[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Wayne State University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":641},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,30,0,25,[9,49,78,103,125,147,177,205,230,247,272,292,311,339,369,394,419,446,472,496,518,546,560,588,614],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100053247","early-phase-1-understanding-non-invasive-vagus-nerve-stimulation-effects-in-ptsd-100053247",false,"NCT06953388","Understanding Non-invasive Vagus Nerve Stimulation Effects in PTSD","SPARK-VNS: Facilitating Adaptive Posttraumatic Processing With Non-Invasive Vagus Nerve Stimulation","SPARK-VNS","Inclusion Criteria:\n\n1. Ages 18-80\n2. Fluent in English\n3. Experience with a DSM-5 Criterion A trauma (LEC-5)\n4. Probable PTSD (PCL-5 ≥ 32)\n\nExclusion Criteria:\n\n1. Visual or Auditory impairment\n2. Major injury at time of screen or study procedures\n3. Taking ≥20 mg morphine per day\n4. Current substance use or intoxication (12-panel drug test)\n5. Intellectual disability (MoCA)\n6. Self-inflicted injury\n7. Occupational injury\n8. Prisoner\n9. Ongoing domestic violence\n10. Pregnant or breastfeeding\n11. Contraindications for taVNS","ALL","18 Years","80 Years",{"count":22,"type":23},60,"ESTIMATED","INTERVENTIONAL",[26],"EARLY_PHASE1","The goal of this study is to determine how non-invasive brain stimulation (delivered through the ear called vagus nerve stimulation) affects fear learning processes in people who have experienced psychological trauma. To answer these questions, we measure bodily responses (heart rate, sweat, startle) and questionnaires. The main questions it aims to answer are:\n\nDoes non-invasive vagus nerve stimulation help reduce anxious arousal? Does non-invasive vagus nerve stimulation help dampen learned fear?",[29],"PTSD - Post Traumatic Stress Disorder",[31,32,33,34,35],"PTSD","brain stimulation","fear learning","autonomics","fear potentiated startle","NOT_YET_RECRUITING","2026-07-09",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":23},"2027-04-01",{"date":44,"type":23},"2031-03-01",{"name":46,"class":47},"Wayne State University","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":18,"minAge":19,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":24,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":48},"100053316","phase-2-pilot-study-of-prenatal-choline-supplementation-100053316","NCT07699393","Pilot Study of Prenatal Choline Supplementation","A Randomized, Double-Blind, Placebo-controlled Clinical Trial of Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure on Growth and Cognitive Development: Pilot Arm for Non-Drinking Women","Inclusion Criteria:\n\n* Age ≥18 yr\n* ≤20 wk gestation\n* Singleton pregnancy\n* Abstinence from alcohol since conception (by report)\n* Current choline dietary intake \\\u003C1 g\u002Fday\n* Language fluency in English or Afrikaans\n\nExclusion Criteria:\n\n* Use of methamphetamine or other illicit drugs other than marijuana during the past year\n* HIV positive\n* Pharmacologic treatment for a serious pre-existing medical condition (e.g., diabetes, hypertension, epilepsy, or cardiac problems)\n* Having another child enrolled in the trial from a previous pregnancy\n* Plans for mother or child to move away from the area prior to study completion",true,"45 Years",{"count":59,"type":23},50,[61],"PHASE2","We are conducting a double-blind, randomized, placebo-controlled trial (RCT; NCT04395196) of prenatal choline supplementation (1) to assess the effectiveness of maternal choline supplementation during pregnancy to mitigate effects of PAE on three primary outcomes: infant recognition memory and postnatal growth restriction (weight and head circumference); (2) to assess the efficacy of this supplementation for mitigating alcohol effects on the following secondary outcomes: infant eyeblink conditioning, postnatal length, and information processing speed. The study design was based on a pilot feasibility study in 70 heavy-drinking pregnant women. Infants in the choline-treated arm were more likely to meet criterion for eyeblink conditioning than those in the placebo arm. Infants born to both the choline- and placebo-treated mothers were small at birth, but those in the choline arm showed considerable catch-up growth in weight and head circumference by 6.5 months, which persisted through 12 months. At 12 months, infants in the choline arm showed markedly better recognition memory compared to placebo-treated on the Fagan Test of Infant Intelligence, which is known to have predictive validity for school-age IQ. Of note, infants with heavy prenatal alcohol exposure whose mothers were in the active choline treatment arm performed better on FTII novelty preference neurobehavioral testing than infants in an observational study that was running in parallel who had no prenatal alcohol exposure. These pilot findings indicate that any beneficial effects of prenatal choline supplementation seen may be due in part or entirely due to general beneficial effects on fetal brain development rather than mechanisms that are specific to the teratogenic effects of alcohol. Thus, we currently seek to enroll and randomize 50 alcohol-abstaining pregnant women to participate in an identical study protocol (same study procedures and primary and secondary outcomes) to NCT04395196, which includes only alcohol-consuming pregnant women. Effect sizes between this pilot, non-drinking group and the larger study of alcohol-consuming women will be compared to explore the degree to which prenatal choline supplementation benefits growth and neurobehavior in infants without prenatal alcohol exposure and to explore the degree to which beneficial treatment effects of choline are specific to prenatal alcohol exposure.",[64,65],"Brain Development","Choline Nutrition",[67,68,69],"Choline","Prenatal nutrition","dietary supplementation","RECRUITING","2026-07-06",{"date":39,"type":40},{"date":74,"type":23},"2026-07-08",{"date":76,"type":23},"2028-05-15",{"name":46,"class":47},{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100440987","prevention-of-bleeding-in-patients-with-moderate-and-severe-hemophilia-a-playing-sports-a-comparison-between-factor-viii-and-emicizumab-prophylaxis-100440987","NCT05022459","Prevention of Bleeding in Patients With Moderate and Severe Hemophilia A Playing Sports: A Comparison Between Factor VIII and Emicizumab Prophylaxis","Prevention of Bleeding in Patients With Moderate and Severe Hemophilia A Playing Sports: A Comparison Between Factor VIII and Emicizumab Prophylaxis -STEP: SporTs Emicizumab Prophylaxis","STEP","Inclusion Criteria:\n\n1. Participant (if 18 years of age or older) or parent\u002FLAR is willing and able to provide written informed consent; minor participant is willing and able to provide assent, if applicable based on site and local regulations\n2. Males and females between 6 to ≤ 19 years of age at time of enrollment with moderate to severe Hemophilia A (FVIII activity ≤ 5%) without inhibitors are eligible for participation in this study\n3. Participants must be on Emicizumab or standard FVIII prophylaxis per institutional\u002Fprimary hematologist recommendations\n4. Participants must be engaging in or registered to start participating in one or more sports activities with moderate to high risk of bleeding as defined by the NHF- Playing it Safe guidelines (numerical rating \\>\u002F= 2).\n5. Participant must be willing to keep activity, bleed, and treatment logs for the duration of the study\n\nExclusion Criteria:\n\n1. Participant\u002Fparent\u002FLAR unwilling to provide informed consent\u002Fassent\n2. Unwilling to log or document bleeds and treatment information as per study guidelines\n3. Participants with any other bleeding disorders will be excluded\n4. Patients who are pregnant, planning to become pregnant, or breastfeeding should not be enrolled in the study\n5. Participants on concomittent FVIII replacement and emicizumab for sports participation","6 Years","19 Years",{"count":89,"type":23},72,"OBSERVATIONAL","Hemophilia A (HA) is a genetic bleeding disorder resulting from a deficiency or absence of factor VIII (FVIII), which is necessary in the clotting process. This disorder occurs mostly in males and in severe cases causes frequent bleeding episodes in joints and muscles which can lead to progressive damage that affects mobility and quality of life. Prophylactic FVIII administered intravenously every other day has been the standard of care treatment for HA for the past few decades.\n\nSports and physical activity are generally encouraged in patients with hemophilia on appropriate prophylactic treatment to increase strength, prevent or decrease obesity, accrue and maintain bone density and encourage normal socialization. To ensure safety with participation in sports in persons with hemophilia A (PWHA), timing of FVIII administration is often adjusted to maximize FVIII at the time of sports. The exact factor level that is needed to safely participate in sports and minimize bleeding risk is not yet known. Based on clinical practice, infusion of FVIII to near the lower limit of normal right before participation in sports generally works to prevent bleeding.