[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Medical University of South Carolina\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":647},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,157,0,25,[9,45,66,94,118,137,163,195,221,245,265,285,311,336,367,393,423,451,476,499,521,548,578,606,627],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100634435","livewell-mbc-adapted-dialectical-behavioral-therapy-skills-training-100634435",false,"NCT07539649","LiveWell mBc: Adapted Dialectical Behavioral Therapy Skills Training","LiveWell mBC: Pilot Test of an Adapted Dialectical Behavioral Therapy Skills Training Program in Groups of Women Living With Metastatic Breast Cancer","Inclusion Criteria:\n\n1. identify as female\n2. be diagnosed with metastatic (AJCC stage IV) breast cancer\n3. be receiving care for metastatic breast cancer at Hollings Cancer Center\n4. endorse \\>3 out of 10 on the NCCN distress thermometer over the past week plus at least one emotional concern on the problem checklist\n5. be \\> 18 years of age\n6. be able to understand, speak, and read English\n7. be able to provide informed consent.\n\nExclusion Criteria:\n\n1. reported or suspected cognitive impairment\n2. presence of untreated serious mental illness (e.g., schizophrenia) indicated by the medical chart or treating oncologist\n3. expected survival \\\u003C6 months, as indicated by a hospice referral","FEMALE","18 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"NA","In this pilot randomized controlled trial, women with metastatic breast cancer and at least mild distress (N=48) will be randomized to receive LiveWell mBC, a group-based adapted Dialectical Behavioral Therapy (DBT) Skills Training protocol, or Usual Care. The investigators will evaluate feasibility, acceptability, and preliminary efficacy of LiveWell to reduce distress (primary outcome) and improve psychological well-being, symptom burden, and quality of life (secondary outcomes).",[27],"Survivorship",[29,30,31,32],"Dialectical Behavioral Therapy","Metastatic Breast Cancer","Distress","Psychosocial Oncology","NOT_YET_RECRUITING","2026-08-18",{"date":36,"type":37},"2026-08-20","ACTUAL",{"date":39,"type":21},"2026-09-30",{"date":41,"type":21},"2027-02-28",{"name":43,"class":44},"Medical University of South Carolina","OTHER",{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100606614","livewell-an-adapted-dialectical-behavioral-therapy-skills-training-protocol-for-patients-living-with-metastatic-lung-cancer-100606614","NCT07177846","LiveWell: An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living With Metastatic Lung Cancer","Inclusion Criteria:\n\n* Age ≥ 18\n* AJCC Stage IV non-small cell lung cancer\n* Receiving treatment with non-curative intent\n* English proficiency\n* Able to provide informed consent\n* National Comprehensive Cancer Network distress screening score ≥ 3\u002F10\n\nExclusion Criteria:\n\n* Cognitive impairment\n* Untreated serious mental illness\n* Expected survival \\\u003C 6 months","ALL",{"count":53,"type":21},80,[24],"In this pilot randomized controlled trial, patients with metastatic non-small cell lung cancer and at least mild distress (N=80) will be randomized to receive LiveWell, an adapted Dialectical Behavioral Therapy (DBT) Skills Training protocol) or Usual Care. The investigators will evaluate feasibility, acceptability, and preliminary efficacy of LiveWell to reduce distress (primary outcome) and improve psychological well-being, symptom burden, and quality of life (secondary outcomes). The investigators will explore emotion regulation as a potential mechanism of change.",[27],[29,32,58,59],"Lung Cancer","Psychological Distress",{"date":36,"type":37},{"date":62,"type":21},"2026-09-15",{"date":64,"type":21},"2028-03-01",{"name":43,"class":44},{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":51,"minAge":75,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100568251","evaluation-of-low-and-high-nicotine-tobacco-free-nicotine-pouches-100568251","NCT06678789","Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches","Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches as a Harm Reducing Substitute for Combustible Cigarettes - (Pack2Pouch)","Pack2Pouch","Inclusion Criteria:\n\n* Age 21+\n* current cigarette smoking (25+ days per previous month, 5 or more cigarettes\u002Fday, for greater than 1yr, greater than 100 lifetime cigarettes)\n* have not used TNFPs more than 5 times during their lifetime\n* willing and able to attend 2 in-person visits in Charleston (to assess biomarkers)\n* have internet access\n\nExclusion Criteria:\n\n* Lack of proficiency in English.\n* Use of other combustible tobacco products (i.e., cigars, cigarillos, hookahs) and\u002For other non-combusted nicotine\u002Ftobacco products (i.e., e-cigarettes, smokeless tobacco) in the past 30 days.\n* Current use of smoking cessation medications (i.e., varenicline, bupropion, nicotine replacement therapy).\n* Use of marijuana within the past month, and unwillingness to abstain from marijuana during course of study.\n* Medical conditions contraindicated to NRT use (including pregnancy, breastfeeding, and nursing, past month myocardial infarction, current untreated cardiac arrhythmia, current severe angina, current uncontrolled severe vascular disease).",true,"21 Years",{"count":77,"type":21},50,[24],"Tobacco-free oral nicotine pouches (such as Zyn brand) are a less harmful alternative to cigarette smoking. Pouches, however, contain nicotine, and addictive substance that is not risk-free. The present study is evaluating how well nicotine pouches, at different nicotine levels, help people switch away from smoking cigarettes. People who smoke cigarettes will be asked to answer questions about their tobacco product use and provide breath samples and cheek swab samples at an in-person visit to MUSC Charleston. Participants will then be provided with a 28-day supply of nicotine pouches, and will be asked to switch from smoking to pouches over the course of 4 weeks. Finally, participants will complete a final visit at MUSC, and will answer more questions about their tobacco use 1-month later.",[81,82,83],"Cigarette Smoking","Nicotine Dependence","Smoking Cessation",[85],"Smoking","RECRUITING",{"date":36,"type":37},{"date":89,"type":37},"2025-02-14",{"date":91,"type":21},"2027-05-28",{"name":43,"class":44},1,{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":74,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":115,"leadSponsor":117,"locationsCount":93},"100627435","phase-4-progesterone-preeclampsia-100627435","NCT07448597","Progesterone Preeclampsia","Progesterone Supplementation for the Prevention of Preeclampsia","Inclusion Criteria:\n\n* Pregnant individuals receiving prenatal care at participating clinics\n* \\\u003C12 weeks gestation with a viable intrauterine pregnancy\n* Age ≥18 years\n* English-speaking\n\nExclusion Criteria:\n\n* Unable or unwilling to self-administer vaginal progesterone\n* Inability or unwillingness to provide informed consent",{"count":102,"type":21},642,[104],"PHASE4","This randomized controlled trial evaluates whether nightly vaginal micronized progesterone (400 mg) initiated before 12 weeks' gestation reduces the incidence of preeclampsia in low-risk pregnant individuals. Participants will be randomly assigned (1:1) to receive either vaginal progesterone through 16 weeks' gestation or routine prenatal care without progesterone. Maternal and neonatal outcomes-including development of preeclampsia, obstetric complications, gestational diabetes, preterm birth, and neonatal morbidity-will be collected via chart review. The study aims to determine whether early progesterone supplementation decreases the risk of preeclampsia.",[107,108],"Preeclampsia","Hypertensive Disorder of Pregnancy",[110],"Progesterone","2026-08-13",{"date":113,"type":37},"2026-08-17",{"date":111,"type":37},{"date":116,"type":21},"2028-08-01",{"name":43,"class":44},{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":74,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":134,"leadSponsor":136,"locationsCount":93},"100596362","social-functioning-in-opioid-use-disorder-100596362","NCT07044466","Social Functioning in Opioid Use Disorder","Real-world Assessment of Social Functioning During OUD Treatment: Integrating Reports From Patients and Their Concerned Significant Others","OUD","Inclusion Criteria:\n\n* Any sex or gender; any race or ethnicity; aged 18 years or older\n* Patient participants must meet DSM-5 diagnostic criteria for current (i.e., past 12 months) OUD (assessed via the Quick Structured Clinical Interview for DSM-5; Quick SCID)\n* Patient participants must be on medication for opioid use disorder (MOUD), as prescribed by their provider, for no more than 12 weeks prior to study initiation\n* Patient participants must be in treatment at a clinic in South Carolina\n* Concurrent substance use disorders (e.g., alcohol, cannabis) for the patient participant are acceptable, provided opioids are the patient participant's primary substance of choice\n* Patient participants must identify a CSO participant who consents to participation in the study as well\n\nExclusion Criteria:\n\n* Moderate-to-severe opioid withdrawal as defined by a score of ≥21 on the Subjective Opioid Withdrawal Scale\n* Meeting DSM-5 criteria for a history of or current psychotic or bipolar disorders\n* Current suicidal or homicidal ideation and intent; participants who present a serious suicide risk are likely to require hospitalization during the study and they will be referred clinically\n* CSO participants meeting DSM-5 criteria for opioid use disorder or any other substance use disorder, excepting tobacco use disorder, mild cannabis use disorder, and mild alcohol use disorder\n* Severe