[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Massachusetts, Worcester\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":684},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,42,0,25,[9,49,79,107,130,165,185,214,241,263,289,312,337,364,392,416,445,471,509,535,560,588,614,643,662],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100635627","supporting-treatment-access-and-recovery-in-re-entry-star-r-100635627",false,"NCT07555145","Supporting Treatment Access and Recovery in Re-entry (STAR-R)","STAR-R","Inclusion Criteria:\n\n* 18 years or older;\n* Proficient in reading and writing in the English language;\n* Are released from one of the participating jail\u002Fs; and\n* Have a current co-occurring substance use and mental health disorder, which includes both any substance use disorder (including alcohol) and mental health disorder (including depression, anxiety, trauma related disorders, bipolar, and\u002For schizophrenia) as documented by the participating jails.\n\nExclusion Criteria:\n\n* Are acutely suicidal based on the CSSRS; or\n* Are acutely psychotic (as this would require a higher level of care) based on SCID-5-RV.","ALL","18 Years",{"count":20,"type":21},240,"ESTIMATED","INTERVENTIONAL",[24],"NA","This application is aimed at testing a multicomponent intervention called \"Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Criminal Justice (MISSION-CJ) or Peer Linkage Support post-release from two jails in Massachusetts for individuals with co-occurring substance use and mental health disorders (COD), given high rates of COD among incarcerated populations. The research will examine engagement in treatment, behavioral health outcomes, mediators and moderators, an economic analysis, and facilitators and barriers of MISSION-CJ implementation.",[27,28,29],"Mental Health","Substance Use Disorders","Co-occurring Mental and Substance Use Disorders",[31,32,33,34,35],"MISSION-CJ","co-occurring disorders","peer linkage support","mental health","substance use disorders","NOT_YET_RECRUITING","2026-06-29",{"date":39,"type":40},"2026-07-01","ACTUAL",{"date":42,"type":21},"2026-08-01",{"date":44,"type":21},"2030-08-31",{"name":46,"class":47},"University of Massachusetts, Worcester","OTHER",2,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100582880","re-engineered-discharge-for-diabetes-care-transitions-100582880","NCT06869057","Re-Engineered Discharge for Diabetes Care Transitions","Re-Engineered Discharge for Diabetes Care Transitions: Screening and Addressing Social Determinants of Health Needs at Hospital Discharge","REDDCAT2","Inclusion Criteria:\n\n* adult aged 18 years or older\n* diagnosed with type 2 diabetes\n* hospitalized at Univ of Massachusetts-affiliated hospital\n* endorsed at least 1 unmet social need via screening survey\n\nExclusion Criteria:\n\n* pregnancy\n* discharge to short or long-term nursing facility or hospital\n* medical contraindication\n* cognitive impairment\n* unable to provide informed consent",{"count":58,"type":21},412,[24],"The goal of this project is to test a novel bedside SDOH screening intervention coupled with post-discharge navigation for hospitalized patients with a diabetes diagnosis to reduce unmet social needs, compared to usual care.",[62,63,64],"Diabetes Mellitus Type 2","Social Determinants of Health (SDOH)","Hospital Readmission",[66,67,68],"diabetes","social determinants of health","hospital readmission","RECRUITING","2026-06-26",{"date":72,"type":40},"2026-06-30",{"date":74,"type":40},"2026-06-08",{"date":76,"type":21},"2029-05-30",{"name":46,"class":47},1,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":78},"100629948","lifestyle-change-implementation-research-network-at-prc-at-umass-chan-100629948","NCT07481305","Lifestyle Change Implementation Research Network at PRC at UMass Chan","LCIRN","Inclusion Criteria:\n\n1. Began using a GLP-1 within the past 6 months\n2. Currently using GLP-1\n3. Plans to continue GLP-1 use\n4. GLP-1 prescribed by their physician (e.g., not online or 3rd party vendor)\n5. BMI ≥27 kg\u002Fm2\n6. Age 18 years of age and older\n7. Speaks and reads English or Spanish\n8. Willing to enroll in a digital lifestyle intervention for 4-months\n9. Willing to wear a Fitbit for 8 months\n\nExclusion Criteria:\n\n1. Was taking a GLP-1 within the 2 months prior to the current GLP-1 start date\n2. Currently participating in a structured lifestyle change program (receiving structured guidance and counseling on physical activity, diet or weight loss)\n3. Currently pregnant",{"count":87,"type":21},220,[24],"The goal of this project is to study how well the Noom digital lifestyle program works for adults who are taking Glucagon-Like Peptide-1 receptor agonist (GLP-1) medications. The study team will assess how the program affects people's behaviors and health outcomes. The team will also look at how digital lifestyle change interventions can be implemented in real-world settings, including how many people it reaches, how well it is put into practice, whether people stick with it over time, and whether it works well for different groups of people.",[91],"GLP - 1",[93,94,95,96,97,98,99],"GLP-1","Physical Activity","Nutrition","Lifestyle Behaviors","Weight","Diabetes","CVD","2026-06-24",{"date":70,"type":40},{"date":103,"type":21},"2026-07-13",{"date":105,"type":21},"2029-09-29",{"name":46,"class":47},{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":114,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":78},"100551211","preventing-t2dm-after-gdm-with-immediate-postpartum-screening-100551211","NCT06457139","Preventing T2DM After GDM With Immediate Postpartum Screening","Preventing Type 2 Diabetes Mellitus After Gestational Diabetes Mellitus With Immediate Postpartum Screening","Inclusion Criteria:\n\n* pregnancy complicated by GDM as diagnosed with traditional two step testing in the third trimester according to Carpenter-Coustan Criteria\n* receiving prenatal care at UMASS Memorial and plans to deliver at UMASS Memorial\n* able and willing to provide informed consent\n* ability to complete immediate in hospital postpartum glucose testing\n* have evidence of impaired glucose metabolism defined as fasting glucose value of ≥126 mg\u002FdL or 2-hour glucose value of ≥200 mg\u002FdL\n\nExclusion Criteria:\n\n* known diagnosis of pre-existing pre-gestational diabetes in pregnancy\n* inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test) in pregnancy or immediately postpartum\n* systemic steroid use","FEMALE",{"count":116,"type":21},116,[24],"The overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening for postpartum patients with pregnancies affected by GDM.",[120,121],"Gestational Diabetes","Type 2 Diabetes",[66],"2026-06-19",{"date":100,"type":40},{"date":126,"type":40},"2025-06-01",{"date":128,"type":21},"2027-12-01",{"name":46,"class":47},{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":114,"minAge":18,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":147,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":78},"100580335","momshome-a-storytelling-based-mobile-health-intervention-to-improve-blood-pressure-management-in-pregnancy-100580335","NCT06835959","Moms@Home: A Storytelling-based Mobile Health Intervention to Improve Blood Pressure Management in Pregnancy","Development of a Mobile Health Intervention to Improve Blood Pressure Management in Pregnancy (Moms@Home)","Moms@Home","Inclusion Criteria:\n\n* Age 18-50\n* English or Spanish speaking\n* A diagnosis of gestational (20-26 weeks gestational age) or chronic hypertension (8-26 weeks gestational age)\n* Singleton or multiple gestation pregnancy,\n* A patient of the University of Massachusetts Memorial Health Obstetrics\u002FMaternal and Fetal Medicine clinics in Worcester, Massachusetts\n* Willing to share home blood pressure monitoring data\n* Comfortable with the use of smartphones and mobile apps\n\nExclusion Criteria:\n\n* Severe hypertension (Systolic blood pressure ≥160 mmHg or Diastolic blood pressure ≥100 mmHg)\n* Current diagnosis of preeclampsia\n* Active substance use\n* Serious physical