[{"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:":690},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,42,0,25,[9,51,81,102,133,155,175,207,231,259,285,312,338,366,394,428,448,476,501,523,547,574,597,625,664],{"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":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100652797","the-medically-tailored-groceries-and-mental-health-study-100652797",false,"NCT07779707","The Medically Tailored Groceries and Mental Health Study","MTG : RCT","Inclusion Criteria:\n\n* A depression diagnosis with active symptoms, defined as having a recent Patient Health Questionnaire (PHQ-9) screening of 5+, or no depression diagnosis but a recent PHQ-9 screening of 10+\n* Experiencing food insecurity (could be either low or very low food security)\n* Lives in Central Massachusetts in Worcester County\n* Can prepare and cook meals independently, or has a family member or caregiver able to prepare food\n\nExclusion Criteria:\n\n* Pregnant women and women who are within one year postpartum at baseline. Women who become pregnant during trial will be allowed to finish their food programming and study participation.\n* New depression diagnosis within the past 3 months\n* Has bipolar depression or bipolar disorder","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"NA","This randomized controlled trial will test whether providing medically tailored groceries for 6 months can improve depressive symptoms among adults with depression and food insecurity.\n\nThe intervention under study is a 6-month, medically tailored grocery program provided by the Boston-based non-profit organization, Community Servings. Food boxes are mailed to participants' homes every two weeks and are designed by a registered dietitian nutritionists to support an individuals' health needs. Participants may also attend optional nutritional counseling sessions.\n\nIn this randomized clinical trial, 300 adults with depression and food insecurity will be assigned to one of two groups. The intervention group will receive medically tailored grocery boxes delivered to their home every two weeks for six months (13 boxes total), along with nutritional counseling support. The comparison group will receive usual medical care plus a $30 monthly grocery gift card for six months to be used to purchase any products of their choice.\n\nParticipants will be recruited from UMass Memorial and health centers associated with Community Care Cooperative in the greater Worcester area in Massachusetts.The main goal of the study is to determine whether the grocery program reduces symptoms of depression. The study will also examine effects on anxiety, food insecurity, diet quality, and healthcare use.",[27,28],"Depression \u002F Major Depressive Disorder","Food Insecurity",[30,31,32,33,34,35,36,37],"Depression","Food insecurity","Food as Medicine","Mental Health","Medically tailored groceries","Randomized controlled trial","Nutrition","Food is Medicine","NOT_YET_RECRUITING","2026-08-18",{"date":41,"type":42},"2026-08-21","ACTUAL",{"date":44,"type":21},"2026-08-31",{"date":46,"type":21},"2029-08-31",{"name":48,"class":49},"University of Massachusetts, Worcester","OTHER",1,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100581824","prospective-phenotyping-and-multi-omic-endotyping-of-progressive-pulmonary-fibrosis-100581824","NCT06855329","PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis","PRIME-PPF: PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis","PRIME-PPF","Inclusion Criteria:\n\n* Age 18-80 years with a diagnosis of non-IPF fibrosing ILD due to CTD-ILD, fHP, or non-IPF IIP based on central review\n* Diagnosis of Fibrotic ILD as determined by site investigator.\n* Willingness to comply with study procedures and follow-up.\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* Site diagnosis of fibrosing ILD \\>5 years prior to Visit 1 (Screening and Baseline Visit).\n* Minimal ILD, defined as reticular opacities and\u002For ground-glass opacities without architectural distortion (traction bronchiolectasis\u002Fbronchiectasis or honeycombing) affecting \\\u003C 5% of the lung on centralized evaluation of HRCT at Visit 1 (Screening and Baseline Visit). High quality historical chest HRCT may be used if performed within 90 days prior to Visit 1.\n* Extent of emphysema \\>15% of total lung volume or greater than extent of fibrosis based on central, qualitative assessment of HRCT at Visit 1. High quality historical chest HRCT may be used if performed within 90 days prior to Visit 1.