interpersonal violence in the past six months between the patient and the CSO, as defined by an adapted version of the Conflict Tactics Scaled Revised (CTS-2)\n* Pregnancy for patient participants\n* Prisoners, institutional individuals, and children will not be recruited for this study.",{"count":127,"type":21},230,[24],"Problems with social functioning are core to opioid use disorder (OUD), though specific, modifiable social functioning targets and how they relate to OUD treatment outcomes are poorly understood. This study will utilize both data from both patients with OUD and their concerned significant other (CSO) to examine associations between specific social functioning metrics and OUD treatment outcomes. Findings from this study will inform future precision-medicine approaches for people with OUD, a population in significant need of enhanced treatment approaches to combat opioid morbidity and mortality.",[131],"Opioid Use Disorder",{"date":113,"type":37},{"date":111,"type":37},{"date":135,"type":21},"2029-08-31",{"name":43,"class":44},{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":12,"sex":51,"minAge":145,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":93},"100476614","cars-cannabis-and-alcohol-reduction-study-100476614","NCT05486234","CARS: Cannabis and Alcohol Reduction Study","Brief Computerized Intervention for Reducing Adolescent Cannabis and Alcohol Use","CARS","Inclusion Criteria:\n\n* between the ages of 13 and 17\n* be seeking treatment for either cannabis or alcohol use;\n* report co-occurring alcohol and cannabis use during the past three months (i.e., participants who report using both alcohol and cannabis during the three months prior to participation in the study, regardless of if the use was simultaneous)\n* have a caregiver willing to participate and provide consent.","13 Years","17 Years",{"count":148,"type":21},52,[24],"The study will test a computerized treatment with subjects ages 13-17 years who are seeking treatment for alcohol and\u002For cannabis use. Follow-up assessments will be conducted at one- and three-months following treatment.",[152,153,154,155],"Cannabis Use","Alcohol Use, Unspecified","Substance Use","Substance Use Disorders","2026-08-11",{"date":111,"type":37},{"date":159,"type":37},"2023-01-25",{"date":161,"type":21},"2026-10-01",{"name":43,"class":44},{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":175,"conditions":176,"keywords":178,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":93},"100646380","phase-2-study-of-chemosensory-enhancement-through-neuromodulation-training-scent-open-label-100646380","NCT07689773","Study of Chemosensory Enhancement Through Neuromodulation Training (SCENT): Open Label","SCENT-OL","Inclusion Criteria:\n\n* Age 18-80\n* Self-reported or medically documented smell loss\n* Treatment-seeking for their smell loss\n* Naïve to TNS\n* Able to comprehend English and provide informed consent\n\nExclusion Criteria:\n\n* Medical Records not available to confirm eligibility\n* Documented\u002FSuspected head injury (e.g. sport, accident, blast exposure)\n* Neurological disorder (e.g. epilepsy, neurodegenerative disorder)\n* Serious mental illness (e.g. schizophrenia, bipolar disorder)\n* Suicidal ideation within the last month\n* Current (≤6 months) and\u002For heavy cigarette smokers (i.e. ≥ 10 pack-years)\n* Oral\u002Fnasal steroids or other intranasal medications\n* Immunomodulatory medications\n* Pregnant or trying to become pregnant","80 Years",{"count":172,"type":21},60,[174],"PHASE2","Smell dysfunction significantly impacts quality of life and safety, with limited effective treatments. This open-label study evaluates the preliminary efficacy of combining non-invasive trigeminal nerve stimulation (TNS) with standard smell training (ST) to improve olfactory function. Participants will complete 8 weeks of at-home treatment and attend three in-person visits for assessment. Improvements in smell, mood, sleep, and quality of life will be measured.",[177],"Olfactory Impairment",[179,180,181,182,183,184,185,186],"olfaction","smell loss","chronic rhinosinusitis","olfactory dysfunction","smell training","olfactory training","trigeminal nerve stimulation","sensory loss","2026-08-10",{"date":189,"type":37},"2026-08-12",{"date":191,"type":37},"2026-07-10",{"date":193,"type":21},"2028-06-30",{"name":43,"class":44},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":205,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":93},"100631676","phase-2-oea-for-young-adults-with-alcohol-use-disorder-100631676","NCT07503782","OEA for Young Adults With Alcohol Use Disorder","Investigating Oleoylethanolamide (OEA) as a Novel Multi-System Based Therapeutic for Young Adults With Alcohol Use Disorder","Inclusion Criteria:\n\n* Age 18 to 25.\n\nCall study team for additional screening and information.","25 Years",{"count":204,"type":21},42,[174],"The goal of this clinical trial is to evaluate the effects of oleoylethanolamide (OEA) supplementation on inflammation, the oral microbiome, neurocognitive function, and alcohol use in young adults ages 18 to 25 with alcohol use disorder (AUD). The main questions it aims to answer are:\n\n* Does OEA reduce peripheral markers of immune activation (IL-6, TNF-α, IL-1β, and LPS)?\n* Does OEA alter oral microbiome composition?\n* Does OEA improve neurocognitive measures of reward sensitivity and impulsivity?\n\nResearchers will compare OEA to a placebo (a look-alike substance with no active ingredient) to determine whether OEA improves biological and behavioral outcomes associated with AUD.\n\nParticipants (N = 42) will:\n\n* Be randomly assigned to receive 300mg TRIPTI (providing 250 mg\u002Fday of OEA) or placebo for 6 weeks.\n* Provide blood, saliva, and urine samples\n* Complete cognitive testing and questionnaires\n* Report alcohol use during the study\n* Attend in-person study visits for monitoring and assessments\n\nThis randomized, double-blind, placebo-controlled pilot trial will provide preliminary data on the potential efficacy of OEA as a multi-system intervention for young adults with AUD.",[208],"Alcohol Use Disorder (AUD)",[210,211,212,213,214],"OEA","oleoylethanolamide","AUD","Oral microbiome","Alcohol",{"date":189,"type":37},{"date":217,"type":21},"2026-11-01",{"date":219,"type":21},"2031-06-01",{"name":43,"class":44},{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":74,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":231,"conditions":232,"keywords":234,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":240,"startDateStruct":241,"completionDateStruct":242,"leadSponsor":244,"locationsCount":4},"100582385","neural-representations-of-memory-transformation-memtrans-100582385","NCT06862622","Neural Representations of Memory Transformation (MEM_TRANS)","Task-based Synchronous Electroencephalography and Functional Magnetic Resonance Imaging (EEG-fMRI) to Explore Neural Representations of Memory Maintenance in the Aging Brain.","Inclusion Criteria:\n\n* Age 18 years or older (80 of the final sample will be ≥60years of age)\n* Cognitively unimpaired, ambiguous, or mildly impaired cognitive function, defined as a score of ≥18 in the Montreal Cognitive Assessment (MOCA).\n* No previous stroke, brain tumor, neurodegenerative disease, or trauma to the head\n* Ability to give consent for study participation\n* Ability to perform a computer task requiring responding to visual cues and typing on a standard computer keyboard with both index and middle fingers for 30 minutes daily.\n\nExclusion Criteria:\n\n* Inability to use both index and middle fingers to type on a standard computer keyboard\n* Dementia defined as a score of \\\u003C18 in the Montreal Cognitive Assessment (MOCA)\n* Uncorrected vision, hindering perception of visual cues presented on a standard computer screen\n* Medication use at the time of study that may interfere with learning, including but not limited to carbamazepine, flunarizine, sulpiride, rivastigmine, and dextromethorphan.\n* Neuromuscular disorders that affect fine motor control of the hands.\n* Presence of neurological or psychiatric disorders\n* Presence of scalp injury or disease\n* Prior intracranial surgery\n* Prior brain radiotherapy\n* Prior history of intracranial tumor, intracranial infection, or cerebrovascular malformation\n* Metal in the head or neck\n* Contraindications to MRI (such as severe claustrophobia, implanted medical devices)",{"count":229,"type":21},40,"OBSERVATIONAL","Investigators overarching goal is to provide evidence for the link between altered spatiotemporal (where and when) neural mechanisms and the extent of changed memory maintenance in healthy older adults and to identify potential neural markers of compensatory function (cognitive resource). Investigators preliminary studies suggest that healthy older adults, compared to younger adults, benefit behaviorally from increased coupling between frontal and parietal brain waves when retrieving and updating well-consolidated visuomotor sequence memory via stronger top-down cognitive control of memory maintenance. Thus, Investigators central hypothesis is that the dynamics across cortical and subcortical regions (i.e., spatiotemporal representations) during transitions between different levels of memory stability indicate the efficiency of memory maintenance. The rationale is that while temporal and spatial neural signatures carry distinct mechanistic information, the joint definition of spatial and temporal representations will allow the differentiation of compensatory versus neurodegenerative mechanisms.",[233],"Healthy Older Adults",[235,236,237,238,239],"Aging","Healthy Volunteer Studies","memory","fMRI","EEG",{"date":189,"type":37},{"date":161,"type":21},{"date":243,"type":21},"2027-09-30",{"name":43,"class":44},{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":74,"sex":51,"minAge":75,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":93},"100525189","a-clinical-trial-of-adaptive-treatment-for-early-smoking-cessation-relapse-100525189","NCT06118502","A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse","ADAPT","Inclusion Criteria:\n\n* Smokers who want to quit\n\nExclusion Criteria:\n\n* Non-smokers",{"count":253,"type":21},544,[24],"This is a research study to find out if treatment decision making can be improved for smokers who find it difficult to quit with medications. Everyone who participates in this study will receive free product, either nicotine replacement therapies (patches and lozenges), varenicline, or a harm reduction product (e-cigarette) for a full 12 weeks. Most participants will receive some combination of these treatments, depending on individual response to each.