illness (e.g., unable to interact with a smart device)\n* Enrolled in another home blood pressure monitoring program\n* Excluded from study participation by their provider\n* Inability to provide informed consent\n* Prisoners\u002Finstitutionalized individuals","50 Years",{"count":140,"type":21},100,[24],"This pilot study will examine the effects of a digital health approach, Moms@Home, on home blood pressure monitoring in a diverse population of pregnant women with hypertension.",[144,145,146],"Hypertension in Pregnancy","Chronic Hypertension","Gestational Hypertension",[148,136,149,150,151,152,153,154,155,156],"Hypertension in pregnancy","Mobile health intervention","Blood pressure","Blood pressure management","Hypertension","Gestational hypertension","Storytelling","Home blood pressure monitoring","Storytelling mobile intervention","2026-06-12",{"date":159,"type":40},"2026-06-16",{"date":161,"type":40},"2025-05-16",{"date":163,"type":21},"2027-11-16",{"name":46,"class":47},{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":78},"100537522","evaluating-signs-of-safety-a-deaf-accessible-therapy-toolkit-for-aud-and-trauma-100537522","NCT06278922","Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma","Inclusion Criteria:\n\n* Self-identification as Deaf or hard-of-hearing\n* Proficiency in American Sign Language (ASL)\n* Age 18 years or older\n* Access to videoconferencing technology for informed consent and, if applicable, study therapy sessions\n* Access to online survey technology for study assessments\n* \"Problematic alcohol consumption, drinking behaviors, and alcohol-related problems\" on the AUD Identification Test (AUDIT), a 10-item screening measure developed by the World Health Organization that demonstrates good sensitivity and specificity in many populations (past-month referent time period; score ≥ 8 for men or ≥ 6 for women)\n* \"Subthreshold or full PTSD,\" on the PTSD Checklist for DSM-5 (PCL-5), a 20-item measure of PTSD symptoms reliably used to monitor symptom change (past-month referent time period; \"subthreshold\" = meets at least two DSM-5 diagnostic categories (B, C, D, and\u002For E) at moderate or high severity)\n\nExclusion Criteria:\n\n* Participation in concurrent formal psychotherapy (Note: Participants in all study conditions will be asked to refrain from concurrent formal psychotherapy. Participants who engage in formal psychotherapy outside of the research will be removed from the study at the point of treatment initiation. Outside treatment engagement will be queried at each assessment timepoint. If endorsed, the participant will be removed from the study at that timepoint, but data collected prior to treatment initiation will remain in the dataset. Aligning with the Seeking Safety model, Alcoholics Anonymous\u002FNarcotics Anonymous\u002FDual Recovery Anonymous attendance will be encouraged; attendance will be tracked as a potential outcome mediator.)\n* Members of the following special populations: Adults unable to consent; Individuals younger than 18 years; Prisoners; Pregnant women (Note: The investigators will not knowingly include pregnant women as participants; however, the investigators will not assess participants' pregnancy status.)",{"count":172,"type":21},144,[24],"The U.S. Deaf community - a group of more than one million Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking and twice the rate of trauma exposure compared to the general population. Although there are several treatments for alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) in hearing populations, none have been developed for or tested with Deaf clients. To address these barriers, the study team developed Signs of Safety, a Deaf-accessible therapy toolkit for treating AUD and PTSD. Their aims are to conduct a nationwide, virtual clinical trial to compare (1) Signs of Safety with (2) treatment as usual and (3) a no treatment control, to collect data on clinical outcomes, and to explore potential mediators and moderators of outcome.",[176,177],"PTSD","Alcohol; Use, Problem",{"date":179,"type":40},"2026-06-15",{"date":181,"type":40},"2024-12-23",{"date":183,"type":21},"2028-11-30",{"name":46,"class":47},{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":114,"minAge":18,"maxAge":192,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":196,"conditions":197,"keywords":202,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":78},"100538777","asha-bangladesh--an-integrated-intervention-to-address-poverty-and-depression-100538777","NCT06295250","ASHA Bangladesh--An Integrated Intervention to Address Poverty and Depression","ASHA Bangladesh--An Integrated Intervention to Address Depression in Low Income Rural Women","Inclusion Criteria:\n\n1. Age 18-45\n2. Meets criteria for Economic Vulnerability as measured by: household income \\\u003C= 15000 Taka per month; food insufficiency in household over previous six months; OR owning \\\u003C= 10 decimals of land\n3. Family willingness to participate in the program\n4. Basic literacy as measured by ability to read a simple sentence;\n5. A score \\>=10 on the Patient Health Questionnaire (PHQ-9 Depression Scale) at baseline\n\nExclusion Criteria:\n\n1. Pregnancy at screen;\n2. Cognitive or physical impairment precluding participation\n3. Plans to relocate or to travel for \\> 1 month during 18 M period.\n4. Household debt greater than 70,000 Taka","45 Years",{"count":194,"type":21},600,[24],"The goal of this randomized controlled trial is to compare the impact of an integrated intervention combining poverty alleviation and depression treatment to depression treatment alone, in low income rural Bangladeshi women with depression. The main question\\[s\\] it aims to answer are whether adding poverty alleviation to depression treatment in an integrated intervention: 1) improves depression outcomes at 6 months post baseline as measured by changes in the PHQ-9 from baseline--compared to depression treatment alone; 2) reduces the chance of relapse (PHQ-9 \\>=5) at 18 months among patients who remitted (PHQ-9\\\u003C5) at six months--compared to depression treatment alone; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention--compared to depression treatment alone. Other outcomes that will be studied include economic vulnerability and psychosocial variables such as anxiety, culturally specific symptoms, quality of life, and function. Participants in both arms will participate in research interviews at 6,12 and 18 months. The project also includes a mixed methods implementation evaluation. Quantitative implementation outcomes to be examined include adoption\u002Fuptake; retention in the intervention, and fidelity of intervention delivery. A qualitative process evaluation will include interviews with 80 study participants and approximately 40 staff members, including research staff, agricultural officers, and interventionist staff.",[198,199,200,201],"Depression","Economic Vulnerability","Anxiety","Culture Specific Symptoms",[203,204,205,206],"Depression treatment","Cash Transfer","Problem Management Plus","Poverty Alleviation","2026-06-11",{"date":179,"type":40},{"date":210,"type":40},"2024-03-01",{"date":212,"type":21},"2026-12",{"name":46,"class":47},{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":114,"minAge":18,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":223,"briefSummary":224,"conditions":225,"keywords":229,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":238,"leadSponsor":240,"locationsCount":4},"100628212","reaching-calm-a-digital-intervention-to-prevent-perinatal-anxiety-disorders-100628212","NCT07458698","Reaching Calm: A Digital Intervention to Prevent Perinatal Anxiety Disorders","Reaching Calm Pilot (K23)","Inclusion Criteria:\n\n* Receiving prenatal care at participating obstetric practice\n* Endorsed mild to moderate anxiety (GAD-7 score 5-15)\n* Currently pregnant (gestational age \\\u003C32)\n* Started Reaching Calm digital intervention, if in intervention group\n\nExclusion Criteria:\n\n* Not pregnant\n* Unable to participate in 60-minute interview\n* Unwilling to be audio recorded\n* GAD-7 \\\u003C5, or GAD-7≥15\n* Adults unable to consent (adults lacking capacity)\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Non-English-speaking",{"count":222,"type":21},60,[24],"The goal of this clinical trial is to find out if a digital program called Reaching Calm can help prevent anxiety in women who are pregnant. The study will offer Reaching Calm at obstetric practices where participants receive prenatal care. The study focuses on people who may be at greater risk for experiencing anxiety during or after pregnancy. The main questions this study aims to answer are:\n\n* Is Reaching Calm easy to use and acceptable to both participants and healthcare professionals?