[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"healthy-volunteers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:healthy-volunteers":571},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,251,0,25,[9,46,73,95,116,129,139,165,191,210,228,255,276,304,330,352,371,391,418,443,461,484,504,522,547],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100053725",false,"NCT06868914","Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)","Phase I Clinical Trial to Study the Safety and After-effects of Transcranial Magnetic Stimulation (TMS) Using A High-density Theta Burst Stimulation (hdTBS) Paradigm","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Be 22-60 years of age.\n\n  --Justification: Many neural processes change with age, and these changes could introduce unwanted variability in behavior. In addition, the risk of difficult-to detect medical abnormalities such as silent cerebral infarcts increase with age. Children under the age of 22 are excluded from this study because safety of rTMS in children has not been studied. In addition, this study is more than minimal risk and presents no direct benefit.\n* Ability and willingness to provide written informed consent.\n\n  --Justification: Written informed consent must be obtained for this study per NIH policy and federal regulations.\n* Generally in good health.\n\n  * Justification: Many illnesses may alter neural functioning. These will be evaluated by the MAI and excluded as needed.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n-Personal history of stroke, brain lesions, previous neurosurgery, any personal history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than two days or other neurological condition deemed by the MAI to be likely to affect response to the TBS being delivered.\n\n* Justification: Stroke or head trauma can lower the seizure threshold, and are therefore contra indications for TMS. Fainting episodes or syncope of unknown cause could indicate an undiagnosed condition associated with seizures.\n\n  -First-degree family history of any form of epilepsy with a potentially hereditary basis.\n* Justification: First-degree family history of epilepsy with a hereditary component increases the risk of the participant having an undiagnosed condition that is associated with lowered seizure threshold.\n\n  -Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object in the body that precludes TMS intervention.\n* Justification: Any metal around the head is a contraindication for TMS, as it involves exposure to a relatively strong magnetic field.\n\n  -Noise-induced hearing loss or tinnitus.\n* Justification: individuals with noise-induced hearing problems may be particularly vulnerable to the acoustic noise generated by TMS equipment.\n\n  -Current use (any use in the past 4 weeks, chronic use within 6 past six months) of any investigational drug or of any medications with psychotropic, anti or pro-convulsive action.\n* Justification: The use of certain medications or drugs can lower seizure threshold and is therefore contraindicated for TMS.\n\n  -Lifetime history of major depressive disorder, schizophrenia, bipolar disorder, mania, or hypomania.\n* Justification: The population of interest here is a healthy control population with no psychiatric disorders. In participants with depression, bipolar disorder, mania or hypomania, there is a small chance that TMS can trigger (hypo)manic symptoms.\n\n  -Current use of nicotine (self-report, urine cotinine test and\u002F or CO consistent with smoker) or history of more than 20 cigarettes or 20 instances of nicotine use in lifetime or history of daily nicotine use.\n* Justification: The population of interest here is a healthy control population with no substance use disorder and therefore a minimal nicotine exposure history in the control group is required.\n\n  -Current regular use of more than 2 cups of coffee or equivalent caffeine intake in the morning (not total daily intake).\n* Justification: Excessive caffeine use can reduce seizure threshold and could potentially increase risk of TMS-induced seizure.\n\n  -Meet current DSM-5 criteria for any substance use disorder, or urine toxicology positive for any illicit substance inconsistent with history given.\n* Justification: The population of interest is a healthy control population with no substance use disorder. Current use of illicit substances could lower seizure threshold and is therefore contraindicated for TMS.\n\n  -Have met DSM-5 criteria for any substance use disorder in the past.\n* Justification: the population of interest is a healthy control population with no present or past substance use disorder.\n\n  -History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or any heart condition currently under medical care.\n* Justifications: the risk of TMS for individuals with a heart condition is unknown.\n\n  -Pregnant individuals or individuals with reproductive potential who are sexually active and do not report using contraception.\n* Justification: it is unknown whether TMS poses a risk to fetuses.\n\n  -Otherwise TMS incompatible or have participated in any noninvasive brain stimulation (NIBS) session in the past two weeks or a NIBS treatment course in the past 6 months.\n* Justification: in order to limit exposure to TMS, we will not enroll participants who have received TMS less than two weeks ago.","ALL","22 Years","60 Years",{"count":20,"type":21},35,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Background:\n\nTranscranial magnetic stimulation (TMS) uses magnetic pulses to affect brain activity. A type of TMS called theta burst stimulation (TBS) is approved to treat people with major depression. Researchers have developed a new form of TBS called high-density TBS (hdTBS). They hope hdTBS will work better than TBS. But first they need to test the new treatment in healthy adults.\n\nObjective:\n\nTo test hdTBS in healthy adults. Also, to compare the aftereffects of hdTBS and TBS.\n\nEligibility:\n\nHealthy adults aged 22 to 60 years.\n\nDesign:\n\nParticipants will have 4 clinic visits over about 3 to 4 weeks. They must abstain from drugs and alcohol and limit caffeine before visits.\n\nAt their first visit, participants will be oriented to TBS. They will wear a cap and earplugs. A device with round coils will be placed near their head. When a brief electric current passes through the coil, it generates a magnetic pulse that stimulates the brain. Participants may feel a pulling sensation on the skin under the coil. Their fingers may move involuntarily.\n\nAt their next 3 visits, participants will receive either TBS or sham TBS. A sham TBS uses a low magnetic field to minimize the effects of the treatment. Participants will have up to 9 electrodes placed on 1 arm. These electrodes will measure the electrical activity in their muscles. Each TBS session will be videotaped.\n\nAt every visit, participants will answer questions about their health, including substance use. They will perform 2 tasks to test their thinking skills. They will perform a test on a computer to test their reaction time....",[27],"Healthy Volunteers",[29,30,31,32],"Substance Use Disorders (SUDs)","Transcranial Magnetic Stimulation (TMS)","Theta Burst Stimulation (TBS)","High-density Theta Burst Stimulation (hdTBS)","NOT_YET_RECRUITING","2026-07-10",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":21},"2026-07-16",{"date":41,"type":21},"2028-01-13",{"name":43,"class":44},"National Institute on Drug Abuse (NIDA)","NIH",1,{"id":47,"slug":4,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":69,"leadSponsor":71,"locationsCount":45},"100054021","NCT07504601","Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain 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\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Aged 18-60\n4. In good general health as evidenced by medical history\n5. Ability to take intravenous medication and be willing to adhere to the (2R,6R)-HNK regimen\n6. For females of reproductive potential: Use of highly effective contraception starting at the time of enrollment and agreement to use such a method during study participation and for an additional four weeks after the end of participation\n7. For males of reproductive potential: Use of condoms or other effective contraceptive methods from the time of enrollment, and for an additional 90 days after the end of participation\n8. Agreement to adhere to Lifestyle Considerations throughout study duration\n9. Ability of participant to understand and the willingness to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:00\n\n1. Current use of disallowed concomitant medications.\n2. Presence of ferromagnetic devices or any devices that could pose a risk relating to the safety of the fMRI procedure, including implanted cardiac pacemaker or auto-defibrillator, insulin pump, ferromagnetic metal in the cranial cavity or eye (e.g. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body), and irremovable body piercings.\n3. Pregnancy or lactation.\n4. Has a clinically important acute or active chronic disease\n5. Has a history of any clinically important cardiovascular findings\n6. Has a history of serious medical illness, including but not limited to the following body systems and organs or those that in the judgment of the Principal Investigator and Medical Advisory Investigator pose a risk to the participant s ability to safely participate in the study:\n\n   1. Hepatic diseases (e.g. active viral hepatitis infection or cirrhosis of the liver)\n   2. Cardiovascular disease (including ischemic heart disease, coronary artery disease, congestive heart failure, poorly controlled hypertension due to risk of further blood pressure elevation and increase in demand on cardiac function from study drug)\n   3. Renal\u002Furologic (e.g chronic kidney disease or acute kidney injury, history of bladder dysfunction due to theoretical risk of ketamine-induced cystitis)\n   4. Endocrinologic (including diabetes due to association with progressive abnormality of the microvasculature and nervous system)\n   5. Central nervous system disorder, neuromuscular disease, or other neurologic disorder (e.g. stroke, brain damage, elevated intraocular pressure or history of or presence of diseases that are associated with elevated intracranial pressure).\n   6. Pulmonary disease (e.g., asthma, emphysema, chronic bronchitis)\n7. Has a clinically important vital sign, ECG, or clinical laboratory finding.\n8. Has a major medical condition or medical history that in a clinician's assessment could affect heat sensitivity, pain thresholds, or somatosensation (e.g., Raynaud s disease, peripheral neuropathy, or circulatory disorder)\n9. Has a significant current psychiatric condition (including mood disorders, anxiety disorders, or substance use disorders) or has a history of psychosis, hospitalization for a mental health condition, or recurrent psychiatric episodes.\n10. Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months).\n11. Has a dermatological condition that might influence cutaneous sensibility such as scars or burns, or has a tattoo in the testing region\n12. Unable to comply with study procedures or follow-up visits.\n13. Those with an abnormality on a structural MRI.\n14. Individuals who are left-handed (based on self-report or score on handedness questionnaire).\n15. Participants who are currently using drugs (except for caffeine, nicotine, or cannabis) must not have used illicit substances or known drugs of abuse in the two weeks prior to screen and must have a negative drug urine test at baseline and on each research visit prior to infusion. Cannabis use is exclusionary if the use is daily, or if participants are unable to abstain during the study, or if function of daily life is impaired by use as determined by a clinician.\n16. Participants with a history of head injury that resulted in loss of consciousness exceeding five minutes.\n17. Participants with unstable clinical hyperthyroidism or hypothyroidism.\n18. Participants with one or more seizures without a clear and resolved etiology.\n19. Clinically significant abnormal laboratory tests specifically defined by:\n\n    1. Alkaline phosphatase (Alk Phos) \\> 150 U\u002FL\n    2. Alanine aminotransferase (ALT) \\>55 U\u002FL\n    3. Aspartate aminotransferase (AST) \\> 34 U\u002FL\n    4. Total bilirubin (TB) \\> 1.2 mg\u002FdL\n    5. Direct bilirubin (DB) \\> 0.5 mg\u002FdL\n    6. 25-hydroxyvitamin D \\\u003C 20 ng\u002FmL\n    7. Folate \\\u003C 2ng\u002FmL\n    8. Vitamin B12 \\\u003C 200 pg\u002FmL\n20. Positive Human Immunodeficiency Virus (HIV) test.\n21. Participants with Coronavirus Disease 2019 (COVID-19) or suspected COVID-19.\n22. NIH employee who is a subordinate\u002Frelative\u002Fco-worker of any investigator on the protocol.\n23. Inability to read and understand English. Non-English speakers will not be eligible as most of the required monitoring and rating instruments are not validated in languages other than English.\n24. Participants may not use any prescription or nonprescription drugs including OTC, herbal medicine, or dietary supplements within 14 days or 5 half-lives, whichever is longer, prior to drug administration.",true,"18 Years",{"count":54,"type":21},92,[56],"PHASE2","Background:\n\nOpioid drugs are often prescribed for acute and chronic pain. But these drugs are addictive, and they lead to more than 14,000 overdose deaths in the United States each year. Researchers want to find new drugs that relieve pain but are not addictive. This study will test whether a single dose of an experimental drug called (2R,6R)-hydroxynorketamine (HNK) can help reduce short term pain in healthy adults. HNK is related to ketamine. Studies suggest HNK might be as effective as ketamine at reducing pain but that it might have fewer side effects. In this study we will test how HNK affects pain and emotion. The results of this study may help us understand whether HNK has pain relieving effects and how it works in the brain, which could inform future pain treatments.\n\nObjective:\n\nTo test the study drug \\[(2R,6R)-hydroxynorketamine (HNK)\\] for treating acute pain in healthy people.\n\nEligibility:\n\nHealthy people aged 18 to 60 years.\n\nDesign;\n\nUp to 92 healthy volunteers between 18 and 60 years old without chronic pain or psychiatric conditions will participate in the study. The study will take place at the NIH Clinical Center in Bethesda, Maryland. Each participant s involvement will last up to two months. The overall study is expected to last about three years (36 months).