[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rhode Island Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":695},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,33,0,25,[9,47,76,107,134,165,199,224,257,279,300,330,360,386,408,430,456,488,509,537,565,594,624,651,672],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100652779","personalized-addiction-treatment-ehancement-100652779",false,"NCT07778394","Personalized Addiction Treatment eHancement","The Vira Platform: A Contextually Triggered Just-in-Time Adaptive Intervention for Opioid Use Disorder","Project Path","Inclusion Criteria:\n\n* Age 22+\n* Current Opioid Use Disorder diagnosis\n* Prescribed buprenorphine or methadone\n* Initiated or reinitiated buprenorphine or methadone treatment recently\n* Access to personal smartphone\n\nExclusion Criteria:\n\n* Not fluent in English\n* Limited mental capacity or inability to provided informed consent","ALL","22 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"NA","Many patients stop medication-based treatments for Opioid Use Disorder (OUD) prematurely, placing them at increased risk for overdose and death. Providing targeted interventions for OUD, particularly through an accessible, digital health platform, is a potential way to enhance recovery and keep patients engaged in care. The current study seeks to test whether a digital mental health platform, delivered by peer recovery support specialists to individuals prescribed buprenorphine or methadone medication, will improve treatment outcomes for this high risk population.",[28,29,30],"Opioid Use Disorder","mHealth","Peer Support",[32,33],"Peer Recovery Support","Digital Support","RECRUITING","2026-08-18",{"date":37,"type":38},"2026-08-21","ACTUAL",{"date":40,"type":38},"2026-08-13",{"date":42,"type":22},"2027-03-31",{"name":44,"class":45},"Rhode Island Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":46},"100649761","connecting-loved-ones-to-support-and-empowering-recovery-100649761","NCT07740395","Connecting Loved Ones to Support and Empowering Recovery","Harnessing mHealth to Support Loved Ones of Individuals in Recovery From Substance Use Disorders","Project Closer","Inclusion Criteria for Individuals in Recovery:\n\n* 18+\n* have met criteria for a substance use disorder (with or without concomitant alcohol use disorder) in the past 24 months\n* have taken steps in the past 12 months to quit using drugs, cut down on drug use, or change the way in which they use drugs in order to improve the quality of their lives\n* willing to nominate a loved one to receive KulaMind-Recovery\n* have a loved one who is willing to participate in the study\n* able to understand and speak English and provide written and verbal consent\n\nInclusion Criteria for Loved Ones:\n\n* 18+\n* have a sustained relationship with the individual in recovery and are perceived to be an important person in the individual in recovery's life\n* do not provide professional substance use disorder-related services to the individual in recovery\n* have regular access to a device to engaged with KulaMind-Recovery\n* able to understand and speak English and provide written and verbal informed consent\n* do not endorse current (past month) suicidality",true,"18 Years",{"count":58,"type":22},60,[25],"Substance use disorders are highly prevalent. However, recovery from them is possible. The recovery process can benefit greatly from support from loved ones. Loved ones may need guidance in the most helpful ways to support recovery. This study aims to refine and test a web-based intervention, known as KulaMind-Recovery, which offers online skill building and educational modules, one-on-one video sessions and \"on-demand\" text-based support from a coach, and access to a community forum to connect with others with shared experience.",[62,29],"Substance Use Disorder (SUD)",[64,65,66,67],"Recovery","Loved Ones","Addiction","Substance Use","2026-08-17",{"date":70,"type":38},"2026-08-19",{"date":72,"type":38},"2026-07-17",{"date":74,"type":22},"2027-04-30",{"name":44,"class":45},{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":18,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":46},"100600042","an-adaptive-intervention-to-increase-engagement-to-community-based-care-after-an-ed-admission-100600042","NCT07092345","An Adaptive Intervention to Increase Engagement to Community-Based Care After an ED Admission","An Adaptive Intervention to Increase Engagement to Community-based Care After an ED Admission: For Youth at Risk for Suicide and Self-injurious Behavior","ED_SMART","Inclusion Criteria:\n\n* Youth 8 to 17 years\n* Youth presenting to the ED with suicide and self-injurious behavior\n* Youth living at home with at least one legal guardian\u002Fcaregiver\n\nExclusion Criteria:\n\n* Youth presenting to the ED with psychosis, sexual assault, child abuse\n* Youth in police custody,\n* Youth with an active investigation with the department of child and youth services (DCYF)\n* Youth unable to assent due to severity of illness or developmental disabilities,\n* Youth who cannot communicate in English or Spanish,\n* Youth without a caregiver\u002Flegal guardian who can provide consent","8 Years","17 Years",{"count":87,"type":22},186,[25],"The goal of this study is to develop a feasible brief, family-based adaptive intervention, via SMART design, for youth with suicidal and non-suicidal self-injurious behavior (SSIB) to increase community-based mental health (MH) care attendance and reduce SSIB risk post emergency department (ED) admission. The intervention will focus to increase understanding on youth MH literacy, MH communication, and MH engagement. Integrating an adaptive intervention via a SMART design in the ED could address subsequent barriers to youth obtaining appropriate level of community-based MH care and therefore reduce ED readmissions.",[91,92],"Suicidal and Self-injurious Behavior","Linkage to Care",[94,95,96,97,98,99],"suicidality","self-injurious behavior","adaptive intervention","emergency department","caregivers","youth",{"date":101,"type":38},"2026-08-14",{"date":103,"type":38},"2025-03-17",{"date":105,"type":22},"2029-03",{"name":44,"class":45},{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":46},"100549891","irrisept-solution-for-instrumented-spine-surgery-100549891","NCT06439953","Irrisept Solution for Instrumented Spine Surgery","Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation","Inclusion Criteria:\n\n* Age: 18+ years old\n* Indications: deformity, oncologic, degenerative, trauma\n* Standard layer-by-layer closure\n* Locoregional flap-based closure\n\nExclusion Criteria:\n\n* Acute\u002Fchronic open wounds (spine or non-spine)\n* On-going non-spinal infection within 30 days of index operation\n* Concurrent antibiotic use (for spine or non-spine infections)\n* History of prior spinal infection\n* Allergy to vancomycin or chlorhexidine\n* Suspicion for osteomyelitis\n* Other surgery within 90 days post-operatively fromm index\n* Concurrent enrollment in other trial",{"count":115,"type":22},200,[25],"Various spine surgeons perform wound irrigation using saline mixed with vancomycin, relying on mechanical debridement of non-viable tissue, physical disruption of biofilm, and bacteriostatic effect against gram positive flora. When used as a powder, topical application of vancomycin has demonstrated increased risk of symptomatic seroma formation, which is an adverse outcome that often requires bedside or intra-operative aspiration. Broad-spectrum antiseptic agents, such as Irrisept, offer bacteriocidal properties to eliminate hardware inoculation, thereby minimizing the risk of deep space infection, while obviating the risk of seroma development.",[119,120,121,122,123,124,125,126],"Post-Op Complication","Spine Surgery","Site Infection","Surgical Site Infection","Spinal Instrumentation","Index Spinal Instrumentation","Layer-by-Layer Closure","Locoregional Flap-Based Closure","2026-08-12",{"date":101,"type":38},{"date":130,"type":38},"2024-10-01",{"date":132,"type":22},"2028-04",{"name":44,"class":45},{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":55,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":144,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":4},"100573510","implementation-science-to-enhance-hiv-testing-services-during-emergency-care-in-kenya-100573510","NCT06747221","Implementation Science to Enhance HIV Testing Services During Emergency Care in Kenya","HIV Enhanced Access Testing in Emergency Department Program Using a Systems Analysis and Improvement Approach (HEATED-SAIA) Cluster Randomized Trial","HEATED-SAIA","Facility Level (Quantitative De-identified Systems Data)\n\nInclusion Criteria:\n\n* Kenya public health facilities in Kwale, Mombassa and Kilifi Counties\n* Have an active emergency department\n* Have HIV testing services either embedded in the emergency department or the facility.