[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Stony Brook University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":633},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,50,82,115,138,165,188,209,237,264,286,306,329,351,376,403,424,446,467,490,514,544,570,592,613],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100642971","postpartum-intervention-for-mothers-with-opioid-use-disorders-r33-100642971",false,"NCT07632053","Postpartum Intervention for Mothers With Opioid Use Disorders (R33)","PIMO","Inclusion Criteria:\n\n* mothers with diagnosis of Opioid Use Disorder (OUD); and\u002For receiving medication assisted treatment (such as buprenorphine or methadone)\n* with a child aged 5 or less\n* able to read, hear and understand English adequately enough to provide informed consent\n\nExclusion Criteria:\n\n* require immediate clinical care for suicidal\u002Fhomicidal risk or psychosis;\n* For magnetic resonance imaging (MRI) of the brain, potential participants will be excluded if they: (1) have ferromagnetic metal in their heads (2) have severe claustrophobia that prevents participation in the neuroimaging (3) have serious neurological condition that could interfere with neuroimaging, including a brain tumor, multiple sclerosis or significant head trauma","FEMALE","18 Years","50 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"NA","Having met the milestones of the R61, this R33 is a 2-site, 2-group, pre\u002Fpost RCT of mothers with OUD (n=\\~80\u002Fgroup). We will test whether the beneficial pre-post changes in OUD mothers randomized to vMP exceed those of mothers assigned to Enhanced Usual Care (EUC) and via changes in Maternal Brain Neurocircuits.",[28,29],"Opioid Use Disorder","Parent-Child Relations",[31,32,33,34,35,36],"parenting intervention","opioid use disorder","parental stress","maternal brain","evoked response potentials","brain fMRI","RECRUITING","2026-06-05",{"date":40,"type":41},"2026-06-09","ACTUAL",{"date":43,"type":41},"2025-07-01",{"date":45,"type":22},"2028-07",{"name":47,"class":48},"Stony Brook University","OTHER",2,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100534619","phase-4-famotidine-and-antacids-for-treatment-of-dyspepsia-100534619","NCT06241183","Famotidine and Antacids for Treatment of Dyspepsia","Comparing Intravenous Famotidine and Oral Antacids in the Treatment of Dyspepsia in the Emergency Department","Inclusion Criteria:\n\n1. Subject Age ≥ 18 years of age\n2. Patient diagnosed with dyspepsia\n3. Present at the ED with upper abdominal pain score of at least 3\n\nExclusion Criteria:\n\n1. Hypersensitivity to an ingredient in Maalox\u002F Mylanta or Famotidine\n2. Moderate to Severe Renal Insufficiency (precaution)\n3. Kidney Failure\n4. Pregnant or Nursing\n5. Verbal pain score less than 3\n6. Inability to tolerate oral medications\n7. Bowel Obstruction\n8. Proton pump inhibitor within 2 hours of study treatment","ALL",{"count":21,"type":22},[60],"PHASE4","The aim of this study is to compare intravenous famotidine, an H2 receptor antagonist, and Maalox\u002F Mylanta, an oral antacid, in treatment of dyspepsia in the emergency department. The goal of this study is to reduce patients' pain based on the verbal numerical pain scale. The anticipated outcome is for pain levels in both groups to decrease. It is expected that antacids will improve symptoms more quickly and to a greater degree within an hour of taking medication based on the results of similar studies.",[63,64,65],"Dyspepsia","GERD","Acid Reflux",[67,64,65,68,69,70,71,72],"dyspepsia","H2 receptor antagonist","antacid","Maalox","Mylanta","Famotidine","2026-06-01",{"date":75,"type":41},"2026-06-02",{"date":77,"type":41},"2023-11-09",{"date":79,"type":22},"2027-12-31",{"name":47,"class":48},1,{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":57,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":81},"100636049","seeme-using-automated-facial-tracking-to-detect-voluntary-behavior-in-brain-injury-100636049","NCT07560631","SeeMe: Using Automated Facial Tracking to Detect Voluntary Behavior in Brain Injury","SeeMe: A Multimodal Behavioral-Electrophysiological Tool for Real-Time Detection of Motor Behavior in Brain Injury Patients","Group 1: Traumatic Brain Injury (TBI) Cohort\n\nInclusion Criteria:\n\n* Adults (22+) with a history of acute traumatic brain injury\n* Documented loss of consciousness with a Glasgow Coma Scale (GCS) score less than or equal to 8 upon hospitalization\n* Clinically stable as determined by the primary neurosurgery or ICU team\n* Intact auditory pathways as confirmed by BAERs\n* Family consent for study participation\n\nExclusion Criteria:\n\n* Hearing Impairment confirmed via absence of Brainstem Auditory Evoked Responses (BAERs) that would prevent the patient from hearing the auditory commands\n* No legal authorized representative (LAR) available to provide informed consent for the patients in a comatose state\n* Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe.\n* Pregnant women\n* Any previous history of traumatic brain injury\n* Any neurodegenerative disease such as dementia\n\nGroup 2: Healthy Control Cohort\n\nInclusion Criteria:\n\n* Adults 22+ with no history of neurological or psychiatric disorders\n* Normal baseline neurological examination\n* Intact auditory pathways\n* Ability to provide informed consent\n* Ability to follow simple auditory commands in English\n\nExclusion Criteria:\n\n* Hearing Impairment that would prevent the participant from hearing the auditory commands\n* Any previous history of severe traumatic brain injury (TBI)\n* Any neurodegenerative disease (e.g., dementia)\n* Any motor impairment (e.g., facial palsy, carpal tunnel syndrome) that would interfere with facial or hand movement tracking\n* Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe\n* Pregnant women\n\nGroup 3: Sedated\u002FAnesthetized Cohort\n\nInclusion Criteria:\n\n* Adults (22+) undergoing elective spine surgery\n* Requirement of general anesthesia and pharmacological paralysis (neuromuscular blockade) as part of the standard surgical procedure\n* Clinically stable for study procedures as determined by the anesthesia and surgical teams.\n* Intact auditory pathways\n* Ability to provide informed pre-operative consent\n\nExclusion Criteria:\n\n* Hearing Impairment that would prevent the patient from hearing the auditory commands\n* Any previous history of severe traumatic brain injury\n* Any neurodegenerative disease such as dementia\n* Significant baseline facial or hand motor deficits prior to the administration of anesthesia\n* Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe\n* Pregnant women",true,"22 Years","85 Years",{"count":21,"type":22},[25],"Objective: This prospective interventional study introduces \"SeeMe,\" an automated, high-resolution computer vision platform designed to objectively quantify microscopic, auditory command-evoked movements in patients with Traumatic Brain Injury (TBI). Current clinical assessments, such as the Glasgow Coma Scale (GCS) and Coma Recovery Scale-Revised (CRS-R), rely on subjective human observation and often fail to detect low-amplitude motor responses, potentially misclassifying up to 25% of patients as unresponsive.\n\nMethodology: SeeMe utilizes vector analysis, cross-correlation, and deep neural networks (DNNs) to track individual facial pores and hand movements with sub-millimeter precision (0.5 mm) and high temporal resolution (0.03s). The study will enroll a cohort of 60-80 TBI patients, alongside healthy controls and pharmacologically paralyzed subjects, to validate SeeMe's sensitivity and specificity.\n\nPrimary Goals:\n\n1. Validation: Compare SeeMe's detection of voluntary motor recovery against gold-standard clinical examinations (CRS-R).\n2. Synchronization: Simultaneously record and time-lock electroencephalography (EEG) and electrocorticography (ECoG) with SeeMe-detected movements.\n3. Biomarker Identification: Characterize neural signatures (specifically Beta-band oscillations) associated with the return of voluntary behavior.