[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Johns Hopkins University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":609},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,305,0,25,[9,37,74,101,127,155,184,213,236,259,278,302,321,348,369,390,410,434,461,484,509,535,545,569,591],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":26,"startDateStruct":29,"completionDateStruct":31,"leadSponsor":33,"locationsCount":36},"100054213",false,"NCT04267588","Using Technology to Track Pain and Pain-related Outcomes","Inclusion Criteria:\n\n* ≥ 21 years of age\n* Pain duration \\> 3 months\n* Average pain level of \\>3 out of 10 (0=no pain; 10=worst pain imaginable)\n* English fluency\n* Are not scheduled to undergo any medical procedures during the course of the study\n* Have a physician-confirmed medical diagnosis associated with chronic pain\n* Are willing to comply with the study protocol and give written informed consent. Patients taking non-narcotic analgesics must be on a stable dose one month prior to participation.\n\nExclusion Criteria:\n\n* Delirium, dementia, or cognitive impairment (i.e., Mini Mental State Exam score \\\u003C24)\n* Unstable major psychiatric disorder or history of schizophrenia\n* Beck Depression Inventory score \\>30 or report of suicidal ideation\n* Active substance abuse;\n* Refusal to provide access to relevant medical record information.","ALL","21 Years",{"count":18,"type":19},100,"ESTIMATED","OBSERVATIONAL","Persistent pain is a public health epidemic. The current protocol seeks to develop technology to aid patients' tracking of patients' pain, medications and pain-related variables. The investigators seek to talk with patients in co-investigator's clinic to solicit feedback, as well as pilot test the technology with pain patients.",[23],"Pain, Chronic","RECRUITING","2026-07-10",{"date":27,"type":28},"2026-07-13","ACTUAL",{"date":30,"type":28},"2020-08-10",{"date":32,"type":19},"2027-06-30",{"name":34,"class":35},"Johns Hopkins University","OTHER",1,{"id":38,"slug":4,"hasResults":11,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":4,"eligibilityCriteria":42,"healthyVolunteers":11,"sex":15,"minAge":43,"maxAge":4,"enrollmentInfo":44,"targetDuration":4,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":61,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100053319","NCT05663034","CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms","CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms","Inclusion Criteria:\n\n1. Current or former member of the uniform services\n2. Meet the Veterans Affairs Medical Center (VAMC) Department of Defense (DoD) criteria for TBI;\n3. Time duration since traumatic brain injury (TBI) injury \\>90 days\n4. Insomnia symptom duration \\>90 days\n5. Endorse insomnia symptoms (Insomnia Severity Index \\[ISI\\] score \\> 10)\n6. Display sufficient cognitive capacity to provide informed consent (Montreal Cognitive Assessment (MoCA) Z-score \\> -2)\n7. \\>18 years of age\n8. Access to and ability and to use computer.\n\nExclusion Criteria:\n\n1. History of neurological diseases other than TBI and not attributable to TBI\n2. Sleep apnea \\[apnea hypopnea index (AHI) \\>15; individuals with mild apnea (AHI \\> 5 and \\\u003C15) will be informed, but allowed to participate\\]. Participants who use a continuous positive airway pressure (CPAP) device for sleep apnea will be eligible for participation if they are below the apnea\u002Fhypopnea cutoff while using CPAP, are adherent to using the device (\\> 4 hours\u002Fnight 21\u002F30 consecutive days) and agree to continue using the device during study participation.\n3. Lastly, people using psychotropic medications may be included if they are on a stable dosage for the last three weeks prior to the study.","18 Years",{"count":45,"type":19},360,"INTERVENTIONAL",[48],"NA","This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).",[51,52,53,54,55,56,57,58,59,60],"Traumatic Brain Injury","Insomnia","Depression","Post-traumatic Stress","Sleep","Memory Impairment","Cognitive Behavioral Therapy","Concussion, Brain","Head Injury","Brain Injury Traumatic Mild",[51,52,62,53,63,59,64,65,66],"Posttraumatic Stress Symptoms","Concussion","Brain Injury","Cognitive Behavioral Therapy for Insomnia","Mindfulness-based Treatment for Insomnia",{"date":27,"type":28},{"date":69,"type":28},"2024-05-10",{"date":71,"type":19},"2027-06",{"name":34,"class":35},5,{"id":75,"slug":4,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":15,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":46,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100053455","NCT07631377","The LalelaLung Study: Digital Stethoscope Clinical Evaluation","LaLeLa","Inclusion Criteria:\n\n* Age 2 to 59 months at the time of screening\n* Presence of cough and\u002For difficulty breathing\n* No WHO-defined emergency\u002Fdanger signs (e.g., grunting, cyanosis, apnea, convulsions, or altered level of consciousness)\n* A legal caregiver is present, able to understand the study information, and willing to provide written informed consent\n* Caregiver is willing and able to provide contact information (e.g., mobile phone number) to allow 7-day follow-up after the clinic visit\n\nExclusion Criteria:\n\n* Presence of WHO-defined emergency signs requiring immediate referral or hospital admission (grunting, cyanosis, apnea, uncompensated shock, convulsions, diarrhea with severe dehydration, or altered level of consciousness)\n* Critical illness or clinical instability judged by the screening clinician or study physician to require urgent medical attention\n* Age outside the target range (younger than 2 months or older than 59 months)\n* Previous enrollment in the study\n* Refusal or withdrawal of informed consent by the legal caregiver at any time prior to randomization","2 Months","59 Months",{"count":83,"type":19},350,[85],"PHASE4","Pneumonia is the leading infectious cause of death in children under five years of age worldwide, and most of these deaths occur in low- and middle-income countries. In these settings, frontline health workers diagnose pneumonia using the World Health Organization's Integrated Management of Childhood Illness (IMCI) guidelines, which rely mainly on counting how fast a child is breathing and checking for chest indrawing. This approach has saved many lives, but it is not very specific. As a result, many children who actually have self-limiting viral illnesses that do not require antibiotics are nonetheless treated with antibiotics, contributing to the global rise of antimicrobial resistance.\n\nNew digital stethoscopes paired with artificial intelligence (AI) can record a child's lung sounds and automatically detect abnormal sounds such as crackles and wheezes with accuracy comparable to physicians. The LaLeLa Lung Study will evaluate whether adding an AI-enabled digital stethoscope to standard IMCI assessment improves the accuracy of pneumonia diagnosis among children aged 2 to 59 months who present with cough and\u002For difficult breathing at a primary care clinic in Cape Town, South Africa.\n\nThe main component (Objective 1) is a randomized, triple-blinded diagnostic accuracy study that will enroll 350 children, randomly assigned in a 1:1 ratio to either IMCI care enhanced by the AI-enabled digital stethoscope or standard IMCI care. An independent panel of physicians, blinded to the AI results and to study-arm assignment, will review each case and serve as the reference standard for determining whether pneumonia was truly present. The investigators hypothesize that IMCI enhanced by the AI stethoscope will diagnose pneumonia more accurately, and target antibiotics more appropriately, than standard IMCI alone. Nested sub-studies will additionally evaluate a second AI stethoscope for tuberculosis detection, a wearable lung-sound and respiratory-rate patch, an automated respiratory-rate monitor, and a smartphone-connected pulse oximeter.\n\nA separate component (Objective 2) is a mixed-methods implementation study at a second clinic that will assess how easily health workers can use these devices, how acceptable the devices are to health workers and caregivers, and how well the devices fit into routine clinic workflows.