[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yale University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":624},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,287,0,25,[9,43,75,99,129,156,186,208,230,252,276,295,315,355,381,404,424,450,474,497,516,540,561,586,605],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100495042","phase-2-empagliflozin-in-patients-with-cirrhosis-and-ascites-100495042",false,"NCT05726032","Empagliflozin in Patients With Cirrhosis and Ascites","Effects of Empagliflozin on Natriuresis and Volume Overload in Patients With Cirrhosis and Ascites","EMPA Liver","Inclusion Criteria:\n\n1. Patients with cirrhosis and ascites on a stable dose of diuretics (spironolactone +\u002F- loop-diuretics based on AASLD guidelines)10 and who do not require large volume paracenteses\n2. eGFR \\>= 30mL\u002Fmin\u002F1.73 m2\n3. \\>=18 years old\n\nExclusion Criteria:\n\n1. Hospitalization due to a complication of cirrhosis in the previous 8 weeks (e.g. variceal hemorrhage, encephalopathy, acute kidney injury, spontaneous bacterial peritonitis)\n2. Direct bilirubin \\>=3 mg\u002FdL\n3. Systolic blood pressure \\\u003C 100 mmHg\n4. Active malignancy including hepatocellular carcinoma undergoing treatment\n5. History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections\n6. Use of SGLT-2 inhibitors in the last 10 days, or previous use with intolerance\n7. Type 1 diabetes\n8. History of frequent hypoglycemic episodes\n9. Use of a non-loop diuretic aside from aldosterone antagonists or amiloride as they are not standard of care in patients with cirrhosis and could potentially increase the risk of hypovolemia when combined with the standard treatment for ascites along with SGLT2 inhibitor.\n10. Hepatic hydrothorax requiring thoracentesis in the prior 8 weeks\n11. Hepatic encephalopathy grade II or greater at the time of enrollment\n12. Patients who have had TIPS placed\n13. Previous liver transplant\n14. Participation in another trial with an investigational drug within the 30 days prior to informed consent\n15. Pregnancy or breastfeeding\n16. Inability to give written informed consent or follow study protocol (e.g. clinically-significant psychiatric, addictive, or neurological disease)\n17. Change in diuretic dose in the prior 2 weeks\n18. Patients with hospitalization for alcoholic hepatitis in the past 6 months\n19. Significant worsening of creatinine (more than 50% increase) in the past 4 weeks\n20. MELD-Na \\> or equal to 20\n21. Hemoglobin \\\u003C8","ALL","18 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","A proof-of-concept placebo-controlled trial to explore the acute and 14-day effects of empagliflozin on natriuresis and total body water in patients with cirrhosis and ascites. We will additionally investigate its effect on neurohumoral activation, and renal hemodynamics.",[28,29],"Cirrhosis","Liver Failure","RECRUITING","2026-08-20",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":34},"2023-09-11",{"date":38,"type":22},"2026-12-01",{"name":40,"class":41},"Yale University","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":42},"100643683","prospective-case-series-evaluating-6-month-and-12-month-outcomes-after-cryoneurolysis-for-chronic-pain-100643683","NCT07639060","Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain","Inclusion Criteria:\n\n* Diagnosis of chronic pain (generally pain duration of at least 3-6 months) localized to an anatomical region appropriate for cryoneurolysis as determined by the treating physician.\n* Planned cryoneurolysis procedure as part of standard clinical care.\n* Ability to provide written informed consent.\n* Ability and willingness to complete baseline and follow-up questionnaires.\n\nExclusion Criteria:\n\n* Cryoneurolysis performed as part of a separate investigational trial in which data sharing is not permitted.\n* Active infection or other clinical contraindication to the procedure as determined by the treating clinician.\n* Life expectancy of less than 12 months in the judgment of the treating clinician.\n* Any condition that, in the investigator's opinion, would interfere with study participation or completion of follow-up, such as severe psychiatric instability or active substance use that precludes reliable follow-up",{"count":50,"type":22},80,"OBSERVATIONAL","To prospectively describe patient-centered and health utilization outcomes through 12 months after cryoneurolysis performed as routine clinical care for chronic pain at Yale.",[54,55,56,57,58,59,60,61,62,63,64,65,66,67],"Chronic Pain","PERIPHERAL NEUROPATHY","Occipital Neuralgia","Chronic Hip Pain","Hip Osteoarthritis","Knee Osteoarthritis","Spasticity","Chronic Low Back Pain","Lumbar Spondylosis","Cervical Spondylosis","Shoulder Arthritis","Causalgia","Chronic Pain Syndrome","Chronic Neck Pain","2026-08-19",{"date":33,"type":34},{"date":71,"type":34},"2026-06-20",{"date":73,"type":22},"2028-07",{"name":40,"class":41},{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":18,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100526550","phase-1-influence-of-mavoglurant-on-alcohol-craving-and-drinking-in-heavy-drinkers-100526550","NCT06136195","Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers","Inclusion Criteria:\n\n1. Ages 21-50 (The lower limit is to avoid offering alcohol to individuals below the drinking age of 21. The upper age is determined by experience recruiting for our prior studies).\n2. Ability to read English at 6th grade level or higher.\n3. Meet DSM-V criteria for moderate or severe Alcohol Use Disorder (AUD).\n4. Average weekly alcohol consumption of 30-70 standard drinks for men and 20-65 drinks for women. The lower limits are consistent with the lower sex-specific cut-offs defining high-risk drinking based on World Health Organization Risk Levels (WHO, 2000); the upper limits are designed to avoid recruiting participants whose drinking is likely to exceed the number of drinks available in the Alcohol Drinking Paradigm (ADP).\n\nExclusion Criteria:\n\n1. Individuals who are seeking alcohol treatment or have been in alcohol treatment within the past 6 months.\n2. Meet current Diagnostic and Statistical Manual v.5 (DSM-V) criteria for substance use disorder, except for tobacco use disorder or mild cannabis use disorder.\n3. Positive urine drug screens at more than 1 baseline appointment for opiates, cocaine, benzodiazepines and barbiturates.\n4. Psychotic or other severe psychiatric disorders as determined by clinical evaluation (Structured Clinical Interview for DSM-V; SCID). Note that if a subject endorses any harm\u002Frisk behaviors (e.g. suicidal\u002Fhomicidal risk) a licensed clinician will be consulted immediately.\n5. Regular use of psychoactive drugs, except for individuals on a stable dose of an antidepressant for at least 2 months.\n6. Medical conditions that would contraindicate the consumption of alcohol or use of mavoglurant.\n7. Clinically significant abnormalities in screening laboratories, including aspartate aminotransferase (AST) \\>3 times upper limit of normal (ULN); alanine aminotransferase (ALT) \\> 3 times ULN; total bilirubin \\>1.5 times ULN; serum creatinine \\>2.0 times ULN.\n8. Neurological trauma or disease, delirium or hallucinations, or clinically significant or unstable medical conditions, including uncontrolled hypertension or diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic diseases, which in the opinion of the study physician and Principal Investigator, may put the patient at risk because of participation in the study.\n9. Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores of 8 or greater or a history of significant repeated alcohol withdrawals to reduce the likelihood of withdrawal symptomatology if subjects reduce their drinking.\n10. Women who are pregnant or nursing.\n11. Participants who refuse to use a reliable method of birth control.\n12. Subjects who report disliking spirits will be excluded because hard liquor will be provided during the ADP.\n13. Subjects who have taken any investigational drug within 4 weeks of the anticipated date of the first study dose.\n14. Individuals who report heavy drinking days in the 2 days prior to their intake appointment but have a negative ethyl glucuronide (EtG) test to rule out subjects who are misrepresenting their drinking history.\n15. Subjects who have donated blood within the past 6 weeks.","21 Years","50 Years",{"count":84,"type":22},63,[86],"PHASE1","The purpose of this research study is to find out about the effects of a drug called mavoglurant on alcohol consumption.",[89,90,91],"Alcohol Consumption","Heavy Drinker","Alcohol Use Disorder (AUD)",{"date":33,"type":34},{"date":94,"type":34},"2024-07-01",{"date":96,"type":22},"2028-05-31",{"name":40,"class":41},2,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100633329","trial-phase-syndemic-adapted-medly-uganda-100633329","NCT07525271","Trial Phase: Syndemic Adapted Medly Uganda","An mHealth Implementation Strategy to Address the Syndemic of Mental Illness, Hypertension, and HIV in Uganda, Clinical Trial: Syndemic Adapted Medly Uganda (SAMU)","SAMU","Inclusion Criteria:\n\n* Patient at a participating HIV clinic site\n* Currently living in Uganda with no intention of moving abroad in next 2 years\n* Access to a mobile phone\n* Basic reading skills in one or more of the offered languages (English, Luganda) as determined by the Research Assistant.