\n\nExclusion Criteria:\n\n* Private health facilities\n* Kenya public health facilities in Kwale, Mombassa and Kilifi Counties without an active emergency department\n* Kenya public health facilities in Kwale, Mombassa and Kilifi Counties without existing HIV testing services\n\nParticipant Level (Qualitative Data) Healthcare Personnel\n\nInclusion Criteria:\n\n* Personnel working at the departments of health in Kwale, Mombassa and Kilifi Counties\n* Personnel working at a Kenya public health facilities randomized to the control or intervention arm in Kwale, Mombassa and Kilifi Counties\n* Age 18 years or greater\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Personnel not working at a Kenya public health facilities randomized to the control or intervention arm in Kwale, Mombassa and Kilifi Counties\n* Age less than 18 years\n* Not able and willing to provide informed consent\n\nParticipant Level (Qualitative Data) ED-HTS Clients\n\nInclusion Criteria:\n\n* Patients receiving emergency care and engaged for ED-HTS at a Kenya public health facilities randomized to the intervention arm of the trial in Kwale, Mombassa and Kilifi Counties\n* Age 18 years or greater\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Not able and willing to provide informed consent",{"count":143,"type":22},184,[25],"There are \\~38 million people living with HIV (PLH), with the majority in low-and middle-income countries (LMICs), where the UNAIDS 95-95-95 HIV targets are at risk of not being achieved. Data show that incident infections are concentrated in sub-Saharan Africa and focused in difficult to reach populations. These harder to reach persons frequently also have higher-risk profiles for HIV, making them essential target populations to receive HIV Testing Services (HTS). Among target populations, men, adolescents and young adults (AYAs) aged 15-24 years, and persons from key populations (KPs) represent crucial groups to be reached. In Africa, Emergency Departments (ED) provide care to large numbers of persons that often do not otherwise access health services. Data from Africa show that those seeking emergency care have high burdens of HIV, and desire ED-HTS. As in higher-income countries, EDs in LMICs provide a strategic opportunity to deliver evidence-based HTS interventions to higher-risk persons. In Kenya one in five PLH are unaware of their status, less than half of men are reached for HIV testing at appropriate frequencies, AYAs account for 42% of new infections and KPs contribute to hyper-endemic transmission. To address this, Kenya national strategy calls for utilizing facilities-based care to deliver HTS for difficult to reach populations. However, while the guidelines include EDs as service delivery points, HTS during emergency care in Kenya is still evolving and the evidence-base on best practices is in early development. The HIV Enhanced Access Testing in Emergency Department (HEATED) program in Kenya was developed by a collaborative team led by PI Aluisio (K23AI145411). The HEATED program was derived using the Capability-Opportunity-Motivation Behavioral model to enhance delivery of HTS, through locally appropriate and pragmatic systems initiatives. HEATED program implementation significantly improved HIV testing for the overall ED population by 31%, while also significantly increasing testing for men, AYA and KP and was found to be acceptable by stakeholders. Although pilot evaluation of the HEATED program demonstrated improved HTS for target populations, more robust understanding of optimal implementation strategies in ED settings, impacts on linkage to HIV care outcomes, costing and maintenance data are needed to inform development of ED-HTS programming in Kenya. To address this, the current proposal will build upon the HEATED program by evaluating use of the Systems Analysis and Improvement Approach (SAIA) implementation strategy (HEATED-SAIA) to improve HTS in a cluster randomized trial in all Ministry of Health EDs in Kilifi, Mombasa and Kwale Counties of the Coast Region of Kenya. The Reach, Effectiveness, Adoption, Implementation and Maintenance framework with quantitative and qualitative data will be used in trial assessment. Building on the K23 pilot data and leveraging SAIA, the HEATED-SAIA program has substantial potential to improve HTS delivery by strategically and pragmatically engaging difficult to reach populations already interfacing with emergency health systems, while being acceptable and cost-effective.",[147],"HIV",[147,149,150,151,152,153,154,155,156],"SAIA","Emergency Care","Africa","Kenya","Emergency Services","HIV Testing Services","Systems Analysis and Improvement Approach","Implementation Science","NOT_YET_RECRUITING","2026-08-10",{"date":127,"type":38},{"date":161,"type":22},"2027-02-01",{"date":163,"type":22},"2030-03-31",{"name":44,"class":45},{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":18,"minAge":173,"maxAge":174,"enrollmentInfo":175,"targetDuration":4,"studyType":23,"phases":177,"briefSummary":180,"conditions":181,"keywords":186,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":46},"100650974","different-treatment-frequencies-for-hepatic-fibrosis-due-to-schistosomiasis-an-rct-100650974","NCT07754617","Different Treatment Frequencies for Hepatic Fibrosis Due to Schistosomiasis","An RCT to Evaluate Different Treatment Approaches to Mitigate the Progression of Schistosomiasis Related Hepatic Fibrosis","SchiFT","Inclusion Criteria:\n\n1. S. mansoni infection as determined by urine Circulating Cathodic Antigen (CCA)\n2. Otherwise healthy as determined by history and physical examination conducted by the study clinician\n3. Not Pregnant\n4. Age 15-40 years\n5. Consent for individuals 18 years of age and older, and parental consent and adolescent assent for participants ages 15-17 years.\n6. The presence of hepatic fibrosis due to S. mansoni (Niamey protocol grade C-F) and compensated (without late-stage portal hypertension) after ruling out other causes of hepatic fibrosis as below.\n\nExclusion Criteria:\n\n1. . History of upper gastrointestinal bleeding\n2. Hepatic fibrosis that is not deemed to be due to schistosomiasis based on ultrasound and hepatitis serologies. For example, alcoholic cirrhosis or presence of chronic Hepatitis B or C by point of care test\n3. Known neurocysticercosis or ocular cysticercosis","15 Years","40 Years",{"count":176,"type":22},600,[178,179],"PHASE2","PHASE3","The goal of this clinical trial is to learn if treating individuals living in Uganda who have liver fibrosis (scarring) due to schistosomiasis would benefit from more frequent treatment with drug praziquantel. This drug is already approved to treat schistosomiasis and is used globally. The study will include individuals who have schistosomiasis and some degree of liver fibrosis. The main questions it aims to answer are:\n\n1. Does treating participants three times per year as compared to once per year as currently recommended improve the likelihood the hepatic fibrosis will improve over three years.\n2. Does treating participants three times per year as compared to once per year as currently recommended decrease the risk they have for bleeding due to portal hypertension over three years.\n3. Is there a blood test that can tell us which individuals will experience worsening liver fibrosis before this happens.