\n\nThroughout the study, all AI-generated results will remain concealed from clinic staff, study clinicians, and caregivers, so the AI-generated results will not influence the care any child receives. All children continue to receive standard IMCI care. Findings will help inform whether AI-enabled digital auscultation should be integrated into childhood pneumonia care in South Africa and similar low-resource settings, with the goal of improving diagnosis, strengthening antibiotic stewardship, and reducing antimicrobial resistance and child mortality.",[88,89,90,91,92,93],"Pneumonia","Tuberculosis, Pulmonary","Respiratory Tract Infections","Bronchiolitis","Respiratory Sounds","Antibiotic Resistant Strain","NOT_YET_RECRUITING",{"date":27,"type":28},{"date":97,"type":19},"2026-08-17",{"date":99,"type":19},"2028-06-30",{"name":34,"class":35},{"id":102,"slug":4,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":15,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":46,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":36},"100054254","NCT07425535","Optic Nerve Head Strain in Non-glaucoma Subjects","Inclusion Criteria:\n\n* Adults who have no history of OAG\n* Have an ocular examination by a glaucoma specialist with no indications of OAG\n* Have normal optical coherence tomography findings in the retinal nerve fiber layer.\n* Over age 30 will be included from\n* Both sexes\n* All ethnic groups.\n* Optic neuropathy.\n* Both suspects and those with glaucoma damage will be included.\n* When both eyes meet inclusion and exclusion criteria, both eyes will be included in the study and statistical methods will be used to account for correlations between eyes within the same individual.\n\nExclusion Criteria:\n\n* in whom sitting in an upright position is impossible due to physical disability\n* with ocular media opacity, corneal scarring, cataract or vitreous hemorrhage, that does not allow adequate imaging resolution.\n* in whom keeping the eyes open during the imaging procedure is not possible or uncomfortable.\n* who cannot perform home tonometry accurately at certification\n* who do not have reliable clinical Optical Coherence Tomography (OCT) testing.\n* with any form of glaucoma\n* with high myopia defined as refractive error \\> -8\n* with past keratorefractive surgery, corneal dystrophy, or corneal ectasia that would make self-tonometry measurements difficult to interpret\n* inability to understand English or with a language or hearing impairment",true,"30 Years","90 Years",{"count":110,"type":19},30,[112],"EARLY_PHASE1","Persons who do not have glaucoma will have pictures taken of the optic nerve with a standard camera before and 2 weeks after starting to take a daily glaucoma eye drop to lower eye pressure. These data will be used to compare to the same procedure performed with glaucoma patients to study how glaucoma injures the eye.",[115],"Glaucoma",[117,118,119,120],"optic nerve","biomechanical strain","normal eye","glaucoma",{"date":27,"type":28},{"date":123,"type":28},"2026-06-24",{"date":125,"type":19},"2028-03-31",{"name":34,"class":35},{"id":128,"slug":4,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":15,"minAge":134,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":46,"phases":137,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},"100053778","NCT07540000","The INTERvening for LUNG Health Trial","The INTERvening for LUNG Health (INTERLUNG) Trial: A Pragmatic Hybrid Implementation-Effectiveness Trial of Community-Based Interventions to Improve Respiratory Health in Bhaktapur, Nepal","INTERLUNG","Inclusion Criteria\n\n* Age ≥9 years at enrollment.\n* Resident of the Bhaktapur district and member of a household willing to participate in study procedures.\n* Pre-bronchodilator FEV1\u002FFVC at or below the 10th percentile (Z-score ≤ -1.28) based on Global Lung Function Initiative reference equations.\n* Presence of at least one respiratory risk factor, including:\n* usual cough or phlegm, wheezing in the past 12 months, self-reported prior pulmonary tuberculosis, physician-diagnosed asthma, ever smoking, or occupational exposure to dust or smoke.\n* Willing and able to provide written informed consent (or assent with parental\u002Fguardian permission for participants \\\u003C18 years).\n* Willing to participate in study assessments and follow-up visits during the 40-month study period.\n\nExclusion Criteria\n\n* Medical condition that precludes safe performance of spirometry.\n* Acute respiratory illness at the time of enrollment that would prevent reliable baseline spirometry testing.\n* Plans to move out of the study area during the follow-up period. Inability or unwillingness to comply with study procedures or follow-up visits.\n* Any other condition that, in the opinion of the investigators, would interfere with participation or interpretation of study results.\n\nHousehold members:\n\n* Household members of enrolled index participants may participate in certain assessments and receive selected intervention components if the index participant is randomized to the intervention arm and provides informed consent or assent.","9 Years",{"count":136,"type":19},800,[85],"This research study is being done to find out whether a community health volunteer-delivered, multi-component program can improve lung health for people at risk of chronic respiratory diseases (such as asthma or COPD) in Bhaktapur, Nepal. The program focuses on reducing tobacco smoke exposure, reducing indoor and outdoor air pollution exposure, preventing respiratory infections (including vaccination and mask use during viral seasons), and encouraging safe physical activity. The \"index participant\" is the main enrolled participant in the household who is randomized to the intervention or control arm.\n\nThe participant will be in the study for about 40 months and will have 11 research visits: one at baseline and then every 4 months through month 40. At visits, staff will do breathing tests (spirometry before and after an inhaled medicine), measure exhaled carbon monoxide, check blood pressure, measure height\u002Fweight at selected visits, and ask questions about symptoms, smoking, infections, vaccines, and quality of life. The participant will also wear an activity monitor (accelerometer) for 2 weeks at baseline and at follow-up visits. If individual is a household member (not the index participant), the participant may be asked to complete baseline and follow-up assessments every 4 months through month 40, will receive the influenza vaccine and will primarily be asked to use masks and handwashing during household respiratory illness episodes (only if the index participant is randomized to the intervention) and will not be asked to wear an activity monitor. If the participant is in the pilot phase, participation will last about 2 months. the participant will complete baseline procedures and pilot follow-up visits during those 2 months instead of the full 40-month schedule.",[140],"Spirometry",[142,143,144,145,146,147],"Tobacco Prevention","Air Pollution","Physical Activity","Behavioral Intervention","Human-Centered Design","Infectious Risk",{"date":27,"type":28},{"date":150,"type":19},"2026-08-10",{"date":152,"type":19},"2030-07-01",{"name":34,"class":35},2,{"id":156,"slug":4,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":15,"minAge":107,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":46,"phases":165,"briefSummary":166,"conditions":167,"keywords":175,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":182,"leadSponsor":183,"locationsCount":4},"100053567","NCT07662616","Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health","Feasibility and Efficacy Pilot of a Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health, Medication Adherence, and Cardiovascular Health","SDM in CKM","Inclusion Criteria:\n\n* Are adults aged 30 to 79 years (to use PREVENT equations to calculate 10- and 30-year risk estimates for total CVD),\n* Are in stage 2 CKM: the presence of metabolic risk factors (hypertension \\[stages 1 and 2\\], hypertriglyceridemia \\[≥135 mg\u002FdL\\], diabetes, Metabolic Equivalents (MetS)\\*) and\u002For Chronic Kidney Disease (CKD) \\[moderate- to high-risk CKD which are stages 1-3 CKD\\]), and\n* Receive primary care at Johns Hopkins Community Physicians (JHCP).\n* Access to smart phone or tablet to use app.