[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Massachusetts General Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":615},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,395,0,25,[9,45,69,95,121,151,171,200,223,244,268,301,324,346,370,394,414,435,461,481,503,523,548,575,587],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100054164","a-randomized-controlled-trial-of-a-smartphone-delivered-treatment-for-suicidal-thoughts-and-behavior-100054164",false,"NCT06686901","A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior","Inclusion Criteria:\n\n* Adults ages 18+\n* Relatively frequent and recent (≥5 days within the past-month) active suicidal thoughts as assessed via SITBI-R.\n* Willing and able to provide at least one emergency contact (name, phone number, relation).\n* Owns an Android or iOS smartphone.\n* Possesses at least occasional access to Wi-Fi-enabled internet for data down\u002Fuploads.\n* Fluent in English and willing to provide informed consent.\n* Living in the Boston metropolitan area (i.e., \\~50 mile radius around Boston, MA)\n\nExclusion Criteria:\n\n* Recent (past 3-month) hypo\u002Fmanic symptoms or homicidal ideation or lifetime psychosis spectrum diagnosis as assessed via MINI 7.0.2.\n* Recent acute suicide risk operationalized as affirmative responses to BOTH below items during structured clinical interview AND evaluation by the PI in consultation with Mentors\u002FAdvisor Drs. Wilhelm, Kleiman, and\u002For Bentley:\n* At any time in past week: ≥ 8\u002F10 current intent to act on suicidal thoughts (0 \\[\"not at all\"\\] to 10 \\[\"extremely strong\"\\]); AND\n* At any time in past week: thought of a specific suicide plan (i.e, known method\u002Fmeans and\u002For location) with access to lethal means\n* Impaired vision (e.g., legal blindness), technological illiteracy, or intellectual disability that might impair ability to provide valid data and\u002For informed consent.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study aims to evaluate the acceptability, safety, and efficacy of a smartphone-delivered intervention called Therapeutic Evaluative Conditioning for Suicide (TEC-S) in reducing suicidal thoughts and behaviors (STB) among adults with recent and frequent suicide ideation.",[26,27],"Suicidal Ideation","Suicide Attempt",[29,30,31],"Suicide","ecological momentary assessment (EMA)","Therapeutic Evaluative Conditioning (TEC)","NOT_YET_RECRUITING","2026-07-10",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":20},"2027-01-30",{"date":40,"type":20},"2029-08-31",{"name":42,"class":43},"Massachusetts General Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100053986","stress-management-and-meditative-movements-for-asian-americans-with-depression-and-physical-symptoms-100053986","NCT07610928","Stress Management and Meditative Movements for Asian Americans With Depression and Physical Symptoms","Integrating the Stress Management and Resiliency Training (SMART) With Qigong\u002FTai Chi (QTC) to Develop a Holistic Treatment for Asian Americans With Depression and Distressing Somatic Symptoms","Inclusion Criteria:\n\n* Self-identify as being of Asian ethnicity\n* English language proficiency\n* Be ≥18 years of age\n* Satisfy DSM-5 criteria for MDD prior to the initiation of the study intervention, as determined by a clinical interview conducted by the Principal Investigator (PI) during screening using DSM-5 diagnostic criteria.\n* A baseline of the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression score ≥ 16\n* A baseline score of PHQ-15 ≥10\n* Have not had Tai Chi\u002FQigong training\u002Fpractice or other forms of mind-body intervention (e.g. yoga, mindfulness training, muscle relaxation training, etc) more than once a week in the past 3 months\n* A total score 24 or higher in Mini-Mental Status Examination for cognitive ability (if the participant endorses a history of cognitive impairment).