[{"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:":702},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,286,0,25,[9,47,72,96,123,153,177,212,242,269,295,318,352,375,402,427,456,488,516,559,583,605,636,661,678],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100652813","phase-2-epidiolex-trial-for-presymptomatic-treatment-of-sturge-weber-syndrome-100652813",false,"NCT07778810","Epidiolex Trial for Presymptomatic Treatment of Sturge-Weber Syndrome","Epidiolex Pilot Trial for Presymptomatic Treatment of Sturge-Weber Syndrome","Epi-Pre","Inclusion Criteria:\n\n* Clinical diagnosis of Sturge-Weber Syndrome.\n* Age 1 to 18 months of age, inclusive.\n* Neuroimaging demonstrating involvement of 3 or more lobes, or bilateral involvement.\n* No history of seizures.\n* Patient's parent or legal guardian provides written informed consent prior to treatment initiation.\n\nExclusion Criteria:\n\nAny severe and\u002For uncontrolled medical conditions at randomization including, but not limited to the following:\n\n* Liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBVDNA and\u002For positive HbsAg, quantifiable HCV-RNA). Specifically the patient should not have either AST or ALT more than 1.5 times the upper limit of normal. The Child- Pugh Score must be A (mild) which is a score of 5-6 (minimum\u002Fnormal score=5). Child-Turcotte-Pugh (CTP) Calculator - Clinical Calculators - Hepatitis C Online (uw.edu)\n* Uncontrolled diabetes as defined by fasting serum glucose \\> 1.5 ULN\n* Active (acute or chronic) or uncontrolled severe infections\n* Active, bleeding diathesis\n\n  * Any other neurological diagnosis that increases the risk of seizure or neurodevelopmental disability.\n  * Patients who have had a major surgery or significant traumatic injury within 4 weeks of study entry, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia), or patients that may require major surgery during the course of the study.\n  * Prior treatment with any investigational drug or use of any other cannabis product within the preceding 4 weeks prior to study entry.\n  * Use of aspirin.\n  * Allergic reaction\u002Fhypersensitivity to Epidiolex or other forms of cannabidiol.\n  * Concern for non-compliance to medical regimens, or concern that the patient will not be able to complete the entire study, whether due to reliability or logistical barriers. This includes those in foster care, or those unable to keep follow-up appointments, maintain close contact with Principal Investigator, or complete all necessary studies to maintain safety.\n  * Use of any seizure medication (whether for seizures or any other reason) (e.g. valproate, clobazam).\n  * Use of chronic medications other than a multi-vitamin and\u002For vitamin D supplements.","ALL","1 Month","18 Months",{"count":22,"type":23},10,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","Patients with Sturge-Weber syndrome (SWS) are frequently affected by seizures, and seizures are associated with poorer neurological outcomes. To date there is no established means of predicting or preventing seizure onset. Cannabidiol (Epidiolex) was well tolerated in an open label study in this population. This trial will evaluate whether Epidiolex in presymptomatic Sturge-Weber patients may delay the onset of seizures and improve neurological outcome.",[29],"Sturge - Weber Syndrome (SWS)",[31,32,33],"Presymptomatic","Open-label","Cannabidiol","NOT_YET_RECRUITING","2026-08-20",{"date":37,"type":38},"2026-08-21","ACTUAL",{"date":40,"type":23},"2026-08",{"date":42,"type":23},"2028-07",{"name":44,"class":45},"Johns Hopkins University","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":24,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":46},"100628380","the-impact-of-low-sodium-salt-substitute-use-on-serum-potassium-levels-among-patients-with-hypertension-100628380","NCT07460882","The Impact of Low Sodium Salt Substitute Use on Serum Potassium Levels Among Patients With Hypertension","Inclusion Criteria:\n\n* Adults ≥18 years with clinically diagnosed hypertension treated with medication \\[on a stable dose at least for 2 months\\]\n* Have a phone for contact\n\nExclusion Criteria:\n\n* Those with baseline K ≥5.0 or K \\\u003C3.0 mmol\u002FL\n* Advanced kidney disease (eGFR \\\u003C45 ml\u002Fmin\u002F1.73m2).\n* Those on potassium sparing diuretics (e.g., spironolactone)\n* Other medical conditions determined by physicians (e.g., heart failure treated with medication; life expectancy less than 12 months)\n* Dine out for dinner more than 3 times a week","18 Years",{"count":55,"type":23},607,[57],"NA","The goal of this pre-post study is to assess the risk of hyperkalemia in adults with hypertension on medication in Bangladesh. The main questions it aims to answer are:\n\nIs the risk of hyperkalemia after the initiation of Low Sodium Salt Substitute (LSSS) in people on antihypertensive medication (especially RASi) large enough to be concerned about its broad use in this population?\n\nDoes initiation of LSSS correct hypokalemia in people on antihypertensive medication (especially RASi) with low serum potassium levels?\n\nParticipants will be asked to reduce overall salt intake and to use LSSS on every occasion where regular salt would normally be used, including as cooking salt.",[60],"Hypertension",[60,62,63,64],"Low sodium salt substitute","Cardiovascular disease","RASi","RECRUITING",{"date":37,"type":38},{"date":68,"type":38},"2026-08-08",{"date":70,"type":23},"2027-09-30",{"name":44,"class":45},{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":24,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":22},"100610478","phase-3-use-of-steroid-injections-to-prevent-the-recurrence-of-tracheal-stenosis-in-idiopathic-subglottic-stenosis-100610478","NCT07228104","Adjuvant Steroid Outcomes in Idiopathic Subglottic Stenosis","ASTRO","Inclusion Criteria:\n\n1. Diagnosis of iSGS following the NoAAC criteria which involves ruling out known causes for airway stenosis. Participants may be newly diagnosed or carry an existing diagnosis of iSGS;\n2. Age Range: 18 years to 80 years old at the time of consent;\n3. Sex distribution: all eligible men and women will be included, and no one will be excluded;\n4. Have a life expectancy of ≥6 months; and,\n5. ECOG performance status of 0 or 1.\n\nExclusion Criteria:\n\n1. History of subglottic stenosis from identifiable cause (not idiopathic), including any of the below clinical criteria:\n\n   1. Prolonged endotracheal intubation or tracheostomy (intervention greater than 7 days immediately prior to diagnosis of subglottic stenosis);\n   2. External physical trauma (including but not limited to blunt, penetration, chemical, or thermal injury) that causes injury to the subglottis;\n   3. Clinical diagnosis of granulomatosis with polyangiitis (GPA);\n   4. Radiation exposure to the neck;\n   5. Complications resulting from the Index Procedure, including needing an endotracheal tube or tracheostomy immediately following surgery or a perforation of the trachea;\n2. Current or previous treatment with SILSI;\n3. Use of systemic corticosteroids (oral, intravenous, or intramuscular glucocorticoids), regardless of indication, within 7 days before triamcinolone administration;\n\n   1. Local administration of corticosteroids (ophthalmic, intranasal, inhaled) is not prohibited. However, the administration of intraarticular corticosteroids during the Study Drug Dosing phase is not recommended due to potential increased risk of infection.\n   2. Intralesional administration, in a site other than the subglottis, of corticosteroids should be discussed with the site PI before enrollment.\n   3. Use of inhaled steroids is permitted during the study if the participant was taking at the time of consent, and no new inhaled steroids can be started while enrolled in the study.\n4. Intraarticular corticosteroids during the Study Drug Dosing phase due to potential increased risk of infection;\n5. Use of anticoagulants other than aspirin (daily aspirin dose should not exceed 81mg);\n6. Pulmonary disease including interstitial lung disease or COPD\u002Femphysema;\n7. Systemic infection requiring treatment with antibiotics, antifungal, or antiviral agents within 21 days of Enrollment;\n8. Poorly controlled diabetes as defined by a HbA1C value greater or equal to 8.0 in the last 180 days;\n9. Participants with active cancer or a history of cancer in the last 5 years prior to enrollment, except for squamous or basal cell carcinoma of the skin;\n10. Participation in any clinical trial involving an investigational drug or device, within four weeks, or 5 half-lives of the investigational agent (whichever time point is longer) prior to enrollment or during this trial participation;\n11. Active autoimmune disease requiring systemic treatment;\n12. History of solid organ transplant due to use of immunosuppression;\n13. Contraindication to any aspect of the index procedure;\n14. Inability to tolerate in-office SILSI procedure;\n15. Contraindication, hypersensitivity, or history of intolerance to oral or injectable steroids;\n16. Contraindication to SMOFlipid including any of the below:\n\n    1. Severe lipid metabolism disorders characterized by hypertriglyceridemia (greater than 500 mg\u002FdL);\n    2. Hypersensitivity to eggs, soybean, peanut protein, or any active ingredient in SMOFlipid;\n    3. History of intolerance to SMOFlipid;\n17. Participants with known, suspected, or plan for becoming pregnant in the next 6 months after the index procedure, or participants who are breastfeeding;\n18. NYHA class II-IV heart failure within the past 6 months prior to Enrollment;\n19. History of angioedema;\n20. Lack of capacity to consent;\n21. Alcohol or substance abuse or dependence in the past 6 months prior to Enrollment;\n22. Participants who for any reason may not complete the study as judged by the PI;\n23. Participants planning to move to another city or state for 6 months after the Index Procedure;\n24. Not able to undergo phlebotomy as reported by the participant or determined by the study coordinator or physician.\n25. The presence of a medical condition, lab test result, and\u002For use of a medication and\u002For any substance, individually or in aggregate, that in the judgement of the site investigator could impair study participation.","80 Years",{"count":81,"type":23},226,[83],"PHASE3","This study will examine the ability of steroid injections into the site of stenosis following surgical dilation to delay the need for repeated surgical dilations.",[86],"Idiopathic Subglottic Stenosis",[88,89],"Steroid injection","Stenosis",{"date":37,"type":38},{"date":92,"type":38},"2026-05-20",{"date":94,"type":23},"2032-01",{"name":44,"class":45},{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":24,"phases":106,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},"100579231","telerehabilitation-for-patients-with-chronic-low-back-pain-teleback-clinical-trial-100579231","NCT06821607","Telerehabilitation for Patients With Chronic Low Back Pain (TeleBACK Clinical Trial)","TeleBACK","Inclusion Criteria:\n\n* Primary care visit in the past 90 days with an LBP-related ICD-10 diagnosis.\n* At least moderate levels of pain and disability requiring Oswestry score ≥24% and average pain rating ≥ 4\u002F10 points.\n* Meets NIH Task Force2 definition of chronic LBP based on two questions: 1) How long has LBP has been an ongoing problem? and 2) How often has LBP been an ongoing problem over the past 6 months? A response of greater than 3 months to question 1, and \"at least half the days in the past 6 months\" to question 2 is required to satisfy the NIH definition of chronic LBP.\n* Can speak and understand English or Spanish (Utah sites only).\n\nExclusion Criteria:\n\n* Recent history (last 6 months) of lumbar spine surgery.\n* Possible non-musculoskeletal cause for low back pain symptoms (e.g., pregnancy).\n* Evidence of serious pathology as a cause of LBP including neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc.\n* Neurological disorder resulting in severe movement disorder, or schizophrenia or other psychotic disorder.