\n\nExclusion Criteria:\n\n* Have diagnosis of CVD,\n* Stage 4-5 CKD, kidney failure, or on dialysis\n* Have a serious medical condition such as cancer;\n* On or planning to start Glucagon-like peptide-1 (GLP-1) receptor agonists in next 6 months;\n* Have cognitive impairment;\n* Are currently involved in other programs on improving LE8; or\n* Unwillingness to provide informed consent\n* Unable to speak, read, or communicate in English.","79 Years",{"count":164,"type":19},94,[112],"The investigators are proposing a new team-based shared decision-making (SDM) program. The goal of this study is to see whether this program is practical and whether it may help adults with cardiometabolic risk factors and cardiovascular-kidney-metabolic syndrome. The investigators will enroll adults from a primary care clinic in Maryland. People in the intervention group will take part in the 6-month program in addition to usual care. People in the control group will receive usual care only.",[168,169,170,171,172,173,174],"Hypertension (HTN)","Diabetes (DM)","Hyperlipidaemia","Kidney Disease","Obesity","Cardiovascular-kidney-metabolic (CKM)","Overweight",[176,177,178,179],"shared decision-making","Cardiovascular-kidney-metabolic","Behavioral counseling","Team-based care",{"date":27,"type":28},{"date":150,"type":19},{"date":99,"type":19},{"name":34,"class":35},{"id":185,"slug":4,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":106,"sex":15,"minAge":191,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":46,"phases":194,"briefSummary":196,"conditions":197,"keywords":200,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":36},"100053654","NCT04601038","Trial of CORT108297 to Attenuate the Effects of Acute Stress in the Allocortex (CORT-X)","Phase II Trial of CORT108297 to Attenuate the Effects of Acute Stress in the Allocortex (CORT-X)","CORT-X","Individuals must meet criteria for mild cognitive impairment due to Alzheimer's disease according to National Institute on Aging (NIA)\u002FAlzheimer's Association recommendations OR be cognitively normal based on clinical and cognitive assessment in the Enrollment Visit and have at least one of the following risk factors for AD:\n\n* Known to have at least 1 apolipoprotein E (APOE) ε4 allele;\n* Subjective cognitive concerns with a T score \\\u003C 40 on the Multifactorial Memory Questionnaire Satisfaction Scale;\n* A first-degree relative with dementia.\n\nInclusion Criteria for all subjects:\n\n* At least 55 years of age;\n* Body mass index \\>17 and \\\u003C30;\n* Post-menopausal (if female)\n* Non-smoker;\n* Availability of a study partner who has frequent contact with the subject (10+ hours\u002Fweek in person and by telephone), and is able to provide an independent evaluation of functioning;\n* Fluent English speaker;\n* Good general health with no disease expected to interfere with the study;\n* Willing and able to participate for the duration of the study.\n\nExclusion Criteria for all subjects:\n\n* Participation in a therapeutic clinical trial at any time during the study;\n* Abnormal corrected QT interval using Bazett's formula (QTcB; defined as \\> 450 ms for men and \\> 470 ms for women) as determined on ECG;\n* Any significant neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities, including lacunes in critical memory structures including the hippocampus and parahippocampal cortex;\n* Bipolar disorder within the past 1 year;\n* History of alcohol or drug dependence;\n* Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol;\n* General surgery within the last 3 months;\n* Sensory impairment (poor vision or hearing) significant enough to interfere with ability to provide valid cognitive test data;\n* Treatment within the last six months with neuroleptics, sedative hypnotics, or glucocorticoids;\n* Treatment within the last six months with medications metabolized by the CYP2C9 or CYP2C19 enzymes, most notably clopidogrel and proton pump inhibitors;\n* Concurrent use of a CYP3A inhibitor, including grapefruit juice, and St. John's Wort;\n* Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the PI.","55 Years",{"count":193,"type":19},52,[195],"PHASE2","CORT-X will examine if mitigation of stress-mediated pathogenesis of Alzheimer's disease (AD) is a feasible target for intervention in individuals at risk for this disease. This single-site (Baltimore, Maryland) phase II clinical trial is a 2-week, randomized, placebo-controlled crossover study of the effects of the selective glucocorticoid receptor antagonist, CORT108297, on cognitive test performance in 26 individuals with mild cognitive impairment (MCI) due to AD and in 26 cognitively normal individuals with an increased risk for AD due to family history, genetics, and\u002For subjective memory complaints. All subjects will participate in a brief stressor (public speaking and mental arithmetic) and provide saliva samples so investigators can measure stress hormone response. Then, following 2 weeks of treatment with placebo or CORT108297, in counterbalanced order, participants will complete cognitive tests assessing memory and executive function. All study participants will receive CORT108297 and placebo over the course of this 10-week trial that requires 6 in-person study visits. The primary aims will compare the effects of CORT108297 to placebo on cognitive test performance in individuals with MCI due to AD and in individuals at risk for AD, and describe the side effects of CORT108297 in study participants. Secondary aims will identify subject characteristics that predict positive response to study drug.",[198,199,56],"Mild Cognitive Impairment","Alzheimer Disease",[201,202,203,204,205,206],"Stress","Memory loss","Dementia","Alzheimer's disease","Cognitive","Impairment",{"date":27,"type":28},{"date":209,"type":28},"2021-06-28",{"date":211,"type":19},"2028-01-01",{"name":34,"class":35},{"id":214,"slug":4,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":46,"phases":222,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":230,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":36},"100054081","NCT07249554","Combination Therapy for Alcohol Use Disorder","Preliminary Safety and Efficacy of Semaglutide and Naltrexone Combination Therapy for Alcohol Use Disorder","Inclusion Criteria:\n\n* Aged 21-65 years old\n* Enrolled at Ashley Addiction Treatment center at least one week prior to beginning study participation.\n* Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for Alcohol Use Disorder\n* Willing to comply with the study protocol\n\nExclusion Criteria:\n\n* Score 9 or greater on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) at randomization\n* Currently pregnant, breastfeeding\n* Unwilling to use contraceptives (e.g., condoms and\u002For hormonal birth control)\n* Meet criteria for another substance use disorder other than AUD, Tobacco Use Disorder, or Caffeine use disorder\n* History of pancreatitis\n* History or current diagnosis of gallbladder disease, hepatic disease, renal disease, hyperparathyroidism, or any physical health condition that would be contraindicated with GLP-1 agonists or naltrexone.\n* Unmanaged diabetes diagnosis or history or current diagnosis of diabetic retinopathy\n* Levels of amylase, lipase, aspartate aminotransferase (AST), and\u002For alanine transferase (ALT) greater than 2x upper limit of normal\n* Personal or family history of medullary thyroid carcinoma given FDA box warning for semaglutide\n* Diagnosis of cancer within past 5 years\n* History of multiple endocrine neoplasia syndrome type 2 (MEN2)\n* Currently taking any medications contraindicated with GLP-1 agonists and\u002For naltrexone.\n* BMI \\\u003C18.5\n* Current elevated suicide risk as assessed by clinic staff or the Columbia Suicide Severity Rating Scale (C-SSRS)\n* Any other medical or psychological condition that is judged by the investigators to impede ability to safely complete study requirements.\n* Legal problems or living situation judged by the investigators as a factor that could interfere with study completion (e.g., impending jail time).\n* Allergies to semaglutide and\u002For naltrexone\n* Use of opioids within the past 10 days as indicated by self-report or a positive urine drug screen\n* Prescribed or taking the following medications in the past four weeks:\n* The following medications will be prohibited during study participation due to interactions with semaglutide: other GLP-1 agonists (e.g. Exenatide, liraglutide, dulaglutide), insulin, insulin-secreting medications (e.g. sulfonylureas, meglitinides), tirzepetide, dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. sitagliptin, saxagliptin, linagliptin, alogliptin, evogliptin, and gemigliptin).\n* The following medications will be prohibited during study participation due to interactions with naltrexone: bremelanotide, peripherally-acting mu-opioid receptor antagonists (e.g. methylnaltrexone, naldemedine), and opioid agonist medications.","65 Years",{"count":221,"type":19},45,[195],"This human laboratory study will collect preliminary safety and efficacy data from a sample of participants enrolled in a 4-week in-patient treatment program for alcohol use disorder.",[225],"Alcohol Use Disorder",[227,228,225,229],"Glucagon-like peptide 1","Naltrexone","Addiction",{"date":27,"type":28},{"date":232,"type":19},"2026-09",{"date":234,"type":19},"2028-09",{"name":34,"class":35},{"id":237,"slug":4,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":106,"sex":15,"minAge":243,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":46,"phases":246,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":36},"100053936","NCT07672717","Cabotegravir-Hormone PK\u002FPD Interactions for HIV Prevention","CHIPP-PrEP: Cabotegravir-Hormone Interrogation of Pharmacokinetics\u002FPharmacodynamics (PK\u002FPD) for HIV Prevention","CHIPP-PrEP","Inclusion Criteria:\n\n* 19 years of age or older\n* For persons using exogenous hormones, must be on a stable regimen for ≥6 months and remain on that regimen throughout study conduct, and exogenous