[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Vanderbilt University Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":633},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,131,0,25,[9,50,83,114,132,157,181,212,234,262,284,308,326,345,366,390,420,439,461,482,508,533,562,582,606],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100422592","use-of-accelerometer-for-quantification-of-neurogenic-orthostatic-hypotension-symptoms-100422592",false,"NCT04782830","Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms","Inclusion Criteria:\n\n* Male and female subjects, age 40-80 years.\n* Possible or probable Multiple Systems Atrophy, Pure Autonomic Failure, or Parkinson's disease with neurogenic orthostatic hypotension.\n* Neurogenic orthostatic hypotension defined as a ≥ 30 mmHg decrease in systolic blood pressure within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes.\n* Patients on treatment for neurogenic orthostatic hypotension with either midodrine or atomoxetine, who have experienced some improvement in their orthostatic symptoms, but still remain symptomatic (Orthostatic hypotension symptom assessment \\[OHSA\\] score of 1 to 5 while on medication).\n* Patients who are able to stay with their caregiver during study participation.\n* Able and willing to provide informed consent.\n\nExclusion Criteria:\n\n* Bedridden, physically disabled, or unable to walk.\n* Patients with Orthostatic hypotension symptom assessment (OHSA) score ≥ 6, or orthostatic systolic blood pressure drop ≥ 30 mmHg on their regular treatment.\n* Patients taking more than one medication for the treatment of neurogenic orthostatic hypotension (concomitant use of pyridostigmine or fludrocortisone are accepted).\n* Pregnancy\n* Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathies, and autoimmune neuropathies.\n* Clinically unstable coronary artery disease (recurrent angina despite medical therapy), or major cardiovascular or neurological event in the past 6 months (myocardial infarction, stroke).\n* Concomitant use of anticoagulants.","ALL","40 Years","80 Years",{"count":20,"type":21},29,"ESTIMATED","INTERVENTIONAL",[24],"NA","The objective of this study is to find a more objective and accurate way to assess the efficacy of the treatment for neurogenic orthostatic hypotension. For this purpose, the investigators will use an activity monitor to determine the amount of time patients spend in the upright position (standing and walking; upright time) during 1 week of placebo (a pill with no active ingredients) and 1 week of their regular medication for orthostatic hypotension (midodrine or atomoxetine at their usual doses). Total upright time (i.e. tolerance to standing and walking) will be compared between placebo and active treatment to test the hypothesis that it can be used to assess the efficacy of the treatment for orthostatic hypotension and whether this outcome is superior to the assessment of symptoms using validated questionnaires.",[27,28,29,30,31],"Orthostatic; Hypotension, Neurogenic","Autonomic Failure","Pure Autonomic Failure","Multiple System Atrophy","Orthostatic; Hypotension, Parkinsonism",[33,34,35,36],"orthostatic hypotension","autonomic failure","accelerometer","orthostatic symptoms","RECRUITING","2026-06-29",{"date":40,"type":41},"2026-07-02","ACTUAL",{"date":43,"type":41},"2021-02-05",{"date":45,"type":21},"2027-10-01",{"name":47,"class":48},"Vanderbilt University Medical Center","OTHER",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":57,"targetDuration":59,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100644920","modeling-mortality-in-duchenne-muscular-dystrophy-cardiomyopathy-identification-of-surrogate-outcome-measures-for-dmd-drug-trials-100644920","NCT07674758","Modeling Mortality in Duchenne Muscular Dystrophy Cardiomyopathy: Identification of Surrogate Outcome Measures for DMD Drug Trials","Evaluating Cardiac Function in Patients With Duchenne Muscular Dystrophy","Inclusion Criteria:\n\n* Clinical phenotype of Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD), or muscular dystrophy carrier (MDC) confirmed with muscle biopsy or genotype\n\nExclusion Criteria:\n\n* Additional genetic or congenital abnormality that may affect cardiovascular function or progression\n* Current investigational therapy that may affect cardiovascular function (would preclude ongoing data collection but prior data would still be used)",{"count":58,"type":21},1000,"5 Years","OBSERVATIONAL","Dystrophin associated heart dysfunction is a leading cause of death in patients with Duchenne and Becker Muscular dystrophy (DMD\u002FBMD) and Duchenne and Becker muscular dystrophy carriers (MDC); however, the evolution of heart dysfunction is not well-understood. The central objectives of this proposal are to elucidate this evolution of heart dysfunction and identify measures from cardiac MRI images that can predict death or significant heart disease in patients with DMD\u002FBMD\u002FMDC. This study will create a large clinical and cardiac MRI registry of dystrophin associated heart dysfunction, will utilize advanced image analysis techniques, including deep learning neural networks, to comprehensively evaluate every patient, and will create a risk toolkit accessible to clinicians around the world; this proposal has the potential to improve the quality of life in patients with dystrophin associated heart dysfunction by allowing for earlier and more intensive therapy in patients with severe disease and by identifying surrogate outcome measures for use in therapeutic trials.",[63,64,65,66],"Duchenne Muscular Dystrophy (DMD)","Cardiomyopathy","Becker Muscular Dystrophy","Carrier of Duchenne Muscular Dystrophy",[68,69,70,71,72,73],"Duchenne Muscular Dystrophy","cardiomyopathy","machine learning","cardiac MRI","Biomarker","Outcome measures","2026-06-24",{"date":76,"type":41},"2026-06-30",{"date":78,"type":41},"2025-01-06",{"date":80,"type":21},"2029-02-01",{"name":47,"class":48},9,{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":16,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":49},"100645169","patient-oriented-research-to-optimize-cochlear-implant-outcomes-100645169","NCT07678879","Patient-Oriented Research to Optimize Cochlear Implant Outcomes","Inclusion Criteria:\n\n1. Adults between ages of 18 years and 95 years\n2. Native language is American English\n3. Have one or two CIs from any of the three FDA-approved CI manufacturers (Cochlear Americas, Advanced Bionics, MED-EL).\n4. Experience of \\>6 of CI use.\n\nExclusion Criteria:\n\n1. Score 24 or below on a visual Mini-Mental State Exam (MMSE; Folstein et al., 1975) to rule out dementia\n2. Known diagnosis of dementia\n3. Under the age of 18 years\n4. Unable to read and write in English (WRAT score \\\u003C70)\n5. Poorer than 20\u002F40 near vision on near-vision screening.","18 Years","95 Years",{"count":92,"type":21},100,[24],"The rationale is that only through understanding how individual Cochlear Implant (CI) patients respond to interventions investigators further develop precision-medicine approaches to optimize outcomes. In the proposed research study to investigate the hypotheses, investigators will address two Specific Aims:\n\nSpecific Aim #1: Define the auditory (bottom-up), cognitive-linguistic (top-down), and functional neuroimaging profiles of adult CI users. Investigators will enroll experienced CI users (\\> 6 months of CI use).\n\nSpecific Aim #2: Determine the feasibility of \"auditory\" (bottom-up) and \"cognitive\" (top-down) interventions to improve speech processing in adult CI users.\n\nThe main hypothesis is that the two interventions are feasible. Investigators also hypothesize that our study protocol will detect the variance in auditory processing profiles and that investigators will show promise in improving both speech processing (using speech recognition and Functional Near-Infrared Spectroscopy (fNIRS) responses)) and real-world functioning (using patient-reported measures), compared with no intervention.