\n\nThe study is looking at how well the newly approved medication Emicizumab works compared to Factor VIII to prevent bleeding in patients with Hemophilia A who play sports. The study will enroll children and adolescents who are already on Emicizumab or Factor VIII who are currently playing sports.",[93],"Hemophilia A","2026-06-30",{"date":96,"type":40},"2026-07-02",{"date":98,"type":40},"2023-08-16",{"date":100,"type":23},"2029-03",{"name":46,"class":47},10,{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":24,"phases":111,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":48},"100642822","increasing-law-enforcement-application-of-automated-external-defibrillators-aeds-for-cardiac-arrest-100642822","NCT07649616","Increasing Law Enforcement Application of Automated External Defibrillators (AED)s for Cardiac Arrest","Increasing Law Enforcement Application of Automated External Defibrillators for Cardiac Arrest","Inclusion Criteria:\n\n* Law enforcement officers from agencies in the greater Portland area served by the Portland Cardiac Arrest Epidemiologic Registry\n* aged 18 years of age and older\n\nExclusion Criteria:\n\n* none",{"count":5,"type":23},[112],"NA","The goal of this study is to learn if an automated external defibrillator (AED) training adjunct video can improve law enforcement self-efficacy, the likelihood of AED application overall, and decrease disparities in women.\n\nParticipants will be asked to:\n\n* complete a brief initial survey\n* view an AED training adjunct video\n* complete another survey following the video",[115,116],"Heart Arrest, Out-Of-Hospital","Defibrillators","2026-06-09",{"date":119,"type":40},"2026-06-16",{"date":121,"type":23},"2026-07-01",{"date":123,"type":23},"2027-12-31",{"name":46,"class":47},{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":24,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":48},"100609808","peer-delivered-behavioral-activation-in-a-ccbhc-100609808","NCT07219394","Peer-Delivered Behavioral Activation in a CCBHC","Hybrid Effectiveness-Implementation Trial to Evaluate a Scalable, Peer-Delivered Intervention for Depression Among People With Substance Use Disorder in a Certified Community Behavioral Health Clinic","Inclusion Criteria:\n\n* Age 18 years old or older\n* Report clinically-significant symptoms of depression, as indexed by a score of 8+ on the PHQ-9.\n\nExclusion Criteria:\n\n* Active, under treated psychotic symptoms or mania that would interfere with participation in study procedures\n* Inability to provide informed consent and\u002For complete procedures in English",{"count":133,"type":23},250,[112],"Low-income individuals have limited access to evidence-based interventions for mental health. Peer recovery specialists, individuals in recovery from mental health and\u002For substance use problems, have the potential to increase access to evidence-based interventions for individuals from low-resource communities, particularly when trained and supervised in models that are acceptable and feasible in these communities. This study will examine the effectiveness and implementation potential of a peer-delivered evidence-based intervention (Behavioral Activation) among individuals receiving services from a community-based treatment setting providing integrated physical and behavioral healthcare.",[137,138],"Major Depressive Disorder","Substance Use Disorders","2026-04-15",{"date":141,"type":40},"2026-04-17",{"date":143,"type":23},"2026-05-01",{"date":145,"type":23},"2029-01-15",{"name":46,"class":47},{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":57,"enrollmentInfo":155,"targetDuration":4,"studyType":24,"phases":157,"briefSummary":159,"conditions":160,"keywords":163,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":48},"100602435","phase-3-cannabidiol-assisted-learning-for-managing-generalized-anxiety-disorder-100602435","NCT07123467","Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder","Cannabidiol-Enhanced Cognitive Behavioral Therapy for Generalized Anxiety Disorder","CALM","Inclusion Criteria:\n\n* Right-handed\n* Age 18-45 years at enrollment\n* Able to consent to the study\n* Agree to adhere to lifestyle considerations throughout study duration\n* Generally medically and neurologically healthy, including no evidence of intellectual disability or serious cognitive impairment\n* Have a current generalized anxiety disorder (GAD) diagnosis according to the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria and\u002For total scores ≥ 8 on the 7-Item Generalized Anxiety Disorders Scale (GAD-7)\n\nExclusion Criteria:\n\n* Clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function and\u002For task performance and\u002For interfere with the study protocol\n* Any current (or within past 2 months) medical condition requiring medication that would interact with cannabidiol or interfere with the study protocol\n* Risk of harm to self or others that requires immediate intervention\n* Presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to cannabinoid-like substances or components of EPIDIOLEX®\n* Positive drug screen or alcohol breathalyzer\n* Unwilling\u002Funable to sign informed consent document\n* Currently pregnant (positive pregnancy test), planning pregnancy, or lactating (women),\n* Under 18 or over 45 years of age\n* Traumatic brain injury, as defined by The American Congress of Rehabilitation as a person who has had a traumatically induced physiological disruption of brain function (i.e., the head being struck, the head striking an object, and\u002For the brain undergoing an acceleration\u002Fdeceleration movement \\[i.e., whiplash\\] without direct external trauma to the head), as manifested by at least one of the following: any loss of consciousness; any loss of memory for events immediately before or after the injury; any alteration in mental status at the time of the incident; or focal neurological deficits that may or may not be transient)\n* Inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia), as determined by self-report and\u002For a preliminary session in a mock scanner\n* Presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel\u002Fretained particles)\n* Receiving concurrent psychotherapy or have received psychotherapy, including for research purposes, within the past year\n* Current moderate or severe alcohol\u002Fdrug use disorder or in the past 8 weeks\n* Current or past diagnosis of bipolar and other related disorders, schizophrenia spectrum, or other psychotic disorders;\n* GAD-7 score \\\u003C 8\n* Use of medications known to have severe drug interactions with cannabidiol or that are strong inducers of cytochrome P450 3A4 (CYP3A4) or cytochrome P450 2C19 (CYP2C19)\n* Visual impairment\n* Baseline labs 3 times outside of normal range\n* Use of as needed anti-anxiety medications (e.g., benzodiazepines), unstable dose of other psychoactive drug (i.e., \\\u003C 4 weeks), or intention to start new treatment during this trial\n* Current or past-month use of cannabis, or a tetrahydrocannabinol (THC) or cannabidiol-containing product (self-report and urine drug screen)\n* Current or past-month coronavirus disease 2019 (COVID-19) diagnosis or febrile illness\n* Treatment with another investigational drug or intervention within the past month\n* Difficulty with or inability to comply with the complete clinical trial.",{"count":156,"type":23},90,[158],"PHASE3","This randomized, double-blind, placebo-controlled clinical trial investigates the use of Food and Drug Administration (FDA)-approved cannabidiol (EPIDIOLEX®) as an adjunct to cognitive behavioral therapy (CBT) in adults with generalized anxiety disorder (GAD). The study aims to evaluate whether cannabidiol-assisted CBT enhances emotion regulation via dorsomedial prefrontal cortex (dmPFC) activation and improves anxiety symptom outcomes compared to CBT with placebo.",[161,162],"Generalized Anxiety Disorder (GAD)","Anxiety Disorders",[164,165,166,167,168],"Cannabidiol","EPIDIOLEX","Cognitive Behavioral Therapy","Generalized Anxiety Disorder","functional magnetic resonance imaging","2026-03-06",{"date":171,"type":40},"2026-03-09",{"date":173,"type":40},"2025-11-03",{"date":175,"type":23},"2027-08-31",{"name":46,"class":47},{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":24,"phases":186,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},"100367596","phase-2-tnf--treatment-of-blast-induced-tinnitus-100367596","NCT04066348","TNF-α Treatment of Blast-Induced Tinnitus","Clinical Trial of Etanercept (TNF-α Blocker) for Treatment of Blast-Induced Tinnitus","Inclusion Criteria:\n\n1. Tinnitus of at least a moderate severity as defined by a score of ≥ 25 points or higher on the Tinnitus Functional Index (TFI) questionnaire associated with one or more of the following:\n\n   1. Blast- or noise exposure\n   2. Traumatic brain injury (TBI) and\u002For concussion diagnosed by a health care provider.\n2. Able to provide written informed consent.\n3. Age: Minimum 18 years of age at the time of enrollment.\n4. Other concurrent treatments for tinnitus: A four-week washout from any other tinnitus treatment or management program is required prior to entering this study.\n\n   a) Hearing aids are permitted if the participant has been wearing them for at least 4 weeks.