hormone regimens must be prescribed and managed under the care of a healthcare professional\n* For females, must be on a non-hormonal contraceptive agent, and must persist in contraceptive use for the duration of the study\n* Body weight greater than 35 kg (77.2 lbs)\n* HIV-1 uninfected at screening and enrollment as documented by an instrumented Ag\u002FAb assay and HIV-1 RNA testing\n* Understand and agree to local STI reporting requirements\n* Willing to abstain from additional antiretroviral agents (including PrEP agents, F\u002FTAF and F\u002FTDF) during the duration of the study\n* Willing to abstain from insertion of anything (drug, enema, penis, or sex toy) in the rectum or vagina for 72 hours before and 72 hours after each flexible sigmoidoscopy\n* Willing to refrain from aspirin and NSAID use for one week before and after each study biopsy visit\n* Willing and able to use condoms for all receptive anal intercourse and receptive vaginal intercourse for the duration of study participation\n* Able and willing to communicate in English\n* Able and willing to provide written informed consent to take part in the study\n* Able and willing to provide adequate information for locator purposes\n* Availability to return for all study visits, barring unforeseen circumstances\n* Agree not to participate in other research studies involving drugs and\u002For medical devices for the duration of the study\n\nExclusion Criteria:\n\n* History of previous long-acting antiretroviral use, including CAB-LA and long-acting lenacapavir\n* History of oral PrEP (F\u002FTDF, F\u002FTAF) use within the prior eight weeks\n* For females, if a participant is pregnant or plans to become pregnant during study duration\n* For females, if the participant is actively breastfeeding\n* For females, if the participant is post-menopausal or accessing exogenous hormone replacement therapy\n* For females, has irregular menstrual cycles\n* Has a tattoo or other dermatological condition which may interfere with product administration or interpretation of injection site reactions\n* Surgically-placed or injected buttock implants or filler, per self-report\n* One or more reactive or positive HIV test results at screening or enrollment, even if HIV infection is not confirmed\n* Current known HIV-infected partner(s)\n* Symptoms suggestive of acute HIV seroconversion at screening and enrollment\n* Known or suspected allergy to CAB-LA\n* Any ≥ Grade 2 laboratory abnormality at baseline as defined by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 - July 2017, and Addendum 3 (Rectal Grading Tables for Use in Microbicide Studies)\n* Significant rectal symptom(s) as determined by medical history or by participant self-report (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, history of inflammatory bowel disease, presence of symptomatic hemorrhoids, and presence of any painful anorectal conditions that would be tender to manipulation)\n* At screening or within the past 2 months: participant-reported symptoms and\u002For clinical or laboratory diagnosis of active rectal or genital infection requiring treatment per current CDC guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions, chancroid, genital sores or ulcers, and, if clinically indicated, genital warts. HSV seropositivity with no active genital lesions is not an exclusion criterion. (Note: if an STI apart from HIV is detected, the participant will be referred for treatment and can be retested in 30 days and re-screened once.)\n* History of significant gastrointestinal bleeding\n* Clinically significant cardiovascular disease, as defined by history of symptomatic arrhythmia, ischemia, or other significant cardiac disease\n* Current use of warfarin or heparin or other anticoagulant medications associated with increased risk for bleeding following mucosal biopsy (e.g., daily high dose aspirin \\[\\>81 mg\\], NSAIDs, or Pradaxa®)\n* Use of systemic or anorectal immunomodulatory medications within 4 weeks of enrollment or planned use at any time during study participation\n* Per participant report, use of any rectally or vaginally administered products containing N-9 (including condoms) or investigational products within 4 weeks of enrollment, or planned use of either at any time during study participation\n* Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements.\n* Individuals with neocervix will be excluded from giving cervical biopsies, if eligible for study participation.","19 Years",{"count":245,"type":19},32,[247],"PHASE1","This is a research study to better understand how long-acting cabotegravir (CAB-LA) works to prevent HIV in people. This study will also evaluate the impact of endogenous and therapeutic hormones on CAB-LA pharmacology. The investigators will also evaluate if participants experience any medical problems when taking CAB-LA.",[250,251,252],"HIV","Prophylaxis","Injectable",{"date":27,"type":28},{"date":255,"type":28},"2026-07-07",{"date":257,"type":19},"2031-12",{"name":34,"class":35},{"id":260,"slug":4,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":15,"minAge":43,"maxAge":264,"enrollmentInfo":265,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":266,"conditions":267,"keywords":269,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":36},"100054035","NCT06161077","Voice Quality Analysis of Patients With Laryngotracheal Stenosis","Inclusion Criteria:\n\n* Current diagnosis of laryngotracheal stenosis\n* Patient age 18 - 80 years old\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1\n* The patient must be able to comprehend and have signed the informed consent.\n* The patient must have documentation of their date of laryngotracheal stenosis diagnosis and prior medical\u002Fsurgical history.\n\nExclusion Criteria:\n\n* Inability to use the app associated with the study.\n* Comorbid laryngeal or glottic disease\n* Concurrent neurological disease which may impact voice use (such as tremor, parkinsonism, laryngeal dystonia)","80 Years",{"count":18,"type":19},"The investigators previously demonstrated that voice changes are common in patients with Laryngotracheal Stenosis (LTS), and patients typically report an improvement in voice outcomes following endoscopic dilation. Recently, NIH based programs such as a Bridge to Artificial Intelligence (Bridge2AI) have highlighted the use of artificial intelligence to identify acoustic biomarkers of disease. Therefore, the investigators hypothesize that progression of LTS scar can be quantified using acoustic measurements and machine learning. The goal of this clinical trial is to remotely monitor patient voice quality in an effort to determine if regularly performed voice recordings can be used as a diagnostic tool in order to predict the need for dilation procedures. The investigators feel that successful use of remote voice recording technology with algorithmic analysis will improve patient quality of life.",[268],"Idiopathic Subglottic Tracheal Stenosis",[270,271],"Tracheal Stenosis","Voice Quality",{"date":27,"type":28},{"date":274,"type":19},"2027-01-01",{"date":276,"type":19},"2030-12-01",{"name":34,"class":35},{"id":279,"slug":4,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":15,"minAge":43,"maxAge":285,"enrollmentInfo":286,"targetDuration":4,"studyType":46,"phases":288,"briefSummary":289,"conditions":290,"keywords":293,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":36},"100053983","NCT07553325","Risk-informed Shared-decision Making Engagement Strategy for Patients With Prediabetes","Pilot Trial of a Risk-informed Shared-decision Engagement Strategy","RISE","Inclusion Criteria:\n\n* prediabetes based on most recent HbA1c (5.7-6.4%) or fasting plasma glucose (100-125 mg\u002FdL) in prior 12 months\n* active patient portal account (MyChart)\n* patient receiving primary care at Johns Hopkins Community Physicians in Frederick\n* have overweight or obesity (BMI ≥ 25 kg\u002Fm2)\n\nExclusion Criteria:\n\n* have diabetes (HbA1c \\> 6.4% in prior 6 months or on diabetes registry)\n* have dementia\n* previously participated in the Diabetes Prevention Program (DPP)","75 Years",{"count":287,"type":19},120,[48],"The goal of this clinical trial is to learn if knowing risk for diabetes can help adult patients with prediabetes take steps to get care and prevent diabetes. The main questions it aims to answer are:\n\n* Does a shared-decision making visit with a health care team member to talk about the participant's diabetes risk increase participants' taking steps to prevent diabetes?\n* Does a simple message in the patient portal about the participant's diabetes risk increase participants' taking steps to prevent diabetes?\n\nResearchers will compare the visit with usual care at the clinic to see if the visit increases participants' taking steps to prevent diabetes. Separately, the researchers will compare the patient message with usual care at the clinic to see if the message increases participants' taking steps to prevent diabetes.