participant has been resting in the supine position for at least 5 minutes; pulse measured automatically). If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.\n* Participant has a mean corrected QT interval by Fridericia (QTcF) of \\> 450 msec on day -1.\n* Participant tests positive for alcohol at screening or on day -1.\n* Participant tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) at screening or on day -1.\n* Participant tests positive for cannabinoids on day -1.\n* Participant has a positive serology test for hepatitis A virus (HAV) antibodies immunoglobulin M (IgM), hepatitis B (HBc) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or antibodies to human immunodeficiency virus (HIV) type 1 and\u002For type 2 at screening.\n* Participant has any condition, that makes the participant unsuitable for study participation.\n* Participant has exposure to significant diagnostic or therapeutic radiation (e.g., serial X ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to day -1.\n* Participant has a known or suspected hypersensitivity to ASP3082 or any components of the formulation used.\n* Participant has a history of smoking \\> 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to day -1 or the participant tests positive for cotinine at screening or day -1.\n* Participant has a history of consuming \\> 10 units of alcoholic beverages per week within 3 months prior to screening (Note: 1 unit = 12 ounces of beer, 5 ounces of wine, 1.5 ounce of spirits\u002Fhard liquor).\n* Participant has used any drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cocaine and\u002For opiates) within 3 months prior to day -1.\n* Participant has had significant blood loss, donated ≥ 1 unit (450 mL) of whole blood or donated plasma within 7 days prior to day -1 and\u002For received a transfusion of any blood or blood products within 60 days prior to day -1.\n* Participant has had previous exposure with ASP3082.\n* Participant is an employee of Astellas, the study-related contract research organizations (CROs) or the clinical unit.","MALE",{"count":311,"type":22},8,[225],"Setidegrasib (ASP3082) is being developed for certain cancers. In this study, the researchers want to understand how it is processed by the body in healthy male volunteers.\n\nTo do this, \\[14C\\] which is a certain chemical (called a tracer, or radionuclide) has been added to setidegrasib. \\[14C\\] gives off radiation, but the dose is very low (about the same as the dose from an x-ray) and will leave the body within a few days. \\[14C\\] will be picked up by a scanner and will be used to follow setidegrasib through the body. \\[14C\\]setidegrasib will be given as 1 single injection slowly through a vein (infusion).\n\nThe men will stay overnight in the clinic for at least 2 weeks. They will give regular blood, urine and stool samples during their stay and will be closely monitored. The men will return to the clinic about 1 week later for a final safety check.",[26],[316,317,318,319],"ASP3082","Setidegrasib","Pharmacokinetics","Healthy Volunteers","2026-08-16",{"date":231,"type":35},{"date":323,"type":22},"2026-08-31",{"date":325,"type":22},"2026-10-31",{"name":327,"class":239},"Astellas Pharma Global Development, Inc.",{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":174,"sex":17,"minAge":18,"maxAge":334,"enrollmentInfo":335,"targetDuration":4,"studyType":100,"phases":337,"briefSummary":338,"conditions":339,"keywords":340,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":43},"100533264","variability-in-mixed-meal-tests-fixed-versus-adjusted-to-energy-needs-caloric-dose-100533264","NCT06223555","Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose","* 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* Agreement to adhere to Lifestyle Considerations throughout study duration.\n* Males and females; Age \\>= 18years\n* Healthy, as determined by medical history, physical examination, and laboratory tests.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this\n\nstudy:\n\n* Current use of medications, dietary supplements, or alternative therapies known to alter energy metabolism.\n* Fasting plasma glucose \\>= 126 mg\u002FdL\n* Type I or Type II Diabetes Mellitus by self-report.\n* Hematologic disorders including significant anemia (male hemoglobin \\\u003C 13.0 g\u002FdL or female hemoglobin \\\u003C 11.0 g\u002FdL)\n* Current pregnancy, pregnancy within the past 6 months or currently lactating\n* History or self-report of gastrointestinal disease, including inflammatory bowel diseases (e.g. Chron s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active) which may alter metabolism or absorption of study food by self-report\n* Evidence of alcohol abuse as defined by an 8-point score on the Alcohol consumption screening AUDIT questionnaire in adults.\n* Participants who report taking large doses of acetaminophen (\\> 3 grams daily) who cannot stop acetaminophen 24 hours prior to and following the meal tests will be excluded from the study.\n* Inability to consume provided food based on a food allergy or intolerance.