[{"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":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,258,0,25,[9,45,74,96,120,148,169,192,213,234,252,273,294,322,345,368,389,412,438,459,481,508,533,556,576],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100650729","survey-to-determine-incarcerated-persons-views-on-surrogate-decision-making-100650729",false,"NCT07751731","Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making","Survey to Determine Incarcerated Persons Views on Surrogate Decision-Making","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Currently incarcerated in a United States facility with Edovo educational tablets\n2. Ability to understand the consent form and survey\n3. Willingness to give informed consent\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1\\. Inability to read or write in English",true,"ALL","18 Years","120 Years",{"count":22,"type":23},75000,"ESTIMATED","OBSERVATIONAL","Background:\n\nAbout 180,000 of the people in US prisons are over 55 years old. Aging people often cannot make medical decisions on their own. People who cannot make their own decisions must rely on a \"surrogate.\" A surrogate is someone who helps the person's doctor make decisions for them. Researchers want to conduct a survey to ask people in prison who they would like to be their surrogates. But first, they need to find out if their survey questions are clear and easy to understand.\n\nObjective:\n\nTo get imprisoned people's feedback on survey questions about surrogate decision making.\n\nEligibility:\n\nPeople currently imprisoned in a US facility with access to Edovo. They must be able to read and write in English.\n\nDesign:\n\nParticipants will answer 26 survey questions. The questions will be on the Edovo Learn software platform. After each question, they will be asked: \"Was this question clear? If not, please explain in the box below what you found unclear. Also, if you have any suggestions for how we might make the question clearer, please include them.\"\n\nParticipants will be asked to imagine themselves in a situation where they cannot make their own medical decisions. They may skip questions or stop the survey if they want. No information that identifies them will be collected.\n\nThe survey will take about 15 minutes.",[27],"Healthy Volunteers",[29,30,31],"Incarcerated","Surrogate","Survey","RECRUITING","2026-08-20",{"date":35,"type":36},"2026-08-21","ACTUAL",{"date":38,"type":23},"2026-08-26",{"date":40,"type":23},"2027-02-28",{"name":42,"class":43},"National Institutes of Health Clinical Center (CC)","NIH",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":70,"leadSponsor":72,"locationsCount":44},"100631739","investigating-the-analgesic-potential-of-2r6r-hnk-in-acute-pain-in-healthy-volunteers-100631739","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 years\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.","60 Years",{"count":53,"type":23},92,"INTERVENTIONAL",[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","NOT_YET_RECRUITING",{"date":35,"type":36},{"date":38,"type":23},{"date":71,"type":23},"2031-12-31",{"name":73,"class":43},"National Center for Complementary and Integrative Health (NCCIH)",{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":54,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":44},"100613830","phase-1-a-study-to-determine-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-ro7806881-in-healthy-participants-100613830","NCT07271693","A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants","A Phase I, Randomized, Investigator\u002FParticipant-blind, Parallel-group, Placebo-controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants","Inclusion Criteria:\n\n* Participants must be males or females who are overtly healthy as determined by medical evaluation\n* Participants must have body weight (BW) ≥ 40 kilograms (kg) (not applicable to Cohort A9) and body mass index (BMI) within the range 18-32 kilograms per square meter (kg\u002Fm\\^2) (inclusive)\n\nInclusion Criteria Specific to Cohort A9 (East Asian Cohort):\n\n* Must be of ethnic Chinese, Korean, or Japanese origin\n* Must have a BW \\>35 kg and BMI within the range 18-32 kg\u002Fm2 (inclusive)\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding, or intention to become pregnant during the study or within 6 months after the final dose of study treatment\n* History of any clinically significant autoimmune, gastrointestinal, renal, hepatic, pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, or allergic disease; metabolic disorder; cancer or cirrhosis\n* Latent tuberculosis (TB) or potentially active TB\n* Any major illness within 1 month before the screening examination or any febrile illness within 1 week prior to the screening visit and up to first dose administration\n* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study\n* History of hypersensitivity to biologic agents or any of the excipients in the formulation, or other allergy that contraindicates participation in the study\n* Live vaccines within 1 month of the first screening visit or during the screening period\n* Non-live vaccines within 2 weeks prior to dosing\n* Previous exposure to RO7806881\n* Positive hepatitis C virus (HCV) antibody test result\n* Positive test results for hepatitis B infection\n* Positive human immunodeficiency virus (HIV) antibody test result\n* Positive test result consistent with cytomegalovirus (CMV) or Epstein-Barr virus (EBV)","50 Years",{"count":83,"type":23},128,[85],"PHASE1","The main purpose of this study is to evaluate the safety and tolerability of single and multiple ascending doses of RO7806881 in healthy participants.",[27],{"date":35,"type":36},{"date":90,"type":36},"2025-12-22",{"date":92,"type":23},"2027-03-01",{"name":94,"class":95},"Hoffmann-La Roche","INDUSTRY",{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":18,"minAge":103,"maxAge":51,"enrollmentInfo":104,"targetDuration":4,"studyType":54,"phases":106,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":116,"leadSponsor":118,"locationsCount":44},"100582869","phase-i-trial-of-high-density-theta-burst-stimulation-hdtbs-100582869","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.","22 Years",{"count":105,"type":23},35,[85],"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],[110,111,112,113],"Substance Use Disorders (SUDs)","Transcranial Magnetic Stimulation (TMS)","Theta Burst Stimulation (TBS)","High-density Theta Burst Stimulation (hdTBS)",{"date":35,"type":36},{"date":38,"type":23},{"date":117,"type":23},"2028-01-13",{"name":119,"class":43},"National Institute on Drug Abuse (NIDA)",{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":54,"phases":129,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":147},"100569590","fermented-vegan-optimized-diet-in-health-and-colitis-100569590","NCT06696222","Fermented Vegan Optimized Diet in Health and Colitis","FAVORIT","Inclusion Criteria:\n\n* Healthy volunteers in two groups\n* IBD in two groups (ulcerative colitis or Crohn's disease)\n\nExclusion Criteria:\n\n* For healthy any disease requiring medication\n* For IBD previous extensive operation\n* For both antibiotics the past month",{"count":128,"type":23},240,[130],"NA","The diet is assumed to contribute to many of our present non-communicable diseases. Vegetarian products are instead considered to be health promoting, However, it is not verified that the modern vegetarian and vegan products are healthier than the ones they are meant to replace. Products based on vegetables are nowadays often produced with advanced techniques and can therefore differ substantially from the original vegetables.\n\nThe epithelium in the gut is protected by a mucus layer that efficiently prevents bacteria to encounter the epithelium and even to translocate into the gut and the blood stream. In several inflammatory conditions such as e.g., inflammatory bowel disease (IBD) the barrier integrity is disrupted, and translocation will occur. Fibers are important for the gut microbiota enabling the production of short chain fatty acids (SCFA) that is necessary as nutrition for the epithelial cells, Fibers also promote the development of mucus.\n\nThe aim of the present study is to evaluate components in the diet that is claimed to be health promoting even though they sometimes can be a hazard to your health. Both fibers and antinutrients can be found in these dietary regimens. The health effects of these products will be studied by analysis of the gut microbiota and the barrier integrity as markers of the health status. Gut microbiota will be analyzed with next generation sequencing and q-PCR (polymerase chain reaction). Diversity and the occurrence of different species will be determined. The barrier integrity will be estimated by analysis of bacterial DNA in blood and presence of live bacteria.\n\nThe study consists of two different parts:\n\n1a. 60 health volunteers are divided into two groups. One group consumes ordinary dairy based yogurt and the other a yogurt based on vegan products for four weeks to enable a change in the gut microbiota. At start and after four weeks fecal samples and questionnaires about the general health and gastrointestinal symptoms will be retrieved. It should be noted that the compounds offered can be bought in the ordinary shops.\n\n1. b. The same design as above but with IBD patients instead. Their disease activity will be monitored by scoring sheets and regular blood tests as a part of their regular check-up.\n2. a. The same design as in 1a but with comparison between a regular meat-based diet and a diet with vegetarian meat substitutes instead.\n\n2b. The same design as I 2a but with IBD patients. Healthy volunteers will be invited wit advertisements. The IBD patients will be recruited at the out-patient clinic at the Dept of Gastroenterology at Skåne university hospital, Sweden. Before inclusion their disease activity will be monitored.\n\nThe study is a prospective non-randomized intervention study including both men and women. Each individual will serve as their own control. The meals based on meat substitutes will be composed in cooperation with a dietitian. The estimated amount of yogurt is 200-250 gram\u002Fday, and the amount of meat is 150-200 gram\u002Fday.",[27,133],"Inflammatory Bowel Disease (IBD)",[135,136,137,138],"diet","ulcerative colitis","Crohn's disease","vegetarian diet",{"date":35,"type":36},{"date":141,"type":36},"2024-11-18",{"date":143,"type":23},"2027-12-31",{"name":145,"class":146},"Region Skane","OTHER",2,{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":154,"targetDuration":4,"studyType":54,"phases":156,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":147},"100558564","cybersickness-prevention-and-mitigation-in-virtual-reality-for-healthy-volunteers-100558564","NCT06552754","Cybersickness Prevention and Mitigation in Virtual Reality for Healthy Volunteers","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Aged 18-60\n* Ability to read, speak, and write in English\n* Normal or corrected-to-normal hearing\n* Normal vision or corrected-to-normal without use of glasses. Contact lenses for corrective purposes are acceptable.