\n\nParticipants will:\n\nBe screened for schistosomiasis using a urine test If participants have schistosomiasis they will undergo other screening procedures including a liver ultrasound, blood tests, and a physical exam if they have both schistosomiasis and liver (fibrosis) they will be invited to participate in the trial\n\nIf they are in the trial they will:\n\nTake the drug praziquantel once per year or three times per year based on randomization for three years Have a liver ultrasound and blood samples for markers of liver fibrosis once per year Provide a urine sample to test for schistosomiasis each year",[182,183,184,185],"Schistosomiasis","Schistosoma Mansoni","Liver Fibrosis","Portal Hypertension",[187,188,189,190,191],"schistosomiasis","schistosome mansoni","hepatic fibrosis","liver fibrosis","portal hypertension","2026-08-07",{"date":127,"type":38},{"date":195,"type":22},"2026-11",{"date":197,"type":22},"2029-11",{"name":44,"class":45},{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":46},"100637991","intraoperative-music-therapy-in-tavr-patients-100637991","NCT07591922","Intraoperative Music Therapy in TAVR Patients","Intraoperative Music Therapy in TAVR Patients: A Randomized Controlled Trial to Reduce Anxiety and Improve Patient Experience","Inclusion Criteria:\n\n* Scheduled to undergo elective transfemoral TAVR under MAC (Monitored Anesthesia Care) at Rhode Island Hospital\n* Able to answer questions about anxiety\n\nExclusion Criteria:\n\n* Transfemoral TAVR procedures requiring general anesthesia\n* Emergent TAVR procedures\n* Significant hearing impairment that would preclude ability to hear music via headphones\n* Documented severe claustrophobia or inability to tolerate headphones\n* Inability to complete questionnaires\n* Inability or unwillingness to provide informed consent",{"count":207,"type":22},100,[25],"The purpose of this study is to evaluate the effect of intraoperative music on patient anxiety and comfort during transcatheter aortic valve replacement (TAVR) procedures.",[211],"Anxiety",[211,213,214,215],"Music","Heart valve surgery","Intraoperative","2026-07-16",{"date":218,"type":38},"2026-07-20",{"date":220,"type":38},"2026-05-26",{"date":222,"type":22},"2027-05",{"name":44,"class":45},{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":18,"minAge":231,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":23,"phases":234,"briefSummary":235,"conditions":236,"keywords":240,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":256},"100646405","phase-2-verapamil-effect-in-cystic-fibrosis-related-dysglycemia-100646405","NCT07688070","Verapamil Effect in Cystic Fibrosis-related Dysglycemia","The Effect of Verapamil on Beta Cell Function in Adolescents and Adults With Cystic Fibrosis-related Dysglycemia","Inclusion Criteria:\n\n1. Age 14 years and older\n2. Genetically-confirmed diagnosis of cystic fibrosis\n3. Clinical diagnosis of pancreatic insufficiency, defined as requiring pancreatic enzyme replacement therapy (PERT)\n4. Diagnosis of AGT or CFRD within 3-months of study enrollment\n\n   1. AGT is defined as having either a OGTT 2-hour glucose \\>140 mg\u002FdL and \\\u003C200 mg\u002FdL or OGTT 1-hour glucose \\>200 mg\u002FdL\n   2. CFRD is defined as having a fasting glucose \\>126 mg\u002FdL and\u002For OGTT 2-hour glucose \\>200 mg\u002FdL\n5. Willing to attempt to maximize verapamil to the goal study dosage of 360 mg PO daily\n6. If taking elexacaftor\u002Ftezacaftor\u002Fivacaftor (ETI), willing to adjust dosing\n\nExclusion Criteria:\n\n1. Severe lung disease indicated by forced expiratory volume in 1 second (FEV1) \\\u003C50% predicted on most recent spirometry testing\n2. Body mass index (BMI) \\\u003C18 kg\u002Fm2\n3. Weight \\\u003C50 kg\n4. Current or planned pregnancy within the next 6 months\n5. Treatment with IV antibiotics for a CF exacerbation within 1 month\n6. Systemic supraphysiologic glucocorticoid use within 1 month\n7. Initiation or discontinuation of a CFTR modulator within 3 months (i.e. recent change in CFTR modulator formulation\u002Fusage)\n8. Current use of insulin, a GLP-1 receptor agonist, or oral anti-diabetic agent\n9. Most recent HbA1c \\>7%\n10. Not taking a CFTR modulator due to genotype-ineligibility\n11. Current use of vanzacaftor\u002Ftezacaftor\u002Fdeutivcaftor\n12. Known hypersensitivity to verapamil\n13. Blood pressure (BP) \\\u003C90\u002F60 (adults) or \\\u003C5th centile for age and gender (youth) in 2 out of 3 measurements\n14. Heart rate (HR) \\\u003C60 bpm (adults) or \\\u003C2nd centile for age and gender (youth) in 2 out of 3 measurements\n15. History of previously diagnosed vasovagal syncopal episodes related to hypotension\n16. History of significant cardiac disease (e.g. severe ventricular dysfunction, hypertrophic cardiomyopathy)\n17. History of certain arrhythmias (e.g. AV block, accessory pathway such as Wolff-Parkinson-White or Lown-Ganong-Levine syndromes)\n18. Abnormal liver function tests defined as AST or ALT \\>1.5 upper limit of normal \\[ULN\\] at the time of screening, or end stage cirrhosis\n19. End stage renal disease on dialysis\n20. History of Duchenne's muscular dystrophy\n21. Need for the use of any pertinent medications (beta blockers, carbamazepine, phenobarbital, phenytoin, HMG-CoA reductase inhibitors, lithium, theophylline, clonidine).\n22. Allergy to any of the components of the MMTT standardized meal","14 Years",{"count":233,"type":22},30,[178],"The investigators are conducting a pilot open-label pre\u002Fpost interventional trial in adolescents and adults with cystic fibrosis (CF) and abnormal glucose tolerance or early CF-related diabetes mellitus (CFRD) to assess the safety and efficacy of verapamil on beta cell function and dysglycemia.",[237,238,239],"Cystic Fibrosis Related Diabetes","Cystic Fibrosis (CF)","Abnormal Glucose Tolerance",[241,242,243,244,245,246,247],"cystic fibrosis related diabetes","mixed meal tolerance test","verapamil","beta cell function","continuous glucose monitoring","abnormal glucose tolerance","cystic fibrosis","2026-07-07",{"date":250,"type":38},"2026-07-09",{"date":252,"type":22},"2026-08-01",{"date":254,"type":22},"2028-08-31",{"name":44,"class":45},2,{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":18,"minAge":264,"maxAge":265,"enrollmentInfo":266,"targetDuration":4,"studyType":23,"phases":267,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":46},"100645590","brief-family-based-cannabis-use-intervention-for-youth-with-early-juvenile-justice-involvement-100645590","NCT07700849","Brief Family-Based Cannabis Use Intervention for Youth With Early Juvenile Justice Involvement","JJ-CAPE","Inclusion Criteria: 1) parent and youth are English or Spanish speaking, 2) legal guardian is able to consent for their own and juvenile's participation, 3) youth flags for CU on either the Drug\u002FAlcohol scale of the MAYSI-2 or on the CRAFFT 2.0, 4) not currently in substance use treatment elsewhere, and 5) youth currently residing in the community.\n\nExclusion Criteria: Youth and parents will not be able to participate in the present study if they have developmental or cognitive delays or a major psychiatric disorder, documented in the intake materials, that would interfere with completing consent, assessments, or the intervention","12 Years","16 Years",{"count":58,"type":22},[25],"The goal of this randomized clinical trial is to learn if a brief family-based intervention in effective in reducing cannabis use and delinquency in youth participating in juvenile diversion. The main questions it aims to answer are:\n\nHypothesis 1: the intervention will be (a) feasible, as evidenced by enrollment rates (\\> 80%), follow-up rates (\\> 80%), and withdrawal rates (\\\u003C 20%); and (b) acceptable, as evidenced by \\> 80% of treatment evaluation ratings in the highest two Likert rating categories and positive exit interview feedback.\n\nHypothesis 2: those parents in the experimental condition, as compared to the active comparison psychoeducation condition, will evidence greater improvement over time in the hypothesized family-level mechanisms proposed in the intervention (i.e., parenting practices and parent well-being) as well as in youth-level outcomes, including cannabis use, recidivism, and HIV\u002FSTI risk.\n\nResearchers will compare the family-based treatment to parenting psychoeducation. Caregiver and youth participants will complete measures relevant to primary outcomes and putative mechanisms at baseline, 3-month, and 6-month follow-ups.",[270,271],"Cannabis Use","Delinquency",{"date":273,"type":38},"2026-07-14",{"date":275,"type":22},"2026-07-15",{"date":277,"type":22},"2029-02-28",{"name":44,"class":45},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":55,"sex":18,"minAge":264,"maxAge":85,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":46},"100608124","adolescent-stress-and-substance-intervention-subsequent-to-trauma-100608124","NCT07197476","Adolescent Stress and Substance Intervention Subsequent to Trauma","Adolescent Injury: Intervening to Prevent Posttraumatic Stress and Substance Use Outcomes","ASSIST","Inclusion Criteria for Youth:\n\n* Must be 12-17 years\n* Fluent in English or Spanish\n* Able to provide informed assent\n* Have a parent able to provide informed consent\n\nInclusion Criteria for Parents:\n\n* Live with an admitted pediatric trauma patient\n* Fluent in English or Spanish\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Prisoner or in police custody\n* Involvement with child protective services\n* Admitted due to suicide attempt or non-suicidal self-injury\n* Any acute condition that would preclude provision of informed consent or assent",{"count":288,"type":22},92,[25],"The long-term goal of this study is to address the adoption of the new trauma center requirement to establish best practices of screening for acute stress with an intervention to prevent both adolescent PTSD and substance use. The investigators will develop, refine, and pilot test the Adolescent Stress and Substance Intervention Subsequent to Trauma (ASSIST) video interventions that build upon the American College of Surgeons Committee on Trauma guidelines to improve mental health care during and after hospitalization for traumatic injury. The aims are:\n\nPHASE I - Primary Aim 1: To develop and refine two ASSIST video interventions for adolescents and parents admitted to a level 1 pediatric trauma center.