\n\nExclusion Criteria:\n\n* No access to a mobile phone\n* Inability to provide informed consent based on assessment by the onsite Research Assistant or HCW\n\nHealthcare Workers\u002FCaregivers Criteria:\n\n* Age \\>=18 years\n* Healthcare worker at participating site or caregiver for study participant at site\n* Basic reading skills in one or more of the offered languages (English, Luganda) as determined by the Research Assistant",{"count":108,"type":22},1500,[110],"NA","The purpose of this study is to evaluate the effectiveness of the Syndemic-Adapted Medly Uganda (SAMU) in improving mental health care among adults living with HIV and hypertension in Uganda. In sub-Saharan Africa (SSA), there is a high prevalence of depression and anxiety among people living with HIV (PLHIV) as well as alcohol use disorder (AUD). PLHIV who experience depression are less likely to link to HIV care, adhere to antiretroviral therapy, and achieve viral suppression. Building on research conducted to adapt Medly Uganda for mental health using a syndemic framework, this study aims to assess the effectiveness of SAMU on mental health screening and diagnosis. This will be accomplished through a two-arm trial in which 1. participants will be enrolled, screened, re-screened, and assessed for diagnosis and linkage to care for depression, anxiety and AUD and 2. evaluate the factors impacting sustained engagement in the SAMU program, through mixed methods.",[113],"Mental Health",[115,116,117,118,119],"Depression","Anxiety","HIV","Alcohol Use Disorder","hypertension","NOT_YET_RECRUITING","2026-08-18",{"date":68,"type":34},{"date":124,"type":22},"2026-09",{"date":126,"type":22},"2028-06",{"name":40,"class":41},3,{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":135,"sex":18,"minAge":19,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":42},"100628138","early-phase-1-evaluation-of-18fgatt-44-for-positron-emission-tomography-imaging-of-the-gaba-transporter-1-100628138","NCT07457736","Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1","Inclusion Criteria:\n\n1. Willing and able to give voluntary written informed consent;\n2. Able to read and write, able to communicate effectively with the investigator, and comply with all study requirements, restrictions, and directions of the research staff;\n3. Male or female, aged 18 to 60, at screening;\n4. In good general health as evidenced by medical history, physical examination, ECG, serum\u002Furine biochemistry, hematology, and serology tests;\n5. Females of childbearing potential, and male subjects, must be willing to practice birth control for the duration of the study (unless medical documentation is provided confirming subject is permanently sterile).\n\nExclusion:\n\n1. Less than 18 years of age;\n2. Pregnant or breastfeeding;\n3. Any significant systemic illness or unstable medical condition;\n4. Pre-existing medical conditions or claustrophobic reactions;\n5. Research-related radiation exposure exceeds current PET Center guidelines;\n6. History of a bleeding disorder or are currently taking anticoagulants.",true,"60 Years",{"count":138,"type":22},32,[140],"EARLY_PHASE1","Evaluate \\[18F\\]GATT-44 (aka \\[18F\\]GAT44), to characterize its pharmacokinetic, metabolic, and in vivo binding profile, and assess the reproducibility of kinetic and binding parameters. Assess specific binding levels of \\[18F\\]GATT-44 by conducting a test-block study in humans. Estimate human dosimetry of \\[18F\\]GATT-44 by performing whole-body imaging studies.",[143],"Healthy Adult Participants",[145,146,147,148,149],"gatt44","experimental radiotracer","first in human radiotracer","GAT-1","GATT-44",{"date":31,"type":34},{"date":152,"type":34},"2026-01-28",{"date":154,"type":22},"2030-01",{"name":40,"class":41},{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":18,"minAge":164,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":167,"briefSummary":169,"conditions":170,"keywords":174,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100614548","phase-3-comparison-between-anakinra-and-tocilizumab-in-norse---combat-norse-100614548","NCT07281027","COMparison Between Anakinra and Tocilizumab in NORSE - \"COMBAT-NORSE\"","Comparing the Effects of Anakinra and Tocilizumab on Outcomes in Patients With New-Onset Refractory Status Epilepticus","COMBAT-NORSE","Inclusion Criteria:\n\n* Age 2 and older.\n* In their usual state of health prior to their onset of SE.\n* Presenting with NORSE as defined in the consensus criteria:\n\n  1. Refractory SE (failed 2 appropriately used anti-seizure medications) in a patient without active epilepsy or other pre-existing relevant neurological disorder and without an acute or active structural, toxic, or metabolic cause found in the first 72 hours.\n  2. Includes patients with any RSE, not just super-refractory SE.\n  3. Includes patients who ultimately are discovered to have a known etiology (infectious, autoimmune, genetic, etc.), as well as those who remain cryptogenic.\n\n     * Additional Inclusion Criteria for the Randomized Arm:\n* Anakinra and\u002For tocilizumab are being planned or considered as part of standard clinical care.\n* The onset of SE was in the prior 7 days at the time of enrollment.\n\nExclusion Criteria:\n\n* Any acute or active systemic medical illness such as metastatic cancer, renal failure, hepatic failure, poorly controlled diabetes, etc., in the opinion of the investigators. If this is unclear, the study PI Dr. Hirsch will determine if this criterion is met.\n\nAdditional Exclusion Criteria for the Randomized Control Cohort:\n\n* Contraindication to either anakinra or tocilizumab as listed in the prescribing information:\n\n  1. Known hypersensitivity to E. Coli-derived proteins, anakinra, tocilizumab, or any component of the products\n  2. Active serious infection at the time of initiation\n  3. Concomitant use of TNF blocking agents; absolute neutrophil count \\\u003C 2000; platelet count \\\u003C 100,000 per mm³; or ALT or AST \\> 1.5 X the upper limit of normal\n  4. Elevated risk of GI perforation.","2 Years",{"count":166,"type":22},438,[168],"PHASE3","The goal of this clinical trial is to find out whether two existing medications-anakinra and tocilizumab-can effectively treat a rare and life-threatening brain condition called NORSE (New-Onset Refractory Status Epilepticus). NORSE causes continuous seizures in previously healthy children and adults and does not respond to standard treatments. It often leads to long-term disability or death.\n\nDoctors currently use anakinra and tocilizumab as second-line treatments when first-line therapies fail, but there is no clear evidence showing which drug works better or when it should be given. This study aims to answer those questions.\n\nThe study will enroll patients across 33 hospitals in the United States, Canada, Europe, and Asia.\n\nIt includes two groups:\n\n1. Randomized Cohort Patients will be randomly assigned to receive either anakinra or tocilizumab within the first 7 days of their illness. Only patients whose doctors were already planning to use one of these medications as part of standard care will be eligible for randomization. Researchers will monitor their recovery and compare outcomes between the two treatments.\n2. Observational Cohort Patients who cannot be randomized-usually because they were diagnosed too late-will still be followed to study how the timing of treatment affects recovery.\n\nParticipants will:\n\n* Receive one of the two medications (depending on their group assignment).\n* Take part in follow-up assessments over the course of one year, including medical evaluations and surveys. Some participants may be followed annually beyond one year.\n* Optionally participate in a 60-minute interview to share their or their caregiver's experience with NORSE.",[171,172,173],"New Onset Refractory Status Epilepticus","New-Onset Refractory Status Epilepticus","Febrile Infection-Related Epilepsy Syndrome (FIRES)",[175,176,177,178,179],"refractory status epilepticus","NORSE","FIRES","anakinra","tocilizumab",{"date":68,"type":34},{"date":38,"type":22},{"date":183,"type":22},"2030-09-30",{"name":40,"class":41},33,{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":195,"conditions":196,"keywords":200,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},"100465283","validation-of-early-prognostic-data-for-recovery-outcome-after-stroke-for-future-higher-yield-trials-100465283","NCT05338697","Validation of Early Prognostic Data for Recovery Outcome After Stroke for Future, Higher Yield Trials","VERIFY","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Unilateral symptomatic stroke due to ischemia. (Note: Bilateral acute stroke is permitted if the stroke that is contralateral to the index stroke is asymptomatic).\n3. Motor deficits in the acutely affected UE, defined as a Shoulder Abduction and Finger Extension (SAFE) score ≤ 8 out of 10 points20,61 (i.e., excluding full or nearly full motor strength in both shoulder abduction and finger extension) within 48 to 96 hours of stroke onset (or time last known well).\n\n   a. Please note that, if significant imbalance is observed in SAFE score or MEP+ rates, the enrollment threshold for SAFE score may be updated with a formal study memo.\n4. Provision of signed and dated informed consent form within 24 to 96 hours of stroke onset, (or time last known well). Note: Participant is considered \"enrolled\" upon starting TMS (at least one stimulation is delivered) or starting study-specific MRI pulse sequence (at least one MRI beep occurs)\n5. Stated willingness to comply with all study procedures and availability for the duration of the study, including Day 90 visit which must occur in-person.\n6. Fluent in study approved languages (i.e., English or Spanish)\n\nExclusion Criteria:\n\n1. UE injury or conditions on paretic side that limited use prior to the stroke\n2. Legally blind\n3. Dense sensory loss on paretic side indicated by a score of 2 on NIHSS sensory item\n4. Unable to abduct the shoulder or extend the fingers of the non-paretic UE on verbal command\n5. Isolated cerebellar stroke\n6. Symptomatic stroke in any location within 30 days prior to index stroke.\n7. Co-enrollment in a trial of an intervention targeting the incident stroke (acute treatment or rehabilitation\u002Frecovery intervention) after baseline assessments for VERIFY are initiated\n8. Known or expected inability to maintain follow-up with study procedures through 90 days\n9. Cognitive or communication impairment precluding informed consent by the participant.\n10. Major medical, neurological, or psychiatric condition that would substantially affect functional status\n11. Non-cerebrovascular diagnosis associated with unlikely survival at 90 days\n12. Pregnancy\n13. Contraindication to noncontrast MRI (certain metallic implants, metallic foreign bodies or severe claustrophobia)\n14. Contraindication to TMS\n\n    1. Implanted electronic cardiac devices (e.g., Automatic Implantable Cardioverter-Defibrillator \\[AICD\\] or pacemaker)\n    2. Any electronic devices in the body at or above the level of the seventh cervical vertebra (such as cochlear implant, cortical stimulator, deep brain stimulator, vagus nerve stimulator, cervical spine epidural stimulator, or ventriculoperitoneal shunt)\n    3. Ferromagnetic intracranial metallic implant\n    4. Skull defect related to current stroke\n    5. Seizure after onset of current stroke\n    6. Seizure within the last 12 months while taking anti-epileptic medications\n    7. Previous serious adverse reaction to TMS\n15. Anticipated inability to perform study procedures within 168 hours of symptom onset\n\n    1. Unable to perform behavioral assessments within 48-120 hours of symptom onset (or time last known well).