\n\nAdditional hypotheses to be explored are that baseline profile (as defined in Aim #1) will impact the magnitude of participants' responses to the interventions, as will order of interventions (Auditory-Cognitive vs. Cognitive-Auditory, AC vs CA).",[96,97,98,99],"Cochlear Implant","Cochlear Implant Users","Cochlear Implant Recipients","Cochlear Implant Listeners",[101,102,103,104,105],"CI users","CI","cochlear implant","cochlear implant user","cochlear","NOT_YET_RECRUITING",{"date":108,"type":41},"2026-07-01",{"date":110,"type":21},"2026-07",{"date":112,"type":21},"2032-06",{"name":47,"class":48},{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":49},"100477766","ansa-cervicalis-and-hypoglossal-nerve-stimulation-in-osa-100477766","NCT05501236","Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA","Ansa Cervicalis and Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea","Inclusion Criteria:\n\n1. Consenting adults with BMI≥ 25 and ≤ 40 kg\u002Fm2\n2. Obstructive sleep apnea with an AHI between 20 and 80 events\u002Fhr (with hypopneas defined by 4% oxyhemoglobin desaturations); ≥80% obstructive events.\n\nExclusion Criteria:\n\n1. Chronic use of opiate medications, illicit drug use, or alcohol dependency\n2. Other known concomitant sleep disorder (e.g., central sleep apnea, periodic limb movements, narcolepsy)\n3. Clinical history or evidence of cardiopulmonary disease (or oxygen use), liver, renal, immunodeficiency, neurodegenerative diseases, or previous adverse reactions to anesthesia.\n4. Prior upper airway reconstructive surgery excluding tonsillectomy (e.g., cleft palate repair, uvulopalatopharyngoplasty)\n5. Indwelling neurostimulation device (e.g. cardiac pacemaker, spinal, vagal, or hypoglossal nerve stimulator)",{"count":92,"type":21},[24],"Polysomnography (PSG) and drug-induced sleep endoscopy (DISE) are widely used diagnostic studies for assessing obstructive sleep apnea (OSA) severity and collapse patterns of the upper airway anatomy during sleep. Hypoglossal nerve stimulation (HNS) therapy for obstructive sleep apnea suffers from variable response at the level of the soft palate. The Investigators propose a study examining the physiologic effect of ansa cervicalis stimulation (ACS) alone and in combination with HNS during PSG and DISE.",[125],"Obstructive Sleep Apnea",{"date":38,"type":41},{"date":128,"type":41},"2022-11-03",{"date":130,"type":21},"2027-11-30",{"name":47,"class":48},{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":138,"sex":16,"minAge":89,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":49},"100457069","phase-2-cholinergic-integrity-in-down-syndrome-in-association-with-aging-alzheimers-disease-pathology-and-cognition-100457069","NCT05231798","Cholinergic Integrity in Down Syndrome in Association With Aging, Alzheimer's Disease Pathology, and Cognition","Inclusion Criteria:\n\n1. Diagnosis of Down syndrome (DS), including mosaic DS or partial trisomy 21.\n2. Provision of signed and dated informed consent form and if needed, assent with signed consent by a legally authorized representative (LAR).\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Male or female, aged 18-55 inclusive.\n5. In good general health as evidenced by medical history with no diagnosis of dementia.\n6. Permitted CNS-active medications, stable in dose for at least 4 weeks or longer. If new medications have been started, the medical monitoring team will review on case-by-case basis to recommend timing of baseline cognitive testing\n7. Adequate visual and auditory acuity to allow neuropsychological testing\n8. For females who are not surgically sterile or post-menopausal by two years: negative pregnancy test 24 hours prior to PET scan.\n9. Mental Age of 4 years or greater (based upon the Kaufman Brief Intelligence Test, 2nd Edition)\n10. English must be first\u002Fnative language\n11. Reliable Study Partner (may be caregiver, sibling, parent) who can provide information about the subject's clinical symptoms and history\n\nExclusion Criteria:\n\n1. Any significant disease or unstable medical condition that could affect neuropsychological testing (i.e., unstable cardiac problems, chronic renal failure, chronic hepatic disease, severe pulmonary disease)\n2. Participants in whom magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant (Dental fillings do not present a risk for MRI)\n3. Participants unable to complete MRI and PET procedures\n4. IQ less than 40 (as assessed by Kaufman Brief Intelligence Test, Second Edition (KBIT-2).\n5. Pregnancy, breast-feeding\n6. History within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment\n7. Clinically significant abnormalities in B12 or TFTs that might interfere with the study. A low B12 is exclusionary unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant. A high TSH is exclusionary unless follow-up T3\u002FT4 levels indicate that it is not physiologically significant.\n8. Clinically significant abnormalities in screening laboratories\n9. For participants undergoing CSF collection: a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening or if on anti-coagulation (e.g warfarin)\n10. Participants whom the Site PI deems to be otherwise ineligible\n11. Clinical diagnosis of dementia\n12. Concurrent participation in a clinical trial for an investigational product or concurrent participation in a longitudinal study with overlapping outcome measures\u002Fprocedures is prohibited",true,"55 Years",{"count":141,"type":21},30,[143],"PHASE2","Progressive age-related cognitive deficits occurring in both AD and DS have been connected to the degeneration of several neuronal populations, but mechanisms are not fully elucidated. The most consistent neuronal losses throughout the progression of AD are seen in cholinergic neurons where these losses negatively affect cognition, particularly in attention, learning, and memory formation. Evidence of reduced cholinergic integrity in DS is largely limited to animal models and post-mortem human data. The investigators propose to use molecular, functional, and structural biomarkers to assess the cholinergic integrity in adults with DS. The investigators anticipate using the data gathered in this pilot study to inform future study designs to determine AD risk stratification in DS by identifying individuals who show an accelerated decline in cholinergic integrity that correlates with cognitive and neurobehavioral changes. Also, our cholinergic biomarkers may identify whether individuals with DS are likely to respond to pro-cholinergic interventions, including the novel cholinergic modulators that are being developed to enhance cholinergic-sensitive cognitive functioning. The investigators anticipate using the data gathered here to inform future treatment studies in TRC-DS and beyond where novel cholinergic treatments may offer opportunities for early intervention in DS and be complementary to disease-modifying approaches such as anti-amyloid treatments.",[146,147,148],"Down Syndrome","Down Syndrome, Partial Trisomy 21","Alzheimer Disease","2026-06-17",{"date":151,"type":41},"2026-06-22",{"date":153,"type":41},"2021-08-19",{"date":155,"type":21},"2027-04-30",{"name":47,"class":48},{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},"100641193","prospective-investigation-of-cirrhotic-cardiomyopathy-in-humans-100641193","NCT07658222","Prospective Investigation of Cirrhotic Cardiomyopathy in Humans","PITCH","Inclusion Criteria:\n\n1. Decompensated cirrhosis, defined as cirrhosis with current or prior occurrence of one or more of the following:\n\n   * portal hypertension-related bleeding,\n   * hepatic encephalopathy, and\u002For\n   * clinical ascites.