\n* Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators.\n* Any disorder, unwillingness, or inability 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 (such as claustrophobia).\n\nConditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators.","99 Years",{"count":336,"type":22},79,[151],"Background:\n\nResearchers use mixed meal tolerance tests (MMTTs) to look at how people s bodies respond to eating a meal. However, researchers do not agree on how to decide the number of calories to give in each meal. Some use fixed meals, which are the same size for everyone, and some use adjusted meals, based on the size of the person s body. Researchers want to know which MMTT is best to use for future research.\n\nObjective:\n\nTo learn how fixed vs adjusted meals affect blood glucose levels in healthy people.\n\nEligibility:\n\nHealthy people aged 18 years or older.\n\nDesign:\n\nParticipants will have 3 or 4 clinic visits of up to 8 hours in 8 weeks.\n\nParticipants will have baseline tests:\n\nTheir height, weight, and waist size will be measured.\n\nThey will have an oral glucose tolerance test: A needle attached to a tube (IV) will be inserted into a vein in the arm. They will have a sugary drink. Blood samples will be taken from the tube at intervals up to 3 hours after the drink.\n\nThey will have a body scan.\n\nParticipants will have 2 MMTT visits. One will include a fixed meal and one will include an adjusted meal. They will have tests at both visits:\n\nResting metabolic rate: A clear hood will be placed over the participant s head while they rest for 20 minutes. This will measure the oxygen they breathe in and out.\n\nMMTT. Participants will have 5 minutes to drink a liquid meal. Blood samples will be taken at intervals for the next 4 hours....",[133,26],[26,133,341,342,343,344],"Body Composition","Diet","Mixed Meal Test","Glucose","2026-08-15",{"date":347,"type":35},"2026-08-18",{"date":349,"type":35},"2024-08-23",{"date":351,"type":22},"2027-12-31",{"name":65,"class":42},{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":174,"sex":17,"minAge":18,"maxAge":199,"enrollmentInfo":359,"targetDuration":4,"studyType":100,"phases":361,"briefSummary":362,"conditions":363,"keywords":365,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":43},"100153235","development-of-magnetic-resonance-spectroscopic-imaging-techniques-for-imaging-metabolites-in-human-brain-and-muscle-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":360,"type":22},300,[151],"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....",[364,26],"Brain Mapping",[366,367,209,368,369],"Brain Metabolism","Neurochemistry","Mental Illness","Magnetic Resonance Spectroscopy",{"date":347,"type":35},{"date":372,"type":35},"2011-01-27",{"date":374,"type":22},"2026-10-23",{"name":89,"class":42},{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":382,"enrollmentInfo":383,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":385,"conditions":386,"keywords":387,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":43},"100309156","recruitment-and-characterization-of-healthy-research-volunteers-for-nimh-intramural-studies-100309156","NCT03304665","Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies","* INCLUSION CRITERIA:\n* 18 - 70 years of age.\n* Able to read, speak, and understand English.\n* Able to provide informed consent.\n* In current good general health.\n\nEXCLUSION CRITERIA:\n\n* Have a history of significant or unstable medical or mental health condition requiring treatment, such as heart or lung disease, depression or psychosis.\n* Endorse current self-injury, suicidal thoughts or behavior.\n* Have current illicit drug use by history or urine drug screen.\n* Are found to have an abnormal physical exam or laboratory result that may require treatment or further evaluation.\n* Less than an 8th grade education.\n* Pregnancy.\n* Positive HIV test as HIV positivity has been associated with neurological changes.\n\nOptional Brain MRI scan exclusion criteria:\n\n* Metal in body which would make having an MRI scan unsafe.\n* Being uncomfortable in small, closed spaces such as the MRI machine.\n* Inability to lie comfortably on back for at least 45 minutes.\n* Pregnancy.\n\nOptional MEG recording exclusion criteria:\n\n-Metal in body which would cause artifacts on MEG recordings.","70 Years",{"count":384,"type":22},2000,"Objective: To screen and create a list of adult volunteers in good health for participation in research studies conducted at the National Institutes of Health (NIH) in Bethesda, Maryland. Develop a normative set of structural and functional brain MRI scans that are linked to healthy research volunteer characteristics. Maximize scientific impact of data from volunteers by broadly sharing with other researchers.\n\nStudy Population: Adult males and females in general good health who are 18 years of age and older.