\n* Willing to keep any psychiatric medications and psychotherapy stable throughout the course of the study (from Week 0 baseline to Week 12 Follow-up)\n* Have access to a device (i.e., smartphone, iPad, personal computer) and a stable network to attend the online group sessions\n* Ability to perform daily physical activity\n\nExclusion Criteria:\n\n* Have a primary psychiatric diagnosis other than MDD\n* Any history of psychosis, mania, or impulsivity and difficulty relating to people and judged by the clinician not appropriate for group intervention\n* Active eating disorder or substance use disorder within the last 6 months\n* Any relevant medical conditions that may be the medical basis of depression including thyroid diseases, epilepsy, history of an abnormal EEG, severe head trauma, or stroke\n* Have serious uncontrolled medical conditions (e.g. poorly controlled diabetes, severe congestive heart failure), or other medical conditions that in the opinion of the investigators represents a risk to the subject, including presence of a pacemaker, cardiac arrhythmia, fever, weakness and hypotension, or vagal nerve stimulator\n* current active suicidal or self-injurious potential (i.e., PHQ-9 item 9 ≥1 and\u002For a positive response to C-SSRS screener items 3, 4, 5, or 6), and assessed by the clinician necessitating immediate treatment\n* Participant who are or who plan to receive confounding treatments (including treatment of endocrinopathies): use of antidepressants, complementary and alternative medical (CAM) treatments thought to have beneficial effects on mood, including St. John's Wort, S-Adenosyl methionine (SAMe), omega-3 fatty acids, light therapy, conventional psychotherapy, mind-body interventions (e.g. Qigong, mindfulness training, muscle relaxation training, etc.)\n* Electroconvulsive therapy (ECT) during the last year as these patients are often among the more refractory and are not optimal candidates for CAM\n* History of refractory to treatment with ≥3 failed antidepressant trials in current depressive episode\n* Participated in other depression-related clinical trials within the past 3 months\n* Antidepressant or psychiatric medications that are initiated less than 8 weeks or a dose change less than 4 weeks prior to screening visit\n* Psychotherapy that has been initiated within the past 3 months",{"count":53,"type":20},70,[23],"Many Asian Americans with depression also struggle with physical symptoms-such as pain, fatigue, or other forms of bodily discomfort-that occur at the same time. Right now, there is no proven treatment that effectively addresses both the depression and these physical symptoms together. This study will test whether it is practical, acceptable, and safe to combine the Stress Management and Resiliency Training (SMART) program with meditative movements for people who have both major depression and these distressing physical symptoms.",[57,58],"Depression \u002F Major Depressive Disorder","Mental Health (Depression)",[60,61,62],"Depression","Asian American","Somatic symptoms",{"date":35,"type":36},{"date":65,"type":20},"2026-08-15",{"date":67,"type":20},"2027-08-31",{"name":42,"class":43},{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":16,"minAge":17,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":44},"100054146","impact-of-sex-and-age-on-non-visual-light-input-that-affects-sleep-and-circadian-rhythms-100054146","NCT05829044","Impact of Sex and Age on Non-visual Light Input That Affects Sleep and Circadian Rhythms","Inclusion Criteria:\n\n* (i) 18-85 years old.\n* (ii) Habitual sleep onset 10 pm- 1 am (healthy controls only);\n* (iii) Habitual wake onset 5:30 am- 8:30 am (healthy controls only);\n* (iv) vision correctable to 20\u002F30;\n* (v) stable medically.\n* (vi) ability to speak, understand, and read English at a high school level\n\nExclusion Criteria:\n\n* (i) Color blind by Ishihara Color Blindness Test;\n* (ii) any history of eye trauma, surgery or abnormality (e.g., retinopathy, glaucoma, cataracts, amblyopia, macular degeneration, congenital color vision deficiencies, or any type of blindness) besides correctable vision abnormalities (e.g., with glasses); any abnormalities on clinical eye exam (e.g., neuritis, Neuromyelitis optica, treated or untreated glaucoma) such that the ophthalmologist recommends the participant not be studied; Limited cataracts (e.g., Lens Opacities Classification (LOCS) III grade \\\u003C2) will be allowed and documented during the eye exam. Eye drops that affect pupil size or contractility (e.g. mydriatics, miotics); drops to treat glaucoma (e.g., pilocarpine, brimonidine, other drops like artificial tear drops, or anti-inflammatory drops would not be exclusionary)\n* (iii) current or history of neurologic or psychiatric disease including autonomic function disorder or migraines; psychiatric disorder requiring medications in a first degree relative (healthy controls only); limited-duration counseling without prescription medications will not be exclusionary; (iv) current or history of circadian rhythm sleep-wake disorder (healthy controls