\n* Knowingly pregnant","64 Years",{"count":105,"type":23},1000,[57],"The investigators will conduct a prospective, randomized, clinical trial addressing key questions to understanding the effectiveness of telerehabilitation (physical therapy delivered via video-visits) and in-clinic physical therapy for patients with chronic low back pain (LBP). The investigators also seek to understand how patients engage with both care options and how these treatment options influence other LBP-related healthcare utilization.\n\nThe investigators will explore implementation outcomes using a mixed methods approach consisting of electronic surveys and semi-structured interviews with patients, physical therapists, practice managers, and outpatient services administration focusing on perceived quality and impact on barriers to care. The investigators will enroll 1000 patients with chronic LBP seeking outpatient care at the healthcare systems in Maryland (Johns Hopkins Medicine (JHM)) and Utah (University of Utah (UU) and Intermountain Healthcare (IHC)). Eligible patients will provide informed consent and be randomized to receive telerehabilitation or in-clinic physical therapy delivered by a trained physical therapist. Primary effectiveness outcome is the difference in change in LBP-related disability (Oswestry Disability Index) after 8 weeks of treatment.",[109],"Chronic Low Back Pain",[111,112,113,114],"chronic low back pain","physical therapy","telehealth","telerehabilitation","2026-08-19",{"date":37,"type":38},{"date":118,"type":38},"2025-04-01",{"date":120,"type":23},"2030-05-01",{"name":44,"class":45},3,{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":18,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":24,"phases":133,"briefSummary":134,"conditions":135,"keywords":140,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":46},"100329283","investigation-on-the-cortical-communication-corticom-system-100329283","NCT03567213","Investigation on the Cortical Communication (CortiCom) System","CortiCom","Inclusion Criteria:\n\n* Clinical diagnosis of tetraplegia (quadriplegia), brainstem stroke , amyotrophic lateral sclerosis (ALS) or Locked-in Syndrome (LIS)\n* Tetraplegia diagnosis, ALS diagnosis, stroke, or LIS etiology onset occurred at least one year prior to enrollment\n* Complete or incomplete tetraplegia (quadriplegia), tetraparesis (quadriparesis), or severe ataxia. In addition, these motor impairments may be combined with severe motor-related speech impairment (dysarthria or anarthria), as in LIS.\n* 22-70 years\n* Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants\n* Ability to communicate reliably, such as through eye movement\n* Willingness and ability to provide informed consent\n* Screened by rehabilitation psychologist with a result showing that the participant has a stable psychosocial support system with caregiver capable of monitoring participant throughout the study\n* Ability and willingness to travel up to 100 miles to study location up to three days per week for the duration of the study\n* Ability to understand and comply with study session instructions\n* Participant consents to the study and still wishes to participate at the time of the study\n\nExclusion Criteria:\n\n* Performance on formal neuropsychological testing that indicates significant psychiatric conditions or cognitive impairments that would interfere with obtaining informed consent or fully participating in study activities.\n* Suicide attempt or persistent suicidal ideation within the past 12 months.\n* Implanted devices that are incompatible with MRI, which may include pacemakers, cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain stimulators, and cochlear implants.\n* History of substance abuse, narcotic dependence, or alcohol dependence in past 24 months\n* Medical conditions contraindicating surgery of a chronically implanted device (e.g. osteomyelitis, diabetes, hepatitis, any autoimmune disease\u002Fdisorder, epilepsy, skin disorders causing excessive skin sloughing or poor wound healing, blood or cardiac disorder requiring chronic anti-coagulation)\n* Other chronic, unstable medical conditions that could interfere with subject participation.\n* Presence of pre-surgical findings in anatomical, functional, and\u002For vascular neuroimaging that makes achieving implant locations within desired risk levels too challenging (to be decided by neurological and neurosurgical team)\n* Prior cranioplasty\n* Inability to undergo MRI or anticipated need for an MRI during the study period\n* Participants with active infections or unexplained fever\n* Participants with other morbid conditions making the implantation of the recording elements unsafe; not limited to: significant pulmonary, cardiovascular, metabolic, or renal impairments making the surgical procedure unsafe\n* Pregnancy (confirmation through blood test)\n* Nursing an infant, planning to become pregnant, or not using adequate birth control\n* Corrected vision poorer than 20\u002F100\n* HIV or AIDS infection\n* Existing scalp lesions or skin breakdown\n* Chronic oral or intravenous use of steroids or immunosuppressive therapy\n* Active cancer within the past year or requires chemotherapy\n* Uncontrolled autonomic dysreflexia within the past 3 months\n* Hydrocephalus with or without an implanted ventricular shunt\n* Participants in whom it is medically contraindicated to stop anti-coagulant medications during surgery","22 Years","70 Years",{"count":122,"type":23},[57],"The CortiCom system consists of 510(k)-cleared components: platinum PMT subdural cortical electrode grids, a Blackrock Microsystems patient pedestal, and an external NeuroPort Neural Signal Processor. Up to two grids will be implanted in the brain, for a total channel count of up to 128 channels, for six months. In each participant, the grid(s) will be implanted over areas of cortex that encode speech and upper extremity movement.",[136,137,138,139],"Tetraplegia","Locked-in Syndrome","Brainstem Stroke","Amyotrophic Lateral Sclerosis",[136,141,137,142,143,144,145,146],"ALS","Brainstem stroke","Brain Computer Interface","Rehabilitation","Stroke","Hopkins",{"date":37,"type":38},{"date":149,"type":38},"2021-12-14",{"date":151,"type":23},"2030-12-31",{"name":44,"class":45},{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":18,"minAge":130,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":24,"phases":163,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":176,"locationsCount":46},"100298134","investigation-on-the-bidirectional-cortical-neuroprosthetic-system-100298134","NCT03161067","Investigation on the Bidirectional Cortical Neuroprosthetic System","BiCNS","Inclusion Criteria:\n\nParticipants must meet all inclusion criteria, verified by medical evaluation, psychological evaluation, and review of medical history. Inclusion criteria include:\n\n* Participants with C4-C6 tetraplegia from any etiology except neurodegenerative disease (e.g. amyotrophic lateral sclerosis) or active cancer.\n* Complete or incomplete spinal cord injury classified by the American Spinal Injury Association (ASIA) as A or B or C if fewer than three muscle groups in the leg and foot (as identified in the ASIA Impairment Scale) can be contracted\n* Injury more than one year prior to enrollment\n* Participant has a life expectancy of greater than 5 years\n* Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants\n* Willingness and ability to provide informed consent\n* Screened by rehabilitation psychologist with a result showing that the participant has a stable psychosocial support system with caregiver capable of monitoring participant throughout the study\n* Ability and willingness to travel to up to fifty miles to study location up to three days per week for the duration of the study\n* Ability to understand and comply with study session instructions\n* Pain well controlled without narcotic medications\n* No other neurological, orthopedic conditions beyond the spinal cord injury\n* Participant consents to the study and still wishes to participate at the time of the study\n\nExclusion Criteria:\n\nAll interested participants will be reviewed for the presence of exclusion criteria by medical evaluation, review of medical history, self (or assistant) report and evaluation by a psychologist. Presence of any of the following criteria will exclude participants from eligibility to participate. In addition, the medical team has the right to withdraw the participant at any time if any of the exclusion criteria emerge and participants can withdraw at any time for any reason. Withdrawal details are outlined below exclusion criteria. Exclusion criteria include:\n\n* Neurological conditions: Impaired receptive and\u002For expressive verbal communication skills\n* Presence of memory impairment on the Rey Auditory Verbal Learning Test\n* Intellectual impairment: score of 26 or less on the Mini-Mental State Examination or history of Intelligence Quotient \\\u003C 80\n* Chronic psychiatric illness, including psychosis and treatment-resistant major depression, as indicated by a diagnosis of Axis I or Axis II on the Symptom Checklist-90-Revised Test\n* Ventilator dependent\n* Implanted devices such as: pacemakers, cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain stimulators, cochlear implants or any other implantable device incompatible with MRI.\n* History of drug or alcohol dependence in past 24 months\n* Cerebral lesions affecting frontal and parietal lobes\n* Medical conditions contraindicating surgery of a chronically implanted device (e.g. osteomyelitis, diabetes, hepatitis, any autoimmune disease\u002Fdisorder, epilepsy, skin disorders causing excessive skin sloughing or poor wound healing, blood or cardiac disorder requiring chronic anti-coagulation)\n* Other chronic, unstable medical conditions that could make control unsuitable (such as tremor or spasticity)\n* Presence of pre-surgical findings in anatomical, functional, and\u002For vascular neuroimaging that makes achieving implant locations within desired risk levels too challenging (to be decided by neurological and neurosurgical team)\n* Prior cranioplasty\n* Inability to undergo MRI or anticipated need for an MRI during the study period\n* Participants with active infections or unexplained fever\n* Participants with other morbid conditions making the implantation of the recording elements unsafe; not limited to: significant pulmonary, cardiovascular, or renal impairments making the surgical procedure unsafe\n* Pregnancy (confirmation through blood test)\n* Nursing an infant, planning to become pregnant, or not using adequate birth control\n* Corrected vision no worse than 20\u002F30\n* HIV or AIDS infection\n* Existing scalp lesions or skin breakdown\n* Chronic oral or intravenous use of steroids or immunosuppressive therapy\n* Active cancer within the past year or requires chemotherapy\n* Uncontrolled autonomic dysreflexia within the past 3 months\n* An implanted ventricular shunt\n* Suicidal ideation within the past 12 months\n* Medications that affect neuroplasticity: neuroleptics, Benzodiazepines (BDZ), Tricyclic Antidepressants (TCA).","65 Years",{"count":162,"type":23},5,[57],"The Bidirectional Cortical Neuroprosthetic System (BiCNS) consists of NeuroPort Microelectrode Array Systems and NeuroPort Electrodes (Sputtered Iridium Oxide Film), Patient Pedestals, the NeuroPort BioPotential Signal Processing System, and the CereStim C96 Programmable Stimulator. The goals of this early feasibility study consist of safety and efficacy evaluations of this device.",[136,166],"Quadriplegia",[136,144,143,168,169,170,171,166],"Intracortical Microstimulation","Upper extremity prosthetics","Cervical spinal cord injury","Bilateral",{"date":37,"type":38},{"date":174,"type":38},"2017-08-01",{"date":151,"type":23},{"name":44,"class":45},{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":185,"sex":18,"minAge":53,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":24,"phases":188,"briefSummary":189,"conditions":190,"keywords":194,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":211},"100652774","augmented-reality-cardiopulmonary-resuscitation-support-for-pediatric-resuscitation-100652774","NCT07778823","Augmented Reality-Cardiopulmonary Resuscitation Support for Pediatric Resuscitation","AR-CPR: Large-Scale Simulation-Based Testing of a Novel Augmented Reality Point of Care Chest Compression Feedback System.","AR-CPR","Inclusion Criteria:\n\n* Actively credentialed pediatric emergency department or pediatric intensive care unit nurse or clinical technician at a participating study site\n* Current American Heart Association (AHA) Pediatric Advanced Life Support (PALS) certification\n\nExclusion Criteria:\n\n* Inability to physically perform chest compressions\n* Need for prescription corrective lenses without having those corrective lenses available at the time of study participation",true,{"count":187,"type":23},252,[57],"This study evaluates whether an augmented reality cardiopulmonary resuscitation feedback system (AR-CPR) can support health care providers in delivering high-quality chest compressions during pediatric cardiac arrest. AR-CPR provides real-time visual feedback on chest compression rate, depth, and recoil through a head-mounted augmented reality display.