\n\nThe study has 2 parts.\n\nIn part 1, participants will have up to 2 clinic visits. They will be screened and have blood draws to make sure they're eligible for the study. They will complete sensory testing and have MRI brain scans.\n\nSensory testing involves feeling and rating painful and non-painful sensations. These may include hot or cold temperatures, pinches or squeezes, and being touched with brushes or pinpricks.\n\nEligible participants will have an imaging scan that shows brain activity: During the scan, they will rate heat, hear pleasant or unpleasant sounds, and view unpleasant or pleasant pictures.\n\nAfter completing part 1, eligible participants will be invited to part 2, which includes overnight stays at NIH.\n\nIn part 2, participants will be assigned to either a treatment group or a no-treatment group.\n\nThe treatment group will have 2 overnight visits of 2 nights each. The visits will be 1 to 3 weeks apart. For one of the visits, treatment group participants will receive the study drug HNK. For the other visit, they will receive a placebo. A placebo looks just like the study drug but contains no medicine. HNK and placebo are given through a tube inserted into a vein in the arm. The sensory tests, blood draws, and MRI scans will be repeated at each visit. Participants will not be told whether they got the drug or placebo on each visit.\n\nThe nontreatment group will have 1 overnight visit. They will not receive the drug or placebo. The sensory tests, blood draws, and MRI scans will be repeated.\n\nParticipants cannot drink alcohol, use recreational drugs, or take certain other kinds of medicine or supplements during the study.",[27],[60,61,62,63,64,65,66],"fMRI","Pain","Quantitative Sensory Testing","Ketamine metabolite","Non opioid analgesic","HydroxyNorKetamine (HNK)","(2R,6R)-hydroxynorketamine",{"date":36,"type":37},{"date":39,"type":21},{"date":70,"type":21},"2031-12-31",{"name":72,"class":44},"National Center for Complementary and Integrative Health (NCCIH)",{"id":74,"slug":4,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":45},"100053851","NCT07495813","A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease","A Phase I, Randomized, Double-Blind, Adaptive, Placebo-Controlled, Single- Ascending Dose and Multiple-Ascending Dose, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of RO7763505 Following Oral Administration in Healthy Participants and Patients With Stable Coronary Artery Disease","Inclusion Criteria:\n\nPart 1:\n\n* Healthy biologically male and female participants of nonchildbearing potential or childbearing potential with no clinically relevant findings on physical examination at screening or baseline (assessed either on Day -2 or Day -1), including detailed medical and surgical history, vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology, and urinalysis\n* No suspicion of cognitive impairment\u002Fdementia as judged by the Investigator\n\nPart 2:\n\n* Myocardial infarction before the screening visit\n* Objective imaging evidence (coronary computed tomography \\[CT\\] angiography or invasive angiography) of coronary atherosclerosis Participants who underwent percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) are eligible if the procedure was done \\>6 months prior to screening\n* A diagnosis of stable CAD, defined as being on stable guideline-directed medical therapy (GDMT) if tolerated for at least 90 days prior to screening with no planned changes or scheduled interventions during the study\n* QTc of \\\u003C= 450 milliseconds (ms) as determined by a single 12-lead ECG recording. If the initial ECG result of the triplicate is exclusionary, consecutive repeat ECG results must be within the acceptable limits. In participants with a stable bundle branch block where the QRS duration is \\> 120 ms, the QTcF will be calculated as: QTcF - (QRS - 100 ms)\n\nExclusion Criteria:\n\nPart 1:\n\n* Any condition or disease detected during the medical interview\u002Fphysical examination that would render the participant unsuitable for the study, place the participant at undue risk, or interfere with the ability of the participant to complete the study in the opinion of the Investigator\n* Vaccination within 28 days prior to Day 1 (non-live vaccines including influenza vaccination are permitted 14 days prior to Day 1) or planned before the end of the study. Investigators are advised to review the immunization status of participants who are considered for treatment with RO7763505 and follow local\u002Fnational guidance for adult vaccination against infectious disease as they deem relevant\n* Positive result on human immunodeficiency virus (HIV)-1 and HIV-2, hepatitis B virus (HBV) (either hepatitis B surface antigen \\[HBsAg\\] or hepatitis B core antibody \\[HBcAb\\]), hepatitis C virus (HCV) antibody test, or tuberculosis (TB)\n\nPart 2:\n\n* Individuals with New York Heart Association (NYHA) Class III or IV heart failure\n* Known or suspected immunocompromised state\n* Treatment with any investigational therapy within 28 days or within five drug-elimination half-lives (whichever is longer; or longer than either if required by local regulations; if the half-life is unknown, the 90-day period applies) prior to Day 1, calculated from the day of the follow-up from the previous study","75 Years",{"count":81,"type":21},196,[24],"This study will evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses (SAD) (Part 1a), multiple ascending doses (MAD) (Part 1b), and the food effect (Part 1c) of RO7763505 in healthy adult participant. In Part 2, the safety, tolerability, PK and PD of multiple doses of RO7763505 in participants with stable coronary artery diseases (CAD).",[85,27],"Stable Coronary Artery Disease","RECRUITING",{"date":36,"type":37},{"date":89,"type":37},"2026-03-31",{"date":91,"type":21},"2028-02-15",{"name":93,"class":94},"Hoffmann-La Roche","INDUSTRY",{"id":96,"slug":4,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100053263","NCT07698210","A Study of LY4178256 in Healthy Participants","A Phase 1, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4178256 in Healthy Participants","Inclusion Criteria:\n\n* Are overtly healthy as determined by medical evaluation including medical history, physical examination, and other screening procedures.\n* Have a body mass index within the range of 19.0 to 32.0 kilograms per square meter (kg\u002Fm²)\n* Individuals assigned male at birth willing to practice effective contraception throughout the study and individuals assigned female at birth not of childbearing potential may participate in this trial.\n\nExclusion Criteria:\n\n* Have significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the Investigational Medicinal Product (IMP); or of interfering with the interpretation of data.\n* Have abnormal blood pressure\n* Have a 12-lead electrocardiogram (ECG) abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study, have a mean QT interval corrected using Fridericia's formula (QTcF) of greater than 450 milliseconds (\\>450 msec) for males, or \\>470 msec for females.\n* Regularly use known drugs of abuse or with positive drug results (within the past 3 months).\n* Have a positive ethanol breath\u002Furine test result or positive urine drugs of abuse screen at screening or check-in.\n* Have hemoglobin level less than 12 grams per deciliter (\\\u003C12 g\u002FdL), or evidence of iron deficiency (ferritin less than 30 nanograms per milliliter (\\\u003C30 ng\u002FmL), or history or presence of hemoglobinopathy, or history hemolytic anemia. Participants who received transfusion within the past 12 weeks, or requiring regular transfusion should be excluded.\n* Have clinically significant abnormal liver function tests at screening: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphate (ALP), or total bilirubin ≥1.5x upper limit normal (ULN). Participants with confirmed Gilbert's syndrome may be enrolled.\n* Have significant renal impairment (estimated glomerular filtration rate less than 60 milliliters per minute per square meter (eGFR\\\u003C60mL\u002Fmin\u002F1.73 m ²)).","65 Years",{"count":103,"type":21},88,[24],"The main purpose of this study is to evaluate how well LY4178256 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to check how much LY4178256 gets into the bloodstream and how long it takes the body to eliminate it. For each participant, the study will last about 7 months and will include either 7 or 12 visits depending on the assigned treatment.",[27],"2026-07-08",{"date":36,"type":37},{"date":110,"type":21},"2026-07",{"date":112,"type":21},"2028-02",{"name":114,"class":94},"Eli Lilly and Company",2,{"id":117,"slug":4,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":18,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":57,"conditions":120,"keywords":121,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":128,"locationsCount":45},"100631739",{"count":54,"type":21},[56],[27],[60,61,62,63,64,65,66],"2026-07-01",{"date":124,"type":37},"2026-07-02",{"date":126,"type":21},"2026-07-07",{"date":70,"type":21},{"name":72,"class":44},{"id":130,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":25,"conditions":133,"keywords":134,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":137,"leadSponsor":138,"locationsCount":45},"100582869",{"count":20,"type":21},[24],[27],[29,30,31,32],{"date":124,"type":37},{"date":126,"type":21},{"date":41,"type":21},{"name":43,"class":44},{"id":140,"slug":4,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":51,"sex":16,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":149,"conditions":150,"keywords":151,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":45},"100327094","NCT03538600","Sample Collection From Healthy Volunteers for Assay Optimization","* INCLUSION CRITERIA:\n\n  1. Aged 3-80 years.\n  2. Able to provide informed consent (for ages \\>=18 years) or has a parent or guardian who can provide informed consent on their behalf (for ages \\\u003C18 years).\n  3. Agree to allow biological samples to be stored for future research.\n  4. Willing to provide blood, stool, saliva, skin\u002Fmucosal\u002Ftonsil swabs, and\u002For skin punch biopsy specimens.\n\nEXCLUSION CRITERIA:\n\nIndividuals meeting any of the following criteria will be excluded from study participation:\n\n1. Pregnancy.\n2. History of autoimmune or autoinflammatory disease.\n3. Diabetes mellitus.\n4. Cancer chemotherapy within the past 5 years.\n5. Currently receiving treatment for an active malignancy.\n6. Surgery within the past 8 weeks.\n7. History of recent (within the past 30 days) infection.\n8. History of significant, active parasitic, amebic, fungal, or mycobacterial infections within the past 5 years (as determined by the PI).\n9. Infected with HIV and\u002For hepatitis B and\u002For C.\n10. Use of an oral or inhaled glucocorticoid within the past 30 days.\n11. History of a bleeding disorder.\n12. Screening lab values are both outside of the NIH Department of Laboratory Medicine normal reference range and deemed clinically significant by the PI.\n13. Receipt of an immunosuppressant or immunomodulatory drug within the past 30 days.\n14. Receipt of a live-attenuated vaccine within the past 30 days.\n15. Receipt of any other type of vaccine within the past 14 days.\n16. Current or past use (within the past 90 days) of immunoglobulin therapy.\n17. Current use of illicit drugs (per subject report).\n18. Current use of nicotine-containing products, including cigarettes and chewing tobacco, nicotine patches, gum, electronic cigarettes, etc.\n19. Current alcohol use disorders (criteria per Diagnostic and Statistical Manual of Mental Disorders, fifth edition).\n20. Any condition that requires active medical intervention or monitoring to avert serious danger to the individual s health or wellbeing.\n21. Any condition that, in the opinion of the PI, contraindicates participation in this study or would significantly affect immune profile.\n\nCo-enrollment guidelines: Participants may be co-enrolled in other studies. The PI may withdraw them from this study for any reason that may contraindicate participation.","3 Years","80 Years",{"count":147,"type":21},600,"OBSERVATIONAL","Background:\n\nThe Laboratory of Immune System Biology (LISB) works with other labs at the National Institutes of Health. They study how parts of living things come together to make a whole. LISB designs and improves research tests on human samples like blood and cells. In order to do its work, LISB needs to have a lot of these samples available.\n\nObjective:\n\nTo collect biological specimens to use for designing and improving research tests. Specimens include blood, stool, saliva, and skin\u002Fmucosal swabs.\n\nEligibility:\n\nHealthy people ages 3-80\n\nDesign:\n\nParticipants will be screened with an interview about their general health and their medical history. They will have a physical exam and blood tests.\n\nIf the results of the screening are normal, participants will be asked to give one or more of these samples:\n\nBlood will be drawn from an arm vein with a needle and syringe.\n\nMucus and skin will be collected by rubbing the area with a cotton swab. The areas may include the top of the tongue, inside the cheek, nostrils, behind the ear, elbow pit, or vagina.\n\nParticipants will spit into a tube to collect saliva.\n\nParticipants will pass stool into a plastic container that fits in the toilet under the seat. They will get sampling kits and instructions.\n\nOver the next 5 years, if more samples are needed, participants will be contacted to set up another visit to the NIH. These visits will each take about 1 hour.\n\nAbout every 2 years, when participants come to NIH for a visit, extra blood will be collected. It will be tested for HIV and hepatitis B and C.\n\n...",[27],[152,153,154,155,156,157],"Blood","Microbiome Analysis","Stool","Saliva","Skin","Natural History",{"date":124,"type":37},{"date":160,"type":37},"2018-06-28",{"date":162,"type":21},"2043-06-30",{"name":164,"class":44},"National Institute of Allergy and Infectious Diseases (NIAID)",{"id":166,"slug":4,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":51,"sex":16,"minAge":171,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":175,"conditions":176,"keywords":179,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":45},"100239105","NCT02390765","Children s Growth and Behavior Study","Children's Growth and Behavior Study","* Eligibility Criteria for Parents\u002FGuardians of Child Participants:\n\nINCLUSION CRITERIA:\n\nParents\u002FGuardians will qualify if they meet the following criteria.