\n\nDesign: Adult individuals who are interested in participating in NIMH IRP clinical studies as a healthy research volunteer can directly visit or be directed to visit the study website where they will first consent electronically and then complete a set of online self-report measures. Items may include: demographic information, mental health symptoms, disability status, substance use patterns, handedness and clinical\u002Ffamily history. Individuals who are flagged based on predetermined responses to survey items will be further screened by a member of the study clinical team. If found to be ineligible for the study because of a clinically significant or unstable medical or mental health condition, these individuals will be referred back to the community and\u002For given information about NIMH clinical studies for which they may be eligible. Respondents with no flags or who pass through additional screening will be scheduled for an in-person assessment. During the outpatient appointment and after in-person informed consent, participants will receive a brief clinical interview to screen for current medical and mental conditions, and risk for self-harm. They will complete assessments of psychological, emotional, physiologic, biological and cognitive functioning. Participants will undergo a physical exam and be asked to provide blood and urine samples for routine clinical labs. Participants can separately consent for an optional baseline brain magnetic resonance imaging (MRI) scan and an optional magnetoencephalography (MEG) exam. All consent forms will explicitly inform participants that if enrolled in the study, their de-identified data will be broadly and publicly shared through NIH-approved data repositories. Participants in this recruitment and characterization study will then be placed on a list of healthy research volunteers from which other NIMH IRP studies may recruit according to the inclusion and exclusion criteria in their respective IRB-approved protocols.\n\nOutcome Measures: Outcome measures may include demographic data, mental and medical history and symptoms, results of psychological, emotional, physiologic, biological, and cognitive testing, physical exam and MRI findings....",[26],[26,388,389],"Mental Health","Common Data Elements","2026-08-14",{"date":274,"type":35},{"date":393,"type":35},"2017-11-01",{"date":395,"type":22},"2028-03-01",{"name":89,"class":42},{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":174,"sex":17,"minAge":18,"maxAge":199,"enrollmentInfo":403,"targetDuration":4,"studyType":100,"phases":405,"briefSummary":406,"conditions":407,"keywords":410,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":43},"100290790","phase-1-neuropharmacologic-imaging-and-biomarker-assessments-of-response-to-acute-and-repeated-dosed-ketamine-infusions-in-major-depressive-disorder-100290790","NCT03065335","Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder","* INCLUSION CRITERIA:\n\nInclusion Criteria: All Subjects (Main Study)\n\n1. 18 to 65 years of age.\n2. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n3. All subjects must have undergone a screening assessment under either protocol 01-M-0254, \"The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers\" or protocol 17-M-0181 (\"Recruitment and Characterization of Research Volunteers for NIMH Intramural Studies\").\n4. Agree to be hospitalized\n\nAdditional Inclusion Criteria: Patients with MDD (Main Study)\n\n1. At the initial study enrollment, subjects must have fulfilled DSM-IV or DSM-5 criteria for Major Depression, single episode or recurrent. Subjects must be experiencing a current major depressive episode of at least 2 weeks duration.\n2. At the initial screening and beginning of Phases II and III, subjects must have a baseline score on the MADRS \\>= 20 and YMRS of \\\u003C 12.\n3. Current or past history of lack of response to one adequate antidepressant trial, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT would count as an adequate antidepressant trial.\n\nKetamine Metabolites Substudy Inclusion Criteria: Healthy Volunteers\n\n1. 18 to 65 years of age.\n2. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n3. All subjects must have undergone a screening assessment under either protocol 01-M-0254 \"The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers\") or 17-M-0181 (\"Recruitment and Characterization of Research Volunteers for NIMH Intramural Studies\").\n4. Agree to be hospitalized.\n\nEXCLUSION CRITERIA:\n\nAdditional Exclusion Criteria: Patients with MDD (Main Study)\n\n1. Current diagnosis of Bipolar Disorder including Bipolar I, Bipolar II, or Bipolar NOS diagnoses.\n2. Current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-5.\n3. Subjects with a history of DSM-IV or DSM-5 drug or alcohol dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3 months. In addition, subjects who currently are using drugs (except for caffeine or nicotine) must not have used illicit substances or known drugs of abuse in the 2 weeks prior to screen and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines or stimulants) urine test at screening.\n4. Treatment with a reversible MAOI within two weeks prior to Phase II.\n5. Subjects who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.