\n* Does Reaching Calm help reduce risk for anxiety among participants?\n* Does personalizing the digital program help participants stay involved? Researchers will compare obstetric practices that offer Reaching Calm to those providing usual care.\n\nParticipants will:\n\n* Receive text messages and use a web-based platform for learning about anxiety and coping strategies\n* Respond to surveys about their experiences and symptoms\n* Some will take part in interviews and focus groups to share their views\n* Healthcare professionals will receive training on how to support the program The study will monitor how many people join, stay involved, and how the program affects their well-being. The results will help prepare for a larger study that could lead to wider use of Reaching Calm across the country.",[226,227,228],"Perinatal Anxiety","Anxiety Sensitivity","Perinatal Depression",[230,231,232,233,234],"Perinatal anxiety","Obstetric care","Perinatal mental health","Digital mental health","Engagement","2026-06-10",{"date":157,"type":40},{"date":39,"type":21},{"date":239,"type":21},"2029-08-31",{"name":46,"class":47},{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":248,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":22,"phases":250,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":260,"leadSponsor":262,"locationsCount":78},"100642945","improving-jail-response-to-the-overdose-crisis-a-hybrid-trial-of-jail-echo-to-improve-moud-implementation-and-public-health-outcomes-100642945","NCT07637994","Improving Jail Response to the Overdose Crisis: A Hybrid Trial of Jail ECHO to Improve MOUD Implementation and Public Health Outcomes","J-ECHO OPS","Inclusion Criteria:\n\n* Administrative, security, or healthcare staff in participating jails\n* Employed at the facility a minimum of 3 months\n\nExclusion Criteria:\n\n* Ongoing or recent participation in similar organizational improvement project\n* Inability to read or understand English or Spanish",true,{"count":140,"type":21},[24],"This project tests a training strategy to help rural jails start or increase their use of medications to treat opioid use disorder (MOUD - methadone, buprenorphine, naltrexone). Staff from participating jails will attend a series of training sessions, called Project ECHO, that include online learning sessions with skilled experts, case-based discussions (real-world examples), and peer-to-peer learning opportunities. Project ECHO is well-studied in healthcare settings but has rarely been used in correctional systems. Staff from 40 rural jails and local treatment programs will participate in 6 months of core sessions (all participants attend the same sessions), followed by 12 months of continuing sessions (where content is tailored to participants' needs). Staff will complete surveys about their knowledge and experience, and jails will provide data about their services. Researchers will measure changes in MOUD services offered by the jails over time, as well as the impact these changes have on staff's work environment. If Project ECHO helps expand MOUD services, it will offer a blueprint for expanding these life-saving services in other jails nationwide.",[253],"Opioid Abuse (Disorder)",[255,256],"Medications for Opioid Use Disorder","Rural Jails","2026-06-05",{"date":235,"type":40},{"date":39,"type":21},{"date":261,"type":21},"2030-05-31",{"name":46,"class":47},{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":274,"conditions":275,"keywords":278,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":288},"100449909","supporting-treatment-access-and-recovery-in-cod-100449909","NCT05138614","Supporting Treatment Access and Recovery in COD","Supporting Treatment Access and Recovery in Co-Occurring Opioid Use and Mental Health Disorders","STAR-COD","Inclusion Criteria:\n\n* Are 18 years-old and older;\n* Are fluent in English or Spanish;\n* Have OUD who (a) are newly admitted into the program with OUD; or (b) who have been active in the program for the treatment of OUD with medications like buprenorphine or naltrexone, but experienced a recent relapse with any substance (e.g., alcohol, cocaine, opioids, or benzodiazepines). This second group is necessary to include because patients who may have been stable for a long period of time may have a relapse and need intensive treatment to help them regain their abstinence and facilitate the path towards recovery. Thus, by taking those newly enrolled and those who were stable on MOUD but had a recent relapse, the second group is clinically similar to the first group and the intervention will be meaningful.;\n* Able to provide consent;\n* Potentially have a concurrent substance use disorder in addition to opioids; and\n* Have a co-occurring mental health disorder (COD) including depression, anxiety, trauma-related disorders, bipolar, and\u002For schizophrenia, and those who are stable on buprenorphine or naltrexone but have recurrence or worsening at any time of symptoms of any co-occurring mental health disorder (COD) including depression, anxiety, trauma-related disorders, bipolar, and\u002For schizophrenia, even if the patient has not relapsed. Instability is defined in two ways in the study: (a) a substance use relapse; and (b) recurrence to symptom exacerbation in regard to a subject's mental health disorder(s). If subjects do not meet criteria for \"a\" (i.e., not having a substance use relapse), but they do meet criteria for \"b\" (i.e., they do in fact have worsening of mental health symptoms), they are then defined as unstable, and will meet study inclusion criteria.\n\nExclusion Criteria:\n\n* Are not fluent in English or Spanish;\n* Are acutely psychotic, acutely suicidal with a plan, or homicidal;\n* Are incompetent and unable to provide informed consent; and\n* Have concurrent severe alcohol use disorder or high dose benzodiazepine needing detoxification. This exclusion factor is based on DSM-5 criteria, and those who are currently drinking or with a history of severe alcohol withdrawal (i.e., alcohol related seizures, and delirium tremens) will also be excluded. High dose benzodiazepine is defined as using Lorazepam equivalent of \\> 10 mg\u002Fday; Diazepam \\> 100 mg\u002Fday; Clonazepam 5 mg\u002F day; Alprazolam 5 mg\u002Fday.",{"count":272,"type":21},1000,[24],"This 4-year study will randomize 1,000 people with co-occurring opioid use and mental health disorders (COD) at medication for opioid use disorder (MOUD) clinics to evaluate the effectiveness of MISSION, a multi-component team approach, or its components with MOUD versus MOUD alone, as well as the incremental benefits of MISSION or its components for improving outcomes. We expect that individuals receiving MISSION or its parts + MOUD will show greater improvement over MOUD alone on: engagement, substance use, and mental health.",[276,277],"Opioid Use Disorder","Mental Health Disorder",[279,34],"opioid use disorder","2026-06-02",{"date":282,"type":40},"2026-06-04",{"date":284,"type":40},"2022-03-11",{"date":286,"type":21},"2026-08-31",{"name":46,"class":47},5,{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":248,"sex":17,"minAge":296,"maxAge":297,"enrollmentInfo":298,"targetDuration":4,"studyType":299,"phases":4,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":311},"100441869","spiromics-study-of-early-copd-progression-source-100441869","NCT05033990","SPIROMICS Study of Early COPD Progression (SOURCE)","SOURCE","Inclusion Criteria:\n\n* 40 of the 1000 will be healthy controls: ages 30-55 years; with no smoking history (\\\u003C 100 cigarettes in lifetime), including vaping and cannabis use; pre-bronchodilator FEV1\u002FFVC \\> 0.70; pre-bronchodilator FEV1 \\> 80% predicted; pre-bronchodilator FVC \\> 80% predicted; Chronic Airway Assessment Test (CAAT) score \\\u003C 10. Willingness to also participate in the bronchoscopy sub-study is only required of the 20 healthy controls recruited from the clinical centers participating in the sub-study.