\n2. Model for End Stage Liver Disease version 3.0 (MELD 3.0) ≥ 15 or Child Pugh Class B-C\n3. Age ≥ 18 years\n4. Longitudinal follow up in either at Vanderbilt University Medical Center (VUMC) or University of Texas Southwestern (UTSW) hepatology clinics\n5. Willing to adhere to study protocol\n6. Able to provide written informed consent\n\nExclusion Criteria:\n\n1. Current or prior obstructive coronary artery disease, ≥ moderate valvular disease, \\> mild pericardial effusion, cardiac amyloidosis, congenital heart disease, pacemaker, or implantable cardioverter defibrillator\n2. End-stage heart, kidney, or lung disease\n3. Pulmonary Arterial Hypertension\n4. Acute on Chronic Liver Failure (ACLF) grade 2-3 (i.e., ≥ 2 extrahepatic organ failures)\n5. Advanced hepatocellular carcinoma (i.e., Barcelona Clinic Liver Cancer (BCLC) Stage C or D)\n6. Ongoing alcohol use, by patient reporting or by phosphatidyl ethanol testing\n7. Pregnancy\n8. Prior TIPS",{"count":165,"type":21},440,"Cirrhotic Cardiomyopathy (CCM) is a recognized complication of cirrhosis, but understudied despite recent retrospective data suggesting it may be common, affecting one in three patients with decompensated cirrhosis, and associated with significantly increased risk of death and adverse hepatic and cardiac events. Moreover, evidence from preclinical models and children suggest elevated bile acids in the blood may contribute to CCM, but data from adults with cirrhosis are scarce. Therefore, we are conducting the first contemporary prospective multi-center investigation of CCM in adults in the USA to define CCM risk factors and impact on outcomes while deepening understanding of the role of bile acids in development of this disease.",[168],"Cirrhotic Cardiomyopathy",[170,171],"Cirrhotic cardiomyopathy","Cirrhosis","2026-06-15",{"date":174,"type":41},"2026-06-18",{"date":176,"type":41},"2026-01-20",{"date":178,"type":21},"2030-06-30",{"name":47,"class":48},2,{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":138,"sex":189,"minAge":89,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":193,"conditions":194,"keywords":201,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":49},"100609439","nicu-utilization-of-remote-voice-technology-to-improve-maternal-experience-nurture-100609439","NCT07214597","NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE)","NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE): A Randomized Controlled Trial","NURTURE","Inclusion Criteria:\n\n1. Infant:\n\n   1. Admitted to the neonatal intensive care unit (NICU)\n   2. Not readmitted after discharge from the NICU\n   3. Expected to survive at least 2 weeks\n   4. Expected to be admitted to the NICU for at least 2 weeks\n   5. Singleton gestation\n2. Mother:\n\n   1. Age ≥ 18 years old\n   2. English speaking\n   3. Mother is the biological mother of the infant admitted to the NICU\n   4. Postpartum day 4 or less\n3. Partner (NOTE: Partner enrollment is not required)\n\n   1. Mother agrees to partner's participation\n   2. Designated by mother as support person with infant access\n\nExclusion Criteria\n\n1. Infant\n\n   a. Re-admission to NICU\n2. Mother\n\n   1. No access to an Android or iOS smartphone\n   2. Unwilling to download the VoiceLove NICU app to their personal smartphone and unwilling to accept the terms and conditions of the VoiceLove app\n   3. No personal email address\n   4. Incarcerated at time of delivery or postpartum\n   5. Inability to obtain informed consent\n\n   i. Patient's clinician refuses enrollment of the patient ii. Patient is either mentally (acute psychosis) or physically (intubated or critically ill in the ICU) unable to provide informed consent f. Unable to approach the patient (staffing, patient unavailable) g. Mother is not the intended parent (plans adoption, is a surrogate, will not have custody of the infant)\n3. Partner (NOTE: Partner enrollment is not required)\n\n   1. Age \\\u003C 18 years old\n   2. Not English speaking\n   3. Inability to obtain informed consent\n   4. No access to an Android or iOS smartphone that is different from the mother's smartphone\n   5. No access to an email address that is different from the mother's email address\n   6. Unwilling to download the VoiceLove NICU app to their personal smartphone and unwilling to accept the terms and conditions of the VoiceLove app","FEMALE",{"count":191,"type":21},150,[24],"The study's objective is to conduct a Phase II randomized controlled trial examining the preliminary efficacy of the VoiceLove app compared to usual care on maternal postpartum depression in mothers with infants admitted to the Neonatal Intensive Care Unit (NICU). Primary aim: Assess the effects of VoiceLove on maternal postpartum depression, measured by the Edinburgh Postnatal Depression Scale (EPDS). The estimates from this study will be used for a future definitive Phase III trial. Secondary aim: Assess feasibility, acceptability, and patterns of communication and engagement among mothers, partners, and NICU clinicians during the NICU hospitalization, measured through app usage metrics, satisfaction surveys, and qualitative interviews. Additionally, we will evaluate effects of infant length of stay.",[195,196,197,198,199,200],"Postpartum Depression (PPD)","Self-Efficacy","Parental Anxiety","Engagement, Patient","Usability","Length of Stay",[202,203,195,204,187,205],"Neonatal Intensive Care Unit","NICU","VoiceLove app","VoiceLove",{"date":149,"type":41},{"date":208,"type":41},"2026-02-04",{"date":210,"type":21},"2028-01",{"name":47,"class":48},{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":221,"conditions":222,"keywords":224,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":4},"100529618","phase-2-clinical-trial-of-2-hoba-in-pulmonary-arterial-hypertension-100529618","NCT06176118","Clinical Trial of 2-HOBA in Pulmonary Arterial Hypertension","Inclusion Criteria:\n\n* Adults aged 18 or older\n* Diagnosed with idiopathic, heritable, simple congenital heart defect, or drug- or toxin-associated pulmonary arterial hypertension (PAH) according to World Health Organization consensus recommendations.\n* Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed.\n* FEV1\\> or = 60% predicted and no more than mild abnormalities on lung imaging\n* WHO Functional Class II-IV\n* Ambulatory\n\nExclusion Criteria:\n\n* Sensitivity to 2-HOBA\n* Sensitivity to aspirin or salicylates\n* Aspirin-related rhinitis or wheezing\n* Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane\u002Fwalker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity\n* Pregnancy\n* Diagnosis of PAH etiology other than idiopathic, heritable, simple congenital heart defect, or associated with drugs or toxins\n* Drug and toxin associated PAH patients with active drug use\n* Prior diagnosis of cirrhosis\n* Malignancy\n* eGFR by MDRD \\\u003C60mL\u002Fmin\n* Non-english speaking",{"count":219,"type":21},12,[143],"Based on existing literature and clinical trials, 2- hydroxbenzylamine (2-HOBA) has clear impact on mechanisms that much of the international field of pulmonary hypertension (PH) research agrees are central to disease progression. The investigator's preliminary data and Phase I studies demonstrate not only a clear positive impact on reducing pulmonary vascular resistances in Group I and II PH, and both cytokine and molecular biomarkers of disease, but also indicated the potential for a substantial positive effect on heart function under load stress. In this Phase II project, investigators will test the safety and efficacy of 2-HOBA in PH patients, improving the function of the right ventricle under stress in a large animal model, and effectiveness in the context of standard-of-care in mouse models and large animals, to establish the remaining data needed to proceed to commercialization.",[223],"Pulmonary Arterial Hypertension",[225,226,227],"2-hoba","Pulmonary Hypertension","Right Ventricular",{"date":149,"type":41},{"date":230,"type":21},"2026-09-01",{"date":232,"type":21},"2027-12",{"name":47,"class":48},{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":245,"conditions":246,"keywords":249,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":49},"100620941","phase-2-exogenous-ketone-supplementation-in-icu-delirium-100620941","NCT07364162","Exogenous Ketone Supplementation in ICU Delirium","Exogenous Ketone Ester Supplementation in ICU Delirium (KETONES ICU)","KETONES-ICU","Inclusion criteria:\n\n1. Adult patients (≥18 years old) admitted to the medical intensive care unit.\n2. Current ICU admission with anticipated ICU stay ≥24 hours.\n3. Enteral access in place, planned enteral access placement, or PO intake appropriate, and the ability to receive enteral dosing within 24 hours of enrollment.\n4. Ability to complete delirium assessments (CAM-ICU feasible) at time of enrollment.\n\nExclusion criteria:\n\n1. Severe metabolic acidosis at screening: blood gas pH \\\u003C7.20 or bicarbonate \\\u003C 8 mmol\u002FL.\n2. Diabetic ketoacidosis as an ICU admission diagnosis or hyperketonemia from any ketoacidosis state.\n3. Hypoglycemia as an ICU admission diagnosis or glucose \\\u003C60 mg\u002FdL.\n4. Patients with a history of type 1 diabetes mellitus.\n5. Hemoglobin \\\u003C7.0.\n6. Fulminant hepatic failure or AST\u002FALT \\> 5× ULN or total bilirubin \\> 3 mg\u002FdL.\n7. Refractory shock (defined as norepinephrine dose ≥20 µg\u002Fmin or use of a second vasopressor agent).\n8. Pregnancy (positive urine\u002Fserum hCG at screening or known pregnancy).