\n5. Hearing function: All degrees of hearing function can be included, recognizing that individuals with profound, bilateral hearing loss will not be able to perform tinnitus evaluations and hearing tests but will be able to rate subjective tinnitus loudness, annoyance and impact on life. This is an important sub-population because of the challenges in treating them with acoustic therapy and the need for a medical intervention.\n6. Additional tinnitus characteristics:\n\n   a) Tinnitus history: Onset associated with blast and\u002For noise exposure or associated with diagnosed TBI and\u002For concussion. Subjects will have blast exposure, noise exposure, traumatic brain injury (TBI), and\u002For concussion impact, defined as exposure\u002Fimpact less than or longer than six months at time of enrollment.\n\n   i. Participants enrolled with tinnitus associated with TBI and\u002For concussion must have received a diagnosis of TBI and\u002For concussion by a health care provider.\n\n   b) Stability: Constant (not pulsatile or intermittent). c) Location of tinnitus perception: Unrestricted. Tinnitus may be unilateral, bilateral, or perceived in the head.\n\nExclusion Criteria:\n\n1. History or evidence of any of the following: Significant brain malformation; cerebral vascular events (such as strokes); neurodegenerative disorders affecting the brain, such as Parkinson's disease, ALS, or Huntington's disease; multiple sclerosis, Guillain-Barré syndrome, or any other disease involving demyelination disorder or any finding suggesting a demyelination disease or disorder; prior brain surgery.\n\n   a. The following surgical procedures are not exclusionary: Evacuation of subdural hematoma, insertion of intracranial pressure monitor device, craniectomy\n2. Active malignant neoplasm such as lymphoma or solid tumors or history of malignant neoplasm, excluding successfully treated squamous cell carcinoma or basal carcinoma of the skin or cervical cancer.\n3. Diagnosis of congestive heart failure.\n4. History of diagnosed seizure disorder or epilepsy.\n5. Diagnosis of myelodysplastic syndrome or aplastic anemia, white blood cell count \\\u003C 4000, or platelet count \\\u003C 150,000.\n6. Subjects who currently have an active infection, including tuberculosis, HIV, hepatitis B, and\u002For chicken pox.\n\n   a. Patients with latent hepatitis B infection are also excluded from participation.\n7. Scheduled to receive a live vaccine during study participation or received a live vaccine within 2 weeks prior to screening visit\u002Fprocedures.\n8. Diagnosis of an auto-immune disease that, in the opinion of the investigator, would cause a weakened immune system.\n\n   a) Autoimmune thyroid disease is not considered an exclusionary autoimmune disease for participation in this study.\n9. Diabetes.\n10. Ongoing treatment with or plans to begin taking any of the following contraindicated medications: Cyclophosphamide or sulfasalazine; abatacept, anakinra, or any other immunomodulatory biologic therapy; sulfonylureas, meglitinides, or insulin.\n11. Subjects who cannot communicate reliably with research team members or who are not likely to be able to complete the requirements of the trial per the discretion of the investigator.\n12. Subjects who have participated in a drug clinical trial within the last 30 days before the start of this one.\n13. Pregnancy or planned pregnancy during the study.\n14. Women who are lactating or are of child-bearing-age without use of contraception.\n15. MMSE score \\\u003C 24.\n16. Clinically significant out of range laboratory values for protocol required laboratory tests as assessed by the investigator.",{"count":185,"type":23},88,[61],"The purpose of this multi-site research study is to determine if Etanercept, compared to a placebo, significantly reduces the severity of tinnitus (ringing in the ears) associated with history of blast and\u002For noise exposure or associated with Traumatic Brain Injury (TBI) and\u002For concussion. Individuals who qualify will be randomized into one of two groups: The group receiving the medication Etanercept or the group receiving a saline solution placebo.",[189],"Tinnitus, Noise Induced",[191,192,193,194,195],"tinnitus","etanercept","tinnitus function index","tinnitus primary function","audiological evaluation","2026-02-19",{"date":198,"type":40},"2026-02-23",{"date":200,"type":40},"2022-07-01",{"date":202,"type":23},"2026-09",{"name":46,"class":47},4,{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":24,"phases":215,"briefSummary":217,"conditions":218,"keywords":220,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":48},"100533165","phase-1-wayne-state-warriors-marijuana-clinical-research-program-cannabinoid-adjunct-to-prolonged-exposure--recovery-100533165","NCT06222268","Wayne State Warriors Marijuana Clinical Research Program: Cannabinoid Adjunct to Prolonged Exposure & Recovery","CAPER","Inclusion Criteria:\n\n* Willing and able to consent to the study\n* Agree to comply with requirements and procedures\n* Veteran who has served in a branch of the US armed forces\n* Between ages 18-60\n* Report using cannabis within the past three years but not more than twice in the past month\n* Exposure to Criterion A stressor defined by CAPS-5 and identified by Life Events Checklist-5 (LEC-5); trauma does not have to be related to combat or military service\n* Significant PTSD severity as indicated by CAPS-5 diagnosis and\u002For score \\>= 25 of at least one month prior to study entry, PTSD is patient's primary concern\n* not currently receiving any psychotherapy for PTSD\n\nExclusion Criteria:\n\n* Pregnant, lactating or are a heterosexually active, pre-menopausal woman who is NOT using medically approved birth control (e.g., oral or depot contraception, contraceptive implant, IUD, condom\u002Ffoam, sterilization, tubal ligation)\n* Current or past diagnosis of any bipolar or related disorder or schizophrenia spectrum and other psychotic disorder as determined by the SCID-5 or previous diagnosis by a licensed psychologist or psychiatrist\n* Determined to be at high risk for suicide requiring immediate intervention based on the C-SSRS and\u002For clinician judgment\n* Meet criteria for substance use disorder other than Cannabis Use Disorder or Alcohol (Mild or Moderate) or Nicotine Use Disorder, determined by the SCID-5\n* Presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to smoking cannabis\n* Concomitant treatment with medication taken daily that has level 1 evidence indicating severe drug-drug interactions with cannabis\n* Currently receiving psychotherapy for PTSD or previously received exposure-based PTSD treatment\n* Current diagnosis or evidence of significant or uncontrolled hematological, endocrine, cerebrovascular, cardiovascular, systemic, pulmonary, pulmonary fibrosis, or other forms of restrictive lung disease, immunocompromising, or neurological disease\n* Current diagnosis of a mood, anxiety, or other disorder that is more clinically salient than PTSD\n* Cognitive exhibit impairment\n* Lack of fluency in English\n* Insufficient memory of the index traumatic event\n* Pervasive development disorder history\n* Seeking or currently undergoing treatment for Cannabis Use Disorder.\n* Traumatic brain injury (TBI) with current cognitive impairment related to TBI\n* Exclusively left-handed (score of -100 on Handedness Questionnaire)\n* claustrophobic\n* MRI contraindications (e.g., ferrous metal in head\u002Fbody)","60 Years",{"count":214,"type":23},280,[216],"PHASE1","The overall strategy is to recruit veterans with PTSD who report minimal current cannabis use but are interested in or considering therapeutic cannabis to manage mental health symptoms (anxiety, depression, PTSD and\u002For suicidality). The information gained from this study could lead to the development of new treatments for persons who suffer from post-traumatic stress disorder and maintain better mental health.",[31,219],"Post Traumatic Stress Disorder",[221],"Veterans","2026-01-29",{"date":224,"type":40},"2026-02-03",{"date":226,"type":23},"2026-03",{"date":228,"type":23},"2031-09",{"name":46,"class":47},{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":24,"phases":238,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":246,"locationsCount":48},"100572993","advanced-wireless-augmented-reality-enhanced-exposure-therapy-for-posttraumatic-stress-disorder-100572993","NCT06740487","Advanced Wireless Augmented Reality-Enhanced Exposure Therapy for Posttraumatic Stress Disorder","Inclusion Criteria:\n\n* Adult male or female over the age of 18 that has served, or is currently serving, in the military.\n* Current diagnosis of PTSD as determined by a Clinician Administered PTSD Scale for DSM-5 (CAPS-5) clinical interview.\n\nExclusion Criteria:\n\n* Active psychosis or dementia at screening.\n* Suicidal ideation with clear intent.\n* Concurrent enrollment in another clinical trial for PTSD or depression.\n* Substance use disorders\n* Visual impairments not allowing use of augmented reality. Visual impairments that are corrected with contact lens visual aid are not considered exclusionary as contacts can be worn under the AR headset. For patients with vision impairment that cannot wear contacts, a diopter value no stronger than -2.00 is acceptable.