\n* Approximately one-third of the 960 will be GOLD 0 participants: ages 30-55 years; with ≥ 10 pack-year smoking history; post-bronchodilator FEV1\u002FFVC \\> 0.70 and FEV1 \\> 80% predicted.\n* Approximately one-third of the 960 will be Preserved Ratio Impaired Spirometry (PRISm) participants: ages 30-55 years; with ≥ 10 pack-year smoking history; post-bronchodilator FEV1\u002FFVC \\> 0.70 and FEV1 \\\u003C 80% predicted.\n* Approximately one-third of the 960 will be GOLD 1-2 participants: ages 30-55 years; with ≥ 10 pack-year smoking history; post-bronchodilator FEV1\u002FFVC \\\u003C 0.70 and FEV1 \\> 50% predicted.\n\nExclusion Criteria:\n\n* Severe asthma, which is defined as any of the following:\n\n  * Current (i.e., at the time of the visit) Global Initiative for Asthma (GINA) Step 4 or higher therapy (medium dose inhaled corticosteroids (ICS)\u002Flong-acting beta agonist (LABA) or high dose ICS or add-on long-acting muscarinic agonist (LAMA); Medium dose \\> 250 fluticasone propionate, = 100 fluticasone furoate, \\> 200 beclomethasone, \\> 400 budesonide, \\> 220 mometasone). We will accept low-dose ICS\u002FLABA or medium dose ICS; or\n  * Three or more unscheduled healthcare visits (provider\u002Furgent care\u002FER) for asthma in the past 12 months; or\n  * One asthma hospitalization in the past 12 months.\n* Concurrent participation in a therapeutic trial where treatment is blinded.\n* Active pregnancy at the time of the baseline visit or planning to become pregnant during the course of the study. This special population is being excluded to minimize potential for fetal radiation exposure.\n* Cognitive dysfunction that prevents the participant from completing study procedures.\n* BMI \\> 35.0 kg\u002Fm\\^2 at baseline, due to the effects of body weight on CT scan imaging quality.\n* The presence of a respiratory condition other than COPD (including chronic bronchitis and emphysema) or asthma, such as interstitial lung disease or pulmonary fibrosis, or of a comorbid condition that in the judgment of the investigator may be the principal cause of respiratory symptoms (e.g., dyspnea or decreased exercise tolerance).\n* Any illness expected to cause mortality in the next three years.\n* Any implanted metallic devices or prosthesis above the waist that could degrade thoracic CT scan image quality.\n* History of thoracic radiation or thoracic surgery with resection of lung tissue.\n* Known HIV\u002FAIDS infection.\n* Current illicit substance abuse, excluding marijuana.\n* History of or current use of IV Ritalin.\n* History of or current use of heroin.\n* History of illegal IV drug use within the last 10 years or more than 5 instances of illegal IV drug use ever.","30 Years","55 Years",{"count":272,"type":21},"OBSERVATIONAL","This is an observational study of 1000 participants to further define the nature of early chronic obstructive pulmonary disease (COPD) in younger, at-risk individuals.\n\nThe study has three main goals:\n\n* To use CT scan imaging to identify which smokers will develop COPD.\n* To identify biomarkers predictive of smokers that will develop COPD.\n* To determine if sputum (phlegm) can be analyzed to predict which smokers will develop COPD.\n\nProcedures (methods): All participants will undergo study related questionnaires assessing medical history, smoke exposure and use, medication use, social and behavioral health, pulmonary symptoms, food frequency, and will provide nasal swab, blood, stool, and urine samples, pulmonary function testing to determine function, sputum induction to provide a sputum sample for airway biospecimen analysis, and CT imaging of the lungs.",[302],"COPD, Early-Onset","2026-06-01",{"date":305,"type":40},"2026-06-03",{"date":307,"type":40},"2021-09-08",{"date":309,"type":21},"2027-05",{"name":46,"class":47},14,{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":318,"enrollmentInfo":319,"targetDuration":4,"studyType":22,"phases":321,"briefSummary":323,"conditions":324,"keywords":327,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":78},"100529464","phase-4-metabolic-effects-of-adjunctive-lumateperone-treatment-in-clozapine-treated-patients-with-schizophrenia-100529464","NCT06174116","Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia","Inclusion Criteria:\n\n* Meets the DSM-5 criteria for diagnoses of schizophrenia or schizoaffective disorder based on the MINI International Neuropsychiatric Interview (MINI 7.0)\n* On clozapine treatment for at least 6 months\n* Stable dose of antipsychotic treatment for at least 1 month\n* Well established compliance with outpatient medications\n* Subjects of child-bearing potential are required to practice appropriate birth control methods during the study.\n\nExclusion Criteria:\n\n* Psychiatrically unstable per clinical judgement by the principal investigator\n* Patients not on stable dose of antipsychotic medications\n* Currently meets DSM-5 criteria for any substance use disorder other than caffeine and nicotine\n* Significant, unstable medical conditions including severe cardiovascular, hepatic, renal or other medical diseases\n* History of a seizure disorder\n* Pregnancy or breastfeeding\n* On lumateperone treatment in the past 3 months\n* On a dopamine partial agonist antipsychotic agent in the past 3 months (aripiprazole, brexpiprazole, cariprazine)","65 Years",{"count":320,"type":21},50,[322],"PHASE4","The main question this study is trying to answer is whether lumateperone, an FDA-approved antipsychotic drug, can help reduce possible side effects of clozapine, such as weight gain and elevated levels of sugar and bad cholesterol.\n\nParticipants will be randomly assigned to either take lumateperone (Caplyta) or a placebo for 12 weeks, in addition to their regularly prescribed clozapine. During their participation, patients will answer questions about their psychiatric and daily functioning, have blood drawn, and have their body composition analyzed (similar to stepping on a scale).",[325,326],"Schizophrenia","Schizo Affective Disorder",[328],"Clozapine","2026-05-20",{"date":331,"type":40},"2026-05-22",{"date":333,"type":40},"2024-04-02",{"date":335,"type":21},"2027-03",{"name":46,"class":47},{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":248,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":22,"phases":346,"briefSummary":347,"conditions":348,"keywords":351,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":363},"100585556","social-needs-screening-and-chronic-diseases-study-we-care-100585556","NCT06903897","Social Needs Screening and Chronic Diseases Study (WE CARE)","Improving Chronic Disease Outcomes Across the Lifespan by Addressing Structural Racism","Inclusion Criteria:\n\n* Adults and children with diagnosed chronic diseases (hypertension, diabetes mellitus, hyperlipidemia, asthma, or depression) who receive Family Medicine care at one of the study sites.\n* Children (\\\u003C18 years of age) with a diagnosis of asthma.\n* Adult patients (18 years or older) with a diagnosis of diabetes mellitus, hypertension, hyperlipidemia and\u002For depression.\n\nExclusion Criteria:\n\n* In adults (\\>18 years of age), those without one or more of the following diagnoses as recorded by ICD-10 codes in their EHR: hypertension, hyperlipidemia, diabetes mellitus, or depression.