\n\nImpact: By providing a real-time, objective measure of motor intention and execution, SeeMe aims to identify \"Cognitive-Motor Dissociation\" (CMD) earlier than current methods, facilitating more accurate prognostications and laying the framework for future closed-loop neuromodulation (e.g., Vagus Nerve Stimulation) to accelerate TBI recovery.",[96,97],"Traumatic Brain Injury (TBI) Patients","Severe Traumatic Brain Injury",[99,100,101,102,103,104,105,106],"Traumatic Brain Injury","Disorders of Consciousness","Coma","Cognitive-Motor Dissociation","Covert Awareness","Computer Vision","Deep Learning","Artificial Intelligence","2026-04-30",{"date":109,"type":41},"2026-05-05",{"date":111,"type":41},"2026-03-30",{"date":113,"type":22},"2029-12",{"name":47,"class":48},{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":124,"phases":4,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":81},"100635959","fear-and-anxiety-in-anesthesia-nave-patients-pre-operatively-vs-post-operatively-100635959","NCT07559461","Fear and Anxiety in Anesthesia-Naïve Patients Pre-operatively vs Post-operatively","Fear and Anesthesia: How Anxiety and Fear in Anesthesia-Naïve Patients Changes From Preop to Postop","Inclusion Criteria:\n\n* 18 years old or over\n* Patients scheduled to undergo surgeries such as but not limited to:\n\ncholecystectomies, appendectomies, hernia repairs, breast surgeries, plastic surgeries, thyroidectomy, parathyroidectomy, tonsillectomy, adenoidectomy, lithotripsy, stent placement, kidney stone surgeries, cystoscopies, bladder tumors, ovarian cystectomies, hysterectomies, tubal ligation, hysteroscopy, Intrauterine Device (IUD) insertion, knee replacement, hip replacement, fracture pinning, sports injury surgery such as knee and shoulder scopes. OR patients undergoing procedures such as but not limited to: colonoscopies and endoscopies\n\n* Patient undergoing anesthesia for the first time\n* Patients who are not pregnant by self report\n\nExclusion Criteria:\n\n* Patients under 18\n* Patients who are pregnant\n* Patients undergoing high-risk surgeries\n* Patients undergoing cancer-related procedures\n* Non-English speaking patients\n* Patients that experience mental status change postoperatively as determined by the medical teams caring for the patient\n* Patients with an existing anxiety disorder, or psychiatric diagnoses\n* Patients on benzodiazepines, antidepressants, chronic opioids",{"count":123,"type":22},40,"OBSERVATIONAL","The goal of this observational study is to understand how fear and anxiety felt by anesthesia-naive patients compares before versus after their scheduled surgery. Patients who are scheduled to undergo a low-risk surgery\u002Fprocedure and have never had anesthesia before will be asked to:\n\n1. Fill out a survey before their surgery in the perioperative setting\n2. Answer follow-up questions over the phone a few days after their surgery.",[127,128],"Anxiety","Anesthesia Awareness",[130,127],"Anesthesia-naïve","2026-04-29",{"date":109,"type":41},{"date":134,"type":41},"2026-02-12",{"date":136,"type":22},"2027-02",{"name":47,"class":48},{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":147,"conditions":148,"keywords":151,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":81},"100581489","foley-balloon-for-cervical-preparation-before-dilation-and-evacuation-100581489","NCT06850974","Foley Balloon for Cervical Preparation Before Dilation and Evacuation","Inclusion Criteria:\n\n* Women 18 years and older presenting to Hospital Central de Maputo requiring abortion for any legal indication between 16-21 weeks gestation.\n* Portuguese speaking\n\nExclusion Criteria:\n\n* Less than age 18\n* Incarcerated\n* Chorioamnionitis\n* Active heavy bleeding\n* A known bleeding diathesis\n* Hemodynamic instability\n* \\> 2 cm dilation\n* History of cervical cerclage\n* Allergy to any study medications\n* Eclampsia\n* Glasgow Coma Score Less than 15",{"count":145,"type":22},102,[25],"To evaluate the Foley Balloon technique for cervical preparation before second trimester surgical abortion between 16 and 21 weeks estimated gestational age in combination with misoprostol to prepare the cervix before dilation and evacuation (D\\&E) instead of osmotic dilators (Laminaria).\n\nSpecific Aim One: Assess definitively whether using a Foley Balloon and Misoprostol is non-inferior to osmotic dilators for cervical preparation before D\\&E.\n\nSpecific Aim Two: Evaluate patient satisfaction with the two methods of second trimester abortion.\n\nSpecific Aim Three: Evaluate provider satisfaction with the two methods of second trimester abortion.",[149,150],"Abortion, Second Trimester","Abortion, Medical",[152,153,154,155,156,157],"second","trimester","abortion","surgical","balloon","Foley","2026-04-26",{"date":107,"type":41},{"date":161,"type":41},"2025-02-10",{"date":163,"type":22},"2027-03",{"name":47,"class":48},{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":89,"sex":57,"minAge":18,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":23,"phases":175,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":187,"locationsCount":81},"100559933","opioid-sparing-effect-of-an-isp-nerve-block-on-post-op-pain-control-in-posterior-cervical-spine-surgery-100559933","NCT06570577","Opioid Sparing Effect of an ISP Nerve Block on Post-Op Pain Control in Posterior Cervical Spine Surgery","The Opioid Sparing Effect of an Inter-semispinalis Plane Block on Postoperative Pain Control in Posterior Cervical Spine Surgery","Inclusion Criteria:\n\n* Having Posterior Cervical Spine Surgery from C2 - C7, which may extend to the upper thoracic vertebrae, inclusive to T3.\n* Capacity to provide informed consent\n\nExclusion Criteria:\n\n* Fusion and decompression due to trauma\n* Emergent procedures\n* Patient is on a medication-assisted treatment, e.g., buprenorphine, naltrexone or methadone.\n* There is an infection near or in the area of neck where the block will be placed.\n* The patient is having a complicated surgery or a revision surgery\n* Female patient with a positive pregnancy test on the day of surgery (hospital standard-of-care).\n* Patient has Diabetes\n* Patients who have had a prior adverse reaction to bupivacaine or dexamethasone\n* Patients with Glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia","75 Years",{"count":174,"type":22},60,[25],"Participants who have a surgical procedure called Posterior Cervical (neck) Spine Surgery will normally need pain medication to relieve post operative pain. This usually includes opioid medications. In this study, the consented participant may receive a nerve block procedure, in addition to the pain relieving medication. There is a fifty-fifty chance to receive the nerve block. The goal is to see if the nerve block group needs less opioid medication, has lower pain scores and is discharged from the hospital sooner.",[178],"Pain, Postoperative",[180,181],"cervical fusion","opioids","2026-04-23",{"date":131,"type":41},{"date":185,"type":41},"2025-02-21",{"date":163,"type":22},{"name":47,"class":48},{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":23,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":201,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":4},"100569878","phase-4-stony-brook-medicine-anti-inflammatory-trial-100569878","NCT06699966","Stony Brook Medicine Anti-Inflammatory Trial","Inclusion Criteria:\n\n* Current consent form signed\n* Capacity to give informed consent\n* Age range 18-65 (inclusive)\n* Diagnosis of MDD or bipolar depression and currently in a major depressive episode\n* Score of at least 29 on the MADRS (at least moderate depression)\n\nExclusion Criteria:\n\n* Hypersensitivity to celecoxib, minocycline, tetracyclines, sulfonamides, aspirin, other NSAIDs, or any component of the formulation; previous asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs\n* History of myocardial infarction or current cardiac condition\n* Heptic impairment, heart failure, severe renal impairment, recent GI bleed, history of peptic ulcer disease, anemia or any other contraindication for celecoxib or minocycline\n* Poor CYP2C9 metabolizer\n* Currently taking medications that interact with celecoxib (digoxin, antihypertensives, diuretics, anticoagulant or anti-platelet treatment, including aspirin), or minocycline (isotretinoin, ergot alkaloids) without providing physicians approval\n* Use of herbs, drugs, or medications with anti-inflammatory or immunomodulatory properties (within 5 half-lives of starting celecoxib or minocycline treatment)\n* Unlikely to tolerate medication washout or the medication-free period following washout.\n* Participant considered at significant risk for suicide.\n* Electroconvulsive therapy (ECT) within 1 month\n* High potential for excessive drug\u002Falcohol use during the treatment period (excluding nicotine or cannabis)\n* Significant active physical illness or neurological deficit that may affect brain functioning.\n* If participant is currently pregnant, breastfeeding, or planning to conceive during the course of study participation.