\n\nExclusion criteria are limited to those factors that would negatively impact the validity of the study findings, or place participants at undue risk.",{"count":237,"type":23},40,[112],"The goal of this trial is to test how augmented reality exposure therapy (ARET) may potentiate the effects of traditional exposure therapy administered to U.S. military personnel diagnosed with PTSD. 40 adult males and females over the age of 18 that have served, or are currently serving, in the U.S. military, with a current diagnosis of PTSD, will be recruited. Participants will be randomized into two groups: 20 participants will receive ARET + traditional ET, with the remaining 20 to receive traditional ET only. The main questions this trial aims to answer are:\n\n* what are the different clinical and psychosocial functioning outcomes between veterans\u002Factive-duty personnel with PTSD who receive ARET + traditional ET versus traditional ET only\n* what are the differences in acceptance and satisfaction of treatment, between ARET + traditional ET and the traditional ET-only group",[31,219],"2026-01-27",{"date":222,"type":40},{"date":244,"type":40},"2025-09-01",{"date":123,"type":23},{"name":46,"class":47},{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":24,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":48},"100439729","phase-2-opioidbenzodiazepine-polydrug-abuse-aim-3-100439729","NCT05006079","Opioid\u002FBenzodiazepine Polydrug Abuse: Aim 3","Opioid\u002FBenzodiazepine Polydrug Abuse: Integrating Research on Mechanisms, Treatment and Policies - Study 3","MAP","Inclusion Criteria:\n\n* must self-report past 10-year experience taking opioid and sedative drugs (for therapeutic or non-therapeutic reasons), but not necessarily at the same time. As an alternative to the sedative drug exposure requirement, participants must have used alcohol on at least 3 separate days during the past month. Participants may have current mild- or moderate-severity Opioid Use Disorder or current mild- or moderate-severity Sedative Use Disorder;\n* must not be seeking treatment for their substance use problems;\n* must be in current good overall health\n\nExclusion Criteria:\n\n* meet DSM-5 criteria for current psychosis, bipolar disorder, or severe depression (i.e. severe psychiatric disorder);\n* meet DSM-5 criteria for severe substance use disorder for any substance (e.g. Sedative, Opioid, Alcohol);\n* past-month benzodiazepine or opioid prescription (which would suggest daily use, tolerance, or withdrawal upon cessation);\n* report of past-year any-drug overdose or suicide attempt\u002Fideation;\n* exhibit cognitive impairment (IQ \\\u003C 80 on the Shipley Institute of Living Scale);\n* neurological, cardiovascular, pulmonary, or systemic diseases (see specific exclusionary conditions under Protection of Human Subjects);\n* body mass index \\> 38 kg\u002Fm2;\n* females who are pregnant (urine), lactating or heterosexually active (self-report) and not using medically approved birth control;\n* treatment with methadone, buprenorphine or naltrexone;\n* past 30-day use of contraindicated medications;\n* alcohol-positive breath sample (\\>.02% breath alcohol concentration);\n* urine sample positive for methadone, cocaine, amphetamines, or barbiturates (\\\u003C300 ng\u002Fml)\n* intolerance of lactose","65 Years",{"count":257,"type":23},24,[61],"In this study, the investigators will measure affective, neurocognitive and behavioral outcomes related to chronic use of opioids and benzodiazepines (screening phase), and in response to the administration of the opioid morphine, the benzodiazepine alprazolam, morphine then alprazolam, alprazolam then morphine, morphine+alprazolam simultaneously, and placebo (laboratory pharmacology experiment). The latter will enable the investigators to assess the effects of an opioid alone, benzodiazepine alone, concurrent and simultaneous administration of opioid+benzodiazepine, relative to a placebo control.",[261,262,263],"Opioid Abuse","Benzodiazepine Abuse","Polysubstance Abuse","2025-12-26",{"date":266,"type":40},"2025-12-30",{"date":268,"type":40},"2024-03-13",{"date":270,"type":23},"2026-12",{"name":46,"class":47},{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":18,"minAge":279,"maxAge":212,"enrollmentInfo":280,"targetDuration":4,"studyType":24,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":48},"100380293","phase-2-effects-of-pharmacological-stress-and-rtms-on-executive-function-in-opioid-use-disorder-100380293","NCT04231708","Effects of Pharmacological Stress and rTMS on Executive Function in Opioid Use Disorder","Effects of Pharmacological Stress and Repetitive Transcranial Magnetic Stimulation Interventions on Executive Function in Opioid Use Disorder","Inclusion Criteria:\n\n* Meet DSM-5 criteria for OUD;\n* Age 21-60 yr;\n* Right handed;\n* Males and non-pregnant\u002Fnon-lactating females;\n* cognitively intact (total IQ score \\>80 on Shipley Institute of Living Scale);\n* Screening cardiovascular indices within ranges for safe use of the pharmacological stressor: resting HR 50-90 bpm, systolic BP 90-140 mmHg, and diastolic BP 50-90 mmHg;\n* Use alcohol and\u002For marijuana \\\u003C3 times\u002Fweek; each \"time\" should consist of \\\u003C1 marijuana \"joint\" equivalent and \\\u003C3 alcoholic drinks.\n\nExclusion Criteria:\n\n* Under influence of any substance during session;\n* Past 7-day use of illicit drugs other than opioids (except marijuana, which is legal in Michigan);\n* Urinalysis positive for cocaine metabolites, benzodiazepines, barbiturates, amphetamines or pregnancy;\n* Medical conditions prohibiting use of rTMS (e.g. seizure history; based on rTMS screening questionnaire);\n* Lifetime diagnosis of: psychotic disorder, bipolar disorder, generalized anxiety disorder, or obsessive compulsive disorder; major depression in the past 5 years; or potentially antisocial personality disorder (if the clinical psychologist judges such behaviors to be potentially disruptive or unsafe in our lab);\n* Past-year SUD other than OUD;\n* Acute\u002Funstable illness: conditions making it unsafe for participation (e.g. neurological, cardiovascular, pulmonary, or systemic diseases);\n* Lactose intolerance (placebo dose);\n* Any prohibited medications: medications that lower seizure threshold, psychiatric medications, prescription pain medications, or blood pressure medications;\n* Chronic head or neck pain; and\n* Past-month participation in a research study.","21 Years",{"count":281,"type":23},20,[61],"This preliminary study is designed to evaluate mechanisms by which excitatory dorsolateral prefrontal cortex (dlPFC) repetitive transcranial magnetic stimulation (rTMS) (vs. sham) and pharmacological stress (vs. placebo) alter behavior in non-treatment seeking individuals with opioid use disorder (OUD). Specific Aims are to (1) Evaluate how stress impacts domains of behavior including (1a) executive function and (1b) opioid-seeking behavior; and (2) Determine whether rTMS stimulation attenuates (2a) executive dysfunction, (2b) stress-reactivity, and (2c) opioid-seeking in individuals with OUD not receiving treatment.",[285],"Opioid Use Disorder",{"date":266,"type":40},{"date":288,"type":23},"2026-10",{"date":290,"type":23},"2028-12",{"name":46,"class":47},{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":302,"conditions":303,"keywords":304,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":310,"locationsCount":48},"100339170","opioidbenzodiazepine-polydrug-abuse-100339170","NCT03696017","Opioid\u002FBenzodiazepine Polydrug Abuse","Opioid\u002FBenzodiazepine Polydrug Abuse: Integrating Research on Mechanisms, Treatment and Policies","Inclusion Criteria:\n\n* Recently admitted and\u002For not clinically stable in treatment for Substance Use Disorder (SUD) in Wayne County\n* Using opioids, benzodiazepines (BZD), or BZD\u002Fopioid.\n\nExclusion Criteria:\n\n* Participants with current psychosis, bipolar disorder, or severe depression (i.e. severe psychiatric disorder)\n* Individuals with serious neurological disorders, e.g. brain tumor, history of stroke, history of traumatic brain injury w\u002F loss of consciousness\n* Cognitive impairment (IQ\\\u003C80)","70 Years",{"count":301,"type":23},120,"Benzodiazepine (BZD)\u002Fopioid polysubstance abuse (PSA) dramatically increases risks of overdose, disability and death; however, little is known about phenotypes that could be targeted to decrease this use and these associated risks.\n\nThe opioid abuse epidemic is generating unprecedented numbers of overdoses (OD) and deaths from prescribed and illegal sources (e.g. fentanyl combined with, or sold as, heroin). Yet, medical and epidemiological data suggest these adverse outcomes are not solely due to over-consumption of opioids.The FDA recognizes the health danger of BZD\u002Fopioid PSA, and issued labeling changes for prescribing BZDs and opioids. Impact of these changes is unclear and could be minimal if people obtain these substances illegally.\n\nBZD abuse can be harmful alone or combined with opioids, as BZDs: (a) contribute to OD\u002Fdeath e.g. 31% of opioid OD-related deaths from 1999 to 2011 were related to coincident BZD use, BZD co-use is dose-dependently related to mortality and rates of BZD OD deaths have sharply increased. (b) exacerbate progression and adverse outcomes of opioid abuse. and (c) worsen behavioral impairment from opioids, increase rates of falls and fractures, motor vehicle accidents, and sleep-disordered breathing.