\n\nAll visits and study assessments will be entirely remote. All treatments will be provided free of charge for the first 12 weeks. After that, the study team will contact the participants 6 months after the first study phone call to complete another survey. The study lasts six months and will involve 8 surveys.",[81,257,258],"Smoking Behaviors","Treatment",{"date":189,"type":37},{"date":261,"type":37},"2024-03-25",{"date":263,"type":21},"2028-03-31",{"name":43,"class":44},{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":93},"100494981","tavns-or-tms-or-both-for-depression-100494981","NCT05725239","taVNS or TMS or Both for Depression","Synchronized Cervical or Auricular VNS With Prefrontal rTMS for Treatment Resistant Depression (TRD)","Inclusion Criteria:\n\n* 18-75 years old\n* Undergoing cervical VNS or have tried and failed two antidepressant medications in the current episode\n* Able to provide informed consent\n* English speaking and can read and write\n* 17-item Hamilton Depression Rating Scale (HAM-D) score ≥20\n* Not responding to talking therapy.\n\nExclusion Criteria:\n\n* Preexisting neurological disorders, or dementia\n* History of major head trauma\n* Life expectancy \\\u003C1 year\n* Any type of cognitive impairment that would require approval\u002Fsignature of a legal guardian\u002Frepresentative for participation\n* A score of \\>2 on question 3 of the Hamilton Depression Rating pertaining to suicidality\n* Current active suicidal intent or plan, prior attempt within the last 6 months, or who in the judgment of the investigator would be at elevated risk for suicide will be excluded\n* Patients who are pregnant will also be excluded. We will require a pregnancy test for individuals of child-bearing potential.","75 Years",{"count":274,"type":21},24,[24],"The purpose of the research is to test out a combined treatment for depression where the investigators stimulate a nerve in the ear while at the same time stimulate the brain with magnets. These treatments are called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) and transcranial (through the skull) magnetic stimulation (TMS). For participants who already have a cervical VNS device, the investigators will not change their treatment and will use this in place of the taVNS. The investigators think this combined method might treat depressive symptoms better than either alone. This study is in person at the Institute of Psychiatry in downtown Charleston on the MUSC campus. First, participants will have a screening session and then will have 6 treatment days total where participants will receive either VNS treatment alone, TMS treatment alone, or both at the same time. The treatment that participants start with will be randomized, and they will have 2 treatment days of each combination.",[278],"Depression",{"date":189,"type":37},{"date":281,"type":37},"2023-03-14",{"date":283,"type":21},"2027-07-01",{"name":43,"class":44},{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":22,"phases":294,"briefSummary":295,"conditions":296,"keywords":298,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":93},"100651083","dose-up-dose-optimization-for-smoking-and-e-cigarette-use-pharmacotherapy-100651083","NCT07754578","DOSE-UP: Dose Optimization for Smoking and E-Cigarette Use Pharmacotherapy","High-Dose Nicotine Replacement Therapy for Quitting Cigarettes and E-cigarettes","Inclusion Criteria:\n\n* age 18+;\n* report nicotine-containing e-cigarette use 5+ times per day, \\>5 days per week, for \\> 6 months;\n* smoking \\>1 cigarette per day, \\>5 days per week, for \\>6 months;\n* interest in quitting cigarettes and e-cigarettes within the next month (\\>6 on 10-point scale);\n* willing to try nicotine replacement therapy;\n* access to text\u002Finternet\u002Femail.\n\nExclusion Criteria:\n\n* report use of other tobacco or nicotine products (i.e., pouches, smokeless tobacco, hookah) \\>1 time per week in the past 3 months;\n* have medical contraindications for nicotine replacement therapy use (patch and lozenge; e.g., recent myocardial infarction, arrhythmias, angina, vascular disease, or medical conditions in which consumption of phenylalanine is contraindicated such as PKU);\n* report current use of smoking cessation medications (varenicline, bupropion, other nicotine replacement therapies);\n* endorse symptoms of Cannabis Use Disorder (using the CUDIT assessment);\n* unable to consent (e.g., cognitive deficit, non-English speaking);\n* live outside the US.",{"count":293,"type":21},321,[174],"This randomized clinical trial evaluates the effectiveness of augmented-dose combination nicotine replacement therapy (NRT) versus standard-dose NRT and no-NRT control for cessation of dual combustible cigarette (CC) and electronic cigarette (EC) use. Adults who currently engage in dual use and are motivated to quit both products will be assigned to one of three 12-week interventions: (1) no pharmacotherapy (behavioral support only), (2) standard-dose NRT (21 mg nicotine patch + 4 mg lozenges, 5-20\u002Fday), or (3) augmented-dose NRT (21 mg + 14 mg patches + 4 mg lozenges, 5-30\u002Fday). All groups receive evidence-based behavioral support through the EX Program. Primary outcomes include biochemically confirmed dual abstinence and CC-only abstinence at 12 and 24 weeks. A subset of participants will provide blood and saliva samples to assess DNA damage biomarkers associated with tobacco use and cessation.",[297],"Dual Use of Cigarettes and E-cigarettes",[299,300,301,302,303],"tobacco","smoking","cigarette","e-cigarette","dual use","2026-08-07",{"date":156,"type":37},{"date":307,"type":21},"2026-10-10",{"date":309,"type":21},"2031-07-10",{"name":43,"class":44},{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":51,"minAge":318,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":22,"phases":321,"briefSummary":322,"conditions":323,"keywords":326,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":93},"100589245","imaging-biomarkers-of-fog-response-to-dbs-100589245","NCT06951906","Imaging Biomarkers of FOG Response to DBS","Imaging Biomarkers of Freezing of Gait Response to Deep Brain Stimulation","Inclusion Criteria:\n\n1. \\>40 years of age.\n2. diagnosis of PD based on UK Brain Bank diagnostic criteria.\n3. presence of FOG, defined as a score of 1 on part 1 of the nFOGQ and confirmed by objective evaluation (a score of 1 represents a positive response of having experienced such an episode over the last month).\n4. clinically selected at the MUSC DBS Conference to undergo STN-DBS surgery.\n\nExclusion Criteria:\n\n1. a history of other significant gait impairment unrelated to PD (e.g. orthopedic deformities).\n2. inability to complete gait assessments (timed-up-and-go task) in the OFF state without assistance or assist devices.\n3. contraindications to MRI, including inability to lie supine in the scanner environment, pregnancy, and non-MRI compatible metal implants.\n4. implantation of non-3 T MRI-compatible DBS devices.","40 Years",{"count":320,"type":21},54,[104],"For this study, the investigators are recruiting 54 individuals with Parkinson's Disease and Freezing of Gait (FOG) who are planning to undergo Deep Brain Stimulation (DBS). The objective of this study is to better understand the FOG response to DBS. Prior to DBS, participants will undergo an MRI scan, behavioral assessment related to walking, a cognitive evaluation, and assessment of other Parkinson's disease symptoms. Following DBS, participants will repeat these assessments at multiple timepoints over the period of one year. Overall, participants will complete a total of 7 visits over a period of approximately 1 year.",[324,325],"Freezing of Gait Symptoms in Parkinson's Disease","Deep Brain Stimulation",[327,328,325],"Freezing of Gait","Parkinson's Disease","2026-08-06",{"date":187,"type":37},{"date":332,"type":37},"2024-11-11",{"date":334,"type":21},"2030-01",{"name":43,"class":44},{"id":337,"slug":338,"hasResults":12,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":51,"minAge":75,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":22,"phases":346,"briefSummary":347,"conditions":348,"keywords":352,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":365,"locationsCount":366},"100596813","combining-rtms--aerobic-exercise-to-treat-depression-and-improve-post-stroke-walking-100596813","NCT07050355","Combining rTMS & Aerobic Exercise to Treat Depression and Improve Post-Stroke Walking","Combining rTMS & Aerobic Exercise to Treat Depression and Improve Post-Stroke Walking (RESTORATION)","RESTORATION","Inclusion criteria:\n\n* age \\>21\n* stroke at least 12 months prior\n* screen positive for depressive symptoms (PHQ-9 \\> 5) and HAM-D17 ≥ 12\n* residual paresis in the lower extremity (Fugl-Meyer LE motor score \\\u003C34)\n* ability to walk without assistance and without an AFO at speeds ranging from 0.2-1.0 m\u002Fs\n* not currently on antidepressant medications or no changes in antidepressant dosage in the last 4 weeks and clinically stable\n* HAM-D17 question #9 regarding suicide \\\u003C2\n* provision of informed consent. I\n* All subjects who screen for major depressive disorder will be formally diagnosed by the project psychiatrist at each site using the Structured Clinical Interview for DSM5 (SCID-5).