\n\nPHASE II\n\n* Primary Aim 2a: To evaluate the feasibility, acceptability and implementation potential of the ASSIST video interventions.\n* Primary Aim 2b: Develop the ASSIST implementation protocol using a national advisory panel of pediatric trauma center leaders.\n\nParticipants in PHASE 1:\n\nParent and child duo:\n\n* Review storyboards for the video interventions\n* Participate in qualitative interviews at hospital admission and 1 month following discharge\n\nPediatric trauma center clinical staff members:\n\n\\- Complete qualitative interviews\n\nParticipants in PHASE II:\n\nParent and child duo:\n\n* Shown their own video interventions\n* Complete assessments at admission and 1-, 2-, 3- months after discharge",[292,62,293],"PTSD","Acute Stress Disorder",{"date":250,"type":38},{"date":296,"type":38},"2026-03-03",{"date":298,"type":22},"2027-04",{"name":44,"class":45},{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":308,"enrollmentInfo":309,"targetDuration":4,"studyType":23,"phases":310,"briefSummary":311,"conditions":312,"keywords":314,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":46},"100583236","pilot-neurobehavioral-therapy-for-functional-neurological-disorder-100583236","NCT06873698","Pilot Neurobehavioral Therapy for Functional Neurological Disorder","A Pilot Randomized Controlled Trial (RCT) of Neurobehavioral Therapy (NBT) vs Standard Medical Care (SMC) for Functional Neurological Disorder (FND)","NBT for mFND","Inclusion Criteria:\n\n* Individuals diagnosed with Motor Functional Neurological Disorder (mFND)\n* Individuals aged 18-100 years\n* At least 1 mFND symptom during the year prior to enrollment\n\nExclusion Criteria:\n\n* Current or past year self-injurious behavior\n* Current suicidality (PHQ-9 question 9 rated as 1 or above)\n* Current or past year psychosis\n* Pending litigation or current application for long term disability\n* Active substance or alcohol use disorders (dependence), at the discretion of the investigator if they preclude participation in the study\n* Serious illness requiring systemic treatment or hospitalization; the participant either completes therapy or is clinically stable on therapy, for at least 30 days prior to study entry\n* Inability to fill out the self-report surveys\n* Inability or unwillingness to participate in NBT and assigned homework\n* Currently enrolled in NBT aimed at mFND","100 Years",{"count":21,"type":22},[25],"The goal of this pilot randomized clinical trial is to learn if Neurobehavioral Therapy (NBT) works to treat motor functional neurological disorder (mFND) (also referred to as functional motor disorder).\n\nThe main questions it aims to answer are:\n\n* Does NBT lower mFND symptoms?\n* Does NBT lower common co-occurring symptoms and improve functioning?\n\nResearchers will compare NBT to standard medical care (SMC).\n\nParticipants will be randomized to receive either:\n\n* 12 weekly sessions of NBT, along with their SMC,\n* or continue receiving their SMC as provided by their treating clinicians.\n* all participants. regardless of group assignment, will complete a total of five in-clinic visits at the following time points: Baseline, 6 weeks, 12 weeks, 8 Months and 12 Months for self-report surveys to assess functional status, quality of life and mFND symptoms.",[313],"Functional Neurological Disorder",[315,316,317,318,319,320,321,322,323],"mFND","Conversion Disorder","Functional Neurologic Disorder","Neurobehavioral Therapy","FND","Psychogenic Movement Disorder","Psychotherapy","motor functional neurological disorder","functional motor disorder",{"date":250,"type":38},{"date":326,"type":38},"2024-09-25",{"date":328,"type":22},"2028-06",{"name":44,"class":45},{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":340,"briefSummary":342,"conditions":343,"keywords":346,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":46},"100362920","phase-1-safety-and-efficacy-of-treprostinil-remodulin-in-reducing-ischemia-reperfusion-injury-during-kidney-transplantation-100362920","NCT04005469","Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation","A Phase I\u002FII Study Evaluating the Preliminary Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During De Novo Adult Kidney Transplantation","Inclusion Criteria:\n\n1. Male and female patients who will receive a deceased donor kidney aged 18 to 65 (inclusive) and are currently on the active transplant list at RIH.\n2. Documentation of a diabetes diagnosis as evidenced by one or more clinical features consistent will be noted for all patients.\n3. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. Under the age of 18 years\n2. Difficult venous access\n3. BMI \\> 40 kg\u002Fm2\n4. Patients with severe clinical gastroparesis as determined by repeated vomiting\n5. Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication\n6. Known or history of inflammatory bowel disease or bezoars\n7. History of diverticulitis, diverticular stricture, and other intestinal strictures\n8. Be receiving any investigational drug other than treprostinil or participating in any other investigational study\n9. Be receiving any prostanoid therapy to treat portopulmonary hypertension\n10. Have any known hypersensitivity to prostaglandins, prostacyclin or treprostinil\n11. Have had a failed kidney transplant within the previous 180 days\n12. Be receiving any non-standard immunosuppression protocol or other non-standard treatment that could affect interpretation of the study results\n13. Those with significant cardiovascular disease including treatment with inotropes\n14. If female, be pregnant or nursing (confirmed by urine test)\n15. Presence of a condition or abnormality that in the opinion of the Investigators that would compromise the safety of the patient or the quality of the data","75 Years",{"count":339,"type":22},20,[341,178],"PHASE1","The objectives of this study are to test the preliminary safety and efficacy of a two-day peri-operative course of treprostinil in reducing ischemia-reperfusion injury in adult patients receiving a deceased donor kidney transplantation. Treprostinil, a prostacyclin analog, is expected to facilitate the restoration of blood supply to the revascularized kidney graft via its vasodilatory actions, well characterized protective effects, and longer elimination half-life. These properties and actions of treprostinil make it a strong drug candidate to reduce kidney graft dysfunction during kidney transplantation. An anticipated 20 participants undergoing deceased donor kidney transplant will be hospitalized and intensively monitored during an entire two-day Treatment Phase. An IV infusion using a dedicated central venous line will be used to administer treprostinil commencing approximately 2-3 hours before transplantation of the kidney graft and will continue for approximately 48 hours after completion of the transplant surgery. The primary endpoints include the safety and efficacy of treprostinil, with secondary endpoints including the evaluation of both biochemical and clinical endpoints post-transplantation.",[344,345],"Ischemia Reperfusion Injury","Delayed Graft Function",[347,348,349,350,351],"Ischemia-reperfusion injury","kidney transplantation","prostacyclin","treprostinil","delayed graft function","2026-04-20",{"date":354,"type":38},"2026-04-23",{"date":356,"type":38},"2020-11-13",{"date":358,"type":22},"2028-06-30",{"name":44,"class":45},{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":367,"enrollmentInfo":368,"targetDuration":4,"studyType":23,"phases":370,"briefSummary":372,"conditions":373,"keywords":375,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":46},"100617249","phase-4-suprainguinal-fascia-iliaca-block-with-vs-without-dexmedetomidine-100617249","NCT07316166","Suprainguinal