\n* In children (\\\u003C18 years of age), those without a diagnosis of asthma.",{"count":345,"type":21},68000,[24],"The goal of this clinical trial is to learn if the implementation of the WE CARE social determinants of health (SDOH) screening and referral intervention with an antiracist lens in primary care settings can lead to a meaningful decrease in chronic disease by monitoring conditions such as hypertension, diabetes, depression, hyperlipidemia, and asthma through clinical measures. The main question it aims to answer is:\n\nDoes the WE CARE SDOH screening and referral intervention applying an antiracism lens informed implementation strategies have the potential to reduce racial\u002Fethnic health inequities in chronic diseases for minoritized patients?",[349,98,198,350,152],"Hyperlipidemias","Pediatric Asthma",[352,353,354,355],"Basic Needs","Social Determinants of Health","Screening tools","Antiracism","2026-05-18",{"date":331,"type":40},{"date":359,"type":40},"2025-10-08",{"date":361,"type":21},"2028-09-30",{"name":46,"class":47},3,{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":372,"enrollmentInfo":373,"targetDuration":4,"studyType":22,"phases":374,"briefSummary":375,"conditions":376,"keywords":379,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":390,"leadSponsor":391,"locationsCount":48},"100625085","preliminary-trial-of-an-avatar-guided-digital-intervention-for-emerging-adults-100625085","NCT07418047","Preliminary Trial of an Avatar Guided Digital Intervention for Emerging Adults","Randomized Controlled Feasibility Trial of an Avatar Guided Intervention for Young Adults Seen in the Emergency Department With Alcohol Use Problems and Suicidal Thoughts","EA-Avatar","Inclusion Criteria:\n\n* (1) emergency department admission for alcohol- or suicide-related reason since turning 18, OR treated for incidental suicide risk in the emergency department\n* (2) aged 18-29\n* (3) speak, read, and understand English\n* (4) binge drinking in the past month OR alcohol use problems (Alcohol Use Disorders Identification Test score \\> 5)\n* (5) active suicidal ideation in the past month\n* (6) owning and having access to a personal smartphone\n* (7) willingness to be randomized to an avatar guided intervention for alcohol use problems and suicidal thoughts OR a freely available suicide safety planning app\n* (8) for remote MyChart-based recruitment only, have MyChart activated\n\nExclusion Criteria:\n\n* (1) severe cognitive delay, active psychosis, or heavy intoxication that precludes research participation\n* (2) imminent safety risk and have been recently unsafe to themselves or others\n* (3) prisoner or are under arrest\n* (4) not interested or not willing to be randomized to receive the avatar-guided digital intervention or safety plan app\n* (5) under the care of a legal guardian","29 Years",{"count":222,"type":21},[24],"The goal of this clinical trial is to learn whether a novel digital avatar (virtual coach) support program can help emerging adults ages 18-29 who present to the emergency department with suicidal thoughts and alcohol misuse (EA-Avatar). The study also aims to learn whether people find the program easy to use and whether daily surveys and the study design are able to be completed by the majority of emerging adult participants.\n\nThe main questions this study aims to answer are:\n\n* Do participants use the digital program and find it helpful?\n* Is it possible for participants to complete daily surveys for twenty-eight days and follow-up surveys over twelve weeks?\n* Are there early signs that the program may help lower alcohol use and suicidal thoughts?\n\nResearchers will compare participants who receive the new digital avatar program plus supportive text messages to participants who receive a freely available suicide safety planning app to see if there are differences in use, engagement, and early signs of benefit.\n\nParticipants will:\n\n* Receive standard care from the emergency department\n* Be randomly put into one of two groups (EA-Avatar or a free suicide prevention app)\n* Depending on their group, use a new avatar-guided digital support program with text message reminders OR use a free suicide safety planning app\n* Complete surveys at the start of the study and again at four, eight, and twelve weeks\n* Complete short daily surveys for twenty-eight days",[377,378],"Binge Alcohol Consumption","Suicidal Ideation",[380,381,382,383,384,385],"suicidal ideation","binge drinking","emerging adults","feasibility","emergency department","digital health","2026-05-14",{"date":388,"type":40},"2026-05-19",{"date":356,"type":21},{"date":286,"type":21},{"name":46,"class":47},{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":396,"acronym":397,"eligibilityCriteria":398,"healthyVolunteers":248,"sex":114,"minAge":399,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":22,"phases":402,"briefSummary":403,"conditions":404,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":78},"100625288","social-media-and-risk-reduction-training-for-preterm-infant-care-practices-100625288","NCT07420686","Social Media and Risk-reduction Training for Preterm Infant Care Practices","SMART Preemie","Inclusion Criteria:\n\n* English- or Spanish- speaking mothers of preterm infants (gestational age \\\u003C37 weeks' weeks)\n* Infant must have been admitted to one of the 16 participating NICUs for at least 7 days\n* Infant must be discharged home from one of the 16 participating NICUs within 56 weeks post-menstrual age (\\>95% of preterm infants)\n* Infant must be discharged to the care of the mother (not a foster family) who intends to care for the child in the US for the first 6 months post-discharge\n* Must have a phone that can receive text messages and view videos\n\nExclusion Criteria:\n\n* Known or reported mental health or other issues that would preclude custody of the infant or being able to participate in the informed consent process.\n* Infant has contraindications to safe sleep positioning (e.g. extremely rare conditions of the airway or lower spine)\n* Meets the definition of a minor according to applicable state law.","13 Years",{"count":401,"type":21},1600,[24],"SMART Preemie is a cluster randomized trial that will investigate the effectiveness of NICU-based and post-discharge interventions to improve adherence to safe sleep practices among mothers of preterm infants. This study includes two complementary, culturally competent, intervention strategies and will test the effectiveness of each strategy, as well as both strategies in combination. The attention matched-control intervention will focus on shared reading.\n\nThe SMART Preemie study will have four arms in which 16 hospitals are randomly assigned to one of the following study groups: 1) Safe Sleep NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages; 2) Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages; 3) Safe Sleep NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages; 4) Shared Reading NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages. A total of 1600 mothers will be recruited (100\u002Fhospital), with 400 in each study group.\n\nThe primary aim is to assess the effectiveness of the interventions aimed at promoting safe sleep practices compared with the shared reading control interventions. The secondary aim is to assess potential mediating factors that may explain the intervention effects on infant care practices and that may inform areas for future improved intervention approaches. The tertiary aim is to assess key implementation outcomes which will be used for future scale-up. With the successful completion of the SMART Preemie study, effectiveness, mechanism, and implementation data will have been provided for two interventions to improve adherence to safe sleep practices that are practical to disseminate nationally in multiple diverse settings.",[405,406,407],"Safe Sleep Education","SUID","Sudden Infant Death Syndrome (SIDS)","2026-05-09",{"date":410,"type":40},"2026-05-13",{"date":412,"type":21},"2027-01-01",{"date":414,"type":21},"2028-12-31",{"name":46,"class":47},{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":423,"maxAge":424,"enrollmentInfo":425,"targetDuration":4,"studyType":22,"phases":427,"briefSummary":428,"conditions":429,"keywords":431,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":78},"100545940","asthma-link-effectiveness-trial-100545940","NCT06388460","Asthma Link Effectiveness Trial","Asthma Link: A Partnership Between Pediatric Practices, Schools, and Families to Improve Medication Adherence and Health Outcomes in Children With Poorly Controlled Asthma","STUDY INCLUSION\u002FEXCLUSION CRITERIA:\n\nChild Inclusion Criteria:\n\n* Meet the eligibility criteria for Asthma Link (as described below)\n* Enrolled in Asthma Link (if randomized to the Asthma Link Condition)\n* Able and willing to provide informed assent\n\nChild Exclusion Criteria:\n\n* Unable or unwilling to provide informed assent\n* Developmental delay that would prevent study participation.