only);\n* (v) prescription or non-prescription drugs affecting the pupil (e.g., affecting autonomic function), sleep, melatonin (e.g., lithium, alpha- and beta-adrenergic antagonists), and\u002For circadian rhythms (e.g., beta blockers, non-steroidal anti-inflammatory drugs, tricyclics);\n* (vi) Other disorders that can affect or may be affected by intrinsically photosensitive Retinal Ganglion Cell (ipRGC) function, including diabetes mellitus, multiple sclerosis, Parkinson's disease, seasonal affective disorder;\n* (vii) shift- or night-work in past three months; history of night work in preceding 3 year period\n* (viii) crossing more than 2 time zones in past three months;\n* (ix) presence of depression as assessed by a Beck Depression Inventory (BDI) score \\>14.\n* (x) pregnant or less than 6 weeks post-partum or breast-feeding",true,"85 Years",{"count":78,"type":20},48,[23],"The goal of this clinical trial is to learn how the pupil responds to different light stimuli and how that relates to sleep and daily rhythms in healthy people of different ages.\n\nThe main questions it aims to answer are:\n\n* Does the eye's pupil response to light stimuli differ by the sex and age of the participant?\n* Is the eye's pupil response to light stimuli related to each participant's sleep timing, their body clock timing, and their hormone responses to light.\n\nParticipants will have a special eye exam and complete questionnaires before starting the study to see if they can participate. If they can participate, they will wear a special watch that monitors their activity and light levels for one week. Then they will live in a research room at the Mass General Hospital for 3 days\u002F2 nights during which we will test their pupil response to light, their body clock timing, and their hormone responses to light.",[82],"Normal Physiology",[84,85,86,87],"eye pupil response","circadian rhythms","light","melatonin","RECRUITING",{"date":35,"type":36},{"date":91,"type":36},"2023-12-01",{"date":93,"type":20},"2027-06-30",{"name":42,"class":43},{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":44},"100054113","petmri-of-primary-sclerosing-cholangitis-100054113","NCT06252610","PET\u002FMRI of Primary Sclerosing Cholangitis","PET\u002FMRI Evaluation in Patients With Primary Sclerosing Cholangitis Using Intercellular Matrix Radiopharmaceuticals","Inclusion Criteria:\n\n* Established clinical diagnosis of large duct PSC\n* Participants receiving treatment for IBD are allowed if on a stable dose from screening and expected to remain stable for the duration of the study\n* Serum AST and ALT concentration ≤ 8 times the upper limit of normal\n\nExclusion Criteria:\n\n* Other causes of chronic liver disease, including secondary sclerosing cholangitis or viral, metabolic, or alcoholic liver disease, as assessed clinically\n* Known or suspected overlapping clinical or histologic diagnosis of autoimmune hepatitis\n* Subjects less than 18 years of age or greater than 85 years of age.\n* Subjects with electrical implants, such as cardiac pacemakers or perfusion pumps.\n* Subjects with ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, prosthetic heart valves that are not compatible with the gradient maps of our scanners, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing.\n* Subjects who anticipate being pregnant or breastfeeding (a negative STAT quantitative serum hCG pregnancy test is required on the day of the scan before the subject can participate).\n* Subjects with claustrophobic reactions\n* Subjects with more significant than average potential for cardiac arrest.\n* Subjects with a history of major head trauma (i.e., multiple concussions, traumatic brain injury).\n* Subjects with a history of bleeding disorders.\n* Subjects whose research-related radiation exposure exceeds current Radiology Department guidelines (i.e., 50 mSv in the prior 12 months).\n* Subjects unable to lie comfortably on a bed inside the PET\u002FMRI bore as assessed by physical examination and medical history (e.g., back pain, arthritis).\n* Subjects under the direct supervision of the principal investigator;\n* Subjects with a body weight of \\> 300 lbs (operational weight limit of the PET\u002FMRI table) or BMI \\>33 kg\u002Fm2 (the Athinoula A. Martinos Center standard procedure to avoid claustrophobia or mechanical impossibility of fitting the subject into the scanner bore, which is less than 60 cm wide).\n* A history of acute or chronic severe renal insufficiency (glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m2\n* Perioperative liver transplantation period.