\n\nThere has been limited systematic research of BZD\u002Fopioid PSA. This is a major gap because BZD are often co-prescribed with opioids (in 33 to 50% of cases) and are easily obtained illegally.\n\nIn response to these problems, there is an urgent need to obtain population-level, clinical pharmacology, and mechanistic data to test our unified hypothesis of dual-deficit in affective\u002Fhedonic regulation.",[263],[261,305],"Benzodiazepine abuse",{"date":266,"type":40},{"date":308,"type":40},"2019-02-08",{"date":270,"type":23},{"name":46,"class":47},{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":18,"minAge":317,"maxAge":318,"enrollmentInfo":319,"targetDuration":4,"studyType":24,"phases":321,"briefSummary":322,"conditions":323,"keywords":326,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":48},"100615775","vr-stimulation-of-exercise-response-in-sedentary-humans-100615775","NCT07296991","VR Stimulation of Exercise Response in Sedentary Humans","Inclusion Criteria:\n\n1. Equal numbers male and female (32 each)\n2. Blood glucose HbA1C: 5.7-6.4% or 100-125 mg\u002FdL\n3. BP: systolic\\\u003C120 and diastolic\\\u003C80 mmHg, systolic 120-129 mmHg and diastolic \\\u003C80 mmHg, or systolic \\>130 mmHg and diastolic \\>80 mmHg\n\nExclusion Criteria:\n\n1. BMI\\>35kg\u002Fm2\n2. Currently involved in an exercise program or similar activity\n3. Taking medications that could affect results, including beta-blockers or SSRIs\n4. Demonstrate any form of discomfort with the VR experience through self-reported feelings of anxiety or nausea\n5. Alcohol consumption above a minimal level(\\\u003C2 oz\u002Fnight)\n6. BP: Systolic \\>160 mmHg and Diastolic \\>110 mmHg","25 Years","40 Years",{"count":320,"type":23},48,[112],"Prolonged sedentary conditions contribute to declining health across human populations and cause significant secondary health consequences for many patients whose illnesses or injuries prevent them from exercising. The investigators have demonstrated that in a small animal fruit fly model, genetic stimulation of neurons that promote adrenergic signaling is sufficient to mimic the benefits of exercise training even in sedentary animals. The investigator's pilot work in humans has confirmed that humans respond to Virtual Reality (VR) stimuli that mimic exercise by increasing heart rate and altering heart rate variability in a way consistent with increased adrenergic activity.\n\nIn this study, the investigators will directly test for the first time whether repeated, controlled exposure to VR stimuli that induce adrenergic activity in sedentary humans can produce adaptive changes to protein expression and endurance performance like those produced by actual exercise in pre-diabetic participants with\u002Fwithout hypertension.",[324,325],"Prolonged Inactivity","Metabolic Syndrome",[327,328,329,330],"Exercise","metabolic syndrome","insulin resistance","virtual reality","2025-12-19",{"date":333,"type":40},"2025-12-23",{"date":335,"type":40},"2025-09-30",{"date":337,"type":23},"2028-08",{"name":46,"class":47},{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":56,"sex":18,"minAge":19,"maxAge":346,"enrollmentInfo":347,"targetDuration":349,"studyType":90,"phases":4,"briefSummary":350,"conditions":351,"keywords":355,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":48},"100610423","timing-of-opioid-administration-and-postoperative-respiratory-depression-100610423","NCT07227389","Timing of Opioid Administration and Postoperative Respiratory Depression.","The Relationship Between Timing of Opioid Administration and Postoperative Respiratory Depression.","Inclusion Criteria:\n\n* Written informed consent\n* Adults ≥18 years of age and ≤85 years of age\n* Patients planned for general anesthesia with an expected anesthetic time of at least 2 hours\n* Patients expected to receive postoperative opioid analgesia\n\nExclusion Criteria:\n\n* Non-operative procedure (imaging)\n* Patients not admitted to the PACU postoperatively\n* Use of patient-controlled analgesia systems\n* Female patients who are pregnant or breastfeeding\n* Patients with asymmetric lung disease\n* American Society of Anesthesiologists (ASA) classification V\n* Emergency surgery (ASA E Modifier)","85 Years",{"count":348,"type":23},52,"1 Day","The goal of this study is to determine if a relationship can be detected between the administration of an opioid and quantitative respiratory depression in spontaneously breathing non-intubated patients who have undergone general anesthesia and have received perioperative opioids.\n\nThe primary aim is to determine the temporal effect of opioid administration on respiratory depression as assessed by minute ventilation with a reduction of at least 20% in the percent of predicted minute ventilation.\n\nA secondary aim is to determine a dose response of opioid administration and its effect on minute ventilation.\n\nThe investigators aim to determine the influence of opioid administration on minute ventilation on spontaneously breathing patients during post-anesthesia care unit (PACU) stay.",[352,353,354],"Respiratory Complications","Opioid Induced Respiratory Depression","Postoperative Respiratory Complications",[356,357,358,359,360],"opioids","bio-impedance","hypoxia","hypercapnia","minute ventilation","2025-11-13",{"date":363,"type":40},"2025-11-14",{"date":365,"type":23},"2025-12",{"date":367,"type":23},"2029-01-01",{"name":46,"class":47},{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":376,"enrollmentInfo":377,"targetDuration":4,"studyType":24,"phases":378,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":4},"100609695","neurofeedback-and-well-being-among-people-with-co-occurring-obsessive-compulsive-disorder-and-post-traumatic-stress-symptoms-100609695","NCT07217925","Neurofeedback and Well-Being Among People With Co-Occurring Obsessive Compulsive Disorder and Post-traumatic Stress Symptoms","Exploring the Influence of Neurofeedback on the Well-Being of People With Symptoms of Obsessive Compulsive Disorder and Post-traumatic Stress Symptoms","Inclusion Criteria:\n\n1. being a client placed on the clinic waitlist to receive exposure-response prevention for OCD symptoms at the Anxiety and OCD Treatment Center of Ann Arbor, in Ann Arbor, MI.\n2. having self-reported symptoms of OCD;\n3. having post-traumatic stress symptoms as indicated by a score of 3 or higher on the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) screening measure;\n4. being age 18+.\n5. being a citizen of the United States of America -\n\nExclusion Criteria:\n\n1. a lifetime history of significant untreated mental illness (not currently treated schizophrenia, schizoaffective disorder, bipolar disorder, or substance use disorder) or neurological or pervasive developmental disorder;\n2. a documented history of epilepsy;\n3. lifetime history of any head injury with loss of consciousness;\n4. current exposure domestic or intimate partner violence or otherwise state that their current living conditions are unsafe;\n5. current experiences of psychosis or suicidality within the last six months;\n6. currently taking, or in the past month has taken benzodiazepines, narcotic drugs, or cannabis;\n7. currently pregnant\n8. engagement in self-harming behaviors in the last 3 months that required medical attention;\n9. lack of competence to understand or consent to the study procedures;\n10. lack of fluency in written and spoken English. -","90 Years",{"count":281,"type":23},[112],"The proposed study will collect novel data evaluating the feasibility of a neurofeedback training program delivered to prospective clients with a history of clinically concerning trauma-related mental health symptoms who are on a wait list to receive obsessive compulsive disorder-specific psychotherapy at an outpatient mental health clinic. This study will evaluate the influence of neurofeedback training on participant's overall sense of well-being, and additionally, whether any enhanced well-being is subsequently associated with positive changes in symptoms of obsessive compulsive disorder, post-traumatic stress, dissociation and other trauma-related mental health symptoms, emotional regulation, etc.",[381,382,383,384,385],"Well-Being, Psychological","Mood Disturbance","Emotional Regulation","Dissociation","Post Traumatic Stress Symptoms","2025-11-10",{"date":388,"type":40},"2025-11-12",{"date":390,"type":23},"2025-11",{"date":392,"type":23},"2029-01",{"name":46,"class":47},{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":402,"enrollmentInfo":403,"targetDuration":4,"studyType":24,"phases":405,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":48},"100545382","phase-1-warrior-care-cannabis-behavioral-health-100545382","NCT06381180","Warrior CARE: Cannabis Behavioral Health","Wayne Warrior CAnnabis Research and Education: Cannabis and Behavioral Health","CBH","Inclusion Criteria:\n\n* a healthy veteran who has served in a branch of the US armed forces\n* report using cannabis within the past year\n* currently meet DSM-5 criteria for PTSD and a score of 25 or greater on the CAPS-5 (the anchor, or index, trauma does not have to be related to military service)\n* between the ages of 19-69 years old\n* not seeking treatment for