\n\nExclusion Criteria: All Subjects (Main Study)\n\n1. Pregnant or nursing women or women who plan to become pregnant. Women who are able to get pregnant must be willing to use at least one form of effective birth control during the entire period of study participation (or until last clinical labs and rating) and have a negative pregnancy test that was obtained no more than 24 hours prior to MRI and infusion of ketamine.\n2. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, coronary artery disease, atherosclerotic ischemic stroke, and atrial fibrillation), endocrinologic, neurologic, immunologic, or hematologic disease.\n3. Clinically significant abnormal laboratory tests.\n4. Subjects with one or more seizures without a clear and resolved etiology or current use of medication known to lower seizure threshold. History of seizure (regardless of age or etiology), history of epilepsy in self or first-degree relatives, stroke, brain surgery, head injury, or known structural brain lesion will be excluded from the TMS procedures.\n5. Treatment with any other concomitant medication 14 days prior to Phase II. An exception of this would be necessary for those who are taking Fluoxetine or Aripiprazole. Prior to Phase II, treatment with Fluoxetine must be discontinued for at least 5 weeks and treatment with Aripiprazole must be discontinued for at least 3 weeks.\n6. Any use of opioid medication in the past 3 months\n7. Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip) (for subjects doing imaging component of the study only).\n8. Presence of any medical illness likely to alter brain morphology and\u002For physiology (e.g., hypertension, diabetes) even if controlled by medications.\n9. Subjects who have hearing loss that has been clinically evaluated and diagnosed\n10. Participants who are uncomfortable in small closed spaces (have claustrophobia), unable to lie comfortably supine for up to 90 minutes, and would feel uncomfortable in the MRI machine (for subjects doing imaging component of the study only).\n11. Positive HIV test\n12. Weight \\> 119 kg\n13. \\[for participants undergoing NPU Threat Test with Auditory Startle\\] Known history of hearing loss\n\nAdditional Exclusion Criteria: Healthy Volunteers (Main Study)\n\n1\\. Current or past history of any DSM-IV or DSM-5 Axis I disorder based on clinical assessment and confirmed by a structured diagnostic interview (SCID).\n\nKetamine Metabolites Substudy Exclusion Criteria: Healthy Volunteers\n\n1. Current or past history of any DSM-IV or DSM-5 Axis I disorder based on clinical assessment and confirmed by a structured diagnostic interview (SCID).\n2. Current (within the past 3 months) or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine)\n3. Pregnant or nursing women or women who plan to become pregnant. Women who are able to get pregnant must be willing to use at least one form of effective birth control during the 4-days of the study participation (or until last clinical labs and rating) and have a negative pregnancy test that was obtained no more than 24 hours prior to infusion of ketamine.\n4. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, coronary artery disease, atherosclerotic ischemic stroke, and atrial fibrillation), endocrinologic, neurologic, immunologic, or hematologic disease.\n5. Clinically significant abnormal laboratory tests.\n6. Subjects with one or more seizures without a clear and resolved etiology or current use of medication known to lower seizure threshold.\n7. Treatment with any other concomitant medication.\n8. Any use of opioid medication in the past 3 months\n9. Positive HIV test\n10. Weight \\> 119 kg\n11. Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip) (for subjects doing neuroimaging component of the study only).\n12. Participants who are uncomfortable in small closed spaces (have claustrophobia), unable to lie comfortably supine for up to 90 minutes, and would feel uncomfortable in the MRI machine (for subjects requiring clinical MRI scans for safety and\u002For structural MRI scans for MEG coregistration).",{"count":404,"type":22},150,[225],"Background:\n\nMost medications that treat depression take weeks or months to work. Researchers want to develop fast-acting treatments. One dose of ketamine has a rapid antidepressant effect. For most people, this lasts a week or less. Repeated doses of ketamine may help maintain this effect.\n\nObjective:\n\nMain Study: To study the effects of ketamine in treating depression.\n\nKetamine Metabolites Substudy: To study how ketamine effects brain chemistry.\n\nTo study how ketamine effects the brain. This is done by looking at metabolites, which are created when a drug is broken down.\n\nEligibility:\n\nMain Study: People ages 18-65 with major depressive disorder and healthy volunteers\n\nKetamine Metabolites Substudy: Healthy volunteers ages 18-65\n\nDesign:\n\nMain Study:\n\nParticipants will be screened in another study, with:\n\n* Medical and psychiatric history\n* Psychiatric and physical exam\n* Blood, urine, and heart tests\n\nParticipants will be inpatients at NIH for 4 phases totaling 14-20 weeks.