\n\nAbility to read, speak and write in English is a requirement because the VR-based study materials and assessment are only available in English and several of the key questionnaires for the study are not validated in other languages.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Reporting motion sickness propensity of 0, 9 or 10 on a 0-10 scale where 0 =never experience motion sickness and 10 = experience motion sickness very frequently (self-assessed by participants).\n* Reporting a history of photo-sensitive seizure disorders, vestibular disorders and\u002For other conditions that may make participants prone to nausea, dizziness, vertigo, ataxia, or incoordination.\n* Known pregnancy\n* Reporting current use of medication or supplements that inhibit nausea, e.g., Zofran\u002Fondansetron, Phenergan\u002Fpromethazine",{"count":155,"type":23},150,[130],"Background:\n\nPeople use virtual reality (VR) technology to play games, socialize, work, or receive medical care. Some people have \"cybersickness\" after using VR. Cybersickness is similar to motion sickness. Symptoms include eye strain, nausea, dizziness, or headache. The symptoms are usually mild and go away after the person stops using VR. New software called Motion Reset is being designed to reduce symptoms of cybersickness during VR use.\n\nObjective:\n\nTo see if Motion Reset software can reduce cybersickness in people using VR.\n\nEligibility:\n\nHealthy adults aged 18 to 60 years.\n\nDesign:\n\nParticipants will have 1 clinic visit that will last about 1 hour. They will answer questions about how they are feeling. They will learn how to use the VR headset and the handheld game controllers.\n\nThe study will be broken into 2 parts. For the first part, participants will be assigned to 1 of 3 groups:\n\nGroup 1 will participate in a VR experience designed to prevent cybersickness. They will view screens and move around while they press buttons on a controller.\n\nGroup 2 will participate in a VR experience that is not designed to prevent cybersickness. They will view screens and move around while they press buttons on a controller.\n\nGroup 3 will have no VR experience.\n\nParticipants will complete 2 questionnaires about their experiences in the first part of the study.\n\nFor the second part, all participants will spend up to 20 minutes playing a commercial VR game called Jurassic World Aftermath. Every few minutes, they will be asked if they are experiencing discomfort.\n\nAfter playing the game, participants will complete 12 questionnaires about their experience....",[27,159],"Virtual Reality",[27,159,161],"cybersickness",{"date":35,"type":36},{"date":164,"type":36},"2025-09-26",{"date":166,"type":23},"2027-02-01",{"name":168,"class":43},"National Human Genome Research Institute (NHGRI)",{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":81,"enrollmentInfo":175,"targetDuration":4,"studyType":54,"phases":177,"briefSummary":178,"conditions":179,"keywords":181,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":44},"100243356","neural-and-psychological-mechanisms-of-pain-perception-100243356","NCT02446262","Neural and Psychological Mechanisms of Pain Perception","* INCLUSION CRITERIA:\n* Healthy\n* Between 18 and 50 years old\n* Fluent in English\n* Able to provide written informed consent.\n\nEXCLUSION CRITERIA (all sub-studies):\n\n* Unable to comply with study procedures or follow-up visits.\n* Has a major medical condition or medical history that in a clinician's assessment could affect heat sensitivity, pain thresholds, or ability to comply with study procedures. This may include cardiovascular, autonomic, or neurological conditions, including stroke, blindness, deafness, a history of brain damage, or a chronic systemic disease (e.g., diabetes).\n* Has a current mood disorder, anxiety disorder, or substance use disorder, or has a history of psychosis, hospitalization for a mental health condition, or recurrent psychiatric episodes.\n* Has a medical condition that in a clinician's assessment might affect somatosensation (e.g., Raynaud's disease, peripheral neuropathy, or circulatory disorder).\n* Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months).\n* Has a dermatological condition affecting the testing region such as scars, burns, or recent tattoos that might influence cutaneous sensibility.\n* Regular use of prescription medication that has a significant effect on pain or heat perception. Excluded medications include central-acting agents such as opiates (morphine, tramadol), antidepressants (amitriptyline, duloxetine, milnacipran), anticonvulsants (gabapentin, pregabalin), anxiolytics (barbituates, benzodiazepines), hypnotics (zolpidem, sodium oxybate), antipsychotics (valproate, lithium, olanzapine), antimigraine agents (sumatriptan, ergotamine), and muscle relaxants (cyclobenzaprine, carisoprodol). Use of analgesic medications, such as non-steroidal anti-inflammatories, salicylates, and acetaminophen, taken on an \"as needed\" basis is acceptable as long as the last dose taken was within 5 half-lives of testing.\n* Is pregnant.\n* NIH staff member who is a subordinate\u002Frelative\u002Fco-worker of any investigator on the protocol.\n\nEXCLUSION CRITERIA (fMRI sub-studies):\n\n* Individuals with conditions that could pose a risk relating to the safety of the fMRI procedure or pain stimulation will be excluded from the MRI portion of the protocol, but may participate in the non-fMRI sessions (with the exception of pregnant women). Such conditions include:\n\n  * Those with ferromagnetic metal in the cranial cavity or eye, e.g. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body.\n  * Those with an abnormality on a structural MRI.\n  * Those with an implanted cardiac pacemaker or auto-defibrillator.\n  * Those with an insulin pump.\n  * Those with irremovable body piercing.\n  * Pregnant women (based on urine test completed within 24 hours prior to scan).\n* Individuals who are left-handed (based on self-report or score on handedness questionnaire) will be excluded from fMRI substudies.\n\nEXCLUSION CRITERIA (placebo analgesia sub-studies):\n\n-Participation in an NIH study of analgesia, as gleaned from CRIS.",{"count":176,"type":23},550,[130],"Background:\n\n\\- Painful stimuli cause changes in a network of brain regions called the \"Pain Matrix.\" But most of these regions respond to many other stimuli, not just pain. Researchers want to understand how different factors influence pain. They want to test what happens when people expect different levels of pain and receive treatments that can modify pain. They want to see if these factors influence decisions about pain and how the body responds to it. They also want to compare pain with responses like taste and vision.\n\nObjectives:\n\n\\- To better understand how pain and emotions are processed and influenced by psychological factors.\n\nEligibility:\n\n\\- Healthy volunteers ages 18-50.\n\nDesign:\n\n* This study requires 1 to 2 clinic visits that last 1 to 3 hours.\n* Participants will be screened with medical history and physical exam.\n* Some participants will have one or more magnetic resonance imaging (MRI) scans of their brain. For MRI, participants will lie on a table that slides in and out of a cylinder. The scanner makes loud knocking noises. They will get earplugs.\n* Participants' heart activity will be recorded with electrocardiogram. Their pulse, sweating, and breathing will be monitored.\n* Some participants will take a taste test. Others may perform simple tasks. Others may receive pain in their arm, leg, or hand. The pain will come from heat or electric shocks. Others may judge pain using a topical pain-relieving cream. Some of these tests may be given during MRI.\n* Participants will fill out questionnaires.\n* The study will last 3 years.",[61,180,27],"Normal Physiology",[61,182,183,184,185],"Visual Analogue Pain Scale","Placebo","Affective Neuroscience","Functional Magnetic Resonance Imaging (fMRI)",{"date":35,"type":36},{"date":188,"type":36},"2015-06-11",{"date":190,"type":23},"2027-02-20",{"name":73,"class":43},{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":54,"phases":201,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":4},"100652932","phase-1-study-to-assess-safety-and-immunogenicity-of-an-egg-based-h5n8-influenza-vaccine-at-multiple-dose-levels-adjuvanted-with-matrix-m-in-healthy-participants-18-years-of-age-and-above-100652932","NCT07779408","Study to Assess Safety and Immunogenicity of an Egg-based H5N8 Influenza Vaccine at Multiple Dose Levels Adjuvanted With Matrix-M in Healthy Participants 18 Years of Age and Above.","A Phase 1\u002F2, Parallel, Observer-blind Study to Assess the Safety and Immunogenicity of an Egg-based H5N8 Influenza Vaccine at Multiple Dose Levels Adjuvanted With Matrix-M in Healthy Participants 18 Years of Age and Above.","Inclusion Criteria:\n\n* Aged 18 years or above on the day of inclusion\n* Participants who are healthy as determined by medical evaluation including medical history\n* Not pregnant\u002Fbreastfeeding; non-childbearing potential or uses effective contraception\u002Fabstinence from ≥4 weeks before the first study intervention dose to ≥8 weeks after the last dose\n* Informed consent form has been signed and dated\n* Able to attend all scheduled visits and to comply with all study procedures\n* Covered by health insurance, if required by local regulations\n\nExclusion Criteria:\n\n* Known or suspected immunodeficiency; immunosuppressive therapy in past 6 months; or long-term systemic corticosteroid (eg, prednisone for more than 2 weeks in the past 3 months)\n* Known hepatitis B or hepatitis C infection (based on medical history)\n* Known personal or family history of previous episodes of Guillan-Barré syndrome (GBS), neuritis (including Bell's palsy), convulsions, encephalitis, transverse myelitis, and vasculitis\n* Known systemic hypersensitivity to any of the study intervention components or history of life-threatening reaction to the study interventions or products with same substances\n* Self-reported thrombocytopenia contraindicating intramuscular (IM) injection based on investigator's judgment\n* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection based on investigator's judgment\n* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion\n* History of A\u002FH5 infection prior to the study participation\n* Moderate or severe acute illness\u002Finfection (per investigator judgment)\u002Ffever (≥ 38.0°C \\[≥ 100.4°F\\]) on study intervention day. Include participant only after the condition or fever has resolved\n* Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion\n* Any vaccine given 4 weeks before first study intervention or any planned vaccination to be given prior to Day 43 (ie, approximately 21 days after the second study intervention)\n* Previous vaccination against A(H5) with an investigational or marketed vaccine. This includes, but is not limited to, influenza subtypes A(H5N1), A(H5N8), and A(H5N6)\n* Has received a blood transfusion or blood-derived products, including immunoglobulins in the past 3 months\n* Participation in another clinical study for a vaccine, drug, medical device, or medical procedure within 4 weeks before enrollment or planned participation during the present study period\n* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily\n* Is an investigator, investigator\u002Fstudy center employee, or immediate family member (parent, spouse, natural\u002Fadopted child) of the investigator\u002Femployee with direct involvement in the study\n* Any screening safety laboratory parameters out of normal ranges and assessed as \\> Grade 2\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":200,"type":23},640,[85,56],"The study aims to evaluate an egg-based H5N8 influenza vaccine up to 3 dose levels (low, medium, and high dose) given with or without adjuvant to see if the adjuvant improves vaccine effectiveness.