\n    2. Unable to receive TMS within 72-168 hours or get MRI within 48-168 hours of symptom onset (or time last known well).",{"count":194,"type":22},657,"VERIFY will validate biomarkers of upper extremity (UE) motor outcome in the acute ischemic stroke window for immediate use in clinical trials, and explore these biomarkers in acute intracerebral hemorrhage. VERIFY will create the first multicenter, large-scale, prospective dataset of clinical, transmagnetic stimulation (TMS), and MRI measures in the acute stroke time window.",[197,198,199],"Stroke","Stroke, Acute","Stroke, Ischemic",[191],{"date":31,"type":34},{"date":203,"type":34},"2022-06-18",{"date":205,"type":22},"2027-10",{"name":40,"class":41},45,{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":214,"minAge":215,"maxAge":81,"enrollmentInfo":216,"targetDuration":4,"studyType":23,"phases":218,"briefSummary":219,"conditions":220,"keywords":223,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":227,"leadSponsor":229,"locationsCount":42},"100389798","evaluation-of-the-clinical-and-psychological-impact-of-vitamin-d-replacement-in-adolescent-females-at-risk-for-polycystic-ovarian-syndrome-pcos-100389798","NCT04355572","Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)","Inclusion Criteria:\n\n\\- Postmenarchal adolescent females aged 13-21 who meet modified Rotterdam criteria for PCOS, with a serum vitamin D level between 6-29 ng\u002FmL.\n\nExclusion Criteria:\n\n* Other causes for hyperandrogenism,\n* Chronic renal diseases,\n* Acquired or inherited calcium and vitamin D metabolic disorders.","FEMALE","13 Years",{"count":217,"type":22},60,[110],"This study is a double blind, placebo controlled, randomized trial of study subjects with PCOS and low vitamin D to 2 groups- placebo and vitamin D replacement. Participants and investigators will be blinded to treatment modality until the end of the trial period",[221,222],"Polycystic Ovarian Syndrome in Adolescent Females","Vitamin D Deficiency",[224],"Anti-Mullerian Hormone (AMH)",{"date":31,"type":34},{"date":124,"type":22},{"date":228,"type":22},"2028-08-31",{"name":40,"class":41},{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":135,"sex":18,"minAge":19,"maxAge":237,"enrollmentInfo":238,"targetDuration":4,"studyType":23,"phases":239,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":42},"100616496","phase-2-psilocybin-assisted-physical-therapy-in-chronic-low-back-pain-100616496","NCT07306364","Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain","Psilocybin in Chronic Low Back Pain: An Integrative Study of Lab-Based Mechanisms and Real-World Physical Therapy Outcomes","Inclusion Criteria:\n\n* 1\\. Ability to provide informed consent in English.\n* 2\\. Provision of signed and dated informed consent form.\n* 3\\. Stated willingness to comply with all study procedures and availability for the duration of the study.\n* 4\\. Male and female participants aged 18-65 years.\n* 5\\. CLBP, uniformly defined as high-impact or bothersome non-cancer low back pain lasting ≥ three months that occurs most days and limits life or work activities.\n* 6\\. At least moderate pain-related disability as measured by a total score on the ODI ≥ 15.\n* 7\\. For women of childbearing potential, must have a negative urine pregnancy test at screening and immediately before dose administration.\n\n  * Negative urine pregnancy test at screening and immediately before dose administration.\n  * Use of one highly effective contraception (e.g., IUD, barrier method) for ≥ 1 month prior to screening.\n* 8\\. Participants are required to commit to employing dual contraceptive methods throughout the study and to abstain from sperm or egg donation during the study period and for 28 days following the final drug dose for ova, and for 90 days following the final drug dose for sperm. Dual contraceptive methods encompass the use of a barrier contraceptive, such as condoms, coupled with another effective method capable of preventing pregnancy, such as oral or parenteral contraceptives, intrauterine devices, spermicide, and the like.\n* 9\\. Resting blood pressure ≤ 140\u002F90 mmHg (average of three screenings) and resting heart rate 60-100 bpm.\n* 10\\. Normal screening EKG: QTcF \\\u003C 450 ms; no clinically significant arrhythmias, ischemia, or bundle branch block.\n* 11\\. Hepatic and renal function within acceptable limits: AST\u002FALT ≤ 2× ULN; bilirubin ≤ 1.5× ULN; eGFR ≥ 50 mL\u002Fmin\u002F1.73 m².\n* 12\\. Ability to safely ingest oral capsules for the dosing visit.\n* 13\\. Safe transportation plan after the dosing session (e.g., designated driver).\n* 14\\. Signed medical release permitting the study team to communicate with outside providers for medication\u002Ftherapy history or crisis management.\n* 15\\. Designation of an adult emergency contact (relative, spouse, close friend) willing to monitor for mood\u002Fbehavior changes post-dose and provide transportation if needed.\n* 16\\. Agreement to attend preparatory and integration sessions, follow-up visits, and to respond to telephone\u002Femail contacts.\n\nExclusion Criteria:\n\n* 1\\. Hallucinogen Use Disorder or Hallucinogen Persisting Perceptual Disorder.\n* 2\\. Personal or family history of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder with psychotic features; any history of substance-induced psychosis or current psychotic symptoms at Screening per the Brief Psychiatric Rating Scale.\n* 3\\. Active suicidal ideation or behavior in the past 3 months, as indicated on the C-SSRS.\n* 4\\. Lifetime use of classic psychedelics (5-HT2A agonists) within the preceding 12 months, or unwillingness to abstain from their use for up to 4 weeks post-dose.\n* 5\\. Current moderate or severe depression, as indicated by a score of ≥ 3 on the depression subscale (items 1 and 2) of the Patient Health Questionnaire-4 (PHQ-4).\n* 6\\. Total score on the ODI ≥ 35, indicating an individual is \"completely disabled.\"\n* 7\\. Meeting DSM-5 criteria for alcohol or substance use disorders (other than tobacco use disorder) within the last year; use of THC-containing products \\> 2×\u002Fweek over the past 30 days or unwillingness to abstain for at least 1 week pre-dose through 4 weeks post-dose. Abstinence will be confirmed via point-of-care urine 11-nor-9-carboxy-THC testing with a cut-off ≤ 50 ng\u002FmL.\n* 8\\. Clinically significant medical disorders (e.g., moderate-to-severe hepatic impairment \\[Child-Pugh B\u002FC\\], AST\u002FALT \\> 2× ULN, bilirubin \\> 1.5× ULN, eGFR \\\u003C 50 mL\u002Fmin\u002F1.73 m², diabetes, uncontrolled thyroid disease).\n* 9\\. Neurological conditions altering nociceptive response (e.g., stroke, neuropathy) or history of seizure\u002Fhead injury with \\> 30 minutes loss of consciousness.\n* 10\\. Contraindications to nociceptive testing (e.g., untreated hypertension \\> 140\u002F90 mmHg).\n* 11\\. Current use of serotonergic medications (e.g., SSRIs, SNRIs, TCAs).\n* 12\\. Current regular use of medications affecting pain (e.g., opioids, gabapentinoids, cyclobenzaprine).\n* 13\\. Current regular use of inhibitors of UGT1A9, UGT1A10, MAO and aldehyde or alcohol dehydrogenase.\n* 14\\. Major neurocognitive disorders (e.g., dementia) or any cognitive deficit impairing consent\u002Fparticipation.\n* 15\\. Abnormal EKG findings (e.g., ischemia, infarct patterns, bundle branch block, atrial fibrillation, QTcF ≥ 450 ms).\n* 16\\. Resting QTcF prolongation or other torsades de pointes risk factors (uncontrolled electrolyte disturbances, family history of sudden death, torsadogenic medications).\n* 17\\. Any other condition that, in the investigator's judgment, would compromise safety or ability to complete the study.\n* 18\\. Known or suspected cardiovascular disease, including but not limited to atrial fibrillation, coronary artery disease, history of myocardial infarction, structural heart disease, congestive heart failure, or uncontrolled hypertension.","65 Years",{"count":207,"type":22},[25],"The purpose of this research study is to investigate whether a single administration of psilocybin can improve interoceptive awareness (awareness of bodily sensations) in individuals with chronic low back pain undergoing physical therapy, and whether these improvements are linked to pain relief and better physical therapy outcomes.",[242,243,244],"Chronic Low Back Pain (CLBP)","Physical Therapy","Psilocybin","2026-08-17",{"date":68,"type":34},{"date":248,"type":22},"2026-10",{"date":250,"type":22},"2029-06",{"name":40,"class":41},{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":259,"enrollmentInfo":260,"targetDuration":4,"studyType":23,"phases":262,"briefSummary":263,"conditions":264,"keywords":266,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":272,"leadSponsor":274,"locationsCount":275},"100592686","phase-2-an-exploratory-study-of-the-potential-for-rational-immune-system-manipulation-to-prevent-emergence-of-synucleinopathy-manifestations-in-persons-with-rem-sleep-behavior-disorder-rbd-100592686","NCT06996652","An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Persons With REM Sleep Behavior Disorder (RBD)","PRISMS","Inclusion Criteria:\n\n* Males, or females who are either\n\n  1. post-menopausal or otherwise not of child-bearing potential, defined as either 1) having had no menses for 12 or months without an alternative medical cause or explanation or 2) having undergone a surgical procedure (hysterectomy, bilateral tubal ligation) that prevents conception, or\n  2. practicing adequate contraception. Female participants of childbearing potential must practice at least 1 protocol-specified method of birth control, that is effective from 30 days before baseline (or earlier) through at least 150 days after the last dose of the study drug. Female participants of non-childbearing potential do not need to use birth control.