\n9. Uncontrolled ileus or gastrointestinal condition, such as an upper gastrointestinal bleed, preventing enteral dosing.\n10. SGLT2 inhibitor use within the prior 7 days.\n11. ADH\u002FALDH inhibitors (e.g., fomepizole, disulfiram) use in the prior 7 days or planned.\n12. Severe dementia or neurodegenerative disease, defined as either impairment that prevents the patient from living independently at baseline or IQCODE \\>4.5, measured using a patient's qualified surrogate. This exclusion also pertains to mental illnesses requiring long-term institutionalization, acquired or congenital intellectual disability, severe neuromuscular disorders, Parkinson's disease, and Huntington's disease. It also excludes patients with severe deficits due to structural brain diseases such as stroke, intracranial hemorrhage, cranial trauma, malignancy, anoxic brain injury, or cerebral edema.\n13. Benzodiazepine dependency or alcohol dependency based on the medical team's decision to institute a specific treatment plan involving benzodiazepines or barbiturates (either as continuous infusions or intermittent intravenous boluses) for this dependency.\n14. Active seizures during this ICU admission being treated with intravenous benzodiazepines.\n15. Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family\u002Fmedical team (e.g., likely to withdraw life support measures within 24 hours of screening).\n16. Admission to ICU only for post-operative monitoring or frequent neurologic assessments.\n17. Incarcerated status.\n18. Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Attending physician refusal.\n19. Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Patient and\u002For surrogate refusal.\n20. Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Patient unable to consent and no surrogate available.\n21. Current enrollment in a study that does not allow co-enrollment.",{"count":243,"type":21},40,[143],"Delirium is a common syndrome in intensive care unit (ICU) patients. Those experiencing delirium may suddenly feel confused, have trouble thinking clearly, struggle to pay attention, or see and hear things that are not real. Delirium is associated with worse long-term outcomes such as cognitive impairment, depression, and PTSD (post-traumatic stress disorder). This study examines whether an investigational medical-grade ketone supplement drink (ketone monoester \\[brand name: Ultrapure Ketone Monoester\\]) is safe and feasible to use in ICU patients, and to look for signals that it might reduce delirium or shorten its duration compared to a volume-, taste-, and calorie-matched placebo.",[247,248],"ICU Delirium","Critical Illness",[250,251,252,253,254],"ICU","Intensive Care Unit","Critical care","Critical illness","Ketones","2026-06-11",{"date":172,"type":41},{"date":258,"type":41},"2026-06-09",{"date":260,"type":21},"2027-12-31",{"name":47,"class":48},{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":22,"phases":270,"briefSummary":271,"conditions":272,"keywords":274,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":49},"100624405","neurophysiology-of-reward-signaling-in-parkinsons-disease-100624405","NCT07409207","Neurophysiology of Reward Signaling in Parkinson's Disease","Inclusion Criteria:\n\n* Scheduled to undergo deep brain stimulation surgery under local anesthesia at Vanderbilt University Medical Center\n* Planned clinical electrode trajectory that contacts caudate\n* Age greater than or equal to 40\n* Diagnosis of Parkinson's disease or other movement disorder\n* Able to participate in intraoperative testing\n* English speaking\n\nExclusion Criteria:\n\n* Age less than 40\n* Not able to participate in intraoperative testing (for example unable to comprehend instructions or follow directions)",{"count":269,"type":21},75,[24],"The goal of this study is to learn more about the brain activity underlying Parkinson's disease risk taking and reward seeking behaviors. The investigators will utilize neural recordings from corticostriatal structures performed during deep brain stimulation surgery to measure neural activity underlying nonmotor symptoms of Parkinson's disease.",[273],"Parkinson Disease",[275],"Deep Brain Stimulation","2026-06-10",{"date":278,"type":41},"2026-06-12",{"date":280,"type":41},"2024-09-01",{"date":282,"type":21},"2029-09-30",{"name":47,"class":48},{"id":285,"slug":286,"hasResults":12,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":292,"conditions":293,"keywords":296,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":303,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":307,"locationsCount":49},"100418184","neural-correlates-of-psychiatric-disorders-100418184","NCT04725409","Neural Correlates of Psychiatric Disorders","Neural Correlates of Neuropsychiatric Functions","Inclusion Criteria:\n\n* Undergoing SEEG monitoring at Vanderbilt University Medical Center\n* At least 18 years of age\n* English speaking\n\nExclusion Criteria:\n\n* Age \\\u003C18\n* Not able to complete questionnaires (e.g., unable to comprehend instructions or follow directions)",{"count":92,"type":21},"This ClincialTrials.gov record originally corresponded to the protocol approved under IRB # 202370. The study was expanded to include stimulation and recordings approved under new IRB #211037. The participant data originally acquired from IRB# 202370 will be included in this new record:\n\nThis study seeks to better understand the neural activity underlying neuro cognitive disorders. Resting state local field potential recordings will be collected from medically refractory epilepsy patients implanted with depth electrodes for seizure localization, and metrics of neural activity will be correlated with psychiatric symptoms as measured from questionnaires. Subjects will also participate in neuro cognitive tasks while neural recordings are performed, and\u002For receive neural stimulation through implanted depth electrodes. A better understanding of disordered neural activity underlying neuropsychiatric disorders may additionally contribute to novel methods for diagnosing, treating, and preventing these diseases.",[294,295],"Psychiatric Disorder","Memory Disorders",[297,298,299,300,301,302],"Depression","Stereo Electroencephalography (SEEG)","Anxiety","Obsessive compulsive disorder","Impulsivity","Memory",{"date":278,"type":41},{"date":305,"type":41},"2021-03-31",{"date":232,"type":21},{"name":47,"class":48},{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":319,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":49},"100417461","corticostriatal-contributions-to-parkinsons-disease-cognitive-impairment-100417461","NCT04715984","Corticostriatal Contributions to Parkinson's Disease Cognitive Impairment","Corticostriatal Neurophysiology in Parkinson's Disease Cognitive Impairment","Inclusion criteria:\n\n* Scheduled to undergo deep brain stimulation surgery under local anesthesia at Vanderbilt University Medical Center\n* Planned clinical electrode trajectory that contacts caudate\n* Age greater than or equal to 40\n* Diagnosis of Parkinson's disease\n* Able to participate in intraoperative testing\n* English speaking\n\nExclusion criteria:\n\n* Age less than 40\n* Not able to participate in intraoperative testing (for example unable to comprehend instructions or follow directions)\n* Movement disorder other than Parkinson's disease",{"count":269,"type":21},[24],"The goal of this study is to learn more about the brain activity underlying Parkinson's disease cognitive impairment. The investigators will utilize neural recordings from corticostriatal structures performed during deep brain stimulation surgery to measure neural activity underlying nonmotor symptoms of Parkinson's disease.",[273],[275],{"date":278,"type":41},{"date":322,"type":41},"2021-06-02",{"date":324,"type":21},"2029-08",{"name":47,"class":48},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":333,"conditions":334,"keywords":335,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":49},"100643110","neural-basis-of-human-working-memory-100643110","NCT07617506","Neural Basis of Human Working Memory","Inclusion Criteria:\n\n* Undergoing SEEG monitoring at Vanderbilt University Medical Center\n* Age \\>18\n* English speaking\n\nExclusion Criteria:\n\n* Age \\\u003C18\n* Not able to complete questionnaires (unable to comprehend instructions or follow directions)",{"count":92,"type":21},"This ClinicalTrials.gov entry corresponds to the Neural Basis of Human Working Memory protocol approved under Vanderbilt University Medical Center IRB #251231.