\n* Need for medications that control mania.","65 Years",{"count":196,"type":22},42,[60],"This is an experimental study designed to measure the effect of celecoxib or minocycline on depressive symptoms in unipolar and bipolar depression. Participants will be equally randomized to either celecoxib or minocycline. All participants will complete a battery of clinical and psychological assessments prior to treatment assignment, and again after treatment completion, to assess any changes or improvements in depression.",[200],"Major Depressive Disorder","NOT_YET_RECRUITING","2026-04-21",{"date":182,"type":41},{"date":205,"type":22},"2027-06",{"date":207,"type":22},"2032-01",{"name":47,"class":48},{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":57,"minAge":90,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":23,"phases":218,"briefSummary":219,"conditions":220,"keywords":223,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":81},"100612784","tavns-for-delirium-100612784","NCT07258082","TaVNS for Delirium","Transauricular Vagus Nerve Stimulation (taVNS) for Delirium","Inclusion Criteria:\n\n* Stony Brook University Hospital inpatient, Age \\> 22\n* Right- handed\n* Screen positive for delirium on ICDSC instrument\n\nExclusion Criteria:\n\n* Severe neurologic disability including severe traumatic brain injury, severe permanent cognitive impairment\n* Pacemaker present\n* Implanted VNS stimulator present\n* Personal history of epilepsy\n* Facial or ear pain or trauma\n* Recent history of substance abuse\n* Any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe.\n* Weight \\\u003C 40kg\n* Pregnant females\n* Intubated patient",{"count":217,"type":22},10,[25],"The goal of this clinical trial is to test whether a non-invasive device called transauricular vagus nerve stimulation (taVNS) is safe, practical, and potentially helpful for patients in the hospital who develop delirium. Delirium is a state of confusion that often happens to people in the hospital who are sick or hurt. It can cause agitation, trouble paying attention and difficulty understanding what is happening. Delirium may slow overall recovery.\n\nThis study will focus on feasibility and safety. Researchers want to learn whether taVNS can be given safely to critically-ill patients, whether patients and staff can tolerate the treatments, and whether the device produces measurable changes in brain activity and brain oxygen levels.\n\nThe main questions this study aims to answer are:\n\n* Is it possible to deliver taVNS safely and consistently to patients in the ICU who have delirium?\n* Do patients tolerate the device without significant side effects or complications?\n* Does taVNS cause short-term changes in brain signals and oxygen levels that may suggest effects on brain function? This is an early feasibility study and there is no randomization or placebo group. All patients enrolled will receive taVNS in addition to their usual hospital care for delirium.\n\nWhat participants will do:\n\n* Be identified by their hospital care team and have a confirmed diagnosis of delirium.\n* Provide consent (or have a legally authorized representative provide consent if the patient cannot.)\n* Undergo brief assessments of thinking and attention (for example, the ICDSC test.)\n* Receive taVNS treatment using a small clip electrode placed on the ear.\n\n  * The device sends gentle electrical pulses to the nerve in the ear.\n  * Each session lasts about 30 minutes, given twice per day (morning and evening, with at least 6 hours between sessions).\n  * Treatment can continue for up to 7 days while the patient is in the ICU.\n* Be monitored during and after each session. The study team will check vital signs, examine the ear for irritation, and ask about any discomfort.\n* On the first day, researchers will also record brain signals (EEG) and brain oxygen levels before and during stimulation using FDA-approved hospital monitoring devices.\n\nPossible risks and discomforts:\n\n* Mild side effects are possible, such as tingling, a tickling or pricking feeling in the ear, or temporary skin redness where the clip is placed.\n* Serious side effects are not expected, but all patients will be closely monitored during and after each session to ensure safety.\n\nPossible benefits:\n\n• Patients may or may not experience personal benefit. The main benefit is helping researchers learn whether this treatment approach is safe and practical. In the future, taVNS could potentially become a new tool to help treat or prevent delirium in hospitalized patients.\n\nStudy size and duration:\n\n* The study will enroll a limited number of ICU patients with delirium at Stony Brook University Hospital.\n* Patients may take part for up to 7 days while hospitalized.\n\nWho can join:\n\n* Right-handed, adult patients in the ICU who are diagnosed with delirium.\n* People with certain medical conditions (such as brain bleeds, new strokes, pacemakers or other contraindications) may not be able to participate, for safety reasons.",[221,222],"Delirium Treatment","Delirium",[224,225,226,227,228],"delirium","tavns","transauricular vagus nerve stimulation","vagus nerve stimulation","transcutaneous vagus nerve stimulation","2026-04-17",{"date":231,"type":41},"2026-04-22",{"date":233,"type":41},"2025-09-26",{"date":235,"type":22},"2028-10",{"name":47,"class":48},{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":23,"phases":247,"briefSummary":248,"conditions":249,"keywords":251,"overallStatus":201,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":49},"100629713","first-responder-safety-training-first-100629713","NCT07478250","First Responder Safety Training (FiRST)","A Large-scale Efficacy Trial of a Resilience Training Program for First Responders","FiRST","Inclusion Criteria:\n\n* Active first responder at fire station or EMS organization\n\nExclusion Criteria:\n\n* NA",{"count":246,"type":22},800,[25],"As a result of chronic exposures to traumatic and stressful events, first responders are at elevated risk for experiencing post-traumatic stress disorder (PTSD) and other mental health problems. Resilience training can reduce the risk for developing mental health symptoms in first responders. The National Institute for Environmental Health Sciences and the Substance Abuse Mental Health Services Administration developed the Worker Resilience Training (WRT) program - a 4-hour interactive workshop to educate responders on the effects of traumatic exposures, PTSD and ways to increase adaptive coping resources and promote resilience. The investigators completed a randomized clinical trial (RCT) of the WRT for active responders (n = 167). Results indicated that the WRT, as compared to a waitlist control group, helped prevent the development of PTSD and depression symptoms, and improved important resilience indicators (i.e., healthy lifestyle behaviors, stress management, physical activity) over the course of three months. The proposed multi-site RCT seeks to build on our initial study by conducting a Stage III efficacy trial of the WRT workshop in N=800 first responders in New York (NY) and Texas (TX). Our specific aims are: Aim 1. To evaluate the efficacy of the WRT program for improving resilience indicators, defined as health promoting lifestyle behaviors, stress management and physical activity, and improving perceived resilience over the course of one year. Aim 2. To evaluate whether the WRT program serves to prevent the development or worsening of psychological symptoms and impairments in functioning over the course of one year among those first responders who are exposed to traumatic events after participation in the study workshop. Aim 3. To identify the target treatment mechanisms of the WRT for preserving mental and occupational health outcomes and functioning over the course of one year in first responders who are exposed to traumatic events post-workshop. Aim 4. To gather qualitative data to further inform a future effectiveness trial including perceptions about the use and potential impact of peer leaders delivering the program content, and perceptions about mode of program delivery via open-ended questions at follow-up. The investigators will use a cluster RCT design and multi-modal assessments including self-report measures, a web-based stress reactivity performance task, and real-time accelerometry. Participants in both conditions will also receive a booster session at 3 months post workshop to reinforce skills and intervention knowledge. This study will contribute to our understanding of how resilience training may serve to protect the mental health and functioning of first responders. This study has important clinical and public health implications, including preserving\u002Fstrengthening mental health and reducing overall personal and financial costs. This study also takes a research to practice approach by working collaboratively with fire departments and EMS organizations in NY and TX. If successful, the investigators will work with these leaders to develop a method for annual WRT trainings to foster resilience and promote well-being long-term for first responders.",[250],"Resilience and Mental Health of First Responders",[252,253,254,255],"PTSD","Trauma","Resilience","first responders","2026-04-15",{"date":258,"type":41},"2026-04-20",{"date":260,"type":22},"2026-04-01",{"date":262,"type":22},"2030-06-30",{"name":47,"class":48},{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":89,"sex":57,"minAge":18,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":23,"phases":273,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":285},"100544755","use-of-ketosis-in-modulating-metabolic-pathways-in-bipolar-disorder-100544755","NCT06373016","Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder","Inclusion\u002FExclusion Criteria:\n\n* Bipolar disorder diagnosis: Patients must have a Diagnostic Statistical Manual (DSM)-V diagnosis of bipolar disorder on the Structured Clinical Interview for DSM (SCID)\n* Bipolar disorder symptoms: Patients must be stable and euthymic at time of consent and testing, documented by no hospitalizations in the prior 4 weeks\n* Age: between 18-45 yrs for patients with bipolar disorder and age-matched controls\n* Weight does not exceed 350lbs.