\n  3. women of childbearing potential must have a negative urine pregnancy test prior to enrollment, and agree to undergo a pregnancy test at each study visit. Women with a positive pregnancy test at screening or at any subsequent study visit will be withdrawn from the study.\n* Diagnosis of idiopathic REM Sleep Behavior Disorder (RBD) based upon:\n\n  1. History of Dream Enactment Behavior during sleep and\n  2. Evidence of REM sleep without muscle atonia based upon polysomnogram obtained in a qualified sleep laboratory, consistent with ICSD-3 Diagnostic Criteria for RBD\n* Hyposmia, defined as score \\\u003C 15th percentile for age-and gender-specific normal values\n* Not diagnosed with motor Parkinson's Disease or Lewy Body Dementia\n* Have a MoCA score at screening and baseline ≥23\n* Able to speak, read and write fluently in the official language of the site's geographical region\n* Participant must be willing and able to attend all study visits as required by the study protocol\n* Participant must have a study partner who is in regular contact with the subject and can accompany the subject to clinic visits and report on subject's functional status\n* Participant must be able to self-inject study drug regularly or have a study partner who is available, willing and able to do so\n* Participant must be able to understand the study requirements and provide written informed consent\n\nExclusion Criteria:\n\n* Women who are pregnant, planning to become pregnant, or currently breastfeeding\n* Alternative explanation or etiology for the presence of RBD (e.g. narcolepsy)\n* Other than RBD, neurologic or medical disorder which may impair cognition including: head trauma, seizure disorder, neurodegenerative disease, hydrocephalus, cerebral\u002Fspinal hematoma, inflammatory disease, CNS infection (e.g., encephalitis or meningitis), neoplasm, toxic exposure, metabolic disorder (including hypoxic or hypoglycemic episodes), or endocrine disorder, or any significant medical conditions that, in the opinion of the investigator, would prohibit their participation in the study.\n* As assessed by the central reader, MRI evidence of (a) more than three lacunar infarcts, (b) territorial infarct or macroscopic hemorrhage, or (c) deep white matter lesions corresponding to a Fazekas score of 3\n* Any contra-indication to undergo MRI, as judged by local PI or radiologist, including but not limited to presence of pacemaker, aneurysm clips, artificial heart valves, ear implants, ventriculoperitoneal shunt, foreign metal objects in the eyes, skin or body or any other circumstance which would contra-indicate an MRI scan or impair MRI image quality, or history of claustrophobia or of not tolerating MRI scanning procedures\n* History or active presence of any of the following neurological, psychiatric or medical conditions:\n\n  1. Large vessel stroke\n  2. Peripheral or CNS demyelinating disease\n  3. Chronic and\u002For recurrent fungal, bacterial or opportunistic infections\n  4. Myocardial infarction or unstable angina within the previous 12 months\n  5. Clinically relevant or significant ECG abnormalities, including ECG with QT interval corrected for heart rate using Fridericia's formula (QT interval corrected for heart rate using Fridericia's formula) \\> 450 msec (males) or \\> 470 msec (females).\n  6. Congestive heart failure, NYHA Class 3 or 4\n  7. Autoimmune disease (e.g., Systemic Lupus Erythematosis (SLE), or symptoms suggestive of a lupus-like syndrome, multiple sclerosis, rheumatoid arthritis, Type 1 diabetes mellitus, inflammatory bowel disease, psoriasis, etc.)\n  8. Immunocompromised systemically due to continuing effects of immune suppressing medication\n  9. Current or previous hepatitis B infection (defined as positive test for hepatitis B surface antigen (HbSAg) and\u002For hepatitis B core antibody (anti-HBc).\n* Participants with immunity to hepatitis B (if due to natural infection defined as negative HBsAg, positive hepatitis B antibody (anti-HBs) and positive anti-HBc; if due to vaccination defined as negative HBsAg, negative anti-HBc and positive anti-HBs are eligible to participate in the study\n* For patients with resolved HBV infection, if anti-HBc negative, HBV DNA testing is needed prior to initiating study drug j. History or positive test at Screening for hepatitis C virus antibody (anti-HCV) in the absence of treatment resulting in cure k. History or positive test at Screening for human immunodeficiency virus (HIV) l. History of untreated or incompletely treated tuberculosis or a positive tuberculosis IGRA test.\n\n  m. History of malignancy other than successfully treated, non-metastatic cutaneous squamous or basal cell carcinoma or localized carcinoma in situ of the cervix n. Major depressive episode requiring initiation of medication or hospitalization within the previous 90 days o. Seated blood pressure \\> 150\u002F90 on 3 separate determinations p. Presence of hallucinations or delusions q. Psychiatric disorder (schizophrenia, schizoaffective disorder, etc.) associated with psychosis r. Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral\u002Fintramuscular anti-infectives within 14 days prior to baseline s. Major surgery within 12 weeks of screening t. Blood donation of 1 unit or more within 8 weeks prior to the first dose of study medication\n* Any of the following laboratory abnormalities at Screening\n\n  1. Screening values for hemoglobin \\\u003C 12 g\u002Fd for men or \\\u003C 11 g\u002FdL for women or other clinically significant hematological abnormality\n  2. Any serum chemistry value (e.g., AST, ALT, alkaline phosphatase, CK, total bilirubin etc. \\> 2x the upper limit of normal on 2 successive determinations less than 2 weeks apart\n  3. Serum creatinine above the ULN or eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2\n  4. Platelet count, INR, PT or PTT not within the normal range or other risk for increased or uncontrolled bleeding\n* Any other significant medical conditions that, in the opinion of the investigator, would prohibit participation in the study, including inability to tolerate the MRI scan\n* For participants agreeing to lumbar puncture: Presence of contra-indication to lumbar puncture as judged by local PI (e.g., known X-ray or other evidence of significant lumbar spine abnormalities or history of lumbar surgery with sequalae that would interfere with or pose risks from the procedure; platelet count below 50,000 cells\u002FmL; need for anticoagulant or antiplatelet medications other than aspirin at a dose of \\\u003C 100 mg\u002Fday or clopidogrel (see item 10 (g) below))\n* Taking any of the following medications:\n\n  1. Symptomatic anti-Parkinson agents, including but not limited to levodopa-containing preparations, dopamine agonists, monoamine oxidase inhibitors, amantadine, and adenosine receptor antagonists taken any time prior to the screening visit\n  2. Cognitive enhancing agents, including but not limited to acetylcholinesterase inhibitors and memantine taken any time prior to the screening visit\n  3. Stimulant medications, including but not limited to lisdexamphetamine, dextroamphetamine\u002Famphetamine (Adderall) and methylphenidate taken at any time prior to the screening visit\n  4. Antipsychotic agents, including pimavanserin\n  5. Antidepressant medications whose dose has not been stable for at least 90 days\n  6. Use of any of the following medications within 12 months prior to Screening: Immunosuppressant medications, including chronic corticosteroids, anakinra and abatacept\n  7. Any previous use of injected or infused antibody therapies, including but not limited antibodies directed against TNF, anti-IL-6, natalizumab, rituximab, conventional or targeted DMARD agents\n  8. For participants agreeing to undergo lumbar puncture: Anticoagulant or anti-platelet medications including warfarin, heparinoids and direct coagulation factor inhibitors (e.g., apixaban, dabigatran, rivaroxaban) within 90 days of the planned first dose of study drug; either aspirin at a dose of \\\u003C¬ 100 mg\u002Fday or clopidogrel at a dose of 75 mg\u002Fday, but use of both in combination is permitted.\n  9. Received any live vaccine, with the exception of non-replicating live viral vaccines such as Jynneos vaccine, within 30 days prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 70 days after the last dose of study drug.\n* History of an allergic reaction or significant sensitivity to adalimumab or constituents of the study drug (and its excipients) and\u002For other products in the same class\n* Participation in any other interventional clinical trial, or treatment with any investigational drug or investigational use of an approved therapy within 30 days (or 5 half-lives of such agent) prior to the first Screening visit.