\n\n1. Age \\>=18 years\n2. Have a child enrolled in this protocol (15-CH-0096).\n\nEXCLUSION CRITERIA:\n\nParents\u002FGuardians will be excluded for the following reasons:\n\n1. If their child is not eligible to participate in the study (see below)\n2. If they are believed by the medical study team to have a medical or psychiatric problem that will not allow them to complete study procedures safely (these will be determined on a case-by-case basis)\n\n   Eligibility Criteria for Child Participants:\n\n   INCLUSION CRITERIA:\n\n   Volunteers will qualify if they meet the following criteria.\n   * Age 8-17 years (NB: children may continue to participate as adults during follow-up).\n   * Weight, height and BMI \\>= 5th percentile for age and sex according to Centers for Disease Control and Prevention 2000 US standards.\n   * Cognitively capable of completing study procedures (FSIQ \\>= 70).\n   * Good general health based on a normal history and physical examination (with the exception of overweight and minor, well-controlled illnesses).\n\n   EXCLUSION CRITERIA:\n\n   Individuals will be excluded (and provided treatment referrals as needed) for the following reasons:\n   * History of major cardiovascular disease or any other serious obesity-related complication as assessed during history and physical exam. Individuals with untreated or major illnesses relating to the endocrine and\u002For cardiovascular systems are excluded because these illnesses will likely influence outcomes. Such obesity-related comorbidities include hypertension (defined by age- sex- and height- specific standards; and fasting hyperglycemia consistent with diabetes (fasting glucose \\> 126 mg\u002FdL).\n   * Presence of other major illnesses: renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing syndrome, untreated hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication). Non-serious medical illnesses, such as seasonal allergies, will be reviewed on a case-by-case basis.\n   * Regular use of any medication known to affect body weight or eating behavior (e.g., many medications prescribed for attention deficit hyperactivity disorder, or ADHD). Medication use for non-serious conditions (e.g., acne) will be considered on a case-by-case basis.\n   * Current pregnancy or a history of pregnancy. A negative pregnancy test before starting the study will be required for postmenarcheal girls.\n   * Current and regular use of tobacco products and\u002For alcohol.\n   * A significant reduction in weight during the past three months, for any reason, exceeding 5% of body weight.\n   * A history of significant or recent brain injury that may considerably influence performance on neurocognitive measures (i.e., any history of loss of consciousness \\>=30 minutes associated with a head injury, any history of memory loss or hospitalization associated with a head injury, or \\>=2 concussions within last year).\n   * Presence of any significant, full-threshold psychiatric disorder based on DSM criteria such as schizophrenia, bipolar disorder, alcohol or substance abuse, anorexia or bulimia nervosa, or any disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study. These individuals will not be permitted to enroll in the current study and will be referred for treatment. Individuals who present with other psychiatric disorders, including sub-threshold psychiatric disorders, will be permitted to enroll in the study. Sub-threshold psychiatric disorders include symptoms that do not meet diagnostic threshold based on the DSM criteria for mental disorders, but which are nevertheless significantly impairing or distressing. If, based on the opinion of the investigators, a participant requires treatment for his\u002Fher psychiatric symptoms, the individual will be referred for treatment. Participants who develop any psychiatric disorder or significant psychiatric symptoms at any follow-up assessment during the study will not be excluded, but will be provided with treatment referrals.\n   * Any other condition in the child or parents\u002Fguardians that, in the opinion of the investigators, would impede compliance or possibly hinder completion of the study (e.g., significant Learning Disorder).\n\n   Additional exclusions for (optional) stool sample collection include:\n\n   Stool Sample only:\n   * Diagnosis or history of inflammatory bowel disease, including ulcerative colitis or Crohn's disease, celiac sprue, irritable bowel syndrome, or other inflammatory disorders of the intestine.\n   * Diarrhea within 1 week prior to sampling.\n   * Antibiotic use within 4 weeks prior to sampling.\n\n   In addition, Experiments 1 and 2 have specific additional exclusions:\n\n   Experiment 1 only:\n   * Regular use of medications that could influence autonomic or endocrine functioning, including alpha and beta blockers, oral contraceptives, or prescription pain medication.\n   * Scoring as \"highly active\" on the International Physical Activity Questionnaire (due to decreased cortisol reactivity).\n\n   Experiment 2 only:\n   * Participants will be excluded if MRI and MEG is contraindicated (metal in\u002Fon body, braces, presence of non-organic \\[e.g., cochlear\\] implants or cerebral clips, permanent tattooed makeup or general tattoos that are recent and\u002For in a dangerous location on the body or made with colors whose content in iron cannot be definitely ruled out.\n   * Youth will be excluded if they are left-handed.\n\n   All participants will receive a written explanation of the purposes, procedures, and potential hazards of the study. Communication of this information and of the participant's assent as well as the consent of the parent or guardian will be documented in the medical record and copies of all signed documents given to each family. All participants will be informed of their right to withdraw from the study.","8 Years","100 Years",{"count":174,"type":21},1500,"Background:\n\n\\- Studies show that many factors affect children's eating behavior and health. These include sleep, mood, thinking skills, and genetics. Studying children over time may identify children at higher risk for eating-related health concerns.\n\nObjective:\n\n\\- To understand how genes and environment influence eating behavior and health over time.\n\nEligibility:\n\n\\- Children ages 8-17 in good general health.\n\nDesign:\n\n* Screening visit 1: Medical history, physical exam, body measurements, and questions.\n* 14 days: Participants will wear a wrist monitor and answer smartphone prompts about eating and mood. They may give a stool sample.\n* Screening visit 2:\n* Body measurements.\n* Saliva, urine, and blood samples.\n* Heart tests.\n* Meals provided (after fasting overnight).\n* Questionnaires and interview.\n* Behavior, thinking, and exercise tests.\n* X-ray of left wrist and full body.\\\u003CTAB\\>\n* Some parents may have medical history, physical exam, and questions at screening visits. They may answer questions at the yearly visits.\n* Participants will have up to 6 yearly visits. They will give a urine sample and body measurements, and repeat the X-rays. They will have questions and behavior and thinking tasks. They may give stool samples. Visits will range from 3 to 8 hours.\n* Participants may choose to participate in other studies:\n* Stress and Hormones, 1 visit: While resting, participants will give saliva samples and have their heart monitored. Then they will do math. They will repeat the resting part, then do a computer task.\n* Brain Imaging, 2 visits: Twice, participants will perform tasks with a magnetic cone on their head then answer questions. Once, they will have an MRI, lying still in a scanner with a coil on their head. Before the first visit, participants will collect at-home saliva samples once a day for three days. During both visits, participants will perform tasks and answer questions that gauge their thinking skills and mood.\n* Experiment 3 (sleep\u002Ffatigue): Participants will complete 2 additional visits. During these visits, participants will complete a task on the computer for 2 hours, or watch a movie for two hours. After completion of the task\u002Fmovie, they will answer questions and be provided with food.\n\nParticipants will be compensated for the time and inconvenience involved with completing study procedures.\n\n...",[177,178,27],"Obesity","Eating Behaviors",[180,181,182,177,183,157],"Stress Response","Binge Eating","Eating Behavior","Disordered Eating",{"date":124,"type":37},{"date":186,"type":37},"2015-04-21",{"date":188,"type":21},"2030-12-31",{"name":190,"class":44},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)",{"id":192,"slug":4,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":18,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":4},"100644828","NCT07674940","A Trial to Assess TEV-56286 at Different Doses in Healthy Participants","A Phase 1 Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Escalating Dose Trial in Healthy Participants to Assess Pharmacokinetics, Safety, and Tolerability of TEV-56286 at Clinical and Supratherapeutic Doses","Inclusion Criteria:\n\n* Participant is a healthy male or female with a body weight of ≥50 kg for males and ≥45 kg for females, and body mass index (BMI) of 18.5 to 32.0 kg\u002Fm2 inclusive.\n* Participant is 18 to 60 years of age inclusive, at the time of signing the informed consent form (ICF).\n* Female participants are eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies:\n* A woman of non-child bearing potential (WONCBP) as defined: Female participants who are either surgically (documented hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or congenitally sterile, or at least 1 year postmenopausal (no menses for at least 12 months without an alternative medical cause plus an increased concentration of follicle stimulating hormone \\[FSH\\] within the menopausal range in women not using hormonal contraception or hormonal replacement therapy).\n* A woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), used consistently and correctly. The acceptable contraceptive regimen in this trial is: non-hormonal intrauterine device (IUD) used for at least 2 consecutive months prior to dosing and willing to continue until at least 28 days after last dose of investigational medicinal product (IMP). A WOCBP must have a negative highly sensitive serum pregnancy test within 24 hours before the first dose of IMP. The participant must be excluded from participation if the serum pregnancy result is positive.\n* Male participants are eligible to participate if they are azoospermic (vasectomized or due to a medical cause) or, alternatively, agree to the following during the trial period, from admission (day -1) and for at least 28 days after last dose of IMP.\n\nRefrain from donating sperm, in addition to following:\n\n* EITHER be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.\n* OR must agree to use contraception\u002Fbarrier as detailed below:\n\n  * Agree to use a male condom with female partner using an additional highly effective contraceptive method with a failure rate of \\\u003C1% per year when having sexual intercourse with a WOCBP who is not currently pregnant.\n  * Agree to use a male condom when having sexual intercourse with a pregnant partner.\n\nNOTE-Additional criteria apply, please contact the investigator for more information\n\nExclusion Criteria:\n\n* Participant presents with or has a history of clinically significant diseases of the renal, hepatic, gastrointestinal, cardiovascular, musculoskeletal system, or presence\u002Fhistory of clinically significant immunological, endocrine, metabolic diseases, neurological, psychiatric, or immunological disorder(s), or a history of any illness that, in the opinion of the Principal Investigator, might pose additional risk to the participant by participation in the trial or confound the results of the trial.\n* Participant presents with a major trauma or surgery during the 60 days prior to screening or at any time between screening and the first dose of IMP, or surgery scheduled during the trial including follow-up period.\n* The participant has a history of any malignant disease (except for treated and cured skin basal cell carcinoma at least 12 months prior to screening).\n* Participant has a known drug hypersensitivity reaction to the active component of IMP, or one of its excipients, or any compound listed as being present in a trial formulation.\n* Participant has a personal or family history of arrhythmia, long QT syndrome, or sudden unexplained death in a first-degree relative before the age of 40; or personal history of syncope, myocardial infarction, cerebrovascular accident, or previous treatment for high blood pressure (BP).\n* Participant has an alkaline phosphatase (ALP), alanine aminotransferase (ALT), or aspartate aminotransferase (AST) \\>1.5 × upper limit of normal (ULN).\n* Participant has a history of alcohol, drug, or any other substance dependence (with the exception of nicotine or caffeine) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (American Psychiatric Association 2013) or are unwilling to comply with the restricted food or beverages during the trial.\n* Participant is a current smoker, has smoked in the last 6 months, is planning to start smoking during the trial, uses tobacco, or uses other nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, e-cigarettes, vaping devices, inhalers), or has a positive urine cotinine test.\n\nNOTE-Additional criteria apply, please contact the investigator for more information",{"count":198,"type":21},60,[24],"The purpose of the trial is to evaluate the pharmacokinetics, safety, and tolerability of TEV-56286 at different doses.\n\nThe main objective is to describe how TEV-56286 is absorbed, distributed, and removed from the body (the pharmacokinetics) following administration of TEV-56286 in single doses of increasing amounts and multiple doses in healthy participants.\n\nA secondary objective is to assess the safety of TEV-56286 and how well it is tolerated.\n\nThe estimated duration for participants in Part 1 with Single Ascending Dose is approximately 58 days; including up to 45 days of screening, a 4-day in-clinic period, and follow-up 8+\u002F-1 days post discharge from the clinical unit.