\n* Diameter does not exceed 60 cm when supine\n* HbA1C \\\u003C 7%\n* No non-MRI-compatible metal in the body (e.g., pacemaker, shrapnel, joint pins)\n* No claustrophobia\n* No history of significant head injury\n* No history of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the last 3 months\n* No history of previous treatment with following procedures: vagus nerve stimulation, or deep brain stimulation\n* Are not deemed a serious suicide or homicide risk\n* No unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease\n* No seizure disorders\n* Have the capacity to sign informed consent\n* No current diagnosis or history of an alcohol or substance use disorder in the last 6 months or positive test for an illicit drug on the screening urine analysis (positive cannabis screen is not exclusionary): confirmed using urine toxicology test during the initial screening visit and before each MRI scan visit.\n* For Healthy Volunteers Only: No psychotropic medication and no history of neurological disease\n* Must have vision that is 20\u002F20 or correctable to 20\u002F20 with contact lenses\n* No Type 1 diabetes mellitus\n* No regular consumption of insulin and other antidiabetics, like Metformin®, GLP1-RA's and others.\n* No kidney disease, as determined by medical history and\u002For blood work\n* No history of heart attack or stroke\n* No difficulty swallowing\n* No myxedema\n* No Pregnancy (pre-menopausal females): confirmed during medical screening and each MRI scan visit using a urine test\n* No breastfeeding","45 Years",{"count":272,"type":22},100,[25],"The goal of this clinical trial is to test how specific components of diet affect brain function and behavior for individuals with bipolar. The main question it aims to answer is how glucose and ketones each affect the brain's response to risk and reward. Participants will be asked to provide blood (to assess baseline measures of how the body uses energy), and then to receive two MRI scan sessions, on separate days. During each MRI scan session, participants will play three games, from which they can win money, before and after drinking glucose (on one day) or ketones (on the other day). Investigators will compare individuals with and without bipolar to test whether the two groups differ in how their brains use energy, and to test how the brain's use of energy affects behavior.",[276,277],"Bipolar Disorder","Bipolar Disorder Type 1","2026-04-10",{"date":256,"type":41},{"date":281,"type":41},"2024-01-26",{"date":283,"type":22},"2027-02-01",{"name":47,"class":48},3,{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":89,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":23,"phases":294,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":81},"100480755","impact-of-art-therapy-on-self-reported-pain-and-anxiety-scores-of-patients-waiting-to-be-seen-in-the-emergency-department-100480755","NCT05540106","Impact of Art Therapy on Self-Reported Pain and Anxiety Scores of Patients Waiting to Be Seen in the Emergency Department","Inclusion Criteria:\n\n* Triage Pain Score \\> 3\n* Age \\>18\n* Able to provide informed consent\n* English-speaking\n* without concern for aggressive behavior\n* Glasgow Coma Scale (GCS) of 15\n* Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score \\> 6\n\nExclusion Criteria:\n\n* Concern for aggression risk, including active concern for suicidal or homicidal ideations\n* Glasgow Coma Scale (GCS) \\\u003C15\n* triage acuity requiring critical care evaluation",{"count":293,"type":22},168,[25],"The objective of this research is to assess the effects of engaging in coloring activities on patients' self-reported pain and anxiety scores while they wait to be seen by a physician in an emergency department (ED). The current literature on patient visits in the ED highlights the significance of anxiety, stress, and frustration in patient experiences, especially when accounting for long wait times before the physician-patient encounter. The study will address this common problem by looking at the potential impact of nature-themed or geometric shape coloring activities on the ED patient experience as it relates to self-reported anxiety and pain scores. Given that long wait times are increasingly being reported across the country, this study may offer a possible meaningful low-budget, low-resource intervention which could be offered to patients.",[127,297],"Pain","2026-03-01",{"date":300,"type":41},"2026-03-03",{"date":302,"type":41},"2023-08-01",{"date":304,"type":22},"2027-12-01",{"name":47,"class":48},{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":23,"phases":314,"briefSummary":315,"conditions":316,"keywords":318,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":81},"100598811","phase-4-the-role-of-mglur5-in-cbt-i-100598811","NCT07076342","The Role of mGluR5 in CBT-I","Mechanistic Clinical Trial Evaluating the Role of the Metabotropic Glutamate Receptor Subtype 5 (mGluR5) in the Antidepressant Mechanism of Cognitive Behavioral Therapy for Insomnia (CBT-I)","Inclusion Criteria:\n\n* capacity to provide informed consent,\n* at least 18 years of age\n* good physical health and absence of significant medical conditions,\n* diagnosis of major depressive disorder (MDD) with current major depressive episode as per DSM-5 criteria\n* Montgomery-Åsberg Depression Rating Scale (MADRS) score \\> 29 (at least moderate depression),\n* uniform range of sleep latencies up to 128 minutes.\n\nExclusion Criteria:\n\n* currently taking effective antidepressants,\n* lifetime history of psychosis,\n* drug or alcohol dependence in the last 6 months or abuse in the last 2 months\n* unstable medical condition (i.e., condition not adequately stabilized for ≥ 3 months)\n* nicotine use within 1 year\n* currently on medication known to affect glutamate,\n* sleep disorders, other than insomnia, such as sleep apnea,\n* recent (within 1 year) regular night shift work (or rotating shift work) or recent (within 3 months) travel across more than one time zone, or plans for this work or travel during the study period,\n* use of medication or substances that affect sleep, for example, ingestion of more \\> 600 mg of caffeine per day,\n* PET or MRI contraindications, including pregnancy or currently breastfeeding",{"count":196,"type":22},[60],"This is mechanistic clinical trial that evaluates the role of one of the glutamate receptors (mGluR5) in cognitive behavioral therapy for insomnia (CBT-I) as a common pathway in improving sleep and depression.",[317],"Major Depressive Disorder (MDD)",[319,320,321,200],"Cognitive Behavioral Therapy","CBT-I","Cognitive Behavioral Therapy &amp; Insomnia",{"date":323,"type":41},"2026-02-17",{"date":325,"type":41},"2025-08-01",{"date":327,"type":22},"2030-03-31",{"name":47,"class":48},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":23,"phases":338,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":81},"100471771","early-phase-1-atezolizumab-and-pre-surgical-brain-radiation-therapy-for-glioblastoma-multiforme-100471771","NCT05423210","Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme","A Pilot Study to Evaluate the Immunogenic Effects of Window-of-Opportunity Fractionated Stereotactic Radiotherapy Combined With Atezolizumab for Patients With Newly Diagnosed WHO CNS Grade 4 Glioma (Glioblastoma Multiforme)","Inclusion Criteria:\n\n* Diagnosis of glioblastoma multiforme WHO Grade IV\n* The patient is a surgical candidate, with the surgical intent for a \\> 80% resection of the lesion\n* Negative pregnancy test\n* ECOG status \\\u003C= 2\n* Tumor volume \\\u003C= 3.5 cm\n* Adequate organ function\n* Negative for infectious disease (human immunodeficiency virus, Hepatitis B Virus, Hepatitis C Virus, tubercolosis)\n\nExclusion Criteria:\n\n* Patient already underwent surgical total or partial tumor resection, or radiation therapy\n* Presence of leptomeningeal disease, gliomatosis cerebri, multifocal disease, bilateral cerebral hemisphere involvement (\"butterfly\" gliomas)\n* Patients at increased risk of neurologic decompensation\n* Continued use of high dose intravenous or oral corticosteroids, or \\> 8milligrams per day of systemic dexamethasone\n* Uncontrolled tumor-related pain\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n* Uncontrolled or symptomatic hypercalcemia\n* History of autoimmune disease or immune deficiency\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis\n* Significant cardiovascular disease\n* History of other malignancy within 1 year prior to screening\n* Severe infection within 4 weeks prior to initiation of study treatment\n* History of allogeneic stem cell or organ transplant\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies\n* Treatment with systemic immunostimulatory agents\n* Treatment with systemic immunosuppressive medication",{"count":337,"type":22},12,[339],"EARLY_PHASE1","This is a single-arm pilot study that will recruit 12 patients with newly diagnosed Glioblastoma, a malignant brain tumor with a poor prognosis. Patients will be treated with fractionated stereotactic radiotherapy (FSRT) for 2 weeks, in addition to two doses of Atezolizumab (Tecentriq), an FDA approved PD- L1 inhibitor drug, 840 mg IV, at the beginning and at the end of the two-week time period, concomitantly with FSRT. After this initial two weeks treatment the patients will undergo craniotomy and maximal safe resection as per normal care for a GB. After surgery patients will follow the normal care for glioblastoma in addition to Atezolizumab 840 mg IV q2 weeks for the duration of adjuvant treatment.",[342],"Glioblastoma Multiforme","2025-12-15",{"date":345,"type":41},"2025-12-22",{"date":347,"type":41},"2022-10-25",{"date":349,"type":22},"2029-08",{"name":47,"class":48},{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":23,"phases":361,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":375},"100394944","phase-2-combination-of-novel-therapies-for-ckd-comorbid-depression-100394944","NCT04422652","Combination of Novel Therapies for CKD Comorbid Depression","Combination of Novel Therapies for CKD Comorbid Depression (CONCORD)","CONCORD","Inclusion Criteria:\n\n1. Male or female adults aged 18 years or greater. There will be no upper age limit.\n2. Presence of CKD stages 3b, 4 or 5, with an estimated glomerular filtration rate (GFR) of \\\u003C45 mL\u002Fmin\u002F1.73 m2 for a period of at least 3 months, as defined by the National Kidney Foundation and determined using the four-variable Modification of Diet for Renal Diseases Study formula.\n3. Presence of a current Major Depressive Disorder (MDD) based on MINI DSM IV-based criteria\n4. Quick Inventory of Depressive Symptomatology-Self-report (QIDS-SR) score of ≥11 at enrollment and ≥11 on QIDS-Clinician Rated (QIDS-C) at randomization.\n5. Able to understand and sign informed consent after the nature of the study has been fully explained\n6. Kidney transplant patients that are at least 6 month post-transplantation (3 months post-transplant, with at least another 3 months to confirm eGFR \\\u003C45)\n\nExclusion Criteria:\n\n1. Unable to understand or give informed consent.\n2. Unwilling or unable to participate in the protocol or comply with any of its components\n3. Significant hepatic dysfunction or liver enzyme abnormalities 3 times or greater than the upper limit of normal\n4. Terminal chronic obstructive pulmonary disease or cancer\n5. Presence of seizure disorder\n6. Current use of class I anti-arrhythmic medications (such as 1C propafenone and flecanide), pimozide, MAO inhibitors, reserpine, guanethidine, cimetidine, or methyldopa; tri-cyclic anti-depressants, neuroleptics, or anti-convulsants\n7. Use of serotonergic drugs or supplements such as triptans, tramadol, linezolid, tryptophan, and St. John's Wort.\n8. Use of medications known to cause QT prolongation on EKG\n9. Ongoing use of antidepressant medications for depression treatment\n10. Past treatment failure on bupropion\n11. Initiation of depression-focused psychotherapy in the 3 months prior to study entry\n12. Active alcohol or substance abuse or dependence that requires acute detoxification at study entry\n13. Present or past psychosis or Bipolar I or II disorder\n14. Dementia or a Mini-Mental State Examination score \\\u003C23\n15. Active suicidal intent\n16. Pregnancy, lactation, or women of childbearing potential not willing to use adequate contraception",{"count":360,"type":22},201,[362],"PHASE2","The overall goal of the study is to determine if treatment of a Major Depressive Disorder (MDD) improves the outcomes of patients with chronic kidney disease (CKD). We showed that MDD is present in 25% of CKD patients and independently associated with progression to End-Stage Kidney Disease, hospitalization, and death. Depression is also associated with lower quality of life (QOL), fatigue, poor sleep, and non-adherence to diet and medications. However, evidence for efficacy and tolerability of commonly-used antidepressant medications or nonpharmacologic treatments are limited in CKD patients. Our group was the first to conduct a double-blind randomized controlled trial for MDD treatment in 201 patients with non-dialysis CKD, and showed that sertraline, a commonly used selective serotonin reuptake inhibitor (SSRI), was no more efficacious than placebo for improving depressive symptoms. It becomes imperative to test novel strategies to treat MDD in CKD. We propose to compare with a control group, the efficacy and tolerability of two novel treatment strategies - (1) Behavioral Activation Teletherapy (BAT) for 16 weeks, with the addition of bupropion, a non-SSRI antidepressant, at 8 weeks for patients whose depression has not remitted (non-remitters); and (2) bupropion for 16 weeks, with the addition of BAT at 8 weeks for non-remitters. In Aim 1, we will investigate the efficacy and tolerability of these 2 strategies vs. control for improvement in a primary endpoint of depressive symptoms in 201 patients (67 per group) with CKD stages 3b-5 and MDD at 2 sites, randomized 1:1:1 to either strategy or a control group of Clinical Management plus placebo. We hypothesize that either approach vs. control will result in a minimal clinically important difference of 2 points improvement in depressive symptoms, as ascertained blindly by the Quick Inventory of Depressive Symptomatology. In Aim 2 we will investigate the efficacy and tolerability of 8 weeks of (1) single-blind BAT plus placebo or (2) double-blind bupropion plus Clinical Management vs. control for improvement in depressive symptoms. In Aim 3, we will compare the efficacy of these 2 treatments strategies vs. control for improvement in CKD patient-centered outcomes including a. adherence to medications and healthcare visits; b. fatigue; c. sleep; and d. overall functioning. A clinical trial is urgently needed to address the evidence gap that exists for MDD treatment in CKD patients.",[365,200,366],"Chronic Kidney Diseases","End Stage Kidney Disease (ESRD)","2025-11-21",{"date":369,"type":41},"2025-11-28",{"date":371,"type":41},"2020-09-24",{"date":373,"type":22},"2027-04-01",{"name":47,"class":48},4,{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":57,"minAge":194,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":124,"phases":4,"briefSummary":385,"conditions":386,"keywords":388,"overallStatus":201,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":81},"100609909","wearable-technology-to-assist-gait-and-mobility-in-the-older-adult-100609909","NCT07220707","Wearable Technology to Assist Gait and Mobility in the Older Adult","A Pilot Study to Assess the Role of Accelera Stochastic Resonance Wearable Technology to Assist Gait and Mobility in the Older Adult","Inclusion Criteria:\n\n1. 65+ years old residing at Independent Living at Jefferson's Ferry\n2. Express interest in the ankle wearable device\n3. Have capacity as measured by being alert and oriented to person, place, and time\n4. Can communicate in English and provide written consent\n5. Able to walk and stand unsupported by others and feel ankle vibrations at maximum amplitude.