\n\nParticipants will:\n\n* Complete surveys at the beginning of the study and up to 2 additional surveys\n* If the participant falls into the shared decision-making group, the participant will have one 30-minute visit with a healthcare team member to talk about risk of diabetes and how to lower it.",[291,292],"Prediabetes","Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)",[176,294,295],"diabetes risk","diabetes prevention",{"date":27,"type":28},{"date":298,"type":19},"2026-08-01",{"date":300,"type":19},"2028-04-01",{"name":34,"class":35},{"id":303,"slug":4,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":15,"minAge":43,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":154},"100053873","NCT05004714","Y of Central Maryland Head Start Asthma Implementation","Implementation of a Multilevel Program to Reduce Asthma Symptoms in Urban Preschoolers","Aim 1\n\nInclusion Criteria:\n\n* Aged 18 or older\n* Head Start Staff member or caregiver of child currently enrolled in Head Start with asthma\n* Cognitive ability to provide consent\n* Willing to be audio recorded",{"count":309,"type":19},500,"Despite a strong evidence-base for the efficacy of multilevel programs in reducing asthma symptoms among low-income preschool minority children, gaps remain in our understanding of how to best translate and scale up these efficacious interventions into sustainable programs that reduce known asthma health disparities. Head Start (HS) serves over one million low income children in the US each year by focusing on early learning, physical health, and family engagement. HS is committed to implementing evidence based programs to promote overall child well-being, and is focused on addressing asthma symptoms due to the deleterious impact on school absences and child development. We have demonstrated the effectiveness of a multi-level staff and family education program (ABC Asthma) that significantly reduced asthma symptoms and courses of oral corticosteroids. However, these interventions are not successfully integrated within community organizations for long-term sustainability. It is unknown how to best scale up and implement these evidence based asthma interventions into low resource community organizations that serve children at risk. Implementation strategies are frequently developed atheoretically and may not be tailored to the setting. The overall purpose of this project is to inform best practices of implementation of an asthma education program by 1) systematically evaluating the use of intervention mapping to develop a tailored implementation strategy in partnership with Head Start stakeholders, 2) examining both staff and organizational level determinants associated with implementation of ABC Asthma, and 3) evaluating the success of tailored implementation strategies on implementation outcomes and school absences and other health outcomes. The YMCA of Central Maryland have enthusiastically agreed to implement the Maryland ABC HS Asthma within 40 sites in four communities: Baltimore City, Baltimore County, Anne Arundel County, and Prince George's County.",[312,313,314],"Asthma in Children","Implementation","Preschool Children",{"date":27,"type":28},{"date":317,"type":28},"2020-08-01",{"date":319,"type":19},"2027-07-31",{"name":34,"class":35},{"id":322,"slug":4,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":15,"minAge":43,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":46,"phases":329,"briefSummary":330,"conditions":331,"keywords":334,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":4},"100054311","NCT07692503","How Institutional Guidelines for Urgent Inpatient Surgeries Affect Intensity of Perioperative Cardiovascular Testing","PERLHS: How Institutional Guidelines for Urgent Inpatient Surgeries Affect Intensity of Perioperative Cardiovascular Testing: A PrePost Study","Inclusion Criteria:\n\n* Adults age 18 years or older\n* Admitted through the Emergency Department at Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center Undergoing urgent inpatient surgery during the index hospitalization\n\nExclusion Criteria:\n\n* Elective surgeries,\n* Outpatient procedures,\n* Procedures followed only by observation or extended-stay recovery rather than inpatient admission,\n* Patients younger than 18 years old",{"count":328,"type":19},3000,[48],"This study will evaluate the impact of implementing an educational clinical decision support (CDS) tool designed to guide perioperative cardiovascular evaluation for adults undergoing urgent inpatient surgery. The CDS tool, integrated within the Epic electronic health record via AgileMD, provides evidence-informed recommendations regarding perioperative cardiac testing and specialty consultation based on American Heart Association guidance and multidisciplinary institutional consensus. The investigators will conduct a retrospective and prospective pre-post observational cohort study comparing perioperative cardiovascular testing intensity, consultation patterns, time to operating room, and clinical outcomes before and after implementation of the tool among adult patients admitted through the emergency department at Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center who undergo urgent surgery. Data will be obtained from the Core for Clinical Research Data Acquisition (CCDA) and Epic electronic health record, with case-level chart review performed as needed to validate rare outcomes such as major adverse cardiac events.",[332,333],"Major Adverse Cardiovascular Events","Cardiovascular Testing and Consultation Intensity",[335,336,337,338,339,340],"Perioperative Care","Preoperative Care","Clinical Decision Support Systems","Hospital Medicine","High Value Care","Testing intensity","2026-07-09",{"date":27,"type":28},{"date":344,"type":19},"2026-12",{"date":346,"type":19},"2028-06",{"name":34,"class":35},{"id":349,"slug":4,"hasResults":11,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":106,"sex":15,"minAge":354,"maxAge":355,"enrollmentInfo":356,"targetDuration":4,"studyType":46,"phases":358,"briefSummary":359,"conditions":360,"keywords":361,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":36},"100053364","NCT04765137","Evaluate the Effect of Atorvastatin on Cerebrovascular Reactivity in Mild Cognitive Impairment (MCI)","Targeting Cerebrovascular Reactivity for Precision Medicine: Pilot Trial of Atorvastatin","Inclusion Criteria are chosen to include participants with MCI, enriched for vascular risk factors:\n\n* MCI defined by Clinical Dementia Rating (CDR) of 0.5 or 1.0.\n* Memory, processing speed, executive function, language - cognitive scores \\> 1.5 standard deviations below age-education norms.\n* Not demented by history.\n* Not taking statins currently or in the last 6 months.\n* Cognitive\u002Ffunctional impairment not likely due to another neurological disease or delirium.\n\nExclusion Criteria:\n\n* Taking a statin currently or have taken a statin in the last 6 months.\n* Contraindications to taking a statin.\n* Transplant patient taking cyclosporine.\n* Unable to undergo MRI procedures (such as having an implanted pacemaker or defibrillator or stimulator or having non MRI compatible metal).\n* Diagnosis of dementia by history.\n* Current diagnosis of substance abuse.\n* History of stroke or myocardial infarction in past 6 months.\n* History of HIV.","60 Years","95 Years",{"count":357,"type":19},20,[195],"The purpose of this study is to evaluate the effect of atorvastatin on brain vessel reactivity and with it on blood flow in people with mild cognitive impairment.",[198],[362],"Cerebral Vascular Reactivity",{"date":27,"type":28},{"date":365,"type":28},"2021-05-21",{"date":367,"type":19},"2027-12-31",{"name":34,"class":35},{"id":370,"slug":4,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":106,"sex":15,"minAge":354,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":46,"phases":377,"briefSummary":378,"conditions":379,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":384,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":4},"100053950","NCT07699146","HEARS Maryland: Extending Capacity for Affordable, Accessible Hearing Care Through Older Adult Peer Mentorship","HEARS MD","Inclusion Criteria:\n\n* Age 60 years or older\n* English-speaking\n* Aural-oral verbal communication as primary communication modality\n* Post-lingual hearing loss (Audiometric pure tone averages \\[0.5-2kHz\\] in better ear \\>25 dB)\n\nExclusion Criteria:\n\n* Current self-reported use of hearing aid or amplification device\n* Medical contraindication to use hearing aids (e.g. draining ears)",{"count":376,"type":19},300,[48],"This study aims to assess the effectiveness of a Community Health Worker (CHW) delivered hearing loss intervention program (HEARS) for older adults in Maryland in