\n\nIn this randomized, multicenter, international, simulation-based non-inferiority study, health care providers perform chest compressions during an 18-minute simulated pediatric cardiac arrest. Participants are assigned to receive either real-time feedback from AR-CPR or coaching from a trained human CPR coach. The primary objective is to determine whether the percentage of chest compressions meeting guideline targets for both rate and depth with AR-CPR is non-inferior to that achieved with human CPR coaching.",[191,192,193],"Cardiac Arrest (CA)","Pediatric Cardiac Arrest (Simulated)","Cardiopulmonary Resuscitation (CPR)",[195,196,197,198,199,200,201,202,203],"augmented reality","cardiopulmonary resuscitation","pediatric cardiac arrest","cpr quality","chest compressions","cpr coaching","real-time feedback","pediatric advanced life support","simulation","2026-08-18",{"date":37,"type":38},{"date":207,"type":38},"2025-06-29",{"date":209,"type":23},"2028-06-30",{"name":44,"class":45},8,{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":24,"phases":221,"briefSummary":222,"conditions":223,"keywords":226,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":46},"100651939","phase-2-herbal-supplement-biocidin-remove-for-bacterial-overgrowth-in-irritable-bowel-syndrome-100651939","NCT07768267","Herbal Supplement (Biocidin REMOVE) for Bacterial Overgrowth in Irritable Bowel Syndrome","A Pilot Study of the Role of an Antimicrobial Herbal Formulation (Biocidin REMOVE) for the Management of Small Intestinal Bacterial Overgrowth (SIBO) in Patients With Irritable Bowel Syndrome (IBS)","Inclusion Criteria:\n\n* Age 18 years or older\n* Irritable bowel syndrome by Rome IV criteria with a positive lactulose breath test for small intestinal bacterial overgrowth, defined as a rise of more than 20 parts per million of hydrogen above baseline in the first 90 minutes of testing and\u002For a methane level of 10 parts per million or greater at any point during the test\n\nOR\n\n* Irritable bowel syndrome by Rome IV criteria with a lactulose breath test showing a \"flat line pattern,\" with exhaled gas levels remaining very low (3 parts per million or less) with no spikes\n* Female participants of childbearing age who are sexually active with male partners must agree to use a highly effective method of contraception, such as abstinence, hormonal contraceptive, intrauterine device, or bilateral tubal occlusion\n\nExclusion Criteria:\n\n* Negative SIBO breath testing at baseline\n* Restricted diets (low carbohydrate, Atkins, gluten-free, low FODMAP, or others)\n* Confirmed celiac disease\n* Immunocompromised (chronic steroids, biologics), CD4 less than 400, AIDS not on therapy, neutropenia, acute and chronic leukemia, lymphoma\n* Portal hypertension\n* Chronic liver disease, defined as: ICD-10 known diagnoses of chronic liver disease; OR known or suspected liver cirrhosis, portal hypertension, or chronic hepatitis; OR serum AST and ALT elevation greater than 2 times the upper limit of normal with decreased serum albumin less than 4.0 g\u002FdL within the last 6 months\n* Pregnant or breastfeeding\n* Diagnosis of inflammatory bowel disease\n* Poorly controlled anxiety or depression despite medication\n* Untreated significant anxiety or depression\n* COVID-19 positive\n* Unable to provide informed consent\n* Insulin dependent or poorly controlled diabetes mellitus (HbA1c greater than 7.0%)\n* Connective tissue disease such as lupus or scleroderma\n* Concurrent narcotic use\n* Antibiotic or probiotic use within 30 days",{"count":220,"type":23},40,[26],"The goal of this clinical trial is to learn if an herbal supplement called Biocidin REMOVE can clear small intestinal bacterial overgrowth (SIBO) in adults with irritable bowel syndrome (IBS). SIBO means there are too many bacteria in the small intestine. It can make IBS symptoms worse.\n\nThis is a small first study, called a pilot study. Its results will help researchers plan larger studies.\n\nThe main questions it aims to answer are:\n\nDoes Biocidin REMOVE clear SIBO? Does it lower IBS symptoms and improve quality of life? Does it change the mix of bacteria in the gut? Researchers will compare Biocidin REMOVE to a placebo. A placebo is a look-alike capsule that contains no active ingredients. Neither the participants nor the research team will know who gets which one. About 40 adults age 18 and older will take part.\n\nParticipants will:\n\nTake capsules by mouth twice a day for about 5 weeks. Participants will start with a low dose and build up to 2 capsules twice a day.\n\nTake a breath test at the start and at the end of treatment. This test checks for SIBO.\n\nCollect a stool sample at home at the start and at the end of treatment. Answer questions about symptoms and quality of life. Report what was eaten during the study. Come back for one check-in about 4 weeks after treatment ends.",[224,225],"Irritable Bowel Syndrome (IBS)","Small Intestinal Bacterial Overgrowth Syndrome (SIBO)",[227,228,229,230,231,232,233,234,235],"SIBO","IBS","Herbal supplement","Antimicrobial herbal therapy","Gut microbiome","Dysbiosis","Rome IV","Hydrogen breath test","Lactulose breath test",{"date":115,"type":38},{"date":238,"type":23},"2026-09-01",{"date":240,"type":23},"2027-08-10",{"name":44,"class":45},{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":18,"minAge":130,"maxAge":250,"enrollmentInfo":251,"targetDuration":4,"studyType":24,"phases":253,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":268},"100503571","phase-3-the-rhythm-evaluation-for-anticoagulation-with-continuous-monitoring-of-atrial-fibrillation-100503571","NCT05836987","The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation","REACT-AF: Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation","REACT-AF","Inclusion Criteria:\n\n1. 22-85 years of age.\n2. English speaking participants. Spanish-only speakers may be included in the future at select sites appropriately translated.\n3. History of non-permanent atrial fibrillation.\n4. CHA2DS2-VASC score of 1-4 for men and 2-4 for women without prior stroke or Transient Ischemic Attack (TIA), The CHA2DS2-VASc score is a point-based system used to stratify the risk of stroke in Atrial Fibrillation (AF) patients. The acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female). Congestive heart failure defined as: The presence of signs and symptoms of either right (elevated central venous pressure, hepatomegaly, dependent edema) or left ventricular failure (exertional dyspnea, cough, fatigue, orthopnea, paroxysmal nocturnal dyspnea, cardiac enlargement, rales, gallop rhythm, pulmonary venous congestion) or both, confirmed by non-invasive or invasive measurements demonstrating objective evidence of cardiac dysfunction and\u002For ejection fraction \\\u003C 40%.\n5. The participant is on a DOAC at the time of screening and willing to stay on DOAC for duration of study.\n6. Willing and able to comply with the protocol, including:\n\n   * Possession of a smart watch-compatible smart phone (iPhone that supports the latest shipping iOS) with a cellular service plan\n   * Be willing to wear the smart watch for the suggested minimum of 14 hours a day\n   * Expected to be within cellular service range at least 80% of the time\n7. Willing and able to discontinue DOAC\n8. The participant is willing and able to provide informed consent.\n\nExclusion Criteria:\n\n1. Valvular or permanent atrial fibrillation.\n2. Current treatment with warfarin and unwilling or unable to take a DOAC.\n3. The participant is a woman who is pregnant or nursing.\n4. The participant is being treated with chronic aspirin, another anti-platelet agent, or chronic NSAIDS outside of current medical guidelines (e.g., primary stroke prevention in patients with atrial fibrillation, primary prevention of cardiovascular events, pain relief, fever, gout) and is unwilling or unable to discontinue use for the study duration.\n5. Existing cardiac rhythm device or indication for a permanent pacemaker, Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) device or planned insertable cardiac monitor. Insertable cardiac monitors are permitted unless they are being used to guide anticoagulation treatment.\n6. Known or suspected symptomatic or asymptomatic atrial fibrillation lasting ≥ 1 hour\u002Fmonth over the last 3 months.\n7. Any documented single AF episode lasting ≥ 1 hour on standard of care or study-provided external cardiac monitor of \\> 6 days duration performed within 45 days prior to randomization. Shorter monitoring durations may be acceptable for inclusion at the discretion of the site PI based on the totality of monitoring data and approval of the study PI.\n8. Ablation for AF within the last 2 months.\n9. Prior or anticipated left atrial appendage occlusion or ligation.\n10. Mechanical prosthetic valve(s) or severe valve disease.\n11. Hypertrophic cardiomyopathy.\n12. Participant needs DOAC for reasons other than preventing stroke or arterial embolism resulting from AF (i.e., preventing Deep Vein Thrombosis (DVT) or PE) or needs permanent OAC (i.e., congenital heart defects, prosthetic heart valve).\n13. Participants deemed high risk for non-cardioembolic stroke (i.e., significant carotid artery disease defined as stenosis \\> 75%) based on the investigator's discretion.\n14. The participant is enrolled, has participated within the last 30 days, or is planning to participate in a concurrent drug and\u002For device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the study manager; there is no concern that co-enrollment could confound the results of this trial.\n15. The participant has a tattoo, birthmark, or surgical scar over the dorsal wrist area on the ipsilateral side that the AFSW may be worn.\n16. The participant has a tremor on their ipsilateral side that the AFSW may be worn.\n17. Any concomitant condition that, in the investigator's opinion, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).\n18. Known hypersensitivity or contraindication to direct oral anticoagulants.\n19. Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack.\n20. Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism). AF ablation does not constitute reversible AF.\n21. \\> 5% burden of premature atrial or ventricular depolarizations on pre-enrollment cardiac monitoring.\n22. History of atrial flutter that has not been treated with ablation (participants in atrial flutter and have been ablated are eligible for enrollment).\n23. Stage 4 or 5 chronic kidney disease.\n24. Conditions associated with an increased risk of bleeding:\n\n    * Major surgery in the previous month\n    * Planned surgery or intervention in the next three months that would require cessation of anticoagulation \\> 2 weeks.