\n6. Answers \"Yes\" to at least one: worry about falling, had a fall within last year, feel unsteady when walking, enrolled in a fall prevention program, or use\u002Fhave used assistive devices, such as canes or walkers\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Diagnosed with neurodegenerative diseases (such as Parkinson's, Alzheimer's, or Amyotrophic Lateral Sclerosis (ALS))\n2. Disability from a stroke or other major neurologic disorder resulting in leg paralysis\n3. Active ulcers\u002Frashes\u002Finfections on feet or legs, or using orthotics other than arch supports or over the counter knee\u002Fankle supports\n4. Significant lymphedema\u002Fperipheral edema\u002For large ankle size that prevents ankle wearable device application or functionality\n5. Cannot give written consent\n6. Unable to walk today or generally use wheelchairs\n7. Unable to participate due to medical or cognitive reasons\n8. Any lower extremity amputation other than one toe\n9. On anticoagulants or antiplatelet agents other than aspirin\n10. Unable to participate due to other medical or cognitive reasons\n11. Age under 65 years",{"count":384,"type":22},20,"This study assesses whether a small wearable ankle bracelet device can improve gait and mobility in the older adult. Before wearing the bracelet, participants will answer a brief questionnaire, have gait and mobility assessed via 3 CDC approved tests and an app, then wear the device and repeat these gait and mobility assessments, and complete a questionnaire.",[387],"Older Adults Who Use an Assistive Device for Mobility",[389,390,391,392,393,394],"older adult","assistive device","stochastic resonance","mobility","gait","fall","2025-10-22",{"date":397,"type":41},"2025-10-24",{"date":399,"type":22},"2025-11",{"date":401,"type":22},"2028-12",{"name":47,"class":48},{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":23,"phases":412,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":81},"100459610","decision-aid-and-thyroid-nodules-management-100459610","NCT05264857","Decision Aid and Thyroid Nodules Management","Decision Aid for Management of Thyroid Nodules and Early Thyroid Cancer","Inclusion Criteria:\n\n* Histology showing indeterminate or malignant thyroid pathology (Bethesda III-VI)\n* Thyroid nodule size less or equal to 2cm\n\nExclusion Criteria:\n\n* History of thyroid surgery\n* History of thyroid cancer",{"count":411,"type":22},134,[25],"Patients with small favorable malignant or indeterminate thyroid nodules will receive information about management of thyroid nodules. Participants will be asked to complete brief surveys at the time of enrollment, shortly after the consultation appointment with the surgeon, and a few months after either the consultation or the surgery, to assess their satisfaction with their decision and decision making process. All participants will receive routine care and counseling by their endocrinologist and surgeon.",[415],"Thyroid Nodule","2025-10-10",{"date":418,"type":41},"2025-10-14",{"date":420,"type":41},"2022-02-08",{"date":422,"type":22},"2027-09-30",{"name":47,"class":48},{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":57,"minAge":4,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":23,"phases":433,"briefSummary":434,"conditions":435,"keywords":437,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":81},"100609477","testing-a-brief-motivational-intervention-to-increase-physical-activity-for-cancer-survivors-100609477","NCT07215091","Testing a Brief Motivational Intervention to Increase Physical Activity for Cancer Survivors","Effectiveness and Implementation of a Brief Motivational Intervention to Increase Physical Activity for World Trade Center Health Program Cancer Survivors","Inclusion Criteria:\n\n* Participation in the World Trade Center Health Program\n* History of cancer, completed treatment\n* Ability to be physically active (at minimum be able to walk slowly)\n\nExclusion Criteria:\n\n* Participants receiving active cancer treatment (excluding hormonal therapy);\n* Late-stage cancer (metastatic);\n* Inability to follow the scheduled visits;\n* Women who are pregnant\n* Patients who would not be safe exercising without medical supervision (ECOG score of 3, significant comorbidities, unable to even walk slowly)\n* Inability to speak and read English.",{"count":432,"type":22},84,[25],"The goal of this study is to test a brief motivational intervention to increase physical activity in a group of cancer survivors who are participants in the World Trade Center Health Program.",[436],"Cancer",[438],"World Trade Center Health Program","2025-10-09",{"date":418,"type":41},{"date":442,"type":41},"2025-01-04",{"date":444,"type":22},"2026-07-01",{"name":47,"class":48},{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":452,"eligibilityCriteria":453,"healthyVolunteers":89,"sex":57,"minAge":18,"maxAge":194,"enrollmentInfo":454,"targetDuration":4,"studyType":23,"phases":456,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":81},"100600262","phase-4-pet-imaging-using-the-tracer-18fvat-to-assess-the-antidepressant-effect-of-nicotine-100600262","NCT07095205","PET Imaging Using the Tracer [18F]VAT to Assess the Antidepressant Effect of Nicotine.","Central Cholinergic Dysfunction in Depression: PET Imaging of a Novel Treatment Target With [18F]VAT to Assess the Antidepressant Effect of Nicotine","VATMDDNicotine","Inclusion Criteria:\n\nFor Non-Depressed Participants:\n\n* Age range 18 to 65 years old.\n* Capacity to consent (able to read, understand, and sign informed consent).\n\nFor Participants with MDD\n\n* Age range 18 to 65 years old.\n* Capacity to consent (able to read, understand, and sign informed consent).\n* Major Depressive Disorder (MDD) as primary diagnosis and currently in a major depressive episode\n* Score of at least 29 on the Montgomery-Asberg Depression Rating Scale (MADRS).\n\nExclusion Criteria:\n\nFor Non-Depressed Participants:\n\n* Nicotine use, including tobacco, e-cigarettes, nicotine patch, nicotine gum, within the past year \\[except for occasional users, who cannot use nicotine products in the week before the scan\\].\n* Need for use of medication during the study that will affect cholinergic levels.\n* Problematic drug\u002Falcohol use that is judged sufficient to interfere with study procedures during the treatment period or impact participant safety.\n* Significant active physical illness or neurological deficit that may affect brain function or imaging.\n* Significant eye conditions such as keratoconus and\u002For need for rigid contact lenses.\n* Current or lifetime history of a major psychiatric diagnosis.\n* Any MRI contraindications, including recent tattoos, metal implants, pacemaker, metal prostheses, orthodontic appliances, or presence of shrapnel that are contraindicated for MRI.\n* Any PET contraindications, including if study imaging will result in the participant receiving greater exposure than the research limit, or if participant is pregnant, currently breastfeeding, or planning to conceive during the course of study participation.\n* Blood donation within 8 weeks of the \\[18F\\]VAT scan.\n\nFor Participants with MDD\n\n* Nicotine use, including tobacco, e-cigarettes, nicotine patch, nicotine gum, within the past year \\[except for occasional users, who cannot use nicotine products in the week before the scan\\].\n* Currently on effective antidepressant medications or need for use of medications that target the cholinergic system.\n* Problematic drug\u002Falcohol use that is judged sufficient to interfere with study procedures during the treatment period or impact participant safety.\n* Significant active physical illness or neurological deficit that may affect the brain function or imaging.\n* Significant eye conditions such as keratoconus and\u002For need for rigid contact lenses.\n* Current or lifetime major psychiatric diagnosis other than MDD.\n* Life-time history of psychosis or current psychosis.\n* Significant risk for suicide.\n* Any MRI contraindications, including recent tattoos, metal implants, pacemaker, metal prostheses, orthodontic appliances, or presence of shrapnel that are contraindicated for MRI.\n* Any PET contraindications, including if study imaging will result in the participant receiving greater exposure than the research limit, or if participant is pregnant, currently breastfeeding, or planning to conceive during the course of study participation.