\n* All subjects who meet criteria for the training portion must complete an exercise tolerance test and be cleared for participation by the study physician.\n\nExclusion criteria:\n\n* unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking\n* history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's\n* history of COPD or oxygen dependence\n* history of traumatic brain injury\n* blindness or severe visual impairment\n* history of psychosis or other Axis I disorder that is primary\n* life expectancy \\\u003C1 yr.\n* severe arthritis or problems that limit participation in testing or training\n* history of DVT or pulmonary embolism within 6 months\n* uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions\n* severe hypertension with systolic \\>200 mmHg and diastolic \\>110 mmHg at rest\n* attempt of suicide in the last 2 years or suicidal risk assessed by SCID\n* history of seizures or currently prescribed anti-seizure medications\n* current enrollment in a trial to enhance motor recovery\n* currently participating in behavioral treatment for depression\n* currently exercising ≥ 2 times per week (≥20 minutes)\n* contraindications to TMS\n* pregnancy or other contraindications to MRI.",{"count":345,"type":21},96,[24],"Investigators primary aim is to carry out a two-site, randomized, double-blind, sham-controlled, phase II trial to systematically examine the potential for aerobic exercise (AEx) to enhance the anti-depressant benefits of rTMS in individuals with post-stroke depression (PSD).\n\nInvestigators propose to determine the efficacy of combining two known anti-depressant treatments shown to be effective in non-stroke depression, aerobic exercise (AEx) and repetitive transcranial magnetic stimulation (rTMS), on post-stroke depressive symptoms. This project is based on the idea that depression negatively affects the potential for the brain to adapt in response to treatment such that rehabilitation may not produce the same changes that it does in non-depressed individuals. Investigators believe that effective treatment for PSD will result in a virtuous cycle whereby reducing depression enhances response to rehabilitation, thereby facilitating functional gains. That is, effectively treating depression will enable individuals to better recover from stroke.",[349,350,351],"Stroke","Depression - Major Depressive Disorder","Walking Impairment",[353,354,355,356,357,358],"stroke","rehabilitation","neuromodulation","TMS","walking","exercise","2026-08-01",{"date":361,"type":37},"2026-08-04",{"date":363,"type":37},"2024-11-01",{"date":135,"type":21},{"name":43,"class":44},2,{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":22,"phases":377,"briefSummary":378,"conditions":379,"keywords":382,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":366},"100579465","phase-4-biologics-in-chronic-rhinosinusitis-with-nasal-polyposis-100579465","NCT06824649","Biologics in Chronic Rhinosinusitis With Nasal Polyposis","SMART Use of Biologics in Chronic Rhinosinusitis With Nasal Polyposis","CRSwNP","Inclusion Criteria:\n\n* Age \\> 18 years\n* Confirmed diagnosis of chronic rhinosinusitis with nasal polyposis using ICAR-21 (International Consensus Statement 20215) criteria\n* Bilateral nasal polyposis visible on sinonasal endoscopy\n* Nasal polyp score \\> 5\n* Baseline SNOT-22 total score \\> 30\n* Patient elects biologic therapy for the management of CRSwNP\n* Capable of receiving all 3 biologic therapy medications.\n* Treatment with intranasal mometasone ≥200 μg. once daily (or equivalent of another intranasal corticosteroid) for 1-month prior to baseline visit.\n\nExclusion Criteria:\n\n* Inability or unwillingness of a participant to give written informed consent or comply with study protocol\n* Endoscopic sinus surgery within 6-months preceding enrollment \u002F randomization.\n* Oral corticosteroid use within 30-days preceding enrollment \u002F randomization.\n* Serum IgE level outside the dosing range for omalizumab (i.e., \\\u003C30 IU\u002Fml. or a weight-based dose with insufficient data to determine dose as per FDA dosing chart)\n* Comorbid atopic dermatitis, urticaria, or any other condition that would require a specific biologic per the standard of care.\n* Currently pregnant or plan to become pregnant within the 6 months after enrollment \u002F randomization.\n* Any previous treatment with any of the 3 biologic medications.\n* Comorbid cystic fibrosis, CVID, or ciliary dyskinesia.\n* Comorbid systemic inflammatory disorders (e.g., GPA, EGPA, Sarcoidosis, SLE)\n* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks for participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.",{"count":376,"type":21},504,[104],"The prevalence of Chronic Sinusitis with Nasal Polyps (CRSwNP) in the United States is estimated at roughly 4%, which equates to over 13 million Americans. Until recently, the only medical treatment options available for patients with CRSwNP were corticosteroids, with surgery reserved for medical failure. The development of biologic medications over the last 5 years has revolutionized the treatment of CRSwNP. Three biologic medications have been FDA approved and available for the treatment of CRSwNP: dupilumab, omalizumab, and mepolizumab. However, data from the clinical trials for these drugs do not show universal improvement across all patients with CRSwNP. In fact, there is a wide range of outcomes for patients in these trials. The result is that clinicians have no way of knowing which specific biologic would be the best option for any given patient, nor do they know whether biomarkers can be used to predict response to biologics. It is hoped that findings from this study will inform whether any one biologic has superior outcomes to another and whether clinicians can identify patients at baseline who are most likely to improve on biologic therapy.",[380,381],"Chronic Sinusitis","Nasal Polyps",[383,384],"Sinusitis","Biologics","2026-07-31",{"date":387,"type":37},"2026-08-03",{"date":389,"type":37},"2026-06-03",{"date":391,"type":21},"2030-02",{"name":43,"class":44},{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":401,"minAge":75,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":22,"phases":404,"briefSummary":405,"conditions":406,"keywords":410,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":366},"100650035","cogot-telerehabilitation-for-adults-with-subjective-cognitive-complaints-100650035","NCT07743229","COG+OT Telerehabilitation for Adults With Subjective Cognitive Complaints","A Comprehensive Cognitive Assessment Protocol and Innovative Neurocognitive Telerehabilitation Pilot Program for Adults With Subjective Cognitive Complaints","CogSCC","Inclusion Criteria:\n\n* Endorsement of subjective cognitive complaints as indicated by a score ≥4 on the Healthy Brain 9 (HB9)\n* Community-dwelling adult aged 60 years or older, or adult aged 21 years or older with a diagnosis of Ehlers-Danlos Syndrome (EDS)\n* English as the primary language\n* Access to and ability to use a smartphone compatible with the NeuroUX platform\n* Access to a device capable of supporting a telerehabilitation visit, such as a phone, tablet, or laptop, and a reliable Wi-Fi or cellular internet connection\n* Able to participate in study assessment sessions as determined by the licensed, experienced telerehabilitation occupational therapist\n\nExclusion Criteria:\n\n* Diagnosis of dementia or mild cognitive impairment\n* Significant or unstable conditions or treatments for medical conditions that may impact cognition, such as traumatic brain injury or brain tumor\n* Inability to engage in study-related procedures as determined by the study team","MALE",{"count":403,"type":21},16,[24],"This pilot study will evaluate a comprehensive cognitive assessment approach and personalized neurocognitive telerehabilitation intervention for adults with subjective cognitive complaints (SCC). The study includes older adults with SCC and adults with Ehlers-Danlos Syndrome (EDS) and SCC. Participants will complete pre- and post-treatment assessments and receive a 6-week COG+OT telerehabilitation intervention that combines cognitive rehabilitation and occupational therapy strategies to support everyday functional cognition.",[407,408,409],"Subjective Cognitive Complaints","Ehlers-Danlos Syndrome","Cognitive Dysfunction",[411,412,413,414,415,408],"Subjective cognitive complaints","Brain fog","Functional cognition","Occupational therapy","Cognitive rehabilitation","2026-07-29",{"date":387,"type":37},{"date":419,"type":21},"2026-09-01",{"date":421,"type":21},"2027-05-01",{"name":43,"class":44},{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":22,"phases":433,"briefSummary":434,"conditions":435,"keywords":438,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":448,"leadSponsor":450,"locationsCount":366},"100650006","phase-2-a-phase-ii-study-of-biomarker-guided-de-escalation-using-anthracycline-free-neoadjuvant-chemoimmunotherapy-in-early-stage-triple-negative-breast-cancer-tnbc-patients-with-high-tumor-infiltrating-lymphocytes-tils-100650006","NCT07743190","A Phase II Study of Biomarker-Guided De-escalation Using Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Early-Stage Triple Negative Breast Cancer (TNBC) Patients With High Tumor-Infiltrating Lymphocytes (TILs)","NeoTILs: A Phase II Study of Biomarker-Guided De-escalation Using Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Early-Stage Triple Negative Breast Cancer (TNBC) Patients With High Tumor-Infiltrating Lymphocytes (TILs)","NeoTILs","Inclusion Criteria:\n\nPre-Screening Phase:\n\n1. Age ≥ 18 years at the time of informed consent.