\n* Active malignancy within one year prior to Visit 1 (except for non-melanoma skin cancer requiring local treatment).\n* Inability to complete full PFT (spirometry and DLCO) at Visit 1. Historical PFT may be used if performed within 90 days prior to Visit 1.\n* Taking nintedanib or nerandomilast at Visit 1.\n* Pregnancy at screening or plans to become pregnant during follow-up.\n* Participation in an interventional clinical trial for fibrotic ILD at the time of Visit 1, or receipt of an investigational drug within the previous 4 weeks of the enrollment visit (Visit 1) or 5 times the half-life, if longer.","80 Years",{"count":61,"type":21},500,"OBSERVATIONAL","This is a prospective, observational cohort study. Participants with non-idiopatic pulmonary fibrosis, interstitial lung disease (ILD) will be followed for 24 months to systematically collect clinical, imaging, and biospecimen data. The primary objective is to optimize progressive pulmonary fibrosis (PPF) classification and establish PPF incidence for key ILD subtypes. Additional exploratory objectives are to 1) Prospectively validate a novel PPF classifier and assess performance durability over time, and 2) Determine whether multi-dimensional PPF prediction outperforms component approaches.",[65,66],"Progressive Pulmonary Fibrosis","Interstitial Lung Disease",[68,69,70,57,71],"Progressive pulmonary fibrosis","Interstitial lung disease","PRIME","PPF","RECRUITING","2026-08-14",{"date":39,"type":42},{"date":76,"type":42},"2025-05-01",{"date":78,"type":21},"2029-12",{"name":48,"class":49},24,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":50},"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",true,{"count":89,"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.",[93],"Wellness, Psychological","2026-08-13",{"date":96,"type":42},"2026-08-17",{"date":98,"type":21},"2026-09-01",{"date":100,"type":21},"2028-07-31",{"name":48,"class":49},{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":17,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":50},"100650996","a-study-to-evaluate-the-efficacy-of-botulinum-toxin-in-patients-with-hidradenitis-suppurativa-100650996","NCT07756346","A Study to Evaluate the Efficacy of Botulinum Toxin in Patients With Hidradenitis Suppurativa","Botulinum Toxin Blockade of Neuronal Signals to Immune Cells as a Novel Treatment for Hidradenitis Suppurativa","Botox in HS","Inclusion Criteria:\n\n1\\) age \\>13 and \\\u003C75, 2) established or suspected diagnosis of Hidradenitis Suppurativa, 2) HS skin lesions of duration at least 1 year, 3) HS lesions in at least two distinct body areas, 4) inadequate response to a trial of an oral antibiotic or exhibited recurrence after discontinuation of antibiotics, 5) abscess and nodule (AN) count ≥ 5 at baseline, 6) draining tunnel count of \\\u003C20 at baseline, and 7) ability to provide written informed consent and\u002For assent.\n\nExclusion Criteria:\n\n1\\) Age\\\u003C13 or \\>75, 2) pregnant or breastfeeding, 3) history of neuromuscular disorder (ex. ALS, myasthenia gravis, Lambert-Eaton syndrome, myopathy), 4) medical co-morbidity ex. end stage congestive heart failure or coagulopathy that is a relative contradiction to skin biopsy procedure, 5) received systemic steroids or started a new systemic (biologic or non-biologic immunomodulator, oral retinoid) therapy with potential therapeutic impact for HS \\\u003C12 weeks prior to baseline visit, 6) use of opioid or non-opioid oral analgesics within 14 days of baseline visit (exception: at a stable dose for at least 14 days prior to baseline), 7) receiving anti-IL-17A\u002FF, anti-IL-23, or anti-IL-1 biologic therapy or oral JAK inhibitor, TYK inhibitor, 8) active COVID-19 infection or history of COVID-19 infection within 4 weeks prior tobaseline, 9) oral or IV antibiotic use during the treatment period (exception: stable dose of doxycycline or minocycline upto 100mg PO BID for 28 days prior to baseline and throughout the 6 month treatment and observation period), 10) initiation of topical therapies for HS within 14 days or baseline visit (may continue stable use of topical therapies started \\> 14 days prior to baseline visit), 11) laser surgery, laser hair removal, or elective surgery to treatment areas within 4 weeks prior to baseline visit, 12) current participation in another clinical