\n\nThe estimated duration for participants in Part 2 with Multiple Dose is approximately 64 days; including 45 days of screening, a 10-day in-clinic period, and follow-up 8+\u002F-1 days post discharge from the clinical unit.",[27],"2026-06-30",{"date":124,"type":37},{"date":205,"type":21},"2026-06-29",{"date":207,"type":21},"2027-01-22",{"name":209,"class":94},"Teva Branded Pharmaceutical Products R&D LLC",{"id":211,"slug":4,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":18,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":45},"100610379","NCT07226817","A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants","A Phase 1, Open-label, Single-site, Multi-part, Non-randomized, Parallel-group Study to Assess the Relative Bioavailability of BMS-986435 Tablet Formulations (Parts 1 & 2) and Food Effect on the Selected BMS-986435 Tablet Formulation (Part 3) in Healthy Adult Participants","Inclusion Criteria\n\n* Participants must have a body weight of ≥ 45 kg and BMI between 18 and 32 kg\u002Fm2, inclusive\n* Participants must be healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), clinical laboratory assessments\n* Participants must have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality at screening, as determined by local transthoracic echocardiogram (TTE) assessment\n* Other protocol-defined Inclusion\u002FExclusion criteria apply",{"count":217,"type":21},140,[24],"This study is designed to evaluate the relative bioavailability (rBA) of multiple test tablet formulations of BMS-986435 compared to an equal dose of the BMS-986435 reference tablet formulation. The effect of food on the selected BMS-986435 tablet formulation will also be evaluated.",[27],{"date":122,"type":37},{"date":223,"type":37},"2025-11-12",{"date":225,"type":21},"2026-12-17",{"name":227,"class":94},"Bristol-Myers Squibb",{"id":229,"slug":4,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":22,"phases":237,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":45},"100250835","NCT02543983","Neurobiology of Suicide","The Neurobiology of Suicide","* INCLUSION CRITERIA:\n\nPhase I: Groups 1-3 and 5 (Patients)\n\n1. 18 to 70 years of age.\n2. A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document and verify understanding by a score \\>= 90% on the Baseline consent quiz\n3. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase I.\n4. Additional Criteria for Group 1 (Active Crisis): Agree to be hospitalized\n\nPhase I: Group 4 (Healthy Volunteers)\n\n1. 18 to 70 years of age.\n2. A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document.\n3. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase I.\n\nPhase II: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)\n\n1. Patients must have completed Study Phase I as a participant in Group 1 or 5\n2. Participants must verify understanding of the protocol by a score \\>= 80% on the Ketamine Response consent quiz.\n3. Patients in Group 1 or 5 must report at least minimal suicidal ideation, depressive or anxiety symptoms to be eligible for this phase.\n\n   * MADRS score of over 10 (10 used as an outcome measure for remission)126\n   * OR HAMA score of over 7 (7 used as an outcome measure for remission)127\n   * OR SSI score of 2 or more (indicates any residual suicidal thoughts)\n4. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase II.\n\nPhase III: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)\n\n1. Participants must have met all inclusion criteria for and completed Study Phase II as a participant in Group 1 (active crisis) or Group 5 (Suicide Ideators).\n2. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase III.\n\nEXCLUSION CRITERIA:\n\nPhase I: Groups 1-3 and 5 (Patients)\n\n1. Current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests\u002Fexaminations.\n2. Current drug or alcohol dependence\n3. Currently intoxicated or under the acute effects of an illicit substance will not be consented into the study.\n4. Pregnant or nursing individuals or those who plan to become pregnant.\n5. Serious, unstable medical conditions\u002Fproblems including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including blood pressure, ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.\n6. Clinically significant abnormal laboratory tests.\n7. Positive HIV test\n8. Participants who, in the investigator s judgment, pose a current homicidal risk or pose suicide risk that cannot be managed in a secure, voluntary inpatient setting.\n9. Non-English speakers\n10. Additional Criteria for Group 1 (Active Crisis): For participants who still experience the effects of their suicide attempt, i.e. someone who overdosed is significantly drowsy or confused, the consenting process will occur after the patient has improved from the effects. If there is a concern around a participant's capacity to consent, the Human Subjects Protections Unit (HSPU) team member who is\n\nmonitoring the informed consent process will complete a capacity assessment. Participants who are determined not to have capacity to consent to research will not be included in the study.\n\nPhase I: Group 4 (Healthy Volunteers)\n\n1. Current or past Axis I diagnosis\n2. Presence of medical illness likely to alter brain morphology and\u002For physiology (e.g., hypertension, diabetes) even if controlled by medications.\n3. Current or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine) (or \"substance abuse disorder\" per DSM-V).\n4. Presence of psychiatric disorders or a history of suicide attempt or death in first-degree relatives.\n5. Pregnant or nursing individuals or those who plan to become pregnant.\n6. No lifetime suicide attempts or ideations\n7. Non-English speakers\n8. Positive HIV test\n\nExclusions for Imaging:\n\n1. Participants with metal objects implanted in the body, such as aneurysm clips, neural stimulators, implanted cardiac pacemakers, or auto-defibrillator, cochlear implant, or ocular foreign body which would make having an MRI scan unsafe\n2. Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine\n3. Participants with a brain abnormality on an initial MRI scan\n4. Subjects with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures\n\nPhase II: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)\n\n1. Treatment with a reversible MAOI within 2 weeks prior to study Phase II.\n2. Treatment with any other concomitant medication not allowed within 5 1\u002F2 half-lives prior to study Phase II.\n3. Subjects with one or more seizures without a clear and resolved etiology\n4. Participants with a positive urine for an illicit substance no more than 24 hours prior to the ketamine infusion.\n5. Presence of current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-V\n6. Pregnant or nursing individuals or those who plan to become pregnant.\n7. A medical finding or condition that in the clinical judgement of the investigator increases the risk of adverse effects from the ketamine administration (for example: findings suggesting difficulties with kidney or cardiac function that may be contraindications for an experimental intervention).\n\nPhase III: Repeated Administration (Group 1) and Group 5 (Suicide Ideators)\n\n1. Intolerable or serious adverse reaction to ketamine during Phase II\n2. Treatment with a reversible MAOI within 2 weeks prior to study Phase III.\n3. Treatment with any other concomitant medication not allowed within 5 1\u002F2 half-lives prior to study Phase III.\n4. Subjects with one or more seizures without a clear and resolved etiology\n5. Participants with a positive urine for an illicit substance no more than 24 hours prior to each ketamine infusion.\n6. Presence of current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-V\n7. Pregnant or nursing individuals or those who plan to become pregnant.\n\nExclusions for Imaging:\n\n1. Participants with metal objects implanted in the body, such as aneurysm clips, neural stimulators, implanted cardiac pacemakers, or auto-defibrillator, cochlear implant, or ocular foreign body which would make having an MRI scan unsafe\n2. Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine\n3. Participants with a brain abnormality on an initial MRI scan\n4. Subjects with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures","70 Years",{"count":236,"type":21},325,[56],"Background:\n\nThere are no good treatments for people considering suicide. Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies. They hope to better understand suicide, so they can help suicidal people.\n\nObjective:\n\nTo understand what happens in the brain when someone has thought about or attempted suicide.\n\nEligibility:\n\nGroup 1: Adults ages 18 70 who have thought about or attempted suicide recently\n\nGroup 2: Adults ages 18 70 who have thought about or attempted suicide in the past\n\nGroup 3: Adults ages 18 70 who have depression or anxiety, but have never thought about suicide\n\nGroup 4: Healthy volunteers the same ages.\n\nDesign:\n\nParticipants will be screened in another protocol. Adults who have recently thought about or attempted suicide must be referred by a doctor. They may do up to 3 phases of this study. Groups 2, 3 and 4 will do only Phase 1 and will not get ketamine.\n\nPhase 1: 1 week in hospital. Participants will have:\n\nPhysical exam.\n\nQuestions about thoughts and feelings.\n\nThinking and memory tests and simple tasks.\n\nBlood and urine tests.\n\nTwo MRI scans. Participants will lie on a table that slides into a metal cylinder that takes pictures. They will have a coil over their head and earplugs and do a computer task.\n\nSleep test. Disks and bands will be placed on the body to monitor it during sleep.\n\nMagnetic detectors on their head while they perform tasks.\n\nA wrist monitor for activity and sleep.\n\nLumbar puncture (optional). A needle will collect fluid from the back.\n\nShock experiments (optional). Participants will observe pictures and sounds and feel a small shock on the hand.\n\nPhase 2: 4 days in hospital. A thin plastic tube will be placed in each arm, one for blood draws, the other to get the drug ketamine once. Participants will repeat most of the Phase 1 tests.\n\nPhase 3: up to 4 more ketamine doses over 2 weeks.\n\nParticipants will have follow-up calls or visits at 6 months and then maybe yearly for 5 years.",[27,240],"Depression",[242,243,244,245,246],"Neurobiology","Suicide","Ketamine","Major Depressive Disorder","Biomarkers","2026-06-27",{"date":202,"type":37},{"date":250,"type":37},"2015-12-01",{"date":252,"type":21},"2030-07-21",{"name":254,"class":44},"National Institute of Mental Health (NIMH)",{"id":256,"slug":4,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":260,"enrollmentInfo":261,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":263,"conditions":264,"keywords":265,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":4,"leadSponsor":274,"locationsCount":45},"100065540","NCT00104325","Cytapheresis of Volunteer Donors","* INCLUSION CRITERIA:\n* Normal healthy males and females, age 18 years and older\n* Adequate venous access in bilateral upper extremities to accommodate at least a #18 gauge dialysis needle.\n* Willingness and ability to come to the NIA Apheresis Unit at Harbor Hospital in Baltimore for a blood collection procedure approximately every 56 days.\n\nEXCLUSION CRITERIA:\n\n* Unable to verify identification of volunteer by state issued ID card, driver s license, or military ID. Participants earning greater than $600.00\u002Fyear are issued a 1099 form, therefore, positive identification is required.\n* Unable to provide informed consent\n* Weight less than 110 pounds as mandated by AABB guidelines.\n* Chronic Immunosuppressive medications such as Steroids, Cellcept or Sirolimus. Steroids given for minor illness ok if taken more than 6 weeks before any cytapheresis procedure. Immunosuppressive medications may not be used at the time of the cytapheresis procedure as they decrease circulating white blood cells.\n* Test results are positive for viral infections such as HIV, Hepatitis B or C and RPR. Researchers are seeking healthy, pristine cells. Due to the ongoing nature of these chronic viral and bacterial infections, the white cell populations in the peripheral blood will change. Researchers want to study changing white cell populations as a factor of aging only and not those altered by infections.\n* Ongoing risk factors for HIV or Hepatitis B or C such as: intravenous drug use, non-monogamous unprotected intercourse, or chronic use of clotting factor concentrates such as prothrombin complexes, Factor XIII or Factor VIIa. These viruses weaken the immune system and cause changes in the white blood cells.\n* Risk factors for Creutzfeldt-Jakob disease such as: a relative with the disease, received beef insulin or growth hormone from human pituitary glands, or residency\u002Ftravel to high risk countries (complete list of countries located in the Cytapheresis Screening manual kept in the NIA apheresis unit). This is a transmittable infectious disease with a very long incubation period.\n* Major medical illnesses such as any type of liquid or solid tumor cancer, diabetes, history of deep vein thrombosis, organ or bone marrow transplant, or liver, kidney, heart or lung disease.\n* A medical finding that shows a participant could not safely go through this procedure. (such as Parkinson s disease, dementia or any uncontrolled behavior that would place the participant s safety at risk)\n* Major infectious diseases such as Chagas disease, babesiosis, syphilis or malaria\n* Bleeding conditions such as hemophilia or von Willebrand s disease.\n* Significant abnormalities are found in the results of blood tests such as elevated liver enzymes, abnormal kidney function, positive viral titers, fasting blood glucose greater than 120.\n* On any medication that can alter white blood cell function such as chronic steroid use, histamine-2 blockers, antivirals or chemotherapy. (complete list located in the Cytapheresis Screening manual stored in the NIA Apheresis unit).\n\nIn addition, eligible participants may not be able to participate in a specific cytapheresis procedure but might be eligible at a later date for:\n\n1. Pregnancy and Nursing Mothers - Females who are pregnant or who have had a pregnancy in the last 6 weeks are temporarily deferred. They may resume apheresis participation 6 weeks after delivery or cessation of lactation and have been cleared by their obstetrician or primary care physician.\n2. Medications: Volunteers taking the following medications would be deferred:\n\n   * Antibiotics, antifungals, antimalarials: Deferred for 2 weeks after course has been completed and volunteer is feeling well.