[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Texas at Austin\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":694},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,60,0,25,[9,47,75,101,131,162,185,204,238,265,292,316,347,379,415,435,468,492,515,538,566,596,624,647,668],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100597565","cognitive-processing-therapy-cpt-for-perinatal-posttraumatic-stress-disorder-ptsd-100597565",false,"NCT07060144","Cognitive Processing Therapy (CPT) for Perinatal Posttraumatic Stress Disorder (PTSD)","Inclusion Criteria:\n\n* Female, ages 18-46, Pregnant (\\\u003C 25 weeks), able to read and write in English, History of at least 1 criterion A trauma, Primary diagnosis of PTSD (confirmed by SCID), Psychotropic medications must be stable with no changes ≥ 2 weeks (≥ 6 weeks for fluoxetine), and no medication changes can be made during the course of therapy\n\nExclusion Criteria:\n\n* Not currently pregnant, Diagnosis of bipolar disorder, psychotic disorders, Suicidal ideation with plan or intent, Substance use disorder, Regular benzodiazepine use (\\> 4x weekly)","FEMALE","18 Years","46 Years",{"count":5,"type":20},"ESTIMATED","INTERVENTIONAL",[23],"NA","Pregnant women with a primary diagnosis of posttraumatic stress disorder (PTSD) (PTSD Checklist for DSM-5 (PCL-5) score \\> 33) will be randomized to receive conventional cognitive processing therapy (CPT) (60-min session once\u002Fweek for 12 weeks) or massed CPT (mCPT) (an intensive schedule of 12 60-min sessions over 5 days, approximately 2-3 sessions per day) via telemedicine, for treatment of PTSD. The research aims will be three-fold: (1) Evaluate the relative efficacy and tolerability of CPT vs. mCPT for treatment of perinatal PTSD and depression; (2) Determine the effect of CPT upon maternal-infant attachment and interaction; (3) Collect pilot data of obstetric and neonatal outcomes among those receiving the two CPT delivery schedules.",[26,27],"Posttraumatic Stress Disorder (PTSD)","Pregnancy",[29,30,31,32,33],"PTSD","pregnancy","cognitive processing therapy","psychotherapy","trauma","RECRUITING","2026-06-15",{"date":37,"type":38},"2026-06-16","ACTUAL",{"date":40,"type":38},"2025-08-01",{"date":42,"type":20},"2027-10",{"name":44,"class":45},"University of Texas at Austin","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100598278","sibwatch-optimizing-intervention-options-for-infants-and-toddler-siblings-of-autistic-children-100598278","NCT07069413","Sibwatch: Optimizing Intervention Options for Infants and Toddler Siblings of Autistic Children","Sibwatch: Optimizing Intervention Options for Infants and Toddlers With a High Likelihood of Social Communication Delays and Language Disorder","Sibwatch","Inclusion Criteria:\n\n* chronological age between 6-24 months\n* has at least one older biological sibling diagnosed with autism\n\nExclusion Criteria:\n\n* adverse neurological history\n* primary sensory deficit (hearing or visual impairment)\n* pre-term birth (gestation \\\u003C37 weeks)\n* pre-existing diagnosis of autism or language delay","ALL","6 Months","24 Months",{"count":59,"type":20},140,[23],"This rigorous randomized controlled trial will evaluate the efficacy and acceptability of a preemptive, telehealth intervention (tele-ImPACT) in a large, representative sample of infant siblings of autistic children, who are known to be at high likelihood of receiving a future diagnosis of autism and\u002For developmental language disorder (HL-Sibs). If our hypotheses are supported, this innovative and interdisciplinary study will provide empirical support for a novel approach to treatment that is theoretically motivated and developmentally informed, as well as accessible for and acceptable to families, and will lend new insights into the developmental windows in which, mechanisms by which, and subgroups for which the treatment works. Such findings would have strong implications for research, policy, theory, and practice in young children at risk for autism and\u002For language disorder.",[63],"Autism Sibling",[65],"autism","2026-06-09",{"date":68,"type":38},"2026-06-12",{"date":70,"type":38},"2026-04-01",{"date":72,"type":20},"2032-03-31",{"name":44,"class":45},2,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":16,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":46},"100579545","unidos-contra-el-vph-100579545","NCT06825689","Unidos Contra el VPH","Unidos Contra el VPH: Screening Preference and Uptake of HPV Self-sampling Among Latinxs Along the US-Mexico Border","Unidos","Inclusion Criteria:\n\n* Individuals with a cervix who are 30-65 years and have not undergone a Pap test in at least three years.\n\nExclusion Criteria:\n\n* Having had a hysterectomy or a personal history of cervical cancer.",true,"30 Years","65 Years",{"count":87,"type":20},735,[23],"The purpose of the Unidos Contra el VPH study is to help find options to screen, or check, for cervical cancer that individuals can do at home to help prevent and detect cervical cancer early. Usually, people get screened for cervical cancer with a Pap smear and human papillomavirus (HPV) test by a health care provider. This is not always easy for individuals who are not able to get to a clinic or feel uncomfortable having the procedure done. That is why we want to find other ways that may be easier and more comfortable for people to be screened for cervical cancer.\n\nThe two main questions the study aims to answer are:\n\n1. How do the following three cervical cancer screening methods compare for improving screening completion rates?\n\n   o In-home HPV self-sampling with a vaginal swab\n   * In-home HPV self-sampling with urine testing\n   * In-clinic traditional Pap smear with HPV test\n2. What are participant beliefs and preferences regarding these three screening methods?\n\n   Participants in the study will be randomly assigned to one of three groups. This means each person has an equal chance of being placed in any group. They will also complete two surveys as part of the study. The three screening method groups are described below:\n\n   Group 1: Urine Self-Sampling\n   * Participants in this group will receive a kit with a urine sample cup to use at home, instructions explaining how to take the sample and a pre-paid mailing box to mail the urine sample to the lab.\n\n   Group 2: Vaginal Swab Self-Sampling o Participants in this group will receive a kit with a vaginal swab and collection tube to use at home, instructions explaining how to take the sample and a pre-paid mailing box to mail the sample to the lab.\n\n   Group 3: In-Clinic Screening\n   * An in-clinic co-testing appointment is scheduled for a Pap smear and HPV test done together at Project Vida Health Center.\n\n   By comparing these approaches, this study aims to improve access to cervical cancer screening and provide better options for those who face barriers to clinic-based screening.",[91,92],"Human Papilloma Virus (HPV)","Cervical Cancers","2026-06-08",{"date":95,"type":38},"2026-06-10",{"date":97,"type":38},"2025-01-28",{"date":99,"type":20},"2029-02",{"name":44,"class":45},{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":83,"sex":55,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":119,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":74},"100571349","mothers-and-caregivers-investing-in-children-study-20-100571349","NCT06719102","Mothers and CareGivers Investing in Children Study 2.0","Mothers and CareGivers Investing in Children: MAGIC 2.0","MAGIC 2","Inclusion Criteria:\n\n* A singleton infant 3-9 weeks of age, born ≥37 weeks gestation.\n* The mother and other caregiver must be at least 18 years of age.\n* The infant must live with the mother.\n* Lives within the Austin metropolitan area.\n* English or Spanish speaking.\n* The primary caregiver must identify as the mother.\n\nExclusion Criteria:\n\n* Infant diagnosed with major physical disabilities and\u002For medical condition that affects feeding and growth, and\u002For born \\\u003C37 weeks gestation.\n* Infant experienced NICU stay \\>7 days.\n* Twins, triplets, or other multiples.\n* Mothers and\u002For other caregivers younger than 18 years old.\n* Mothers that do not consent to being video recorded with their baby.\n* Families that do not speak either English or Spanish will be excluded from this study. Families that only speak English or Spanish, or families that speak English or Spanish and another language, will be accepted.\n* Do not plan to remain in Austin area for the next two years.","0 Years","90 Years",{"count":112,"type":20},266,[23],"The study will use a longitudinal, randomized control trial design to determine intervention impact on parent and child behaviors, and infant health. The two intervention groups include: 1) MAGIC-FEED+; and 2) MAGIC-SAFE. This trial is an efficacy trial of the MAGIC-FEED and MAGIC-SAFE program that has been successfully implemented with families as part of the MAGIC 1.0 program trial (IRB#: 2015040017).\n\n* The primary aim is to investigate each intervention's impact on infant BMIZ at 13 months.\n* The investigators will also assess the effect of MAGIC-FEED on caregiver nutrition knowledge and feeding practices, responsive feeding, infant diet, and child self-regulatory abilities and assess how these factors impact child self-regulation of eating and adiposity.