\n2. Ability to understand and willingness to sign a written informed consent document in accordance with institutional and federal guidelines.\n3. Histologically confirmed diagnosis of triple-negative breast cancer (TNBC) or hormone receptor-low invasive breast carcinoma, with clinical anatomic Stage II or Stage IIIA\u002FB as defined by the AJCC 8th Edition Anatomic Breast Cancer Staging System.\n\n   a. Invasive tumor must be estrogen receptor (ER) and\u002For progesterone receptor (PR) negative or low, defined as ≤10% positive staining by immunohistochemistry (IHC).\n\n   b. HER2-negative disease, defined in accordance with current ASCO-CAP HER2 testing guidelines.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n\nScreening and Treatment Phases:\n\nGeneral Eligibility\n\n1. Individuals of childbearing potential must be willing and able to use highly effective contraception from the time of informed consent, throughout study treatment, and for at least 6 months after the last dose of trial therapy.\n\n   a. NOTE: Highly effective contraception is defined as methods with a failure rate \\\u003C1% per year when used consistently and correctly, and include: copper intrauterine device (IUD); bilateral tubal ligation\u002Focclusion or other documented surgical sterilization; vasectomized partner with documented azoospermia, provided this is the sole sexual partner; or true sexual abstinence, defined as complete abstinence from heterosexual intercourse, when this is the participant's usual and preferred lifestyle. Use of hormonal contraceptive methods (including combined oral contraceptives, progestin-only pills, injectables, implants, hormonal IUDs, patches, or vaginal rings) is not permitted during the study and for at least 6 months after the last dose of study treatment.\n2. Willingness and ability to comply with all study procedures, including scheduled visits, treatment plans, laboratory tests, and other protocol-specified requirements.\n3. Willingness and ability to sign and date written informed consent prior to initiation of any study-specific procedures.\n\n   Disease Characteristics\n4. Breast and axillary imaging (mammogram, ultrasound, or MRI) must have been completed within 45 days prior to registration.\n5. Patients with abnormal axillary lymph nodes (identified clinically and\u002For radiographically) must undergo routine pathological confirmation via image-guided core biopsy or fine needle aspiration.\n6. Presence of:\n\n   1. Measurable disease in the breast measuring at least 1cm with or without nodal involvement; or\n   2. Clinical T0 disease with biopsy-proven regional lymph node involvement (cT0N1-2M0), consistent with an overall anatomic stage II-IIIB classification.\n\n   i. For patients with clinical T0 disease confirmed by mammogram\u002FUS and MRI, nodal involvement must be documented by core needle biopsy or fine needle aspiration of an axillary or other regional lymph node demonstrating invasive breast carcinoma prior to initiation of neoadjuvant systemic therapy.\n\n   ii. Patients must not have undergone prior surgical excision of an invasive breast primary tumor that would account for the T0 designation (i.e., T0 must not be the result of complete prior excision of the primary breast lesion).\n7. Patients with multifocal or multicentric disease are allowed if the dominant tumor is confirmed ER and\u002For PR ≤10%, and HER2-negative.\n8. Patients with bilateral breast cancer are eligible if both tumors are HER2-negative.\n9. Staging scans (e.g., CT chest\u002Fabdomen\u002Fpelvis with a nuclear bone scan) must be performed to rule out metastatic disease under any of the following conditions:\n\n   a. Two or more abnormal axillary lymph nodes on imaging, or b. Clinical suspicion of metastatic disease, or c. At the discretion of the treating physician.\n\n   Clinical and Laboratory Requirements\n10. Peripheral neuropathy must be Grade ≤1 per CTCAE v5.0.\n11. Complete history and physical examination performed within 45 days prior to registration.\n12. Adequate hematologic and organ function as defined by the following:\n\n    a. Hematologic i. Hemoglobin ≥9.0 g\u002FdL (without transfusion or erythropoietin support within 14 days prior to testing) ii. Leukocytes ≥3,000\u002FμL iii. Absolute neutrophil count (ANC) ≥1,500\u002FμL iv. Platelet count ≥100,000\u002FμL b. Hepatic i. AST (SGOT) and ALT (SGPT) ≤3 × ULN ii. For participants without a history of Gilbert's syndrome, total bilirubin ≤1.5 × upper limit of normal (ULN) iii. For participants with a history of Gilbert's syndrome, total bilirubin ≤5 × ULN c. Renal i. Serum creatinine ≤1.5 mg\u002FdL or creatinine clearance ≥50 mL\u002Fmin\u002F1.73 m² by Cockcroft-Gault formula.\n\n    ii. Note: Patients with creatinine clearance 30-50 mL\u002Fmin may be enrolled at the discretion of the Principal Investigator, given that paclitaxel is primarily hepatically metabolized and carboplatin dosing can be adjusted to renal function.\n13. Cardiac function must be within acceptable limits, as follows: left ventricular ejection fraction (LVEF) ≥50% by\n\n    a. Echocardiogram (ECHO), or b. Multi-gated acquisition (MUGA) scan.\n14. Participants with known human immunodeficiency virus (HIV)-infection must be on effective antiretroviral therapy (ART) at randomization and have an undetectable viral load test on the most recent test results obtained within six (6) months prior to randomization.\n15. Participants with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within six (6) months prior to randomization, if indicated.\n\n    a. NOTE: No testing for HBV is required unless mandated by local health authority.\n16. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have an undetectable HCV viral load test on the most recent test results obtained within six (6) months prior to randomization, if indicated.\n\n    1. NOTE: No testing for HCV is required unless mandated by local health authority.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\nPre-Screening Phase:\n\n1\\. Presence of tumor-infiltrating lymphocytes (TILs) \\\u003C30% based on central pathology review of hematoxylin and eosin (H\\&E) stained slides.\n\nScreening and Treatment Phases:\n\nDisease-Related Exclusions\n\n1. Presence of N3, inflammatory, or metastatic (M1) breast cancer.\n2. History of other malignancies within the past 3 years, with the exception of:\n\n   1. Adequately treated non-melanoma skin cancer, or\n   2. Cervical carcinoma in situ, or\n   3. Other malignancies with a ≥3-year disease-free interval. Prior and Concurrent Therapy\n3. Prior systemic therapy, radiation therapy, or definitive surgery for current breast cancer.\n4. Prior treatment with immune checkpoint inhibitors, including anti-PD-1, anti-PD-L1, or any other T-cell co-inhibitory or co-stimulatory agents.\n5. Use of investigational agents or devices within 28 days prior to registration\n6. Participant is planning to participate, currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.\n\n   Medical Conditions\n7. History of severe (Grade ≥3) allergic reactions or hypersensitivity to study drugs or their components.\n8. Uncontrolled diabetes mellitus or hypertension.\n9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy (7-day clearance period for immunosuppressant therapy prior to starting study treatment, if applicable).\n10. History of solid organ transplant.\n11. Active autoimmune disease requiring systemic treatment within the past 1 year.\n12. Recent (within 12 weeks) or active non-infectious pneumonitis requiring corticosteroid therapy.\n13. Major surgical procedure or active\u002Fsevere infection within 14 days prior to registration.\n14. Subject is a WOCBP who has had a positive pregnancy test within 24 hours prior to initiation of study treatment. Females will be determined to be not of child-bearing potential with a history of hysterectomy or with postmenopausal status of \\>12 months.\n15. Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 180 days after the last dose of trial treatment.\n16. History of hypersensitivity to compounds that are similar to carboplatin and paclitaxel.\n17. Has received major surgery and has not recovered adequately from the toxicity and\u002For complications before starting study treatment.\n18. Has a history of non-infectious pneumonitis that required high-dose steroids and\u002For has current pneumonitis.\n19. Has an active bacterial infection requiring systemic therapy.\n20. Known psychiatric or substance abuse disorders that would interfere with the requirements of the trial.\n\n    Vaccination\n21. Administration of live vaccines within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza or COVID vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.",{"count":432,"type":21},55,[174],"This study tests a new treatment approach for people with early-stage triple negative breast cancer whose tumors have a high number of immune cells, called tumor-infiltrating lymphocytes or TILs, as seen by a pathologist on tissue review. A high TIL count is a sign the cancer may respond especially well to chemotherapy and immunotherapy together, meaning more toxic treatment may not be needed for everyone.\n\nAll patients with high TILs will receive 12 weeks of chemotherapy (carboplatin and paclitaxel) with the immunotherapy drug pembrolizumab before surgery, without anthracyclines, a class of chemotherapy drugs that is effective but carries risks of heart damage and, rarely, bone marrow disorders or leukemia. Patients with no cancer found at surgery continue on pembrolizumab alone. Those with residual cancer receive anthracycline-based chemotherapy plus pembrolizumab, closer to current standard treatment.