\n   * Temporary steroids (tapers): Deferred for 72 hours after symptoms are resolved and prescription is completed if taken orally, intravenously, or intramuscular. No deferral if taken intranasal or for joint injection.\n   * Hepatitis B immune globulin: Volunteers are deferred 6 months if given after exposure to hepatitis B to insure the volunteer has not been infected. If administered for prophylaxis, no deferral is necessary.\n   * Live Attenuated Virus Vaccinations: Defer for 4 weeks if symptom-free.\n   * Inactivated (Killed Virus) Vaccinations: Defer for 2 weeks if symptom-free.\n   * Rabies Vaccine: Deferred for 1 year if given for rabies exposure; otherwise accept immediately if symptom-free.\n   * Smallpox Vaccine: Deferred until the scab has separated from the skin spontaneously or 21 days from date of immunization, whichever is longer, if volunteer had no other symptoms or complications. Visual verification of absence of vaccine scab is required. If scab was otherwise removed (not spontaneously separated), defer for 2 months after vaccination date.\n   * Blood thinners such as Plavix, Ticlid or Lovenox. Deferral for 5 days after last dose to decrease bleeding risk at needle puncture sites. Participants are not deferred for the use of aspirin or aspirin products.\n   * Experimental Medication or Unlicensed (Experimental) Vaccine is usually associated with a research protocol and the effect on blood donation is unknown. Deferral is one year unless otherwise indicated by the Principal Investigator.\n3. Temporary health issues\n\n   * Infection or fever: Deferred until 2 weeks after antibiotics are completed and volunteer is feeling well.\n   * Surgical Procedures: Deferred for 3 months after procedure and released to return to normal activities by primary care physician or surgeon.\n   * Close contact with someone else s blood, accidental needle-stick, treatment for syphilis or gonorrhea Volunteers are deferred for 6 months to insure they have not been infected. Viral\u002Fserology testing will be repeated and verified as negative prior to apheresis procedure.\n   * Factors that are high risk (but are non on-going) for HIV, Hepatitis B or C such as: (Volunteers will be deferred for 6 months after to insure they have not been infected with an infectious disease or virus. Viral testing and annual labs will be repeated and verified as within normal limits prior to apheresis procedure)\n\n     i. Having sexual contact with anyone who has HIV\u002FAIDS or has had a positive test for the HIV\u002FAIDS virus\n\n   ii. Received money, drugs or other payment for sex or having sexual contact with a prostitute or anyone else who takes money or drugs or other payment for sex\n\n   iii. Had sexual contact with anyone who has hemophilia or has used clotting factor concentrates.\n\n   iv. Has used needles to take drugs, steroids or anything NOT prescribed by their doctor or had sexual contact with anyone who has ever used needles to take drugs or steroids, or anything NOT prescribed by their doctor.\n\n   v. Had sexual contact with or living with anyone who has hepatitis.\n\n   vi. Had a tattoo using non-sterile needles or reused ink.\n\n   vii. Had a body piercing that used non-sterile needles or multi-use equipment.\n\n   viii. Has been in juvenile detention or prison for more than 72 hours.\n   * Had close contact with someone who had a smallpox vaccination such as touching the vaccination site, handling bedding or clothing that has been in contact with an unbandaged vaccination site to insure they have not been infected: Deferral is 2 months if volunteer is symptom-free.\n   * Anemia\u002FLeukopenia\u002FThrombocytopenia:\n\n     i. Female volunteers with a hemoglobin of \\\u003C 11.0 or hematocrit \\\u003C35, or males with a hemoglobin of \\\u003C12.5 or hematocrit \\\u003C38 may return in 8 weeks to repeat labs to verify anemia. Deferred until values return to the levels stated required levels.\n\n   ii. White blood cell count \\\u003C3.0 in African-American participants or \\\u003C3.5 in all other races. Deferred until values return to the levels stated required levels.\n\n   iii. Platelet count \\\u003C150,000. Deferred until values return to the levels stated required levels.\n\n   iv. Mean Corpuscular Volume (MCV) \\\u003C80. Deferred until values return to the levels stated required levels.\n\n   v. Whole blood donation (450 mL): Deferred for 56 days from date of last donation as mandated by AABB guidelines.\n\n   vi. Double unit red cell donation: Deferred for 112 days (16 weeks) as mandated by AABB guidelines.\n\n   vii. Platelet or plasma donation: Deferred for 28 days from date of last donation as mandated by AABB guidelines.\n\n   viii. Leukocyte donation: Deferred for 56 days from date of last donation as mandated by AABB guidelines.\n   * Received blood transfusion, transplant such as tissue, or had a graft such as bone or skin: Deferral is for 12 months to insure volunteer has not acquired an infectious disease. Annual laboratory testing will be repeated prior to apheresis procedure.\n   * It is less than six weeks since participation in another research study which is felt by the Principal Investigator to be incompatible with this study. (for example: studies that collect blood, investigational drug studies, vaccine trials, etc)\n4. Travel:\n\n   * Malaria-endemic countries: Volunteers who are residents of such countries will be deferred for 3 years after departure from the country if they remain free from unexplained symptoms suggestive for malaria. Residence is defined as a continuous stay of longer than 5 years in a country or countries having any malaria-endemic area. Donors who are not prior residents of malaria-endemic countries and travel to a malaria-endemic area will be deferred for 12 months after departure from that area. The duration of travel to a malaria-endemic area is defined as more than 24 hours to less than 5 years. Note that a passage greater than 24 hours through a malaria-endemic area while on route to a malaria-free area is considered a sufficient possible exposure to trigger deferral.\n\n(A complete list of malarial-endemic countries is kept in the Cytapheresis Screening Manual and is stored in the NIA Apheresis Unit.)","120 Years",{"count":262,"type":21},10000,"Background:\n\n\\- National Institute on Aging researchers are looking at studies that require large numbers of white blood cells for lab use. Standard blood samples do not provide enough white blood cells for these studies. Researchers want to use cytapheresis to collect white blood cells from volunteer donors. This procedure can collect larger amounts of white blood cells and reduce the amount of fluid and other cells that are lost.\n\nObjectives:\n\n\\- To use cytapheresis to collect white blood cells for study.\n\nEligibility:\n\n\\- Healthy blood donors at least 18 years of age.\n\nDesign:\n\n* Participants will be screened according to the usual blood donation procedures.\n* Participants will provide white blood cells through cytapheresis. The blood cells will be collected in a machine that separates the white blood cells from the rest of the blood. The rest of the blood will be returned to the donor.\n* Participants may have this type of donation every 56 days (six times per year). They will be asked to become a repeat donor. A donation schedule may be set up.\n* Once a year, participants will have blood tests to continue to be eligible as a donor.",[27],[266,267,268,269,270,157],"Cell Separation","White Blood Cells","Immune Studies","Cell Function","Machine Collection",{"date":202,"type":37},{"date":273,"type":37},"2003-01-30",{"name":275,"class":44},"National Institute on Aging (NIA)",{"id":277,"slug":4,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":101,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":284,"briefSummary":286,"conditions":287,"keywords":288,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":4},"100645311","NCT07681076","Study to Assess Safety and Tolerability of KarXT With Administration of Antiemetics in Healthy Volunteers","A Phase 4, Randomized, Open Label Study to Evaluate the Safety and Tolerability of Twice Daily Xanomeline\u002FTrospium Chloride (KarXT) With Prophylactic and PRN Antiemetic Use in Healthy Volunteers","Inclusion Criteria:\n\n* Participants must be healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, VS, and clinical laboratory determinations.\n* Participants must be willing and able to be confined to an inpatient setting for a 3-week duration, follow instructions, and comply with the protocol requirements.\n* Participants must have BMI ≥ 18 and ≤ 40 kg\u002Fm2.\n* Individuals of childbearing potential (IOCBP) must be willing and able to adhere to the contraception guidelines.\n\nExclusion Criteria:\n\n* Participants must not have history or presence of clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, gastrointestinal (\\[GI\\] eg, obstructive disorders \\[including conditions that may decrease GI motility, such as ulcerative colitis, intestinal atony, and myasthenia gravis\\], active biliary disease \\[including symptomatic gallstones\\]), endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.\n* Participants must not have history of moderate to severe alcohol use disorder or a substance (other than nicotine or caffeine) use disorder within the past 12 months or a positive urine drug screen (UDS) for a substance other than cannabis at screening or baseline.\n* Participants must not have history or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.\n* Participants must not have active biliary disease (eg, symptomatic gallstones). Participants with other biliary histories are eligible and should be discussed with the medical monitor.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":283,"type":21},225,[285],"PHASE4","This study looks at how to reduce nausea and vomiting in people taking KarXT which is used to treat mental health conditions like schizophrenia. KarXT can cause stomach-related side effects, especially in the first couple of weeks. In this study, healthy volunteers will take KarXT along with anti-nausea medication, either regularly (to prevent symptoms) or as needed.\n\nThe goal is to see how well these strategies help reduce nausea and vomiting and how safe the combination is. The results will help doctors better manage side effects and make treatment more comfortable for patients starting KarXT.",[27],[289,290,291,292,293,294,295],"BMS-986510","KarXT","Xanomeline\u002FTrospium","Antiemetics","Nausea","Vomiting","Gastrointestinal side effects","2026-06-26",{"date":124,"type":37},{"date":299,"type":21},"2026-08-03",{"date":301,"type":21},"2026-11-30",{"name":303,"class":94},"Karuna Therapeutics, Inc., a Bristol Myers Squibb company",{"id":305,"slug":4,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":51,"sex":16,"minAge":309,"maxAge":310,"enrollmentInfo":311,"targetDuration":4,"studyType":22,"phases":313,"briefSummary":315,"conditions":316,"keywords":318,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":45},"100632056","NCT07508722","Transcranial Ultrasonic Neuromodulation of Primary Visual Cortex and Primary Auditory Cortex in Humans","The inclusion criteria for this study are as follows:\n\n1. Healthy male and female adults aged 21-55.\n2. No contraindications to magnetic resonance imaging (MRI) scans, such as claustrophobia.\n\nThe exclusion criteria for this study are as follows:\n\n1. History of major medical, neurological (including peripheral nerve disease) or psychiatric illness.\n2. History of vsacular conditions, predisposition to hemorrhage, or blood thinner medications\n3. History of head trauma with loss of consciousness.\n4. Use of sedatives, analgesics and agents that affect brain function.\n5. Contraindications for exposure to the high magnetic field of MRI imaging\n6. History of skin irritation from acoustic coupling materials such as a water-based gel and polyvinyl alcohol (PVA; a common household plastic bag material).\n7. Vulnerable subpopulations (pregnant women, children, institutionalized individuals).\n8. Use of excessive alcohol (e.g., no more than one can of beer or glass of wine) or strenuous exercise (e.g., no more than daily routine) on the day of the visit","21 Years","55 Years",{"count":312,"type":21},20,[314],"NA","There are a number of disorders of the brain that have limited treatment options, such as chronic pain, addiction, and major depression. A new technology has emerged in the last decade known as transcranial focused ultrasound, which can deliver focused acoustic signals through the skull to modulate brain activity over a small region, including structures deep in the brain. This has resulted in many ongoing clinical trials for various disorders, but there is still a lack of understanding of the optimal sonication parameters for increasing versus decreasing brain activity. The investigators aim to address this open question by sonicating the primary visual cortex and primary auditory cortex in human with a range of sonication parameters. These brain structures were chosen to target because they are expected to elicit perceptual responses in the subject (i.e., the subject will report visual and auditory perception during sonication), allowing the experimenters to infer directly the extent to which neural signals can propagate through the visual and auditory systems in a way that is sufficient to produce conscious perception. Such findings have applications not only in clinical treatments, but also in the fundamental science of the neural basis of sensory perception. Previous work has shown that sonicating the visual cortex in humans can elicit visual perception, but the ultrasonic system in prior work did not have the focusing capabilities that will be employed in this study. At the end of this study, the investigators will have determined the optimal sonication parameters that can elicit neural responses over a small volume over sensory cortex, which can be inferred from visual percepts being localized in space (e.g., a bright spot as opposed to a diffuse light), and auditory percepts that sound like pure tones rather than a broad set of frequencies (e.g., sounding like white noise or static).",[27,317],"no Condition, Basic Science",[319,320,321],"Transcranial Focused Ultrasound","Non-invasive Brain Stimulation","Ultrasound Neuromodulation",{"date":205,"type":37},{"date":324,"type":21},"2026-10-01",{"date":326,"type":21},"2027-06-01",{"name":328,"class":329},"Massachusetts Institute of Technology","OTHER",{"id":331,"slug":4,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":336,"enrollmentInfo":337,"targetDuration":4,"studyType":22,"phases":339,"briefSummary":340,"conditions":341,"keywords":342,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":45},"100645233","NCT07679113","IPG1094 Phase I Study for China Healthy Participants","A Phase I Clinical Trial Evaluating Pharmacokinetic Characteristics of IPG 1094 in Chinese Healthy Adults","Inclusion Criteria:\n\n1. Male and female healthy Chinese participants aged 18 to 50 years (inclusive).