\n* Finally, the investigators will determine if the interventions demonstrate the factors necessary to be a successful intervention as determined by the RE-AIM and PRISM frameworks.",[116,117,118],"Childhood Obesity Prevention","Parenting Behavior","Infant Growth",[120,121,122,123,124],"Parenting","Infant Feeding","Infant Nutrition","Prevention","Trial",{"date":95,"type":38},{"date":127,"type":38},"2025-02-13",{"date":129,"type":20},"2029-12-31",{"name":44,"class":45},{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":83,"sex":55,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":21,"phases":140,"briefSummary":142,"conditions":143,"keywords":150,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":46},"100555412","early-phase-1-educational-support-group-program-for-bilingual-and-spanish-speaking-carepartners-and-people-with-progressive-aphasia-100555412","NCT06511752","Educational Support Group Program for Bilingual and Spanish-speaking Carepartners and People With Progressive Aphasia","Educational Support Group Program for Carepartners of Bilingual and Spanish-speaking Persons With Progressive Forms of Aphasia and for Persons With Progressive Forms of Aphasia","Inclusion Criteria:\n\nAll participants must:\n\n* speak Spanish and\u002For English (although participants may speak other languages in addition to Spanish and\u002For English)\n* identify as Hispanic and\u002For Latinx,\n* or their spouse\u002Ffamily member with PA identifies as Hispanic and\u002For Latinx\n* see and hear well enough to participate\n* have access to a computer or mobile device with video capability\n* have an internet connection\n\nAdditional inclusion criteria for PA\u002F language-led dementia support group participants:\n\n* Individuals with PA:\n* Has a diagnosis of PA, or language-led dementia, and aphasia is one of the primary causes of difficulty with activities of daily living\n* Aware of language difficulties and willing to discuss them\n* Able to actively engage in group discussion and complete activities with minimal support\n* Able to regularly attend meetings\n* Willing to follow the rules of the support group for interacting with others respectfully\n\nAdditional inclusion criteria for care partner support group plus implementation phase participants:\n\n* Individuals with PA:\n* Diagnosis of aphasia or dementia that is progressive in nature, and aphasia is one of the primary causes of difficulty with activities of daily living\n* Have some ability to communicate and understand communication in order to participate in training sessions\n* Are functionally able to engage in training sessions (e.g., able to maintain some attention, minimal challenging behavior that would cause disruption)\n* Have a care partner who also consents to participating in the project\n* Care partners:\n* Self-identification as a caregiver of an individual with a diagnosis of PA or language-led dementia\n* Willing to discuss caregiving for individuals with PA\u002F language-led dementia\n* Able to regularly attend meetings\n* Willing to follow the rules of the support group for interacting with others respectfully\n\nExclusion Criteria:\n\n• Beyond the inclusion criteria included above, no additional exclusion criteria apply",{"count":139,"type":20},120,[141],"EARLY_PHASE1","The current study aims to examine the benefits of an education\u002Fsupport group program for individuals with progressive aphasia (caused by various etiologies, diagnoses) and their carepartners. The current study utilizes pre-, post-treatment, and follow-up assessments to measure effects of a psychoeducational support group and an implementation\u002Fcommunication skills training phase on measures of psychosocial function, communicative effectiveness and speech\u002Flanguage function. Analysis of study-specific surveys and semi-structured interviews will provide qualitative data regarding outcomes. Before beginning the education and support group, focus groups will be run in order to set priorities for the themes to be included in the education program. Participants will join via tele-based means if preferred and these participants may reside in the United States, or internationally including Mexico and Spain.",[144,145,146,147,148,149],"Alzheimer Disease","Dementia","Primary Progressive Aphasia","Aphasia","Progressive Aphasia","Progressive Aphasia in Alzheimer's Disease",[151,152,153,154,155],"bilingual","Spanish","Castellano","multicultural","multilingual",{"date":95,"type":38},{"date":158,"type":38},"2024-05-21",{"date":160,"type":20},"2030-12",{"name":44,"class":45},{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":21,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":46},"100522645","cancer-pain-management-using-a-web-based-intervention-100522645","NCT06085313","Cancer Pain Management Using a Web-based Intervention","Cancer Pain Management: A Technology-Based Intervention for Asian American Breast Cancer Survivors","CAI","Inclusion Criteria:\n\n* women aged 18 years and older who identify as Chinese, Korean, or Japanese;\n* have had a breast cancer diagnosis in the past;\n* can read and write English, Mandarin (simplified or traditional), Korean, or Japanese;\n* have access to the internet through computers or mobile devices (mobile phones and tablets);\n* have experienced cancer pain during the past week (at least 1 on a scale from 0 to 5 \\[no symptom=0, mild symptom that does not bother=1, somewhat bothering symptom=2, moderate symptom=3, severe symptom=4, and worst possible symptom=5\\]);\n* have experienced depressive symptoms during the past two weeks (1 to 10 on the Patient Health Questionnaire) which is equivalent to the cut-point of minimal to moderate depression.\n\nExclusion Criteria:\n\n* less than 18 years old because their cancer experience would be different from that of adults.\n* Those who are in treatment or not in treatment, but who were diagnosed with breast cancer within the past five years, will be excluded.\n* Those who participated in the PI's pilot studies will be excluded.\n* The participants of R33 phase will exclude those in active depression treatment regardless of their level of depression.\n* Those without Internet access will be excluded, but those with Internet access through community\u002Fgroup computers will be included.",{"count":171,"type":20},300,[23],"This study is funded by the HEAL Initiative (https:\u002F\u002Fheal.nih.gov\u002F). Based on Preliminary Studies (PSs), the research team developed and pilot-tested an evidence-based Web App-based information and coaching\u002Fsupport program for cancer pain management (CAPA) that was culturally tailored to Asian American breast cancer survivors using multiple unique features. However, CAPA rarely considered depressive symptoms accompanying pain in its design or components, and PSs indicated the necessity of further individualization of the intervention components of CAPA due to diversities in the needs of ABD. The purpose of the proposed 2-phase study is to further develop CAPA with additional components for ABD and the individual optimization functionality (CAI) and to test the efficacy of CAI in improving cancer pain experience of ABD. The specific aims are to: a) develop and evaluate CAI through an expert review and a usability test (R61 phase); b) determine whether the intervention group (that uses CAI and usual care) will show significantly greater improvements than the active control group (that uses CAPA and usual care) in primary outcomes (cancer pain management and cancer pain experience including depressive symptoms) from baseline to post 1-month and post 3-months; c) identify theory-based variables (attitudes, self-efficacy, perceived barriers, and social influences) that mediate the intervention effects of CAI on the primary outcomes; and d) determine whether the effects of CAI on the primary outcomes are moderated by selected background, disease, genetic, and situational factors. This study is guided by the Bandura's Theory and the stress and coping framework by Lazarus and Folkman. The R61 phase includes: (a) the intervention development process, (b) a usability test among 15 ABD, 15 family members, and 15 community gatekeepers; and (c) an expert review among 10 experts in oncology. The R33 phase adopts a randomized repeated measures control group design among 300 ABD. Long-term goals are: (a) to extend and test CAI in various healthcare settings with diverse subgroups of ABD, (b) examine the costeffectiveness, sustainability, and scalability of CAI in the settings, and (c) translate CAI into health care for ABD.",[175,176,177],"Cancer of Breast","Depressive Symptoms","Cancer Pain","2026-06-06",{"date":66,"type":38},{"date":181,"type":38},"2024-02-20",{"date":183,"type":20},"2027-08-31",{"name":44,"class":45},{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":83,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":46},"100469112","domestic-violence-enhanced-perinatal-care-program-in-china-100469112","NCT05388565","Domestic Violence Enhanced Perinatal Care Program in China","Testing the Domestic Violence Enhanced Perinatal Care in China","Inclusion Criteria:\n\n* Being in early pregnancy (less than 13 weeks gestation) and screened positive for IPV in the year before pregnancy or during the current pregnancy.\n\nExclusion Criteria:\n\n* Women who are not able to read and understand Chinese.",{"count":193,"type":20},100,[23],"The proposed project addresses intimate partner violence (IPV) against pregnant women, which is a serious social and health issue. Pregnant women represent a particularly vulnerable population of IPV survivors in China, who have been largely underserved. There have been no interventions developed in China to prevent maternal IPV and its effects on maternal and infant health. The proposed project is the first structured IPV intervention integrated into prenatal care in China, which may have the potential to be translated into more prenatal clinics in China to prevent violence against pregnant women and improve maternal and infant health.",[197],"Intimate Partner Violence",{"date":66,"type":38},{"date":200,"type":38},"2023-02-25",{"date":202,"type":20},"2026-10-30",{"name":44,"class":45},{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":83,"sex":16,"minAge":84,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":214,"briefSummary":215,"conditions":216,"keywords":219,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":74},"100629856","increased-dietary-protein-intake-during-glp-1-medication-use-in-middle-aged-women-with-overweightobesity-100629856","NCT07480109","Increased Dietary Protein Intake During GLP-1 Medication Use (in Middle-aged Women With Overweight\u002FObesity)","The 'Power of Pork Protein' (From Diverse Pork Products) to Promote Health and Well-being During GLP-1 Medication Use in Middle-aged Women (With Overweight\u002FObesity)","Inclusion Criteria:\n\n* Adult women (30-60 years)\n* Having overweight or obesity (BMI \\>25 kg\u002Fm2)\n* Prescribed or taking GLP-1 medicine (within 4 weeks) by a physician\n* Willing and able to maintain current inactivity patterns throughout the study\n* Willing and able to follow all study procedures\n* Generally healthy, as assessed from the medical history questionnaire\n\nExclusion Criteria:\n\n* Adults (\\\u003C30 years or \\>60 years)\n* Having normal weight (BMI \\\u003C25 kg\u002Fm2)\n* Not prescribed GLP-1 medication by a physician\n* Those on GLP-1 medication longer than 4 weeks (during time of screening)\n* Currently on a high-protein or other specific diet\n* Unwilling and\u002For unable to maintain current inactivity patterns throughout the study\n* Unwilling and\u002For unable to follow all study procedures\n* Unwilling and\u002For unable to eat pork (for the GLP-1 + Protein group)\n* Not generally healthy, as assessed from the medical history questionnaire","60 Years",{"count":213,"type":20},75,[23],"Middle-aged women with (overweight\u002F)obesity who will begin or have begun GLP-1 medication use will be recruited to complete a 12-week diet intervention study. For 12-weeks, participants will continue to take their GLP-1 medication and may be provided with protein-rich foods to consume every day. Body composition, eating behavior, health, and well-being will be measured before and after the study.",[217,218],"Obesity","Women (Between 30 to 60 Years Old)",[220,217,221,222,223,224,225,226,227,228,229,230],"GLP-1 Medication","Increased Dietary Protein","Pork","satiety","D3 Creatine","breakfast","weight loss","sleep quality","muscle mass","eating behaviors","food noise","2026-06-05",{"date":66,"type":38},{"date":234,"type":38},"2026-06-01",{"date":236,"type":20},"2027-09-30",{"name":44,"class":45},{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":83,"sex":55,"minAge":17,"maxAge":110,"enrollmentInfo":245,"targetDuration":4,"studyType":21,"phases":246,"briefSummary":247,"conditions":248,"keywords":250,"overallStatus":258,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":46},"100626860","enhancing-attention-in-elderly-using-a-brain-computer-interface-100626860","NCT07441122","Enhancing Attention in Elderly Using a Brain-Computer-Interface","Building Cognitive Reserve Through Brain-Computer-Interfaces","Inclusion Criteria:\n\nYounger adults:\n\n* Good general health.