\n    * History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intra- articular bleeding\n    * Gastrointestinal hemorrhage within the past year unless the cause has been permanently eliminated (e.g., by surgery)\n    * Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days\n    * Hemorrhagic disorder or bleeding diathesis\n    * Need for anticoagulant treatment for disorders other than AF\n    * Uncontrolled hypertension (Systolic Blood Pressure \\>180 mmHg and\u002For Diastolic Blood Pressure \\>100 mmHg)","85 Years",{"count":252,"type":23},5350,[83],"REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk.",[256],"Atrial Fibrillation",[256,258,259,260,261],"Anticoagulation","AF-sensing Smart Watch","Ischemic Stroke","Systemic Embolism",{"date":115,"type":38},{"date":264,"type":38},"2023-07-13",{"date":266,"type":23},"2029-07-31",{"name":44,"class":45},93,{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":18,"minAge":275,"maxAge":160,"enrollmentInfo":276,"targetDuration":4,"studyType":24,"phases":278,"briefSummary":279,"conditions":280,"keywords":284,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":46},"100604386","phase-2-cannabidiol-as-an-adjunct-treatment-for-alcohol-withdrawal-and-craving-100604386","NCT07148843","Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving","Inclusion Criteria\n\n* Meets DSM-5 criteria Moderate or Severe Alcohol Use Disorder\n* Age 21-65\n* Report at least one prior episode of alcohol withdrawal symptoms at least one day in duration that caused significant impairment in functioning (i.e., unable to attend work or engage in typical activities) AND\u002FOR required medications to manage symptoms.\n* Drinking at least 8 drinks a day over the two weeks prior to screening.\n* Negative human chorionic gonadotropin (hCG) on qualitative urine pregnancy screen\n* Shipley vocabulary score \\> 18, corresponding to 5th grade reading level.\n* Demonstrated understanding of informed consent and ability to consent to participation in the study.\n\nExclusion Criteria\n\n* Current or past alcohol-related medical complications including but not limited to cirrhosis of the liver, esophageal varices, pancreatitis, severe gastritis, hemoptysis, hematochezia, or melena.\n* Use of gabapentin, benzodiazepines, or other sedative-hypnotic medications within the week prior to admission\n* Regular use (e.g., more than twice a week) of cannabis or CBD products.\n* Regular use of benzodiazepines (e.g., twice a week or more) within the last three months\n* Meet DSM-5 criteria for moderate-to-severe substance use disorder (SUD), including Cannabis Use Disorder (except for alcohol and tobacco)\n* Urine drug screen indicating the presence of substances other than cannabis at screening.\n* Unstable and\u002For compromising medical or psychiatric conditions that would interfere with participant safety as determined by study physician.\n* Current pregnancy\n* BMI \\\u003C17\n* History of anorexia nervosa or bulimia in the past 2 years\n* History of seizures or seizure disorder outside of alcohol-withdrawal related seizures\n* Systolic blood pressure (SBP) \\> 180, Diastolic Blood Pressure (DBP) \\> 120 or pulse \\> 120 during screening or upon admission\n* Any of the following laboratory values during screening or upon admission:\n\n  * AST \\> 165 U\u002FL (normal range 19-55)\n  * ALT \\> 216 U\u002FL (normal range 19-72)\n  * Alkaline phosphatase \\> 378 U\u002FL (normal range 38-126)\n  * Total bilirubin \\>2.5 mg\u002Fdl (normal values=0.3-1.0 mg\u002FdL)\n  * Non-fasting glucose \\> 250 mg\u002Fml (normal range 65-179)\n  * Hematocrit \\\u003C 38 % (normal range 41-53)\n  * Hemoglobin \\\u003C 12 g\u002Fdl (normal range 13.5-17.5) or any other laboratory value significantly outside the normal range\n* Use of a prescription medication (except for birth control prescriptions) within 14 days of study entry, which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject. This includes any medication in which CYP2C9, CYP2C19, CYP1A2, CYP2B10, or CYP3A4 enzymes are major metabolizers.\n* ECG with corrected QT interval (QTC) \\>\u002F= 500 ms and\u002For presence of clinically significant abnormality\n* Participation in other clinical trials within the past 60 days\n* Court-mandated participation in alcohol treatment or pending incarceration","21 Years",{"count":277,"type":23},105,[26,83],"Cannabidiol (CBD), one of the most prevalent cannabinoids in cannabis (marijuana) has been shown to reduce alcohol withdrawal symptoms in laboratory animals. In people without alcohol use disorder (AUD), CBD has been show to be effective in reducing anxiety, sleep problems, and seizures; all of these are common symptoms of alcohol withdrawal. This randomized placebo-controlled clinical trial will evaluate the potential of CBD to improve alcohol withdrawal symptoms and reduce craving during acute abstinence among individuals with moderate-to-severe AUD. Adult participants with moderate-to-severe AUD will be admitted to an inpatient research unit at the Johns Hopkins Hospital for a 5-day, 4-night stay that includes alcohol abstinence with management of their alcohol withdrawal. In addition to standard care, participants will receive CBD or placebo (no CBD), complete assessments of withdrawal, sleep quality and provide breath and blood samples.",[281,282,283],"Alcohol Use Disorder (AUD)","Withdrawal From Addictive Substance; Detoxification","Craving",[285,286,287],"alcohol abstinence","alcohol withdrawal treatment","detoxification","2026-08-17",{"date":204,"type":38},{"date":291,"type":23},"2026-10-01",{"date":293,"type":23},"2030-10-31",{"name":44,"class":45},{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":24,"phases":305,"briefSummary":306,"conditions":307,"keywords":309,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":211},"100559772","phase-2-bedaquiline-roll-out-evidence-in-contacts-and-people-living-with-hiv-to-prevent-tb-100559772","NCT06568484","Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB","Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB (BREACH-TB)","BREACH-TB","INCLUSION CRITERIA\n\nFor Index Patient\n\n• Any age\n\n* A diagnosis of bacteriologically proven pulmonary TB\n* Initiated on treatment for pulmonary TB within the past 90 days\n* Have at least one close contact that is likely to be eligible for the study\n\nFor PLHIV Indication\n\nIndividuals must meet all of the following inclusion criteria to participate in this study:\n\n* On a dolutegravir-based or other approved integrase inhibitor antiretroviral therapy (ART) regimen that does not interact with bedaquiline or rifapentine.\n\n  * If on a protease inhibitor-based ART regimen, a participant can be enrolled following a 5-day washout with switch to a dolutegravir-based regimen prior to enrollment. A 14-day washout is required for efavirenz-based ART regimen with switch to a dolutegravir-based regimen prior to enrollment\n  * If a participant is not currently on ART or is ART-naïve, the participant must have started a dolutegravir-based ART regimen prior to Enrollment.\n* PLHIV who meet criteria for a TBD close contact should be enrolled under the close contact indication\n\nFor Close Contact Indication (DS- or RR-TB Index Patient)\n\n* Definition of Close Contact (either\u002For):\n\n  o Lives or lived in the same dwelling unit or plot of land and shares or has shared the same housekeeping arrangements as the Index Patient for one or more nights ≤ 90 days prior to the Index Patient starting TB treatment\n\n  o Has shared more than four hours of indoor airspace with the Index Patient during any one-week period ≤ 90 days prior to the Index Patient starting TB treatment. This may include indoor airspace within or outside the home.\n* Close contacts must be in one of the following high-risk groups:\n\n  * All children 0 to \\\u003C5 years old at the time of Enrollment, regardless of LTBI or HIV status\n  * Adults, adolescents, and children ≥5 years of age who are TBI test positive (either skin test positive\\* or IGRA-positive) and whose HIV status is negative, indeterminate, or unknown.\n  * Adults, adolescents, and children ≥5 years of age who have a documented HIV infection regardless of TBI test status.\n\nUniversal Enrollment Inclusion Criteria for PLHIV and Close Contacts of DS- or RR-TB Index Patient\n\nA. Ability and willingness of participant (and\u002For parent\u002Fguardian) to provide informed consent (and assent, as applicable)\n\nB. Documentation of HIV Status\n\nFor participants \\>=18 months of age known to be PLHIV:\n\n* Certified copy of HIV clinic card or\n* Certified copy of HIV testing that includes date, assay used and result\n\nFor participants \\\u003C18 months of age who have never tested, or previous HIV test result was indeterminate, unknown, or negative more than three months prior to screening and\u002For result is not available:\n\n• HIV-1 testing should be performed per Section 5.4.5 (HIV-1 Testing) during the study screen period.\n\nFor participants \\\u003C18 months known to be CLHIV:\n\n• Certified copies of HIV DNA and\u002For RNA testing that includes date, assay used, and result\n\nFor participants \\\u003C18 months who have never tested, or previous HIV test result was indeterminate, unknown, or negative more than three months prior to screening and\u002For result is not available:\n\n• HIV-1 testing should be performed per Section 5.4.5 (HIV-1 Testing) during the study screen period\n\nC. Documentation of ART\n\n* All PLHIV (for PLHIV indication and CC that are PLHIV) must be on a dolutegravir-based or other approved integrase inhibitor ART regimen that does not interact with bedaquiline or rifapentine.\n* If on a protease inhibitor-based ART regimen, a participant can be enrolled following a 5-day washout with switch to a dolutegravir-based regimen prior to enrollment. A 14-day washout is required for efavirenz-based ART regimen with switch to a dolutegravir-based regimen prior to enrollment.\n* If a participant is not currently on ART or is ART-naïve, they must have started a dolutegravir-based ART regimen prior to Enrollment.\n\nD. Chest radiograph without evidence of active TBD, performed within 30 days prior to Enrollment\n\nE. The following laboratory values obtained within 30 days prior to Enrollment.\n\n* Alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal\n* Total bilirubin ≤ 2.5 times the upper limit of normal\n* Alkaline phosphatase ≤ 3 times the upper limit of normal\n* Creatinine clearance ≥ 29 ml\u002Fmin\n* Serum potassium at or above the lower limit of normal\n* Serum magnesium at or above the lower limit of normal\n* Serum calcium at or above the lower limit of normal\n* Platelet count of ≥ 50,000 \u002Fmm3\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm3\n\nF. Pregnancy test (for study candidates of childbearing potential\\*)\n\n• Negative serum or urine pregnancy test within 7 days prior to enrollment.\n\n\\*NOTE: Participants of childbearing potential are defined as females who have reached menarche or who have not been post-menopausal for at least 24 consecutive months (i.e., who have had menses within the preceding 24 months) or have not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or bilateral tubal ligation).\n\nEXCLUSION CRITERIA\n\nExclusion Criteria for Index Patient A. Unwilling or unable to provide informed consent B. No close contacts likely to be eligible for the study C. Study staff unable to obtain status of TB drug susceptibility or resistance D. Known bedaquiline resistance of M. tb isolate E. Known fluoroquinolone resistance of M. tb isolate (for Index Patients with RR-TB)\n\nExclusion Criteria for PLHIV and Close Contacts of DS- or RR-TB Index Patient\n\nA. Unwilling or unable to provide informed consent\n\nB. Weight ≤ 3 kg\n\nC. A current diagnosis of confirmed or probable or possible pulmonary or extrapulmonary TB at time of enrollment or confirmed or unconfirmed TB for children.\n\nD. Previously completed treatment for TBD.\n\nE. Prior completion of TPT (including but not limited to 6 or 9H, 1HP, 3HP, 4R, 3HR, 6Lfx) \\*\n\n\\*NOTE: Completion of TBD treatment or TPT based on the opinion of the site investigator that a sufficient course of TPT was taken to constitute treatment completion\n\nF. Current enrollment into another therapeutic clinical trial (See Section 5.8).\n\nG. Any of the following medical conditions:\n\n* Severe renal impairment (DAIDS Grade 4) or end-stage renal disease requiring hemodialysis or peritoneal dialysis\n* Severe hepatic impairment (Child-Pugh C)\n* Evidence of acute hepatitis, such as abdominal pain, jaundice, dark urine, and\u002For light stools within 90 days prior to enrollment\n* Severe cardiac arrythmia requiring medication\n* Peripheral neuropathy ≥ Grade 2 (DAIDS)\n* Diagnosis of porphyria at any time prior to study enrollment\n* Corrected QTcF (Fridericia's formula) of \\>460 msec\n* Unable to take oral medication\n* Active drug or alcohol use or dependence that, in the site investigator's opinion, would interfere with adherence to study treatment.