\n\nThe study will enroll healthy adults aged 18 years and over. Participants will receive 2 injections in their arm of either one of the 3 dose levels of the study vaccine (low, medium, or high dose) with the adjuvant or the unadjuvanted vaccine (high dose).\n\nStudy duration per participant: approximately 14 months (including screening visit).",[27,204],"Influenza","2026-08-19",{"date":35,"type":36},{"date":208,"type":23},"2026-08-10",{"date":210,"type":23},"2028-02-22",{"name":212,"class":95},"Sanofi",{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":220,"enrollmentInfo":221,"targetDuration":4,"studyType":54,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":147},"100645820","phase-1-a-study-of-ly4178256-in-healthy-participants-100645820","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":222,"type":23},88,[85],"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],"2026-08-18",{"date":33,"type":36},{"date":229,"type":36},"2026-07-16",{"date":231,"type":23},"2028-03",{"name":233,"class":95},"Eli Lilly and Company",{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":220,"enrollmentInfo":241,"targetDuration":4,"studyType":54,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":147},"100645673","phase-1-a-study-of-eloralintide-ly3841136-in-healthy-participants-100645673","NCT07701083","A Study of Eloralintide (LY3841136) in Healthy Participants","A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Two Eloralintide Solutions in Healthy Participants","Inclusion Criteria:\n\n* Are overtly healthy as determined by medical evaluation\n* Have a body mass index (BMI) within the range of 20.0 to 32.0 kilogram per square meter (kg\u002Fm2), inclusive\n\nExclusion Criteria:\n\n* Have known allergies to related compounds of eloralintide, or any of the components of the formulations\n* Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data\n* Have been diagnosed with Type 1 or Type 2 diabetes mellitus, or have glycated hemoglobin greater than or equal to 6.5% or 48 millimole per mole (mmol\u002Fmol)\n* Have a history of any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years\n* Have a history or presence of a gastrointestinal (GI) disorder or previous surgery that impacts gastric emptying for example, gastric bypass surgery or pyloric stenosis\n* Have obesity induced by other endocrinologic disorders for example, Cushing syndrome, or diagnosed monogenetic or syndromic forms of obesity for example, Melanocortin 4 Receptor deficiency or Prader Willi syndrome\n* Have taken approved or investigational medication for weight loss, including glucagon-like peptide-1 receptor agonists (GLP-1 RAs), within the previous 3 months of study screening\n* Intend to use any weight loss medications during study participation",{"count":242,"type":23},58,[85],"The main purpose of this study is to learn about safety, tolerability and how well the body processes two different eloralintide solutions. Participation in this study will last about 13 weeks, including screening, inpatient treatment, and follow-up.",[27],{"date":33,"type":36},{"date":248,"type":36},"2026-07-20",{"date":250,"type":23},"2026-10",{"name":233,"class":95},{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":220,"enrollmentInfo":259,"targetDuration":4,"studyType":54,"phases":261,"briefSummary":262,"conditions":263,"keywords":264,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":44},"100641587","phase-1-a-phase-1-study-to-evaluate-pharmacokinetics-safety-and-tolerability-of-zl-1503-in-healthy-volunteers-100641587","NCT07658482","A Phase 1 Study to Evaluate Pharmacokinetics, Safety and Tolerability of ZL-1503 in Healthy Volunteers","A Phase 1, Randomized, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-1503 Following a Single Dose of Subcutaneous or Intravenous Administration in Healthy Volunteers.","Inclusion Criteria:\n\n* Healthy male and female volunteers, 18-65 years of age\n* Body mass index (BMI) between ≥ 18.5 and \\\u003C 32.5 kg\u002Fm2\n* Negative pregnancy tests for women of childbearing potential.\n\nExclusion Criteria:\n\n* Significant health issues, such as positive tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), active tuberculosis, immunodeficiencies or autoimmune diseases.\n* History of major metabolic, liver, kidney, hematologic or other significant disorders.\n* Abnormal Electrocardiogram (ECG) findings\n* Clinically relevant abnormal lab results, including low blood counts, or abnormal liver and kidney function.\n* History of drug abuse or addiction within 6 months prior to screening\n* Current smoker or use of any nicotine or tobacco containing products within the last 6 months prior to dosing.\n* Donated \\>500mL blood within 2 months of dosing.",{"count":260,"type":23},36,[85],"This is a phase 1, single dose, randomized, open-label, parallel-group study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of ZL-1503 and to explore its PD biomarkers following a single subcutaneous (SC) or intravenous (IV) administration in healthy volunteers.",[27],[265],"Healthy volunteers",{"date":33,"type":36},{"date":268,"type":23},"2026-09-03",{"date":270,"type":23},"2027-11-10",{"name":272,"class":95},"Zai Lab (Shanghai) Co., Ltd.",{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":279,"targetDuration":4,"studyType":54,"phases":281,"briefSummary":282,"conditions":283,"keywords":284,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":44},"100305620","sociocultural--biobehavioral-influences-on-pain-expression-and-assessment-100305620","NCT03258580","Sociocultural & Biobehavioral Influences on Pain Expression and Assessment","* INCLUSION CRITERIA:\n\nAll Sub-Studies:\n\n* Healthy\n* Between 18 and 60 years old\n* Fluent in English\n* Able to provide written informed consent\n\nEXCLUSION CRITERIA:\n\nAll Sub-Studies:\n\n* Unable to comply with study procedures\n* Has a major-medical condition or medical history that in a clinician's assessment could affect ability to comply with study procedures, including neurological conditions (including stroke, blindness or deafness, or a history of brain damage)\n* Has a current mood disorder, anxiety disorder, or substance use disorder, or has a history of psychosis, hospitalization for a mental health condition, or recurrent psychiatric episodes.\n* NIH staff member who is a subordinate\u002Frelative\u002Fco-worker of any investigator on the protocol\n* Prior completion of a different sub-study within this protocol.\n* Is born outside of the states or territories of the United States of America\n* Does not currently reside in a state or territory of the United States of America\n\nSub-study 1:\n\n* Has a major-medical condition or medical history that in a clinician's assessment could affect heat sensitivity or pain thresholds. This may include cardiovascular, autonomic, or neurological conditions or a chronic systemic disease (e.g., diabetes)\n* Has a medical condition that in a clinician's assessment might affect somatosensation (e.g., Raynaud's disease, peripheral neuropathy, or circulatory disorder)\n* Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months)\n* Has a dermatological condition affecting the testing region, such as scars, burns, or recent tattoos that might influence cutaneous sensibility\n* Regular use of prescription medication that has a significant effect on pain or heat perception. Excluded medications include central-acting agents such as opiates (morphine, tramadol), antidepressants (amitriptyline, duloxetine, milnacipran), anticonvulsants (gabapentin, pregabalin), anxiolytics (barbituates, benzodiazepines), hypnotics (zolpidem, sodium oxybate), antipsychotics (valproate, lithium, olanzapine), antimigraine agents (sumatriptan, ergotamine), and muscle relaxants (cyclobenzaprine, carisoprodol). Use of analgesic medications, such as non-steroidal anti-inflammatories, salicylates, and acetaminophen, taken on an \"as needed\" basis is acceptable as long as the last dose was not taken was within 5 half-lives of testing.\n* Is left handed\n\nSub-study 4, FMRI participants:\n\n* Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months)\n* Is left-handed\n* Any FMRI contraindications, including:\n\n  * Ferromagnetic metal in the cranial cavity or eye, e.g. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body.\n  * Implanted cardiac pacemaker or auto-defibrillator.\n  * Insulin pump.\n  * Irremovable body piercing.\n* Pregnant women (based on urine test completed within 24 hours prior to scan).\n* Those with an abnormality on a structural MRI that has functional consequences based on clinician assessment.",{"count":280,"type":23},700,[130],"Objective\n\nThe current proposal investigates behavioral, psychophysiological, and social processes that may help explain biases and disparate outcomes in pain. Health disparities, or health outcomes that adversely affect disadvantaged populations, are pervasive and apparent in many diseases and symptoms, including pain. Pain is the number one reason individuals seek medical treatment. Health disparities in pain encompass both differences in pain experience and treatment for pain. For instance, research indicates that Black individuals report increased pain and have reduced pain tolerance relative to White individuals, yet doctors are less likely to treat minority patients pain and underestimate their pain experience. This project aims to address this systemic discrepancy by focusing on interpersonal processes that may contribute to these disparities, including socially-relevant responses to pain (i.e. pain expression) and pain assessment (e.g. visual attention). The proposed research aims to determine whether the study of pain expressions and their assessment can yield insights on how social factors shape pain and its treatment. Further, we test the efficacy of potential interventions designed to improve accuracy and reduce biases in pain assessment. If successful, this work will form the foundation of a new research program that will link the field of pain research with the field of social neuroscience, and forge new insights on the critical problem of health disparities in pain.