\n\nThis study investigates the neural activity underlying human working memory, via local field potential changes (macro level) and\u002For single neuronal spiking changes (micro level) from depth electrodes placed for invasive seizure monitoring. Subjects will complete neurocognitive tasks while neural recordings are collected. Some patients will complete neurocognitive tasks while stimulation is applied via depth electrodes. Further understanding the neural activity changes underlying normal and impaired working memory may help to identify novel diagnostic methods and treatments for impaired working memory and may support the use of stimulation for treatment of memory disorders.",[295],[336,337,338,298],"Neural stimulation","Memory disorders","Working Memory",{"date":255,"type":41},{"date":341,"type":41},"2025-06-04",{"date":343,"type":21},"2027-04",{"name":47,"class":48},{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":351,"minAge":89,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":22,"phases":353,"briefSummary":355,"conditions":356,"keywords":357,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":363,"leadSponsor":365,"locationsCount":49},"100642538","phase-1-glucagon-like-peptide-1-receptor-agonists-to-attenuate-metabolic-risk-in-individuals-with-duchenne-muscular-dystrophy-100642538","NCT07642635","Glucagon-Like Peptide-1 Receptor Agonists to Attenuate Metabolic Risk in Individuals With Duchenne Muscular Dystrophy","Inclusion Criteria:\n\n* Male\n* Age ≥18years\n* BMI ≥ 30kg\u002Fm2 or BMI ≥ 27kg\u002Fm2 with at least one weight-related comorbid condition (e.g., hypertension, T2D, or dyslipidemia).\n* Clinical phenotype of DMD confirmed with muscle biopsy or genotype\n\nExclusion Criteria:\n\n* Type 1 diabetes, uncontrolled type 2 diabetes (HbA1c \\>8%) or type 2 diabetes requiring the use of insulin or sulfonylurea.\n* History of pancreatitis\n* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2\n* History of allergic reaction to semaglutide or medication components\n* Contraindication to MRI. If unable to tolerate whole body\u002Fcardiac MRI but able to undergo lower extremity MRI, the participant may be invited to complete extremity MRI (Aim 1) and not complete MRI for Aim 2\u002F3 (secondary Aims\u002Foutcomes)\n* Uncontrolled major depressive disorder, lifetime history of suicide attempt, history of other severe psychiatric disorders (e.g., schizophrenia, bipolar disorder), PHQ-9 score ≥15 or suicidal ideation type 4 or 5 (C-SSRS)\n* Unable to comply with study procedures or unsafe to complete the study in the opinion of the investigator","MALE",{"count":141,"type":21},[354,143],"PHASE1","Duchenne Muscular Dystrophy (DMD) is a rare, genetic disease that leads to muscle weakness, breathing difficulties, heart disease, and early death. Approximately half of individuals with DMD have elevated body mass indices (BMIs) in the overweight or obesity range. High BMI is due to a combination of factors including limited mobility and steroid medications, which are used to treat DMD.\n\nThere are new medications, glucagon-like peptide-1 receptor agonists (GLP-1 RAs) that promote weight loss in the general population. GLP-1 RAs are approved for weight loss in children and adults and have beneficial effects on the heart. There is a concern that these medications could have unwanted side effects in individuals with DMD, specifically decreasing their muscle mass. While it is important to consider the use weight-loss medications in DMD, the investigators want to ensure that they are safe and well-tolerated. Therefore, this study will systematically evaluate whether the use of GLP-1 RAs in adolescents and young adults with DMD affects muscle mass.\n\nThe overall goal of this study is to assess the safety and tolerability of GLP1-RAs in individuals with both DMD and obesity. The primary focus will be on muscle health, but the study will also evaluate activity levels, mood, gastrointestinal symptoms, and quality of life. Secondary goals will be to understand the impact of GLP1-RAs on weight, fat mass, glucose and insulin levels, and heart and lung function in individuals with DMD. The investigators hypothesize that GLP1-RAs will be well-tolerated and will decrease fat mass, without a large decrease in muscle mass.\n\nParticipants will:\n\n* Take oral semaglutide or a placebo every day for 24 weeks (randomized controlled trial)\n* Then take oral semaglutide every day for 40 weeks (open label extension)\n* Complete in-person study visits at 3 timepoints\n* Study visits may include: an MRI of the body to evaluate muscle and fat tissue, laboratory testing, a mixed meal tolerance test, questionnaires, an MRI of the heart, pulmonary function tests, and additional measures\n* Calls with the study team between visits (monthly or every other month)",[63],[358,359,360],"Duchenne muscular dystrophy","Obesity","Glucagon-Like Peptide-1 Receptor Agonists",{"date":255,"type":41},{"date":230,"type":21},{"date":364,"type":21},"2030-12",{"name":47,"class":48},{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":16,"minAge":373,"maxAge":374,"enrollmentInfo":375,"targetDuration":4,"studyType":22,"phases":377,"briefSummary":378,"conditions":379,"keywords":381,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":384,"startDateStruct":385,"completionDateStruct":386,"leadSponsor":388,"locationsCount":389},"100634845","creation-of-a-decision-aid-for-coronary-anomalies-100634845","NCT07544979","Creation of a Decision Aid for Coronary Anomalies","Development of a Shared Decision Aid for Anomalous Aortic Origin of a Coronary Artery","Inclusion Criteria:\n\n* Patients\n\n  * English-speaking\n  * 10-35 years of age\n  * Diagnosis of R-AAOCA without evidence of myocardial ischemia\n\nParents\n\n* English-speaking\n* Child 10-17 years of age\n* Diagnosis of R-AAOCA without evidence of myocardial ischemia\n\nExclusion Criteria:\n\n* Patients\n\n  * Other significant cardiac anomalies\n  * Unwilling or unable to provide consent\n  * Non-English Speaking Parents\n  * Child with other significant cardiac anomalies\n  * Unwilling or unable to provide consent\n  * Non-English Speaking","10 Years","35 Years",{"count":376,"type":21},60,[24],"The coronary arteries supply blood to the heart muscle. Typically, the left coronary artery comes from the left side of the aorta and the right coronary artery comes from the right side. In some cases the coronary artery comes from the wrong side of the aorta. This is known as anomalous aortic origin of a coronary artery (AAOCA). In AAOCA, the major concern is the risk of sudden cardiac death (SCD). The risk of is significantly higher in left AAOCA (L-AAOCA) compared to right AAOCA (R-AAOCA). With the increased risk in L-AAOCA, surgery is recommended to \"normalize\" the coronary artery position. R-AAOCA has a low absolute risk of SCD. But the risk is higher than the general population. Patients, families, and clinicians must weigh the risks of surgery with the risks of observation. This leads to stress and anxiety around making the management choice. There is no \"right\" management choice. Shared decision making (SDM) is a strategy of including patient values, preferences, and risk tolerance in medical choices. SDM is particularly useful in settings where there is no clear correct management choice. Decision aids support SDM. No decision aid exists in R-AAOCA. This proposal will create a decision aid and collect pilot data of its implementation. We hypothesize that the use of an aid in R-AAOCA will improve SDM, comfort in the choice, and quality of life. We will engage patients, families, and clinicians to understand their needs to make management choices. This will inform the development of the aid. We will gather feedback on the aid from stakeholders and will revise it. The aid will include data and methods for patients to identify their preferences. When the aid is optimized, we will run a pilot study to evaluate its impact compared to not using the aid. We will evaluate SDM, comfort in the choice made, and quality of life at that time, at 3 months and at 6 months. The pilot data will be used to inform a larger study of the aid. This proposal can be an example how to design decision aids for other congenital heart conditions. This aligns with the AHA's mission of improving lifelong health of the whole person. By improving SDM , patients can feel more confident in their choice and relieve anxiety from the diagnosis. Overall, this proposal supports a shift to patient-centered care with a focus on improving meaningful lifelong outcomes.",[380],"AAOCA",[380,382,383],"Coronary Anomalies","Shared Decision Making",{"date":255,"type":41},{"date":110,"type":21},{"date":387,"type":21},"2029-03-30",{"name":47,"class":48},5,{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":400,"conditions":401,"keywords":404,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":49},"100628925","endoscopic-colorectal-mucosal-evaluation-of-oxygen-tension-100628925","NCT07467980","Endoscopic COlorectal Mucosal Evaluation of Oxygen Tension","Anastomotic Site Mucosal Oxygen Tension and Its Association With Anastomotic Complications","e-COMET","Inclusion Criteria:\n\n* Adult patients (≥18 years).