\n\nPhase I (2-7 weeks):\n\n* Gradually stop current medications\n* MRI: Participants lie and perform tasks in a machine that takes pictures of the body.\n* Mood and thinking tests\n* Blood and urine tests\n* Sleep test: Monitors on the skin record brain waves, breathing, heart rate, and movement during sleep.\n* Transcranial magnetic stimulation: A coil on the scalp gives an electrical current that affects brain activity.\n* Stress tests: Electrodes on the skin measure reactions to loud noises or electric shocks.\n\nPhase I tests are repeated in Phases II and III and in the final visit.\n\nPhase II (4-5 weeks):\n\n* 4 weekly IV infusions of ketamine or a placebo during an MRI or MEG. For the MEG, a cone over the head records brain activity.\n\nPhase III (optional):\n\n* 8 infusions of ketamine over 4 weeks\n\nPhase IV (optional):\n\n* Symptoms monitoring for 4 weeks\n* Participants will have a final visit. They will be offered standard treatment at NIH for up to 2 months.\n\nKetamine Metabolites Substudy:\n\nParticipants will be screened in another study, with:\n\n* Medical and psychiatric history\n* Psychiatric and physical exam\n* Blood, urine, and heart tests\n\nParticipants will be inpatients at NIH for 4 days.\n\nStudy Procedures:\n\nMood and thinking tests\n\nBlood and urine tests\n\n1 infusion of ketamine\n\nSpinal tap and spinal catheter: Used to get samples of cerebrospinal fluid (CSF). This is a fluid that moves around and within the brain and spinal cord. Studying CSF will help us learn how ketamine effects brain chemistry",[26,408,409],"Major Depressive Disorder","Depression",[209,411,408,412,413],"Magnetoencephalography","Ketamine","Neuropharmacology",{"date":274,"type":35},{"date":416,"type":35},"2017-05-25",{"date":418,"type":22},"2028-01-01",{"name":89,"class":42},{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":174,"sex":17,"minAge":18,"maxAge":97,"enrollmentInfo":427,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":429,"conditions":430,"keywords":431,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":43},"100272105","collection-of-peripheral-blood-mononuclear-cells-pbmcs-from-healthy-people-for-the-expansion-of-t-cells-for-adoptive-cell-therapy-100272105","NCT02821806","Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy People for the Expansion of T Cells for Adoptive Cell Therapy","Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy Subjects for the Expansion of T Cells for Adoptive Cell Therapy","* INCLUSION CRITERIA:\n* Age greater than or equal to 18 years old and able to give consent.\n* Adequate clinical parameters (all of the following):\n\n  * Afebrile (temperature less than or equal to 37.5 degree C)\n  * Systolic blood pressure less than or equal to180 mmHg\n  * Diastolic blood pressure less than or equal to100 mmHg\n  * Weight greater than or equal to 110 lbs.\n  * Heart rate between 50-100 beats\u002Fminute\n  * Adequate bilateral antecubital venous access for a 2 arm apheresis procedure\n* Females of child-bearing potential should not be pregnant or breast-feeding.\n* Within 30 days of pheresis donation, donors must be negative for infectious disease work-up: Antibody screen for Hepatitis B, Hepatitis C; HIV, HTLV-I\u002FII, T. cruzi (Chagas agent), West Nile, and syphilis (RPR)\n* Within 30 days of pheresis donation, donor must have:\n\n  * Hemoglobin:\n\n    * Women greater than or equal to 12.5 gm\u002FdL\n    * Men greater than or equal to 13.0 gm\u002FdL\n  * Platelets greater than or equal to 100,000\u002Fmicroliter\n  * Total WBC greater than or equal to 2 K\u002Fmicroliter\n\nEXCLUSION CRITERIA:\n\n* History of medical illness that in the estimation of the PI or DTM physician precludes donation of PBMCs.\n* Current psychiatric diagnosis that would compromise compliance with donation or precludes appropriate informed consent.\n* Presence of any blood transmissible infectious disease that cannot be cleared prior to PBMC donation and poses an unacceptable risk for the recipient.\n* Active malignancy will exclude the donor. Any history of malignancy will be considered on a case by case basis in accordance with NIH\u002FDTM criteria.\n* If the participant answers Yes to any initial screening question, the participant will be considered ineligible.\n* If the participant is deferred according to DTM Cellular Therapy Screening Standard Operating Procedures (SOP), the participant will be considered ineligible.",{"count":428,"type":22},500,"Title: Collection of Peripheral Blood Mononuclear Cells (PBMCs) from Healthy People for the Expansion of T Cells for Adoptive Cell Therapy\n\nBackground:\n\nNew therapies are being developed that use a person s own immune system to fight tumors. Some of the tumors being studied include cancers caused by viruses. Researchers want to use the healthy cells of volunteers to perform research studies. To do this, they are collecting lymphocytes through leukapheresis.\n\nObjectives:\n\nTo collect healthy cells from volunteers for research studies for new cancer therapies.