study involving the administration of an investigative drug for the treatment of HS, or prior participation in such a study within 60 days prior to baseline visit, 13) active bacterial, fungal, or viral infection in the treatment area at baseline visit, 14) immunocompromised state, 15) known hypersensitivity to botulinum toxin A preparations or any of their components (human albumin, saline, lactose, sodium succinate).","13 Years","75 Years",{"count":113,"type":21},40,[115],"PHASE2","This study will build on data from mice and humans implicating TRPV1 nociceptors in the pathogenesis of the type-17 chronic inflammatory skin disease hidradenitis suppurativa (HS). In this study, the investigators will extend data from a 12-week pilot study to rigorously test the hypothesis that botulinum toxin (BoNT) therapy reduces disease severity and relieves HS pain symptoms..",[118],"Hidradenitis Suppurativa (HS)",[120,121,122,123,124],"botulinum toxin","Botox","ultrasound","tunnel area","mechanistic","2026-08-04",{"date":127,"type":42},"2026-08-10",{"date":129,"type":21},"2026-10",{"date":131,"type":21},"2029-04",{"name":48,"class":49},{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":87,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":152,"leadSponsor":154,"locationsCount":50},"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",{"count":141,"type":21},100,[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.",[145],"Opioid Abuse (Disorder)",[147,148],"Medications for Opioid Use Disorder","Rural Jails",{"date":150,"type":42},"2026-08-07",{"date":98,"type":21},{"date":153,"type":21},"2030-05-31",{"name":48,"class":49},{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":111,"enrollmentInfo":163,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":50},"100470274","botulinum-toxin-therapy-in-hidradenitis-suppurativa-100470274","NCT05403710","Botulinum Toxin Therapy in Hidradenitis Suppurativa","Targeting Nociceptors in Hidradenitis Suppurativa","HS","Inclusion:\n\n* Adults between ages 18 and 75 years with established diagnosis of hidradenitis suppurativa (HS)\n* HS skin lesions of duration at least 1 year, HS skin lesions in at least two different body areas\n\nExclusion:\n\n* Age \\\u003C 18 years or \\> 75 years\n* pregnant or breastfeeding\n* neuromuscular disorder (ex. ALS, myasthenia gravis, Lambert-Eaton syndrome, myopathy)\n* medical co-morbidity that is a relative contraindication to skin biopsy procedure (ex. end stage congestive heart failure or coagulopathy)\n* active bacterial, fungal, or viral infection in the treatment area\n* known hypersensitivity to botulinum toxin A preparations or any of their components (human albumin, saline, lactose, sodium succinate)\n* prisoners\n* adults unable to consent for themselves.",{"count":164,"type":21},20,"This study will build on data from mice and humans implicating TRPV1 nociceptors in the pathogenesis of the type-17 chronic inflammatory skin disease Hidradenitis Suppurativa (HS). In this study, the investigators will test the hypothesis that inhibiting neuropeptide activity with botulinum toxin reduces pathogenic inflammation.",[167,168],"Hidradenitis Suppurativa","Hyperhidrosis",{"date":150,"type":42},{"date":171,"type":42},"2022-06-07",{"date":173,"type":21},"2028-04-30",{"name":48,"class":49},{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":183,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":191,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},"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":185,"type":21},60,[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",[189,190],"Binge Alcohol Consumption","Suicidal Ideation",[192,193,194,195,196,197],"suicidal ideation","binge drinking","emerging adults","feasibility","emergency department","digital health","2026-07-30",{"date":200,"type":42},"2026-08-03",{"date":202,"type":42},"2026-06-10",{"date":204,"type":21},"2027-08-31",{"name":48,"class":49},2,{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":214,"minAge":18,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":218,"conditions":219,"keywords":222,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":50},"100463660","continuous-glucose-monitor-use-in-pregnancy-100463660","NCT05317585","Continuous Glucose Monitor Use in Pregnancy","Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial","Inclusion Criteria: Women will be deemed eligible for the study by the following inclusion