\n* Undergoing a colo-rectal anastomosis.\n* Patients who consent to study participation\n\nExclusion Criteria:\n\n* Patients undergoing a revision surgery.\n* Participants with missing data.\n* Patients who do not undergo intraoperative ICG-FA and StO2 endoscopic imaging promptly after the formation of a viable anastomosis.",{"count":399,"type":21},80,"Anastomosis refers to the surgical connection between two segments of the bowel, typically performed during colon and rectal surgeries to restore the continuity of the digestive tract after a section has been removed. It is necessary that the ends of the tissue at the anastomotic site are healthy (and capable of healing properly) as this will prevent dreaded complications like anastomotic leaks or strictures which can occur in almost a fifth of patients leading to increased hospital length of stay, costs, and mortality.\n\nCurrently, the most widely used method for assessing tissue viability during anastomosis is indocyanine green fluorescence angiography (ICG-FA). This technique involves injecting a fluorescent dye (indocyanine green) into the bloodstream, which highlights blood flow and tissue perfusion under a special camera. However, ICG-FA has limitations due to allergies and reliability due to the dye's rapid disappearance from the bloodstream. Additionally, the dye cannot be administered repeatedly. This study explores a new method of measuring tissue oxygenation by evaluating mucosal oxygen saturation (StO2) as an alternative to ICG-FA. By evaluating StO2 levels, the research aims to provide a more reliable and repeatable way to assess tissue viability without the drawbacks of using fluorescent dyes. Secondly, any blood supply interruption to the bowel will first lead to mucosal ischemia, which can potentially be reliably captured by measuring mucosal StO2 levels only.\n\nIn this single-center prospective single-arm study, we will evaluate whether mucosal StO2 levels are associated with or can predict anastomotic complications. This study will not involve any intervention that would affect the standard of care.",[402,403],"Anastomotic Leak Rectum","Anastomotic Leak Large Intestine",[405,406,407,408,409,410,411,412],"anastomotic leak","colorectal","endoscopic","oxygen tension","oxygen saturation","mucosal","colon","rectum","2026-06-08",{"date":255,"type":41},{"date":416,"type":41},"2026-03-16",{"date":418,"type":21},"2028-04",{"name":47,"class":48},{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":22,"phases":429,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":436,"leadSponsor":438,"locationsCount":49},"100624584","individual-vs-co-treatment-in-acute-stroke-rehabilitation-and-evaluation-100624584","NCT07411534","Individual vs Co-Treatment in Acute Stroke Rehabilitation and Evaluation","ICARE","Inclusion Criteria:\n\n* Inpatient admission to the neurology stroke service AND\n* Orders placed for both PT and OT within 96 hours of admission to the service\n\nExclusion Criteria:\n\n* Patient is known to be \\\u003C18 years\n* Patient is known to be a prisoner\n* Patient is known to be pregnant\n* Prior evaluation or treatment by PT and\u002For OT while admitted under the stroke service before study enrollment\n* Clinician determines that either individual PT and OT or co-treatment is required or contraindicated for the optimal care of the patient",{"count":428,"type":21},567,[24],"This is a single center, pragmatic, randomized trial comparing the effectiveness of two commonly used approaches (co-treatment and individual treatment) in acute care rehabilitation.",[432,433],"Stroke","Stroke Acute",{"date":276,"type":41},{"date":230,"type":21},{"date":437,"type":21},"2027-12-28",{"name":47,"class":48},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":22,"phases":447,"briefSummary":449,"conditions":450,"keywords":453,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":455,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":49},"100601893","early-phase-1-effect-of-rose-odor-exposure-on-ictal-apnea-100601893","NCT07116421","Effect of Rose Odor Exposure on Ictal Apnea","Effect of 2-phenylethanol Odor Exposure on Ictal Apneic Episode Occurrence Rate in Patients With Epilepsy","Inclusion Criteria:\n\n* Adult epilepsy patients over the age of 18\n* Admission to the inpatient epilepsy monitoring unit (EMU) at Vanderbilt University Medical Center (VUMC)\n* Undergoing observational EEG monitoring without treatment involving seizure medication changes or other interventions for at least 48 hours\n\nExclusion Criteria:\n\n* Patients under the age of 18\n* Patients receiving EEG monitoring without interventions from baseline for less than 48 hours\n* Patients who are not receiving EEG monitoring as a part of their inpatient admission.",{"count":243,"type":21},[448],"EARLY_PHASE1","This study will investigate the potential benefits of rose scent in reducing the risk of Sudden Unexpected Death in Epilepsy (SUDEP) in patients with epilepsy. Participants will engage in their routine inpatient observational EEG monitoring for 24 hours followed by an additional 24 hours of observational EEG monitoring with continuous exposure to rose scent, during which an essential oil diffusor with rose scent will be placed in their hospital room. During these 48 total hours of the study, participants will wear a respiratory monitoring belt across their upper chest to measure their breathing.\n\nPotential risks include distress or discomfort when smelling the rose scent used in the study, a physical reaction to the rose scent, and discomfort or feelings of restrictiveness when wearing the respiratory monitoring belt. The total time commitment of the study is 48 consecutive hours over the course of the participants' inpatient EMU stay, during which there will be no restrictions on daily activities during the standard inpatient EMU admission except that participants must wear their respiratory belt for a majority of this 2-day period.",[451,452],"Epilepsy","Sudden Unexpected Death in Epilepsy",[454,451,452],"SUDEP",{"date":255,"type":41},{"date":457,"type":41},"2025-07-01",{"date":459,"type":21},"2027-05-08",{"name":47,"class":48},{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":138,"sex":16,"minAge":139,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":22,"phases":470,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":49},"100516281","early-phase-1-attentional-mechanisms-in-scd-100516281","NCT06002477","Attentional Mechanisms in SCD","Attentional Mechanisms of Cognitive Compensation in Subjective Cognitive Decline","AMoCC-SCD","Inclusion Criteria:\n\n1. age ≥ 55\n2. Montreal Cognitive Assessment (MoCA) \\> 25 AND Global Deterioration Scale (GDS) rating \\\u003C 3\n3. Non-smokers\n\nExclusion Criteria:\n\n1. medical contraindications to the drug challenge\n2. primary neurological disorder (such as stroke, epilepsy, etc.)",{"count":399,"type":21},[448],"This study will use an anticholinergic pharmacological probe to examine attention network function in SCD using EEG. The overall hypothesis is that in older adults with SCD, normal cognitive performance is maintained by compensatory attention network activity, supported by enhanced cholinergic function. The investigators anticipate that SCD will be associated with greater compensatory attention network activity and that disrupting this compensatory process through anticholinergic challenge will result in a