\n\nEligibility:\n\nHealthy people ages 18 and older\n\nDesign:\n\nParticipants will be screened with a standard donor questionnaire. It asks about their health and past medical problems. It also asks about risky behaviors that could increase their exposure to viruses or bacteria that could be transmitted through a transfusion. Participants will give a blood sample to make sure they are able to donate. They will have a physical exam. A finger stick test will check their hemoglobin, or red blood cell, level. They might give a urine sample.\n\nParticipants will undergo apheresis. For this, a needle is placed in a vein in each of their arms. Their blood is taken from one arm. A machine separates the white cells from the red cells and plasma by a spinning process. The white cells are removed and directed into a plastic bag. The red cells and plasma are returned through the needle in the other arm. The entire procedure takes 4 6 hours.\n\nParticipants may donate every 21 days in this protocol if they choose to.",[26],[432,433,434,435,210],"Normal Volunteer","Donation","Adoptive T Cell Therapies","Peripheral Blood Mononuclear Cells",{"date":274,"type":35},{"date":438,"type":35},"2016-08-08",{"date":440,"type":22},"2035-02-01",{"name":442,"class":42},"National Cancer Institute (NCI)",{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":174,"sex":17,"minAge":450,"maxAge":451,"enrollmentInfo":452,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":453,"conditions":454,"keywords":455,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":4,"leadSponsor":463,"locationsCount":43},"100180885","normal-values-in-hearing-and-balance-testing-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":428,"type":22},"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.",[26],[456,457,458,319,459,210],"Normative Data","Vestibular","Auditory","Hearing",{"date":274,"type":35},{"date":462,"type":35},"2012-09-21",{"name":464,"class":42},"National Institute on Deafness and Other Communication Disorders (NIDCD)",{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":174,"sex":17,"minAge":18,"maxAge":147,"enrollmentInfo":472,"targetDuration":4,"studyType":100,"phases":474,"briefSummary":475,"conditions":476,"keywords":477,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":43},"100645339","study-to-assess-how-different-oral-formulations-of-ubrogepant-move-through-the-body-in-healthy-adult-participants-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":473,"type":22},52,[225],"This study will assess how different oral formulations of ubrogepant move through the body in healthy adult participants under fasting and fed conditions.",[26],[26,478],"Ubrogepant","2026-08-07",{"date":481,"type":35},"2026-08-10",{"date":483,"type":35},"2026-07-14",{"date":485,"type":22},"2026-10",{"name":487,"class":239},"AbbVie",{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":494,"eligibilityCriteria":495,"healthyVolunteers":174,"sex":17,"minAge":199,"maxAge":496,"enrollmentInfo":497,"targetDuration":4,"studyType":100,"phases":498,"briefSummary":499,"conditions":500,"keywords":502,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":514},"100632647","safety-and-tolerability-trial-of-psilocybin-in-healthy-older-adults-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":21,"type":22},[225],"This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.",[26,501],"Older Adults (65-85 Years)",[503,504,505],"healthy older adults ages 65-85","psilocybin safety","psilocybin tolerability","2026-08-06",{"date":481,"type":35},{"date":509,"type":35},"2026-04-01",{"date":511,"type":22},"2028-03",{"name":513,"class":260},"University of Colorado, Denver",6,{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":174,"sex":17,"minAge":18,"maxAge":522,"enrollmentInfo":523,"targetDuration":4,"studyType":100,"phases":524,"briefSummary":525,"conditions":526,"keywords":4,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":528,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":43},"100599872","power-nap-with-tes-ti-100599872","NCT07090135","Power Nap With TES-TI","Enhance the Restorative Power of Sleep Through TES-TI Power Naps","Inclusion Criteria:\n\n* Adults aged 18-75 of any gender identity\n* Self-reported non-restorative sleep, as measured by a REST-Q score\n* English-speaking (able to provide consent and complete questionnaires)\n* Capable of taking daytime naps\n* US Citizen\n\nExclusion Criteria:\n\n* Any current or history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions\n* History of inpatient psychiatric hospitalization\n* History of head trauma resulting in prolonged loss of consciousness; or a history of \\>3 grade I concussions\n* Current history of poorly controlled headaches including intractable or poorly controlled migraines\n\n  • Any systemic illness or unstable medical condition that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n* History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG, or family history of treatment resistant epilepsy except for a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist\n* Possible pregnancy or