criteria:\n\n* 1\\) age greater than or equal to 18 years old\n* 2\\) singleton gestation less than or equal to 14 weeks at initial obstetric visit\n* 3\\) established diagnosis of T2DM by laboratory criteria including hemoglobin A1c ≥6.5%, oral glucose tolerance test ≥200 mg\u002FdL, or fasting plasma glucose ≥126 mg\u002FdL\n* 4\\) receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC\n* 5\\) able and willing to provide informed consent\n\nExclusion Criteria: Women will be deemed ineligible for the study based on the following exclusion criteria:\n\n* 1\\) known diagnosis of type 1 diabetes or gestational diabetes\n* 2\\) plan to receive prenatal care or delivery outside of UMMHC\n* 3\\) inability to provide informed consent\n* 4\\) multifetal gestation","FEMALE",{"count":216,"type":21},180,[24],"The purpose of this study is to perform a randomized controlled trial among 180 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.",[220,221],"Type 2 Diabetes Treated With Insulin","Pregnancy, High Risk",[223,224],"Type 2 diabetes","Pregnancy",{"date":200,"type":42},{"date":227,"type":42},"2024-05-23",{"date":229,"type":21},"2027-07-01",{"name":48,"class":49},{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":241,"conditions":242,"keywords":244,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":50},"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\n4. Planning to become pregnant in the next year\n5. Active diagnosis of an eating disorder",{"count":239,"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.",[243],"GLP - 1",[245,246,36,247,248,249,250],"GLP-1","Physical Activity","Lifestyle Behaviors","Weight","Diabetes","CVD","2026-07-27",{"date":253,"type":42},"2026-07-28",{"date":255,"type":42},"2026-07-22",{"date":257,"type":21},"2029-09-29",{"name":48,"class":49},{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":266,"maxAge":267,"enrollmentInfo":268,"targetDuration":4,"studyType":22,"phases":270,"briefSummary":271,"conditions":272,"keywords":275,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":282,"leadSponsor":284,"locationsCount":50},"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","5 Years","17 Years",{"count":269,"type":21},50,[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.",[273,274,28],"Type I Diabetes","Pediatrics",[37,273,274,28,276,277],"Continuous Glucose Monitoring","Medically-tailored Meals","2026-07-13",{"date":280,"type":42},"2026-07-14",{"date":200,"type":21},{"date":283,"type":21},"2029-12-31",{"name":48,"class":49},{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":214,"minAge":18,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":22,"phases":293,"briefSummary":294,"conditions":295,"keywords":299,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":311,"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":185,"type":21},[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.",[296,297,298],"Perinatal Anxiety","Anxiety Sensitivity","Perinatal Depression",[300,301,302,303,304],"Perinatal anxiety","Obstetric care","Perinatal mental health","Digital mental health","Engagement","2026-07-08",{"date":307,"type":42},"2026-07-10",{"date":309,"type":21},"2026-07-15",{"date":46,"type":21},{"name":48,"class":49},{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":87,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":22,"phases":322,"briefSummary":323,"conditions":324,"keywords":327,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":50},"100611088","arise-at-umass-chan-100611088","NCT07236034","ARISe at UMass Chan","ARISe at UMass Chan: Remote Eye Tracking Study of Vaccine Messaging in Rural Populations","ARISe","Inclusion Criteria:\n\n* Age 18+\n* Living in New England state (CT, MA, ME, NH, VT RI) in a zip code as defined by each individual state's definition of rural\n* Able to read and write in English\n* Access to an internet connected computer or laptop with a web-camera\n\nExclusion Criteria:\n\n* N\u002FA",{"count":321,"type":21},700,[24],"The goal is to identify the most impactful strategies for capturing attention and enhancing effectiveness of vaccine promotion messages. This will be done using an online survey that employs remote eye-tracking and self report measures to evaluate response to sample vaccine promotion social media content in rural populations in New England. Participants will be randomly assigned into one of 14 conditions in a 2(source: expert vs. influencer) by 7 (themes: constructs from 7C Vaccine Framework) experiment and view sample messages and then answer questions about their attitudes and beliefs while being monitored for eye-tracking.",[325,326],"Vaccination","Vaccination Promotion",[328,325,329],"Message perceptions","Immunization","2026-07-06",{"date":332,"type":42},"2026-07-07",{"date":334,"type":42},"2025-12-01",{"date":336,"type":21},"2026-12-30",{"name":48,"class":49},{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":22,"phases":347,"briefSummary":348,"conditions":349,"keywords":352,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":206},"100635627","supporting-treatment-access-and-recovery-in-re-entry-star-r-100635627","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.",{"count":346,"type":21},240,[24],"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.",[33,350,351],"Substance Use Disorders","Co-occurring Mental and Substance Use Disorders",[353,354,355,356,357],"MISSION-CJ","co-occurring disorders","peer linkage support","mental health","substance use disorders","2026-06-29",{"date":360,"type":42},"2026-07-01",{"date":362,"type":21},"2026-08-01",{"date":364,"type":21},"2030-08-31",{"name":48,"class":49},{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":22,"phases":376,"briefSummary":377,"conditions":378,"keywords":382,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":50},"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":375,"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.",[379,380,381],"Diabetes Mellitus Type 2","Social Determinants of Health (SDOH)","Hospital Readmission",[383,384,385],"diabetes","social determinants of health","hospital readmission","2026-06-26",{"date":388,"type":42},"2026-06-30",{"date":390,"type":42},"2026-06-08",{"date":392,"type":21},"2029-05-30",{"name":48,"class":49},{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":214,"minAge":18,"maxAge":402,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":404,"briefSummary":405,"conditions":406,"keywords":410,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":50},"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":141,"type":21},[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.",[407,408,409],"Hypertension in Pregnancy","Chronic Hypertension","Gestational Hypertension",[411,400,412,413,414,415,416,417,418,419],"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":422,"type":42},"2026-06-16",{"date":424,"type":42},"2025-05-16",{"date":426,"type":21},"2027-11-16",{"name":48,"class":49},{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":22,"phases":436,"briefSummary":437,"conditions":438,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":50},"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":435,"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.",[439,440],"PTSD","Alcohol; Use, Problem",{"date":442,"type":42},"2026-06-15",{"date":444,"type":42},"2024-12-23",{"date":446,"type":21},"2028-11-30",{"name":48,"class":49},{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":214,"minAge":18,"maxAge":455,"enrollmentInfo":456,"targetDuration":4,"studyType":22,"phases":458,"briefSummary":459,"conditions":460,"keywords":464,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":50},"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":457,"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.",[30,461,462,463],"Economic Vulnerability","Anxiety","Culture Specific Symptoms",[465,466,467,468],"Depression treatment","Cash Transfer","Problem Management Plus","Poverty Alleviation","2026-06-11",{"date":442,"type":42},{"date":472,"type":42},"2024-03-01",{"date":474,"type":21},"2026-12",{"name":48,"class":49},{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":22,"phases":486,"briefSummary":487,"conditions":488,"keywords":491,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":499,"locationsCount":500},"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":485,"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.",[489,490],"Opioid Use Disorder","Mental Health Disorder",[492,356],"opioid use