\n* Serious illness requiring systemic treatment including parenteral therapy (e.g., antibiotics) and\u002For hospitalization within 30 days prior to Enrollment\n* Prior exposure to bedaquiline or clofazimine\n* Receipt of more than 7 cumulative days of isoniazid, a rifamycin, or a fluoroquinolone in the 90 days prior to enrollment\n* Known bedaquiline resistance in Index Patient\n* Known allergy\u002Fsensitivity or any hypersensitivity to components of study drugs or their formulation\n* Currently taking another medication that is prohibited with study medicines which cannot be stopped (with or without replacement) or requires a washout period longer than 14 days (See Appendix 7)\n* Known pregnancy or breastfeeding\n\nSpecific Exclusion Criteria for Close Contacts of RR-TB Index Patient\n\n* Known fluoroquinolone resistance in Index Patient\n* Severe tendinopathy related to fluoroquinolones",{"count":304,"type":23},2530,[26,83],"A seamless, staged Phase II\u002FIII, open-label, multicenter, non-inferiority trial, to compare the efficacy and safety of 4 weeks of bedaquiline (BDQ) versus a a standard regimen for preventing regimen for preventing confirmed or probable tuberculosis disease (TBD) during 72 weeks of follow-up among people living with HIV (PLHIV) and high-risk Close Contacts (CC) of adults with Drug Susceptible (DS) or Rifampin Resistant (RR) TB.",[308],"Tuberculosis, Latent",[310],"Bedaquiline","2026-08-16",{"date":204,"type":38},{"date":314,"type":38},"2026-05-08",{"date":316,"type":23},"2027-09",{"name":44,"class":45},{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":322,"acronym":323,"eligibilityCriteria":324,"healthyVolunteers":185,"sex":18,"minAge":275,"maxAge":325,"enrollmentInfo":326,"targetDuration":4,"studyType":24,"phases":328,"briefSummary":330,"conditions":331,"keywords":333,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":46},"100636423","early-phase-1-psilocybin-administration-with-5-ht1a-blockade-100636423","NCT07565493","Psilocybin Administration With 5-HT1a Blockade","PsilBlock1","Inclusion criteria:\n\n* 21 - 60 years old\n* Must give written or electronic informed consent\n* Must have at least a high-school level of education or equivalent (e.g. GED) and are fluent in English\n* Must be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests\n* Must agree not to take any as needed (PRN) medications on the mornings of drug sessions\n* Must agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.\n* Must agree to refrain from using all psychoactive substances within 24 hours or 5 elimination half-lives (whichever is greater) before psilocybin administration. Caffeine is the exception.\n* Must have a negative urine toxicology report on the same day as drug dosing.\n* Who are female and of child-bearing potential and are sexually active, must agree to use highly effective means of birth control (i.e. implants, injectables, combined oral contraceptives, progestin-containing intrauterine device (IUD) or vasectomized partner) for the duration of this study.\n* Who are male and sexually active, must agree to use contraception and refrain from sperm donation within 90 days of completing dosing sessions. Effective methods of contraception are barrier, hormonal, and sterilization methods.\n\nExclusion Criteria:\n\n* Are currently taking a medication with any significant pharmacokinetic or pharmacodynamic interactions with pindolol (e.g. beta-blockers or other anti-hypertensive medications).\n* Have a history of orthostatic hypotension or low blood-pressure.\n* Have elevated transaminases (2x the upper limit of normal)\n* Have a Child-Pugh score that falls within classes B or C.\n* Are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing.\n* Have cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g. atrial fibrillation, corrected QT interval (QTc) \\> 450 msec), artificial heart valve, symptomatic valvopathy, history of pulmonary hypertension or transient ischemic attack (TIA) in the past year; systolic blood pressure \\> 139, diastolic blood pressure \\> 89\n* Have epilepsy or a history of seizures\n* Have insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia\n* Are currently taking on a regular (e.g. daily) basis any medications having a centrally acting serotonergic effect, including monoamine oxidase inhibitors (MAOIs). For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least five half-lives of the agent have elapsed after the last dose.\n* Have a current diagnosis of schizophrenia spectrum disorders\n* Have a current diagnosis of bipolar spectrum disorders\n* Have a current diagnosis of major depressive disorder or Generalized Anxiety Disorder\n* Have a current diagnosis or history of substance induced psychotic disorder\n* Have a current DSM-5 moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine)\n* Have a first degree relative with bipolar I disorder, or schizophrenia spectrum disorder.\n* Have a psychiatric condition judged to be incompatible with establishment of safe exposure to psilocybin.\n* Have a BMI ≥ 40\n* Report a known history of sleep apnea, symptoms indicative of sleep apnea, or have an Apnea-Hypopnea Index (AHI) \\> 15, or STOP BANG \\>5\n* Taking prescribed hypnotics or other medications known to alter sleep physiology: i.e., Z-drugs, Benzodiazepines, Orexin Agonists or Antagonist, Beta Blockers.\n* Regularly taking over-the-counter sleep aids (inc. melatonin and diphenhydramine) and unwilling to abstain during the study.\n* Insomnia Severity Index ≥ 10","60 Years",{"count":327,"type":23},18,[329],"EARLY_PHASE1","The purpose of this study is to assess the effects of 5-HT1A receptor blockade on the acute subjective effects of psilocybin, as measured through subjective survey measures and acute electroencephalography (EEG). Further, the investigators will assess the effects of psilocybin on post-acute sleep and dreaming through the use of sleep EEG and sleep and dream diaries.",[332],"Psychedelic Effects in Healthy Volunteers",[334,335,336,337,338,339,340,341,342,343],"Psilocybin","Sleep","Dreaming","EEG","5-HT1A","Antagonism","Altered state of consciousness","Subjective experience","Serotonin receptor","Psychedelic","2026-08-13",{"date":346,"type":38},"2026-08-14",{"date":348,"type":38},"2026-08-12",{"date":350,"type":23},"2028-06-15",{"name":44,"class":45},{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":185,"sex":18,"minAge":53,"maxAge":325,"enrollmentInfo":358,"targetDuration":4,"studyType":24,"phases":359,"briefSummary":361,"conditions":362,"keywords":366,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":372,"leadSponsor":374,"locationsCount":46},"100543105","phase-1-examining-the-role-of-tolerance-on-dose-dependent-effects-of-acute-thc-on-oculomotor-and-cognitive-performance-100543105","NCT06351540","Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance","Inclusion Criteria:\n\n* Inclusion criteria: Healthy non-treatment seeking adults (age 18 to 60, N = 40) who report\n* (a) infrequent cannabis use defined as at least one reported use in the past year with a negative THC urine toxicology at baseline, or\n* (b) report frequent cannabis use defined as \\> 5 days per week for \\> 1 year with a positive THC urine toxicology at baseline.\n\nThese criteria were selected to target individuals with low and high-frequency cannabis use in order to examine the direct effect of tolerance on study outcome measures.\n\nExclusion Criteria:\n\n* (1) meet DSM-V criteria for substance use disorders other than tobacco, cannabis, or caffeine,\n* (2) are currently receiving or interested in immediately receiving behavioral treatment or medication for cannabis cessation,\n* (3) current use of any medications that could affect study outcomes,\n* (4) test positive for drugs of abuse (other than cannabis) and\u002For breath alcohol test at study admission,\n* (5) have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity,\n* (6) are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding,\n* (7) have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g. Prinzmetal's angina), or (8) are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.",{"count":220,"type":23},[360],"PHASE1","The purpose of this research is to determine the extent to which oculomotor function accurately detects THC-impairment, if cannabis use experience impacts this detection threshold, and to examine how the oculomotor index corresponds to a measure of sustained attention. A double-blind, placebo-controlled, within-subjects crossover design will be used to examine the dose-effects of THC (0, 5mg, 30mg) on oculomotor performance tasks and a sustained attention task in frequent and infrequent cannabis users. Results from the study will advance the investigators' understanding of the effect of THC and cannabis use frequency on oculomotor function and sustained attention, and will directly inform the validity of the investigators' oculomotor platform for identifying acute THC- induced impairment in frequent and infrequent users.",[363,364,365],"Cannabis Use","Impaired Driving","Cognitive Impairment",[367,368,369],"cannabis","THC","impairment",{"date":346,"type":38},{"date":291,"type":23},{"date":373,"type":23},"2027-07-01",{"name":44,"class":45},{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":18,"minAge":382,"maxAge":383,"enrollmentInfo":384,"targetDuration":4,"studyType":24,"phases":385,"briefSummary":386,"conditions":387,"keywords":389,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":396,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":46},"100391815","phase-2-use-of-n-acetylcysteine-in-the-treatment-of-repetitive-and-self-injurious-behaviors-in-cornelia-de-lange-syndrome-100391815","NCT04381897","Use of N-Acetylcysteine in the Treatment of Repetitive and Self-Injurious Behaviors in Cornelia de Lange Syndrome","Use of N-Acetylcysteine (NAC) in the Treatment of Repetitive Behaviors (RB) and Self-Injurious Behaviors (SIB) in Cornelia de Lange Syndrome: A Randomized Double-Blind Placebo-Controlled Pilot Study","Inclusion Criteria:\n\n* Ages 13 to 35 years\n* A diagnosis of CdLS as determined by a physician during routine care meeting the major and minor criteria from CdLS guidelines\n* Threshold criteria for the presence of RB\u002FSIB as reported on initial screening Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders (CYBOCS-PDD) \\> 6 OR Aberrant Behavior Checklist (ABC) stereotypy subscale \\> 7)\n* Being able to attend 4 visits over the course of 18 weeks at the Johns Hopkins Hospital\n* No acute safety concerns or need for hospitalization due to psychotic, manic or depressive episode\n* Not currently pregnant or lactating\u002Fbreastfeeding. Whether a participant is pregnant or not will be determined by the participant\u002Fcaregiver report based on date last menses. If there is any suspicion of pregnancy, the PI will confer with the family to obtain testing through the primary care provider.\n\nExclusion Criteria:\n\n* Allergy to NAC\n* Allergy to Quinine\n* Contraindication to NAC (organ transplant; untreated or symptomatic gastric condition)\n* Need for another medication with which NAC is contraindicated (antibiotics)","13 Years","35 Years",{"count":22,"type":23},[26],"This research project is a randomized cross-over pilot trial which aims to test the efficacy of N-acetylcysteine (NAC) for the treatment of Repetitive Behaviors (RB) and self-injurious behavior (SIB) in patients with Cornelia de Lange Syndrome (CdLs).\n\nNAC is a known anti-oxidative stress and neuroprotective agent, which has been shown to decrease the occurrence of SIB such as skin picking. NAC has also shown partial response in trials for compulsive behaviors in Obsessive Compulsive Disorder (OCD) and related disorders in autism.