Cannabis Use Disorder\n* stable (i.e., under the care of a physician or therapist and not experiencing acute symptoms) on psychotropic medications and\u002For psychotherapy before the study begins (participants can be in treatment for PTSD)\n* agree to adhere to study procedures\n\nExclusion Criteria:\n\n* pregnant, lactating, or heterosexually active women and not using medically approved birth control\n* current or past bipolar or psychotic disorder as determined using the SCID-5\n* at immediate high risk for suicide based on the C-SSRS\n* current SUD other than Nicotine Use Disorder and Alcohol Use Disorder (mild or moderate)\n* allergies and\u002For other contradictions for using cannabis\n* any clinically significant medical problems\n* systolic\u002Fdiastolic BP \\>140\u002F90 mmHg or systolic BP \\\u003C95 mmHg\n* elevated liver function tests\n* exhibit cognitive impairment (\\\u003C80 IQ)\n* enrolled in another clinical trial or have received any drug as part of a research study within 30 days of dosing\n* used a prescription medication (with the exception of birth control) within 14 days of study entry that in the opinion of the medically responsible investigator will interfere with the safety of the participant or the study results\n* unable to provide informed consent","69 Years",{"count":404,"type":23},500,[216,61],"This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation.",[219,408,409,221,410],"Cannabis Use","Suicide","Marijuana","2025-09-23",{"date":413,"type":40},"2025-09-29",{"date":415,"type":23},"2025-09-22",{"date":417,"type":23},"2030-12-31",{"name":46,"class":47},{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":56,"sex":18,"minAge":426,"maxAge":427,"enrollmentInfo":428,"targetDuration":4,"studyType":24,"phases":430,"briefSummary":431,"conditions":432,"keywords":434,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":48},"100538933","exercise-facilitation-of-adolescent-fear-extinction-frontolimbic-circuitry-and-endocannabinoids-100538933","NCT06297278","Exercise Facilitation of Adolescent Fear Extinction, Frontolimbic Circuitry, and Endocannabinoids","BRAINS","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and available for the duration of the study\n3. 14-17 years of age upon enrollment\n4. Right-handed\n5. In good general health as evidenced by medical history\n6. Adolescent and parent\u002Fguardian are English-speaking, as study assessments are in English\n7. Availability of a parent or legal guardian who is willing to provide consent and attend all study visits\n\nExclusion Criteria:\n\n1. Traumatic brain injury with ongoing symptoms\n2. Sensory (e.g., hearing) or physical (e.g., motor, balance) impairment or significant developmental delay\n3. MRI participants: MRI contraindication (e.g., braces, implants, claustrophobia)\n4. Any condition that would contraindicate blood draws (e.g., hemophilia, sickle cell)\n5. Past or current diagnosis or presence of likely neurological disorder (e.g., epilepsy), psychotic disorder (e.g., schizophrenia, schizoaffective disorder), or bipolar disorder\n6. Severe\u002Funstable medical condition (e.g., diabetes, rheumatoid arthritis)\n7. Current (past 1-month) use of cannabis or cannabinoid products including CBD unless willing to stop for at least 4 weeks prior to entering the study\n8. Currently pregnant, lactating, or positive pregnancy test at screening visit\n9. Current homicidal thoughts or suicide attempt in the past year\n10. Current suicidal thoughts requiring immediate intervention\n11. Concurrent use (past 6 weeks) of oral contraceptives\n12. Diagnosed or probable substance use disorder (past 1-month)\n13. Positive drug test at baseline visit (e.g., THC, cocaine)\n14. Moderate\u002Fsevere drug or alcohol use in the past 8 weeks\n15. Current or recent (past 1-month) COVID-19 diagnosis or febrile illness\n16. Treatment with investigational drug or intervention (past 1-month)\n17. Current smoker, vaper, or tobacco or nicotine use (past 1-month)\n18. Ongoing exposure to abuse","14 Years","17 Years",{"count":429,"type":23},174,[112],"Anxiety disorders commonly begin during adolescence, and are characterized by deficits in the ability to inhibit or extinguish pathological fear. Recent research has provided new understanding of how fear is learned and can be regulated in the adolescent brain, and how the endocannabinoid system shapes these processes; however, these advances have not yet translated into improved therapeutic outcomes for adolescents with anxiety. This study will test whether a behavioral intervention, acute exercise, can help to improve fear regulation by enhancing brain activity and endocannabinoid signaling. This line of research may ultimately lead to more effect treatments for adolescent anxiety, and to new preventive strategies for at-risk youth.",[433],"Adolescence",[435,436,437],"anxiety","exercise","fear","2025-08-06",{"date":440,"type":40},"2025-08-07",{"date":442,"type":40},"2024-05-17",{"date":444,"type":23},"2028-04-30",{"name":46,"class":47},{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":452,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":18,"minAge":454,"maxAge":426,"enrollmentInfo":455,"targetDuration":4,"studyType":24,"phases":457,"briefSummary":458,"conditions":459,"keywords":462,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":471,"locationsCount":204},"100537252","family-intervention-for-black-teens-with-type-1-diabetes-100537252","NCT06275412","Family Intervention for Black Teens With Type 1 Diabetes","Family mHealth Intervention to Improve Health Outcomes in Black Youth With Type 1 Diabetes","3Ms","Inclusion Criteria:\n\n* Age: 10 years, 0 months - 14 years, 11 months\n* Diagnosed with Type 1 diabetes\n* Diagnosed for at least 6 months\n* Black\n* Primary caregiver willing to participate\n* Residence within 30 miles of a recruitment site\n* Caregiver ownership of an Internet-enabled device (cell phone, laptop or desktop computer, tablet, etc)\n\nExclusion Criteria:\n\n* Mental health conditions that might compromise data integrity (e.g., developmental delay, schizophrenia, psychosis, current suicidality, homicidality)\n* Co-morbid medical condition resulting in atypical diabetes management (e.g., cystic fibrosis)\n* Inability to speak or read English\n* Child is in out-of-home placement","10 Years",{"count":456,"type":23},216,[112],"The purpose of this study is to conduct a multicenter, randomized effectiveness trial of The 3Ms 2.0 compared to an educational control condition for improving adolescent glycemic control and diabetes-related family relationships and reducing primary caregiver diabetes-related distress among Black adolescents with type 1 diabetes (T1D) and their primary caregivers. The proposed study would develop and test The 3Ms 2.0 adapted intervention when delivered using a mobile health approach (accessed via parents' cell phone). The intervention will also include new family intervention content (videoclips and text messages).",[460,461],"Type 1 Diabetes","Family Relations",[460,463,464],"mobile health","Family-based intervention","2025-07-14",{"date":467,"type":40},"2025-07-15",{"date":469,"type":40},"2024-09-16",{"date":444,"type":23},{"name":46,"class":47},{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":56,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":24,"phases":480,"briefSummary":481,"conditions":482,"keywords":485,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":48},"100561694","addressing-cardiometabolic-health-in-populations-through-early-prevention-in-the-great-lakes-region-project-1---epidemiology-achieve-p1-epi-100561694","NCT06593496","Addressing Cardiometabolic Health In Populations Through Early Prevention in the Great Lakes Region Project 1 - Epidemiology (ACHIEVE P1-EPI)","Inclusion Criteria:\n\n* Mobile Health Unit Patients with blood pressure above normal (≥120 systolic and\u002For ≥80 mmHg)\n* Has a phone with the ability to receive text messages\n* 18+ years old\n* Consent to allow prospective follow-up including through EHR review\n\nExclusion Criteria:\n\n* Non-mobile health unit patients\n* MHU patients with systolic BP \\\u003C 120 mmHg AND diastolic BP \\\u003C 80 mmHg\n* Pregnant Women\n* Children less than 18 years old\n* Individuals viewed by the investigative team as unable to understand and sign the informed consent form\n* Currently enrolled in another on-going interventional trial initiated on the mobile health unit",{"count":479,"type":23},1000,[112],"This project is part of the ACHIEVE GREATER (Addressing Cardiometabolic Health In Populations Through Early PreVEntion in the GREAT LakEs Region) Center (IRB# 100221MP2A), the purpose of which is to improve cardiometabolic health in two uniquely comparable cities: Detroit, Michigan, and Cleveland, Ohio. The ACHIEVE GREATER Center involves separate but related projects that aim to improve cardiometabolic health outcomes through better risk factor control for three chronic conditions that are of tremendous public health importance, (hypertension (HTN), heart failure, and coronary heart disease), all of which contribute significantly to premature death in Detroit and Cleveland.