disorder","2026-06-02",{"date":495,"type":42},"2026-06-04",{"date":497,"type":42},"2022-03-11",{"date":44,"type":21},{"name":48,"class":49},5,{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":87,"sex":17,"minAge":508,"maxAge":509,"enrollmentInfo":510,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":522},"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":485,"type":21},"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.",[513],"COPD, Early-Onset","2026-06-01",{"date":516,"type":42},"2026-06-03",{"date":518,"type":42},"2021-09-08",{"date":520,"type":21},"2027-05",{"name":48,"class":49},14,{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":529,"enrollmentInfo":530,"targetDuration":4,"studyType":22,"phases":531,"briefSummary":533,"conditions":534,"keywords":537,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":50},"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":269,"type":21},[532],"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).",[535,536],"Schizophrenia","Schizo Affective Disorder",[538],"Clozapine","2026-05-20",{"date":541,"type":42},"2026-05-22",{"date":543,"type":42},"2024-04-02",{"date":545,"type":21},"2027-03",{"name":48,"class":49},{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":87,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":554,"targetDuration":4,"studyType":22,"phases":556,"briefSummary":557,"conditions":558,"keywords":561,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":573},"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":555,"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?",[559,249,30,560,415],"Hyperlipidemias","Pediatric Asthma",[562,563,564,565],"Basic Needs","Social Determinants of Health","Screening tools","Antiracism","2026-05-18",{"date":541,"type":42},{"date":569,"type":42},"2025-10-08",{"date":571,"type":21},"2028-09-30",{"name":48,"class":49},3,{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":578,"acronym":579,"eligibilityCriteria":580,"healthyVolunteers":87,"sex":214,"minAge":110,"maxAge":4,"enrollmentInfo":581,"targetDuration":4,"studyType":22,"phases":583,"briefSummary":584,"conditions":585,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":50},"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.",{"count":582,"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.",[586,587,588],"Safe Sleep Education","SUID","Sudden Infant Death Syndrome (SIDS)","2026-05-09",{"date":591,"type":42},"2026-05-13",{"date":593,"type":21},"2027-01-01",{"date":595,"type":21},"2028-12-31",{"name":48,"class":49},{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":4,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":17,"minAge":266,"maxAge":604,"enrollmentInfo":605,"targetDuration":4,"studyType":22,"phases":607,"briefSummary":608,"conditions":609,"keywords":611,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":50},"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","14 Years",{"count":606,"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.",[610],"Childhood Asthma",[612,613,614,615,616],"asthma","childhood asthma","medication adherence","school-supervised asthma therapy","real-world","2026-04-30",{"date":619,"type":42},"2026-05-05",{"date":621,"type":42},"2024-04-04",{"date":623,"type":21},"2028-04",{"name":48,"class":49},{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":629,"acronym":630,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":632,"enrollmentInfo":633,"targetDuration":4,"studyType":22,"phases":635,"briefSummary":636,"conditions":637,"keywords":642,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":50},"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":634,"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.",[296,298,380,638,639,640,641],"Peer Support","Obstetric Care","Substance Use Disorder (SUD)","Perinatal Depression, Substance Use",[643,644,645,646,647,648,649,650,651,652,653,654,655],"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","2026-04-14",{"date":658,"type":42},"2026-04-20",{"date":660,"type":42},"2025-12-05",{"date":662,"type":21},"2030-10-01",{"name":48,"class":49},{"id":665,"slug":666,"hasResults":12,"nctId":667,"briefTitle":668,"officialTitle":668,"acronym":669,"eligibilityCriteria":670,"healthyVolunteers":87,"sex":17,"minAge":671,"maxAge":455,"enrollmentInfo":672,"targetDuration":4,"studyType":22,"phases":674,"briefSummary":675,"conditions":676,"keywords":679,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":689,"locationsCount":50},"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":673,"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.",[677,678],"Dental Caries","Obesity Risk",[680,681,682],"early childhood caries","child obesity","social network intervention","2026-04-09",{"date":656,"type":42},{"date":686,"type":42},"2026-02-01",{"date":688,"type":21},"2029-03-30",{"name":48,"class":49},""]