\n* History of drug or alcohol abuse within the last 5 years (including cannabis use disorder)\n* Positive urine drug test at screening\n* Unwillingness or inability to comply with study requirements, including self-administration of study medication, or history of noncompliance in prior clinical trials","80 Years",{"count":261,"type":22},108,[25],"This is a phase 2 study to assess the ability of adalimumab as compared to placebo to reduce or prevent progression of synuclein-related neurodegeneration in persons with idiopathic REM Sleep Behavior Disorder (RBD). The Primary Endpoint will be change from baseline in expression of the Parkinson Disease Related Pattern (PDRP) will be assessed using change in 18-flurodeoxyglucose (FDG) Positron Emission Tomography (PET) imaging.",[265],"REM Sleep Behavior Disorder",[267,268,269],"Parkinson Disease Related Pattern","adalimumab","Synucleinopathy",{"date":68,"type":34},{"date":245,"type":34},{"date":273,"type":22},"2030-01-01",{"name":40,"class":41},19,{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":18,"minAge":81,"maxAge":237,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":283,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":42},"100521519","phase-1-the-potential-therapeutic-effects-of-psychedelic-n-n-dimethyltryptamine-dmt-on-alcohol-use-disorder-aud-100521519","NCT06070649","The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)","Inclusion Criteria:\n\n* Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnosis of Alcohol Use Disorder\n* Medically healthy\n* Ability to provide consent\n\nExclusion Criteria:\n\n* Unstable medical conditions",{"count":84,"type":22},[86],"This proposed study is a double-blind, randomized, placebo-controlled, parallel-group, laboratory study to determine the effects of DMT, plus psychotherapy, on Alcohol Use Disorder.",[91,286,287],"Alcohol-Related Disorders","Alcohol Use","2026-08-16",{"date":121,"type":34},{"date":291,"type":34},"2025-08-04",{"date":293,"type":22},"2027-08-01",{"name":40,"class":41},{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":135,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":23,"phases":304,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":42},"100491750","phase-1-omar-opioid-use-disorder-100491750","NCT05683184","OMAR Opioid Use Disorder","Characterization of CB1 Receptors Using [11-C]OMAR in Opioid Use Disorder","Inclusion Criteria:\n\n* Able to provide informed consent\n* Male and female 18 years and older\n* DSM-5 diagnosis of opioid use disorder (for OUD group)\n* Physically healthy i.e., no clinically unstable medical conditions\n* Written informed consent and have capacity to consent and comply with study procedures\n\nExclusion Criteria:\n\n* Current neuro-psychiatric illness or severe systemic disease (opioid use disorder is permitted in the OUD group).\n* Presence of ferromagnetic metal in the body or heart pacemaker\n* Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits\n* Are claustrophobic",{"count":303,"type":22},30,[86],"The goal of this research study is to examine the endocannabinoid (eCB) function in vivo in individuals with opioid use disorder (OUD) by measuring cannabinoid receptor 1 (CB1R) availability.",[307,308],"Healthy Control","Opioid Use Disorder",{"date":121,"type":34},{"date":311,"type":34},"2023-03-10",{"date":313,"type":22},"2027-12-15",{"name":40,"class":41},{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":135,"sex":18,"minAge":19,"maxAge":259,"enrollmentInfo":323,"targetDuration":4,"studyType":23,"phases":325,"briefSummary":326,"conditions":327,"keywords":332,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":42},"100484326","phase-1-sv2a--tspo-pet-imaging-measures-to-reveal-mechanisms-of-hiv-neuropathogenesis-during-antiretroviral-therapy-100484326","NCT05586581","SV2A & TSPO PET Imaging Measures to Reveal Mechanisms of HIV Neuropathogenesis During Antiretroviral Therapy","PET Imaging of Synaptic Density Combined With Neuroimmunologic Measures to Reveal Mechanisms of HIV Neuropathogenesis During ART","ART","PLWH Inclusion Criteria:\n\n* Voluntary, written, informed consent (signed and dated)\n* For females, a negative urine or serum pregnancy (HCG) test at screening and on each scan day before initiation of any scan procedures.\n* HIV infection on cART with documented viral suppression for at least one year. Plasma viral suppression will be defined as no more than one viral load\n* Test above 20 HIV RNA cps\u002FmL in the year prior to screening and no HIV RNA tests above 200 cps\u002FmL in the same span.\n* Willingness to participate in MRI, PET, phlebotomy, and Neuropsychological Testing (NPT) Assessments \\& Surveys.\n\nPLWH Exclusion Criteria:\n\n* Active substance dependence (e.g., heroin, alcohol, cocaine, sedative hypnotics, methamphetamine) as determined by the standardized Behavioral Assessments.\n* A history of significant non-HIV related neurological illness (e.g., cerebrovascular, seizures, traumatic brain injury).\n* Medical contraindications to the administration of radioactivity (e.g., prior radiation exposure within the past year from research, or from workplace exposure, that in combination with the planned scans would exceed the FDA limit for annual radiation exposure).\n* Medical contraindications to participation in a magnetic resonance imaging procedure (e.g., ferromagnetic implants\u002Fforeign bodies, claustrophobia, cardiac pacemaker, prosthetic valve, otologic implant, etc.).\n* History of a bleeding disorder, low platelet count, or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).\n\nHIV - Inclusion Criteria:\n\n* Voluntary, written, informed consent (signed and dated)\n* For females, a negative urine or serum pregnancy (HCG) test at screening and on each scan day before initiation of any scan procedures.\n* Willingness to participate in phlebotomy, NPT Assessments \\& Surveys, MRI, and PET.\n* Physically healthy by medical history, physical, neurological, and laboratory examinations, as judged by the principal investigator.\n* Have a negative test for HIV on file within the last three months or willing to have an HIV test in the current study.\n\nHIV- Exclusion Criteria:\n\n* Active substance dependence (e.g., heroin, alcohol, cocaine, sedative hypnotics, methamphetamine) as determined by the standardized Behavioral Assessments.\n* A history of significant neurological illness (e.g., cerebrovascular, seizures, traumatic brain injury).\n* Medical contraindications to the administration of radioactivity (e.g., prior radiation exposure within the past year, from research, or from workplace exposure, that in combination with the planned scans would exceed the FDA limit for annual radiation exposure)\n* Medical contraindications to participation in a magnetic resonance imaging procedure (e.g., ferromagnetic implants\u002Fforeign bodies, claustrophobia, cardiac pacemaker, prosthetic valve, otologic implant, etc.\n* History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto",{"count":324,"type":22},70,[86,25],"The purpose of this study is to longitudinally characterize and evaluate changes in synaptic density in the brain using novel positron-emission tomography (PET) scans; magnetic resonance imaging (MRI), and clinical laboratory markers associated with HIV-related injury in the central nervous system. This study will test hypotheses relating to the presence and mechanisms of aberrant brain structure at the synaptic level in living humans with virologically controlled HIV on antiretroviral therapy. To evaluate associations between PET imaging radiotracers \\[11C\\]UCB-J, a ligand for presynaptic vesicle protein 2A (SV2A), a vesicle membrane protein expressed in synapses, and PET \\[11C\\]PBR28 a measure of microglia function in the brain, the Yale PET center has developed an advanced approach of combining multiple distinct ligands in coordinated same-day PET imaging. Additionally, the study will evaluate the associations of this novel synaptic density marker with well-established clinical measures of neurocognitive performance and laboratory measures of blood and cerebrospinal fluid (CSF).",[328,329,330,331],"HIV Associated Neurocognitive Disorder","HIV Dementia","HIV Encephalitis","Healthy",[333,334,335,336,337,338,339,340,341,342,343,344,345,346,347],"Human immunodeficiency virus","Positron-Emission Tomography Imaging","Magnetic Resonance Imaging","Cerebrospinal Fluid","SV2A PET","TSPO PET","Neuro-immune dysfunction","Neuro-Inflammation","Biomarkers of inflammation","Neuronal Injury","Neurocognitive functioning","Hippocampus","Microglia","Neuropathogenesis","antiretroviral therapy","2026-08-15",{"date":121,"type":34},{"date":351,"type":34},"2023-05-17",{"date":353,"type":22},"2030-12",{"name":40,"class":41},{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":362,"enrollmentInfo":363,"targetDuration":4,"studyType":23,"phases":365,"briefSummary":366,"conditions":367,"keywords":369,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":42},"100652472","phase-1-semaglutide-dose-effects-on-metabolic-and-stress-hormone-craving-and-alcohol-use-outcomes-100652472","NCT07772960","Semaglutide Dose Effects on Metabolic and Stress Hormone, Craving and Alcohol Use Outcomes","SEMA AUD","Inclusion Criteria:\n\n* Male and females ages 18-60 and BMI in 30-49.9 kg\u002Fm2;\n* regular weekly alcohol use (at least 3X\u002Fweek) prior to admission;\n* must meet current DSM-V criteria for moderate to severe Alcohol Use Disorders (AUDs) using SCID-I for DSM-V;\n* Good health as verified by screening and physical examination;\n* Able to read English and complete study evaluation;\n* Able to provide informed written and verbal consent.\n\nExclusion Criteria:\n\n* Meet current criteria for moderate to severe substance use disorders from abuse of any another psychoactive substance, excluding nicotine;\n* Current use of opiates;\n* Current use of psychiatric medications, including benzodiazepine-based sedatives\u002Fanxiolytics and anticonvulsants, non SSRI antidepressants, oral prescription analgesics (other than non-steroidal anti-inflammatory drugs), acamprosate, naltrexone, antabuse, baclofen, varenicline;\n* Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);\n* Endocrine or immune disorders, including diagnosis of diabetes (T2D or T1D) by American Diabetes Association (ADA) criteria or a history of HgbA1c \\>6.5% and on current medications for T2D treatment;\n* Significant underlying medical conditions, including history of pancreatitis, acute kidney injury, medullary thyroid cancer, or MEN syndrome, as well as other cerebral, renal, thyroid or cardiac pathology that would preclude study participation;\n* Current use of any anti-obesity medications;\n* Prior history of bariatric surgery or current intragastric balloon;\n* Current participation in structured meal replacement or weight loss program;\n* Weight loss of \\>=10% over the preceding 6 months;\n* Women who are pregnant, nursing or refuse use of reliable form of birth control.","68 Years",{"count":364,"type":22},90,[86],"This study will examine two doses of 1.0 mg and 2.0 mg of Semaglutide versus placebo in patients with Alcohol Use Disorder (AUD) and Obesity (Ob) to assess if these doses improve alcohol craving, stress and alcohol use outcomes.",[91,368],"Obesity (BMI Equal to or >30)",[118,370,371,372,373],"alcohol craving","Semaglutide","food craving","alcohol