\n\nThe goal is to personalize treatment, sparing anthracyclines for patients likely to do well without them while reserving stronger therapy for those who need it. The main measure of success is the pathologic complete response rate, with cancer-free survival and overall survival also assessed.",[436,437],"Triple Negative Breast Cancer (TNBC)","Elevated Tumor-Infiltrating Lymphocytes",[439,440,441,442,443,444,445],"Triple Negative Breast Cancer","Neoadjuvant chemoimmunotherapy","Neoadjuvant treatment","TILs","TIL","anthracycline sparing","non-anthracycline based",{"date":387,"type":37},{"date":161,"type":21},{"date":449,"type":21},"2030-03-01",{"name":43,"class":44},{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":22,"phases":460,"briefSummary":462,"conditions":463,"keywords":464,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":366},"100625320","early-phase-1-pilot-of-mailing-buprenorphine-100625320","NCT07421102","Pilot of Mailing Buprenorphine","A Pragmatic Remote Approach to Improve Transitions of Care and Retention in Opioid Use Disorder Treatment","Inclusion Criteria:\n\n* Age ≥ 18\n* English-speaking\n* Diagnosed with OUD and initiated on buprenorphine during hospitalization\n* Discharging to a South Carolina address with a stable mailbox\n* Access to phone or computer\n\nExclusion Criteria:\n\n* Active psychosis or suicidal ideation\n* Severe medical or neurocognitive impairment\n* Pending incarceration",{"count":459,"type":21},20,[461],"EARLY_PHASE1","This pilot study evaluates the feasibility, acceptability, and preliminary effectiveness of mailing buprenorphine to individuals with opioid use disorder (OUD) following medical hospitalization. The intervention aims to improve retention in treatment by overcoming barriers such as transportation and pharmacy access.",[131],[465,466,467,468],"mailing buprenorphine","transitions of care","opioid use disorder","barriers to buprenorphine",{"date":470,"type":37},"2026-07-30",{"date":472,"type":37},"2026-04-08",{"date":474,"type":21},"2027-03",{"name":43,"class":44},{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":170,"enrollmentInfo":483,"targetDuration":4,"studyType":22,"phases":485,"briefSummary":486,"conditions":487,"keywords":490,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":498,"locationsCount":93},"100606766","motoneuron-recruitment-and-motor-evoked-potential-up-conditioning-mep-in-spinal-cord-injury-sci-100606766","NCT07179822","Motoneuron Recruitment and Motor Evoked Potential Up-Conditioning (MEP) in Spinal Cord Injury (SCI)","Can MEP Conditioning Improve Corticospinal Recruitment of Motoneurons in Chronic Cervical SCI?","Inclusion Criteria:\n\n* Adult (≥18 yrs old)\n* a history of injury to spinal cord at or above C6\n* neurologically stable (\\>1 year post SCI)\n* medical clearance to participate\n* weak wrist extension at least unilaterally\n* expectation that current medication will be maintained without change for at least 3 months.\n\n  * Stable use of anti-spasticity medication (e.g., baclofen, diazepam, tizanidine) is accepted. (Because only neurologically stable subjects will enter this study, medication changes will be unlikely.)\n  * In participants with bilateral wrist extension weakness in whom Extensor Carpi Radialis (ECR) MEP can be elicited in both arms, the more severely impaired arm is studied. In participants with unilateral wrist weakness or in participants with bilateral wrist weakness in whom an ECR MEP can be elicited in only one arm, that arm is studied.\n\nExclusion Criteria:\n\n* motoneuron injury\n* unstable medical condition\n* cognitive impairment (because the studied intervention is a learning-based intervention)\n* a history of epileptic seizures\n* a pre-existing or confounding neurological condition (e.g., history of MS, Stroke, Parkinson's disease)\n* metal implants in the cranium\n* implanted biomedical device in or above the chest (e.g., a cardiac pacemaker, cochlear implant)\n* no measurable MEP elicited in the ECR\n* inability to produce any voluntary ECR EMG activity\n* extensive use of functional electrical stimulation to the arm on a daily basis (as it may interfere with or augment the effects of MEP conditioning itself)\n* pregnancy (due to changes in posture and potential medical instability)\n* inability or unwillingness of subject or legal guardian\u002Frepresentative to give informed consent",{"count":484,"type":21},15,[24],"The purpose of this research study is to examine the effect of a brain stimulation training to improve the function of brain-spinal cord- muscle connections. Because brain-to-muscle pathways are very important in our movement control, restoring function of these pathways may improve movement problems after injuries. Spinal cord injury causes damage to the brain-to-muscle connection. However, when the injury is \"incomplete\", there is a possibility that some of the brain-to-muscle pathways are still connected and may be trained to improve movement function. For examining brain-to-muscle pathways, investigators use a transcranial magnetic stimulator. Investigators hope that the results of this research study will help us develop new treatments for people who have movement disabilities. This study will require about 42 visits over the first 14 weeks, and another 6 visits over an additional 3 months. Each visit will take about 1 ½ hours.",[488,489],"Spinal Cord Injuries and Disorders (SCI\u002FD)","Spinal Cord Injury",[491,492],"Movement Disorders","Rehabilitation Studies","2026-07-28",{"date":416,"type":37},{"date":496,"type":37},"2025-11-03",{"date":243,"type":21},{"name":43,"class":44},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":74,"sex":51,"minAge":506,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":509,"conditions":510,"keywords":512,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":93},"100114570","systemic-lupus-erythematosus-in-gullah-health-100114570","NCT00756769","Systemic Lupus Erythematosus in Gullah Health","SLEIGH","Inclusion Criteria:\n\n* Age 2 years and above;\n* Self-identified as African-American \"Gullah\" from the Sea Island region of South Carolina;\n* Have had at least 4 of the 11 diagnostic criteria for SLE as designated by the American College of Rheumatology (ACR), be a relative of a known SLE patient, or be an unrelated healthy Gullah control;\n* Ability to speak and understand English;\n* Ability and willingness to give informed consent\n\nExclusion Criteria:\n\n* Race defined by participant as other than Black or African-American;\n* Being a prisoner, mentally ill patient, or institutionalized individual;\n* Unwilling or unable to give informed consent","2 Years",{"count":508,"type":21},750,"Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by the production of autoantibodies, multiple organ involvement, and diverse clinical symptoms and immunologic manifestations. African Americans are at a disproportionately higher risk of developing SLE, develop SLE at an earlier age, and have increased morbidity and mortality compared with European Americans. Our central study hypothesis is that there are specific genetic factors that interact with environmental exposures leading to the development of SLE. The African American Gullah population from the Sea Islands of South Carolina and Georgia are unique in their genetic homogeneity with minimal non-African genetic admixture, making them an ideal cohort to address questions of environmental and genetic influence on the development and progression of SLE.",[511],"Systemic Lupus Erythematosus",[513],"African Americans","2026-07-27",{"date":493,"type":37},{"date":517,"type":4},"2003-04",{"date":519,"type":21},"2028-06",{"name":43,"class":44},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":22,"phases":529,"briefSummary":530,"conditions":531,"keywords":535,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":93},"100564872","early-phase-1-efficacy-of-intramuscular-steroid-injection-for-chronic-cough-100564872","NCT06634823","Efficacy of Intramuscular Steroid Injection for Chronic Cough.","Prospective Placebo-Controlled Trial of Intramuscular Steroid Administration for the Treatment of Unexplained Chronic Cough","Inclusion Criteria:\n\n* History consistent with chronic unexplained or refractory cough\n* Age ≥ 18\n\nExclusion Criteria:\n\n* Current smokers\n* Uncontrolled diabetes (A1c\\>7%)\n* Patients on ACE inhibitors or Angiotensin II receptor blockers (ARBs)\n* Abnormal pulmonary function testing (PFTs) since start of the cough\n* Patients with uncontrolled obstructive sleep apnea\n* Abnormal chest X-ray within past 6 months\n* Uncontrolled reflux\n* Prior superior laryngeal nerve injection\n* Current neuromodulating medication use for chronic cough\\*",{"count":229,"type":21},[461],"The primary goal of this study is to test the hypothesis that injecting steroid intramuscularly is an effective treatment for unexplained chronic cough. This will be achieved through the design of a prospective, placebo-controlled, single-blind, randomized clinical trial in which one group of patients will undergo a steroid injection into the deltoid muscle and the second group will undergo a placebo injection into the deltoid muscle. Data to determine if a clinically significant difference exists between the outcomes of the two groups will be measured by a dichotomous yes\u002Fno response to improvement, the Leicester Cough Questionnaire, and a visual analogue scale for symptom severity. This will provide the answer to the general question of whether or not the intramuscular injections are clinically effective for patients with unexplained chronic cough. Furthermore, any