\n\nStudy population\n\nWe will accrue up to 700 total healthy volunteers to target 240 completers\n\nDesign\n\nOur overall aim is to understand how social factors influence the assessment and management of pain, and to gain insight into psychosocial processes that may underlie health disparities in pain. We propose a series of studies designed to test these links. First, we will measure pain perception and physiological responses to painful stimuli in a diverse group of individuals to test for sociocultural and biological influences on pain and pain-related responses. In subsequent studies, new participants (\"perceivers\") will view images of these initial participants (\"targets\") and will provide estimates of 'targets' pain experience. We will measure a) whether perceivers can accurately estimate 'targets' pain experience; b) whether accuracy differs as a function of similarity between target and perceiver (ingroup vs outgroup); and c) whether individuals can improve accuracy through feedback.\n\nOutcome measures\n\nPrimary outcome measures for all experiments will be decisions about pain (experienced by self or other) measured with visual analogue scales, reaction time, and\u002For categorical judgments (pain\u002Fno pain). We will also measure physiological responses (e.g., facial muscle response, skin conductance, pupil dilation) and brain responses using functional magnetic resonance imaging (fMRI) as secondary outcome measures. We will test whether pain and pain-related responses varies as a function of sociocultural\u002Fdemographic factors (e.g. race, ethnicity, sex) and whether accuracy in assessing others' pain is influenced by group similarity (i.e. ingroup vs. outgroup) and training (e.g. performance-related feedback)....",[180,27,61],[61,182,285,286,287],"Healthy Volunteer","EYE TRACKING","Eye Movement",{"date":205,"type":36},{"date":290,"type":36},"2018-05-09",{"date":292,"type":23},"2027-05-30",{"name":73,"class":43},{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":17,"sex":18,"minAge":301,"maxAge":302,"enrollmentInfo":303,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":304,"conditions":305,"keywords":309,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":44},"100245278","studies-of-dermatologic-diseases-biospecimen-acquisition-protocol-100245278","NCT02471352","Studies of Dermatologic Diseases Biospecimen Acquisition Protocol","Studies of Dermatologic Diseases-Biospecimen Acquisition Protocol","* INCLUSION CRITERIA:\n* Eligible participants must:\n\n  * Have a dermatologic condition, as determined by the PI or AIs, OR --be at risk for developing a dermatologic condition, as determined by the PI or AIs, OR\n  * be a family member of a person with a dermatologic condition OR\n  * be a healthy volunteer, as defined as a person with no known significant health problems.\n  * Be willing to provide biospecimens for research and clinical studies, and for storage to be used for future research.\n  * Subjects of age greater than 0 years old (including only viable neonates) are eligible.\n\nEXCLUSION CRITERIA:\n\n* Presence of conditions that, in the judgment of the investigator, may put the subject at undue risk or make them unsuitable for participation in the study.\n* Inability to comply with the requirements of the protocol.","1 Day","100 Years",{"count":280,"type":23},"Background:\n\n\\- Skin disease can have many causes. It can have widespread consequences, and in rare cases can lead to death. Researchers want to determine the causes of various types of skin diseases and find a way to treat them.\n\nObjectives:\n\n\\- To determine the causes of various skin diseases and find ways to treat them.\n\nEligibility:\n\n* People ages 2 and older who have:\n\n  * A skin disease or at risk of developing a skin disease OR\n  * A family member of persons with a skin disease\n* Healthy volunteers ages 2 and older\n\nDesign:\n\n* Participants will be screened under a separate protocol.\n* Participants may take a survey about how their skin condition affects their quality of life.\n* Participants will have a medical history and a physical exam including a detailed skin exam. Pictures will be taken of their skin to document any skin disease.\n* Participants will have specimens collected. This may include:\n\n  * Several teaspoons of blood taken at each visit\n  * Stool samples\n  * Nail and body fluid (like saliva) samples\n  * Cheek swabs. The inside of the cheek will be scraped for about a minute in each direction to collect cells.\n  * Collection of skin samples with:\n\n    * A swab (like a Q-tip)\n    * Gently scraping skin to remove the outer layers of cells\n    * Applying and removing 1-inch pieces of tape\n* Participants may have up to 4 skin biopsies in 12 months, with 4 separate biopsies taken each time.\n\n  * An area of skin will be numbed with an injection.\n  * A piece of skin the size of a pencil eraser will be removed using a small instrument.\n  * A flat scar usually develops at the biopsy site.",[306,27,307,308],"Dermatologic Conditions","Normal Volunteers","Carcinoma, Merkel Cell",[310,311,312,27,313,314],"Dermatologic Condition","Skin Disease","Biospecimen","Merkel Cell Carcinoma","Natural History",{"date":205,"type":36},{"date":317,"type":36},"2015-06-19",{"date":319,"type":23},"2035-01-31",{"name":321,"class":43},"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)",{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":17,"sex":18,"minAge":329,"maxAge":330,"enrollmentInfo":331,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":333,"conditions":334,"keywords":335,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":340,"startDateStruct":341,"completionDateStruct":4,"leadSponsor":343,"locationsCount":44},"100090851","collection-and-analysis-of-blood-bone-marrow-and-buccal-mucosa-samples-from-healthy-volunteers-100090851","NCT00442195","Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers","Procurement and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers to Support Clinical and Translational Research Projects in the NHLBI","* INCLUSION CRITERIA:\n\nSelf-declared healthy volunteer (for blood and buccal mucosa sample donors).\n\nBe healthy, as determined by Principal Investigator or designee based on recent (\\\u003C3 months) history, physical and laboratory results (for bone marrow and skin tissue sample donors).\n\n\\\u003CTAB\\>\\\u003CTAB\\>\\\u003CTAB\\>\\\u003CTAB\\>\\\u003CTAB\\>\n\nAge 8 years and older (no upper limit) for blood and buccal mucosa sampling.\n\nOR\n\nAges 18 years or older (no upper limit) for bone marrow or skin tissue sampling.\n\nEXCLUSION CRITERIA:\n\nUnable to comprehend the investigational nature of the protocol participation.\n\nCBC determined outside expected normal ranges for the subject (bone marrow and skin tissue donors only).\n\nPregnancy\n\nAge less than 18 years for skin tissue sampling, bone marrow aspirate and biopsy.\n\nOff campus volunteers for skin tissue sampling bone marrow aspirate and biopsy.","8 Years","99 Years",{"count":332,"type":23},1000,"The Hematology Branch of the National Heart, Lung, and Blood Institute is doing a variety of laboratory research experiments that require blood and tissue samples from healthy volunteers. This protocol provides a mechanism for collecting these tissue samples. Research includes studies of normal and abnormal formation of blood cells, viral blood diseases, the role of the immune system in marrow failure and genetic risk factors for aplastic anemia.\n\nHealthy normal volunteers 8 years of age and older may be eligible for this study. Samples are collected as follows:\n\n* Blood samples: Participants 8 years of age and older donate up to 4 tablespoons of blood, which is obtained from a needle placed in an arm vein.\n* Participants 8 years of age and older donate a buccal mucosa sample (cells from the inside of the cheek). The inside of the cheek is scraped gently with a nylon brush.\n* Participants 18 years of age and older donate a bone marrow sample. The bone marrow is obtained from the hip bone. The skin over the area is wiped clean with alcohol and iodine, and then a local anesthetic is injected under the skin and also into the bone. When the area is numb, a bone marrow aspiration needle is introduced through the bone surface into the marrow. The marrow cells are collected using a syringe connected to the needle.",[27],[336,337,338,339,314],"Tissue Procurement","Sample Collection","Biologic Samples","Laboratory Research Specimens",{"date":205,"type":36},{"date":342,"type":36},"2007-03-03",{"name":344,"class":43},"National Heart, Lung, and Blood Institute (NHLBI)",{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":17,"sex":18,"minAge":81,"maxAge":353,"enrollmentInfo":354,"targetDuration":4,"studyType":54,"phases":356,"briefSummary":357,"conditions":358,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":44},"100648808","effect-of-fpp-on-cutaneous-barrier-integrity-100648808","NCT07725835","Effect of FPP on Cutaneous Barrier Integrity","Pilot Study of Fermented Papaya Preparation (FPP) Impact on Transepidermal Water Loss of Skin on Face, Arms, and Hands","FPP OSATO","Inclusion Criteria:\n\n1. 50-75 years\n2. Willing to allow collection of 3 blood samples (Baseline, Week 12 and Week 20)\n3. Willing to log daily compliance with FPP intake during the study period (12 weeks)\n4. Absence of active systemic disease per investigator judgement.\n5. No current use of immunosuppressant or immunomodulatory medications.\n6. No active dermatological conditions at measurement sites that could impair measure, per investigator judgement.\n7. Investigator determination of general good health.\n\nExclusion Criteria:\n\n1. Co-morbidity or concurrent medication that the Investigator deems impactful to patient safety or ability to adhere to FPP dosage.\n2. Co-morbidity or concurrent medication that the Investigator deems confounding to outcome measure (i.e., topical or systemic steroid).\n3. Current or history of allergy to FPP ingredients: Dextrose, Carica papaya, or Food yeast.\n4. Concurrent participation in another interventional trial that may impact measures, per investigator judgement.\n5. Uncontrolled diabetes (A1c \\>7%).\n6. Open wounds or actively receiving Wound Care services.\n7. Pregnant or breastfeeding women.