\n\nCornelia de Lange syndrome (CdLS) is a genetic disorder with autistic features, including RBs and SIB. In this randomized clinical trial, participants with CdLS will be blindly assigned one of two possible treatment arms: 1) placebo (8 weeks) and NAC (8 weeks); or 2) NAC (8 weeks) and placebo (8 weeks), with an intermediate 2-week washout period.",[388],"Cornelia de Lange Syndrome",[390,391,392,393,394,395],"Repetitive behaviors","Self-injurious behavior","N-acetylcysteine","Genetic disorder","Children","Psychiatric disease",{"date":346,"type":38},{"date":398,"type":23},"2026-11-01",{"date":400,"type":23},"2027-05-01",{"name":44,"class":45},{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":18,"minAge":408,"maxAge":409,"enrollmentInfo":410,"targetDuration":412,"studyType":413,"phases":4,"briefSummary":414,"conditions":415,"keywords":418,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":421,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":46},"100370524","patient-reported-outcomes-for-vascular-malformations-embolization-proven-100370524","NCT04104464","Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)","Inclusion Criteria:\n\n* Male and Female pediatric patients, aged between 0-17 with diagnosis of vascular malformations.\n* Male and Female adult patients aged 18-100 with diagnosis of vascular malformations.\n* Vascular malformation symptoms significant enough to seek treatment.\n\nExclusion Criteria:\n\n* Patients with extensive VM not suitable for sclerotherapy.\n* Prior therapy for treatment of a VM within 3 months.\n* Condition or impairment that may render the patient unable to take part in the study (e.g. cognitive, sight, hearing, etc.).","0 Years","100 Years",{"count":411,"type":23},200,"1 Year","OBSERVATIONAL","The purpose of this study is to develop a standardized assessment for patients treated for venous malformations (VM).\n\nVenous malformations result from the abnormal development of veins which may result in pain, swelling, bleeding, functional impairment, disfigurement, and psychological distress. The impact of VM on patient quality of life varies based on the location and size of the malformation.\n\nA patient reported outcome (PRO) is a patient's own account of patient's health condition. PRO measures are valued to clinicians, as many treatment effects are known only to the patient. No studies to date have analyzed the validity of existing PRO measures for VM patients.\n\nCurrent assessment does not include all symptoms or take in to account the relevance of VM location. Past studies show a discrepancy between treatment outcomes reported by patients and physicians. Therefore, there is a need to develop VM-specific PROs to better understand the effectiveness and benefits of treatment for VM.",[416,417],"Vascular Malformations","VM - Vascular Malformation",[419,420],"vascular malformation","VM",{"date":346,"type":38},{"date":423,"type":38},"2019-07-22",{"date":425,"type":23},"2028-07-31",{"name":44,"class":45},{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":79,"enrollmentInfo":433,"targetDuration":4,"studyType":24,"phases":435,"briefSummary":436,"conditions":437,"keywords":439,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":455},"100649374","phase-2-tirzepatide-for-treatment-of-ccca-100649374","NCT07734870","Tirzepatide for Treatment of CCCA","Inclusion Criteria:\n\n* Age 18 to 80 years.\n* Clinical and\u002For biopsy-confirmed diagnosis of central centrifugal cicatricial alopecia (CCCA).\n* Active CCCA, defined as a C-CAT disease activity score greater than 1.\n* No treatment for CCCA during the 6 weeks before enrollment.\n* Able and willing to complete the study and follow all study procedures.\n* Managed by a Johns Hopkins dermatologist throughout the study.\n\nExclusion Criteria:\n\n* Currently taking an oral or systemic blood glucose-lowering medication.\n* Currently taking another medication for weight loss.\n* Hemoglobin A1C below 5.4%.\n* Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) score below 2.\n* Body mass index below 19 kg\u002Fm².\n* Pregnant, breastfeeding, or planning a pregnancy.\n* Personal or family history of medullary thyroid cancer.\n* Personal or family history of multiple endocrine neoplasia type 2.\n* History of chronic kidney disease.\n* History of pancreatitis.\n* History of diabetic retinopathy.\n* Severe gastrointestinal disease.\n* Recent or planned major surgery.\n* Type 1 diabetes.\n* Any other contraindication to tirzepatide.\n* History of keloids or hypertrophic scarring.\n* History of poor wound healing.\n* History of a blood-clotting disorder.\n* Allergy to lidocaine or epinephrine.\n* Known sensitivity to local numbing medication.\n* Any significant medical condition that the investigator believes would make participation unsafe or prevent completion of the study.",{"count":434,"type":23},20,[26],"The goal of this pilot clinical trial is to learn if tirzepatide can treat active central centrifugal cicatricial alopecia (CCCA), a type of permanent scarring hair loss, in adults. The main questions it aims to answer are:\n\n* Does tirzepatide improve the symptoms and signs of active CCCA?\n* Does tirzepatide change the activity of genes in the scalp, especially genes related to scarring?\n* Does tirzepatide promote hair regrowth?\n\nParticipants will:\n\n* Inject tirzepatide once a week for 12 months.\n* Visit the clinic for scalp examinations, photographs, and other health assessments.\n* Have scalp biopsies at the beginning of the study and after 6 months of treatment.\n* Have blood tests and other safety monitoring during the study.\n\nThere is no separate comparison group. Researchers will compare each participant's results during treatment with the participant's results at the beginning of the study.",[438],"Central Centrifugal Cicatricial Alopecia (CCCA)",[440,441,442,443,444,445,446,447],"Scarring alopecia","Hair loss","Hair regrowth","Scalp fibrosis","Tirzepatide","Metabolic dysfunction","Insulin Resistance","Gene expression","2026-08-11",{"date":348,"type":38},{"date":451,"type":23},"2026-09-15",{"date":453,"type":23},"2028-05-25",{"name":44,"class":45},2,{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":18,"minAge":464,"maxAge":465,"enrollmentInfo":466,"targetDuration":4,"studyType":24,"phases":468,"briefSummary":469,"conditions":470,"keywords":478,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":487,"locationsCount":4},"100643950","early-phase-1-team-based-shared-decision-making-program-in-cardiovascular-kidney-metabolic-health-100643950","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.","30 Years","79 Years",{"count":467,"type":23},94,[329],"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.",[471,472,473,474,475,476,477],"Hypertension (HTN)","Diabetes (DM)","Hyperlipidaemia","Kidney Disease","Obesity","Cardiovascular-kidney-metabolic (CKM)","Overweight",[479,480,481,482],"shared decision-making","Cardiovascular-kidney-metabolic","Behavioral counseling","Team-based care",{"date":348,"type":38},{"date":485,"type":23},"2026-09-10",{"date":209,"type":23},{"name":44,"class":45},{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":494,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":18,"minAge":496,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":24,"phases":499,"briefSummary":501,"conditions":502,"keywords":504,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":511,"startDateStruct":512,"completionDateStruct":513,"leadSponsor":515,"locationsCount":455},"100634462","phase-4-the-intervening-for-lung-health-trial-100634462","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":498,"type":23},800,[500],"PHASE4","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.",[503],"Spirometry",[505,506,507,508,509,510],"Tobacco Prevention","Air Pollution","Physical Activity","Behavioral Intervention","Human-Centered Design","Infectious Risk",{"date":348,"type":38},{"date":451,"type":23},{"date":514,"type":23},"2030-07-01",{"name":44,"class":45},{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":409,"enrollmentInfo":524,"targetDuration":4,"studyType":24,"phases":525,"briefSummary":526,"conditions":527,"keywords":532,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":46},"100651293","early-phase-1-guanfacine-and-cromolyn-sodium-for-pots-the-dbpots-trial-100651293","NCT07757555","Guanfacine and Cromolyn Sodium for POTS: The DBPOTS Trial","Efficacy and Mechanisms of Guanfacine and Cromolyn Sodium in Adults With Postural Orthostatic Tachycardia Syndrome (POTS): A Randomized, Double-Blind, Placebo-Controlled Crossover Clinical Trial. Acronym is DBPOTS (Double Blind POTS)","DBPOTS","Inclusion Criteria:\n\n* Documented diagnosis of POTS per current consensus guidelines:\n* a heart rate increase of ≥30 bpm within the first 10 minutes of standing or tilt-table testing, without orthostatic hypotension (systolic BP drop ≥20 mmHg)\n* Frequent symptoms of orthostatic intolerance (e.g., dizziness, palpitations, GI complaints) persisting ≥3 months\n* Symptom onset within 3 months of a recognized POTS trigger (e.g., infection, vaccination, injury, surgery, pregnancy, or puberty)\n* Symptomatic response to mediator-targeting medications (e.g., antihistamines, mast cell stabilizers) - also eligible\n* Presence of flushing, pruritis, urticaria, or angioedema - also eligible\n* Alternative diagnoses must be excluded via prior clinical workup and laboratory assessment\n\nExclusion Criteria:\n\n* Alternative medical causes for symptoms, including:\n* Anemia,\n* Active infection,\n* Dehydration,\n* Hyperthyroidism,\n* Pheochromocytoma,\n* Adrenal insufficiency,\n* Paraneoplastic conditions\n* Active neurologic disease (including stroke and epilepsy)\n* Prolonged immobilization\n* Current use of medications that cannot be safely discontinued during study enrollment (safety-based exclusion)\n* Pregnancy or breastfeeding",{"count":7,"type":23},[329],"The goal of this clinical trial is to learn whether guanfacine or cromolyn sodium can improve symptoms and physical functioning in adults with Postural Orthostatic Tachycardia Syndrome (POTS). Both medications are FDA-approved for other conditions but are investigational for the treatment of POTS.\n\nThe main questions this study aims to answer are:\n\nDoes treatment with guanfacine or cromolyn sodium improve physical functioning in adults with POTS compared with placebo? Does treatment with guanfacine or cromolyn sodium improve fatigue, cognitive function (\"brain fog\"), gastrointestinal symptoms, and overall symptom burden in adults with POTS?\n\nResearchers will compare guanfacine, cromolyn sodium, and placebo to determine whether either active treatment provides greater improvement in symptoms and physical functioning than placebo.\n\nParticipants will:\n\nBe randomly assigned to receive guanfacine, cromolyn sodium, and placebo during separate 4-week treatment periods in a randomized, double-blind crossover study.\n\nContinue standard non-drug POTS management, including recommendations for fluid and salt intake, exercise, compression garments, and other lifestyle measures.\n\nComplete questionnaires that measure physical function, fatigue, cognitive symptoms, gastrointestinal symptoms, and overall health throughout the study.\n\nAttend scheduled study visits for safety monitoring and assessment of study outcomes.\n\nProvide blood, urine, and sputum samples so researchers can evaluate biomarkers related to POTS and better understand how these treatments may work.",[528,529,530,531],"Postural Orthostatic Tachycardia Syndrome (POTS)","Dysautonomia","Orthostatic Intolerance","Autonomic Nervous System Diseases",[528,529,530,533,534,535,536,537,538,539,540,541,542,543,544,545,546,547,548,549,550,551],"Autonomic Nervous System Disorders","Hyperadrenergic POTS","Adult POTS","Guanfacine","Cromolyn Sodium","Re-purposed FDA-approved drugs","Sympatholytic therapy","Placebo-Controlled","Phase II Exploratory Trial","Comparative Effectiveness","Autonomic Dysfunction","Voltage-Gated Sodium Channels","SCN9A","SCN10A","NaV Channels","Ion Channelopathy","Cognitive Dysfunction","Brain Fog","Fatigue","2026-08-10",{"date":348,"type":38},{"date":555,"type":23},"2026-08-15",{"date":557,"type":23},"2028-02-02",{"name":44,"class":45},{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":185,"sex":18,"minAge":53,"maxAge":566,"enrollmentInfo":567,"targetDuration":4,"studyType":24,"phases":568,"briefSummary":569,"conditions":570,"keywords":572,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":577,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":46},"100637962","phase-1-the-pharmacokinetics-of-a-hemp-based-topical-product-100637962","NCT07603518","The Pharmacokinetics of a Hemp-Based Topical Product","The Pharmacokinetics of a Hemp-Based Topical Cannabinoid Product in a Sanitized and Controlled Environment","Inclusion Criteria:\n\n* Have provided written informed consent\n* Be between the ages of 18 and 55\n* Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests\n* Test negative for recent cannabis use in urine at the screening visit and again upon admission for the inpatient stay.