\n\nThe present study is the prospective observational cohort component of ACHIEVE P1- EPI (Project 1) of the ACHIEVE GREATER Center and serves to characterize the population of patients with blood pressure (BP) levels above normal attending The Wayne Health Mobile Health Unit (MHU) events to better understand key factors (e.g., social determinants of health) that convey information about baseline BP levels and related clinical outcomes (e.g., follow-up clinic visits, BP control, and cardiovascular events).",[483,484],"Hypertension","High Blood Pressure",[486,487,488],"Epidemiology","Mobile Health Unit","Prospective","2025-07-09",{"date":467,"type":40},{"date":492,"type":40},"2025-06-11",{"date":494,"type":23},"2028-06-01",{"name":46,"class":47},{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":56,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":24,"phases":504,"briefSummary":505,"conditions":506,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":48},"100593430","surgical-operating-room-enhancement-curriculum-for-medical-students-100593430","NCT07006337","Surgical Operating Room Enhancement Curriculum for Medical Students","Surgical Operating Room Enhancement Curriculum for Medical Students: A Quality Improvement and Prospective Cohort Study","Inclusion Criteria:\n\n* Medical students currently enrolled in the Wayne State University OBGYN clinical rotation (5-week block)\n* Willingness to voluntarily participate in surveys and training sessions\n* Ability to attend all didactic lectures\n\nExclusion Criteria:\n\n* Prior completion of a structured surgical operating room enrichment course (e.g., elective subspecialty training)\n* Inability to participate virtual sessions due to conflicting clinical\u002Facademic schedules\n* Non-English speakers (due to English-language survey instruments)",{"count":22,"type":23},[112],"The goal of this clinical trial is to assess whether integrating an enhanced Surgical Operating Room (OR) curriculum into the medical student program improves knowledge and proficiency in gynecologic surgical techniques and procedures among medical students at Wayne State University. The main questions it aims to answer are:\n\nDoes the Surgical Operating Room Enrichment Course increase medical students' knowledge and comfort with gynecologic surgical procedures?\n\nDoes participation in the course improve students' clinical perceptions and management of gynecologic emergencies?\n\nResearchers will compare students who participate in the Surgical Operating Room Enrichment Course (intervention group) to those who complete the standard rotation (control group) to see if the enhanced curriculum leads to greater improvements in knowledge and clinical skills.\n\nParticipants will:\n\nAttend virtual didactic lectures covering gynecologic anatomy, perioperative care, surgical techniques, and management of gynecologic emergencies\n\nComplete pre- and post-training surveys assessing knowledge, skills, and perceptions related to gynecologic surgery\n\nThis study involves approximately 60 medical students, with participation being voluntary and all responses de-identified.",[507,508,509],"Gynecology","Medical Education","Operating Rooms","2025-05-27",{"date":512,"type":40},"2025-06-05",{"date":514,"type":40},"2025-05-15",{"date":516,"type":23},"2026-09-01",{"name":46,"class":47},{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":56,"sex":18,"minAge":525,"maxAge":4,"enrollmentInfo":526,"targetDuration":4,"studyType":24,"phases":527,"briefSummary":528,"conditions":529,"keywords":531,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":545},"100534736","train-your-brain-20---improving-memory-and-decision-making-among-youth-100534736","NCT06242704","Train Your Brain 2.0 - Improving Memory and Decision Making Among Youth","Train Your Brain 2.0: Improving Memory and Decision Making to Improve Outcomes Among Youth - A Randomized Controlled Trial","Adolescent Inclusion Criteria:\n\n1. Between the ages of 11 and 15 and have a parent\u002Fguardian willing to provide consent for their participation\n2. Proficient in English\n3. Willing to commit to participate in computer-based trainings over the course of 5-8 weeks (duration dependent on site)\n4. Access to internet services, cell phone, and\u002For email\n5. Willing to receive\u002Fsend study-related text messages\n\nAdolescent Exclusion Criteria:\n\n1. Self-disclosure or identification with psychological disturbance, suicidality, or evidence of active suicide ideation\n2. Self-disclosure of current substance use disorder\n\nParent Inclusion Criteria:\n\n1. Provide consent for child's participation in study\n2. Proficient in English\n3. Access to internet services, cell phone, and\u002For email\n4. Willing to receive\u002Fsend study-related text messages\n\nParent Exclusion Criteria:\n\n1. Self-disclosure or identification with psychosis, suicidality, or evidence of active suicide ideation\n2. Self-disclosure of current substance use disorder","11 Years",{"count":89,"type":23},[112],"The goal of this clinical trial is to deliver a computer-based working memory training program to improve delay discounting (DD) and prevent substance misuse among at-risk adolescents in a traditionally underserved area. Results from the study will inform future substance use prevention efforts targeted at youth exposed to adverse childhood experiences. Findings will also refine future models of intervention delivery in traditionally underserved communities.\n\nThe main aims of the project are are:\n\n1\\) To examine to examine changes in hypothesized mechanisms of substance use initiation and escalation, and 2) to assess whether changes in DD are a mechanism for reducing substance misuse during early adolescence. The investigators will evaluate whether changes in DD following active treatment predict substance use outcomes over the three-month follow-up period.",[530],"Behavior, Health",[532,533,534,535,536],"delay discounting","computer-based intervention","executive functioning","substance use","working memory","2025-05-20",{"date":539,"type":40},"2025-05-25",{"date":541,"type":40},"2024-06-25",{"date":543,"type":23},"2026-08-01",{"name":46,"class":47},2,{"id":547,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":548,"targetDuration":4,"studyType":24,"phases":549,"briefSummary":27,"conditions":550,"keywords":551,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":48},"100589359",{"count":22,"type":23},[216],[29],[31,32,33,34,35],"2025-05-13",{"date":554,"type":40},"2025-05-18",{"date":556,"type":23},"2026-02-01",{"date":558,"type":23},"2032-12",{"name":46,"class":47},{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":566,"eligibilityCriteria":567,"healthyVolunteers":56,"sex":18,"minAge":525,"maxAge":426,"enrollmentInfo":568,"targetDuration":4,"studyType":24,"phases":569,"briefSummary":570,"conditions":571,"keywords":575,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":586,"leadSponsor":587,"locationsCount":545},"100588753","school-based-practices-in-arts-and-resilience-for-kids-100588753","NCT06945497","School-based Practices in Arts and Resilience for Kids","School-based Practices in Arts and Resilience for Kids (SPARK Study)","SPARK","Inclusion Criteria:\n\n1. Ages 11-14 years, inclusive.\n2. Any gender identity or sex assigned at birth.\n3. English-speaking, given that study interventions and assessments will be in English.\n4. Ability to provide written informed assent or oral assent.\n5. Caregiver ability to provide informed consent and ability to assist in completing study.\n6. Student enrolled in collaborating school.\n\nNote: here, we define 'caregiver' as the participant's parent and\u002For legal guardian.\n\nExclusion Criteria:\n\n1. Current or past bipolar I\u002FII disorder\n2. Current or past psychotic disorder\n3. Autism spectrum disorders or any other severe developmental disorder",{"count":133,"type":23},[112],"This proposal will implement and test feasibility and efficacy of school-based art therapy and yoga\u002Fmindfulness programming to reduce mental health disparities and foster resilience in youth. We will conduct a cross-over randomized trial with n=250 youth (any race\u002Fethnicity or gender, ages 11-14) from two schools: one serving majority Black\u002FAfrican American students and one serving a population-representative ethnoracial demographic with 50% economically disadvantaged students. Baseline data collection will assess experiences of discrimination, negative experiences, positive experiences, and severity of posttraumatic stress, anxiety, depression, somatic symptoms, and resilience. Youth will be randomly assigned to art therapy or yoga\u002Fmindfulness for a quarter. Hour-long weekly sessions will occur during elective course times within school to bolster accessibility and generate data to inform future school-based care models for sustainability. Target schools co-developed this design with the research team. At the end of the quarter, participants will engage in post-intervention data collection, including qualitative interviews regarding their experience with the school-based programming. Participants will then cross over to the yoga\u002Fmindfulness or art therapy for the subsequent quarter, such that all participants receive both modalities. The methods described above will be repeated, including the assessments. Academic performance will be assessed throughout. We hypothesize that both modalities will be