\n8. Current use of warfarin.","75 Years",{"count":355,"type":23},30,[130],"This pilot study will test how Fermented Papaya Preparation (FPP) impacts overall TEWL of areas that commonly display diminished barrier function, such as the skin from face, arms, and hands. Areas of diminished barrier function are defined as those not visible to the eye but identified as areas of high transepidermal water loss (TEWL) as measured by a non-invasive pen-like device. A TEWL value of 20 or higher at a location would be considered high TEWL. Participants will attend 5 visits over 20 weeks, with 12-weeks of FPP treatment, and 8-weeks of follow-up.",[359,27],"Skin Barrier Dysfunction","2026-08-17",{"date":205,"type":36},{"date":363,"type":23},"2026-09",{"date":365,"type":23},"2028-07",{"name":367,"class":146},"University of Pittsburgh",{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":54,"phases":377,"briefSummary":378,"conditions":379,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":381,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":388},"100553070","phase-1-a-study-to-evaluate-bms-986470-in-healthy-volunteers-and-participants-with-sickle-cell-disease-100553070","NCT06481306","A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease","A Phase 1\u002F2a, First-in-human, Randomized, Double-blinded, Placebo-controlled, Dose-finding Study in Healthy Volunteers and Participants With Sickle Cell Disease to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, pH and Food Effect, and Preliminary Efficacy of BMS-986470","Inclusion Criteria:\n\nCohort A:\n\n* Healthy male and female (who are not of childbearing potential) participants, as determined by the investigator based on medical history and other determinations. Females not of childbearing potential must have been amenorrhoeic for at least 12 months without an alternative medical cause and have follicle-stimulating hormone (FSH) levels of at least 40 IU\u002FL or have undergone a hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.\n* Body mass index (BMI) of 18.0 to 32.0 kg\u002Fm2, inclusive. BMI = weight (kg)\u002F\\[height (m)\\]2 as measured at screening.\n* No evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory assessments beyond what is consistent with the target population.\n\nCohort B:\n\n* Participants with a documented diagnosis of sickle cell disease (SCD) with genotype HbSS, HbSβ0-thal, or HbSβ+-thal.\n* For Cohort B Part 1 only: Participants with ≥ 4 vaso-occlusive crises (VOCs) within the previous 12 months or ≥ 2 VOCs within the previous 6 months. For Cohort B Part 2 only: Participants with ≥ 2 VOCs and ≤ 15 VOCs within the previous 12 months.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have the following laboratory values:\n\n  i) Hemoglobin ≥ 5.5 and ≤ 12 g\u002FdL (males) or ≥ 5.5 and ≤ 10.6 g\u002FdL (females). ii) Absolute neutrophil count ≥ 1500\u002FμL. iii) Platelet count ≥ 100 × 10\\^3\u002FμL. iv) Absolute reticulocyte count \\> 100 × 10\\^3\u002FμL or \\> 50 × 10\\^3\u002FμL if taking hydroxyurea.\n\nExclusion Criteria:\n\nCohort A:\n\n* Any significant medical condition or any condition that confounds the ability to interpret data from the study.\n* Participant has any condition, including the presence of laboratory abnormalities, that places the participant at unacceptable risk if the participant was to participate in the study.\n* Any major surgery or planned surgery (except GI surgery) within 12 weeks of the first study intervention administration.\n\nCohort B:\n\n* Participants with any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study.\n* For Cohort B Part 1 only: participants with more than 6 severe VOCs defined as VOCs requiring ≥ 24 hours of hospital admission within 12 months prior to the first dose of study intervention.\n* For Cohort B Part 1 only: participants with any episode of acute chest syndrome within the last 6 months prior to the first dose of study intervention.\n* Creatinine clearance (CrCl) \\\u003C 60 mL\u002Fmin\u002F1.72m2 using Chronic Kidney Disease Epidemiology (CKD-EPI) equation.\n\nCohort A and B:\n\n* Participant is receiving regularly scheduled RBC or platelet transfusions or has received a RBC transfusion within 28 days and a platelet transfusion within 14 days prior to starting treatment with BMS-986470.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":376,"type":23},224,[85,56],"The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, pH and food effect, and preliminary efficacy of BMS-986470 in healthy volunteers and participants with sickle cell disease.",[380,27],"Anemia, Sickle Cell",{"date":226,"type":36},{"date":383,"type":36},"2024-07-17",{"date":385,"type":23},"2027-11-16",{"name":387,"class":95},"Bristol-Myers Squibb",32,{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":17,"sex":18,"minAge":395,"maxAge":396,"enrollmentInfo":397,"targetDuration":4,"studyType":54,"phases":399,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":405,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":44},"100491235","early-phase-1-mefamp-for-imaging-system-a-amino-acid-transport-in-primary-and-metastatic-brain-tumors-100491235","NCT05676489","MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors","Inclusion Criteria for all cohorts:\n\n1. 18 years of age or older at the time of enrollment\n2. Females with childbearing potential must have a negative urine human chorionic gonadotropin (hCG) test on the day of procedure or a serum hCG test within 48 hours prior to the administration MeFAMP.\n3. Must have a life expectancy greater than 12 weeks.\n\nExclusion Criteria for all cohorts:\n\n1. Use of an investigational drug for any indication within 3 months prior to the imaging study.\n2. Pregnancy or breast feeding\n3. Inability to complete the PET scans.\n4. Significant renal or hepatic dysfunction (estimated glomerular filtration rate (GFR) \\\u003C 60 mL\u002Fmin)\n5. Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team.\n\n6.4.9.3. Inclusion criteria specific to Dosimetry Cohort\n\n1. Normal complete metabolic profile (CMP) and cell blood count (CBC) with differential at baseline.\n2. Normal ECG at baseline.\n\nExclusion criteria specific to Dosimetry Cohort\n\n1\\) Major medical problems (e.g. renal, hepatic, inflammatory) that could interfere with biodistribution of MeFAMP as assessed by the study team.\n\nInclusion Criteria specific to HGG Cohort\n\n1. Grade III or Grade IV glioma previously treated with radiation therapy\n2. Standard of care contrast-enhanced MRI showing an enhancing lesion at least 1-cm in maximum dimension that is equivocal or suspicious for recurrent glioma.\n3. Eastern Cooperative Oncology Group (ECOG) performance score of 2 or better\n\nInclusion Criteria specific to Metastasis Cohort\n\n1. At least one brain metastasis from melanoma, lung cancer (small or non-small cell), or breast cancer measuring at least 1-cm in maximum dimension on contrast-enhanced MRI\n2. Plan for stereotactic radiation therapy within 2 weeks of initial MeFAMP-PET\u002FMRI scan.\n3. ECOG performance score of 2 or better\n\nInclusion of Women and Minorities\n\nPatients 18 years of age or older will be eligible for study participation. No other discriminatory factors, including age, sex, or ethnic background will be used to determine eligibility. Every effort will be made to ensure that minorities are recruited for study participation.","18 Months","89 Years",{"count":398,"type":23},28,[400],"EARLY_PHASE1","This first-in-human study will establish the human safety and radiation dosimetry of the system A amino acid transport substrate, (R)-3-\\[F-18\\]fluoro-2-methyl-2-(methylamino)propanoic acid (\\[F-18\\]MeFAMP), for positron emission tomography (PET) imaging of primary and metastatic brain tumors. This study will include 3 cohorts: healthy volunteers for whole body dosimetry estimates (n=6-8, Dosimetry Cohort), patients undergoing evaluation for recurrent high grade glioma after radiation therapy (n=10, high grade glioma (HGG) Cohort), and patients with brain metastases from extra-cranial solid tumors before and after radiation therapy (n=10, Metastasis Cohort). Exploratory assessment of the diagnostic accuracy of MeFAMP for distinguishing recurrent\u002Fprogressive brain tumors from radiation-related treatment effects will also be performed for subsequent trial design. The study will complete accrual and safety assessment in the Dosimetry Cohort before recruiting for the HGG and Metastasis Cohorts.",[27,403,404],"Recurrent Glioma","Brain Metastases From Extra-cranial Solid Tumors",{"date":33,"type":36},{"date":407,"type":23},"2027-04-01",{"date":409,"type":23},"2029-08-30",{"name":411,"class":146},"University of Alabama at Birmingham",{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":353,"enrollmentInfo":418,"targetDuration":4,"studyType":54,"phases":420,"briefSummary":421,"conditions":422,"keywords":424,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":44},"100553283","phase-1-suvorexant-for-alcohol-use-disorder-aud-neural-mechanisms-100553283","NCT06484075","Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms","* INCLUSION CRITERIA:\n* All Participants\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Male or female, ages 18-75 years old.\n* Ability to understand and the willingness to sign a written informed consent document.\n\n  * AUD Participants\n\nTo be eligible to participate in this study, an individual with AUD must meet all of the \"All Participants\" inclusion criteria (listed above) and also meet the following criteria:\n\n* DSM 5 diagnosis of moderate or severe AUD.\n* Participants seeking treatment for their AUD.\n* Current AUD with minimum 5-year lifetime history of heavy drinking (SAMSHA's criteria for heavy drinking: for men 5 or more drinks\u002Fday on at least 5 different days per month; and for women 4 or more drinks\u002Fday on at least 5 different days per month).\n* Last alcohol use within the 7 days prior to enrollment in the Natural History protocol 14AA0181.\n* Self-reported insomnia\u002Fsleep problems: PSQI score \\> 4 and\u002For endorsing \"problems falling asleep or staying asleep throughout the night\".\n* Ability to take oral medication and be willing to adhere to the suvorexant\u002Fplacebo regimen.\n* Agreement to commit to at least 28 days, and up to 40 days, inpatient stay (starting from Natural History protocol enrollment).\n* Agreement to adhere to Lifestyle Considerations throughout study duration.\n\nEXCLUSION CRITERIA:\n\n-All Participants\n\nAn individual who meets any of the following criteria will be excluded from participation:\n\n* Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard contraindication to MRI.\n* Cannot lie comfortably flat on his\u002Fher back for up to 2 hours in the MRI scanner.\n* Body weight \\> 400 lbs. The PET scanner bed is tested to a weight limit of 400 lbs.\n* Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that, with the exposure from this study, would exceed NIH annual research limits as determined by medical history and physical exam.\n* Pregnant or breast-feeding: Females of childbearing potential, or with tubal ligation, or are post-menopausal and are age 55 or less will undergo a urine pregnancy test and it must be negative to continue participation. Urine pregnancy tests will be repeated on subsequent days of study (i.e., within 24 hours before study procedures). Females must not be currently breastfeeding.