\n* Test negative for other drugs of abuse, including alcohol, at the screening visit and again upon admission for the inpatient stay.\n* Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at each study visit.\n* Have a body mass index (BMI) in the range of 18 to 38 kg\u002Fm2\n* Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg\n* Report prior experience using cannabis or CBD products.\n\nExclusion Criteria:\n\n* Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the month prior to the screening visit.\n* History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.\n* Current use of medications which, in the opinion of the investigator or medical monitor, will interfere with the study results or the safety of the subject.\n* History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.\n* Known allergy to any ingredients in the study drug.\n* Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.","55 Years",{"count":434,"type":23},[360],"This study will evaluate the pharmacokinetic effects of acute and chronic dosing of a hemp-based cannabidiol (CBD) topical lotion with low levels of delta-9-tetrahydrocannabinol (THC) in a sanitized and controlled environment.",[571],"Cannabis",[573,574,575,576],"Cannabinoids","Pharmacology","Contamination","Hemp lotion",{"date":348,"type":38},{"date":579,"type":38},"2026-05-26",{"date":581,"type":23},"2026-09",{"name":44,"class":45},{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":18,"minAge":408,"maxAge":79,"enrollmentInfo":589,"targetDuration":4,"studyType":24,"phases":591,"briefSummary":592,"conditions":593,"keywords":597,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":4},"100599024","3d-printed-occlusal-splints-for-intraoperative-use-100599024","NCT07079111","3D Printed Occlusal Splints for Intraoperative Use","Inclusion Criteria:\n\n* Patients of any age who require any orthognathic surgery (including, but not limited to, facial fracture reduction and fixation, mandibular or maxillary reconstruction, cranial vault reconstruction, mandibular osteotomies, maxilla osteotomies) at Johns Hopkins Hospital.\n\nExclusion Criteria:\n\n* Patients who are non-English speaking.\n* Surgeons who do not perform orthognathic surgery with occlusal splints.",{"count":590,"type":23},70,[57],"A 3D printed intraoperative occlusal splint is a custom-made biocompatible resin guide that allows surgeons properly align a patient's upper and lower dentition during surgery. This alignment further places maxilla and mandible into proper position. An occlusal splint contains outlines maxillary and mandibular dentition allowing the teeth to lock into place with correct alignment.\n\nAt Johns Hopkins, traditionally hand-made and industry-made 3D printed splints have been used safely. However, prior studies have demonstrated the ability of in-house 3D prints to save time and money compared to industry. In-house models are similarly produced with FDA-clear, biocompatible resin for 3D printing, and maintain equivalent safety for patients compared to industry-made models.",[594,595,596],"Malocclusion, Angle Class I","Malocclusion, Angle Class II","Malocclusion, Angle Class III",[598],"malocclusion",{"date":448,"type":38},{"date":601,"type":23},"2026-12-30",{"date":603,"type":23},"2030-08-30",{"name":44,"class":45},{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":611,"eligibilityCriteria":612,"healthyVolunteers":185,"sex":613,"minAge":53,"maxAge":614,"enrollmentInfo":615,"targetDuration":4,"studyType":24,"phases":616,"briefSummary":617,"conditions":618,"keywords":620,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":630,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":46},"100488967","phase-2-uterus-transplantation-to-treat-infertility-100488967","NCT05646992","Uterus Transplantation to Treat Infertility","OPRTUNTI: Offering Potential for Reproduction Through Transplantation of Uterus iN the Treatment of Infertility","OPRTUNTI","INCLUSION CRITERIA -\n\nRecipient Inclusion Criteria:\n\n* Genotypic female of any race, color, or ethnicity.\n* Uterine factor infertility.\n* Aged 18-38 years at time of egg retrieval.\n* Strong desire to undergo uterus transplant in order to become pregnant and give birth to a child.\n* Embryo cryopreservation with embryos located at Johns Hopkins:\n\n  * Has a minimum of 4-8 cryopreserved normal embryos following Preimplantation Genetic Screening (PGS-screening).\n\nOR o Is willing to undergo egg retrieval, in vitro fertilization, and PGS-screening to cryopreserve a minimum of 4-8 normal embryos.\n\n* Willingness to undergo embryo implantation after uterus transplantation to achieve pregnancy.\n* In the opinion of the study team, makes a reasonable effort to identify and refer her own potential uterus donor to the study team.\n* Completes the protocol informed consent form.\n* Non-smoker, defined by having never smoked or having quit \\>6 consecutive months prior to screening.\n* No co-existing medical condition which, in the opinion of the study team, could affect the immunosuppression protocol, surgical procedure, or ability to be pregnant or bear a child. (See Donor and Recipient Exclusion Criteria below. If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of uterus transplantation.)\n* Negative serum pregnancy test.\n* Blood type compatible with donor.\n* Negative crossmatch with donor.\n* Patient agrees to comply with the protocol and states a dedication to the treatment regime.\n* Agrees to uterus explanation following birth of a child and or 5 years without successful pregnancy.\n\nDonor Inclusion Criteria:\n\n* Genotypic female with an intact uterus.\n* Medical history includes known successful pregnancy (e.g., gravid uterus).\n* Aged 25 - 65 years.\n* Consents to uterus donation and required pre-donation screening.\n* For females of child-bearing potential: Negative serum pregnancy test.\n* Blood type compatible with recipient.\n* Negative crossmatch with recipient.\n\nDonor and Recipient Inclusion Criteria:\n\n* USA citizen or equivalent.\n* No co-existing psycho-social problems (i.e., alcoholism, drug abuse).\n* BMI ≤35\n\n  o A higher BMI may be accepted at the discretion of the study team.\n* Negative for HIV at transplant.\n* Negative for malignancy for past 5 years.\n\nEXCLUSION CRITERIA-\n\nDonor and Recipient Exclusion Criteria:\n\n* Positive for any of the following conditions:\n\n  * Insulin-dependent diabetes mellitus.\n  * Untreated sepsis.\n  * HIV (active or seropositive).\n  * Active tuberculosis.\n  * Active Hepatitis B infection.\n  * Active Hepatitis C infection.\n  * Viral encephalitis.\n  * Toxoplasmosis.\n  * Current\u002Frecent (within 3 months of donation\u002Fscreening consent) IV drug abuse.\n  * Significant cardiac disease\n  * Significant vascular disease o\n* Sensitized recipients with high levels (50%) of panel-reactive Human Leukocyte Antigens (HLA) antibodies.\n* Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias, Sickle Cell disease, etc.\n* Mixed connective tissue diseases and collagen diseases that can result in poor wound healing after surgery.\n* Severe neurologic deficits.\n* Patients considered unsuitable per the consulted Psychiatric\u002FPsychologic appraisal.\n* A history of medical non-compliance.\n\nDonor Only Exclusion Criteria:\n\n* Previous injury to the uterus including giving birth by Cesarean section.\n* History of radiation therapy to the abdominal area.\n* Other medical conditions, as determined by the study physicians, that would preclude donation.\n\nRecipient Only Exclusion Criteria:\n\n• Conditions that, in the opinion of the study team, may expose the recipient to unacceptable risks under immunosuppressive treatment.","FEMALE","38 Years",{"count":220,"type":23},[26,83],"This research study will use uterus transplantation to treat uterine factor infertility, also known as the inability to bear children due to not having a uterus. The purpose of this study is to enable women seeking genetically-related children and the childbearing experience to experience pregnancy and birth a child. In this study, living donors will undergo surgery to give the donor's uterus to another woman. The woman who receives the transplant will take immunosuppression to keep the uterus and herself healthy. Because taking immunosuppressive medicine has side effects, uterus transplantation is intended to be temporary, lasting about 5 years.\n\nThe goals of the study are successful pregnancy and the birth of one, and possibly two, healthy babies per transplant patient. The uterus is to be removed and immunosuppression stopped following the birth of a child. Offspring are delivered by Caesarian section, at which time the transplant may also be removed.\n\nTransplant candidates must have fertilized, frozen (cryopreserved) embryos at a Johns Hopkins facility before undergoing transplantation. Transplant candidates will be asked to identify candidates' potential uterus donor. Altruistic donors, or women who want to donate without knowing a potential recipient, may also participate. All potential donors will be screened to see if the donors are a good match for a recipient and are healthy enough to have the donation surgery.\n\nStudy Duration:\n\n* Uterus Donors: Screening through about 12 months following the transplant operation.\n* Uterus Recipients: Recipients may have the uterus for about 5 years. After the transplant is removed, the study team will ask for yearly follow-ups for another 5 years.\n* Children born from transplanted uteruses: The study team asks to follow offspring yearly through age 21 years.",[619],"Uterine Factor Infertility",[621,622,623,624,625,626,627,628,629],"Uterus\u002FTransplantation","Uterus\u002FSurgery","Vascularized Composite Allotransplantation (VCA)","Immunosuppression","Mayer-Rokitansky-Küster-Hauser (MRKH)","Allotransplantation","Humans","Female","Hysterectomy",{"date":448,"type":38},{"date":632,"type":38},"2023-03-01",{"date":634,"type":23},"2043-02-28",{"name":44,"class":45},{"id":637,"slug":638,"hasResults":12,"nctId":639,"briefTitle":640,"officialTitle":640,"acronym":4,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":160,"enrollmentInfo":642,"targetDuration":4,"studyType":24,"phases":644,"briefSummary":645,"conditions":646,"keywords":653,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":655,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":660,"locationsCount":46},"100200733","phase-2-human-craniomaxillofacial-allotransplantation-100200733","NCT01889381","Human Craniomaxillofacial Allotransplantation","Inclusion Criteria:\n\n* Recent (≥6 months) or remote (i.e., several decades) craniomaxillofacial injury\n* Male or female and of any race, color, or ethnicity.\n* Aged 18-65 years.\n* Strong desire to undergo craniomaxillofacial transplantation.\n* Completes the protocol informed consent form.\n* Non-smoker, defined by having never smoked or having quit \\>6 consecutive months prior to screening.\n* No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results (see Exclusion Criteria below. If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of full or partial craniomaxillofacial transplantation.)\n* No co-existing psycho-social problems (i.e., alcoholism, drug abuse).\n* Negative for malignancy for past 5 years.\n* Negative for HIV at transplant.\n* Negative crossmatch with donor.\n* If female of child-bearing potential, negative serum pregnancy test.\n* If female of child-bearing potential, consent to use reliable contraception for at least one year following transplantation.