Fascia Iliaca Block With vs Without Dexmedetomidine","Comparison of Suprainguinal Fascia Iliac Block With and Without Dexmedetomidine as an Adjunct to Ropivacaine for Postoperative Analgesia Following Hip Surgery: a Randomized, Double-blinded Study.","Inclusion Criteria:\n\n* Patients undergoing elective total hip arthroplasty\n* 18-80 years old\n* ASA 1-3 classifications\n\nExclusion Criteria:\n\n* ASA classification of 4 or greater\n* Infection at the site of nerve blockade\n* Coagulopathy\n* Known allergy to study medications\n* Chronic opioid consumption (\\>3 months)\n* Currently using lidocaine patches\n* Pre-existing neuropathy\n* A history of CVA\n* High grade atrioventricular block (cardiac conduction system impairment)\n* Organ dysfunction (cardiac failure, respiratory failure, end stage renal disease, hepatic dysfunction, hypoalbuminemia)\n* Morbid obesity (≥40 kg\u002Fm2)\n* Prior surgery in supra and\u002For infrainguinal region\n* Non-English-speaking participants","80 Years",{"count":369,"type":22},120,[371],"PHASE4","The investigators are evaluating postoperative outcomes in patients undergoing hip replacement surgery performed with either spinal or general anesthesia, who also receive a suprainguinal fascia iliaca block using either perineural ropivacaine alone or ropivacaine combined with dexmedetomidine.",[374],"Postoperative Pain Management",[376,377],"Hip Surgery","Nerve block","2026-03-24",{"date":380,"type":38},"2026-03-25",{"date":382,"type":38},"2026-01-20",{"date":384,"type":22},"2027-06",{"name":44,"class":45},{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":394,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":46},"100493226","early-phase-1-pilot-trial-of-supplemental-vitamin-a-and-nicotinamide-100493226","NCT05702398","Pilot Trial of Supplemental Vitamin A and Nicotinamide","Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide","Inclusion Criteria:\n\n* 18 years old or greater;\n* Either History of 2 or more histologically confirmed invasive cutaneous SCCs in the past 2 years or\n* At least one previously billed Healthcare Common Procedure Coding System code 17004 (destruction of 15 or more benign or premalignant lesions of the integumentary system);\n* Understands, reads, and writes English proficiently.\n\nExclusion Criteria:\n\n* Liver disease;\n* Active peptic ulcer disease;\n* Recent myocardial infarction;\n* Hypotension;\n* Internal malignancy within past 5 years;\n* Renal impairment with eGFR\\\u003C15 mL\u002Fmin\u002F1.73 m2;\n* Being unable for follow up due to social reasons;\n* Gorlin's syndrome or other genetic skin cancer syndrome;\n* Huge number of current skin cancers;\n* Metastatic SCC or invasive melanoma within the past 5 years;\n* Pregnancy or lactation;\n* Need for ongoing carbamazepine use (which could have a possible interaction with NAM);\n* Use of acitretin or other oral retinoids within the past 6 months;\n* Use of supplemental NAM, niacin, vitamin A, or beta carotene within the past 6 months;\n* Field treatment for actinic keratoses (AKs) within the previous 4 weeks;\n* Use of topical steroids.",{"count":233,"type":22},[395],"EARLY_PHASE1","The goal of this clinical trial is to assess the feasibility and safety of oral nicotinamide (NAM; a derivative of vitamin B3 \\[niacin\\]) and vitamin A in a high-risk population of kidney transplant recipients with a history of skin cancer to generate preliminary data for future cancer prevention clinical trials.",[398,399],"Skin Cancer","Kidney Transplant Recipients","2026-03-18",{"date":402,"type":38},"2026-03-20",{"date":404,"type":38},"2023-04-01",{"date":406,"type":22},"2028-03-01",{"name":44,"class":45},{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":18,"minAge":173,"maxAge":414,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":417,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":4},"100609171","improving-the-treatment-of-depression-among-youth-with-hiv-100609171","NCT07211087","Improving the Treatment of Depression Among Youth With HIV","Inclusion Criteria:\n\n* aged 15- 24 years\n* engaged in care at a participating HIV care site\n* have documented HIV-1 confirmed by medical records\n* a diagnosis as determined by a site clinician of nonpsychotic depression requiring treatment \\[either Major Depressive Disorder (MDD), Depression not otherwise specified, or Dysthymia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)\n* significant symptomatology at Entry (as defined by the PHQ-9)\n* aware of their HIV status as determined by site staff\n* English-speaking\n* able and willing to provide written informed assent\u002Fconsent and written parental or guardian permission\n\nExclusion Criteria:\n\n* by site review, have a history of any psychotic disorders and\u002For Bipolar I or II Disorder\n* have of a severe alcohol or substance dependence according to DSM-V or had moderate symptoms and are experiencing withdrawal or dependence symptoms within the month prior to enrollment\n* have depression and\u002For suicidal ideation requiring more intensive services\n* intend to relocate from the study site; 5) are in therapy with a non-study therapist (unless willing to switch to a study-trained therapist)\n* if they are in imminent danger to themselves or others. If wards of the state meet all eligibility requirements, they will be eligible if the state allows them to participate in research. Otherwise, they will be excluded.","24 Years",{"count":416,"type":22},130,[25],"Depression is a common psychiatric condition among Youth with HIV (YWH), with prevalence as high as 25% in the United States. The treatment of depression is essential for improving both psychiatric and medical outcomes for YWH (e.g., adherence to antiretroviral treatment). Practice guidelines for the treatment of depression and substantial research (including for those with and without HIV), indicate that measured-care treatment (care decisions guided by systematic symptom measurement) and using a combination of a medication management algorithm (MMA) and cognitive behavioral therapy (CBT) that is tailored to the population is efficacious. Unfortunately, these methods are seldom fully implemented in practice, leading to markedly reduced intervention effectiveness.\n\nThis proposed project will compare an enhanced version of combination treatment (COMBEX) to our previously tested combination treatment (COMB) in a Hybrid Type 2 Cluster Randomized Trial. COMBEX will be enhanced by five ERIC implementation strategies as suggested in our post-trial interviews from our efficacy trial and it will also continue to use the ERIC strategies used in COMB. It is hypothesized that these additional ERIC strategies will improve sustainability and depression outcomes at 48 and 72 weeks.",[420,421],"Depression Disorders","HIV (Human Immunodeficiency Virus)","2026-02-25",{"date":424,"type":38},"2026-02-27",{"date":426,"type":22},"2026-04-01",{"date":428,"type":22},"2029-07-01",{"name":44,"class":45},{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":18,"minAge":437,"maxAge":438,"enrollmentInfo":439,"targetDuration":4,"studyType":23,"phases":441,"briefSummary":442,"conditions":443,"keywords":445,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":4},"100616310","deep-brain-stimulation-of-the-anterior-cingulate-bundle-acb-and-the-ventral-anterior-limb-of-the-internal-capsule-valic-in-patients-with-intractable-obsessive-compulsive-disorder-ocd-100616310","NCT07303946","Deep Brain Stimulation of the Anterior Cingulate Bundle (ACB) and the Ventral Anterior Limb of the Internal Capsule (vALIC) in Patients With Intractable Obsessive Compulsive Disorder (OCD)","Double-Blind, Crossover, Feasibility Study of Deep Brain Stimulation of the Anterior Cingulate Bundle (ACB) and the Ventral Anterior Limb of the Internal Capsule (vALIC) in Patients With Intractable Obsessive Compulsive Disorder (OCD)","Inclusion Criteria:\n\n1. OCD, diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV), judged of disabling severity with a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 30 and a Global Assessment of Functioning (GAF) score of 45 or less.\n2. Persistence of severe symptoms and impairment for five or more years despite at least three adequate (≥3 months at the maximum tolerated dose) serotonin transporter inhibitor trials (fluoxetine, sertraline, fluvoxamine, paroxetine, citalopram, escitalopram, or clomipramine) alone or in combination with ii. Adequate behavior therapy (≥20 sessions of expert exposure and response prevention), and iii. Augmentation of one of the selective SRIs with clomipramine, a neuroleptic, and clonazepam.