\n* Severe head trauma with loss of consciousness \\> 60 minutes.\n* Chronic recurrent primary psychotic disorders like schizophrenia and bipolar 1 disorder.\n* Montgomery-Asberg depression rating scale (MADRS) total score \\> 35 or 'suicidal thoughts' item score \\> 3, indicating severe depression or moderate suicidality, respectively.\n* Major medical problems that can permanently impact brain function (e.g., seizures, psychosis, stroke, Alzheimer's disease, Parkinson's disease, traumatic brain injury, clinically significant arrhythmias except bradycardia, and HIV+).\n* Hepatic enzymes (ALT\u002FGPT, AST\u002FGOT, Total Bilirubin, Direct Bilirubin) that are \\>5x the upper limit of normal, indicating severe hepatic impairment.\n\n  * Non-English speakers (must also be able to read and comprehend English).\n\n    * The intent of the research has no prospect of direct benefit to the subject. Therefore, we are excluding non-English speakers in this research study since it includes the administration of questionnaires, surveys and assessments that are validated for English; only some are available in Spanish. In addition, our fMRI paradigms require that the subject be able to speak, read and comprehend English.\n\n      * AUD Participants\n\nAn individual with AUD who meets any of the \"All Participants\" exclusion criteria (listed above) or any of the following criteria will be excluded from participation in this study:\n\n* Current daily use of stimulant medications, modafinil, wellbutrin, naltrexone, antipsychotics, or strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan).\n* Current benzodiazepine, opioids, or stimulant misuse (must have misused 5+ days\u002Fweek for \\>1 year, and most recent use must have been within 7 days of inpatient admission).\n* Current severe substance use disorders (other than alcohol, cannabis, nicotine or caffeine). If a subject had a severe SUD (other than alcohol, cannabis, nicotine or caffeine), they must be in remission for at least 6 months prior to enrollment.\n* Major medical problems that are contraindicated for the use of suvorexant (narcolepsy, severe obstructive sleep apnea or severe chronic obstructive pulmonary disease, REM behavioral disorder) as determined by history and clinical exam.\n\nNote that AUD subjects will not be excluded from enrollment onto this study if their urine test or breath alcohol level (BAL) is positive for drugs\u002Falcohol on initial screening. The following guidelines will be followed for positive drug\u002Falcohol screens on study procedure days involving imaging scans and neuropsychological testing:\n\n-If a subject's urine drug\u002Fbreath alcohol (\\>=0.08%) screen test is positive on days involving imaging (MRI and\u002For PET) and NP testing, the procedures will be postponed until BrAC \\\u003C0.08. This is not expected to happen in most cases especially since participants will have been detoxifying for 1-5 days (possibly longer) and should no longer test positive for BrAC at this point. After initial screening under 14AA0181, subjects will be in the inpatient unit detoxifying.\n\n* If urine drug screen is positive for THC-COOH, a saliva drug screen will be performed. However, there are reports that THC can still be detected in saliva even eight days after cessation of drug use. Because of this, AUD subjects may proceed with study day testing procedures even if saliva results for THC are positive. If any AUD participants test positive for saliva THC-COOH, we may include those results as a covariate in our statistical analyses.\n* If any other urine results are positive, we may include those results as a covariate in our statistical analyses. It is important to note that the subjects will have been in the inpatient unit detoxifying from alcohol and won't have access to drugs of misuse during this time. Positive results could be indicative of slow metabolizers of drugs and subject may stay enrolled and participate in the imaging scans.\n\nWe minimized exclusion criteria pertaining to current medication use in the AUD group participants to make recruitment feasible and so the outcome can be better generalized to vulnerable AUD populations which have high rates of comorbid mental and physical illness requiring medication. Note however that although current daily use of naltrexone is an exclusion per above, once the imaging scans and study drug dosing are completed, standard of care treatment will be started a few days prior to discharge and this could include taking naltrexone daily. This will not be considered a violation or non-compliance or deviation from criteria listed above once the imaging studies are complete. Standard of care may start within 24 hours of last study drug medication dose or last brain imaging scan under the current protocol, whichever happens last. This treatment is initiated for a few days under the 14AA0181 Natural History protocol prior to discharge from the unit.\n\n-Control Participants\n\nA control individual who meets any of the criteria listed under \"All Participants\" exclusion criteria (listed above) or any of the following criteria will be excluded from participation in this study:\n\n* Current DSM-5 diagnosis of a psychiatric disorder that requires\u002Frequired daily psychoactive medications (antidepressant, antipsychotics, stimulants, opioids, benzodiazepines or barbiturates) in the past two months and that could impact brain function at the time of the study as determined by history and clinical exam.\n* History of moderate or severe substance use disorders (other than nicotine or caffeine).\n* The following current chronically used (past 2 months) medications are exclusionary: stimulant or stimulant-like drugs and medications (cocaine, methamphetamine, amphetamine, methylphenidate, modafinil); opioid drugs or medications; antianginal agents; antiarrhythmics; systemic corticosteroids; anticholinergics; anticoagulants; anticonvulsants; antidepressants; antihistamines (sedating); beta-blocker antihypertensives; antineoplastics; antiobesity; antipsychotics; anxiolytics (benzodiazepine or barbiturates); lithium; muscle relaxants; psychotropic drugs not otherwise specified (nos); sedatives\u002Fhypnotics, systemic steroids. Note that nicotine and\u002For caffeine is not exclusionary.\n\nWhen developing this protocol to include healthy volunteers, we needed a population not taking medications that could impact our interpretation of dopamine level measurements, since we are hoping to get estimates of 'baseline' dopamine levels in this control population.\n\nNote that subjects will not be excluded from enrollment onto this study if their urine test or breath alcohol level (BAL) is positive for drugs\u002Falcohol on initial screening. The following guidelines will be followed for positive drug\u002Falcohol screens on study procedure days involving imaging scans and neuropsychological testing in HV participants:\n\n* If a subject's urine drug\u002Fbreath alcohol (\\>0.08%) screen test is positive on days involving imaging (MRI and\u002For PET) and NP testing, the procedures will be postponed and rescheduled. We will allow for up to 3 rescheduled study days resulting from positive urine drug\u002Fbreath alcohol screens. If urine drug screen is positive for THC-COOH, a saliva drug screen will be performed and subject may proceed with study day testing procedures if saliva results for THC are negative. If the urine\u002Fsaliva drug test is positive on the third rescheduled visit, the participant will be withdrawn from the study.\n* If a participants urine drug screen test is positive for marijuana (urine drug screen positive for THC-COOH) on the day of the scan, we will then perform a saliva drug screen to verify if THC is present. If positive, procedures will be postponed until it becomes negative.\n* If a participants urine drug screen test is positive for cocaine, heroin or methamphetamine they will be excluded.",{"count":419,"type":23},180,[85,56],"Background:\n\nAlcohol use disorder (AUD) is a leading cause of disease and death worldwide. New treatments for AUD are needed. Dopamine, a chemical that carries signals between brain cells, is thought to play a role in alcohol addiction. Researchers want to learn how Suvorexant, a drug used to treat sleep disorders, affects dopamine receptors in the brain.\n\nObjective:\n\nTo see how Suvorexant affects dopamine receptors in people with AUD and in healthy people.\n\nEligibility:\n\nPeople aged 18 to 75 years seeking treatment for AUD. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants with AUD will stay in the clinic for at least 10-28 days for alcohol detoxification. They will receive normal treatment for AUD.\n\nSuvorexant is a medicine used to treat sleep problem that is taken taken by mouth, once a day. Some participants will take the study drug. Others will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking.\n\nParticipants will wear a device that looks like a wristwatch to track their movements during their clinic stay.\n\nParticipants will have blood tests and 3 brain imaging scans before starting on the study drug: 2 positron emission tomography (PET) and 1 magnetic resonance imaging (MRI) scan. They will be injected with a radioactive tracer during each PET scan.\n\nParticipants will have tests to assess their thinking, memory, and attention. They will have sleep studies.\n\nImaging scans and other tests will be repeated at the end of the study.\n\nHealthy volunteers will have 1 MRI and 2 PET scans. They will have tests to assess of their thinking, memory, and attention. They will wear a wristwatch like movement monitor for 1 week.\n\n...",[27,423],"Alcohol Use Disorder (AUD)",[425,426,427,428,423,429],"Suvorexant","Sleep","Dopamine D2R","Dopamine D1R","Alcohol Craving","2026-08-15",{"date":226,"type":36},{"date":433,"type":36},"2024-11-21",{"date":435,"type":23},"2029-12-31",{"name":437,"class":43},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)",{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":444,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":446,"conditions":447,"keywords":448,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":4,"leadSponsor":457,"locationsCount":44},"100065540","cytapheresis-of-volunteer-donors-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.)",{"count":445,"type":23},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],[449,450,451,452,453,314],"Cell Separation","White Blood Cells","Immune Studies","Cell Function","Machine Collection",{"date":226,"type":36},{"date":456,"type":36},"2003-01-30",{"name":458,"class":43},"National Institute on Aging (NIA)",{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":466,"targetDuration":4,"studyType":54,"phases":468,"briefSummary":469,"conditions":470,"keywords":471,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":44},"100316015","mechanism-of-non-invasive-magnetic-stimulation-100316015","NCT03394066","Mechanism of Non-invasive Magnetic Stimulation","Understanding the Acute Modulation of Brain Activity by Transcranial Magnetic Stimulation","* INCLUSION CRITERIA:\n\nSubjects must be:\n\n1. 