adverse reactions will be thoroughly documented. If this hypothesized treatment is proven effective, this can greatly improve the care of chronic cough patients by allowing for an evidence-based treatment option and a treatment option that may improve access to care. While the superior laryngeal nerve (SLN) injection is typically performed by fellowship trained laryngologists, intramuscular injections could be more widely utilized by general otolaryngologists or providers in other fields of medicine.",[532,533,534],"Chronic Cough (CC)","Laryngeal Disease","Coughing",[536,537,538,539],"Throat","Chronic cough","Neurogenic cough","Unexplained cough","2026-07-21",{"date":542,"type":37},"2026-07-22",{"date":544,"type":37},"2024-12-02",{"date":546,"type":21},"2027-06-30",{"name":43,"class":44},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":554,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":17,"minAge":556,"maxAge":557,"enrollmentInfo":558,"targetDuration":4,"studyType":22,"phases":560,"briefSummary":561,"conditions":562,"keywords":564,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":572,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":93},"100537100","healing-equity-advocacy-and-respect-for-mamas-100537100","NCT06273436","Healing, Equity, Advocacy and Respect for Mamas","Comparing Standard of Care Versus a Technology-Based Approach To Reduce Postpartum Emergency Department Visits","HEAR4Mamas","Inclusion Criteria for Postpartum Women\n\n* Postpartum woman within approximately 2 weeks of delivering a baby of gestational age ≥ 26 weeks in South Carolina.\n* Aged 16-49 years old.\n* Insured by Medicaid.\n\nExclusion Criteria for Postpartum Women\n\n* Plans to relocate outside of SC anytime during the postpartum year.\n* Plans to discontinue Medicaid health insurance during the postpartum year.\n* Speaks a language other than English or Spanish.\n* Incarcerated\u002Fpending incarceration during peripartum period.\n* Currently institutionalized.\n* Enrolled in current MUSC study funded by PCORI (#Pro00123833)\n* Does not have and\u002For does not wish to use their personal cell phone for the study.\n\nInclusion Criteria for Obstetric Providers and Hospital Administrators\n\n\\- OB provider working at a delivery hospital in SC and directly involved in the care of postpartum women; or hospital administrator working in a delivery hospital in SC and job responsibilities relate to the postpartum unit.\n\nExclusion Criteria for Obstetric Providers and Hospital Administrators\n\n* Less than 1 month of HEAR 4 Mamas experience if involved in the hospital where participants are recruited from.\n* Unable or unwilling to commit to completing surveys or an interview.\n* Speaking a language other than English.","16 Years","49 Years",{"count":559,"type":21},2894,[24],"The goal of the proposed research is to test the comparative effectiveness of AIM safety bundles for post-partum women delivered in-person vs. via text\u002Fphone to improve early detection of and timely care for complications during the first six weeks postpartum for women experiencing significant health disparities.",[563],"Postpartum Complication",[565,566,567,568,569,570,571],"AIM (Alliance for Innovation on Maternal Health) safety bundles","Randomized Controlled Trial (RCT)","Emergency Department (ED) visits","Shared Decision Making (SDM)","Patient-Reported Outcomes (PROs)","Patient Stakeholder Group (PSG)","Study Advisory Committee (SAC)",{"date":542,"type":37},{"date":574,"type":37},"2024-05-28",{"date":576,"type":21},"2030-03-30",{"name":43,"class":44},{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":4,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":51,"minAge":585,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":22,"phases":588,"briefSummary":589,"conditions":590,"keywords":592,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":602,"completionDateStruct":603,"leadSponsor":605,"locationsCount":4},"100628520","early-phase-1-topical-minocycline-for-carp-100628520","NCT07462702","Topical Minocycline for CARP","Topical Minocycline Foam for Treatment of Confluent and Reticulated Papillomatosis (CARP)","Inclusion Criteria:\n\n* Age ≥ 9 years\n* Clinical diagnosis of CARP\n\nExclusion Criteria:\n\n* Current or recent (within 6 months) use of oral minocycline\n* Pregnancy or breastfeeding\n* History of intracranial hypertension, autoimmune disorder, liver\u002Fkidney disease\n* Immunocompromised status\n* Hypersensitivity to tetracyclines\n* Unstable medical condition\n* Inability or unwillingness to provide informed consent","9 Years",{"count":587,"type":21},35,[461],"This proof-of-concept trial evaluates the efficacy, safety, and patient satisfaction of topical minocycline foam (AMZEEQ®) in patients aged 9 and older with confluent and reticulated papillomatosis (CARP). Participants will apply AMZEEQ® to one side of the body and a topical emollient to the other for 5 weeks, followed by an optional extension period. The study aims to assess whether topical minocycline is a well-tolerated and effective alternative to oral antibiotics.",[591],"Confluent and Reticulated Papillomatosis (CARP)",[593,594,595,596,597,598,599],"Topical Minocycline","Confluent and reticulated papillomatosis (CARP)","CARP","Confluent and reticulated papillomatosis","Minocycline","Tetracycline","Pruritus","2026-07-20",{"date":540,"type":37},{"date":62,"type":21},{"date":604,"type":21},"2028-02",{"name":43,"class":44},{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":74,"sex":51,"minAge":75,"maxAge":4,"enrollmentInfo":613,"targetDuration":4,"studyType":22,"phases":615,"briefSummary":616,"conditions":617,"keywords":619,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":93},"100508102","impact-of-cigarette-and-e-cigarette-menthol-regulation-on-current-smokers-of-menthol-cigarettes-100508102","NCT05896033","Impact of Cigarette and E-cigarette Menthol Regulation on Current Smokers of Menthol Cigarettes","The Impact of Menthol Regulation for Cigarettes and E-cigarettes on Tobacco Use Patterns for Current Menthol Smokers","Inclusion Criteria:\n\n1. adults (21+) who a) have been smoking at least 5 cigarettes daily for one year\n2. usual brand (the brand used most often) is mentholated\n3. have a smartphone that can receive text messages and access the internet (necessary for diary completion).\n\nExclusion Criteria:\n\n1. other tobacco and pharmacotherapy criteria\n2. health and safety criteria\n3. planning to move out of the area within the next 3 months",{"count":614,"type":21},240,[24],"In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well-established methodology for simulating tobacco regulatory policies. To model a ban, smokers will be instructed to only use their assigned products. Primary outcomes include cigarette smoking and e-cigarette use during Week 6. However, because a menthol ban may impact the ability to abstain from smoking, the investigators will incentivize participants to abstain from smoking during Week 7 (continued e-cigarette use allowed) and assess the time to first lapse. Participants will complete daily electronic diaries assessing tobacco product use throughout, which will be corroborated by biomarkers for menthol, nicotine, and smoke. Finally, to maximize the utility of these data for FDA regulation, the investigators will assess whether any demographic or baseline smoking characteristics moderate the observed treatment effects, calibrate the treatment effects to the US adult menthol smoking population, and model the effects of menthol regulation in cigarettes and e-cigarettes on smoking and vaping-attributable deaths and life-years lost.",[618],"Smoking Prevention and Control",[85,620],"Menthol",{"date":540,"type":37},{"date":623,"type":37},"2023-10-23",{"date":625,"type":21},"2027-08-31",{"name":43,"class":44},{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":632,"acronym":633,"eligibilityCriteria":634,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":170,"enrollmentInfo":635,"targetDuration":4,"studyType":22,"phases":636,"briefSummary":637,"conditions":638,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":93},"100648388","phase-2-study-of-autologous-metabolically-optimized-cd137-tumor-infiltrating-lymphocytes-followed-by-consolidative-oral-cyclophosphamide-bevacizumab-and-pembrolizumab-100648388","NCT07720180","Study of Autologous, Metabolically Optimized, CD137+ Tumor-Infiltrating Lymphocytes Followed by Consolidative Oral Cyclophosphamide, Bevacizumab, and Pembrolizumab","OVAFIT-TIL: A Phase Ib Study of Autologous, Metabolically Optimized, CD137+ Tumor-Infiltrating Lymphocytes Followed by Consolidative Oral Cyclophosphamide, Bevacizumab, and Pembrolizumab in Recurrent Ovarian Cancer","OVAFIT-TIL","Inclusion Criteria:\n\n5.1.1 STEP 1: RESECTION OF TUMOR \\& INITIATION OF TIL EXPANSION Patients must fulfill all of the following criteria to be eligible for the study at the time of tumor resection and initiation of TIL expansion.\n\n1. Provision of signed and dated informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Female, aged 18 to 80 years.\n4. Patients must have recurrent epithelial ovarian cancer, all subtypes will be eligible.\n5. Measurable disease for target lesion(s) per RECIST prior to resection. If only one measurable lesion prior to surgery, residual disease measurable lesion must be present after resection on baseline imaging.\n6. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 to 1 and life expectancy of \\> 6 months.