\n2. Comprehensive assessments including physical examination, vital signs, 12-lead ECG, chest X-ray and laboratory tests are normal or with abnormalities judged not clinically significant by the investigator.\n3. Body weight: Male ≥50.0 kg, Female ≥45.0 kg; Body Mass Index (BMI) ranges from 19.0 to 26.0 (inclusive). BMI = Weight(kg) \u002F Height(m)².\n4. Female participants are non-pregnant and non-lactating.\n5. Participants have no pregnancy plan and no sperm\u002Fegg donation plan from 2 weeks before screening to 6 months after the end of the study, and agree to use effective contraception during this period.\n6. Voluntarily sign the written informed consent form, and fully understand the trial content and potential adverse reactions.\n\nExclusion Criteria:\n\n1. History of severe cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological, psychiatric or other systemic diseases with clinical significance.\n2. QTcF interval \\>450 ms (male) or \\>470 ms (female).\n3. History of recurrent headache, nausea or vomiting.\n4. Blood loss ≥400 mL within 3 months before screening, or plan to donate blood during the study.\n5. History of orthostatic hypotension or dysphagia.\n6. History of gastrointestinal diseases affecting drug absorption.\n7. Lactose intolerance, special dietary restrictions, or unable to follow unified diet requirements during the trial.\n8. History of drug\u002Ffood allergy, drug abuse or alcohol abuse.\n9. Heavy smoking, excessive intake of tea, coffee or caffeinated beverages within 3 months before screening.\n10. Use of any prescription drugs, over-the-counter drugs, health products or Chinese herbal medicines within 14 days before screening.\n11. Use of drugs affecting liver metabolism or gastrointestinal environment within 30 days before screening.\n12. Intake of citrus fruits\u002Fjuices within 5 days before screening or during the trial.\n13. Participated in other clinical trials within 3 months before screening.\n14. Positive result of urine drug screen or breath alcohol test at admission.\n15. Difficulty in venous blood collection, history of syncope during blood collection.\n16. Acute illness before screening, or other conditions judged inappropriate for participation by the investigator.","50 Years",{"count":338,"type":21},24,[24],"This Phase 1 open-label study enrolls 24 healthy Chinese adults to investigate the pharmacokinetics, safety and tolerability of oral IPG1094 tablets. The trial includes two parts. Part A (12 participants) uses a crossover design to explore the impact of food on a single 200 mg dose of IPG1094; participants will receive the drug under fasting and post-meal conditions on separate days, with intensive blood sampling for PK analysis. Part B (12 participants) evaluates multiple-dose PK, where participants take 200 mg IPG1094 twice daily for 10 days to observe drug exposure and accumulation. All participants will undergo comprehensive safety checks such as lab tests, ECG and adverse event monitoring during screening, treatment and post-dosing follow-up. No placebo or blinding is applied in this study.",[27],[343],"Healthy Volunteers，Phase 1, IPG1094, Pharmacokinetics, Safety,","2026-06-25",{"date":122,"type":37},{"date":347,"type":21},"2026-07-29",{"date":349,"type":21},"2027-01-30",{"name":351,"class":94},"Nanjing Immunophage Biotech Co., Ltd",{"id":353,"slug":4,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":310,"enrollmentInfo":358,"targetDuration":4,"studyType":22,"phases":360,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":364,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":45},"100641149","NCT07656454","A Study Understanding How Much CDR132L Enters the Bloodstream After Injection Under the Skin Compared to Injection Into a Vein in Healthy Participants","A Bioavailability Study Comparing the Pharmacokinetics of CDR132L Following Subcutaneous and Intravenous Administration in Healthy Participants","Inclusion Criteria:\n\n* Male or female (sex at birth).\n* Age 18-55 years (both inclusive) at the time of signing the informed consent.\n* Body mass index 18.5-29.9 kilograms per square metre (kg\u002Fm\\^2) (both inclusive) and body weight less than or equal to (≤) 120 kilograms (kg) at screening (visit 1).\n* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit (visit 1), as judged by the investigator.\n\nExclusion Criteria:\n\n* Any laboratory safety parameters at screening (visit 1) outside the below laboratory ranges, see laboratory manual for specific values.\n\n  * Alanine aminotransferase (ALT) greater than (\\>) upper limit of normal (ULN) +10 percentage (%)\n  * Aspartate aminotransferase (AST) \\>ULN +20%\n  * Bilirubin \\>ULN +20%\n  * Creatinine \\>ULN +10%\n  * Estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\]) less than (\\\u003C) 90 milliliters per minute\u002F1.73square meter (mL\u002Fmin\u002F1.73m\\^2)\n  * Urine albumin-to-creatinine ratio (UACR) greater than or equal to (≥) 30 milligrams per gram (mg\u002Fg)\n* Second or third degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds (ms), or of the QT interval corrected using Fridericia's formula (QTcF) interval over 450 ms, or any other clinically significant abnormal electrocardiogram results as judged by the investigator at screening (visit 1).\n* Supine blood pressure at screening (visit 1) outside the range of 90-139 millimeters of mercury (mmHg) for systolic or 50-89 mmHg for diastolic.\n* Heart rate outside the range of 50-89 beats\u002Fminute at screening (visit 1).\n* Presence or history (as declared by the participant or reported in the medical records) of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemia, stroke, heart failure, cardiac decompensation, clinically significant arrhythmia and clinically significant conduction disorders.\n* Known history of severe symptomatic untreated anaemia in the 90 days prior to screening (visit 1) (e.g., haemoglobin \\\u003C90 grams per litre (g\u002FL))\n* Presence or history (as declared by the participant or reported in the medical records) of acute or chronic kidney disease or injury.\n* Presence of thrombocytopenia, defined as thrombocyte count \\\u003C150 x 10\\^9 cells\u002FL at screening (visit 1), or history (as declared by the participant or reported in the medical records) of bleeding disorder.\n* Presence or history (as declared by the participant or reported in the medical records) of conditions associated with disruption of blood-brain barrier (e.g. multiple sclerosis).",{"count":359,"type":21},32,[24],"This study is being done to understand how much of the medicine (CDR132L) enters the bloodstream after injection under the skin compared to injection into a vein in healthy people. This will help us find the best way to give the medicine to people living with heart failure. The study will assess what the body does to the medicine, and how safe it is.",[27,363],"Heart Failure",{"date":202,"type":37},{"date":366,"type":37},"2026-06-17",{"date":368,"type":21},"2026-12-31",{"name":370,"class":94},"Novo Nordisk A\u002FS",{"id":372,"slug":4,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":51,"sex":16,"minAge":336,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":22,"phases":379,"briefSummary":380,"conditions":381,"keywords":382,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":386,"completionDateStruct":387,"leadSponsor":389,"locationsCount":45},"100644094","NCT07665671","Vitamin B12 Absorption Study","A Randomized, Double-Blind, Cross-Over Clinical Trial to Compare the Absorption of Different Forms of Vitamin B12 (AMPLIB12)","Inclusion Criteria:\n\n1. Males and females 50 years of age and older\n2. BMI between 18 to 29.9 kg\u002Fm2\n3. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,\n\n   Woman of child-bearing potential (WOCBP) must be following appropriate contraceptive methods until the last visit:\n   * Sexual abstinence.\n   * Oral contraceptive.\n   * Trans dermal patches or depot injection of a progestogen drug (starting at least 4 weeks prior to product administration).\n   * Intrauterine device (IUD), intrauterine system (IUS), subdermal implant, or vaginal ring (placed at least 4 weeks prior to product administration).\n   * Sterilised male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).\n   * Contraceptives must be effective before product administration.\n4. Agrees not to take any vitamin B12 containing supplements until the completion of the study.\n5. Agrees to avoid consuming liver, kidney, organ meats and very high B12 containing shellfish (e.g. clams and crab) 72 hours prior to study visits\n6. Agrees to consume the standardized meals for each of the study visits\n7. Agrees to avoid alcohol intake 48 hours prior to study visits\n8. Agrees to maintain current lifestyle habits (physical activity, medications, supplements, and sleep) as much as possible throughout the study\n9. Able to fast for 10 hours prior to study visits\n10. Provided voluntary, written, informed consent to participate in the study\n\nExclusion Criteria:\n\n1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study\n2. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational products\n3. History or current diagnosis of any clinically significant disease that may alter vitamin B12 absorption, accumulation, metabolism or excretion\n4. Taking vitamin B12 supplements or a multivitamin supplement containing vitamin B12 within the prior 2 months from study product administration.\n5. Current use of prescribed and\u002For over-the-counter (OTC) medications, supplements, and\u002For consumption of food\u002Fdrinks that may impact the absorption of vitamin B12\n6. Have a serious illness e.g. mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, diabetes, liver disease, autoimmune disease, bleeding disorders or heart conditions\n7. Have an unstable illness e.g. diabetes and thyroid gland dysfunction\n8. Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years\n9. Gastrointestinal or absorption issues (IBD, IBS, Celiac disease, Crohn's disease, history of GI surgery, Small Intestinal Bacterial Overgrowth)\n10. Poor venous access\n11. Current use of cannabinoid products (\\>2 times\u002Fweek). Occasional users will be required to washout and abstain for the duration of the study period\n12. Active smokers, nicotine use or drug (prescription or illegal substances) abuse.\n13. Chronic past and\u002For current alcohol use (\\>14 alcoholic drinks week)\n14. Blood donation 60 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit\n15. Participation in other clinical research studies 30 days prior to baseline, as assessed by the PI\n16. Any other condition or lifestyle factor, that, in the opinion of the PI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant",{"count":378,"type":21},12,[285],"This randomized, double-blind, crossover trial (Phase IV) aims to compare the absorption of a novel permeability-enhanced oral vitamin B12 formulation (Ampli-B) versus standard oral vitamin B12 in 12 healthy adults aged 50 years and older. Each participant receives a single dose of each formulation in randomized sequence, separated by a minimum 10-day washout. The primary outcome is time to peak serum concentration (Tmax) of total and active vitamin B12 (holotranscobalamin). Secondary outcomes include Cmax and AUC parameters.",[27],[383],"50 years and older","2026-06-24",{"date":205,"type":37},{"date":110,"type":21},{"date":388,"type":21},"2026-12",{"name":390,"class":94},"RDC Clinical Pty Ltd",{"id":392,"slug":4,"hasResults":11,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":397,"enrollmentInfo":398,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":399,"conditions":400,"keywords":402,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":414,"leadSponsor":416,"locationsCount":45},"100644975","NCT07676149","Testing the Reliability of Kinovea Video Analysis Software in Measuring Knee and Hip Angles During Sit-to-Stand Tasks","Reliability of Kinovea for Knee and Hip Angle Measurements During Sit-to-Stand","Inclusion Criteria:\n\n* Be between the ages of 18 and 45\n* Have a body mass index (BMI) between 18 and 25 kg\u002Fm²\n* Be able to sit down and stand up independently\n* Be a volunteer\n\nExclusion Criteria:\n\n* Having previously undergone lower extremity and spinal surgery\n* Having a neurological, orthopedic, or vestibular condition that may affect balance and muscle strength\n* Having sustained a lower extremity and\u002For spinal injury within the last 6 months\n* Having spinal problems such as scoliosis or lumbar disc herniation\n* Having congenital orthopedic problems such as hemimelia, dysmelia, or leg length discrepancy\n* Being pregnant","45 Years",{"count":20,"type":21},"The purpose of this study is to evaluate the intra-observer and inter-observer reliability of the Kinovea video analysis software in measuring knee and hip angles during the sit-to-stand movement. Participants will perform sit-to-stand tasks while being video-recorded. The recorded movements will be analyzed using the Kinovea software to determine the consistency and reliability of joint angle measurements.",[401,27],"Biomechanical Phenomena",[403,404,405,406,407,408,409,410,411],"Kinovea","Reliability","Sit-to-stand","Video analysis","Joint angles","Inter-rater reliability","Intra-rater reliability","Hip joint","Knee joint",{"date":202,"type":37},{"date":205,"type":21},{"date":415,"type":21},"2026-07-20",{"name":417,"class":329},"Ankara Yildirim Beyazıt University",{"id":419,"slug":4,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":51,"sex":16,"minAge":424,"maxAge":425,"enrollmentInfo":426,"targetDuration":4,"studyType":22,"phases":427,"briefSummary":428,"conditions":429,"keywords":430,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":45},"100536881","NCT06270589","Acute Effects of High-intensity Interval Training With Mindfulness-based Recovery on Executive Function in Children","Supporting High-intensity Interval Training With Mindfulness for Enhancing Childhood Executive Function","Inclusion Criteria:\n\n* Age between 10-12 years old\n* Intelligence Quotient ≥ 85\n* Capable of performing exercise based on pre-participation health screening\n* No formal diagnosis of cognitive disorders (e.g., attention deficit hyperactivity disorder) and neurological diseases (e.g., epilepsy)\n\nExclusion Criteria:\n\n* Age outside of the range of 10-12 years old\n* Intelligence Quotient \\\u003C 85\n* No capable of performing exercise based on pre-participation health screening\n* Has formal diagnosis of cognitive disorders (e.g., attention deficit hyperactivity disorder) and neurological diseases (e.g., epilepsy)","10 Years","12 Years",{"count":198,"type":21},[314],"The goal of this randomized cross-over trial is to learn about the effect of a single bout of 20-min mindfulness-based high-intensity interval training (MF-HIIT), MF-only, and HIIT-only in relative to sitting rest on executive function (EF) in 10-12 years old children. The main question it aims to answer are:\n\nQuestion 1: Whether a single bout of 20-min MF-HIIT has larger beneficial effect on EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting rest\n\nQuestion 2: Whether a single bout of 20-min MF-HIIT has a larger beneficial effect on brain functioning, as measured by the N2 and P3 components of event-related potential (ER) during EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting rest\n\nParticipants will visit the laboratory on 5 separate days (\\> 2-day washout between days) in which they have not previously participated in structured physical activities.