collaboration with community organizations.",[380,381,382,383],"Hearing Loss","Hearing Impairment","Age Related Hearing Loss","Age-related Hearing Impairment",{"date":27,"type":28},{"date":386,"type":19},"2026-11",{"date":388,"type":19},"2029-12",{"name":34,"class":35},{"id":391,"slug":4,"hasResults":11,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":11,"sex":15,"minAge":43,"maxAge":354,"enrollmentInfo":397,"targetDuration":4,"studyType":46,"phases":398,"briefSummary":399,"conditions":400,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":154},"100631186","NCT07497399","Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis","Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis (TAG-MS): A Phase 2, Randomized, Double-Blind, Parallel-Arm Study","TAG-MS","Inclusion Criteria:\n\n* Diagnosis of MS (2024 criteria); clinically stable on MS therapy for ≥12 months without relapse or new lesions on brain MRI\n* Aged 18-60 years\n* Body mass index ≥27.0 kg\u002Fm2\n\nExclusion Criteria:\n\n* No GLP-1RA or GIP\u002FGLP-1 RA in past year; no known hypersensitivity to medication class\n* No known Barrett's esophagus\u002Fgastroesophageal reflux disease, pancreatitis (including past), or gastroparesis\n* No personal\u002Ffamily history of medullary thyroid carcinoma or history of multiple endocrine neoplasia syndrome type 2\n* No chronic kidney disease (estimated glomerular filtration rate ≤50 mL\u002Fmin) in past year, type 1 diabetes, known diabetic retinopathy, use of insulin or insulin-inducing medications\\*, dipeptidyl peptidase IV inhibitors\\*\\*, or warfarin; current\u002Factive alcohol or illicit substance abuse\n* No concerns about candidacy of individual on part of person's neurologist or study team clinicians\n* Current or planned (next 2 years) pregnancy\u002Fbreastfeeding; if able to become pregnant, agree to reliable contraception (contraception requirements as discussed below)\\*\\*\\*\n\n  * currently-approved: Lispro, Aspart, Glulisine, Afrezza, Regular, Concentrated Regular, or Novolin, Velosulin, NPH, glargine, detemir, degludec, and premixed; approved secretagogues: sulphonylureas (e.g. glipizide (± metformin), glyburide (± metformin), glimepiride, pioglitazone\u002Fglimepiride) \\& meglitinide analogues (nateglinide and repaglinide); \\*\\* currently-approved:sitagliptin, saxagliptin, linagliptin, alogliptin \\*\\*\\*Contraception: Participants of childbearing potential (participant has a uterus and is pre-menopausal) must agree to use contraception, using either one method with a failure rate of \\\u003C1%\u002Fyear, or two methods of lesser effectiveness:\n\nContraceptive methods with a failure rate of \\\u003C 1% per year includes the following:\n\n* Combined (estrogen and progesterone containing) hormonal contraception (vaginal ring, birth control patch) or progesterone-only hormonal contraception (birth control injections, intrauterine device (IUD), or hormone-releasing implant), or copper IUD\n* Complete abstinence from sexual encounters with a person who has testes\n\nThose who do not wish to use one of the above methods of contraception must use two methods. Options include:\n\n* Oral hormonal contraception plus one barrier method during sexual encounter with a person who has testes (below). While typically oral hormonal contraception has a low failure rate, it is possible that the absorption of contraceptive pills taken by mouth will be impacted by the study drug and thus lower contraceptive effectiveness. Thus, people using pills as primary contraception must, during asexual encounter with a person who has testes, use a second form of barrier contraceptive (below) or must change to one of the other contraceptive methods listed above.\n* Two forms of barrier contraception during sexual encounter with a person who has testes. Examples of barrier contraceptive methods include the following:\n\n  * A condom with or without spermicide\n  * A cap, diaphragm, or sponge with or without spermicide\n\n    * Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.",{"count":287,"type":19},[195],"The goal of this clinical trial is to evaluate if the study drug will reduce brain and retinal atrophy by reducing inflammation and subsequently slowing neurodegeneration in people with Multiple Sclerosis. The main outcome for the trial is change in normalized brain parenchymal volume (nBPV), measured by magnetic resonance imaging (MRI).\n\nResearchers will compare outcomes from participants randomized to the study drug, versus participants randomized to placebo, to see if there are signs of slowed neurodegeneration (i.e., reduction in brain and retinal atrophy).",[401],"Multiple Sclerosis","2026-06-30",{"date":404,"type":28},"2026-07-01",{"date":406,"type":28},"2026-04-28",{"date":408,"type":19},"2030-01",{"name":34,"class":35},{"id":411,"slug":4,"hasResults":11,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":11,"sex":15,"minAge":43,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":46,"phases":418,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":36},"100605090","NCT07157995","Phase 4 of Designed With You","Building Active Living and Addressing Needs for Caregiver Empowerment (BALANCE) Study - Phase 4 of Designed With You","BALANCE","Inclusion Criteria:\n\n* 18 years of age and older,\n* Community dwelling in the state of Maryland,\n* Self report of physical or sensory disability and\n* self-report of serving as a family caregiver for a person for at least 10 hours\u002Fweek.\n\nExclusion Criteria:\n\n* have a terminal diagnosis (\\\u003C1 year expected survival), and\n* \\> severe cognitive impairment (5-7 errors) based on the Short Portable Mental Status Questionnaire (SPMQ)",{"count":357,"type":19},[48],"The purpose of this study is to provide evaluate the feasibility of a structured 8-10-week, multi-component intervention that integrates individualized resource navigation, personalized self-care planning, emergency and end of life (EOL) preparedness, and peer support to improve the well-being, resource access and social connectedness of caregivers with disabilities. For this study we are interested in caregivers over the age of 18 who have some form (e.g. mobility or sensory) disability and are caring for a person with a disability and\u002For a chronic illness.",[421],"Disability Physical",[423,424,425,426],"Caregivers","Disability","Sensory Disability","Mobility Disability",{"date":428,"type":28},"2026-07-02",{"date":430,"type":28},"2026-01-01",{"date":432,"type":19},"2026-10-30",{"name":34,"class":35},{"id":435,"slug":4,"hasResults":11,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":11,"sex":15,"minAge":43,"maxAge":440,"enrollmentInfo":441,"targetDuration":4,"studyType":46,"phases":443,"briefSummary":444,"conditions":445,"keywords":448,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":456,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":460,"locationsCount":36},"100541211","NCT06326905","CAPABLE Transplant","Addressing Inactive Kidney Transplant Waitlist Status Through Adapting a Tailored Psycho-Social-Environmental Program","Inclusion Criteria:\n\n* Deceased Donor Waitlist\n* ≥18 years old\n* Community dwelling\n* Current Inactive status or active and had been inactive in the last 18 months for cardiovascular disease, frailty, obesity, social support, mental health, incomplete testing OR Active on the waitlist and low-income\n\nExclusion Criteria:\n\n* Living Donor Waitlist\n* Severe cognitive impairment\n* Inactivity expected to last \\> 3 months (eg cancer treatment)\n* \\>4 hospitalizations in the last 12 months\n* Current home nursing, physical or occupational therapy","99 Years",{"count":442,"type":19},43,[48],"The purpose of this mixed methods study is to adapt CAPABLE as CAPABLE Transplant to accomplish two things: 1) To resolve barriers to being classified as active on the Kidney Transplant (KT) waitlist, 2) as a surgical prehabilitation intervention targeting the pre-frail\u002F frail KT waitlist population. It consists of two phases- an open label pilot and a randomized waitlist control trial, and 3) pilot test the feasibility and acceptability for CAPABLE Transplant in symptom and waitlist specific metrics amongst low-income active kidney transplant waitlist candidates.",[446,53,447,421],"Quality of Life","End Stage Renal Disease",[449,450,451,452,453,454,455,447],"Activities of Daily Living","Instrumental Activities of Daily Living","Physical Function","Executive Function","Home","Intervention","Kidney Transplant",{"date":428,"type":28},{"date":458,"type":28},"2025-01-25",{"date":404,"type":19},{"name":34,"class":35},{"id":462,"slug":4,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":11,"sex":15,"minAge":468,"maxAge":16,"enrollmentInfo":469,"targetDuration":4,"studyType":46,"phases":470,"briefSummary":471,"conditions":472,"keywords":476,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":36},"100474852","NCT05463289","ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2","Implementing Digital Retinal Exams Into Comprehensive Pediatric Diabetes Care","ACCESS2","Inclusion Criteria:\n\nMeets American Diabetes Association (ADA) criteria for diabetic retinopathy screening:\n\n* Diagnosis of Type 1 diabetes for ≥3 years, and age 11 or in puberty\n* Diagnosis of Type 2 diabetes\n\nEnriched cohort:\n\n* Patients with Type 1 or Type 2 diabetes,\n* 8-21 years of age with known diabetic retinopathy (true positives).