\n\nParent Inclusion Criteria:\n\n* Parent\u002Fguardian to patient\n* 18 years or older\n* Able to understand and communicate in English or Spanish\n* Able and willing to provide informed consent.\n\nChild eligibility for children enrolled in Asthma Link:\n\n* children aged 5-14 years (enrolled in grade K-8)\n* prescribed daily inhaled corticosteroid (ICS) for asthma\n* Asthma Control Test (ACT) score ≤19 OR 1 or more of ANY of following in the past 1 year: course of oral steroids, hospitalization, Emergency Department visit, sick visit for asthma\n* parent\u002Fchild report of poor ICS adherence on adherence checklist- i.e. child or parent says \"Yes\" when provider asks if they have difficulty remembering to take their medication or if they regularly take medication holidays or breaks\n* able and willing to assent\n* parental permission\n* English or Spanish speaking","5 Years","14 Years",{"count":426,"type":21},350,[24],"The goal of this cluster Randomized Control Trial is to determine the effectiveness of Asthma Link, a school supervised asthma therapy program, compared with an educational asthma workbook, in improving asthma symptoms for children with poorly controlled asthma aged 5-14.",[430],"Childhood Asthma",[432,433,434,435,436],"asthma","childhood asthma","medication adherence","school-supervised asthma therapy","real-world","2026-04-30",{"date":439,"type":40},"2026-05-05",{"date":441,"type":40},"2024-04-04",{"date":443,"type":21},"2028-04",{"name":46,"class":47},{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":17,"minAge":423,"maxAge":452,"enrollmentInfo":453,"targetDuration":4,"studyType":22,"phases":454,"briefSummary":455,"conditions":456,"keywords":460,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":468,"leadSponsor":470,"locationsCount":78},"100634116","food-is-medicine-in-pediatric-patients-with-diabetes-100634116","NCT07535502","Food is Medicine in Pediatric Patients With Diabetes","The Effect of a Novel Food is Medicine Program on Outcomes in Pediatric Patients With Diabetes: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Current patients of the UMMMC Pediatric Endocrinology Clinic\n* Children and Adolescents less than or equal to 17 years of age at the time of enrollment\n* Diagnosed with Type 1 Diabetes at least 3 months ago\n* Public (MassHealth or Medicaid) Health Insurance\n\nExclusion Criteria:\n\n* Celiac disease or severe gluten allergy\n* Congenital, genetic, or chronic comorbidities\n* DCF Custody\n* Pregnant women\n* Prisoners\n* Non-English speaking subjects","17 Years",{"count":320,"type":21},[24],"The objective of this randomized controlled trial is to evaluate the effect of novel Food is Medicine Programming in the form of medically tailored pre-packaged meals for pediatric patients with Type 1 Diabetes. The provision of medically-tailored meals to children and adolescents with diabetes that have potential food security or access concerns in addition to nutrition counseling will improve clinical outcomes, decrease healthcare utilization, and improve health-related quality of life (HRQOL). Consulting with a Registered Dietician is the established multidisciplinary standard of care for pediatric patients with diabetes at UMass. Community Servings provides a medically-tailored pre-packaged meal plan designed for pediatric patients with Type 1 Diabetes. The addition of Community Servings to the current standard of care in pediatric patients with potential food security or access concerns will further improve clinical, decrease healthcare utilization, and improve HRQOL outcomes in pediatric patients with Type 1 Diabetes.",[457,458,459],"Type I Diabetes","Pediatrics","Food Insecurity",[461,457,458,459,462,463],"Food is Medicine","Continuous Glucose Monitoring","Medically-tailored Meals","2026-04-14",{"date":466,"type":40},"2026-04-17",{"date":329,"type":21},{"date":469,"type":21},"2029-12-31",{"name":46,"class":47},{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":475,"acronym":476,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":478,"enrollmentInfo":479,"targetDuration":4,"studyType":22,"phases":481,"briefSummary":482,"conditions":483,"keywords":488,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":78},"100576849","pathways-to-perinatal-mental-health-equity-100576849","NCT06790641","Pathways to Perinatal Mental Health Equity","Pathways","Inclusion Criteria for perinatal care setting team members:\n\n* Be employed by a participating perinatal care setting in a clinical role (including as an obstetrician-gynecologist, midwife, nurse practitioner, a nurse, a navigator, or administrative staff member who implemented the respective intervention during the study period).\n* Be 18 years of age or older\n* Provide verbal consent prior to the focus group or interview\n* Be proficient in English\n\nInclusion Criteria for peer mentors:\n\n* Have completed PSI training to be a peer mentor\n* Be 18 years of age or older\n* Provide verbal consent prior to the focus group or interview\n* Be proficient in English\n\nInclusion Criteria for perinatal individuals:\n\n* Have received perinatal care at a study partnering perinatal care setting during the study period\n* Be 18 years of age or older\n* Provide verbal consent prior to the focus group or interview\n* Be proficient in English or Spanish\n\nExclusion Criteria:\n\nAn individual who does not meet the inclusion criteria listed above will be excluded from participation in this study. There are no additional exclusion criteria.","70 Years",{"count":480,"type":21},1270,[24],"Mental health conditions occurring during pregnancy and up to one year postpartum (the perinatal period) occur in 1 in 5 perinatal individuals. To improve mental health care during the perinatal period, this study will implement and compare a health care model of improving mood and anxiety disorder care in practices with a health care-community partnership model. The study will include 32 perinatal care settings across the United States. Half of them will have the health care model, the other half will have the health care-community partnership model. The study is designed to answer the question, \"Should states and healthcare systems put resources into a healthcare system approach or a healthcare-community partnership approach to mental health care?\" The results of this study will help states and healthcare systems decide how to develop pathways for increasing access to mental health care for pregnant and postpartum individuals.",[226,228,63,484,485,486,487],"Peer Support","Obstetric Care","Substance Use Disorder (SUD)","Perinatal Depression, Substance Use",[489,490,491,492,493,494,495,496,497,498,499,500,501],"implementation strategies","obstetric care","perinatal mental health","perinatal anxiety","perinatal depression","perinatal mood disorders","qualitative study","focus groups","mixed methods","perinatal care","peer mentors","peer support","healthcare-community partnership",{"date":503,"type":40},"2026-04-20",{"date":505,"type":40},"2025-12-05",{"date":507,"type":21},"2030-10-01",{"name":46,"class":47},{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":248,"sex":17,"minAge":516,"maxAge":192,"enrollmentInfo":517,"targetDuration":4,"studyType":22,"phases":519,"briefSummary":520,"conditions":521,"keywords":524,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":78},"100574006","mothers-action-project-for-child-health-100574006","NCT06753669","Mothers' Action Project for Child Health","MAP-CH","Inclusion Criteria:\n\n* Mother:\n\n  * Age \\>=18;\n  * Speaks and reads\u002Fwrites Bengali or Hindi\u002FUrdu;\n  * Mother born in a South Asian country;\n  * Mother is primary caretaker of child\n* Child:\n\n  * Aged \\>=12 and \\\u003C=48 months\n  * Has Medicaid or CHIP (NYS health plan for low income families not qualifying for Medicaid)\n\nExclusion Criteria:\n\n* Mother:\n\n  * Unable to provide informed consent,\n  * Lack of availability--either plans to travel for \\> 1 month during 12 month initial study period or other barriers to attendance;\n  * Mother has exclusionary health condition--either intellectual\u002Fcognitive or medical.