\n* Normal or corrected vision.\n* no history of neurological\u002Fpsychiatric disease\n* ability to read and understand English\n* ability to understand information and ability to give a free and informed consent\n\nOlder adults:\n\n* Normal or corrected vision.\n* Self-reports no current diagnosis of dementia.\n* Ability to provide written\u002Felectronic, informed consent.\n\nExclusion Criteria:\n\nYounger Adults:\n\n* Neurological or psychiatric diseases that could be contraindicated for tACS (e.g., personal history of epilepsy\u002Fseizure brain damage, history of fainting, bipolar disorder, schizophrenia, current substance use disorder, etc.).\n* Medications that elevate seizure threshold (e.g., stimulant medication, high dose bupropion).\n* Factors hindering EEG acquisition and tACS delivery (e.g., skin infection, wounds, dermatitis, inability to access the scalp of the participant).\n\nOlder Adults:\n\n* Neurological or psychiatric diseases that could be contraindicated for tACS (e.g., personal history of epilepsy\u002Fseizure brain damage, pacemakers, history of fainting, bipolar disorder, schizophrenia, current substance use disorder, etc.).\n* Medications that elevate seizure threshold (e.g., stimulant medication, high dose bupropion).\n* Factors hindering EEG acquisition and tACS delivery (e.g., skin infection, wounds, dermatitis, inability to access the scalp of the participant).\n* Diagnosis of dementia.\n* Do not have the capacity to provide informed consent.",{"count":193,"type":20},[23],"Cognitive reserve refers to the brain's ability to maintain cognitive performance despite age-related changes or neuropathology. Enhancing cognitive reserve is thought to delay cognitive decline and improve functional outcomes in aging and neurodegenerative conditions. Attention and memory-related neural processes are considered key contributors to cognitive reserve, yet it remains unclear whether these neural markers can be deliberately strengthened through targeted training and non-invasive interventions.\n\nThe goal of this clinical study is to investigate whether mindfulness-based meditation and non-invasive brain stimulation can enhance neural markers of attention and memory that serve as proxies for cognitive reserve in cognitively healthy adults and older adults diagnosed with mild cognitive impairment (MCI). Investigators hypothesize that strengthening these neural markers will lead to measurable improvements in cognitive reserve-related functions in both healthy aging and MCI populations.\n\nThis study further hypothesizes that neural markers of attention can be selectively enhanced using an electroencephalography (EEG)-based brain-computer interface (BCI) combined with non-invasive interventions such as mindfulness-based relaxation or neuromodulation. During the study, participants will perform a computerized memory task while their EEG signals are recorded in real time. A BCI will analyze these signals to decode the presence or absence of the P300 event-related potential, a well-established neural marker of attentional control and cognitive resource allocation. Real-time feedback and intervention will be used to modulate these neural processes with the goal of promoting adaptive changes in attention-related brain activity.\n\nBy integrating EEG-based decoding, behavioral training, and non-invasive interventions, this study aims to determine whether targeted modulation of attention-related neural activity can support cognitive reserve in aging and mild cognitive impairment.",[249],"Mild Cognitive Impairment (MCI)",[251,252,253,254,255,256,257],"MCI","Memory","Cognitive Decline","Older Adults","Memory Impairment","Cognitive Control","Attention","NOT_YET_RECRUITING",{"date":66,"type":38},{"date":261,"type":20},"2026-09-01",{"date":263,"type":20},"2029-02-01",{"name":44,"class":45},{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":55,"minAge":17,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":21,"phases":275,"briefSummary":276,"conditions":277,"keywords":280,"overallStatus":258,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":289,"leadSponsor":291,"locationsCount":4},"100638091","original-medical-notes-versus-ai-plain-language-summaries-100638091","NCT07602725","Original Medical Notes Versus AI Plain-Language Summaries","Patient Experience and Trust When Viewing Original Medical Notes Versus Large Language Model (LLM)-Generated Plain Language Summaries","Inclusion Criteria:\n\n* Adult (18-89)\n* Seeking outpatient musculoskeletal specialty care\n* English language literacy\n* Return patient to the clinic\n\nExclusion criteria:\n\n\\- Any impairment precluding completion of a survey on a tablet","89 Years",{"count":274,"type":20},135,[23],"The goal of this clinical trial is to learn how patients feel when reading their medical notes. The study compares reading the original doctor's note with reading a simpler, Artificial Intelligence (AI)-generated version written in plain language in adults receiving musculoskeletal specialty care.\n\nThe main questions the study aims to answer are:\n\n1. Does reading a plain-language summary change how patients feel about their doctor or their clinic experience?\n2. Does the type of note affect how comfortable, reassured, or worried patients feel?\n\nResearchers will compare patients who read their original clinic note with patients who read an Artificial Intelligence (AI)-generated plain-language summary to see whether simpler language changes patient understanding, trust, or emotional responses.\n\nParticipants will:\n\n* Read either their original clinic note or a plain-language summary of the note\n* Complete short questionnaires about their experience, emotions, and trust in their clinician\n* Optionally provide written comments about how it felt to read the information",[278,279],"Musculoskeletal Disease","Orthopedic Patients",[281,282,283,284],"Artificial intelligence","Musculoskeletal Care","Patient experience","Medical documentation","2026-05-18",{"date":287,"type":38},"2026-05-22",{"date":234,"type":20},{"date":290,"type":20},"2027-02-01",{"name":44,"class":45},{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":83,"sex":55,"minAge":17,"maxAge":110,"enrollmentInfo":298,"targetDuration":4,"studyType":21,"phases":300,"briefSummary":301,"conditions":302,"keywords":304,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":46},"100508970","closed-loop-brain-stimulation-as-a-potential-intervention-for-cognitive-decline-100508970","NCT05907343","Closed-Loop Brain Stimulation as a Potential Intervention for Cognitive Decline","Inclusion Criteria:\n\n* Cognitively normal younger adults\n\n  1. Ages between 18 to 35 years\n  2. Good general health\n  3. Normal or corrected vision\n  4. Completed elementary school education or able to understand middle school level experiment instructions\n* Cognitively normal older adults\n\n  1. Ages between 60 to 90 years\n  2. Good general health\n  3. Normal or corrected vision\n  4. Completed elementary school education or able to understand middle school level experiment instructions\n  5. Score of 23 or higher on the Montreal Cognitive Assessment, a brief formal cognitive screening test, which is used to indicate absence of cognitive impairment\n* Older adults with mild cognitive impairment (MCI)\n\n  1. Ages between 60 to 90 years\n  2. Diagnosis of MCI according to the National Institute on Aging - Alzheimer's Association (NIA-AA) criteria\n  3. Good general health\n  4. Normal or corrected vision\n  5. Completed elementary school education or able to understand middle school level experiment instructions\n\nExclusion Criteria:\n\n1. Neurological or psychiatric diseases (e.g., personal history of epilepsy\u002Fseizure brain damage, multiple sclerosis, schizophrenia, substance use disorder, etc.).\n2. Current use of psychotropic medications with cognitive side effects (e.g., benzodiazepines, anticonvulsants, antipsychotics, etc.)\n3. Current use of cognitive enhancing medications (e.g., Adderall, Memantine, etc.)\n4. Factors hindering EEG acquisition and TMS delivery (e.g., skin infection, wounds, dermatitis, etc.)\n5. Factors hindering MRI acquisition (e.g., implants, metallic tattoos, etc.)",{"count":299,"type":20},180,[23],"The goal of this clinical study is to investigate the effectiveness of non-invasive stimulation to enhance cognitive control abilities in cognitively healthy adults and older adults diagnosed with mild cognitive disorder (MCI). The main questions it aims to answer are:\n\n* whether it is possible to restore various cognitive functions in older adults diagnosed with MCI by delivering theta burst stimulation (TBS), a form of transcranial magnetic stimulation, and\n* whether closed-loop TBS is able to induce therapeutic benefits that outperform open-loop TBS.\n\nParticipants play a cognitive video game while a brain-computer interface (BCI) analyzes their electroencephalogram (EEG) signals and decodes the presence or absence of the contingent negative variation (CNV) potential, a marker of cognitive control. The BCI triggers TBS when its outputs indicate that the participant is not engaged properly in the video game.