intake","2026-08-14",{"date":68,"type":34},{"date":377,"type":22},"2026-10-01",{"date":379,"type":22},"2031-10-31",{"name":40,"class":41},{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":4,"eligibilityCriteria":387,"healthyVolunteers":135,"sex":18,"minAge":19,"maxAge":388,"enrollmentInfo":389,"targetDuration":4,"studyType":23,"phases":391,"briefSummary":392,"conditions":393,"keywords":395,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":398,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":42},"100551992","speech-motor-learning-and-retention-master-protocol-100551992","NCT06467292","Speech Motor Learning and Retention (Master Protocol)","Sensorimotor Basis of Speech Motor Learning and Retention","Inclusion Criteria:\n\n* Fluent English speakers\n* Right-handed\n* Normal hearing\n* No speech disorder or reading disability\n\nExclusion Criteria:\n\n* Cardiac pacemaker\n* Aneurysm clip\n* Heart or Vascular clip\n* Prosthetic valve\n* Metal implants\n* Metal in brain, skull, or spinal cord\n* Implanted neurostimulator\n* Medication infusion device\n* Cochlear implant or tinnitus (ringing in ears)\n* Personal and\u002For family history of epilepsy or other neurological disorders or history of head concussion\n* Psychoactive medications\n* Pregnancy","40 Years",{"count":390,"type":22},330,[110],"The overall goal of this research is to test a new model of speech motor learning, whose central hypothesis is that learning and retention are associated with plasticity not only in motor areas of the brain but in auditory and somatosensory regions as well.",[394],"Speech",[396,397],"Speech Motor Learning","Retention",{"date":121,"type":34},{"date":400,"type":34},"2024-10-01",{"date":402,"type":22},"2029-05-31",{"name":40,"class":41},{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":18,"minAge":81,"maxAge":410,"enrollmentInfo":411,"targetDuration":4,"studyType":23,"phases":413,"briefSummary":414,"conditions":415,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":42},"100652149","phase-1-impact-of-sweeteners-on-the-addictive-threshold-of-nicotine-100652149","NCT07771725","Impact of Sweeteners on the Addictive Threshold of Nicotine","Inclusion Criteria:\n\n* Smoking at least for one year and more frequently than once a week, smoking status confirmed with a semi-quantitative urine nicotine test. Smokers will be stratified by level of dependence, assessed with the FTND 29 low or no dependence ≤3 and moderate or high dependence ≥ 4.\n* In good health as verified by medical history, screening examination, and screening laboratory tests.\n* For women, report using acceptable birth control methods.\n\nExclusion Criteria:\n\n* History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the participant to be in the study;\n* regular current use of certain psychotropic medications (such as mood stabilizers, antipsychotics, or anxiolytics being prescribed to treat bipolar disorder, psychosis or anxiety spectrum disorders, respectively);\n* current untreated alcohol or substance use disorder for any other recreational or prescription drugs other than nicotine;\n* for women, pregnant as determined by pregnancy screening, or breastfeeding; and 5) seeking (or undergoing) treatment for tobacco dependence or smoking.","59 Years",{"count":412,"type":22},36,[86],"To determine if sucralose, an artificial sweetener, modulates nicotine threshold doses for discrimination, subjective-rewarding effects, and reinforcement in smokers with varying levels of dependence.",[416],"Smoking ( Cigarette)","2026-08-13",{"date":121,"type":34},{"date":420,"type":22},"2026-09-01",{"date":422,"type":22},"2029-12-31",{"name":40,"class":41},{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":135,"sex":18,"minAge":431,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":23,"phases":434,"briefSummary":435,"conditions":436,"keywords":438,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":445,"startDateStruct":446,"completionDateStruct":447,"leadSponsor":449,"locationsCount":42},"100635507","survey-to-test-the-nicotine-concentration-and-nicotine-flux-labels-for-e-cigarettes-100635507","NCT07553585","Survey to Test the Nicotine Concentration and Nicotine Flux Labels for E-cigarettes","Using Novel Labeling to Improve Public Understanding of Nicotine in Electronic Nicotine Delivery Systems (ENDS): Nicotine Concentration and Nicotine Flux","Inclusion Criteria:\n\n* Youth\\* (14-20 years) or an adults (21 years and older)\n\n  * The legal age for purchasing tobacco in the U.S. is 21 years. Therefore, ages for youth and adults were split at the legal age for purchase.\n* Resides in the United States\n* Reports no history of tobacco product use (25% of the youth and adult samples, respectively) or past-month use of e-cigarettes (but not cigarettes; 25%), cigarettes (but not e-cigarettes; 25%), or both e-cigarettes and cigarettes (25%).\n\nExclusion Criteria:\n\n* Children under 14 years","14 Years",{"count":433,"type":22},2500,[110],"Current labels for the nicotine in e-cigarette\u002Fvaping products do not sufficiently convey information to the public. The aims of this study include developing and validating two new types of labels for the nicotine in vaping products: nicotine concentration and nicotine flux (reflecting nicotine emissions). Investigators will survey youth (ages 14-20) and adults (ages 21+ \\[21 is the legal age to purchase tobacco products in the U.S.\\]) to evaluate the utility of several new labels investigators have developed.",[437],"Nicotine Labeling for E-cigarettes",[439,440,441,442,443,444],"Nicotine Labeling","E-cigarette","Electronic Nicotine Delivery System","Nicotine Concentration","Nicotine Flux","Nicotine Emissions",{"date":245,"type":34},{"date":377,"type":22},{"date":448,"type":22},"2026-12-15",{"name":40,"class":41},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":135,"sex":18,"minAge":457,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":460,"conditions":461,"keywords":463,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":42},"100570292","social-disconnection-study-100570292","NCT06705348","Social Disconnection Study","Role of Synaptic Density in Mediating the Relation Between Social Disconnection and Late-life Suicide Risk","Inclusion Criteria:\n\n* able to give written informed consent\n* age 55+\n* English speaking\n\nExclusion Criteria:\n\n* contraindication to MRI scanning including claustrophobia, high girth, moderate to significant white matter atrophy, and presence of ferromagnetic material in the body, including orthodontic braces or other non MR-compatible foreign bodies. All participants will be screened for metal objects by the same methods used for routine clinical MRI scanning\n* for women: pregnancy or breastfeeding\n* serious medical or neurological illness that in the opinion of the PI would interfere with the scientific goals of the study or participant safety\n* pervasive developmental disorders (PDD) or primary psychotic disorders\n* meet DSM-5 criteria for current severe substance use disorder (except marijuana or nicotine)\n* head injury that led to significant long term decline in cognitive abilities as seen by decline in grades or work performance\n* current psychosis, active significant suicidal (score of 6 on MADRS suicide item) or homicidal ideation\n* lifetime history of neurologic abnormality including seizure disorder, cerebrovascular, or neoplastic lesion, neurodegenerative disorder, or significant head trauma resulting in post-traumatic amnesia \\>24 hours\n* full scale IQ lower than 70\n* contraindications to PET (e.g. poor venous access for placement of venous lines)\n* history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year\n* history of a bleeding disorder or currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto) \\*for subjects obtaining arterial line.\n* blood donation within 8 weeks of the start of the study\n* REM sleep disorder\n* brain injury (TBI, seizure\u002Fepilepsy, stroke, TIA) in lifetime (self-report and medical chart review)\n* electroconvulsive or ketamine therapy, or similar therapies that have rapid effects on brain neurochemistry within the past 6 months\n* high risk for stroke (above first quartile on Framingham Stroke Risk Profile)\n* current cancer","55 Years",{"count":459,"type":22},100,"The purpose of this research study is to examine the effect of social connectedness on the brain. Study procedures include one Magnetic Resonance Imaging (MRI) or functional Magnetic Resonance Imaging (fMRI) scan, one Positron Emission Tomography (PET) scan, one Magnetic Resonance Spectroscopy (MRS) scan, an electroencephalogram (EEG), and in-person and phone call follow-ups.",[462],"Social Disconnection",[464,465,466],"loneliness","social disconnection","isolation","2026-08-12",{"date":374,"type":34},{"date":470,"type":34},"2023-05-08",{"date":472,"type":22},"2028-02",{"name":40,"class":41},{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":483,"conditions":484,"keywords":489,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":98},"100450437","crush-pad-real-world-outcomes-following-use-of-shockwave-intravascular-lithotripsy-ivl-technology-in-calcified-common-femoral-lesions-100450437","NCT05145478","CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions","CTA_IIT_CRUSH PAD: Real-world Outcomes Following Use of the Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions","Inclusion Criteria:\n\n* Subjects presenting with claudication or CLI by Rutherford Clinical Category 2, 3, 4, 5, or 6 of the target limbs\n* Subject is a suitable candidate for angiography and endovascular intervention per the latest clinical guidelines\n* Patient is scheduled to undergo treatment with Shockwave Intravascular Lithotripsy (IVL) technology followed by standard of care treatment with DCB, BMS, DES at the physician's discretion.\n\nAngiographic Inclusion Criteria\n\n* Target lesion that is located in a native, de novo common femoral artery\n* Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate.\n* Target lesion is ≥70% stenosis by investigator via visual estimate.\n* Target lesion length is ≤50mm for lesions 70-99% stenosed. Target lesion can be all or part of the 50mm treated zone.\n* Chronic total occlusion, lesion length is ≤50mm of the total ≤50 mm target lesion.\n* Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending \\> 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is \\\u003C50mm in length.