plan to become pregnant in the next 6 months\n* Any metal in the head\n* Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator)\n* Dental implants\n* Permanent retainers\n* Any hair braid, dreadlocks, hair pieces, or extensions which cannot be taken out before the study sessions\n* Any head coverings or headdress that participant feels uncomfortable removing for the purposes of study sessions\n* Any medication that may alter seizure threshold taken during the study i.e., ADHD stimulants (Adderall, amphetamine); Tricyclic\u002Fatypical antidepressants (amitriptyline, doxepine, imipramine, maprotiline, nortriptyline, bupropion); Antipsychotics (chlorpromazine, clozapine), Bronchodilators (theophylline, aminophylline); Antibiotics (fluoroquinolones, imipenem, penicillin, cephalosporins, metronidazole, isoniazid); Antivirals (valacyclovir, ritonavir); OTC antihistamines (diphenhydramine, Benadryl)\n* Claustrophobia (a fear of small or closed places)\n* Back problems that would prevent lying flat for up to two hours\n* Regular night-shift work (second or third shift)","75 Years",{"count":7,"type":22},[151],"The goal of this clinical trial is to find out whether stimulating the brain with electrical current during naps can increase certain kinds of brain activity that happen during sleep and lead to improvements in mental fatigue.\n\nParticipants will attend 2 study visits, each of which may last up to 4-5 hours. During these visits, participants will wear a high density electroencephalography (hdEEG) cap and take a nap.",[527,26],"Non-restorative Sleep",{"date":481,"type":35},{"date":530,"type":35},"2025-12-19",{"date":532,"type":22},"2026-09",{"name":534,"class":260},"University of Wisconsin, Madison",{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":174,"sex":17,"minAge":18,"maxAge":97,"enrollmentInfo":542,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":544,"conditions":545,"keywords":548,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":554,"startDateStruct":555,"completionDateStruct":4,"leadSponsor":557,"locationsCount":43},"100057075","study-of-new-magnetic-resonance-imaging-methods-of-the-brain-100057075","NCT00004577","Study of New Magnetic Resonance Imaging Methods of the Brain","Characterization of Brain Morphology and Activity Using Functional and Anatomical MRI Contrast","* INCLUSION CRITERIA:\n* 18 years of age and older\n* in good general health\n* able to understand the procedures and requirements and give informed consent\n\nEXCLUSION CRITERIA:\n\nAll Subjects will undergo a neurological physical and answer the Healthy volunteer form, and the most-recent version of the NMR safety screening form\n\nA subject will be excluded if he\u002Fshe:\n\n1. has any metal implant or objects of unknown identity or composition, or if it s known to be non-compatible with MRI, such as pacemakers, medication pumps, aneurysm clips, metallic prosthesis (such as heart valves or cochlear implants), certain orthopedic implants (pins and rods), shrapnel, or small metal fragments in the eye;\n2. has claustrophobia;\n3. cannot lie comfortably for up to 120 minutes;\n4. underwent brain surgery or suffered a traumatic head trauma;\n5. has migraines that require medication;\n6. has ever been hospitalized for a psychiatric disorder;\n7. has medical health problems such as pulmonary or airway disease, heart failure, coronary artery disease, and uncontrolled hypertension which would require physiological monitoring during the scan;\n8. has a history of any medical condition that could result in an emergency medical situation while undergoing the MRI scan;\n9. has hearing problems which would make it difficult to tolerate scanner noise;\n10. is pregnant;\n11. has body\u002Fmake-up tattoos (e.g. lips, eyebrows, eyeliner). Each tattoo will be considered on a case-to-case basis, taking into account of the age and location of the tattoo;\n12. has a sleep apnea diagnosis;\n13. has a neurological disorder, such as Stroke, Parkinson s, and Epilepsy;\n14. a member of the NINDS Laboratory of Functional and Molecular Imaging.\n\nThe contraindications to MRI at the various field strengths are almost identical, except the 7 T also excludes subjects with gold dental crowns.",{"count":543,"type":22},1100,"The purpose of this investigation is to develop improved magnetic resonance imaging (MRI) techniques and hardware for studying brain function. MRI is a diagnostic tool that provides information about brain chemistry and physiology. This study will evaluate new MRI methods for monitoring blood flow to regions of the brain in response to simple tasks. The MRI machine used in this study is more powerful than those in most hospitals, permitting a higher visual resolution.