\n\nResearchers will compare the effects of sham, closed-loop, and open-loop TBS using the outcome metrics described below to see how much cognitive restorations is achievable with each stimulation modality.",[303],"Mild Cognitive Impairment",[251,305,306,307],"Older adults","Cognitive control","Memory impairment","2026-04-28",{"date":310,"type":38},"2026-04-29",{"date":312,"type":38},"2023-05-31",{"date":314,"type":20},"2027-10-31",{"name":44,"class":45},{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":55,"minAge":17,"maxAge":85,"enrollmentInfo":324,"targetDuration":4,"studyType":21,"phases":325,"briefSummary":326,"conditions":327,"keywords":333,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":46},"100523519","psychotherapy-effects-on-reward-processing-in-ptsd-100523519","NCT06096740","Psychotherapy Effects on Reward Processing in PTSD","The Effects of Trauma-focused Psychotherapy on Reward Circuitry Function and Information Encoding","PERPP","Inclusion Criteria:\n\n* English as primary language, and comprehension suitable to understand experimenter instructions.\n* Current and chronic syndromic PTSD, defined as being exposed to a DSM-5 Criterion A traumatic event, with the presence DSM-5 qualifying PTSD symptoms for at least 3 months, as assessed by the Clinician-Administered PTSD Scale for DSM-5.\n* Able and willing to undergo functional magnetic resonance imaging (fMRI).\n* Willingness to participate in repeated assessments and as part of a delayed treatment group.\n\nExclusion Criteria:\n\n* Evidence of current or prior history of psychosis or bipolar disorder as evidenced by self-report or clinical interview.\n* Active substance dependence within the past 6 months as evidenced by clinical interview.\n* Current regular psychiatric medication use (i.e. antidepressants), except for as-needed benzodiazepine or opiate medication no more than three times per week, on average, or for short-duration stimulant medication for attention deficit hyperactivity disorder that can be skipped within 24 hours of study visits.\n* A recent (\\\u003C6 months) suicide attempt or current active ideation with intent.\n* Unremovable ferrous metal in body.\n* History of neurological disorder, stroke, seizures\u002Fconvulsions (except febrile seizures in childhood), epilepsy, brain surgery, electroconvulsive or radiation treatment, brain hemorrhage or tumor, or thyroid disorder.\n* Anyone who is pregnant or trying to become pregnant.\n* Current or past year (\\> 3 sessions), psychotherapy with a prominent exposure or cognitive restructuring component.\n* Previous or current (es)ketamine treatment and\u002F or brain stimulation\u002Fneuromodulation treatment.\n* Other ongoing treatment that is likely to confound experimental effects.\n* Previous penetrating head injury\u002Ftraumatic brain injury. Mild-to-moderate traumatic brain injury without penetrating injury is allowable.",{"count":139,"type":20},[23],"The purpose of this study is to identify how trauma-focused psychotherapy changes the function of brain circuitry in posttraumatic stress disorder (PTSD) and how this mediates improvements in the diminished ability to experience positive emotions following a traumatic or extremely stressful life event. In this instance, the investigators will be using cognitive processing therapy (CPT), a widely-utilized and evidence-based treatment for PTSD.",[328,329,330,29,331,332],"Post Traumatic Stress Disorder","Diminished Pleasure","Anhedonia","Chronic PTSD","Chronic Post-Traumatic Stress Disorder",[29,334,335,336,337,338,331],"Post Traumatic Stress","Emotional Numbing","CPT","Cognitive Processing Therapy","Therapy","2026-04-27",{"date":341,"type":38},"2026-05-01",{"date":343,"type":38},"2024-06-01",{"date":345,"type":20},"2029-05-01",{"name":44,"class":45},{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":55,"minAge":17,"maxAge":85,"enrollmentInfo":355,"targetDuration":4,"studyType":21,"phases":357,"briefSummary":359,"conditions":360,"keywords":363,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":373,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":46},"100507850","phase-4-establishing-multimodal-brain-biomarkers-for-treatment-selection-in-depression-100507850","NCT05892744","Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression","Establishing Multimodal Brain Biomarkers Using Data-driven Analytics for Treatment Selection in Depression","Re-EMBARC","Inclusion Criteria:\n\n* English as primary language, and comprehension suitable to understand experimenter instructions\n* Meet criteria for a current major depressive episode diagnosed through the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) (SCID-5)\n* Meet criteria for early onset (prior to age 30) of depression and either: a) current major depressive episode lasts for \\> 2 years; or b) participant meets criteria for recurrent major depression as evidenced by 2 or more major depressive episodes (including current episode) in their lifetime. These criteria will be assessed by the SCID-5.\n* Have a Quick Inventory of Depression Symptomology Self-Report Measures (QIDS) score \\> 14 at baseline and the week prior to first Sertraline administration\n* Willing and able to undergo MRI and EEG procedures.\n\nExclusion Criteria:\n\n* Non-early onset (i.e., after age 30), non-chronic (current episode lasting less than 2 years or only one lifetime major depressive episode, including current episode) qualifying Major Depressive Disorder\n* Must not have failed to respond to any prior antidepressant treatment in the current episode of sufficient duration and dose as defined by the Massachusetts General Hospital (MGH) Antidepressant Treatment Response Questionnaire\n* Currently pregnant, planning to become pregnant, or breastfeeding\n* Evidence of current or prior history of psychosis or bipolar disorder as evidenced by self-report or clinical interview\n* Meeting DSM-5 criteria for a substance-use disorder of moderate or greater severity in the past 6 months\n* Unstable psychiatric or medical conditions that may require hospitalizations or contraindicate study medication (i.e. autism spectrum disorder, schizophrenia, cancer, congestive heart failure, etc.)\n* Contraindications to MRI including, but not limited to, history of stroke, brain tumors, brain hemorrhages, internal wires, electrodes, pacemakers, implants, irremovable ferromagnetic objects in head that are unsafe for MRI and\u002For cause large distortions in imaging data, etc.\n* History of epilepsy, moderate or severe traumatic brain injury, penetrating head injury, brain surgery, brain tumors, or any condition requiring an anticonvulsant\n* Treatment with electroconvulsive therapy, vagus nerve stimulation, or transcranial magnetic stimulation during the current depressive episode\n* Concomitant medication use that are likely to interfere or obscure effects from the study medication, including but not limited to antipsychotics and mood stabilizers\n* Current regular depression-specific evidence-based psychotherapy treatment\n* Considered by the investigative team to be a significant suicide risk as evidence by self-report or clinical interview",{"count":356,"type":20},50,[358],"PHASE4","The purpose of the study is to identify brain biomarkers and characteristics that predict individual responses to treatment of major depression with the antidepressant drug sertraline (tradename Zoloft), a common selective serotonin reuptake inhibitor (SSRI) antidepressant. Our central hypothesis is that brain activity and connections jointly measured with functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) will be able to predict an individual's response to sertraline treatment.",[361,362],"Major Depressive Disorder","Chronic Major Depression, Recurrent",[364,365,366,367,368,369,370,371,372],"Depression","Chronic Depression","Major Depression","Recurrent Depression","antidepressant","sertraline","fMRI","EEG","biomarker",{"date":341,"type":38},{"date":375,"type":38},"2023-09-30",{"date":377,"type":20},"2027-07-15",{"name":44,"class":45},{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":83,"sex":55,"minAge":17,"maxAge":386,"enrollmentInfo":387,"targetDuration":4,"studyType":21,"phases":388,"briefSummary":389,"conditions":390,"keywords":400,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":46},"100453331","non-invasive-bci-controlled-assistive-devices-100453331","NCT05183152","Non-invasive BCI-controlled Assistive Devices","Non-invasive Brain-computer Interfaces for Control of Assistive Devices","Inclusion Criteria:\n\n1. Able-bodied participants:\n\n   * good general health\n   * normal or corrected vision\n   * no history of neurological\u002Fpsychiatric disease\n   * ability to read and understand English (Research Personnel do not speak Spanish)\n2. Subjects with motor disabilities\n\n   * motor deficits due to: unilateral and bilateral stroke \u002F spinal cord injury \u002F motor neuron diseases (i.e. amyotrophic lateral sclerosis, spino-cerebellar ataxia, multiple sclerosis) \u002F muscular diseases (i.e. myopathy) \u002F traumatic or neurological pain \u002F movement disorders (i.e. cerebral palsy) \u002F orthopedic \u002F traumatic brain injury \u002F brain tumors\n   * normal or corrected vision\n   * ability to read and understand English\n   * ability to provide informed consent\n\nExclusion Criteria:\n\n1. Subjects with motor disabilities\n\n   * short attentional spans or cognitive deficits that prevent the subject from concentrating during the whole experimental session\n   * heavy medication affecting the central nervous system (including vigilance)\n   * concomitant serious illness (e.g., metabolic disorders)\n2. All participants\n\n   * factors hindering EEG\u002FEMG acquisition and the delivery of non-invasive electrical stimulation (e.g., skin infection, wounds, dermatitis, metal implants under electrodes)\n   * criteria identified in safety guidelines for MRI and TMS, in particular metallic implants","80 Years",{"count":193,"type":20},[23],"Injuries affecting the central nervous system may disrupt the cortical pathways to muscles causing loss of motor control. Nevertheless, the brain still exhibits sensorimotor rhythms (SMRs) during movement intents or motor imagery (MI), which is the mental rehearsal of the kinesthetics of a movement without actually performing it. Brain-computer interfaces (BCIs) can decode SMRs to control assistive devices and promote functional recovery. Despite rapid advancements in non-invasive BCI systems based on EEG, two persistent challenges remain: First, the instability of SMR patterns due to the non-stationarity of neural signals, which may significantly degrade BCI performance over days and hamper the effectiveness of BCI-based rehabilitation. Second, differentiating MI patterns corresponding to fine hand movements of the same limb is still difficult due to the low spatial resolution of EEG. To address the first