\n\nExclusion Criteria:\n\n* Subjects with any medical condition that would make him\u002Fher an inappropriate candidate for treatment with Shockwave Medical Peripheral Lithoplasty® System as per Instructions for Use (IFU) or investigator's opinion.\n* Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.\n* Cognitive impairment as documented in medical records\n* Not speaking English or Spanish\n* Currently a prisoner\n* Pregnancy or nursing\n* Estimated survival less than 12 months at the time of screening\n* Prior history of CFA endarterectomy",{"count":482,"type":22},50,"The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of endpoints, including target lesion revascularization and health status, to enable future planning of comparative effectiveness research.",[485,486,487,488],"Femoral Arterial Calcification","Peripheral Arterial Disease","Claudication","Critical Limb Ischemia",[490],"Peripheral Artery Disease",{"date":374,"type":34},{"date":493,"type":34},"2021-12-01",{"date":495,"type":22},"2027-06-01",{"name":40,"class":41},{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":82,"enrollmentInfo":504,"targetDuration":4,"studyType":23,"phases":505,"briefSummary":506,"conditions":507,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":42},"100652036","real-time-opioid-study-100652036","NCT07768007","Real-time Opioid Study","Neurofeedback in Individuals With Substance Use Disorders","Inclusion Criteria:\n\n* ≥3 months of methadone treatment for OUD\n* Presence of anhedonia, as assessed via SHAPS\n* Baseline autobiographical memory deficit, as assessed via AMT\n\nExclusion Criteria:\n\n* Failure to pass an MRI screening\n* Women who are pregnant\n* Psychosis, as assessed via Yale PRIME Early Psychosis Screening Test\n* Serious suicidal ideation\n* Serious medical condition\n* Legally blind",{"count":128,"type":22},[110],"This feasibility study collects initial data on the use of an fMRI neurofeedback protocol for treating anhedonia in methadone-treated individuals with opioid use disorder (OUD). The intervention tested has previously been shown to reduce anhedonia in individuals with depression and this study is collecting first-in-human data in an OUD population. Investigators will assess tolerability of the intervention and collect preliminary data from 2-3 subjects monitoring changes in anhedonia, non-substance-related autobiographical memory recall, and meaning in life.",[508],"Substance Use Disorder (SUD)","2026-08-11",{"date":245,"type":34},{"date":512,"type":22},"2026-08",{"date":514,"type":22},"2027-02",{"name":40,"class":41},{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":523,"enrollmentInfo":524,"targetDuration":4,"studyType":23,"phases":525,"briefSummary":526,"conditions":527,"keywords":529,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":534,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":98},"100285001","physician-modified-fenestrated-and-branched-aortic-endografting-for-taaa-100285001","NCT02989948","Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA","Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal Aortic Aneurysms (TAAA)","MAIN ARM - Inclusion Criteria:\n\n1. Must be a man or woman 50 years of age or older by the date of informed consent.\n2. Must have a thoracoabdominal aortic aneurysm of any Crawford classification (extent I-V) that extends no more proximal than the left subclavian artery.\n3. Must have an aneurysm size that meets standard indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta).\n4. Must be considered, in the judgment of the S-I, to be a high risk candidate for open surgical repair.\n5. Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft.\n6. Must be able to provide informed consent.\n7. Must be able to comply with the five year study assessment schedule of events.\n8. Must have a non-aneurysm-related life expectancy, in the judgment of the S-I, of greater than 2 years.\n\nMAIN ARM - Exclusion Criteria:\n\n1. Aneurysm due to acute or chronic dissection, intramural hematoma, penetrating aortic ulceration, pseudoaneurysm, mycotic aneurysm, or traumatic transection.\n2. Ruptured or acutely symptomatic aortic aneurysm.\n3. Known connective tissue disorder.\n4. Imaging demonstrating any of the following:\n\n   * Lack of 20 mm non-aneurysmal proximal seal zone (zone 3, or zone 2 with a carotid-subclavian bypass or transposition).\n   * Lack of 15 mm non-aneurysmal distal seal zone(s) (aortic, common iliac, or external iliac).\n   * Branch vessel target (renal, superior mesenteric, or celiac) \\\u003C 5 mm or \\> 10 mm in average diameter.\n   * Untreated left subclavian artery stenosis or occlusion.\n   * Untreated unilateral or bilateral hypogastric artery occlusion.\n   * Signs that the inferior mesenteric artery is indispensable.\n   * Have branching, duplication, aneurysm, or untreatable stenosis of the celiac, superior mesenteric artery, or renal arteries that would preclude implantation of the investigational devices.\n5. Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold.\n6. History of anaphylaxis to contrast, with inability to prophylax appropriately.\n7. Have uncorrectable coagulopathy.\n8. Have unstable angina.\n9. Have a body habitus that would inhibit X-ray visualization of the aorta.\n10. Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤30 days of the endovascular repair.\n11. Known to be participating in any other clinical study which may affect performance of this device.\n12. Known, visible, or suspected pregnancy, confirmed with a Urine Pregnancy Test (UPT)\n13. Contraindication to oral antiplatelet therapy.\n14. Prisoners or those on alternative sentencing.\n15. Known systemic infection with potential for endovascular graft infection.\n16. Anticipated need for MRI scanning within 3 months of insertion of investigational product.\n17. Other conditions or comorbidities that, in the opinion of the S-I, would exclude the patient.\n\nEXPANDED ACCESS ARM - Inclusion Criteria\n\n1. Must be a man or woman 50 years of age or older by the date of informed consent\n2. Must have a thoracic, thoracoabdominal, or abdominal aortic aneurysm that necessitates coverage of one or more visceral vessels (celiac, superior mesenteric, or renals) for establishment of proximal and\u002For distal seal.\n3. Must have an aneurysm size that meets standard size indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta); or, in the judgment of the S-I, has aneurysm characteristics that portend a high risk of near-term rupture\n4. Must be considered, in the judgement of the S-I, to be a high risk candidate for open surgical repair\n5. Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft\n6. Patient must be able to provide informed consent\n7. Must be able to comply with the five year study assessment schedule of events\n8. Must have a non-aneurysm-related life expectancy, in the judgement of the S-I, of greater than 2 years\n\nEXPANDED ACCESS ARM - Exclusion Criteria\n\n1. Known or suspected mycotic aneurysm\n2. Ruptured aneurysm with hemodynamic instability\n3. Known connective tissue disorder\n4. Imaging demonstrating any of the following:\n\n   * Lack of 20 mm non-aneurysmal proximal seal zone (in either native aorta, elephant trunk graft, or aortic arch endograft)\n   * Lack of 15 mm non-aneurysmal distal seal zone(s) (in either native aortoiliac vessels, prosthetic aortoiliac grafts, or aortoiliac endografts)\n   * Branch vessel target (renal, superior mesenteric, or celiac) \\> 10 mm in average diameter\n5. Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold\n6. History of anaphylaxis to contrast, with inability to prophylax appropriately.\n7. Have uncorrectable coagulopathy\n8. Have a body habitus that would inhibit X-ray visualization of the aorta\n9. Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair\n10. Known to be participating in any other clinical study which may affect performance of this device\n11. Known, visible, or suspected pregnancy, confirmed with a Urine Pregnancy Test (UPT)\n12. Contraindication to oral antiplatelet therapy\n13. Prisoners or those on alternative sentencing\n14. Known systemic infection with potential for endovascular graft infection\n15. Anticipated need for MRI scanning within 3 months of insertion of investigational product\n16. Other conditions or comorbidities that, in the opinion of the S-I, would exclude the patient","95 Years",{"count":50,"type":22},[110],"The primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis for the treatment of thoracoabdominal aortic aneurysms (TAAAs). The goal of the primary analysis is to demonstrate both the safety and effectiveness of using a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft as compared to previously published results of open surgical replacement of the aneurysmal aorta.",[528],"Aortic Aneurysm, Thoracoabdominal",[530,531,532,533],"endovascular","physician-modified","graft","fenestration",{"date":417,"type":34},{"date":536,"type":34},"2020-04-22",{"date":538,"type":22},"2031-12-31",{"name":40,"class":41},{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":23,"phases":548,"briefSummary":549,"conditions":550,"keywords":553,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":558,"leadSponsor":560,"locationsCount":42},"100651840","pcdd-generation-1-oral-liquid-acetaminophen-delivery-evaluation-100651840","NCT07765238","PCDD Generation 1 Oral Liquid Acetaminophen Delivery Evaluation","Evaluation of the Patient-Controlled Dispenser & Deactivator (PCDD) Generation 1 System for Oral Liquid Acetaminophen Delivery","Inclusion Criteria:\n\nParticipants\n\n* Admitted to the participating orthopedic service for elective total shoulder replacement\n* Received a preoperative brachial plexus block\n* English speaking - as on-site study members are only fluent in English\n* Able to independently use the PCDD system and follow basic operating instructions\n\nNurses\n\n* Registered nurse employed at Yale New Haven Hospital.\n* Provides clinical care to an enrolled study participant during the participant's hospitalization.\n* Willing and able to provide informed consent.