\n* Blood donation within 8 weeks of the \\[18F\\]VAT scan.",{"count":455,"type":22},14,[60],"In the brain, certain nerve cells communicate using a chemical called acetylcholine. Acetylcholine is thought to be important for several functions including mood, memory and wakefulness. The purpose of this study is to explore the role of these nerve cells in depression. Also, we would like to understand how nicotine, the study drug, works in depression and how it affects these nerve cells. To do this, brain imaging will be used before and after this treatment.",[317],"2025-07-23",{"date":461,"type":41},"2025-07-31",{"date":463,"type":41},"2024-10-03",{"date":465,"type":22},"2029-09-30",{"name":47,"class":48},{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":194,"enrollmentInfo":474,"targetDuration":4,"studyType":23,"phases":476,"briefSummary":477,"conditions":478,"keywords":480,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":81},"100593688","hydrogen-water-intervention-with-heart-rate-variability-as-an-outcome-biomarker-in-mecfs-100593688","NCT07009691","Hydrogen Water Intervention With Heart Rate Variability as an Outcome Biomarker in ME\u002FCFS","Heart Rate Variability as an Autonomic Marker of Improvement in ME\u002FCFS in a Hydrogen Water Treatment Study","Inclusion Criteria: Meets Institute of Medicine criteria for myalgic encephalomyelitis\u002Fchronic fatigue syndrome -\n\nExclusion Criteria: Medical illness that explains presenting fatigue; Any psychosis.\n\n\\-",{"count":475,"type":22},50,[25],"The goal of this clinical trial is to learn if the OTC supplement, hydrogen water, works to treat the fatigue-related symptoms and functional limitations in adults with myalgic encephalomyelitis\u002Fchronic fatigue syndrome (ME\u002FCFS). It will also examine if heart rate variability (HRV) can be used to predict who will benefit from the hydrogen water treatment. The main questions it aims to answer are:\n\nDoes the OTC supplement, hydrogen water, work to reduce the fatigue-related symptoms and improve functioning in participants who have ME\u002FCFS?\n\nCan HRV be used to predict who will benefit from treatment with hydrogen water?",[479],"Chronic Fatigue Syndrome",[481],"Chronic fatigue syndrome; heart rate variability; treatment; hydrogen water.","2025-06-03",{"date":484,"type":41},"2025-06-08",{"date":486,"type":22},"2025-06-09",{"date":488,"type":22},"2026-05-31",{"name":47,"class":48},{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":496,"eligibilityCriteria":497,"healthyVolunteers":89,"sex":57,"minAge":498,"maxAge":499,"enrollmentInfo":500,"targetDuration":4,"studyType":23,"phases":502,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":81},"100544495","monetary-incentive-delay-task-for-probing-reward-related-neural-processes-100544495","NCT06369623","Monetary Incentive Delay Task for Probing Reward-related Neural Processes","Neuromelanin MRI: A Tool for Non-invasive Investigation of Dopaminergic Abnormalities in Adolescent Substance Use","MID","Inclusion Criteria:\n\n* Males and females ages 14-17 years-old;\n* English-speaking for assent and interview completion;\n* Capacity to provide assent.\n* For parents, the inclusion criteria will be willing and capacity to provide parental permission\u002Fconsent.\n\nExclusion Criteria:\n\n* current (within 6 months) use of medication that may affect cerebral function\n* history of severe medical or neurological illness, including stroke or seizure;\n* history of head trauma with loss of consciousness;\n* presence of metal in the body;\n* pregnancy or breastfeeding;\n* recent drug or alcohol use determined by positive urine toxicology or breathalyzer (to validate self-report assessment of substance use history);\n* lifetime use of psychotropic or other medication that could likely influence dopamine function, namely stimulant medication or antipsychotic medication, except a subgroup of 25 youth with history of prescribed stimulant medication and a subgroup of 15 youth with history antipsychotic medication will be enrolled for comparison purposes.","14 Years","17 Years",{"count":501,"type":22},300,[25],"150 males and 150 females ages 14-17 years-old will be enrolled in an observational, longitudinal study. There are three planned in-person visits: a baseline assessment, an 18-month follow-up, and a 36-month follow-up. The in-person visits will include assessment of substance use and other individual differences (e.g., reward function, psychiatric history), neuromelanin-sensitive MRI, as well as functional brain activation collected while the participant is at rest (resting-state fMRI) and while the participant completes a Monetary Incentive Delay task. Subjects will also be asked to complete past 90-day substance use assessments remotely every 90 days for 36 months.",[505],"Adolescent Development","2025-05-12",{"date":508,"type":41},"2025-05-15",{"date":510,"type":41},"2024-04-06",{"date":512,"type":22},"2028-11-30",{"name":47,"class":48},{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":57,"minAge":522,"maxAge":523,"enrollmentInfo":524,"targetDuration":526,"studyType":124,"phases":4,"briefSummary":527,"conditions":528,"keywords":531,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":81},"100533495","long-term-outcomes-of-children-with-congenital-cmv-in-new-york-state-100533495","NCT06226558","Long-Term Outcomes of Children With Congenital CMV in New York State","Prospective Observational Study of Asymptomatic cCMV Transmission to Infants for Virological Evaluation in New York State","PROACTIVE NYS","Inclusion Criteria:\n\n* Neonates born in New York State during cCMV NBS Pilot Program (September 27, 2023 - October 1, 2024)\n* cCMV evaluation provided by a designated NYS cCMV clinical referral site\n* Family willing and able to complete all study procedures\n* Study participants meet criteria for one of the following four categories:\n* 1\\. Category 1 (Confirmed cCMV identified by NBS Program): cCMV NYS newborn screen positive AND cCMV confirmatory test positive\n* 2\\. Category 2 (Confirmed cCMV not identified by NBS Program): cCMV NYS newborn screen negative AND cCMV confirmatory test positive\n* 3\\. Category 3 (False-positive cCMV screen): cCMV NYS newborn screen positive AND negative cCMV confirmatory test\n* 4\\. Category 4 (Premature infants with confirmed CMV infection on late positive NBS): Infant born prior to 37 weeks gestation AND cCMV positive on any NYS newborn screen collected prior to 44 weeks gestational age AND Positive cCMV confirmatory test obtained within 14 days of a positive NBS\n\nExclusion Criteria:\n\n* Neonate whose parents refuse participation in the long-term follow-up study","0 Days","1 Year",{"count":525,"type":22},1000,"2 Years","PROACTIVE NYS is a long-term follow-up study of all infants who test positive for congenital Cytomegalovirus infection (CMV) throughout New York State on the Newborn Screen. By following all infants who screen positive, we will learn important information about the range of symptoms caused by congenital CMV, from those babies with more severe findings to those with no symptoms.\n\nIn particular, our study will provide new information about many facets of congenital CMV, including:\n\n* Developmental, hearing, neurologic, and vision outcomes\n* The spectrum and timing of symptoms\n* The impact congenital CMV has on the baby and its family\n* How many babies are infected with congenital CMV in New York State How antiviral medications and other interventions impact outcomes of children with congenital CMV\n\nThroughout the duration of the study, children will undergo routine developmental and hearing assessments, which will assist with early diagnosis of any infection complications.\n\nAny child found to have a neurodevelopmental, hearing, or vision abnormality will be referred for appropriate evaluation and treatment.\n\nFamilies will also be asked to complete periodic surveys about their experience with congenital CMV, both as a medical diagnosis and as it affects their day-to-day activities.",[529,530],"Congenital CMV Infection","Sensorineural Hearing Loss",[532,533,534,535,536],"Congenital CMV","cCMV","Congenital infection","Sensorineural hearing loss","SNHL",{"date":538,"type":41},"2025-05-13",{"date":540,"type":41},"2024-02-01",{"date":542,"type":22},"2026-10-01",{"name":47,"class":48},{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":23,"phases":552,"briefSummary":553,"conditions":554,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":569,"locationsCount":81},"100528795","phase-2-definitive-radiation-for-high-risk-spine-metastases-100528795","NCT06165419","Definitive Radiation for High-Risk Spine Metastases","A Phase II Study Evaluating Definitive Radiosurgical Decompression in Patients With High-Risk Spinal Metastases","Eligible patients must have:\n\n* Any pathologically proven solid tumor diagnosis not of central nervous system origin with radiographic or pathologic evidence of metastatic disease\n* Metastatic spine involvement documented by imaging\n* Involvement of maximum 3 contiguous vertebral bodies at the index site\n* Intact neurologic function, or only minor neurologic deficits with muscle strength greater or equal to 4 out of 5 with or without