challenge, subjects usually learn to elicit reliable SMR and improve BCI control through longitudinal training, so a fundamental question is how to accelerate subject training building upon the SMR neurophysiology. In this study, the investigators hypothesize that conditioning the brain with transcutaneous electrical spinal stimulation, which reportedly induces cortical inhibition, would constrain the neural dynamics and promote focal and strong SMR modulations in subsequent MI-based BCI training sessions - leading to accelerated BCI training. To address the second challenge, the investigators hypothesize that neuromuscular electrical stimulation (NMES) applied contingent to the voluntary activation of the primary motor cortex through MI can help differentiate patterns of activity associated with different hand movements of the same limb by consistently recruiting the separate neural pathways associated with each of the movements within a closed-loop BCI setup. The investigators study the neuroplastic changes associated with training with the two stimulation modalities.",[391,392,393,394,395,396,397,398,399],"Motor Disorders","Healthy","Spinal Cord Injuries","Muscular Diseases","Motor Neuron Disease","Stroke","Traumatic Brain Injury","Movement Disorders","Multiple Sclerosis",[401,402,403,404,405,406,407,408],"motor deficits","able-bodied, healthy","unilateral and bilateral stroke","spinal cord injury","motor neuron diseases","muscular diseases (i.e. myopathy)","traumatic or neurological pain","movement disorders",{"date":341,"type":38},{"date":411,"type":38},"2021-06-16",{"date":413,"type":20},"2028-12-30",{"name":44,"class":45},{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":83,"sex":55,"minAge":17,"maxAge":421,"enrollmentInfo":422,"targetDuration":4,"studyType":21,"phases":424,"briefSummary":425,"conditions":426,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":434,"locationsCount":46},"100635053","usability-of-the-regen-gait-therapy-robot-in-healthy-adults-100635053","NCT07547683","Usability of the Regen Gait Therapy Robot in Healthy Adults","Inclusion Criteria:\n\n1. Healthy study participants: adults (18-50 years) who can walk independently on a treadmill for at least 6 minutes\n2. Physical therapist (PT) with a license and experience in gait rehab (self-reported)\n\nExclusion Criteria:\n\n(1) For healthy study participants:\n\n1. Any neurological or orthopedic condition that can affect walking (Self-reported)\n2. Uncontrolled cardiovascular or metabolic condition that can affect walking (Self-reported)\n3. Current lower-limb pain or discomfort\n4. Lower-limb surgery within the past six months\n5. On medications that may impair balance (Self-reported)\n6. Open wound in the lower limb\n\n(2) For PT:\n\n1. Not having license\n2. No experience in gait rehab","50 Years",{"count":423,"type":20},10,[23],"Regen is a robot-assisted device designed to help therapists and improve the quality of treatment. It works by replicating the movement of the therapist and providing assistance as needed for the patient. This study aims to assess the safety, feasibility, usability, and ability to Regen to replicate the movement pattern of therapist in young healthy adults during treadmill walking.",[427],"Healthy Adult Participants","2026-04-16",{"date":430,"type":38},"2026-04-23",{"date":432,"type":20},"2026-03-26",{"date":234,"type":20},{"name":44,"class":45},{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":21,"phases":445,"briefSummary":446,"conditions":447,"keywords":452,"overallStatus":258,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":46},"100634055","phase-4-suzetrigine-for-opioid-free-recovery-after-cesarean-delivery-100634055","NCT07534709","Suzetrigine for Opioid-Free Recovery After Cesarean Delivery","Suzetrigine Versus Placebo for Opioid-Free Recovery After Cesarean Delivery: A Randomized Controlled Trial","SPARE","Inclusion Criteria:\n\n* Women aged ≥18 years.\n* Undergoing scheduled or unscheduled cesarean delivery during the current admission, with or without concomitant salpingectomy.\n* Planned delivery under neuraxial anesthesia (spinal, epidural, or combined spinal-epidural).\n* Planned Pfannenstiel skin incision.\n* Able to provide informed consent in English or Spanish.\n* Willing and able to complete required remote follow-up assessments through postoperative day 14 (POD14).\n\nExclusion Criteria:\n\n* Planned provision of breast milk to the neonate during the period of suzetrigine exposure (while the study drug is being taken and for 96 hours after last dose), due to the absence of human lactation safety data for suzetrigine.\\*\n* Known allergy, hypersensitivity, or contraindication to suzetrigine or any component of its formulation.\n* Chronic opioid use, defined as daily opioid use for more than 7 consecutive days in the month prior to delivery, or current treatment for opioid use disorder.\n* Significant hepatic disease, defined as AST or ALT \\>3 times the upper limit of normal or Child-Pugh class B or C.\n* Severe renal impairment, defined as estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin.\n* Concurrent use of medications known to significantly alter suzetrigine metabolism, including strong CYP3A inhibitors or inducers, such as:\n\n  * ketoconazole\n  * ritonavir\n  * carbamazepine\n  * rifampin\n  * St. John's wort (or other agents deemed clinically significant CYP3A modulators by the study investigator team)\n* Planned cesarean delivery under general anesthesia without neuraxial anesthesia.\n* Planned non-Pfannenstiel skin incision (e.g., vertical midline incision).\n* Participation in another interventional pain-management clinical trial during the current hospitalization.\n* Additional operative procedures (excluding salpingectomy) performed at the time of cesarean delivery (e.g., hysterectomy, hernia repair).\n* Inability to provide informed consent or to complete required study procedures and follow-up.\n* Receipt of opioid or sedating medications prior to completion of the informed consent process.\n\n  * Feeding decisions are made independently of study participation. The study does not require participants to alter infant feeding plans; eligibility is determined solely by whether breast milk will be provided to the neonate during the period of study drug exposure (while the study drug is being taken and for 96 hours after last dose). Participants who plan to breastfeed but independently elect not to provide breast milk to the neonate during the period of suzetrigine exposure are eligible.",{"count":444,"type":20},90,[358],"The goal of this clinical trial is to determine whether suzetrigine increases the proportion of patients who remain completely opioid-free from completion of surgery through 72 hours after cesarean delivery.\n\nThe main question it aims to answer is:\n\nDoes adjunctive suzetrigine, when added to a standardized multimodal postoperative analgesic regimen, increase the proportion of patients who remain opioid-free during the first 72 hours after cesarean delivery?\n\nResearchers will compare suzetrigine to a placebo (a look-alike substance that contains no drug) to evaluate this outcome.\n\nParticipants will:\n\n* Receive either suzetrigine or placebo after cesarean delivery\n* Receive standard postoperative pain management, including acetaminophen, nonsteroidal anti-inflammatory drugs, and neuraxial morphine\n* Have opioid medications available as needed for breakthrough pain\n* Be followed during hospitalization and after discharge to assess pain, recovery, and medication use",[448,449,450,451],"Cesarean Delivery","Cesarean Section","Pain, Postoperative","Opioid Consumption, Postoperative",[453,448,454,455,456,457,458,459,460],"suzetrigine","cesarean section","postoperative pain","opioid-free recovery","opioid-sparing","multimodal analgesia","postpartum opioid use","NaV1.8 Inhibitor","2026-04-14",{"date":428,"type":38},{"date":464,"type":20},"2026-06",{"date":466,"type":20},"2028-05",{"name":44,"class":45},{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":55,"minAge":17,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":21,"phases":477,"briefSummary":478,"conditions":479,"keywords":482,"overallStatus":258,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":489,"leadSponsor":491,"locationsCount":4},"100617485","development-of-menu-protocol-100617485","NCT07319234","Development of MENU Protocol","MENU: A Novel Family-Driven Approach to Support Families Awaiting Autism Diagnostic Evaluation","MENU","Inclusion Criteria:\n\n* Caregivers of young children between the ages of 2 and 5 years who were referred for autism diagnostic evaluation but have not yet been received services\n* Caregivers from underserved populations, including families from racial and ethnic minority backgrounds (e.g., Latino and Black communities), rural communities, immigrant families, and Medicaid-eligible families in Texas\n* Caregivers aged 18 years or older\n\nExclusion Criteria:\n\n* Caregivers of children who have no concerns related to autism spectrum disorder\n* Caregivers who are unable to provide informed consent",{"count":5,"type":20},[23],"The overarching goal of this project is to reduce autism-related health disparities. The investigators will develop and pilot MENU, a culturally responsive and caregiver-driven intervention specifically designed to support underserved families of young autistic children during the diagnostic wait period. MENU will equip underserved caregivers with flexible, evidence-based strategies to improve parent mental health, child social communication, and challenging behaviors. The intervention consists of modular content drawn from three well-established practices targeting core characteristics of autism: Acceptance and Commitment Therapy for caregiver mental health and well-being, Enhanced Milieu Teaching for child social communication, and RUBI Parent Training for managing a child's challenging behaviors.