\n* Child:\n\n  * Weighed \\\u003C 5lbs at birth,\n  * Has an exclusionary health condition and\u002For is taking long term (\\>1 m) antibiotics;\n  * Not the youngest eligible child in family","12 Months",{"count":518,"type":21},460,[24],"This randomized controlled trial will recruit Bangladeshi mothers and their young children into a 12 month intervention that provides child health and oral health education and seeks to build social networks among mothers.",[522,523],"Dental Caries","Obesity Risk",[525,526,527],"early childhood caries","child obesity","social network intervention","2026-04-09",{"date":464,"type":40},{"date":531,"type":40},"2026-02-01",{"date":533,"type":21},"2029-03-30",{"name":46,"class":47},{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":17,"minAge":543,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":22,"phases":546,"briefSummary":548,"conditions":549,"keywords":551,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":556,"completionDateStruct":557,"leadSponsor":559,"locationsCount":78},"100632932","phase-3-metformin-to-attenuate-progressive-respiratory-decline-in-idiopathic-pulmonary-fibrosis-100632932","NCT07520110","Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis","Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis (MAVRIC)","MAVRIC","Inclusion Criteria:\n\n1. IPF diagnosis by enrolling investigator (following the 2022 updated guidelines on diagnosis and management of IPF)\n2. Age 40 years or older\n3. HbA1c \\\u003C 9% at screening\n4. High risk by proteomic signature (proteomic signature present) for participants randomized only (for participants randomized only; participants that are proteomic signature absent will undergo remote study assessments at 12 and 24 months only).\n5. If on FDA-approved treatment(s) for IPF, on a stable dose for at least 8 weeks prior to randomization\n6. Ability to provide informed consent\n\nExclusion Criteria:\n\n1. Taking metformin within 3 months of randomization\n2. Allergy or intolerance to metformin\n3. Use of insulin or insulin secretagogue(s) at randomization\n4. Pregnancy, planning to become pregnant, or lactating\n5. Women of childbearing potential not willing to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of \\\u003C1% per year during study participation\n6. History of biochemically-confirmed acidosis (lactate \\> 5.0 mmol\u002FL)\n7. Estimated glomerular filtration rate less than 45 mL\u002Fmin\u002F1.73 m2 at screening\n8. Moderate-to-severe liver disease, decompensated heart failure, or any other condition that may make the participant unsuitable for inclusion as assessed by the study investigator at each site\n9. Receipt of an investigational study agent as part of a therapeutic trial within 30 days of the Screening Visit (Visit 0)\n10. Continuous supplemental oxygen use at rest greater than 2 L\u002Fmin\n11. Unable to swallow pills\n12. Taking a medication that has a major interaction with metformin, including acetazolamide (Diamox), cimetidine (Tagamet), dolutegravir, gatifloxacin, levoketoconazole, ranolazine, or carbonic anhydrase inhibitors. Occasional use of carbonic anhydrase inhibitors for travel is permitted.\n13. Current alcohol intake ≥ 15 drinks per week in men, ≥ 8 drinks per week in women or ≥ 5 drinks per occasion in men, ≥ 4 drinks per occasion in women\n14. Listed for transplant at the time of randomization","40 Years",{"count":545,"type":21},800,[547],"PHASE3","This is a randomized, placebo-controlled trial of metformin in 400 participants with idiopathic pulmonary fibrosis (IPF) who are at high risk of adverse clinical outcomes based on a proteomic classifier. The primary objective is to assess the safety and efficacy of metformin compared to placebo in participants with IPF who are at high-risk for adverse clinical events.\n\nApproximately 800 participants with IPF will be screened. 400 participants who are at high risk for adverse clinical events (proteomic signature present) will be randomized into receiving metformin (n\\~200) or matching placebo (n\\~200). Participants that meet the eligibility criteria but do not have the proteomic signature (proteomic signature absent) will be contacted by phone at 12 and 24 months to review medical history.",[550],"Idiopathic Pulmonary Fibrosis",[550,552,553],"IPF","metformin","2026-04-08",{"date":464,"type":40},{"date":42,"type":21},{"date":558,"type":21},"2029-03-15",{"name":46,"class":47},{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":22,"phases":569,"briefSummary":570,"conditions":571,"keywords":574,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":78},"100629708","prehab-for-pancreatic-cancer-surgery-100629708","NCT07478185","Prehab for Pancreatic Cancer Surgery","Multimodal Prehabilitation Prior to Pancreatic Cancer Surgery: A Pilot Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of pancreatic ductal adenocarcinoma (PDAC)\n* Planned neoadjuvant chemotherapy prior to planned surgical resection\n* Medically stable and cleared to participate in physical activity\u002Fexercise programming\n* Able to provide informed consent\n* Ability to read, write and understand English\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Pregnant\n* Prisoner\n* Severe cognitive impairment that precludes informed consent or participation\n* Contraindications to physical activity, including unstable cardiac disease, severe pulmonary disease, or recent myocardial infarction",{"count":568,"type":21},20,[24],"The goal of this clinical study is to test whether a structured prehabilitation program can be successfully used by adults with pancreatic cancer who are receiving chemotherapy before planned surgery. Prehabilitation is a program designed to improve a person's physical fitness, nutrition, and symptom control before surgery.\n\nThe study's main hypothesis is that patients with pancreatic cancer can take part in and adhere to a multimodal prehabilitation program during chemotherapy, and that doing so may improve physical function, patient experience, and early recovery after surgery.",[572,573],"Pancreatic Cancer, Adult","Prehabilitation",[573,575,576,577,578,579],"Nutritional status","Functional capacity","Pancreatic cancer","Pancreatectomy","Pancreaticoduodenectomy","2026-04-01",{"date":582,"type":40},"2026-04-03",{"date":584,"type":40},"2026-03-31",{"date":586,"type":21},"2028-12",{"name":46,"class":47},{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":4,"eligibilityCriteria":594,"healthyVolunteers":12,"sex":114,"minAge":18,"maxAge":4,"enrollmentInfo":595,"targetDuration":4,"studyType":22,"phases":597,"briefSummary":598,"conditions":599,"keywords":602,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":78},"100469118","early-detection-of-gestational-diabetes-mellitus-in-pregnancy-100469118","NCT05388643","Early Detection of Gestational Diabetes Mellitus in Pregnancy","Early Detection of Gestational Diabetes Mellitus in Pregnancy: A Randomized Trial","Inclusion Criteria:\n\n* 1\\) age greater than or equal to 18 years old,\n* 2\\) singleton gestation less than or equal to 12 weeks at initial obstetric visit,\n* 3\\) receiving prenatal care at UMMHC and plans to deliver at UMMHC,\n* 4\\) able and willing to provide informed consent,\n* 5\\) English or Spanish speaking, and\n* 6\\) are at high risk for developing GDM by ACOG clinical risk factor guidelines.