steroids\n* An evaluation by an radiation oncology and orthopedic spine\u002Fneurosurgery attending\n* ECOG Performance Status of 0-3\n\nPatients are ineligible if they have:\n\n* An unstable spine defined as a Spinal Instability Neoplastic Score (SINS) greater than 12\n* Had previous surgery or radiation to address the target spinal metastases\n* Radiosensitive tumors (e.g. small cell lung cancer, lymphoma, multiple myeloma, and germ-cell tumors)",{"count":5,"type":22},[362],"This study is looking at whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy only and avoid a large spine surgery",[555,556,557,558,559,560,561,562],"Metastatic Cancer","Metastatic Lung Cancer","Metastatic Breast Cancer","Metastatic Tumor","Metastatic Tumor of Bone","Metastatic Tumor to the Spine","Spine Metastases","Metastasis","2025-05-09",{"date":565,"type":41},"2025-05-14",{"date":567,"type":41},"2023-12-14",{"date":488,"type":22},{"name":47,"class":48},{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":89,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":23,"phases":579,"briefSummary":581,"conditions":582,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":81},"100458100","phase-3-double-simultaneous-uterotonic-agents-versus-single-agent-regimen-to-prevent-early-postpartum-hemorrhage-100458100","NCT05245227","Double Simultaneous Uterotonic Agents Versus Single Agent Regimen to Prevent Early Postpartum Hemorrhage","A Randomized Controlled Trial of Double Simultaneous Uterotonic Agents (Misoprostol Plus Intravenous Oxytocin) Versus Single Agent Regimen (Intravenous Oxytocin Only) to Prevent Early Postpartum Hemorrhage","Inclusion Criteria:\n\n\\- All women 18 years and older admitted to delivery at Stony Brook University hospital who agree to participate in the study\n\nExclusion Criteria:\n\n* Women under 18 years old\n* Women with known coagulation disorders\n* Women with planned cesarean hysterectomy\n* Women with known placental accreta spectrum disorders\n* Women with known allergy to prostaglandins",{"count":578,"type":22},1358,[580],"PHASE3","To determine the effectiveness of using two medications simultaneously versus one medication, as is standard of care, in preventing early postpartum hemorrhage.\n\nThere have been studies that looked at giving two medications and that there were reduced odds of postpartum hemorrhage.\n\nSpecific Aim 1: Determine if double simultaneous uterotonic agent regimen (misoprostol and oxytocin) is superior to single agent (oxytocin only) in reducing postpartum hemorrhage.\n\nSpecific Aim 2: Determine any potential side effects of a double simultaneous uterotonic agentregimen (misoprostol and oxytocin) versus a single agent (oxytocin only).",[583],"Postpartum Hemorrhage","2025-04-30",{"date":586,"type":41},"2025-05-04",{"date":588,"type":41},"2025-01-27",{"date":590,"type":22},"2027-01-01",{"name":47,"class":48},{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":89,"sex":57,"minAge":598,"maxAge":4,"enrollmentInfo":599,"targetDuration":4,"studyType":23,"phases":601,"briefSummary":602,"conditions":603,"keywords":605,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":612,"locationsCount":81},"100557005","addressing-durable-health-disparities-through-critical-time-legal-interventions-in-medically-underserved-latinx-and-migrant-communities-100557005","NCT06532487","Addressing Durable Health Disparities Through Critical Time Legal Interventions in Medically Underserved Latinx and Migrant Communities","Inclusion Criteria:\n\n* Patients will be included in the trial if they meet all the following criteria: 1) ages 13 or older, 2) impacted by acute health-harming legal needs or risks (confirmed by screening developed in preparation for this proposal); 3) willing and able to consent to participate in the trial (including accessing EHR at the FQHC); and, 4) do not intend to relocate within the 12 months following their enrollment in the study.\n\nExclusion Criteria:\n\n* Patients who do not meet the inclusion criteria will be excluded from the trial. Individuals who self-report having been sentenced to serve under state or federal custody, with a sentence to begin within 12 months from proposed enrollment in the study, will also be excluded from the trial.","13 Years",{"count":600,"type":22},1140,[25],"This clinical trial will examine the effects of legal services on primary care outcomes for medically underserved communities.\n\nThe aims of the study are:\n\n1. To test the effectiveness and cost-benefits of a critical-time intervention Medical-Legal Partnership (CTI-MLP) on patient outcomes.\n2. To determine the most efficient mechanisms for CTI-MLP delivery.\n3. To develop innovative community engagement strategies for addressing health-harming legal needs within community health centers.\n\nEligible patients will be asked to complete a questionnaire 4 times, first when they join the study and then at 3 months, 6 months, and 12 months. In the survey, they will be asked to provide information about themselves, their health care, aspects of their daily life, and hardships they face. They will also allow researchers to access their electronic health record information housed in the community-based organization and attorney notes.\n\nPatient information will be completely confidential and de-identified, meaning, the research team will not know the identity of the person who answered the questions.\n\nParticipating community health centers will be randomized (assigned by chance) to provide basic legal information and referral to legal aid; or have an attorney on-site to provide legal aid to those who screen for legal needs.",[604],"Health Harming Legal Needs",[606],"medical-legal partnerships, health harming legal needs, medically underserved communities, Latinx communities, Migrant communities, FQHC",{"date":608,"type":41},"2025-02-12",{"date":610,"type":41},"2024-11-28",{"date":205,"type":22},{"name":47,"class":48},{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":15,"eligibilityCriteria":619,"healthyVolunteers":89,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":620,"targetDuration":4,"studyType":23,"phases":621,"briefSummary":622,"conditions":623,"keywords":624,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":49},"100486483","postpartum-intervention-for-mothers-with-opioid-use-disorders-100486483","NCT05614661","Postpartum Intervention for Mothers With Opioid Use Disorders","Postpartum Intervention for Mothers With Opioid Use Disorders - Brain-Behavior Mechanisms","Inclusion Criteria:\n\n* mothers aged 18-50 from SBU or UM with diagnosis of Opioid Use Disorder (OUD); and\u002For receiving medication assisted treatment (such as buprenorphine or methadone)\n* with a child aged 5 or less\n* able to read, hear and understand English adequately enough to provide informed consent\n\nExclusion Criteria:\n\n1. require immediate clinical care for suicidal\u002Fhomicidal risk or psychosis (please see Protection of Human Subjects section for clinical management of suicidal risk);\n2. For magnetic resonance imaging (MRI) of the brain, potential participants will be excluded if they:\n\n1\\) have ferromagnetic metal in their heads 2) have severe claustrophobia that prevents participation in the neuroimaging 3) have serious neurological condition that could interfere with neuroimaging, including a brain tumor, multiple sclerosis or significant head trauma 4) Exclusion from MRI does not necessarily exclude participant from study.",{"count":475,"type":22},[25],"Opioid use disorder (OUD) is a fast-growing and devastating epidemic in the US with many mothers suffering cravings, depression, impaired interpersonal interactions and maladaptive parenting behaviors that may lead to child maltreatment and costly utilization of foster care. This interdisciplinary multisite project will begin with the high risk R61 phase, in which the investigators will administer the parenting intervention \"Mom Power\" to mothers with OUD during the first 6 months postpartum and look for effects on drug use, mood and brain mechanisms; and, If validated, the investigators will continue in the R33 with more brain mechanism investigation and outcome studies a larger sample. The completion of this grant will clarify the effects of parenting intervention for mothers with OUD, and yield brain-based biomarkers that may be connected with inexpensive measures toward improved treatment of families suffering OUD, their children and society - which ultimately bears much of the cost for the common trans-generational problems of peripartum drug use.",[28],[31,28,33,34,35],"2024-12-10",{"date":627,"type":41},"2024-12-16",{"date":629,"type":41},"2023-02-14",{"date":631,"type":22},"2025-05-01",{"name":47,"class":48},""]