\n\nIn this model, caregivers collaborate with the research team to select and sequence modules based on individual needs, preferences, and priorities, making MENU highly personalized, family-centered, and accessible. Families will engage with MENU modules over approximately 12 weeks, with duration varying based on individual goals and pacing. The project utilizes a explanatory, sequential mixed methods design, an approach that examines preliminary effectiveness and gathers detailed information on contextual factors relevant to future scale-up and sustainability within public systems of care in Texas, including Part C Early Intervention programs. Up to 50 underserved families representing diverse racial, ethnic, and linguistic backgrounds will be recruited in strategic partnership with trusted community organizations throughout Texas. To maximize accessibility and reduce barriers associated with the digital divide, the project will provide iPads and cellular data plans to families lacking adequate Internet access or devices. Following comprehensive baseline assessments, including standardized measures and clinical interviews, caregivers will collaborate with the research team to select and tailor MENU modules aligned with individual goals and needs across the three evidence-based practices. Quantitative data will be collected at baseline, immediately post-intervention, and at 3-month follow-up using validated measures of parent mental health, child social communication, and challenging behaviors. Implementation outcomes (e.g., acceptability, feasibility, usability) will be assessed in partnership with community advisors, with regular reviews informing iterative refinements to maintain cultural and contextual relevance for Texas families. By pioneering scalable supports delivered before a formal autism diagnosis, MENU challenges conventional service timelines and introduces a new model of early autism care in Texas. The project will also generate actionable data to inform policy shifts, reimbursement pathways, and integration into early childhood systems, contributing to reductions in health and educational disparities among autistic children and their families.",[480,481],"Autism","Mental Health",[65,483,484],"mental health","diagnostic evaluation waitlist","2026-04-11",{"date":487,"type":38},"2026-04-15",{"date":341,"type":20},{"date":490,"type":20},"2027-10-01",{"name":44,"class":45},{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":498,"eligibilityCriteria":499,"healthyVolunteers":83,"sex":55,"minAge":500,"maxAge":211,"enrollmentInfo":501,"targetDuration":4,"studyType":21,"phases":503,"briefSummary":504,"conditions":505,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":46},"100516293","approach-avoidance-and-alcohol-challenge-study-in-ptsd-100516293","NCT06002633","Approach-Avoidance and Alcohol Challenge Study in PTSD","Alcohol, Approach-Avoidance, and Neurocircuitry Interactions in PTSD","PACS","1. Inclusion criteria for all participants:\n\n   * between 21 and 60 years of age\n   * having consumed at least 4 (men) or 3 (women) drinks on at least two occasions over the last year\n2. Inclusion criteria for PTSD participants:\n\n   \\- Meeting diagnostic criteria for PTSD, confirmed by structured interview\n3. For all subjects exclusion criteria include:\n\n   * history of significant medical illness, particularly if possible changes in cerebral tissue\n   * neurologic abnormality including significant head trauma (loss of consciousness of ≥5-min)\n   * full Scale IQ \\\u003C85\n   * contraindication to MRI scanning\n   * positive pregnancy test\n   * severe alcohol use disorder\n   * current severe cannabis use disorder\n   * any current substance use disorder (other than alcohol, cannabis, or nicotine)\n   * scores \\> 15 on the alcohol Use Disorders Identification Test (AUDIT; part of phone screen)\n   * ever being in an abstinence-oriented treatment program for alcohol use\n   * reporting wanting to quit drinking but not being able to\n   * any medical, religious, or other reasons for not drinking alcohol\n   * history of heart attack, heart trouble, high blood pressure, diabetes, or liver disease\n   * an adverse reaction to alcoholic beverages\n   * reporting never consuming 4 (men) or 3 (women) or more drinks on at least two occasions over the last year\n   * unwillingness to have a friend or family member drive them home after the alcohol administration sessions\n4. Additional exclusion criteria for participants in PTSD and IPV-exposed but no PTSD groups:\n\n   * not taking medications for \\>4 weeks (i.e. participants must be stable on meds)\n   * acute suicidality with intent\n5. Additional exclusion criteria for participants in IPV-exposure but no PTSD group:\n\n   \\- history of PTSD\n6. Additional exclusion criteria for healthy comparison subjects also include:\n\n   * any prior psychiatric hospitalizations\n   * lifetime history of a neurodevelopmental disorder, affective disorder, psychotic disorder, suicide attempt, or eating disorder\n   * greater than 1 month of lifetime psychotropic medication","21 Years",{"count":502,"type":20},200,[23],"Individuals with posttraumatic stress disorder (PTSD) have greater prevalence of alcohol use disorders (AUDs), with this comorbidity associated with worse illness outcomes, yet there remains limited mechanistic understanding of how PTSD confers risk for AUD. Understanding risk factors that associate with and predict the development of AUDs in PTSD could inform interventions and prevention efforts to reduce the rate of this comorbidity and improve outcomes of both disorders. Identifying predictors of risk requires longitudinal studies in PTSD aimed at capturing the mechanisms leading to the emergence of AUDs. There is growing evidence PTSD is related to biased decision-making during approach-avoidance conflict. Alcohol is also suggested to alter approach-avoidance decision-making. AUDs and acute alcohol intoxication is associated with a bias to seek out reward despite the possibility of threat (e.g., contributing to relapse following alcohol cue exposure and risky behavior during intoxication respectively). Alcohol-induced changes in approach-avoidance decision-making have not been investigated in the context of PTSD, but emerging data support the investigators' hypothesis that an interaction between alcohol and approach-avoidance conflict in PTSD may occur and contribute to risk for alcohol misuse and development of alcohol problems. No current data, cross-sectional or longitudinal, have tested the role of alcohol-induced changes in approach-avoidance conflict as a mechanism of risk for AUD among individuals with PTSD. To address this gap, the investigators propose to leverage the group's expertise in placebo-controlled alcohol administration procedures, longitudinal modeling, functional neuroimaging, and computational neuroscience approaches to investigate the effects of acute alcohol on approach-avoidance decision-making and mediating changes in multivariate neurocircuitry patterns in limbic, striatal, and salience networks.",[506,507],"Post-Traumatic Stress Disorder","Alcohol Drinking","2026-04-10",{"date":487,"type":38},{"date":511,"type":38},"2023-10-23",{"date":513,"type":20},"2028-05-31",{"name":44,"class":45},{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":55,"minAge":17,"maxAge":4,"enrollmentInfo":522,"targetDuration":56,"studyType":524,"phases":4,"briefSummary":525,"conditions":526,"keywords":528,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":46},"100628663","optimizing-non-statin-agents-for-ascvd-100628663","NCT07464574","Optimizing Non-statin Agents for ASCVD","Using Pharmacy Extenders to Optimize Non-statin Agents for Secondary ASCVD Prevention Outcomes in a Federally Qualified Health Center","Inclusion Criteria:\n\n* Adult patients (\\>18 years) who have seen a CommUnityCare provider in the previous 12 months at time of enrollment, who have a documented history of clinical ASCVD, and are not achieving LDL targets (either \\\u003C55 or \\\u003C70 mg\u002FdL based on risk factors)\n\nExclusion Criteria:\n\n* Patients will be excluded if they do not have a clearly documented history clinical ASCVD, are already achieving LDL targets (either \\\u003C55 or \\\u003C70 mg\u002FdL based on risk factors), having cholesterol managed by outside provider (e.g. outside cardiologist\u002Flipid specialist), current pregnancy, have not seen a CUC provider in the previous 12 months, or otherwise do not qualify for clinical pharmacy intervention",{"count":523,"type":20},1000,"OBSERVATIONAL","* The purpose of the study is to improve care for patients with high cholesterol.\n* If you choose to join the study, you will be asked to answer a phone call from study personnel. They will help you coordinate follow up appointments, review your medications and lab with you, and answer any questions you have about your medications. You will also continue to be seen by a clinical pharmacy team member. Your cholesterol medications may change to better lower your cholesterol. We will collect information about your visits, medicines, and cholesterol levels for 6 months.\n* If you choose not to participate, you will receive the same information and treatment at your next scheduled visit. You will receive the same care regardless of choosing to participate in the study.\n* Participation might involve a very low risk of some loss of privacy. There is low risk that someone outside the research study could see information about you.\n* A possible benefit is lower cholesterol.\n* Taking part in this research study is your choice. You do not have to participate, and you can stop at any time without any penalty.",[527],"ASCVD Management",[529],"non-statin","2026-03-05",{"date":532,"type":38},"2026-03-11",{"date":534,"type":38},"2026-01-16",{"date":536,"type":20},"2027-05-01",{"name":44,"class":45},{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":542,"acronym":543,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":55,"minAge":17,"maxAge":545,"enrollmentInfo":546,"targetDuration":4,"studyType":21,"phases":548,"briefSummary":549,"conditions":550,"keywords":552,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":46},"100606550","impact-of-stress-first-aid-for-workers-in-substance-misuse-settings-100606550","NCT07177014","Impact of Stress First Aid for Workers in Substance Misuse Settings","SFA-Impact","Inclusion Criteria:\n\n* At least 18 years of age\n* In a paid or volunteer role as a substance use outreach worker or community health\u002Foutreach worker (whose work includes substance use outreach) with people who use drugs within TX, LA, AR, OK, NM and tribal areas\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n\\- Inability to provide consent","100 Years",{"count":547,"type":20},500,[23],"Test the effectiveness of SFA adapted for the substance use outreach workforce compared to a no treatment control condition on social-support and burnout of HRWs in a cluster-randomized hybrid type I trial.",[551],"Occupational Health",[553,554,555,556,557],"Stress First Aid","Persons who use drugs","overdose prevention","community outreach workers","substance use outreach workers","2026-02-27",{"date":560,"type":38},"2026-03-03",{"date":562,"type":38},"2025-12-05",{"date":564,"type":20},"2029-02-28",{"name":44,"class":45},{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":55,"minAge":574,"maxAge":575,"enrollmentInfo":576,"targetDuration":4,"studyType":21,"phases":578,"briefSummary":580,"conditions":581,"keywords":585,"overallStatus":258,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":593,"leadSponsor":595,"locationsCount":74},"100625120","phase-2-pressure-targeting-during-high-flow-therapy-in-premature-infants-100625120","NCT07418502","Pressure Targeting During High Flow Therapy in Premature Infants","A Phase 2 Crossover Trial of Pressure Targeted High Flow Therapy in Premature Infants","NeoMATCH","Inclusion Criteria:\n\n* Delivery at \\>24+0 weeks and ≤32+6 weeks of gestation\n* Postnatal age \\>7 days but \\\u003C 6 weeks old\n* Weight ≥1,000grams at the time of study\n* Receiving clinically prescribed CPAP at pressures of 5-8cm H2O\n* Requiring an FiO2 of ≤0.60\n\nExclusion Criteria:\n\n* Chromosomal disorder (aneuploidy)\n* Presence of major congenital birth defect including airway anomalies, congenital diaphragmatic hernia or cardiac defects (other than patent foramen ovale and patent ductus arteriosus)\n* Prior pneumothorax\n* Infants in whom chance of survival is uncertain","7 Days","40 Weeks",{"count":577,"type":20},78,[579],"PHASE2","The goal of this study is to see if a new approach to breathing support ('Pressure Targeted High Flow') is as effective as standard of care ('Continuous Positive Airway Pressure') in prematurely born infants. It will also learn about the effect of these types of breathing support on infant comfort and impact on staffing. The main question it aims to answer is:\n\nDoes Pressure Targeted High Flow provide enough support in premature infants?