\n\nParticipants will complete the testing and\u002For receive treatments below:\n\nDay 1:\n\n* Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient\n* Treadmill-based exercise test to measure cardiorespiratory fitness (maximum oxygen consumption)\n\nDays 2-5\n\n* Each day, participants will complete each of the four intervention conditions (MF-HIIT, MF-only, HIIT-only, sitting)\n* Participants' heart rate and self-reported affect and rating of physical exertion will be measured\n* Participants will complete a modified flanker task and a task-switching task to assess inhibitory control and cognitive flexibility\n* Participants will wear an EEG cap to measure the N2 and P3 components of the event-related potential during the inhibitory control and cognitive flexibility performance\n\nResearcher will compare the cognitive outcome measures following the MF-HIIT, MF-only, and HIIT-only conditions with the sitting condition to see if MF and HIIT has beneficial effects on children's EF.\n\nFurther, researcher will compare the cognitive outcome measures following the MF-HIIT compared with MF-only and HIIT-only conditions to see if combining MF with HIIT has greater beneficial effects on children's EF than MF and HIIT alone.",[27],[431,432,433,434,435],"Interval Exercise","Mindfulness","Executive function","Brain function","Children",{"date":205,"type":37},{"date":438,"type":37},"2024-06-15",{"date":440,"type":21},"2027-05-31",{"name":442,"class":329},"Purdue University",{"id":444,"slug":4,"hasResults":11,"nctId":445,"briefTitle":446,"officialTitle":422,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":51,"sex":16,"minAge":171,"maxAge":425,"enrollmentInfo":448,"targetDuration":4,"studyType":22,"phases":450,"briefSummary":451,"conditions":452,"keywords":453,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":456,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":460,"locationsCount":45},"100535985","NCT06258941","Classroom Break, Cognition, and Fitness in Elementary School Children","Inclusion Criteria:\n\n* Age between 8-12 years old\n* Intelligence Quotient ≥ 70\n* Capable of performing exercise based on pre-participation health screening\n* No formal diagnosis of neurological diseases (e.g., epilepsy)\n\nExclusion Criteria:\n\n* Age outside of the range of 8-12 years old\n* Intelligence Quotient \\\u003C 70\n* No capable of performing exercise based on pre-participation health screening\n* Has formal diagnosis of neurological diseases (e.g., epilepsy)",{"count":449,"type":21},352,[24,56],"The goal of this randomized controlled trial is to learn about the effect of a 12-week school-based intervention combining mindfulness with high-intensity interval training (MF-HIIT), MF-only intervention, and HIIT-only intervention in relative to sedentary activities on executive function (EF) in 8-12 years old children. The main question it aims to answer is whether a 12-week school-based MF-HIIT intervention has larger beneficial effect on EF performance than that following a 12-week school-based MF-only and HIIT-only in relative to the sedentary activities.\n\nMultiple cohorts of participants will be recruited to participate this one-semester study, including the pretest, intervention, and posttest phases.\n\nDuring the pretest phase, participants an their parents will complete the following\n\n1. Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient\n2. Fitnessgram test to assess aerobic capacity, muscle endurance, flexibility, and body mass index\n3. Child and Adolescent Mindfulness Measure (CAMM) questionnaire to assess dispositional mindfulness\n4. Computerized tasks to assess EF\n5. Parent-reported demographic and health information\n\nFollowing the pretest phase, participants will receive the 12-week classroom-based intervention, with the classroom as the intervention unit.\n\nFollowing the intervention and during the posttest phase, participants will complete the fitness, measures, EF measures, and dispositional mindfulness measure again.\n\nResearcher will compare the EFn outcome measures following the MF-HIIT, MF-only, and HIIT-only interventions with the sedentary activity intervention to see if MF and HIIT has beneficial effects on children's EF.\n\nFurther, researcher will compare the EF measures following the MF-HIIT compared with MF-only and HIIT-only interventions to see if combining MF with HIIT has greater beneficial effects on children's EF than MF and HIIT alone.",[27],[433,432,454,435,455],"Interval exercise","Fitness",{"date":344,"type":37},{"date":458,"type":37},"2025-02-14",{"date":440,"type":21},{"name":442,"class":329},{"id":462,"slug":4,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":51,"sex":16,"minAge":144,"maxAge":467,"enrollmentInfo":468,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":470,"conditions":471,"keywords":475,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":480,"startDateStruct":481,"completionDateStruct":4,"leadSponsor":483,"locationsCount":45},"100059955","NCT00024635","Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers","The Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers","* INCLUSION CRITERIA:\n* Subjects ages 3 to 99 may enroll in the protocol.\n* Subjects must be competent to comprehend the purpose of the screening process and to provide written informed consent and be willing to participate in NIMH IRB approved research protocols. Minors will be asked to assent and their parents will sign the consent form.\n\nEXCLUSION CRITERIA:\n\n-Current alcohol or substance use or dependence (excluding nicotine) within the past 3 months of sufficient magnitude to require independent, concurrent treatment intervention (e.g. Antabuse or opiate treatment, but not including self-help groups).","99 Years",{"count":469,"type":21},16000,"The purpose of this protocol is to allow for the careful screening of patients and healthy volunteers for participation in research protocols in the Experimental Therapeutics and Pathophysiology Lab (ETPB) at the National Institute of Mental Health (NIMH) and for the collection of natural history data. In addition the protocol will allow clinicians to gain more experience in the use of a variety of polysomnographic and high-density EEG recordings. Subjects in this protocol will undergo an evaluation which may include: a psychiatric interview; a diagnostic interview; rating scales; a medical history; a physical exam; brain magnetic resonance imaging (MRI); electroencephalography (EEG); electrocardiography (EKG), magnetoencephalography (MEG); blood, saliva and urine laboratory evaluation; and a request for medical records. Subjects may also be asked to complete questionnaires about attitudes towards research and motivation for research participation. The data collected may also be linked with data from other mood and anxiety disorder protocols (e.g., brain imaging, DNA, psychophysiology tests, treatment studies, etc) for the purposes of better understanding the diagnosis, pathophysiology, and treatment response of patients with mood disorders. Parents of minors will be interviewed. Upon conclusion of the screening process, subjects will either be offered participation in a research protocol and will sign the appropriate informed consent, or will be considered not appropriate for participation in research and will be referred back into the community. The current protocol thus serves as an entry point for individuals with mood or anxiety disorders or healthy volunteers to enter NIMH IRB approved ETPB protocols.",[472,473,27,474,240],"Mood Disorders","Anxiety Disorders","Bipolar Disorder",[476,477,478,479,157],"Screening","Anxiety","Mood","Diagnostic Testing",{"date":344,"type":37},{"date":482,"type":37},"2001-02-02",{"name":254,"class":44},{"id":485,"slug":4,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":310,"enrollmentInfo":490,"targetDuration":4,"studyType":22,"phases":492,"briefSummary":493,"conditions":494,"keywords":495,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":502,"locationsCount":45},"100644746","NCT07673120","A Study to Assess Safety, Tolerability, and How Single and Multiple Injections or Infusions of ABBV-313 Affects the Body of Adult Participants","A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Doses and Multiple Doses of ABBV-313","Inclusion Criteria:\n\n* BMI is \\>= 18.0 to \\\u003C= 29.9 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 any clinically significant sensitivity or allergy to any medication or food.\n* History of any clinically significant illness\u002Finfection\u002Fmajor febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study treatment.\n* Participant has prior exposure to ABBV-313 within the past 300 days.",{"count":491,"type":21},64,[24],"The objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of single and multiple doses of ABBV-313 in healthy adult participants.",[27],[27,496],"ABBV-313","2026-06-23",{"date":205,"type":37},{"date":500,"type":21},"2026-06-22",{"date":112,"type":21},{"name":503,"class":94},"AbbVie",{"id":505,"slug":4,"hasResults":11,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":310,"enrollmentInfo":511,"targetDuration":4,"studyType":22,"phases":513,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":518,"leadSponsor":520,"locationsCount":4},"100644692","NCT07674446","Dimotec (Diosmin) 1000 mg Film Coated Tablet Fed Study","Comparative Bioavailability Study of Dimotec 1000 mg Film-coated Tablet Versus Detralex 1000 mg Film Coated Tablets in Healthy Subjects Under Fed Conditions: Randomized, Four-period, Full-replicate Crossover","Diosmin","Inclusion Criteria:\n\n* Healthy adult human participants aged 18 to 55 years (inclusive)\n* BMI between 18.50 and 30.00 kg\u002Fm2 (inclusive), capable of giving informed consent\n* Normal health as determined by personal medical history, clinical examination, and laboratory examinations including serological tests during screening within 28 days of enrollment\n* Normal 12-lead electrocardiogram (ECG)\n* Normal chest X-Ray (P\u002FA view) taken not more than 180 days prior to check-in of Period 1\n* Non-smoker or ex-smoker who stopped smoking at least 6 months before first dosing\n* Non-alcoholic\n* Female participants of childbearing potential must practice a medically acceptable method of contraception (double barrier, IUD, or abstinence); females with no childbearing potential defined as surgically sterile or post-menopausal for at least 1 year\n\nExclusion Criteria:\n\n* Contraindications or hypersensitivity to the study drug, related drug group, or excipients\n* History or presence of significant asthma, urticaria, seizures, diabetes, migraine, hypertension, cardiovascular, pulmonary, neurological, psychiatric, endocrine, immunological, hematopoietic, diarrheal, or ongoing infectious diseases, or any other significant abnormality\n* History or presence of gastrointestinal inflammation, bleeding, ulceration, hemorrhage, or perforation of the stomach, small intestine, or large intestine\n* History of dermatological diseases (skin reactions, skin rash) related to drug use, or presence of any dermatological diseases\n* Unable to swallow large-size tablets\n* Use of any food supplements containing flavonoids within 14 days before first dosing or during the study\n* Blood donation (500 mL) or participation in any clinical study within 90 days prior to check-in\n* Use of any prescribed medications, OTC medications, or herbal medications within 30 days prior to first dose\n* Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids, barbiturates) in urine at check-in\n* Positive urine\u002Fbreath alcohol test at check-in\n* Positive pregnancy test\n* Currently pregnant, breast-feeding, or likely to become pregnant during the study\n* Use of implanted or injected hormonal contraceptives within 6 months prior to study, or hormonal contraceptives within 14 days before dosing",{"count":512,"type":21},72,[24],"This study aims to compare the bioavailability of Dimotec 1000 mg film-coated tablet (Test; Keri Pharma Hungary Kft.) with Detralex 1000 mg film-coated tablets (Reference; Les Laboratoires Servier Industrie, France) in healthy adult human participants under fed conditions. The study will also evaluate the safety and tolerability of a single dose of the investigational products.",[27],{"date":205,"type":37},{"date":205,"type":21},{"date":519,"type":21},"2026-08-27",{"name":521,"class":94},"Keri Pharma Hungary Kft",{"id":523,"slug":4,"hasResults":11,"nctId":524,"briefTitle":525,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":51,"sex":527,"minAge":52,"maxAge":18,"enrollmentInfo":528,"targetDuration":4,"studyType":22,"phases":530,"briefSummary":531,"conditions":532,"keywords":534,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":45},"100317012","NCT03407079","Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)","* INCLUSION CRITERIA:\n\n  1. Age: between 18 and 60 years\n  2. Female adults who self-identify as Hispanic and\u002For Black\n  3. Body weight greater than 50 kg (110 lb)\n  4. Body mass index between 25 kg\u002Fm\\^2 and 40 kg\u002Fm\\^2\n  5. Consumption of less than or equal to one 12-ounce beverage sweetened with NNS per month or food equivalent\n  6. Healthy with no known active medical condition or illness that requires drug treatment\n  7. Able and willing to consume approximately 4 mg\u002Fkg sucralose daily or placebo in form of capsules for\n\n  4 weeks\n\n  8\\. Able and willing to avoid eating grapefruit, parsnips, celery, drinking grapefruit juice or sodas containing quinine (e.g. tonic water) during the study\n\n  9\\. Able and willing to collect stool specimens\n\n  10\\. Able and willing to consume digoxin and midazolam during study visits\n\nEXCLUSION CRITERIA:\n\n1. Current use of prescription or non-prescription medication(s), herbal medications and oral contraceptives are also excluded. Certain exceptions are permitted, including vitamins. Other medications may be permitted at the discretion of the investigators.