18 - 60 years of age.\n\n   -Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals. In addition, the risk of difficult-to-detect medical abnormalities such as silent cerebral infarcts increases with age.\n\n   --Screening tool: History.\n2. In good health.\n\n   * Justification: Many illnesses may alter neural functioning as well as fMRI signals.\n   * Screening tools: Vital Signs, height\u002Fweight measurements, Medical History, Physical Examination, and lab tests. Labs may include, but are not limited to: CBC, Hemoglobin A1C, CMP, ESR, and salivary HIV (blood may be tested for HIV if needed to confirm a positive salivary test). Elevated serum glucose may be followed up to assess for diabetes. MAI will assess if participants are generally healthy and will make the final judgment on any questionable lab results.\n3. Right-handed.\n\n   * Justification: Using right-handed individuals will reduce variability in BOLD MRI data.\n   * Screening tool: self-report.\n\nEXCLUSION CRITERIA:\n\n1. 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.\n\n   * Justification: Stroke or head trauma can lower the seizure threshold and are therefore contraindications for TMS. Fainting episodes or syncope of unknown cause could indicate an undiagnosed condition associated with seizures. Neurological symptoms could potentially alter BOLD signal.\n   * Screening tool: TMS safety questionnaire and History and Physical including a neurological exam.\n2. First-degree family history of any form of epilepsy with a potentially hereditary basis.\n\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   * Screening tool: TMS safety screening, Medical History.\n3. 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 either MRI scanning or TMS intervention.\n\n   * Justification: Any metal around the head is a contraindication for both MRI and TMS, as both methods involve exposure to a relatively strong magnetic field.\n   * Screening tool: TMS safety screening, MRI safety screening, Medical History.\n4. Any contraindications to MRI or TMS.\n\n   * Justification: There are additional contraindications that would exclude participation in MRI or TMS (e.g., claustrophobia).\n   * Screening tool: MRI safety screening, TMS Safety Screening, and mock scanner trial (if deemed necessary).\n5. Noise-induced hearing loss or tinnitus.\n\n   * Justification: individuals with noise-induced hearing problems may be particularly vulnerable to the acoustic noise generated by TMS and MRI equipment.\n   * Screening tools: TMS safety screening.\n6. 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\n   * Justification: The use of certain medications or drugs can lower seizure threshold and is therefore contraindicated for TMS.\n   * Screening tools: MRI safety screening questionnaire and Medical history. A Urine toxicology that analyzes for presence of a broad range of prescription and nonprescription drugs may also be completed per the NIDA IRP screening protocol.\n7. Lifetime history of major depressive disorder, schizophrenia, bipolar disorder, mania, or hypomania.\n\n   * Justification: The population of interest here is a healthy control population with no psychiatric disorders. In subjects with depression, bipolar disorder, mania or hypomania, there is a small chance that TMS can trigger (hypo)manic symptoms. Psychiatric symptoms could potentially alter BOLD signal.\n   * Screening tools: a mental health screening questionnaire and \u002For a semi-structured or structured psychiatric interview such as the Structured Clinical Interview for the DSM (SCID) or clinician assessment. Potential diagnoses will be further evaluated by a mental health professional.\n8. Current use of nicotine or history more than about 20 cigarettes or 20 instances of nicotine use in lifetime or history of daily nicotine use.\n\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   * Screening tools: Self-report and CO \\\u003C 6. A commercial urine cotinine test may also be used, with the expectation that results correspond to non-smoker status for the specific test being used, typically corresponding to a urine cotinine under about 20 ng\u002Fml.\n9. Meet current DSM-5 criteria for any substance use disorder, smoke daily, or urine toxicology positive for any illicit substance inconsistent with history given.\n\n   * Justification: The population of interest here 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   * Screening tools: a drug use survey (DUS) and urine qualitative drug screen for common drugs of abuse. SUD may also be evaluated in a structured\u002Fsemi-structured psychiatric interview such as the SCID and follow up with a mental health professional). Participants who test positive at screening (under the NIDA IRP screening protocol) may be assessed for current intoxication. For participants who are not found to be currently intoxicated, screening staff will assess for SUD and coherence of their drug use history and toxicology with particular attention to substances for which they are positive and may require a return screening visit to demonstrate ability to produce a negative urine before allowing them to proceed to clearance for this study.\n10. Have met DSM-5 criteria for any substance use disorder in the past.\n\n    * Justification: the population of interest here is a healthy control population with no present or past substance use disorder.\n    * Screening tools: a drug use survey (DUS) and\u002For a structured\u002Fsemi-structured psychiatric interview such as the SCID and follow up with a mental health professional).\n11. Pregnant individuals or those with reproductive potential who are sexually active and not using an acceptable form of contraception.\n\n    * Justification: it is unknown whether TMS or MRI poses a risk to fetuses.\n    * Screening tool: Medical assessments (urine pregnancy test) at the beginning of each visit that involves TMS or MRI.\n12. Participation in a TMS session less than two weeks ago.\n\n    * Justification: in order to limit exposure to TMS, we will not enroll subjects who have received TMS less than two weeks ago.\n    * Screening tool: TMS safety screening questionnaire, and\u002For medical history.\n13. History of learning disability, current ADHD or cognitive impairment\n\n    * Justification: Cognitive impairment and learning disabilities are associated with alterations in brain regions and may introduce significant variably into the data.\n    * Screening tool: self-report of special education classes, history of specific learning disability or mental retardation, and medical history. A validated IQ test such as Wechsler Abbreviated Scale of Intelligence (WASI) or Shipley-2 may also be completed.\n14. Non-English Speaking\n\n    * Justification: There is no direct benefit to participants in this study, and some of the study procedures involve more than minimal risk. To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify given the small sample size for each experiment. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI and TMS procedures. The inability to effectively communicate MRI and TMS safety procedures could compromise the safety of non-English speaking participants.\n    * Screening tool: self-report.",{"count":467,"type":23},95,[130],"Background:\n\nTranscranial magnetic stimulation (TMS) is form of non-invasive brain stimulation. It is approved to treat depression. TMS may help decrease drug craving. It is important to understand how TMS affects the brain. Such a better understanding would help to design ways to treat drug addiction.\n\nObjectives:\n\nTo learn how TMS affects the brain when it stimulates an area in the front of the brain. Also, to see how the stimulation affects the area stimulated and other connected areas.\n\nEligibility:\n\nHealthy, right-handed adults ages 18-60 who are non-drug users.\n\nDesign:\n\nParticipants will be screened under protocol 06-DA-N415.\n\nParticipants will have at least 3 visits. The first visit will last about 3 hours. All other visits will last up to 6 hours. Participants cannot use drugs or alcohol at least 24 hours before a visit. They cannot have more than half a cup of a caffeinated drink at least 12 hours before a visit.\n\nEach visit will include a brief medical history update, urine test for drugs and pregnancy (if female), a breath test for alcohol and smoking, and questionnaires.\n\nParticipants will have a TMS orientation visit. A wire coil will be placed on the head. An electrical current will pass through the coil to create a magnetic pulse that stimulates the brain.\n\nThe other visits will include 2 sessions of TMS-MRI. Participants will lie on a table that slides into a cylinder. The TMS coil and the MRI coil will be placed over the head. Pictures will be taken of the brain with and without stimulation.\n\nParticipants will complete a questionnaire about how they feel before and after each TMS session and in a follow-up call 1-3 days after their last session.",[27],[472,473],"Repetitive TMS (rTMS)","Simultaneous TMS and MRI","2026-08-14",{"date":360,"type":36},{"date":477,"type":36},"2018-09-19",{"date":479,"type":23},"2028-12-31",{"name":119,"class":43},{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":488,"enrollmentInfo":489,"targetDuration":4,"studyType":54,"phases":491,"briefSummary":492,"conditions":493,"keywords":495,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":501,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":44},"100250835","phase-2-neurobiology-of-suicide-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":490,"type":23},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.