\n\nParticipants will:\n\nTake spend 24 hours supported by Pressure Targeted High Flow and 24 hours supported by CPAP. During this time their breathing rate, oxygen requirement and other markers of comfort will be monitored.",[582,583,584],"Preterm Infants","Respiratory Distress Syndrome (Neonatal)","BPD - Bronchopulmonary Dysplasia",[586,587,588],"preterm","CPAP","High Flow","2026-02-10",{"date":591,"type":38},"2026-02-18",{"date":341,"type":20},{"date":594,"type":20},"2027-09",{"name":44,"class":45},{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":83,"sex":55,"minAge":211,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":21,"phases":603,"briefSummary":604,"conditions":605,"keywords":608,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":623},"100587431","cognitive-screening-made-easy-for-pcps---administrative-supplement-100587431","NCT06928298","Cognitive Screening Made Easy for PCPs - Administrative Supplement","Inclusion Criteria:\n\n* Inclusion Criteria:\n* Aged 60 years and older;\n* Ethnic\u002Fracial background consistent with NIH policy\n* Male or female\n* Fluent in Spanish.\n\nExclusion Criteria:\n\n* Confounding conditions that could impact ability to participate in the study (e.g., cognitive impairment sufficient to impact ability to follow instructions on the iPad, motor impairment that would prohibit independent use of RACS, poor visual acuity)\n* Prior diagnosis of dementia\n* Non-Spanish speaking.",{"count":193,"type":20},[23],"This project will facilitate early detection of cognitive decline in older adults through development and implementation of an automated risk assessment and cognitive screening tool for use in primary care. By providing an automated tool developed specifically to address the needs of PCPs, it will be easier to screen for cognitive impairment, increasing the number of older adults who are screened and thus identified and treated.",[606,253,607],"Cognitive Impairment","Dementia, Mild",[609,610,611,612,613,614],"older adults","mild cognitive impairment","mild dementia","cognitive screening","primary care","dementia screening","2026-02-02",{"date":617,"type":38},"2026-02-05",{"date":619,"type":38},"2025-06-10",{"date":621,"type":20},"2027-04-30",{"name":44,"class":45},3,{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":630,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":55,"minAge":500,"maxAge":632,"enrollmentInfo":633,"targetDuration":4,"studyType":21,"phases":634,"briefSummary":635,"conditions":636,"keywords":4,"overallStatus":258,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":46},"100621322","phase-4-neurocircuitry-mechanisms-and-efficacy-of-lumateperone-as-adjunctive-therapy-for-major-depressive-disorder-and-history-of-early-life-abuse-100621322","NCT07369115","Neurocircuitry Mechanisms and Efficacy of Lumateperone as Adjunctive Therapy for Major Depressive Disorder and History of Early Life Abuse","Intra-Cellular Therapies, Inc. \u002F \"A Randomized, Double-blind, Placebo-controlled, Single Site Study to Evaluate the Efficacy of Lumateperone for the Treatment of Major Depressive Disorder (MDD) and Early Life Trauma in Adult Patients Aged 21 to 70 Years","ITI-ELA-MDD","Inclusion Criteria:\n\n1. Provide written informed consent before the initiation of any study-specific procedures.\n\n   NOTE: Patients who are unable to independently provide informed consent will be ineligible to participate in this study.\n2. Male or female, between the ages of 21 and 70 years, inclusive;\n3. Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision (DSM-5-TR) criteria for Major Depressive Disorder (MDD) without psychotic symptoms, as confirmed by a trained rater using the modified Structured Clinical Interview (DIAMOND) for DSM-5,\n4. MADRS total score ≥ 22 at Screening (Visit 1) and Baseline (Visit 2)\n5. Endorse \\>=1 physical or sexual assault prior to age 16 on the interview-based trauma assessment.\n\n   Many studies refer to early life trauma as prior to age 18. Here we define early life assault as less than 16, rather than 18, in order to ensure a clearer separation between early life and adulthood. While another option might be to restrict even further (e.g., age of trauma \\\u003C 10), for feasibility (e.g., facilitating recruitment) and generalizability (e.g., results extend to MDD and early life trauma more broadly than just early childhood trauma), we decided on physical or sexual assault prior to age 16.\n\n   Regarding the focus on physical or sexual assault, there are two main reasons. First, the definition of physical and sexual assault can more easily be operationalized through a behavioral description of an event (e.g., has anyone hit you with a fist, has anyone hit you with an object, etc), enabling more precise assessment and detection. Second, there is a robustly elevated risk for mood disorders following assaultive traumas relative to non-assaultive traumas. As such, there is greater clinical need to establish adjunctive treatments among those experiencing assaultive traumas.\n6. Participants must have been treated with the same dose of antidepressant therapy for at least 6 weeks, with less than 50% improvement, and be committed to stay on the same stable dosing regimen for the Screening period and for the entire study, at or above the minimally adequate dose in the ATRQ. Documentation of stable and ongoing ADT must be verified by documentation from the subject's psychiatrist, pharmacist, primary care physician, or other qualified healthcare professional.\n7. Females of childbearing potential agree to use at least an acceptable method of birth control (including but not limited to hormonal contraception, intrauterine device, vasectomized partner, bilateral tubal occlusion, condom with or without spermicide, cap with spermicide, diaphragm with spermicide, sponge with spermicide, or double barrier methods) from the time informed consent is provided through the end of the SFU period. NOTE: Females of non-childbearing potential (defined as either permanently sterilized, or post-menopausal females \\[defined as at least one year with no menses without an alternative medical explanation\\]) are exempt from the birth control requirement.\n8. Ability to follow study instructions and likely to complete all required visits.\n\nExclusion Criteria:\n\n1. Has a current primary DSM-5-TR psychiatric diagnosis other than Major depressive disorder. These include: PTSD, OCD, Bipolar Disorder, Schizophrenia, schizoaffective disorder, or other psychotic disorder. Intellectual disability, Dementia or other cognitive disorders. Moderate or severe substance use disorder (excluding for nicotine)\n2. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of his\u002Fher participation in the study or\n\n2a. At Screening (Visit 1), the patient scores \"yes\" on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS within 6 months prior to Screening; or\n\n2b. At Screening (Visit 1), the patient has history of suicidal attempt(s) within 1 year prior to Screening (Visit 1); or\n\n2c. At Baseline\u002Frandomization (Visit 2), the patient scores \"yes\" on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS since the Screening Visit; or\n\n2d. At Screening (Visit 1) or Baseline (Visit 2), scores ≥ 4 on Item 10 (suicidal thoughts) on the rater administered MADRS; or\n\n2e.Considered to be an imminent danger to himself\u002Fherself or others.\n\n3\\. MRI contraindications: History of shrapnel or other metal or electronic implants in the body(such as pacemakers, aneurysm clips, ferrous surgical devices, metallic tattoos on the head, etc.). The patient has received electroconvulsive therapy (ECT), vagal nerve stimulation, or repetitive trans-cranial magnetic stimulation within the past 1 year;\n\n4\\. The patient has known hypersensitivity or intolerance to lumateperone, or to any of the excipients\n\n5\\. Treatment with a depot\u002Flong-acting injectable antipsychotic within 1 cycle before Screening (Visit 1)\n\n6\\. The following agents are excluded and must be discontinued at Screening (Visit 1):\n\n6a. Any moderate or strong cytochrome P450 3A4 inhibitor (CYP3A4), or any CYP3A4 inducer 6b. Central opioid agonists\u002Fantagonists, including tramadol 6c. Central opioid agonists\u002Fantagonists, including tramadol 6d. Dietary supplements and medical foods unless approved by the Sponsor or designee. Daily multivitamin use is permitted\n\n7\\. Monoamine oxidase inhibitors within 14 days prior to Baseline\u002FRandomization (Visit 2)\n\n8.Other drugs with known psychotropic properties or any non-psychotropic drugs with known or potentially significant central nervous system.\n\n9\\. The patient plans to initiate psychotherapy or make changes to existing psychotherapy during the study (patients who are participating in stable psychotherapy or psychotherapy as a part of their treatment are allowed to enroll);\n\n10\\. The patient has participated in a previous clinical trial with lumateperone, or has had exposure to any investigational product within 6 months of the baseline visit or participated in \\> 2 clinical studies of an investigational product with a central nervous system indication.