effective in reducing stress, anxiety, and depression related to discrimination, adversity, and trauma that disproportionately impacts racially and ethnically minoritized youth. We anticipate that qualitative feedback will identify points of optimization for programming and inform which students may be most responsive to what intervention(s).",[572,573,574],"Anxiety","Posttraumatic Stress Disorder","Trauma",[576,574,577,572,573,578,579,580,581],"Adversity","Stress","Art Therapy","Yoga","Mindfulness","Child and Adolescent","2025-04-18",{"date":584,"type":40},"2025-04-25",{"date":244,"type":23},{"date":175,"type":23},{"name":46,"class":47},{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":4,"eligibilityCriteria":594,"healthyVolunteers":56,"sex":18,"minAge":19,"maxAge":57,"enrollmentInfo":595,"targetDuration":4,"studyType":24,"phases":597,"briefSummary":598,"conditions":599,"keywords":602,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":613,"locationsCount":48},"100392836","phase-2-rct-of-prenatal-choline-supplementation-during-pregnancy-to-mitigate-adverse-effects-of-prenatal-alcohol-exposure-100392836","NCT04395196","RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure","A Randomized, Double-Blind, Placebo-controlled Clinical Trial of Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure on Growth and Cognitive Development","Inclusion Criteria:\n\n* Age ≥18 yr\n* ≤20 wk gestation\n* Singleton pregnancy\n* Currently heavy drinking (average of ≥15 ml AA\u002Fday or binge drinking (≥4 standard drinks\u002Foccasion) on at least 1.5 occasions\u002Fmonth on average since becoming pregnant)\n* Current choline dietary intake \\\u003C1 g\u002Fday\n* Language fluency in English or Afrikaans\n\nExclusion Criteria:\n\n* Use of methamphetamine or other illicit drugs other than marijuana during the past year\n* HIV positive\n* Pharmacologic treatment for a serious pre-existing medical condition (e.g., diabetes, hypertension, epilepsy, or cardiac problems)\n* Having another child enrolled in the trial from a previous pregnancy\n* Plans for mother or child to move away from the area prior to study completion",{"count":596,"type":23},288,[61],"Although the adverse effects associated with prenatal alcohol exposure (PAE) are well known, many women continue to drink heavily during pregnancy, putting their infants at risk for fetal alcohol spectrum disorders. Animal studies have shown that choline supplementation can mitigate effects of PAE on growth and development. Choline, an essential nutrient, serves as a methyl-group donor for DNA methylation and is a constituent of the neurotransmitter acetylcholine and a precursor to major components of cell membranes. In an R21 feasibility trial, 70 heavy drinkers were randomly assigned to receive a daily dose of 2g of choline or a placebo from initiation of antenatal care to delivery in Cape Town, South Africa, where the incidence of heavy drinking during pregnancy and fetal alcohol syndrome are among the highest in the world. When compared with infants in the placebo arm, infants in the choline-treated arm were more likely to meet criterion for eyeblink conditioning, demonstrated markedly better recognition memory on the Fagan Test of Infant Intelligence, which is known to have predictive validity for school-age IQ, and had better postnatal gains in weight and head circumference. Key features of this study included the higher choline dose (4.4 times adequate intake (AI), compared to 1.7-2.5 in previous human studies) and initiation of treatment early in pregnancy. We are now conducting a fully-powered, double-blind, randomized, placebo-controlled choline supplementation trial in heavy drinking pregnant women from a rural community in South Africa (1) to assess the effectiveness of maternal choline supplementation during pregnancy to mitigate effects of PAE on three primary outcomes: infant recognition memory and postnatal growth restriction (weight and head circumference); (2) to assess the efficacy of this supplementation for mitigating alcohol effects on the following secondary outcomes: infant eyeblink conditioning, postnatal length, and information processing speed; (3) to use innovative methods in causal inference analysis to examine protocol adherence as an important source of variation in treatment efficacy and to identify sociodemographic factors associated with non-compliance in order to facilitate implementation of the intervention protocol in clinical settings; and (4) in exploratory analyses, to examine whether maternal choline supplementation is particularly effective in women with lower dietary choline intake or poor nutritional status.",[600,601],"Fetal Alcohol Spectrum Disorders","Fetal Alcohol Syndrome",[603,604,605,606],"Prenatal Alcohol Exposure","Choline Supplementation","Infant Neurodevelopment","Growth","2025-03-25",{"date":609,"type":40},"2025-04-01",{"date":611,"type":40},"2023-04-13",{"date":76,"type":23},{"name":46,"class":47},{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":4,"eligibilityCriteria":620,"healthyVolunteers":56,"sex":621,"minAge":19,"maxAge":622,"enrollmentInfo":623,"targetDuration":4,"studyType":24,"phases":625,"briefSummary":626,"conditions":627,"keywords":629,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":640,"locationsCount":48},"100538950","phase-1-ondansetron-use-for-preventing-pruritus-in-patients-undergoing-cesarean-section-100538950","NCT06297499","Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section","Timing of Ondansetron Use for Maximum Efficacy in Preventing Pruritus in Patients Undergoing Cesarean Section Under Spinal Anesthesia with Preservative Free Morphine.","Inclusion Criteria:\n\n1. American Society of Anesthesiologists (ASA) physical status 1-3\n2. Adult parturient (18 -50 years of age) scheduled to undergo elective cesarean delivery under spinal anesthesia\n3. Patients must be willing and cognitively able to give written informed study consent\n\nExclusion Criteria:\n\n1. Patients with an ASA physiological assessment greater than grade 3\n2. Allergies to local anesthetics, opioids, or ondansetron\n3. Coagulopathies precluding provision of spinal anesthesia\n4. Pre-eclampsia with severe features\n5. Eclampsia\n6. Pre-intrathecal pruritus\n7. Psychiatric or language deficiencies affecting assessment of pain\n8. Insufficient understanding of the pain scoring system\n9. Patients who receive any other regional anesthesia techniques\n10. Patients on higher than a 100mg of daily morphine equivalent\n11. Cardiac issues that would preclude spinal anesthesia (Congestive heart failure, Mitral or Aortic valve pathology.\n12. Confounding neural issues that would preclude spinal anesthesia.\n13. Coadministration of drugs that would potentially interact with ondansetron. Including Apomorphine, Phenytoin, Carbamazepine, Rifampicin, Tramadol and Chemotherapy drugs.\n14. Coadministration of drugs that would potentially prolong QTc interval. Including Antiarrhythmic, Antidepressants, Antipsychotics, and the following list of medications.\n\n    a. Levofloxacin, Ciprofloxacin, Gatifloxacin, Moxifloxacin, Clarithromycin, Erythromycin, Ketoconazole, Itraconazole, Cisapride, Sumatriptan, Zolmitriptan, Arsenic, Dolasetron, Methadone\n15. Coadministration of drugs that would potentially lead to the development of serotonin syndrome. Including the following:\n\n    a. Selective serotonin reuptake inhibitors, Serotonin and norepinephrine reuptake inhibitors, antidepressants, carbamazepine , valproic acid, triptans, Chronic pain medications prior to procedure (Fentanyl, Hydrocodone, Meperidine, Oxycodone, tramadol),Lithium, dextromethorphan, Linezolid and Ritonavir\n16. Patients having the following\n\n    1. Patients known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any components of the formulation\n    2. Concomitant use of apomorphine\n    3. History of QTc interval prolongation (QTc \\>440) and Torsade de Pointes\n    4. Serotonin syndrome\n    5. Phenylketonuric patients\n    6. Concurrent use of selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs)","FEMALE","50 Years",{"count":624,"type":23},66,[216],"Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients. However, spinal opioids are associated with a wide variety of side effects such as nausea, vomiting, (N\u002FV) and pruritus (itching). The occurrence of pruritus can vary between 30% and 100% making pruritus the most common side-effect of intrathecal opioids and this rate is even higher in pregnant patients. Pruritus may require treatment which can be ineffective or sometimes reverse the analgesic effect of the opioids. Ondansetron is a safe and very commonly used Serotonin receptor antagonist treatment for local anesthetic opioid-induced pruritus used in pregnancy. The effect of different administration times of ondansetron in reducing pruritus or N\u002FV in cesarean section (CS) cases has not been extensively studied and thus, this prospective study can help guide future clinical management of side effects caused by spinal intrathecal morphine administration.",[628],"Pruritus Caused by Drug",[630,631,632],"Cesarean Section","Intrathecal Morphine","Ondansetron","2025-03-24",{"date":635,"type":40},"2025-03-28",{"date":637,"type":40},"2024-08-22",{"date":639,"type":23},"2025-12-01",{"name":46,"class":47},""]