greater negative effect on attentional performance (Attention Network Test, ANT) and attention network functioning (EEG) in older adults with greater subjective cognitive concern.",[473],"Subjective Cognitive Decline","2026-06-02",{"date":476,"type":41},"2026-06-04",{"date":478,"type":41},"2025-06-06",{"date":480,"type":21},"2028-06-30",{"name":47,"class":48},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":22,"phases":491,"briefSummary":492,"conditions":493,"keywords":496,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":49},"100635369","suction-vs-underwater-seal-for-hemopneumothorax-trial-100635369","NCT07551791","Suction vs Underwater Seal for HemoPneumoThoraX Trial","SUS-HPTX Trial: Suction vs Underwater Seal for HemoPneumoThoraX Trial","SUS-HPTX","Inclusion Criteria:\n\n* Admitted to trauma service\n* Patient has hemothorax or hemopneumothorax requiring chest tube\n\nExclusion Criteria:\n\n* Less than 18 years old, pregnant, prisoner, chest tube placed prior to CT scan",{"count":191,"type":21},[24],"Traumatic pneumothorax and hemothorax are common consequences of chest injury, often requiring prompt tube thoracostomy to re-expand the lung and drain accumulated blood or air. Current practice varies widely regarding whether chest tubes should initially be placed to suction or to water seal, and prior studies have reported mixed findings. While suction may theoretically improve drainage and lung expansion, some studies suggest it may prolong air leaks and chest tube duration. Conversely, initial water seal has been associated with shorter tube duration without an increase in complications. The predecessor to this trial, the SEAL IT Trial, demonstrated that water seal reduced chest tube duration in patients with pneumothorax without an increase in complication, but excluded those with significant hemothorax. This single-center, randomized controlled trial (SUS-HPTX) will expand upon those findings by evaluating the effect of initial chest tube management strategy, suction versus water seal, in trauma patients with hemopneumothorax or hemothorax. Patients will be assigned to one of the two groups based on calendar month of enrollment, with clinicians able to adjust management as needed. The primary outcome is chest tube duration. Secondary outcomes include chest tube-related complications (e.g., empyema, pneumonia, re-accumulation of pneumothorax or hemothorax, need for additional procedures), hospital length of stay, readmissions, and mortality. Because both suction and water seal are accepted standards of care, the study involves minimal incremental risk. Findings will expand prior evidence and inform best practices for chest tube management in trauma",[494,495],"Hemothorax; Traumatic","Hemopneumothorax; Traumatic",[497,498,499,500],"traumatic","hemothorax","hemopneumothorax","thoracostomy tube","2026-05-29",{"date":474,"type":41},{"date":504,"type":41},"2026-04-14",{"date":506,"type":21},"2027-03",{"name":47,"class":48},{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":138,"sex":16,"minAge":89,"maxAge":514,"enrollmentInfo":515,"targetDuration":4,"studyType":22,"phases":516,"briefSummary":517,"conditions":518,"keywords":523,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":532,"locationsCount":49},"100608046","precision-brain-stimulation-to-reduce-cannabis-craving-in-schizophrenia-100608046","NCT07196462","Precision Brain Stimulation to Reduce Cannabis Craving in Schizophrenia","Inclusion Criteria for Psychosis Participants:\n\n* Age between 18-65 years\n* Diagnosis of a psychotic disorder according to DSM-5 criteria and confirmed by SCID\n* Current cannabis use of at least 2\u002F10 on a Visual Analog Scale\n* Current cannabis use (confirmed by urine cannabis testing)\n* Must be able to read, speak and understand English\n* Must be judged by study staff to be capable of completing the study procedures\n* Participants will be in stable outpatient psychiatric treatment and psychiatrically stable with no recent (within the past 30 days) psychiatric hospitalizations or changes in their psychiatric medication regimens.\n\nInclusion Criteria for Healthy Controls:\n\n\\- All of the above except for participants will not have a diagnosis of a psychotic disorder nor a first-degree relative with a psychotic disorder.\n\nExclusion Criteria for ALL participants:\n\n* DSM-5 intellectual disability\n* Substance use disorder (other than cannabis or nicotine) within the past three months\n* Positive urine drug screen for illicit substance use that can increase seizure risk (cocaine, benzodiazepines, amphetamine, methamphetamine)\n* Any history of a progressive or genetic neurologic disorder (e.g. Parkinson's disease, multiple sclerosis, tuberous sclerosis, Alzheimer's Disease) or acquired neurological disease (e.g. stroke, traumatic brain injury, tumor), including intracranial lesions\n* History of head trauma resulting in any loss of consciousness (\\>15 minutes) or neurological sequelae\n* Current history of poorly controlled headaches including chronic medication for migraine prevention\n* History of fainting spells of unknown or undetermined etiology that might constitute seizures\n* History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist\n* Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n* Any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g. MRI compatible joint replacement)\n* Any devices such as pacemaker, medication pump, nerve stimulator, TENS unit, ventriculo-peritoneal shunt unless cleared by the responsible covering MD\n* All female participants of child-bearing age will be required to have a pregnancy test; any participant who is pregnant or planning to become pregnant will not be enrolled in the study\n* Medications will be reviewed by the responsible covering physician and a decision about inclusion will be made based on the participant's past medical history, drug dose, history of recent medication changes or duration of treatment, and use of CNS active drugs. The published TMS guidelines review of medications to be considered with rTMS will be taken into consideration given their described effects on cortical excitability measures.\n* Any changes in medications or hospitalizations within the past 30 days.\n* Participants who, in the investigator's opinion, might not be suitable for the study or would be unable to tolerate the study visit\n\nThese exclusion criteria strictly follow all recommended guidelines as endorsed by the International Federation of Clinical Neurophysiology and the International Society for Transcranial Stimulation.","65 Years",{"count":92,"type":21},[24],"The central hypothesis is this: Brain circuits most relevant to cannabis use in schizophrenia are distinct from pathways identified in healthy controls who use cannabis. This study seeks to provide evidence that targeted stimulation of the DMN leads to both altered network activity and a concomitant behavioral change in cue-induced craving and cognitive performance in individuals with schizophrenia and schizoaffective disorder, while targeted stimulation of the L DLPFC leads to these changes in healthy controls who use cannabis. This study will test a model that integrates brain network pathophysiology and cognition to 1) explain the prevalence of cannabis use in schizophrenia and 2) identify a target for engagement in schizophrenia. This study seeks to establish a neuroscientific framework to guide future treatment-oriented studies aimed at reducing craving and improving cognitive performance in individuals with schizophrenia and schizoaffective disorder.\n\nThis is a study of the effect of 2 rTMS interventions on functional connectivity and craving in individuals with schizophrenia or schizoaffective disorder and healthy controls who use cannabis.\n\nAim 1: Target Engagement: Determine if rTMS manipulates functional connectivity of each target (DMN, L DLPFC) (n=100).\n\nAim 2: Clinical Efficacy: Determine if rTMS affects cue-induced craving and if craving change correlates with change in functional connectivity (n=100).