\n\nExclusion Criteria:\n\nParticipants\n\n* Patient refusal to participate\n* Pregnancy: all child bearing age patients will receive a urine screening test on the day of surgery and this result will be documented in the EMR epic. This is an elective procedure and the surgery will almost always be cancelled in the case of positive pregnancy test. In the extremely rare event the care proceeds, we will exclude the patient from the study. Emergency surgery\n* Cognitive impairment preventing informed consent or independent use of the device\n* Chronic pain requiring ongoing pain management or home opioid use\n* Substance use disorder\n* Failed preoperative brachial plexus block, defined as significant postoperative pain in the PACU requiring early escalation of analgesic management\n\nNurses\n\n* Declines or is unwilling to provide informed consent.",{"count":217,"type":22},[110],"This prospective randomized pilot study evaluates the feasibility, acceptability, and preliminary efficacy of the Patient-Controlled Dispenser and Deactivator (PCDD) Generation 1 system for patient-controlled oral liquid acetaminophen administration in postoperative total shoulder replacement inpatients compared with standard nurse-administered oral acetaminophen delivery.",[551,552],"Pain Management","Postoperative Pain",[554],"total shoulder replacement surgery","2026-08-10",{"date":374,"type":34},{"date":512,"type":22},{"date":559,"type":22},"2027-12",{"name":40,"class":41},{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":135,"sex":18,"minAge":19,"maxAge":136,"enrollmentInfo":568,"targetDuration":4,"studyType":23,"phases":569,"briefSummary":570,"conditions":571,"keywords":574,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":581,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":585,"locationsCount":98},"100560999","drinking-acetate-and-stress-100560999","NCT06584448","Drinking, Acetate, and Stress","Role of Acetate in Heavy Drinking","Inclusion 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* Medically stable male or female, aged 18-55.\n* Able to read, write and complete a multitude of self-assessments in English\n* Meets DSM-5 criteria for current Alcohol Use Disorder (AUD)\n* Participants who have Alcohol Use Disorder and are actively drinking must be willing to receive (at no cost) inpatient treatment for AUD for a period of up to 30 days. Participants who have been treated for an Alcohol Use Disorder and are now sober three months or longer will NOT be required to go inpatient.\n\nExclusion Criteria:\n\n* Subjects with any significant current medical conditions (neurological, cardiovascular, endocrine, thyroid, renal, liver), seizures (for LTS subjects only- seizures directly related to alcohol detoxification are not an exclusion) , delirium or hallucinations, or other unstable medical conditions, including HIV.\n* Current DSM-5 substance use disorder (other than AUD or tobacco use disorder)\n* Any metallic objects implanted in their body which would make imaging unsafe (pacemaker, etc)\n* Claustrophobia, or other inability to participate in an MRI\n* A positive test result at intake appointment and subsequent appointments on urine drug screens conducted for illicit drugs. (Note: participants will not be paid for study visits if they test positive for an illicit drug and will be immediately excluded from study).\n* Women who are pregnant or nursing. Women who have an IUD that would make imaging unsafe.\n* Recent taking of medications that may influence study outcomes (e.g., disulfiram, naltrexone, acamprosate, anticonvulsants).\n* Subjects likely to exhibit clinically significant alcohol withdrawal during the study.",{"count":482,"type":22},[110],"The purpose of this study is to learn how drinking alcohol affects how people experience stress and how that is affected by the body's chemistry. Specifically, the investigators will be studying relationships of drinking and a stress hormone called cortisol. The investigators believe that results will lead us to find more effective ways to help people stop or reduce drinking when participants are drinking at harmful levels.",[118,572,90,573],"Alcohol Use, Unspecified","Alcohol Use Disorder, Moderate, in Sustained Remission",[575,576,577,578,579,580],"Brain","Stress","Imaging","Detoxification","Recovery","Sobriety",{"date":467,"type":34},{"date":583,"type":34},"2024-11-06",{"date":154,"type":22},{"name":40,"class":41},{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":590,"acronym":591,"eligibilityCriteria":592,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":593,"targetDuration":4,"studyType":23,"phases":595,"briefSummary":596,"conditions":597,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":602,"leadSponsor":604,"locationsCount":42},"100626076","pragmatic-trial-of-messaging-to-providers-about-treatment-of-chronic-kidney-disease-100626076","NCT07430930","Pragmatic Trial of Messaging to Providers About Treatment of Chronic Kidney Disease","PROMPT-CKD","Inclusion Criteria:\n\n1. Male or female, aged ≥18 years\n2. Diagnosed with CKD defined by an eGFR ≤60 mL\u002Fmin\u002F1.732 on two occasions at least ≥3 months apart with most recent being ≤60 or eGFR 60-90 mL\u002Fmin\u002F1.73m2 with an uACR ≥30 mg\u002Fg or eGFR \\>90 mL\u002Fmin\u002F1.73m2 with an uACR ≥30 mg\u002Fg.\n3. Eligible to receive at least 1 of the following CKD GDMT: ACEi\u002FARB, SGLT2i, MRA or GLP-1 RA based on the following criteria.\n4. To receive an ACEi\u002FARB: eGFR ≥15 ml\u002Fmin\u002F1.732 and have diagnosis of hypertension based on ICD10 code or proteinuria (uACR ≥30 mg\u002Fg).\n5. To receive an SGLT2i: have heart failure (defined by ICD10 code); or T2D; or uACR ≥200 mg\u002Fg; or eGFR ≥20 ml\u002Fmin\u002F1.732.\n6. To receive an MRA: ns-MRA: have an eGFR ≥25 ml\u002Fmin\u002F1.732, diagnosis of T2D, normal serum potassium (≤4.8 mmol\u002FL) and albuminuria (\\>30 mg\u002Fg). s-MRA: have an eGFR ≥45 ml\u002Fmin\u002F1.732 and heart failure, hyperaldosteronism, or refractory hypertension.\n7. To receive a GLP-1 RA: have T2D.\n8. Ability to take oral medication.\n\nExclusion Criteria:\n\n1. Allergy to the GDMT for which the patient is eligible\n2. End-stage kidney disease\n3. CKD stage 5 (eGFR \\\u003C15 ml\u002Fmin\u002F1.73m2)\n4. Glomerulonephritis (by ICD-10 code)\n5. Polycystic kidney disease (by ICD-10 code)\n6. History of kidney transplant\n7. End-stage heart failure\n8. Eligible to receive ACEi\u002FARB but having blood pressure \\\u003C110\u002F70 mmHg or have known renal artery stenosis\n9. Eligible to receive SGLT2i but pregnant or breastfeeding, type 1 DM, history of euglycemic diabetic ketoacidosis or Fournier's gangrene based on ICD10 code.\n10. Eligible to receive MRA but serum potassium ≥5 mmol\u002FL, have office SBP \\\u003C100 mmHg, adrenal insufficiency based on ICD10 code or concomitant treatment with CYP3A4 inhibitors (Strong: grapefruit, grapefruit juice, itraconazole. Moderate: erythromycin. Weak: amiodarone).\n11. Eligible to receive GLP-1 RA but pregnant; or found to have personal history of pancreatitis; or personal or family history of medullary thyroid cancer or MEN type 2 based on ICD10 code or gastroparesis based on ICD10 code.\n12. Opted out of EHR-based research.",{"count":594,"type":22},1000,[110],"This study is a cluster-randomized clinical trial to evaluate whether a tailored, user-centered, clinical decision support (CDS) tool can positively influence prescriber behavior and increase prescription of guideline-directed medical therapy (GDMT) among patients with Chronic Kidney Disease (CKD) across a single healthcare center.",[598],"Chronic Kidney Diseases","2026-08-07",{"date":509,"type":34},{"date":124,"type":22},{"date":603,"type":22},"2028-09",{"name":40,"class":41},{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":18,"minAge":215,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":23,"phases":614,"briefSummary":615,"conditions":616,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":618,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":622,"locationsCount":623},"100587897","subcortical-arousal-in-perceptual-awareness-100587897","NCT06934356","Subcortical Arousal in Perceptual Awareness","Shared Subcortical Arousal Systems Across Perceptual Modalities","A. The following are the inclusion\u002Fexclusion criteria for healthy participants age 18 years and up (Aim 1 and 2):\n\nInclusion: (1) normal vision with or without the use of corrective lenses; (2) normal hearing not needing an assistive hearing device.\n\nExclusion: (1) past history of diagnosis of a psychiatric or neurologic disease; (2) current psychiatric or neurologic disease; (3) requires hard contact lenses or glasses to maintain normal vision (prevents accurate pupil and eye gaze measurements); (4) pregnant or nonremovable ferrous metal objects inside or on the body (prevents MRI).\n\nB. The following are the inclusion\u002Fexclusion criteria for epilepsy patients with thalamic electrodes age 13 years and up (Aim 3A):\n\nInclusion: (1) normal vision with or without the use of corrective lenses\n\nExclusion: (1) severe vision impairment even with correction preventing ability to see stimuli (prevents accurate pupil and eye gaze measurements); (2) unable to perform the perception task due to cognitive impairment. All participants must be capable of consenting for themselves.\n\nC. The following are the inclusion\u002Fexclusion criteria for epilepsy patients with thalamic electrodes age 18 year and up (Aim 3B):\n\nInclusion: (1) normal vision with or without the use of corrective lenses; (2) A female subject must have a negative pregnancy test and if sexually active, must be using a reliable form of birth control for the duration of the trial, be surgically sterile, or be at least two years post-menopausal.\n\nExclusion: (1) severe vision impairment even with correction preventing ability to see stimuli (prevents accurate pupil and eye gaze measurements); (2) unable to perform the perception task due to cognitive impairment. All participants must be capable of consenting for themselves; (3) Pregnancy.",{"count":613,"type":22},202,[110],"The study consists of prospective enrollment of healthy participants and patients with epilepsy, as well as analysis of an existing data set. Healthy participants will be studied with fMRI, eye metrics and behavioral testing at Yale. Patients will be studied with intracranial thalamic and cortical recording and stimulation, eye metrics and behavioral testing.",[617],"Epilepsy",{"date":555,"type":34},{"date":620,"type":34},"2025-10-13",{"date":353,"type":22},{"name":40,"class":41},8,""]