\n\n...",[27,494],"Depression",[496,497,498,499,500],"Neurobiology","Suicide","Ketamine","Major Depressive Disorder","Biomarkers",{"date":360,"type":36},{"date":503,"type":36},"2015-12-01",{"date":505,"type":23},"2030-07-21",{"name":507,"class":43},"National Institute of Mental Health (NIMH)",{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":17,"sex":18,"minAge":515,"maxAge":20,"enrollmentInfo":516,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":518,"conditions":519,"keywords":522,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":527,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":44},"100235143","genetic-and-epigenetic-signatures-of-translational-aging-laboratory-testing-gestalt-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 \\>= 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 \\>= 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\u002Fvape and have not done so 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":517,"type":23},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)",[27,520,521],"Non-Healthy\u002FNon-Frail","Frail",[523,500,524,525,526,314],"Genome Wide Association","Methylation","Phenotype","Cytometry",{"date":360,"type":36},{"date":529,"type":36},"2015-03-15",{"date":531,"type":23},"2099-12-31",{"name":458,"class":43},{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":302,"enrollmentInfo":540,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":542,"conditions":543,"keywords":545,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":551,"startDateStruct":552,"completionDateStruct":4,"leadSponsor":554,"locationsCount":44},"100089853","physical-and-behavioral-traits-of-overweight-and-obese-adults-100089853","NCT00428987","Physical and Behavioral Traits of Overweight and Obese Adults","Study of the Phenotype of Overweight and Obese Adults","* INCLUSION CRITERIA:\n\nObese subjects:\n\n1. Obese men and women over the age of 18 years\n2. BMI \\> 30\n\nOverweight subjects:\n\n1. Overweight men and women over the age of 18 years\n2. BMI \\> 25 and \\\u003C 30\n\nControl subjects (may be matched for age, sex and years of education):\n\n1. Normal weight men and women over the age of 18 years\n2. BMI \\> 18.5 and \\\u003C 25\n\nEXCLUSION CRITERIA:\n\n1. Patients with significant physical limitations that may preclude them from completing the majority of the tests in this study\n2. Current unstable medical conditions including cardiac ischemia, severe respiratory insufficiency requiring oxygen therapy, hepatic or cardiac failure as assessed by history and physical exam\n3. Any psychiatric condition that would preclude participation in the study\n4. Patients unwilling or unable to give informed consent\n5. Pregnant woman.\n\nAdditional exclusion for lean control subjects:\n\n1. Previous history of obesity as an adolescent or adult\n2. Current or past history of eating disorders such as anorexia nervosa or bulimia\n\nThe NIH Patient Recruitment and Public Liaison Office will receive inquiries from interested study subjects. Pre-screening by this office will exclude patients who require more than minimal assistance to complete activities of daily living in order to select subjects who can safely participate in the full phenotyping protocol. All others will be contacted by the protocol team to review exclusion criteria. Eligible patients will be invited to Clinical Research Center for a screening visit.",{"count":541,"type":23},2000,"This study will describe the phenotype (physical and behavioral traits) of overweight and obese people. It will characterize the hormones, metabolism, food preferences, fitness and physical activity levels, sleep patterns and thought processes in people with and without weight problems. Genetic material will be collected for studies of the internal codes that influence body weight.\n\nPeople over 18 years of age from all weight categories (lean, overweight, obese) who are reasonably healthy may be eligible for this study. Participants undergo the following tests and procedures:\n\n* Physical exam, electrocardiogram, blood and urine tests, instructions for recording food intake for 7 days\n* Metabolic studies for menstruating women.\n* Resting metabolic rate to study how many calories the body burns at rest.\n* Mixed meal test to measure hormones such as insulin that regulate blood sugar.\n* Glucose tolerance test to determine how sensitive the body is to insulin.\n* 24-hour energy expenditure to measure the amount of oxygen breathed in and the amount of carbon dioxide breathed out.\n* Repeat 24-hour energy expenditure.\n* Diurnal blood sampling and temperature assessment to study the body s internal clock.\n* Air-displacement plethysmography (Bod Pod) to measure body composition.\n* Dual energy x-ray absortiometry (DEXA) to measure body fat and bone density.\n* Repeat Bod Pod and DEXA.\n* Anthropometric measurements and bioelectrical impedance to measure height, weight, and circumferences, skinfold thickness, fluid status and percentage body fat.\n* Bromide dilution to measure the amount of water not in cells in the body.\n* Doubly labeled water to measure the amount of calories burned in a 7-day period.\n* 24-hour diet reports.\n* Endothelial reactivity to measure how the blood vessels stretch or dilate for assessing cardiovascular health.\n* Treadmill or bicycle exercise capacity test.\n* Physical activity monitor.\n* Unicorder to detect any breathing difficulties that may interfere with sleep.\n* Fat and muscle biopsy to look for variations in gene expression in fat tissue and muscle.\n* Neurocognitive testing to check memory, decision-making, hand-eye coordination, and reasoning.\n* Evaluation of mood problems and assess personality type.\n* Evaluation to assess the quantity and quality of pain experienced.\n* Taste testing to determine the response to bitter, salty, sweet and sour substances.\n* Occupational therapy evaluation to explore the subject's adaptations, if any, for performing personal, social or professional activities; the subject's views on his or her weight, body size and shape, and strategies to control weight.",[544,27],"Obesity",[546,547,544,548,525,314,549,550,285],"Energy Expenditure","Body Composition","Metabolism","Morbid Obesity","Overweight",{"date":360,"type":36},{"date":553,"type":36},"2007-03-08",{"name":555,"class":43},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)",{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":4,"eligibilityCriteria":562,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":563,"enrollmentInfo":564,"targetDuration":4,"studyType":54,"phases":566,"briefSummary":567,"conditions":568,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":44},"100597811","phase-1-a-study-to-evaluate-novel-karx-and-kart-prototypes-versus-the-karxt-and-karx-ec-reference-following-single-doses-and-to-explore-the-effect-of-food-after-multiple-doses-of-selected-prototypes-in-healthy-adult-participants-100597811","NCT07063342","A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, Explore the Effect of Food After Multiple Doses of Selected Prototypes, and Evaluate Alternative Formulations of KarX and KarXT Following Single and Multiple Ascending Doses","Phase 1, 4-Part, Open-label (Parts 1 to 3) and Double-blind (Part 4) Study to Evaluate the Pharmacokinetics of Novel KarX (BMS-986519) and KarT (BMS-986520) Prototypes Versus the KarXT (BMS-986510) and KarX-EC (BMS-986519) Reference Following Single Doses, and to Explore the Effect of Food After Multiple Doses of Selected Prototypes in Healthy Adult Participants, and to Evaluate Alternative Formulations of KarX (BMS-986519) and KarXT (BMS-986510) Following Single and Multiple Ascending Doses in Healthy Adult Participants","Inclusion Criteria:\n\n* BMI between 18.0 kg\u002Fm2 to 32.0 kg\u002Fm2, inclusive, at screening.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","55 Years",{"count":565,"type":23},236,[85],"The purpose of this study is to evaluate novel KarX and KarT prototypes versus the KarXT and KarX-EC reference following single doses, to explore the effect of food after multiple doses of selected prototypes, and to evaluate alternative formulations of KarX and KarXT following single and multiple ascending doses in healthy adult participants.",[27],"2026-08-13",{"date":360,"type":36},{"date":572,"type":36},"2025-06-27",{"date":574,"type":23},"2027-03-29",{"name":387,"class":95},{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":563,"enrollmentInfo":583,"targetDuration":4,"studyType":54,"phases":584,"briefSummary":585,"conditions":586,"keywords":589,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":44},"100652287","hyperventilation-effects-on-bodily-self-consciousness-100652287","NCT07769710","Hyperventilation Effects on Bodily Self-Consciousness","HYPERSELF","Inclusion Criteria:\n\n* Healthy adult aged 18-55 years\n* Able to provide written informed consent\n* Normal or corrected-to-normal vision\n* Sufficient German or English to follow instructions and complete questionnaires\n* Tolerates the \\~5-minute VR-guided hyperventilation test at screening\n\nExclusion Criteria:\n\n* Cardiovascular or cerebrovascular disease posing a risk during hyperventilation (e.g., myocardial infarction or stroke within 12 months, significant\u002Funstable cardiac disease, heart failure, uncontrolled\u002Fsevere hypertension, aneurysm, Moyamoya)\n* Respiratory disease (asthma, COPD, restrictive lung disease, pulmonary fibrosis, recent severe lung infection, dyspnoea at rest)\n* Haematological disease (sickle cell disease or trait, severe anaemia)\n* Neurological disease (epilepsy or seizures, severe\u002Frecurrent migraine, neurodegenerative disorder)\n* Psychiatric disorder (panic or severe anxiety disorder, psychosis or schizophrenia, severe bipolar disorder, acute major depression, acute addiction)\n* Metabolic disease (Type 1 or poorly controlled Type 2 diabetes, BMI \\> 35)\n* Pregnancy (confirmed by urine test at screening) or planned pregnancy during the study period\n* Medication affecting respiration or brain function\n* Physical inability to cooperate or to remain seated for the \\~188-minute experimental visit\n* Insufficient understanding of study procedures and risks\n* Intolerable reaction to the hyperventilation tolerance test at screening",{"count":105,"type":23},[130],"This study examines how voluntary fast, deep breathing (hyperventilation) affects the way healthy adults perceive their own body. Participants wear a virtual-reality (VR) headset and see a virtual body; a glowing halo around it either pulses exactly in time with their own breathing or is time-shifted. During the study, breathing, heart activity, blood-oxygen level, the carbon-dioxide content of exhaled air, and brain activity (EEG, measured non-invasively from the scalp) are recorded continuously, and participants complete questionnaires about their experience.\n\nThe aim is to understand whether and how altered breathing changes the interplay between what people see and what they feel inside their body, and thereby the sense of being located within one's own body. The study uses a 2×2 within-subjects design crossing Breathing (normal vs. hyperventilation) with Visual synchrony (synchronous vs. asynchronous), with the asynchronous and normal-breathing conditions serving as within-subject controls.\n\nNo medication is administered and no medical device is being tested; the instruments used serve only for monitoring and measurement. Participation involves a screening visit (including a short, \\~5-minute guided-hyperventilation tolerance test) and an experimental visit.",[587,588,27],"Bodily Self-Consciousness","Interoception",[590,591,592,593,594,595,596,597,598,599],"hyperventilation","bodily self-consciousness","full-body illusion","respiratory-visual synchrony","interoception","virtual reality","EEG","heartbeat-evoked potential","altered states of consciousness","breathwork","2026-08-12",{"date":226,"type":36},{"date":603,"type":23},"2026-09-01",{"date":605,"type":23},"2027-07-31",{"name":607,"class":146},"University of Fribourg"]