\n\n11\\. The patient is pregnant or breast-feeding. Female patients of childbearing potential must have a negative serum pregnancy test at Screening (Visit 1). On Day 1 (Baseline\u002FVisit 2), female patients of childbearing potential must have a negative urine pregnancy test prior to study drug administration;\n\n12\\. The patient has a positive test for alcohol or drugs of abuse (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, or opioids\u002Fopiates) at Screening (Visit 1).\n\n13\\. The patient has abnormal laboratory values or clinical findings at Screening (Visit 1) including, but not limited to:\n\n13a. Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\> 2 × the upper limit of normal (ULN) 13b. Total bilirubin \\> 1.0 × ULN 13c. Hemoglobin \\\u003C 8 g\u002FdL (80 g\u002FL) for females and \\\u003C 9 g\u002FdL (90 g\u002FL) for males 13d. Absolute neutrophil count (ANC) \\\u003C 1200 cells\u002FμL (1.2 × 109 cells\u002FL); 13e. Thyroid-stimulating hormone (TSH) outside of normal reference range AND free T3 or free T4 outside of the reference range. Free T3 and Free T4 will only be evaluated if TSH is outside of reference range; 13f. Poorly controlled diabetes as defined by a glycosylated hemoglobin (HbA1c) \\>7.5%, despite standard care \\[\\> 58 mmol\u002Fmol\\]; 13g. Positive test for hepatitis B surface antigen and\u002For hepatitis B core antibody immunoglobulin M at screening; positive hepatitis C antibody at Screening (Visit 1), with the exception of a patient for whom the reflex HCV RNA test is negative; 13h. Any other clinically significant abnormal laboratory result obtained at screening (Visit 1)\n\n14\\. ECG abnormalities where the patient has corrected QT interval using the Fridericia formula (QTcF) \\> 450 msec for males or \\> 470 msec for females and\u002For heart rate \\\u003C 50 bpm, or evidence of clinically significant bundle-branch blocks at Screening (Visit 1)\n\n15\\. The patient has any of the following conditions:\n\nCardiac: uncontrolled angina, or history of a myocardial infarction within 3 months prior to screening, or history of a clinically significant cardiac arrhythmia including antipsychotic drug-induced corrected QT interval prolongation, or any other cardiac disorder;\n\nMalignancy: Any diagnosis of cancer (except basal or squamous cell skin carcinoma), unless in remission for at least 5 years;\n\nGastrointestinal: history of gastric bypass or any other condition that results in malabsorption;\n\nEndocrine: hypo- or hyperthyroidism unless treated and stable with no medication changes for at least three months prior to screening, diabetes, unless considered stable with no changes in treatment for at least three months prior to screening;\n\nHepatic: Hepatitis B or Hepatitis C; moderate or severe hepatic impairment (Child-Pugh B or C);\n\nPulmonary: history of diagnosed and untreated obstructive sleep apnea;\n\nNeurological: history of epilepsy, seizure or convulsion, or electroencephalogram with clinically significant abnormalities, delirium, dementia, amnestic, or central sleep apnea, or significant brain trauma, or other cognitive disorder; History of movement disorders.\n\nInfectious: History of human immunodeficiency virus (HIV) infection.\n\nNote: Any other medical condition, or medical conditions that are stable with treatment (eg, hypertension, hypercholesterolemia, or thyroid abnormalities) are allowed as long as the condition has been stable for at least 3 months prior to Screening (Visit 1); treatments for these conditions are documented, kept stable, and are expected to be unchanged during the study; and the condition is not thought to affect safe participation in the study or relevant study outcomes in the opinion of the Investigator.\n\n16\\. The patient is judged by the Investigator to be inappropriate for the study;\n\n17\\. Patient is homeless;\n\n18\\. Patient does not speak english;","70 Years",{"count":356,"type":20},[358],"The purpose of this clinical research study is to understand how effective and safe an investigational study drug called lumateperone is and whether it works to reduce the severity of depressive symptoms in adults with Major Depressive Disorder (MDD) and early life trauma. The main questions it aims to answer are:\n\nAim 1: To assess the efficacy of lumateperone 42 mg administered once daily compared with placebo in the treatment of patients with Major Depressive Disorder and early life abuse.\n\nAim 2: To assess neurocircuitry encoding of threat and reward learning as predictors of lumateperone response and as mechanisms of treatment action, and assess the change from pre-dose to post-dose of task-evoked brain activation.",[637,638],"Major Depressive Diorder","Early Life Trauma","2026-01-23",{"date":641,"type":38},"2026-01-27",{"date":643,"type":20},"2026-02",{"date":645,"type":20},"2030-01",{"name":44,"class":45},{"id":648,"slug":649,"hasResults":12,"nctId":650,"briefTitle":651,"officialTitle":652,"acronym":4,"eligibilityCriteria":653,"healthyVolunteers":83,"sex":55,"minAge":84,"maxAge":211,"enrollmentInfo":654,"targetDuration":4,"studyType":21,"phases":656,"briefSummary":657,"conditions":658,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":663,"completionDateStruct":665,"leadSponsor":667,"locationsCount":74},"100620764","evaluating-whether-hyperbaric-oxygen-therapy-can-improve-vo-max-and-reduce-inflammation-markers-in-healthy-adults-ages-30-60-100620764","NCT07361861","Evaluating Whether Hyperbaric Oxygen Therapy Can Improve VO₂-Max and Reduce Inflammation Markers in Healthy Adults Ages 30-60.","The Effects of Hyperbaric Oxygen Therapy at Intermediate Pressure (1.75 ATA) on VO₂ Max and Inflammatory Cytokine Profiles","Inclusion Criteria:\n\n* physically active individuals with no history of chronic illness or HBOT exposure within the last three months.\n\nExclusion Criteria:\n\n* individuals with contraindications to HBOT, including lung diseases or claustrophobia.",{"count":655,"type":20},30,[23],"The purpose of this study is to determine whether hyperbaric oxygen therapy (HBOT) at 1.75 atmospheres of pressure (ATA) improves cardiovascular fitness (VO₂ max) and reduces inflammation in healthy adults. HBOT involves breathing pure oxygen in a pressurized chamber and is considered investigational for this use.\n\nRecent research has shown that different HBOT pressures can have different effects on inflammation. Specifically, some inflammatory cytokines (measurable markers of inflammation in the body) appear to decrease at low pressures like 1.3 ATA, while a different set of cytokines responds better at higher pressures, such as 2.0 ATA.\n\nCytokines are small proteins that play a crucial role in cell signaling, particularly within the immune system. They help regulate inflammation, infection response, and overall immune function. While some cytokines promote inflammation to fight off threats, others help reduce inflammation when it's no longer needed. An imbalance in cytokines - especially excessive inflammatory cytokines - can contribute to chronic inflammation, cardiovascular disease, and other health issues.\n\nIn this study, we are testing an intermediate pressure - 1.75 ATA - to see if we can target both sets of cytokines at once. If successful, this approach could offer broader anti-inflammatory benefits.\n\nWe are also interested in how this intermediate pressure may improve VO₂ max, a key indicator of cardiovascular fitness. Since VO₂ max is strongly linked to heart health and overall longevity, finding a safe and effective way to improve it has meaningful implications not just for athletes, but for anyone looking to enhance their fitness and well-being.",[659,660],"Cardiovascular Fitness","Inflammation","2026-01-21",{"date":639,"type":38},{"date":664,"type":20},"2026-01",{"date":666,"type":20},"2026-07",{"name":44,"class":45},{"id":669,"slug":670,"hasResults":12,"nctId":671,"briefTitle":672,"officialTitle":673,"acronym":674,"eligibilityCriteria":675,"healthyVolunteers":12,"sex":55,"minAge":17,"maxAge":4,"enrollmentInfo":676,"targetDuration":4,"studyType":21,"phases":678,"briefSummary":679,"conditions":680,"keywords":682,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":687,"lastUpdatePostDateStruct":688,"startDateStruct":689,"completionDateStruct":691,"leadSponsor":693,"locationsCount":46},"100490844","rct-of-sensor-controlled-digital-game-for-hypertension-self-care-in-a-native-american-community-100490844","NCT05671406","RCT of Sensor-controlled Digital Game for Hypertension Self-care in a Native American Community","A Sensor-controlled Digital Game-based Approach to Improve Self-care Behaviors Among Adults Diagnosed With Hypertension in a Native American Community","N-SCDG","Inclusion Criteria:\n\n* Adults in a Native American tribal community in southeastern U.S.\n* Age 18 years or older\n* Systolic BP ≥140mm Hg and\u002For diastolic BP ≥90mm Hg on 2 separate measurements or who are on antihypertensive medication will be included.\n* Pass a mini-cognitive screen\n* Able to independently walk without using a walker or requiring human assistance (ambulation\u002Flocomotion item on the Outcome and Assessment Information).\n\nExclusion Criteria:\n\n* Severe visual (e.g., legal blindness) or tactile (e.g., severe arthritis) impairments that adversely prevent use of a smart phone or sensor devices;\n* Chronic kidney disease stage 4-5,\n* Diagnosis of end stage or terminal illness (e.g., cancer or heart failure)\n* Prior heart transplantation or implantation of a durable mechanical circulatory support device (e.g., left ventricular assist devise) due to unique self-care needs.",{"count":677,"type":20},220,[23],"This study evaluates a sensor-controlled digital game (SCDG) to motivate self-management behaviors of physical activity in Native American adults with hypertension (HTN). Half of the participants will receive the SCDG app and physical activity sensors and the other half will receive only the physical activity sensors.\n\nNative American participants with hypertension (HTN) in the sensor controlled digital game intervention group will show increased PA behaviors; improved HTN knowledge, self-care behaviors, self-efficacy, motivation, and quality of life (QoL); and larger reduction in systolic and diastolic blood pressure and cardiac hospitalizations at baseline,3 months, and 6 months as compared to participants in the sensor-only control group.",[681],"Hypertension",[683,684,685,686],"hypertension","self-care","digital game","Native American","2026-01-19",{"date":661,"type":38},{"date":690,"type":38},"2024-06-27",{"date":692,"type":20},"2027-03-31",{"name":44,"class":45},""]