\n* No time limit on last diabetic eye exam.\n\nExclusion Criteria:\n\n* Known diabetic eye exam in the last 12 months","8 Years",{"count":309,"type":19},[48],"The purpose of this study is to determine if use of a nonmydriatic fundus camera using autonomous artificial intelligence software at the point of care increases the proportion of underserved youth with diabetes screened for diabetic retinopathy, and to determine the diagnostic accuracy of the autonomous AI system in detecting diabetic retinopathy from retinal images of youth with diabetes.",[473,474,475],"Type 1 Diabetes","Type 2 Diabetes","Cystic Fibrosis-related Diabetes",[477],"Diabetic Retinopathy",{"date":428,"type":28},{"date":480,"type":28},"2022-07-11",{"date":482,"type":19},"2026-09-30",{"name":34,"class":35},{"id":485,"slug":4,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":106,"sex":15,"minAge":16,"maxAge":490,"enrollmentInfo":491,"targetDuration":4,"studyType":46,"phases":492,"briefSummary":493,"conditions":494,"keywords":497,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":508},"100598753","NCT07075588","Integrating Free-choice Marketplace, dieTitian coacHing, cultuRally Tailored messagIng to improVE Blood Pressure","iTHRIVE","Inclusion Criteria:\n\n* 21-70 years\n* Self-identify as Black\u002FAfrican American or Hispanic\u002FLatino\n* Have Stage 2 CKM defined as:\n* Systolic BP ≥130mmHg (measured at screening) AND at least one of:\n* Hypertension (ICD-10: I10-I16)\n* Prediabetes (HbA1c 5.7-6.4%) or Type 2 Diabetes (HbA1c ≥6.5%)\n* Stage 3 chronic kidney disease (CKD) (eGFR 30-59 mL\u002Fmin\u002F1.73m²)\n* Live in census tracts identified by the Montgomery\u002F Prince George's\u002FBaltimore City County Departments of Planning as HFPA:\n* Healthy Food Availability Index score is low (0-9.5),\n* Median household income ≤185% of Federal Poverty Level\n\n  * 30% of households have no vehicle,\n* Distance to supermarket \\>1\u002F4 mile. 5. Have refrigeration, food preparation appliances (microwave, stove), and cell phones for the App\n\nExclusion Criteria:\n\n* Age \\\u003C21 years\n* Diagnosis of end-stage renal disease (ESRD), dialysis\n* Serious medical condition that either limits life expectancy or requires active management (e.g., cancer)\n* Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence\n* Active alcohol or substance use disorder (i.e., not sober\u002Fabstinent for ≥ 30 days)\n* Patients with cognitive impairment or other condition preventing their participation in the intervention\n* Pregnant, breastfeeding, or planning pregnancy\n* Current participation in a care management program related to health conditions (e.g., weight reduction, smoking cessation) or another clinical trial that could interfere with the study protocol\n* Planning to move out of the geographic area in 12 months","70 Years",{"count":18,"type":19},[48],"iTHRIVE intervention is a 2-arm randomized controlled trial testing the effects of digital FARMacy, personalized dietitian coaching with produce prescriptions, and home blood pressure measurement in 100 hypertensive adults living in high food priority areas in counties in Maryland.",[495,496],"Hypertension","Hypertension Complicated With Type 2 Diabetes",[498,499,500],"Digital Farmacy","DASH Diet","Personalized dietitian coaching","2026-06-29",{"date":402,"type":28},{"date":504,"type":28},"2026-06-25",{"date":506,"type":19},"2028-03-20",{"name":34,"class":35},3,{"id":510,"slug":4,"hasResults":11,"nctId":511,"briefTitle":512,"officialTitle":512,"acronym":513,"eligibilityCriteria":514,"healthyVolunteers":11,"sex":15,"minAge":515,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":518,"conditions":519,"keywords":520,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":36},"100645344","NCT07681726","Project HOPE (Hypertension Outreach Through Partnership and Engagement)","HOPE","Patient Participant Inclusion Criteria:\n\n* Adults aged ≥25 years\n* Stage 2 hypertension defined as either:\n\n  * Systolic Blood Pressure (SBP) ≥160 mmHg at screening (Group A); OR\n  * SBP 140-159 mmHg at screening with either documented elevation on more than one visit or a known history of hypertension (e.g., prior clinician diagnosis or current use of antihypertensive medication) (Group B)\n\nPatient Participant Exclusion Criteria:\n\n* \\\u003C25 years of age\n* Hypertensive emergency with SBP ≥180 mmHg at screening (these patients will be referred to the nearest health center per local protocol; they may be re-screened for eligibility at a subsequent visit if SBP meets the inclusion criteria above)\n* Diagnosis of end-stage renal disease (ESRD)\n* Condition which interferes with outcome measurement (e.g., dialysis)\n* Serious medical condition which either limits life expectancy or requires active management (e.g., certain cancers)\n* Cognitive impairment or other condition preventing participation in the intervention\n* Active alcohol or substance use disorder (i.e., not sober\u002Fabstinent for ≥30 days), screened using the NIAAA Single Alcohol Screening Question\n* Pregnant or planning pregnancy in the next 24 months\n* Currently nursing a child\n* Current participation in another research study focused on reducing blood pressure\n* Current participation in a care management program related to health conditions (e.g., weight reduction, smoking cessation)\n* Planning to move out of the geographic area within 7 months\n* Unwillingness to provide informed consent\n\nCommunity Health Nurse (CHN) Participant Inclusion Criteria:\n\n* CHNs who were directly involved in delivering the nurse-led community-based hypertension intervention\n* Willing to provide oral informed consent for participation in pre\u002Fpost-training surveys and semi-structured interviews\n\nCommunity Health Nurse (CHN) Participant Exclusion Criteria:\n\n* CHNs who were not directly involved in the delivery of the intervention","25 Years",{"count":517,"type":19},150,"The goal of this study is to learn if a nurse-led, task-shifting, community-based program can help lower blood pressure in adults aged 25 and older with uncontrolled high blood pressure (hypertension) in Monrovia, Liberia. The program is delivered through community-based mobile clinics by community health nurses (CHNs) trained in WHO-aligned hypertension care within the Ministry of Health's (MOH) Community Health hypertension management protocols.\n\nParticipants will:\n\n* Receive blood pressure treatment from trained community health nurses (CHNs) at community-based mobile clinics in their communities, including medication and lifestyle counseling.\n* Complete surveys at their first visit, at 4 to 6 weeks, and at 3 months about their experience, satisfaction, and medication use.\n* Attend follow-up visits at the mobile clinic based on their blood pressure levels.\n\nCommunity health nurses delivering the program will complete structured training and be invited to complete surveys before and after training, and to take part in interviews about their experience at the end of the study.\n\nThe study will take place over 7 months in five high-thoroughfare communities in Monrovia, Liberia, and aims to enroll 150 participants.",[168],[495,521,522,523,524,525,526,527],"Blood Pressure","Nurse-Led Intervention","Task Shifting","Community Health Nurses","Liberia","Mobile Clinic","Low-Resource Settings","2026-06-26",{"date":428,"type":28},{"date":531,"type":19},"2026-09-01",{"date":533,"type":19},"2027-04-30",{"name":34,"class":35},{"id":536,"slug":4,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":106,"sex":15,"minAge":243,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":46,"phases":538,"briefSummary":248,"conditions":539,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":544,"locationsCount":36},"100644787",{"count":245,"type":19},[247],[250,251,252],{"date":402,"type":28},{"date":542,"type":19},"2026-07",{"date":257,"type":19},{"name":34,"class":35},{"id":546,"slug":4,"hasResults":11,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":11,"sex":15,"minAge":43,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":46,"phases":554,"briefSummary":555,"conditions":556,"keywords":559,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":563,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":36},"100623512","NCT07397598","Peer Support for Liver Transplant Recipients With History of ALD","Peer Support to Enhance Care for Liver Transplant Recipients Who Had Alcohol-Associated Liver Disease","THRIVE","Inclusion Criteria:\n\n* English speakers\n* Received a liver transplant for alcohol-associated liver disease\n* Has 1 to 3 years of continuous alcohol abstinence at the time of trial entry\n\nExclusion Criteria:\n\n* Liver transplant recipients without a history of alcohol-associated liver disease\n* Inability to provide informed consent\n* Active participation in a separate intervention trial for alcohol use disorder",{"count":553,"type":19},95,[48],"Liver transplant (LT) recipients with a history of alcohol-related liver disease (ALD) may encounter various psychosocial and medical challenges during post-LT recovery, even beyond the initial post-transplant period. Effective and sustainable interventions will be crucial for improving patient outcomes. This clinical trial will examine the impact of peer support specialists (PSS) on the recovery experience of individuals who received LT for ALD. The trial seeks to answer two main questions:\n\n* Are LT recipients who work with PSS less likely to resume alcohol use or tend to drink less overall?