\n\nNormal healthy volunteers over 18 years old may be eligible for this study. Candidates will be screened with a medical history and questionnaire, and a neurological examination. Study participants will have a yearly MRI scan. For this procedure, the subject lies on a stretcher that is moved into a donut-shaped machine with a strong magnetic field. A lightweight circular or rectangular coil-a device that improves the quality of the images-may be placed on the head. The scan time varies from 20 minutes to 3 hours; most scans last between 45 and 90 minutes. During the scan, the subject may perform simple tasks, such as listening to tapes, tapping a finger, moving a hand, watching a screen, or smelling a fragrance. More complex tasks may require thinking about tones or pictures and responding to them by pressing buttons.\n\nInformation from this study will be used to develop better imaging methods that will, in turn, permit a greater understanding of normal and abnormal brain behaviors.",[26,209,546,83,364,547],"Healthy","Adult",[549,550,551,552,553,210],"Brain Morphology","Cerebral Blood Volume","Functional Imaging","Development","MEG",{"date":479,"type":35},{"date":556,"type":35},"2000-07-01",{"name":558,"class":42},"National Institute of Neurological Disorders and Stroke (NINDS)",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":174,"sex":17,"minAge":566,"maxAge":19,"enrollmentInfo":567,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":569,"conditions":570,"keywords":574,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":584,"completionDateStruct":4,"leadSponsor":586,"locationsCount":43},"100176270","oral-bacteria-and-immune-system-problems-involved-in-gum-disease-periodontitis-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":568,"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.",[571,572,573,26],"Immunosuppression","Periodontal Disease","Healthy Subjects",[575,576,577,578,210,579,572,580,26,581],"Microbiome","Periodontitis","Oral Mucosal Immunity","Oral Infection","Immune Disorder","Gum Disease","HV","2026-08-05",{"date":506,"type":35},{"date":585,"type":35},"2012-10-05",{"name":587,"class":42},"National Institute of Dental and Craniofacial Research (NIDCR)",{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":174,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":100,"phases":595,"briefSummary":596,"conditions":597,"keywords":600,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":43},"100637325","phase-1-novel-biomarkers-of-non-ige-immediate-hypersensitivity-drug-reactions-100637325","NCT07605806","Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions","Inclusion Criteria:\n\n* Male or female age ≥ 18 years.\n* Adequate kidney function as defined by creatinine level within normal institutional limits at the participant's first visit.\n* Women of child bearing potential must agree to a reliable form of highly effective contraception (hormonal, device, or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 days following completion of vancomycin therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform the Principal Investigator and her treating physician immediately.\n* Ability to understand and the willingness to sign a written informed consent.\n* Ability to clearly understand and speak English at an 8th grade reading level. For safety reasons, participants must speak English due to the anticipated need for clear and timely communication with investigators and the study team in emergency situations, since the investigators and study team are English speaking.\n\nExclusion Criteria:\n\n* Participants who have previously received vancomycin in any formulation, including oral or intravenous.\n* History of allergic reactions to study drug or reactions attributed to compounds of similar chemical or biologic composition to vancomycin, including active product or excipients.\n* Concurrent use of medications thought to cause non-specific mast cell activation (e.g. opioids)\n* Baseline serum tryptase over 8.0 ng\u002FmL and\u002For known mast cell disorder, including, but not limited to, mastocytosis, idiopathic mast cell activation syndrome, and hereditary alpha tryptasemia\n* Active infection or immunodeficiency\n* Unstable cardiovascular disease\n* Renal insufficiency\n* Current hearing deficit\n* Current use of beta-blockers\n* Use of immunomodulatory therapies or oral corticosteroids within the previous 1 month\n* Use of biologics in the previous 6 months, including omalizumab\n* Participants taking antihistamines must stop these drugs for one week prior to enrollment and must refrain from taking antihistamines during the duration of the study so as not to interfere with responses during drug challenge",{"count":7,"type":22},[225,102],"The goal of this clinical trial is to investigate biomarkers of non-IgE-mediated immediate hypersensitivity reactions during infusion of intravenous vancomycin. The main question it aims to answer is:\n\n• Identifying novel biomarkers in blood that occur during infusion reaction\n\nParticipants will:\n\n* Have allergy skin testing for vancomycin\n* Receive an infusion of vancomycin",[26,598,599],"Hypersensitivity Reactions","Vancomycin",[601,602,603],"non-IgE-mediated hypersensitivity reaction","Healthy volunteer","vancomycin","2026-08-03",{"date":582,"type":35},{"date":607,"type":35},"2026-05-21",{"date":609,"type":22},"2027-06-30",{"name":611,"class":260},"Johns Hopkins University"]