\n3. Age between 21 and 65 years.\n4. Able to understand and comply with instructions.\n5. Able to give fully informed, written consent in the judgment of the site Consent Monitor.\n6. Either drug free or on a stable drug regimen for at least 6 weeks.\n7. Good general health.\n8. A family member or significant other, in contact with the patient every 1-3 days, is available and willing to communicate with the research team if the patient's clinical status worsens, and if necessary to accompany patients to study visits.\n9. The local referring psychiatrist is willing to provide ongoing care during and after the trial\n\nExclusion Criteria:\n\n1. personal\u002Ffamily history (1st\u002F2nd degree relatives) of schizophrenia or schizoaffective disorder, other primary psychotic disorder, bipolar disorder;\n2. present PTS;\n3. present acute suicidality or suicidal ideation;\n4. personal history of head injury, epilepsy, tic or other neurological disorders, neurodevelopmental (e.g., autism), systemic medical (metabolic, endocrine, chronic inflammatory, vascular, autoimmune) disease from medical records and self-report (all of which may confound interpretation of neuroimaging measures);\n5. MMSE score \\\u003C 24;\n6. premorbid IQ estimate \\\u003C 85;\n7. visual disturbance (\\\u003C20\u002F40 Snellen visual acuity, corrected);\n8. left\u002Fmixed handedness;\n9. current, or alcohol or illicit substance abuse\u002Fdependence in the last 3 months, determined by clinical assessment and urine toxicology;\n10. contraindications to MRI,: metallic foreign objects, e.g., aneurysm clips\u002Fpacemakers, or questionable history of metal fragments, claustrophobia raising the risk of panicking in enclosed spaces;\n11. positive pregnancy test for women of reproductive age, or women not using medically acceptable birth control throughout the study (barrier and\u002For oral contraceptives);\n12. current psychotic symptoms (potential confounding effect on neuroimaging measures; see above);\n13. an increased risk of seizure, determined by history;\n\n4\\) potentially proconvulsant medications (e.g., bupropion, tricyclic antidepressants, first-generation antipsychotics, lithium), and medications reducing cortical excitability (e.g., anticonvulsants, benzodiazepines, atypical antipsychotics).","21 Years","65 Years",{"count":440,"type":22},4,[25],"This is a double blind pilot feasibility study, with a within subject crossover design of DBS of the anterior cingulate bundle(ACB) and the ventral anterior limb of the internal capsule(vALIC) in four patients with intractable OCD. Patients will be screened according to inclusion exclusion criteria listed above, approved by an independent Neuropsychiatric review board and informed consent obtained.",[444],"Obsessive-Compulsive Disorder",[446,447],"deep brain stimulation","intractable OCD","2025-12-23",{"date":450,"type":38},"2025-12-26",{"date":452,"type":22},"2026-01",{"date":454,"type":22},"2031-01",{"name":44,"class":45},{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":464,"minAge":56,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":23,"phases":467,"briefSummary":468,"conditions":469,"keywords":474,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":256},"100604062","peroneal-electrical-nerve-stimulation-in-pregnancy-for-restless-legs-syndrome-100604062","NCT07144631","Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome","PENS-P: Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome (RLS)","PENS-P","Inclusion Criteria:\n\n* Age ≥18 years\n* Pregnant individuals between 21 and 26 weeks' gestation at enrollment\n* Singleton pregnancy without known fetal anomalies\n* Confirmed clinical diagnosis of Restless Legs Syndrome (RLS) according to International Restless Legs Syndrome Study Group (IRLSSG) criteria, confirmed by a sleep medicine specialist to exclude RLS mimics\n* Able and willing to provide informed consent\n* Able and willing to comply with study procedures, including device usage, questionnaires, adherence diaries, and follow-up assessments up to 3 months postpartum\n\nExclusion Criteria:\n\nPregnancy-related:\n\n* History of preterm labor\n* Known fetal anomalies identified prior to enrollment\n\nNeurological and neuromuscular disorders:\n\n* Pre-existing neuromuscular disorders affecting balance or gait\n* Severe peripheral neuropathy involving the lower legs\n* Epilepsy or history of seizures\n\nCardiovascular and circulatory conditions:\n\n* History of deep vein thrombosis (DVT)\n* Circulatory conditions contraindicating peroneal nerve stimulation (PNS) device use\n\nDermatological conditions:\n\n* Skin conditions at device application sites\n* Known allergy to device materials\n\nOther sleep disorders:\n\n• Inadequately treated severe primary sleep disorders other than RLS (e.g., untreated severe sleep apnea, severe insomnia unrelated to RLS)\n\nDevice and treatment experience exclusions (based on RESTFUL trial criteria):\n\n* Prior use of the study device or any neurostimulation device for RLS treatment\n* Presence of active medical implants (e.g., pacemakers, spinal cord stimulators)\n\nOther medical conditions:\n\n* Participants undergoing dialysis treatment\n* Severe psychiatric conditions (e.g., bipolar disorder, psychosis, severe anxiety or depression) that may interfere with adherence or accurate symptom reporting\n* Any condition deemed by investigators to pose safety risks or impede participation\n\nOther exclusions:\n\n* Unable or unwilling to operate the device safely and independently\n* Unable to participate reliably in follow-up assessments or complete self-reported diaries","FEMALE",{"count":466,"type":22},15,[25],"The goal of this study is to evaluate whether peroneal electrical nerve stimulation (PNS) using the TOMAC™ device is a feasible, acceptable, and safe non-pharmacologic intervention for managing Restless Legs Syndrome (RLS) during pregnancy. This pilot study will also collect preliminary information on symptom relief, sleep quality, and maternal-fetal safety associated with device use.\n\nThe main questions the study aims to answer are:\n\nIs TOMAC™ PNS a feasible and acceptable intervention for RLS in pregnant individuals? Are there any maternal, fetal, or neonatal safety concerns with PNS use during pregnancy? What are the patterns of adherence, tolerance, and usability of the TOMAC™ device in this population?\n\nParticipants will:\n\nUse a non-invasive TOMAC™ peroneal nerve stimulator during 30-minute sessions as needed, for 8 weeks.\n\nComplete questionnaires assessing feasibility, acceptability, symptom severity, and sleep quality (including AIM, IAM, FIM, IRLS, PGI-I, PSQI, ESS, FOSQ, and MOS-II).\n\nWear an actigraphy monitor to collect objective sleep data at baseline and at 4 weeks.\n\nAttend scheduled follow-up visits and phone check-ins for maternal vital signs, uterine contraction and fetal monitoring, and neonatal outcome assessment.\n\nThis is a prospective, open-label, single-arm pilot study enrolling 15 pregnant participants between 21 and 26 weeks' gestation. Findings will provide the first dataset on the feasibility, acceptability, and safety of TOMAC™ PNS in pregnancy and inform the design of a future randomized controlled trial.",[470,471,472,473],"Restless Leg Disorder","Restless Leg Syndrome (RLS)","Pregnancy","Sleep Disorder (Disorder)",[475,472,476,477,478,479],"Restless Legs Syndrome","Sleep Disorders in Pregnancy","Maternal Sleep Health","Peroneal Nerve Stimulation","Neuromodulation","2025-11-10",{"date":482,"type":38},"2025-11-12",{"date":484,"type":38},"2025-10-15",{"date":486,"type":22},"2026-10-31",{"name":44,"class":45},{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":494,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":23,"phases":498,"briefSummary":499,"conditions":500,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":46},"100540437","phase-2-identifying-optimal-buprenorphine-dosing-for-opioid-use-disorder-treatment-and-prevention-of-overdose-100540437","NCT06316830","Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose","Randomized Clinical Trial of a 16 mg vs. 24 mg Maintenance Daily Dose of Buprenorphine to Increase Retention in Treatment Among People With Opioid Use Disorder","Optimal Bup","Inclusion Criteria:\n\n* English-speaking\n* Age 18 years-old or older\n* Identified by the treating physician as having moderate to severe opioid use disorder (OUD)\n* Initiating or continuing buprenorphine for treatment of opioid use disorder\n* History of fentanyl use (confirmed by fentanyl positive urine drug screen (UDS) at intake OR if on buprenorphine maintenance treatment fentanyl plus a positive UDS within the last month OR self- reported ongoing fentanyl use during treatment)\n\nExclusion Criteria:\n\n* Previous enrollment in the trial\n* Incarcerated or in police custody\\*\n* Pregnant\n* Live outside of Rhode Island (RI)\n* Unable to provide informed consent\n* Allergy to Buprenorphine\n* Concomitant medication use deemed to present potential for serious medication interaction by the treating clinician \\*Participants that become incarcerated\u002For in police custody during the study will be withdrawn.",{"count":497,"type":22},250,[178,179],"The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg).\n\nThe main question it aims to answer is: will patients who are randomly assigned to the high 24 mg maintenance dose, as compared to patients randomly assigned to the standard 16 mg maintenance dose, have improved retention in buprenorphine treatment (primary outcome), improved treatment response based on use of non-prescribed opioids (secondary outcome), decreased opioid cravings (secondary outcome), and decreased risk of fatal and non-fatal opioid overdose (exploratory outcome).",[28],"2025-10-21",{"date":503,"type":38},"2025-10-23",{"date":505,"type":38},"2025-01-06",{"date":507,"type":22},"2027-11-01",{"name":44,"class":45},{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":18,"minAge":516,"maxAge":517,"enrollmentInfo":518,"targetDuration":4,"studyType":23,"phases":520,"briefSummary":521,"conditions":522,"keywords":526,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":46},"100471583","impact-of-sleep-duration-on-immune-balance-in-urban-children-with-asthma-100471583","NCT05420766","Impact of Sleep Duration on Immune Balance in Urban Children With Asthma","AIMS","Inclusion:\n\n* Children 7-11 years old\n* Has physician-diagnosed asthma, per parent and pediatrician report\n* Meets criteria for current persistent asthma with a current prescription for an asthma controller medicine\n* Obtains 9.0-11.0 h of sleep per 24 h day in the past month\n* Has a positive allergy skin test performed at the clinic visit\n* Resides and attend school in one of the targeted urban areas (Rhode Island: East Providence, North Providence, Providence, Warwick, Cranston, Woonsocket, Central Falls, Pawtucket, Lincoln, Johnston. Massachusetts: Attleboro, North Attleboro, Fall River.\n* Has a primary caregiver who speaks English\n\nExclusion:\n\n* No asthma diagnosis\n* No use of asthma controller medication\n* Severe persistent asthma that is poorly controlled\n* Diagnosis of additional pulmonary disease or medical condition or immune deficiency disorders\n* Use of systemic steroids \\\u003C30 days of screening\n* Asthma-related emergency department visit and\u002For asthma-related hospitalization in past 90 days\n* Marked developmental delay, psychiatric conditions, academic\u002Fbehavioral problems, learning disabilities\n* Tanner stage 3-5 of pubertal development\n* Diagnosed ADHD; Use of stimulants to treat ADHD\n* An Apnea-Hypoxia Index \\>5 (indicator of sleep disordered breathing)","7 Years","11 Years",{"count":519,"type":22},204,[25],"Urban children with asthma are at high risk for short sleep, due to an environment that jeopardizes both sleep and asthma management. Further, urban children with asthma suffer from altered immune balance, a key biological process contributing to individual differences in asthma morbidity and sleep health. In the proposed research, the researchers will examine the effects of shortened and recovery sleep on immune balance and associated changes in lung function in urban children with allergic asthma through an experimental design.",[523,524,525],"Asthma in Children","Sleep Hygiene","Sleep, Inadequate",[524,527,528],"Children with asthma","Immune function in children","2025-09-19",{"date":531,"type":38},"2025-09-22",{"date":533,"type":38},"2022-05-15",{"date":535,"type":22},"2026-07-31",{"name":44,"class":45},{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":544,"enrollmentInfo":545,"targetDuration":4,"studyType":23,"phases":546,"briefSummary":547,"conditions":548,"keywords":552,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":256},"100494843","the-effects-of-a-low-glycemic-load-diet-on-dysglycemia-and-body-composition-in-adults-with-cystic-fibrosis-related-diabetes-100494843","NCT05723445","The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes","DINE","Inclusion Criteria:\n\n* 18 years and above\n* Genetically confirmed diagnosis of CF\n* Diagnosis of pancreatic insufficiency, requiring pancreatic enzyme replacement\n* Criteria for CFRD:\n\nA.) Most recent OGTT 2-hour glucose \\>200 mg\u002FdL within the past two years, and\u002For; B.) HbA1c \\>6.5% in the past two years, and\u002For; C.) Current use of insulin\n\nExclusion Criteria:\n\n* FEV1 \\\u003C50% predicted on most recent pulmonary function testing\n* BMI \\\u003C18 kg\u002Fm2\n* Currently receiving enteral nutrition support via GT feeds\n* Pregnancy, plan to become pregnant in the next 3-months, or sexually active without use of contraception\n* Use of IV antibiotics or systemic supraphysiologic glucocorticoids for CF exacerbation within 1 month\n* Started or stopped treatment with a CFTR modulator within 3 months of enrollment\n* Currently adhering to an LGL or other carbohydrate-restricted diet (carbohydrate intake \\\u003C30% of total daily caloric intake)","70 Years",{"count":466,"type":22},[25],"This study will evalute the effect of a low glycemic load (LGL diet on dysglycemia, insulin requirements, DXA-derived body composition, gastrointestinal symptoms and quality of life measures in adults with cystic fibrosis-related diabetes (CFRD). We will use continuous glucose monitors (CGM) to assess the LGL diet both in a controlled setting (via a meal delivery company) and in free-living conditions.",[549,550,551],"Cystic Fibrosis","Cystic Fibrosis-related Diabetes","Cystic Fibrosis With Intestinal Manifestations",[553,554,555,556],"Cystic Fibrosis-Related Diabetes","Low Glycemic Load","Continuous Glucose Monitoring","Body Composition","2025-08-16",{"date":559,"type":38},"2025-08-22",{"date":561,"type":38},"2023-09-01",{"date":563,"type":22},"2026-07-01",{"name":44,"class":45},{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":569,"acronym":570,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":18,"minAge":572,"maxAge":264,"enrollmentInfo":573,"targetDuration":4,"studyType":23,"phases":575,"briefSummary":576,"conditions":577,"keywords":579,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":256},"100516016","the-puerto-rico-asthma-integrated-response-program-pr-air-100516016","NCT05999032","The Puerto Rico Asthma Integrated Response Program (\"PR-AIR\")","PR-AIR","Inclusion Criteria:\n\n1. Children between the ages of 2 and 12 years old\n2. Children must reside in one of the identified catchment areas\n3. Children must meet the screening criteria as having not well controlled or poorly controlled asthma\n\nExclusion Criteria:\n\n1\\. Children with complex medical conditions","2 Years",{"count":574,"type":22},480,[25],"The purpose of this study is to adapt and deliver an evidence-based multi-level intervention to reduce asthma disparities, and that promote and improve population health in the high-burden communities of San Juan, Puerto Rico.\n\nThe Puerto Rico-Asthma Integrated Response Program (PR-AIR) will be implemented and evaluated to address pediatric asthma disparities in San Juan, PR, an area of high asthma burden. This study unfolds in two phases: In Phase 1, the researchers will collaborate with community stakeholders to identify needs, barriers and facilitators of PR-AIR implementation. Phase 2 consists of an evaluation of low-intensity (virtual) and high-intensity (in-person) methods of PR-AIR implementation outcomes using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework and a mixed methods approach.",[578],"Pediatric Asthma",[580,581,582,583,584,585],"Pediatric asthma","Community intervention program","Hybrid Type III","Effectiveness and implementation","Home-based intervention","School-based intervention","2025-08-14",{"date":588,"type":38},"2025-08-20",{"date":590,"type":38},"2024-12-16",{"date":592,"type":22},"2027-07-31",{"name":44,"class":45},{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":598,"acronym":599,"eligibilityCriteria":600,"healthyVolunteers":55,"sex":18,"minAge":517,"maxAge":601,"enrollmentInfo":602,"targetDuration":4,"studyType":23,"phases":604,"briefSummary":605,"conditions":606,"keywords":611,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":256},"100588519","a-sleep-hygiene-intervention-to-improve-sleep-health-in-urban-latino-middle-school-children-100588519","NCT06942455","A Sleep Hygiene Intervention to Improve Sleep Health in Urban, Latino Middle School Children","SIESTA","Inclusion Criteria:\n\n* children must be middle schoolers between 11-13 years old, live and go to school in one of the targeted school districts and sleep no more than 9 hours on an average night\n\nExclusion Criteria:\n\n* Children are not eligible to take part in the study if they have a medical, psychiatric, or developmental condition and\u002For are taking medicine for any condition that might affect their ability to and comfort with taking part in the study.","13 Years",{"count":603,"type":22},300,[25],"The main goal of this study is to evaluate the \"SIESTA\" intervention, a culturally and contextually tailored sleep hygiene intervention that has the potential to exert greater improvements in sleep hygiene and sleep outcomes for group that may be more vulnerable to poor sleep health.