\n* Do LT recipients who work with PSS engage more with recommended medical care and have better overall survival?",[225,557,558],"Alcohol Related Liver Disease","Liver Transplant Recipient",[560,557,561,562],"Alcohol use disorder","Liver transplant recipient","Peer support specialist",{"date":402,"type":28},{"date":565,"type":19},"2026-08",{"date":567,"type":19},"2029-06",{"name":34,"class":35},{"id":570,"slug":4,"hasResults":11,"nctId":571,"briefTitle":572,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":106,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":46,"phases":576,"briefSummary":577,"conditions":578,"keywords":580,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":585,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":508},"100474044","NCT05452772","5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder","Inclusion Criteria:\n\n* 21 years old or older\n* Be a daily smoker (minimum of 5 cigarettes\u002Fday on a typical day and breath CO of 6 or greater at screening) with multiple unsuccessful previous quit attempts, and report a continued desire to quit smoking\n* Read, write, and speak English\n* Agree to abstain from smoking for the psilocybin\u002Fniacin session from 1 hour before psilocybin\u002Fniacin administration until at least 8 hours afterward\n* Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of psilocybin\u002Fniacin administration\n* Be healthy as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis lab tests. See Exclusion Criteria below for specific ECG and specific blood test criteria\n\nExclusion Criteria:\n\n* The use of e-cigarettes or tobacco products other than machine-manufactured combustible cigarettes (e.g., cigarillos) on more than 5 of the previous 30 days\n* Women who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control\n* Positive urine drug screen for illicit drugs (excluding cannabis)\n* Positive urine breath test for alcohol. Participants with positive tests will be rescheduled\n* For blood samples, the following lab values will be exclusionary: transaminases greater than x2 the upper limit of normal lab reference range, hemoglobin less than 11 g\u002Fd, and creatinine clearance \\\u003C 40 ml\u002Fmin using the Cockroft-Gault equation.\n* For ECG screening: The ECG will be read by a cardiologist. Corrected heart rate (QTc) greater than 450 msec will be excluded.\n* Patients who have baseline vital signs that exceed the following measurements will be excluded from participation: Systolic blood pressure (SBP) \\> 139 mmHG, diastolic blood pressure (DBP)\\> 89 mmHG, and heart rate of \\\u003C=95 beats per minute (BPM). The investigators will perform serial heart rate monitoring with 3 total attempts. That is, heart rate must be \\\u003C=95 bpm on one of these attempts to be included in the study.\n* Currently taking on a regular basis (e.g., daily) antidepressants of any drug class, antipsychotics, or monoamine oxidase inhibitors (MAOIs), or serotonin-acting dietary supplements (e.g., 5-hydroxy- tryptophan, St. John's wort). Currently taking efavirenz, Acetaldehyde dehydrogenase inhibitors such as disulfiram (Antabuse), Alcohol dehydrogenase inhibitors, or uridine diphosphate glucuronosyltransferase 1-9 (UGT1A9) inhibitors or uridine diphosphate glucuronosyltransferase 1-10 (UGT1A10) inhibitors such as phenytoin, regorafenib, eltrombopag. For individuals who have intermittent or \"as needed\" use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose\n* Current use of medications for smoking cessation (i.e., varenicline, nicotine replacement products, bupropion)\n* Current neurological illnesses including, but not limited to, seizure disorders, frequent migraines or on prophylaxis, multiple sclerosis, movement disorders, history of significant head trauma (loss of consciousness \\> 24 hours), or central nervous system (CNS) tumor\n* Recent (within the past 12 months) or an extensive history of psychedelic use (\\>20 lifetime uses)\n* Current or past history of meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I or II Disorder. Current or past history within the last 5 years of meeting DSM-5 criteria for alcohol or drug use disorder (excluding caffeine and nicotine) or severe major depression\n* Recent (past year) history of suicidal behavior or attempt or high-level current suicidal ideation assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)\n* Have a first- or second-degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I or II disorder\n* Currently meets DSM-5 criteria for Dissociative Disorder, Anorexia Nervosa, Bulimia Nervosa, Major Depression, or Post-traumatic Stress Disorder",{"count":575,"type":19},66,[195],"This is a multi-site, double-blind, randomized clinical trial of the 5-HT2A receptor agonist psilocybin for smoking cessation. Four sites with experience in conducting psilocybin research will be involved in this trial: Johns Hopkins University (JHU), the University of Alabama at Birmingham (UAB), and New York University (NYU). The proposed study will treat 66 participants (22 at each site), randomized to receive either: 1) oral psilocybin (30 mg in session 1 and either 30 mg or 40 mg in session 2); or 2) oral niacin (150 mg in session 1 and either 150 mg or 200 mg in session 2), with sessions 1 week apart.",[579],"Tobacco Use Disorder",[581,582,583,584],"Smoking Cessation","Smoking","Cigarettes","Cigarette Smoking",{"date":501,"type":28},{"date":587,"type":28},"2023-11-01",{"date":589,"type":19},"2027-05",{"name":34,"class":35},{"id":592,"slug":4,"hasResults":11,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":11,"sex":15,"minAge":43,"maxAge":4,"enrollmentInfo":597,"targetDuration":4,"studyType":46,"phases":599,"briefSummary":600,"conditions":601,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":604,"completionDateStruct":605,"leadSponsor":607,"locationsCount":608},"100644095","NCT07665372","Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes (Expanding HOPE Liver)","HOPE in Action Liver Transplantation From Donors With HIV: Impact on Opportunistic Infections, Cancer, and Long-Term Outcomes","Inclusion Criteria:\n\n* Participant meets local criteria for liver or simultaneous liver kidney (SLK) transplant.\n* Participant or legally authorized representative (in accordance with Johns Hopkins Medicine Institutional Review Board (IRB) and local IRB policy) is able to understand and provide informed consent.\n* Participant has documented HIV infection by any licensed assay or documented history of detectable HIV-1 RNA.\n* Participant is ≥ 18 years old.\n* Most recent HIV-1 RNA \\\u003C 50 copies RNA\u002FmL. Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements \\> 200 copies\u002FmL. Organ recipients who are unable to tolerate Antiretroviral Therapy (ART) due to organ failure or recently started ART may be eligible despite a detectable viral load if safe and effective ART to be used by the recipient after transplantation is described.\n\nExclusion Criteria:\n\n* Participant has prior progressive multifocal leukoencephalopathy (PML), cryptosporidiosis of \\> 1 month duration, or prior primary Central Nervous System (CNS) lymphoma.\n* Participant is pregnant or breastfeeding.\n* Past or current medical problems or findings from medical history, physical examination, or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.",{"count":598,"type":19},80,[48],"This research is being done to better understand opportunistic infections and cancer in transplant recipients with HIV who receive livers from a donor with HIV compared to livers from donors without HIV.",[250],"2026-06-23",{"date":528,"type":28},{"date":232,"type":19},{"date":606,"type":19},"2031-08",{"name":34,"class":35},19,""]