\n\nExclusion Criteria:\n\n* 1\\) known diagnosis of pre-existing pregestational diabetes,\n* 2\\) plan to receive prenatal care or deliver outside of UMMHC,\n* 3\\) inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test), or\n* 4\\) systemic steroid use.",{"count":596,"type":21},80,[24],"The purpose of this study is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of gestational diabetes mellitus (GDM).",[600,601],"Gestational Diabetes Mellitus in Pregnancy","Pregnancy, High Risk",[603,120,604,605,606],"Pregnancy","Screening","Maternal Outcomes","Neonatal Outcomes",{"date":608,"type":40},"2026-04-06",{"date":610,"type":40},"2025-07-01",{"date":612,"type":21},"2026-12-01",{"name":46,"class":47},{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":4,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":621,"targetDuration":4,"studyType":22,"phases":623,"briefSummary":624,"conditions":625,"keywords":630,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":635,"lastUpdatePostDateStruct":636,"startDateStruct":638,"completionDateStruct":640,"leadSponsor":642,"locationsCount":78},"100556683","effects-of-erector-spinae-plane-block-on-postoperative-pain-following-lumbar-fusion-surgery-100556683","NCT06528288","Effects of Erector Spinae Plane Block on Postoperative Pain Following Lumbar Fusion Surgery","Opioid Usage and Patient Reported Outcome Comparison Following Erector Spinae Plane Block or Subcutaneous Anesthetic in Spinal Fusion Procedures","Inclusion Criteria:\n\n* The individual has signed and dated a study specific informed consent form approved by the Institutional Review Board at UMMHC.\n* The individual is at least 18 years of age.\n* The individual is skeletally mature (over the age of 18).\n* The patient is scheduled for a one or two level lumbar spinal fusion.\n\nExclusion Criteria:\n\n* Patients unable to consent for themselves.\n* Pregnant women.\n* Non-English speaking subjects.\n* Prisoners.\n* Spinal fusion procedures for a diagnosis of fracture, tumor, and\u002For infection.\n* Patients who have used greater than 150 morphine milligram equivalents of opioids in the month prior to their operation.\n* Patients with a body mass index (BMI) of 40 or greater.",{"count":622,"type":21},66,[24],"The purpose of this study is to determine if the method for injecting local anesthesia affects patients' pain and opioid usage after surgery. The investigators will compare subcutaneous anesthesia, injections of anesthesia under the skin, to a method called erector spinae plane block (ESPB). An ESPB injection involves placing local anesthesia along the muscles and bones in the back, using a special type of x-ray called fluoroscopy for guidance. The Investigators will use patient reported outcomes (PROs) and track subjects' opioid usage to find out if there is a difference between ESPB and subcutaneous anesthesia. The investigators hypothesize that patients who get ESPB injections will use less opioids and report less pain after lumbar fusion surgery compared to patients who receive subcutaneous anesthesia injections.",[626,627,628,629],"Fusion of Spine, Lumbar Region","Anesthesia, Local","Pain, Postoperative","Opioid Use",[631,632,633,634],"Erector Spinae Plane Block","Spinal Fusion","Patient Reported Outcomes","Opioid Usage","2026-03-12",{"date":637,"type":40},"2026-03-16",{"date":639,"type":40},"2024-09-13",{"date":641,"type":21},"2027-07-01",{"name":46,"class":47},{"id":644,"slug":645,"hasResults":12,"nctId":646,"briefTitle":647,"officialTitle":647,"acronym":4,"eligibilityCriteria":648,"healthyVolunteers":248,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":649,"targetDuration":4,"studyType":22,"phases":651,"briefSummary":652,"conditions":653,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":655,"lastUpdatePostDateStruct":656,"startDateStruct":658,"completionDateStruct":659,"leadSponsor":661,"locationsCount":78},"100535031","impact-of-a-virtual-reality-based-mindfulness-program-on-clinician-wellness-100535031","NCT06246539","Impact of a Virtual Reality-based Mindfulness Program on Clinician Wellness","Inclusion Criteria:\n\n* physician or APP employed by the Medical Group\n\nExclusion Criteria:\n\n* Not willing to receive 2 texts per week",{"count":650,"type":21},32,[24],"Burnout shares symptoms with anxiety and depression. While there is no single intervention for burnout, there are validated interventions (which are amenable to virtual reality (VR)) for anxiety and depression. UMassMemorial data from the Professional Well-Being Academic Consortium show that MD burnout and distress has increased since 2020. The investigators believe providing clinicians with a unique tool (VR) will be a feasible and efficacious way to tackle distress. It is known that only 1% of our MDs have done mindfulness training but nearly 50% are interested in doing so. Therefore, a self-administrable, interactive mindfulness program delivered over VR has great potential to reach clinicians who want to practice a more active form of mindfulness at a time convenient to them. The results of the study will provide preliminary evidence to determine if a take-home VR mindfulness program decreases clinician stress.",[654],"Wellness, Psychological","2026-03-11",{"date":657,"type":40},"2026-03-13",{"date":303,"type":21},{"date":660,"type":21},"2028-07-31",{"name":46,"class":47},{"id":663,"slug":664,"hasResults":12,"nctId":665,"briefTitle":666,"officialTitle":667,"acronym":4,"eligibilityCriteria":668,"healthyVolunteers":248,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":669,"targetDuration":4,"studyType":22,"phases":671,"briefSummary":672,"conditions":673,"keywords":676,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":655,"lastUpdatePostDateStruct":678,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":683,"locationsCount":78},"100523830","does-fatigue-coaching-improve-functioning-and-fatigue-in-resident-night-shifts-100523830","NCT06100809","Does Fatigue Coaching Improve Functioning and Fatigue in Resident Night Shifts","Personalized Fatigue-Mitigation Lifestyle Coaching (PFMLC) to Improve Performance and Recovery Among Emergency Medicine Residents on Night Shifts","Inclusion Criteria:\n\n* emergency medicine resident\n* scheduled to work at least 4 overnight consecutive shifts\n\nExclusion Criteria:\n\n* not willing to wear Fitbit device during the study\n* not willing to answer questionnaires\n* not willing to receive text messages during the study\n* not willing to meet with a lifestyle coach during the study\n* not willing t0 download app to their personal smartphone or residency-supplied smartphone",{"count":670,"type":21},30,[24],"Emergency Medicine (EM) requires 24\u002F7 staff coverage resulting in healthcare workers' circadian rhythm disruptions that impair clinical and cognitive performance, physical recovery, and contribute to burnout. Multiple well-being surveys continue to highlight EM's challenges with sleep impairment due to the nature of the specialty. Despite evidence that lifestyle strategies effectively optimize performance and recovery, EM residents have variable lifestyle choices to prepare for overnight shifts. This prospective randomized controlled trial will examine whether a pre-shift personalized fatigue-mitigation lifestyle coaching (PFMLC) for EM residents on overnight shifts minimizes the effects of circadian rhythm disruptions on performance and recovery compared to those who receive one-time passive information on lifestyle practices. All participants will receive lifestyle strategy materials on fatigue mitigation to improve performance. Residents' self-reported and biometric data will inform PFMLC in the active arm. Performance and recovery from night shifts will be assessed by changes in sleep, heart rate variability, readiness\u002Frecovery, alertness, cognitive performance, and mental health using Fitbit and validated measures.",[674,675],"Fatigue","Shift Work Type Circadian Rhythm Sleep Disorder",[674,677],"Shift Work",{"date":657,"type":40},{"date":680,"type":21},"2026-07-15",{"date":682,"type":21},"2027-12-30",{"name":46,"class":47},""]