\n7. Patients must have progressed on at least one prior standard of care treatment regimen for metastatic disease, may include platinum sensitive and resistant patients. Platinum sensitive disease as defined by recurrence of disease more than 6 months following a complete response to initial treatment and platinum recurrent as defined by recurrence less than 6 months after a complete response to initial treatment. If patients are 2nd line platinum sensitive, they must have progressed \\\u003C 1 year of last platinum therapy. Also, for 2nd line platinum sensitive patients that are candidates for PARP maintenance, they must have had a frontline PARP maintenance or attempt at PARP maintenance with unacceptable toxicity\u002Fintolerance. For 3rd line or more platinum sensitive patients, all platinum free intervals (PFI) are acceptable.\n\n   a. The allowance of platinum sensitive patients is based on the high response rate and durability (Sensitive: ORR-60% DOR-11.5 mos, vs Resistant: ORR 43.3, DOR 5.5 mos) seen in the study that gave rationale for the consolidative regimen of oral cyclophosphamide, bevacizumab, pembrolizumab (Zsiros et al, 2021). As well, higher responses are observed to targeted therapies in platinum sensitive patients (mirvetuximab Plat Sens: ORR 51% vs Plat resistant: 32%), similar to platinum combination response rates and PFS. By introducing an immunotherapeutic-targeted regimen in platinum sensitive patients, it further extends the platinum free interval (PFI) increasing later platinum response potential, especially those in the 6-12 mos PFI.\n8. A negative pregnancy test (urine or serum) must be documented at screening for women of childbearing potential.\n9. A MUGA\u002FECHO scan (ejection fraction \\> 45% is required) ≤ 6 months prior to lymphodepletion. New York Heart Association functional classification Class \\\u003C1 are required.\n10. Patients who have a history of ischemic heart disease, angina, or clinically significant atrial and\u002For ventricular arrhythmias must undergo a cardiac stress test, patients with abnormal cardiac stress test, may be considered for study if they have adequate ejection fraction (\\>45%) and cardiology clearance with approval of Primary Investigator.\n11. Screening Pulmonary function tests should be performed for select patients (see below) with postbronchodilator values: Forced expiratory volume in 1s, (FEV1)\u002Fforced vital capacity\\>70%' or FEV1\\>50% of predicted normal is recommended.\n\n    1. History of cigarette smoking of ≥ 20 pack-years\n    2. Cessation of smoking withing past 2 years or still smoking\n    3. History of pneumonitis (including related to prior cancer treatment), COPD, or asthma\n    4. Significant signs of respiratory dysfunction on exam (wheezing, rales, chronic cough)\n    5. History of pleural drainage in the past 3 months\n\n    i. For patients with pleural effusions, if parameters are not met, consideration of drainage prior repeat PFT is reasonable, in this scenario, if reaccumulated on baseline CT after tumor procurement, consider drainage again prior to lymphodepletion.\n12. Adequate renal function, including creatinine ≤ 1.5 mg\u002FdL and CrCl \\>40L\u002Fmin, ideally \\>60L\u002Fmin. If creatinine is 1.6-2 mg\u002FdL, then will need CrCl\\>60L\u002Fmin to be considered.\n13. Adequate hepatic function total bilirubin ≤ 2.0 mg\u002FdL, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg\u002FdL, AST and ALT of less than 3 X institutional upper limit of normal (ULN), patients with liver metastasis may have up to 5xULN.\n14. Adequate hematologic function, hemoglobin (hgb) of 8 gm\u002FdL or more, and platelets of 75,000 per mm3 or more for surgical resection. A packed red blood cell transfusion is acceptable, though must remain stable above 8mg\u002FdL on repeat evaluation remains stable on or after 7 days.\n15. Patients must have a positive screening EBV antibody titer on screening test.\n16. Participants may have had prior bevacizumab, cyclophosphamide, and\u002For pembrolizumab.\n\n5.1.2 STEP 2: CHEMOTHERAPY\u002FCELL INFUSION INCLUSION CRITERIA\n\nTo be eligible for chemotherapy\u002Fcell infusion, patients must fulfil the following criteria:\n\n1. Patients must have adequate TILs expanded, (\\>1x109 cells).\n2. Women of childbearing potential (WOCBP) must practice birth control while on regimen and for 3 months after receiving the preparative regimen.\n3. Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), the patient agrees to continue to use a method of contraception throughout the study and for 90 days after your last treatment such as: barrier (i.e. condom, diaphragm), hormonal, IUD, or sponge plus spermicide.\n4. For women who have menstruated within the past 12 months and have not had a surgical procedure to accomplish sterilization, pregnancy testing (serum) will be performed within 7 days prior to treatment.\n5. Clinical performance status of ECOG 0 to 1 at the time of chemotherapy infusion.\n6. Absolute neutrophil count greater than or equal to 1000\u002Fmm3.\n7. Platelet count greater than or equal to 100,000\u002Fmm3.\n\n17\\. Adequate renal function, including creatinine ≤ 1.5 mg\u002FdL and CrCl \\>40L\u002Fmin, ideally \\>60L\u002Fmin. If creatinine is 1.6-2 mg\u002FdL, then will need CrCl\\>60L\u002Fmin to be considered.\n\na. Fludarabine dose should be reduced (20 mg\u002Fm2 in patients with CrCl 40-59 mL\u002Fmin) 8.Adequate hepatic function total bilirubin ≤ 2.0 mg\u002FdL, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg\u002FdL, AST and ALT of less than 3 X institutional upper limit of normal (ULN), patients with liver metastasis may have up to 5xULN.\n\n9.Adequate hematologic function, platelet count greater than or equal to 100,000\u002Fmm3. Hemoglobin (hgb) of 8 gm\u002FdL or more, a packed red blood cell transfusion is acceptable, though must remain stable above 8mg\u002FdL on repeat evaluation remains stable on or after 7 days.\n\n10.Prothrombin time (PT) and partial thromboplastin time (PTT) within 1.5 times the institutional upper limit of normal.\n\n11.Urinalysis within 14 days demonstrating no evidence of a urinary tract infection.\n\nExclusion Criteria:\n\n5.2.1 STEP 1: RESECTION OF TUMOR \\& INITIATION OF TIL EXPANSION\n\nPatients who meet the following criteria will be excluded from study participation:\n\n1. Patients with active systemic infections requiring intravenous antibiotics, coagulation disorders, or other major medical illnesses of the cardiovascular, respiratory, or immune system.\n2. Frontline platinum refractory patients (progression on or \\\u003C90 days from last platinum dose)\n3. Patients that have completed an adoptive cellular therapy regimen which included a non-myeloablative lymphodepletion strategy. Prior Bi-specific T-cell engagers are allowed if done without lymphodepletion and no grade 3 CRS\u002FICANs events were experienced.\n4. Patients testing positive for HIV titer, hepatitis B surface antigen, human T-cell leukemia-lymphoma virus (HTLV) I or II antibody, or both rapid plasma regain (RPR) and fluorescent treponemal antibody (FTA). Patients with hepatitis C antibody must have a negative (undetectable) viral load by polymerase chain reaction (PCR).\n5. Patients who are pregnant or nursing.\n6. Patients needing chronic immunosuppressive systemic steroids (\\>10mg\u002Fday prednisone or equivalent).\n7. Patients with autoimmune diseases that require immunosuppressive medications.\n8. Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent or render immunotherapy unsafe or contraindicated.\n9. Patients with active untreated central nervous system metastases. Patients will be allowed with historically treated brain metastasis (treatment completed \\>28 days prior to consenting to study) and they undergo MRI at screening that reveals no new or worsening brain lesions and does not require ongoing corticosteroid treatment (\\>10mg\u002Fday prednisone or equivalent). Patients with leptomeningeal disease are excluded regardless of prior brain treatment response.\n10. Patients with a separate primary malignancy within the past 3 years (except those that did not require more than excisional curative treatment for early stage, or have been curatively treated, and in the judgement of the investigator does not pose a significant risk of recurrence, including but not limited to non-melanoma skin cancer, ductal\u002Flobular carcinoma in situ of the breast, or superficial bladder cancer).\n11. Patients with recent clinical evidence of malignant bowel obstruction (small intestine or colon) in the past 60 days unless was unrelated to malignancy and surgically corrected (ex. - hernia) \\>28 days prior to signing consents.\n12. Participants with any form of primary immunodeficiency (ex. Severe combined immunodeficiency disease or AIDS).\n13. Patient with history of hypersensitivity to any component of the study intervention (cyclophosphamide, mesna, fludarabine, IL-2). Or to the components of the TIL product including dimethyl sulfoxide (DMSO), human serum albumin, IL-2. Patients will be allowed if they have hypersensitivity to any of the supportive medications as long as there is acceptable alternative, per primary investigator.\n14. Patients with an inability to comprehend and give informed consent.",{"count":459,"type":21},[174],"Patients with recurrent ovarian cancer will undergo resection of a safely accessible metastatic lesion, from which tumor-infiltrating lymphocytes (TIL) will be cultured, metabolically reprogrammed for metabolic fit T cells, then selected for CD137+ activated T cells, and then expanded. This expanded TIL product will be infused following nonmyeloablative lymphodepletion chemotherapy. High-dose IL-2 will be given after TIL infusion to support the cell product expansion. Once recovered from TIL infusion, patients will start consolidative systemic therapy with oral cyclophosphamide, bevacizumab, and pembrolizumab.",[639],"Ovarian Cancer","2026-07-17",{"date":542,"type":37},{"date":643,"type":21},"2026-12-01",{"date":645,"type":21},"2032-12-01",{"name":43,"class":44},""]