\n\nAs an exploratory analysis, the factors that explain individual variance in rTMS-induced connectivity change will also be explored.",[519,520,521,522],"Cannabis Use","SCHIZOPHRENIA","Psychosis","rTMS",[524,525,522,526],"cannabis use","schizophrenia","brain stimulation","2026-05-28",{"date":474,"type":41},{"date":530,"type":41},"2026-01-15",{"date":260,"type":21},{"name":47,"class":48},{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":539,"eligibilityCriteria":540,"healthyVolunteers":12,"sex":16,"minAge":89,"maxAge":541,"enrollmentInfo":542,"targetDuration":4,"studyType":22,"phases":543,"briefSummary":544,"conditions":545,"keywords":548,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":561},"100624235","rehabilitation-with-empowered-strategies-to-optimize-recovery-100624235","NCT07406997","Rehabilitation With Empowered STrategies to Optimize REcovery","Rehabilitation With Empowered STrategies to Optimize REcovery After Spine Surgery","RESTORE","Inclusion Criteria:\n\n* Surgical treatment of a lumbar degenerative condition using a laminectomy with or without fusion procedure\n* English speaking\n* Age between 18-85 years\n\nExclusion Criteria:\n\n* Surgery due to trauma, fracture, tumor, infection, or spinal deformity\n* Revision surgery\n* Prior history of lumbar spine surgery in last 12 months\n* Involved in litigation or a workers' compensation claim due to injury\n* Currently undergoing treatment for cancer\n* Unable to access a reliable internet connection\n* Unable to provide a stable telephone or physical address\n* Unable to participate in follow-up assessment for 6 months after surgery","85 Years",{"count":92,"type":21},[24],"The main goal of this clinical trial is to understand the benefits of remotely delivered Empowered Relief in patients undergoing lumbar spine surgery. The main question the trial aims to answer is:\n\nDoes a postoperative behavioral intervention, Empowered Relief, performed early after back surgery have a measurable impact on postoperative outcomes?\n\nAdditional questions are whether changes in pain catastrophizing are related to improvements in outcomes and whether preoperative pain catastrophizing is a moderator of response to treatment.\n\nResearchers will compare remotely delivered Empowered Relief to remotely delivered education to see if Empowered Relief helps patients manage their pain and functional limitations after back surgery.\n\nParticipants will:\n\n* Complete one group session of remotely delivered Empowered Relief or Education after back surgery\n* Complete surveys before surgery and 3- and 6-months after surgery",[546,547],"Lumbar Spine Degenerative Changes","Lumbar Spine Surgery",[549,550,551,552],"behavioral research","Patient Reported Outcomes Measures","Pain","Pain Catastrophizing","2026-05-27",{"date":555,"type":41},"2026-06-01",{"date":557,"type":41},"2026-02-24",{"date":559,"type":21},"2029-08-31",{"name":47,"class":48},4,{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":569,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":570,"conditions":571,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":49},"100474797","right-ventricle-lipid-in-pulmonary-arterial-hypertension-pah-100474797","NCT05462574","Right Ventricle Lipid in Pulmonary Arterial Hypertension (PAH)","Clinical and Mechanistic Understanding of Right Ventricular Steatosis in Pulmonary Arterial Hypertension (PAH)","Inclusion criteria:\n\n* ≥ 18 years old\n* Diagnosed with idiopathic, heritable, connective tissue disease-associated PAH, associated pulmonary arterial hypertension (PAH), or drug-or toxin-associated PAH according to World Health Organization (WHO) consensus recommendations.\n* Stable PAH-specific medication regimen for three months prior to enrollment. Adjustments in IV prostacyclin for side effect management are allowed. Diuretic adjustments are permitted.\n* WHO Functional Class I-III\n* Ambulatory\n* Able to have an MRI\u002FMRS, perform a 6MWD test, and cardiopulmonary exercise test\n\nExclusion criteria:\n\n* Pregnancy\n* Diagnosis of PAH etiology other than idiopathic, heritable, connective tissue disease - associated PAH or associated with drugs and toxins\n* WHO Functional class IV heart failure\n* Requirement for continuous oxygen\n* Unable to have an MRI\u002FMRS, perform a 6MWD test, or cardiopulmonary exercise test.\n* Patients with implanted\u002Fembedded ferromagnetic material that would preclude cardiac MRI",{"count":269,"type":21},"The investigators propose to study the relationship between right ventricle (RV) steatosis and RV function, exercise capacity, and outcomes in humans with pulmonary arterial hypertension (PAH) and to identify potential drivers of lipid accumulation.",[572,573,574],"Idiopathic Pulmonary Arterial Hypertension","Heritable Pulmonary Arterial Hypertension","Pulmonary Arterial Hypertension Associated With Connective Tissue Disease","2026-05-26",{"date":501,"type":41},{"date":578,"type":41},"2023-01-17",{"date":580,"type":21},"2027-09-30",{"name":47,"class":48},{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":189,"minAge":89,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":22,"phases":591,"briefSummary":592,"conditions":593,"keywords":595,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":49},"100610048","feasibility-and-safety-of-single-port-robotic-assisted-deep-inferior-epigastric-pedicle-flap-harvest-100610048","NCT07222514","Feasibility and Safety of Single-Port Robotic-Assisted Deep Inferior Epigastric Pedicle Flap Harvest","Feasibility and Safety of Single-Port Robotic-Assisted DIEP Flap Harvest for Breast Reconstruction: A Prospective Evaluation","(DIEP)","Inclusion Criteria:\n\n* Female patients aged ≥18 years.\n* Candidates for unilateral or bilateral breast reconstruction using a DIEP flap.\n* No contraindications for general anesthesia or robotic surgery.\n* Patients with adequate abdominal donor tissue for DIEP flap harvest.\n\nExclusion Criteria:\n\n* History of prior abdominal surgery that significantly compromises perforator vessel integrity.\n* Pregnant woman.\n* Prisoners.\n* BMI \\> 35, as measured during the preoperative evaluation.\n* Presence of comorbidities that contraindicate elective surgery.\n* Active cancer other than breast cancer at the time of evaluation.\n* Active metastatic disease confirmed via imaging or biopsy.\n* Inability to comply with follow-up visits.\n* The research team decides to exclude the patient.",{"count":561,"type":21},[24],"The primary aim of this study is to evaluate the feasibility of single-port robotic surgery for DIEP flap breast reconstruction. The investigators will also investigate complications of the procedure, incision length, flap success rate, post operative pain, vascular pedicle length and caliber, and VMP-B score (quality of life\u002Fsatisfaction of breast procedures survey).",[594],"DIEP Flap Breast Reconstruction",[596,597,598],"DIEP flap breast reconstruction","Robotic Surgery","Breast Reconstruction","2026-05-23",{"date":553,"type":41},{"date":602,"type":41},"2026-05-20",{"date":604,"type":21},"2028-12",{"name":47,"class":48},{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":610,"acronym":611,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":16,"minAge":613,"maxAge":614,"enrollmentInfo":615,"targetDuration":4,"studyType":22,"phases":616,"briefSummary":617,"conditions":618,"keywords":620,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":627,"lastUpdatePostDateStruct":628,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":632,"locationsCount":49},"100638848","hemorrhage-elimination-during-lumbar-puncture-using-ultrasound-measurements-helpus-100638848","NCT07612644","Hemorrhage Elimination During Lumbar Puncture Using Ultrasound Measurements (HELPUS)","HELP","Inclusion Criteria:\n\n* \\- Neonates and infants (\\\u003C 12 months)\n* Hemodynamically stable\n* Undergoing a lumbar puncture for diagnostic testing\n\nExclusion Criteria:\n\n* \\- Infants \\> 12 months and 1 day\n* Signs of clinical instability\n* Known spinal anomalies (e.g., spina bifida, meningomyelocele) or previous spinal surgery","1 Day","12 Months",{"count":399,"type":21},[24],"This is a clinical trial to determine the extent to which ultrasound-assisted lumbar puncture using a standardized procedure, including use of ultrasound to ascertain the presence of cerebrospinal fluid (CSF) at L3 - L5 and the optimal needle insertion distance, increases the acquisition rate of CSF that is interpretable for patient management.",[619],"Lumbar Puncture",[621,622,623,624,625,626],"Infant","Meningitis","sepsis","fever","lumbar puncture","ultrasound","2026-05-22",{"date":501,"type":41},{"date":630,"type":41},"2026-05-16",{"date":480,"type":21},{"name":47,"class":48},""]