\n2. Diabetes (fasting blood glucose of 126 mg\u002Fdl or higher, or 2-hour blood glucose of 200 or higher on OGTT)\n3. Taken medications that affect blood sugar in the past 3 months or that include antibiotics\n4. GI history, at the discretion of the investigators\n5. Known allergy, sensitivity, or other contraindication to study procedures\n6. ALT or AST more than 1.5 times the upper limit of normal\n7. Abnormal thyroid function or abnormal serum electrolytes \\& minerals (specifically potassium, calcium, and magnesium)\n8. Narrow angle glaucoma or untreated open angle glaucoma\n9. Regular use of alcohol (more than 1 drink per day) or drug use\n10. History of cardiac abnormalities, especially arrhythmia\n11. Unable or unwilling to cooperate with study procedures\n12. Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to provide informed consent, or to comply with study procedures\n13. Pregnant, planning to become pregnant or lactating (digoxin and midazolam are Category C and D medications, respectively).","FEMALE",{"count":529,"type":21},150,[56],"Background:\n\nArtificial sweeteners like sucralose are found in many foods and drinks. Sucralose might affect hormones and cause health changes.\n\nObjective:\n\nTo see if sucralose changes how medicines are absorbed and processed, how hormones are secreted, gut bacteria, and how fat cells are metabolized.\n\nEligibility:\n\nPeople ages 18-60 who:\n\n* Are black or Hispanic\n* Weigh more than 110 pounds\n* Have a body mass index of 25-40\n* Do not have a condition that requires drug treatment\n\nDesign:\n\nParticipants will be screened with:\n\n* Medical history\n* Physical exam\n* Blood, heart, and urine tests\n\nParticipants must not eat or drink anything with artificial sweeteners throughout the study.\n\nOver 7 days, Participants will answer questions, and give daily urine samples and 1 stool sample. Participants will repeat these throughout the study.\n\nOvernight Visit 1: participants will fast starting the night before. They will get breakfast at the visit. The visit includes:\n\n* An IV will be placed in the arm. Participants will get 2 tablets of medicines. Blood will be drawn several times over 24 hours.\n* A piece of fat tissue may be taken from the abdomen (biopsy).\n* Participants will have a sweet drink. Blood samples will be taken over 2 hours.\n\nThen participants will be randomly assigned to take either a sucralose capsule or placebo. They will take it twice a day for 2 weeks. They will complete two 24-hour food diaries.\n\nOvernight Visit 2 repeats Visit 1 except the biopsy.\n\nThen participants will take the capsules for another 2 weeks.\n\nOvernight Visit 3 repeats Visit 1.\n\nParticipants may be contacted by phone within 4 weeks after they finish.",[27,533],"Overweight",[535,536,537,538,539],"Drug Metabolism","Artificial Sweetener","P-Glycoprotein","Cytochrome P450","Microbiome",{"date":384,"type":37},{"date":542,"type":37},"2018-04-05",{"date":544,"type":21},"2027-12-26",{"name":546,"class":44},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)",{"id":548,"slug":4,"hasResults":11,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":51,"sex":16,"minAge":553,"maxAge":260,"enrollmentInfo":554,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":556,"conditions":557,"keywords":560,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":565,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":45},"100235143","NCT02339012","Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)","The Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)","* Since the study of gene expression and epigenetic regulation are essential aims of GESTALT, all participants are required to consent to DNA\u002FRNA testing and storage at all visits. Participants that refuse genetic testing and storage will not be eligible to participate or to continue to participate in the study.\n\nThe criteria below for each group pertains only to the Screening and Baseline Visits, except where otherwise noted. If any of the conditions develop while the participant is in the study, the participant remains in the study. However, participants that develop severe cognitive problems and are diagnosed by the cognition group with dementia, will no longer be able to participate in the study.\n\nINCLUSION CRITERIA for the Healthy Group:\n\n* Age greater than or equal to 20 years of age.\n* Are willing to return every 2 years for study visit procedures.\n* Agree to genetic (DNA\u002FRNA) sample collection, analysis and storage.\n* Have good venous access for cytapheresis and are in good health as determined by the Apheresis Health History Questionnaire and are found eligible for apheresis (Apheresis Eligibility form).\n* Weigh greater than or equal to 110lbs and a body mass index (BMI) \\\u003C 30.\n* Do not have established genetic diseases such as sickle cell, hemochromatosis (iron overload), cystic fibrosis or Ehlers-Danlos syndrome (connective tissue disorder).\n* Do not have autoimmune diseases such as Hashimoto's thyroiditis, Myasthenia Gravis or Rheumatoid arthritis.\n* Report that they are able to perform daily self- care without assistance.\n* Report that they able to walk independently for at least 400 meters without assistance and without developing severe symptoms.\n* Report they are able to perform normal activities of daily living without shortness of breath (walking or climbing stairs) or other severe symptoms.\n* Do not have cognitive impairment based on mental status screening tests and evaluations and in the absence of any drug treatment.\n* Do not have a history of cardiovascular disease or cerebrovascular disease including angina (requiring treatment), myocardial infarction, congestive heart failure, uncontrolled hypertension, pacemaker, stroke, or transient ischemic attacks (TIA).\n* Do not have a history of diabetes (requiring any medical treatment other than diet and exercise) and their fasting Glucose is \\\u003C126 mg\u002FdL.\n* Do not have active (any activity in the last 10 years) cancer, except for locally limited squamous and basal cell cancer.\n* Do not have clinically significant hormonal dysfunction (Self-reported or laboratory values out of range. Mild hypothyroidism in participants over 60 is not considered exclusion).\n* Do not have a history of neurological diseases or birth defects (other than minor anatomical abnormalities, which do not affect physical and\u002For cognitive function).\n* Do not have a history of kidney or liver disease (associated with reduced kidney or liver function).\n* Do not have a history of severe gastrointestinal (G.I.) diseases, with symptoms or requiring chronic treatment such as gastroesophageal reflux disease (GERD), Crohn s disease or ulcerative colitis.\n* Do not have a history of severe pulmonary disease such as chronic obstructive pulmonary disease (COPD) or asthma requiring continuous medication use.\n* Do not have muscle-skeletal conditions due to diseases or traumas (that cause pathological weakness and\u002For chronic pain).\n* Do not have a history of severe psychiatric conditions associated with behavioral problems or requiring absolute and continuous need for medical treatment.\n* Do not have any medical condition that requires absolute and continuous need for long term treatment with antibiotics, corticosteroids, immunosuppressors, H2 blockers and\u002For proton pump inhibitors, or pain medications.\n* Do not have a medical condition that requires the use of chronic anticoagulant medication such as Coumadin, heparin, or antiplatelet agents other than low dose aspirin.\n* Do not have important sensory deficits (legally blind and\u002For any condition that precludes the participant from being tested with standard neuropsychological tests or providing informed consent).\n* Are able to read and speak English.\n* Are able to understand the study risks and procedures, and consent to participate in the study.\n* Not currently pregnant or a nursing mother.\n* Do not currently smoke and have not smoked in the past 3 months.\n* Veins are adequate for cytapheresis.\n* No current illness that as judged by the study physician substantially increases the risks associated with cytapheresis (active infections, allergies, etc.).\n* No history of allergy to acid- citrate- dextrose (ACD) anticoagulant.\n* No history of an active bleeding disorder such as hemophilia or Von Willebrand disease.\n* No history of seizures within the last 3 months.\n* No history of Lyme disease, unless six weeks' post treatment and no new symptoms, of Chagas disease, Babesiosis, or Leishmanias.\n* Are not claustrophobic and are eligible to perform 3TMRI as per the MRI eligibility form.\n* Do not have hip or knee replacements or other medical conditions that prevent 3TMRI research scans from being performed.\n\nINCLUSION CRITERIA for the Non-Healthy-or-Frail and Frail groups:\n\n* Age \\>= 20 years of age in the NHF group.\n* Age \\>= 50 years of age in the F group.\n* Are willing to return every 2 years for study visit procedures.\n* Agree to genetic (DNA\u002FRNA) sample collection, analysis, and storage.\n* Have good venous access for blood sampling.\n* Weigh \\>= 110lbs and a body mass index (BMI) \\\u003C= 35.\n* Do not have established genetic diseases such as sickle cell, hemochromatosis (iron overload), cystic fibrosis or Ehlers-Danlos syndrome (connective tissue disorder).\n* Do not have important sensory deficits (legally blind and\u002For any condition that precludes the participant from being tested with standard neuropsychological tests or providing informed consent).\n* Are able to read and speak English.\n* Are able to understand the study risks and procedures, and consent to participate in the study.\n* Not currently pregnant or a nursing mother.\n* No current acute medical condition.\n* No history of an active bleeding disorder such as hemophilia or Von Willebrand disease.\n* No history of seizures within the last 3 months.\n* Are not claustrophobic and are eligible to perform 3TMRI as per the MRI eligibility form.\n* Do not have other medical conditions that prevent 3TMRI research scans from being performed.\n* Frail participants meet the A and B criteria as reported.\n* Not-Healthy-or-Frail participants will not be eligible for the Healthy group because of medical or functional problems and also do not meet the criteria for the Frail Group.\n\nParticipant Exclusion Criteria:\n\nThese criteria pertain to the Screening and Baseline Visits. If conditions considered as exclusion criteria for study entry develop any time after the Baseline evaluation, the participant remains in the study.\n\nExclusion Criteria:\n\n* HIV virus infection (all groups).\n* Hepatitis B or C (all groups).\n* Active syphilis, gonorrhea or TB requiring treatment (all groups).\n* WBC \\\u003C3,000 or \\> 12,000\u002Fk\u002FmicroL (only Healthy group).\n* Platelets \\\u003C 100,000 or \\>600,000 k\u002F microL (only Healthy group).\n* Hemoglobin \\\u003C 11.0 gm\u002FdL in women and \\\u003C 12.0 gm\u002FdL in men (only Healthy group).\n* GFR \\\u003C50 mL\u002Fmin\u002F1.73 m\\^2 (only Healthy group)\n* GFR \\\u003C= to 30 (only non-Healthy-or-Frail group or Frail group)\n* Bilirubin \\> 1.5 mg\u002Fdl (unless higher levels can be ascribed to Gilbert's disease (only Healthy group).\n* ALT, AST, or alkaline phosphatase twice the normal serum concentration (only Healthy group).\n* Corrected calcium \\\u003C 8.5 or \\> 10.7 mg\u002Fdl (all groups).\n* Albumin \\\u003C 3.1 g\u002Fdl (only Healthy group).\n* Cholesterol, LDL and\u002For Triglycerides \\>1.5x normal (only Healthy group).\n* Positive Urine Drug Screen (unless taking prescribed medication and at the discretion of the PI) (all groups).\n* Currently pregnant or a nursing mother (all groups).\n\nFurthermore, if the participant is found eligible at Screening and Baseline but fails a urine drug screen (unless taking a prescribed medication and at the discretion of the PI) at any of the subsequent visits, the participant will be asked to return to repeat the test and if positive, will no longer be eligible to participate in the study.","20 Years",{"count":555,"type":21},900,"Background:\n\n\\- Biomarkers are substances in people s blood and tissues. They help researchers understand diseases and signs of aging. Scientists want to do more research on biomarkers to find ways to improve quality of life in old age.\n\nObjective:\n\n\\- To learn more about biomarkers and their relationship to aging.\n\nEligibility:\n\n\\- Adults at least 20 years old who weigh at least 110 pounds and have a body mass index below 30. They must agree that their genetic samples can be collected, studied, and stored.\n\nDesign:\n\n* Participants will be screened with medical history, physical exam, EKG and blood and urine tests.\n* Participants will have 3-day visits. They will return every 2 years.\n* All visits include:\n* Blood and urine collection\n* Physical performance tests\n* Health questionnaires\n* Memory and problem-solving tests\n* Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT) scans.\n* Muscle metabolism\u002F exercise tests\n* Taste strips\n* Muscle and\u002For skin biopsies\u002F red light therapy\n* Retinal imaging\u002F eye tracking\n* Sleep study\n* ODD visits also include:\n* Cytapheresis\n* Bone marrow aspirate\n* EVEN visits also include:\n* Hyperglycemic CLAMP\n* Lumbar Puncture (LP)\n* Continuous Glucose Monitor (CGM)",[27,558,559],"Non-Healthy\u002FNon-Frail","Frail",[561,246,562,563,564,157],"Genome Wide Association","Methylation","Phenotype","Cytometry",{"date":384,"type":37},{"date":567,"type":37},"2015-03-15",{"date":569,"type":21},"2099-12-31",{"name":275,"class":44},""]