\n* Consents to cell collection, storage, and bone marrow infusion as part of the treatment regime.\n* USA citizen or equivalent.\n* Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime.\n\nExclusion Criteria:\n\n* Positive for any of the following conditions:\n\n  * Untreated sepsis.\n  * HIV (active or seropositive).\n  * Active tuberculosis.\n  * Active Hepatitis B infection.\n  * Hepatitis C.\n  * Viral encephalitis.\n  * Toxoplasmosis.\n  * Malignancy (within past 5 years).\n  * Current\u002Frecent (within 3 months of donation\u002Fscreening consent) IV drug abuse.\n  * Paralysis of ischemic, traumatic, or congenital origin.\n  * Infectious, post infectious, or inflammatory (axonal or demyelinating) neuropathy.\n  * Toxic neuropathy (i.e. heavy metal poisoning, drug toxicity, industrial agent exposure).\n  * Mixed connective tissue disease.\n* Conditions that, in the opinion of the study team, may impact the immunomodulatory protocol potentially exposing the recipient to an unacceptable risk under immunosuppressive treatment.\n* A history of medical non-compliance.\n* Sensitized recipients with high levels (50%) of panel-reactive Human Leukocyte Antigen (HLA) antibodies.\n* Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias, Sickle Cell disease, etc.\n* Mixed connective tissue diseases and collagen diseases can result in poor wound healing after surgery.\n* Conditions that may impact functional outcomes including Lipopolysaccharidosis and amyloidosis (may impact nerve regeneration) or rare disorders of bone healing like osteopetrosis.\n* Subjects with inadequate donor sites for autologous reconstruction in the event of post-transplant flap failure.\n* Patients considered unsuitable per the consulted Psychiatric\u002F Psychologic appraisal.",{"count":643,"type":23},15,[26],"Background: The human face is critically important for breathing, eating, seeing, and speaking\u002F communicating, but its most important job may be to look like a human face. Devastating facial deformities often cause affected individuals to avoid human contact and disappear from society. Although current surgical advancements can somewhat restore facial defects, this process often requires many operations and the resulting face only resembles the human face. To date, over 20 face transplants have been performed with highly encouraging functional and aesthetic results, but widespread clinical use has been limited due to the adverse effects of life-long and high-dose immunosuppression needed to prevent graft rejection. Risks include infection, cancer, and metabolic problems, all of which can greatly affect recipients' quality of life, make the procedure riskier, and jeopardize the potential benefits of face transplantation.\n\nStudy Design: This non-randomized, Phase II clinical trial will document the use of a new immunomodulatory protocol (aka - Pittsburgh Protocol, Starzl Protocol) for establishing face transplantation as a safe and effective reconstructive treatment for devastating injuries\u002F defects by minimizing maintenance immunosuppression therapy in face transplant patients. This protocol combines lymphocyte depletion with donor bone marrow cell infusion and has enabled graft survival using low doses of a single immunosuppressive drug followed by weaning of treatment. Initially designed for living-related solid organ donation, this regimen has been adapted for use with grafts donated by deceased donors. The investigators propose to perform 15 full or partial human face transplants employing this novel protocol.\n\nSpecific Aims: 1) To establish face transplantation as a safe and effective reconstructive strategy for the treatment of devastating facial injuries\u002Fdefects; 2) To reduce the risk of rejection and enable allograft survival while minimizing the requirement for long-term, high-dose, multi-drug immunosuppression.\n\nSignificance of Research: Face transplantation could help injured individuals recover functionality, self-esteem, and the ability to reintegrate into family and social life as \"whole\" individuals. This protocol offers the potential for minimizing the morbidity of maintenance immunosuppression, thereby beneficially shifting the risk\u002Fbenefit ratio of this life-enhancing procedure and enabling a wider clinical application of face transplantation.",[647,648,649,650,651,652],"Facial Injuries","Traumatic Wounds and Injuries","Craniofacial Injuries","Craniofacial Defects","Facial Transplantation","Facial Deformity",[647,654,651,652],"Face Transplant",{"date":448,"type":38},{"date":657,"type":38},"2012-08",{"date":659,"type":23},"2031-08",{"name":44,"class":45},{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":665,"acronym":4,"eligibilityCriteria":666,"healthyVolunteers":12,"sex":18,"minAge":53,"maxAge":4,"enrollmentInfo":667,"targetDuration":4,"studyType":24,"phases":669,"briefSummary":670,"conditions":671,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":672,"lastUpdatePostDateStruct":673,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":677,"locationsCount":46},"100566555","early-phase-1-effects-of-psilocybin-in-patients-with-amyotrophic-lateral-sclerosis-100566555","NCT06656702","Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis","Inclusion Criteria:\n\n1. Patients aged 18 years and older.\n2. Patients must fulfill ALS El Escorial criteria for possible, probable, laboratory supported probable or definite ALS.\n3. Patients with a pulmonary forced vital capacity (FVC) \\>50%. The investigators have chosen this measure of function to account for respiratory decompensation during the 6-month longitudinal portion of the study.\n4. Patients with ability to swallow tablets by mouth. Participants may have a feeding tube, but must be able to swallow by mouth and cannot use the feeding tube to administer the psilocybin tablet.\n5. Clinically significant depressive symptoms as evidenced by an Assessment of Depression Inventory (ADI)-12 score \\>22.\n\nExclusion Criteria:\n\n1. Patients with severe speech impairments, including those who are nonverbal, require assisted speech devices, and those who can only communicate by writing or texting.\n2. Patients who are unable to consent for themselves.\n3. Patients with tracheostomy or continuous continuous positive airway pressure (CPAP) or BiPAP.\n4. Known clinical evidence of frontotemporal dementia.\n5. Cardiovascular conditions: corrected QT interval (QTc) \\>450 msec, uncontrolled hypertension (i.e., systolic blood pressure (SBP)\\> 139 mm Hg, diastolic blood pressure (DBP)\\> 89 mm Hg), resting heart rate (HR)\\> 90 beats per minute, angina, a clinically significant ECG abnormality (e.g., atrial fibrillation), transient ischemic attack (TIA) in the last 6 months, stroke, peripheral or pulmonary vascular disease (no active claudication).\n6. Epilepsy with history of seizures\n7. Renal disease (creatinine clearance \\\u003C40 ml\u002Fmin using the Cockraft and Gault equation)\n8. Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia\n9. Females who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control (i.e., intrauterine systems\u002Fdevices, hormonal methods including implant, shot, patch, ring, or oral contraceptive, condom, diaphragm, sterilization, and abstinence).\n10. Currently taking medications that interact with psilocybin on a regular (e.g., daily) basis: Atypical antidepressants, such as mirtazapine (Remeron), trazodone (Oleptro), vortioxetine (Brintellix), and vilazodone (Viibryd); Tricyclic antidepressants, such as amitriptyline, imipramine (Tofranil), nortriptyline (Pamelor), desipramine (Norpramin), doxepin, trimipramine (Surmontil), and protriptyline (Vivactil); and Monoamine oxidase inhibitors (MAOIs), such as Selegiline (Emsam), tranylcypromine (Parnate), phenelzine (Nardil) and isocarboxazid (Marplan).\n11. Currently taking Nuedexta (dextromethorphan\u002Fquinidine combination), efavirenz, Acetaldehyde dehydrogenase inhibitors such as disulfiram (Antabuse), Alcohol dehydrogenase inhibitors, or UGT1A9 inhibitors or UGT1A10 inhibitors such as phenytoin, regorafenib, eltrombopag.\n12. Current or history of meeting Diagnostic and Statistical Manual (DSM)-5 criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I Disorder\n13. Have a first degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I disorder.",{"count":668,"type":23},24,[329],"This study aims to study the feasibility of psilocybin therapy for patients with Amyotropic Lateral Sclerosis (ALS) with depressed mood. The secondary objective is to assess its impact on depression, quality of life, hopelessness, and functional status in this patient population.",[139],"2026-08-07",{"date":448,"type":38},{"date":675,"type":38},"2025-04-09",{"date":373,"type":23},{"name":44,"class":45},{"id":679,"slug":680,"hasResults":12,"nctId":681,"briefTitle":682,"officialTitle":682,"acronym":683,"eligibilityCriteria":684,"healthyVolunteers":12,"sex":18,"minAge":275,"maxAge":4,"enrollmentInfo":685,"targetDuration":4,"studyType":24,"phases":687,"briefSummary":688,"conditions":689,"keywords":691,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":672,"lastUpdatePostDateStruct":696,"startDateStruct":697,"completionDateStruct":699,"leadSponsor":701,"locationsCount":46},"100510637","self-administered-gaming-and-exercise-at-home-sageh-100510637","NCT05929027","Self-Administered Gaming and Exercise at Home (SAGEH)","SAGEH","Inclusion Criteria:\n\n1. Age 21 years and over\n2. Stroke confirmed by CT or MRI within the previous 6 weeks.\n3. Arm and\u002For hand impairment induced by the stroke.\n4. Meet JSTTEP criteria and are enrolled in JSTTEP.\n5. Admitted to the Johns Hopkins Hospital (JHH) inpatient stroke service.\n6. Proficient in speaking and reading English.\n7. Willing and capable to contacted remotely for all necessary telemedicine contacts.\n8. No history of prior ischemic or hemorrhagic stroke with associated motor deficits (prior stroke with no upper limb motor symptoms is allowed)\n9. Ability to give informed consent.\n\nExclusion Criteria:\n\n1. Arm impairment that is too severe (FM-UE \\\u003C 40) on day of baseline testing prior to beginning of the study.\n2. Recent Botox injection to upper limb (since stroke onset).\n3. History of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, Parkinson's disease).\n4. Terminal illness with life expectancy \\\u003C 6 months.\n5. Inability to sit in a chair and perform hand exercises for 20 minutes at the time.\n6. Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤ 20.\n7. Social and\u002For personal circumstances that prevent telemedicine follow-up.",{"count":686,"type":23},60,[57],"This study aims at comparing manual function outcomes between the standard of care and additional self-administered hand therapy after stroke. Strokes are common neurological injuries, and although rates of survival have increased in recent decades, survivors often continue to experience deficiencies in hand dexterity and bimanual function. Most motor recovery takes place within the first 3 months after a stroke. This initial period is necessary for stabilizing the patient but also provides different opportunities to foster motor recovery. Functional gains, including instances after the post-acute period, have been observed after regular and frequent (high dosage) therapy, suggesting that recovery is likely influenced by practice-driven sensorimotor learning. These findings motivate the implementation of daily therapeutic regimes beyond post-stroke hospitalization and basic motor function, aiming instead at addressing overlooked deficiencies in manipulation and bimanual coordination. While some hand therapy is often provided during outpatient therapy visits (the standard of care), self-administered sessions play a large role in implementing additional daily therapy. As a result, the investigators are interested in both the implementation of self-administered regimes and measuring clinical outcomes with and without self-administered therapy.",[145,690],"Hand Weakness",[692,693,694,695],"stroke","stroke recovery","hand weakness","video game",{"date":448,"type":38},{"date":698,"type":38},"2023-09-28",{"date":700,"type":23},"2027-12",{"name":44,"class":45},""]