\n\nThe main question is: do SIESTA participants have improved sleep outcomes, sleep hygiene behaviors and less sleep-related impairment compared to Control Group participants?\n\nParticipants randomized to the SIESTA intervention will:\n\n1. Attend 4 remotely administered group sleep hygiene education sessions\n2. Complete along with a parent\u002Fguardian, two individualized sessions administered by a SIESTA intervention facilitator\n3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention.\n4. Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality.\n\nParticipants randomized to the Child Health Control condition will:\n\n1. Attend 4 remotely administered group sessions covering general health topics\n2. Complete along with a parent\u002Fguardian, two individualized sessions administered by a SIESTA intervention facilitator\n3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention.\n4. Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality.\n\nA secondary goal of the study is to conduct a process evaluation to prepare for future larger scale use of the intervention in other urban school settings. This will entail assessing Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) of the program through several methods, such as by conducting in-depth interviews with research participants and their parents\u002Fguardians, as well as school staff and by looking at rates of participation in the program.",[607,608,609,610],"Sleep","Sleep Quality","Intervention Study","Ethnic Minority",[612,613,614,615],"pediatric sleep intervention","sleep hygiene intervention","intervention determinants","sleep outcomes","2025-07-22",{"date":618,"type":38},"2025-07-25",{"date":620,"type":38},"2025-06-25",{"date":622,"type":22},"2029-03-31",{"name":44,"class":45},{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":4,"eligibilityCriteria":630,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":367,"enrollmentInfo":631,"targetDuration":4,"studyType":23,"phases":633,"briefSummary":634,"conditions":635,"keywords":638,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":46},"100525126","non-inferiority-trial-between-sotair-device-attached-to-manual-resuscitator-versus-mechanical-ventilation-100525126","NCT06117683","Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation","Non-inferiority Comparative Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation in Patients Undergoing Non-emergent Surgery With General Anesthesia","Inclusion Criteria:\n\n* Adult patients who are scheduled for non-emergency surgery with general anesthesia at Rhode Island Hospital.\n* American Society of Anesthesiologists physical status 1 and 2\n\nExclusion Criteria:\n\n* ASA PS \\>3 (e.g., respiratory disease)\n* Oropharyngeal or facial pathology",{"count":632,"type":22},310,[25],"Effective respiratory ventilation is achieved by moving the right amount of air in and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this non-inferiority study, we will perform a pre-post study design (single group, within-group comparison) to test the non-inferiority of the Adult Sotair® device compared to mechanical ventilation.",[636,637],"Airway Management","Respiration, Artificial",[639,640,641,642],"Mechanical Ventilation","General Anesthesia","Bag Mask Ventilation","Adult Sotair Device","2025-07-09",{"date":645,"type":38},"2025-07-11",{"date":647,"type":38},"2023-12-20",{"date":649,"type":22},"2025-07",{"name":44,"class":45},{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":655,"acronym":4,"eligibilityCriteria":656,"healthyVolunteers":55,"sex":657,"minAge":231,"maxAge":85,"enrollmentInfo":658,"targetDuration":4,"studyType":23,"phases":659,"briefSummary":660,"conditions":661,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":664,"lastUpdatePostDateStruct":665,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":671,"locationsCount":46},"100593832","prepping-for-the-talk-helping-trusted-adults-and-youth-talk-about-sexual-health-100593832","NCT07011563","Prepping for The Talk: Helping Trusted Adults and Youth Talk About Sexual Health","Inclusion Criteria:\n\n* Age 14-17\n* Assigned male\n* Oral OR anal sex with an assigned male\n* Live in the United States\n* English-speaking\n\nExclusion Criteria:\n\n* None","MALE",{"count":21,"type":22},[25],"The goal of this study is to help young people talk to trusted adults (including their parents, but also other adults) about sexual health more openly and honestly- including how to prevent sexually transmitted diseases like HIV - while also respecting a young person's right to privacy. If youth don't have a parent they can talk to about sexual health, we want to help them find a trusted adult to talk to. We also want to help youth take control of their own health by learning about different ways to protect their health.",[662,663],"HIV Prevention","Sexual Health","2025-06-05",{"date":666,"type":38},"2025-06-09",{"date":668,"type":38},"2025-05-16",{"date":670,"type":22},"2025-11-01",{"name":44,"class":45},{"id":673,"slug":674,"hasResults":12,"nctId":675,"briefTitle":676,"officialTitle":677,"acronym":4,"eligibilityCriteria":678,"healthyVolunteers":55,"sex":18,"minAge":173,"maxAge":679,"enrollmentInfo":680,"targetDuration":4,"studyType":23,"phases":681,"briefSummary":682,"conditions":683,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":686,"lastUpdatePostDateStruct":687,"startDateStruct":689,"completionDateStruct":691,"leadSponsor":693,"locationsCount":694},"100497858","a-mobile-gaming-app-to-improve-adherence-to-prep-100497858","NCT05762705","A Mobile Gaming App to Improve Adherence to PrEP","A Multisite Randomized Trial of Viral Combat: A Mobile Gaming App to Improve Adherence to PrEP","Inclusion Criteria:\n\n* 15-34 years old\n* English speaking\n* Initiated PrEP in the last 30 days or re-initiated PrEP after not taking PrEP for at least 1 month\n* HIV negative as per clinician and clinical record\n* Able to give consent\u002Fassent and not impaired by cognitive or medical limitations as per clinical assessment.\n\nExclusion Criteria:\n\n* None","34 Years",{"count":115,"type":22},[25],"In this study, the investigators will test the mobile game, Viral Combat, for efficacy and acceptability among diverse participants, ages 15-34 years, receiving PrEP care in clinical settings in New England and Mississippi. Formative evaluation interviews will be conducted with stakeholders (healthcare workers, clinic administrators, and patients taking PrEP) to inform intervention delivery. Data from the formative interviews will also be used to make necessary adaptations to the game and assess acceptability for diverse populations and clinics. Viral Combat will then be further tested with 200 participants ages 15-34 years, receiving PrEP care at clinical sites in the South (n=100 Jackson, MS) and New England (n=100, Providence, RI; Boston, MA) in a multisite Hybrid Type 1 effectiveness-implementation randomized controlled trial (RCT). This trial will test the efficacy of the intervention compared to a control condition (a non-PrEP related game) on biological and behavioral measures. At the end of the trial, a summative evaluation of the implementation context using the i-PARIHS framework will occur. These interviews with study participants and clinic staff will inform future implementation and dissemination of Viral Combat.",[684,685],"Medication Adherence","HIV\u002FAIDS","2025-05-08",{"date":688,"type":38},"2025-05-14",{"date":690,"type":38},"2024-06-21",{"date":692,"type":22},"2027-03-03",{"name":44,"class":45},3,""]