\n* A history of systemic lupus, multiple myeloma, nephrogenic systemic fibrosis, or other comorbidities resulting in chronic kidney disease stage IV or higher","99 Years",{"count":104,"type":20},10,"OBSERVATIONAL","This study aims to use positron emission tomography (PET)\u002Fmagnetic resonance imaging (MRI) to diagnose and quantify PSC-related biliary tract fibrosis and to improve upon the currently available non-invasive diagnostic capabilities by investigating the ability of combined PET\u002FMRI to detect and quantify fibrosis using a novel collagen-binding radiotracer. Specifically, the investigators will be comparing \\[68Ga\\]CBP8- and \\[18F\\]-FAPI-74 PET\u002FMRI to a liver transient elastography scan in the diagnosis of biliary tree fibrosis.",[108],"PSC",[108,110,111,112,113],"[18F]-FAPI-74","[68Ga]CBP8-PET","PET\u002FMR","Fibrosis","2026-07-09",{"date":35,"type":36},{"date":117,"type":20},"2026-08-10",{"date":119,"type":20},"2029-04-30",{"name":42,"class":43},{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":12,"sex":128,"minAge":17,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":131,"briefSummary":132,"conditions":133,"keywords":140,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":44},"100053713","facilitated-transitions-from-postpartum-to-primary-care-coordination-for-people-with-chronic-conditions-100053713","NCT06557005","Facilitated Transitions From Postpartum to Primary Care Coordination for People With Chronic Conditions","Bridges to Primary Care: Transforming Postpartum Primary Care Coordination for People With Chronic Conditions","Inclusion Criteria\n\n* Receiving obstetric care at an MGH-affiliated obstetrics practice (except for the MGH HOPE Clinic, which has a unique care model that provides prenatal and postnatal care for individuals with substance use disorder, including the provision of primary care through 2+ years postpartum)\n* Pregnant with a live fetus or delivered a live-born neonate ≥24 weeks of gestation, based on the clinical estimate of gestational age\n* If postpartum, has a neonate that is currently living at the time of enrollment\n* Has one or more of the following conditions listed in the \"Problem List,\" \"Medical History,\" or clinical notes during prenatal, intrapartum, or postpartum encounters in the EHR (or in the case of BMI, the patient's anthropometric measurements):\n\n  * Chronic or essential hypertension\n  * Hypertensive disorders related to pregnancy (e.g., pre-eclampsia)\n  * Type 1 or 2 diabetes (i.e., pre-existing diabetes)\n  * Gestational diabetes\n  * Class II Obesity (pre-pregnancy body mass index ≥35 kg\u002Fm2; or if pre-pregnancy body mass index is not known, a first trimester BMI of ≥35 kg\u002Fm2)\n  * Depression or anxiety disorder\n* Has a primary care clinician listed in the patient's medical record\n* Has access to or agrees to be enrolled in the electronic health record patient portal and consents to be contacted via these modalities\n* Able to read\u002Fspeak English or Spanish language\n* Is age ≥18 years old\n\nExclusion Criteria\n\n• Any individual not meeting all inclusion criteria","FEMALE",{"count":130,"type":20},1320,[23],"The lack of postpartum primary care coordination is a missed opportunity to increase primary care engagement and manage chronic conditions early in life, especially for the \\>30% of pregnant people who have or are at risk for these conditions. This study aims to increase postpartum primary care engagement, quality, and experience by strengthening postpartum transitions to primary care using a behavioral economics-informed, multi-component intervention integrated into usual inpatient postpartum care. Using a randomized controlled trial and repeated outcome assessments through administrative and survey data, this study will generate rigorous, actionable evidence to ensure primary care coordination becomes standard postpartum care practice, potentially catalyzing sustained primary care engagement throughout life.",[134,135,136,137,138,60,139],"Hypertension","Diabetes","Postpartum","Pregnancy","Anxiety","Obesity",[141,142,143,144],"Postpartum Care","Primary Care","Care Transitions","Chronic Disease",{"date":35,"type":36},{"date":147,"type":36},"2025-05-23",{"date":149,"type":20},"2028-05-23",{"name":42,"class":43},{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":128,"minAge":17,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":21,"phases":160,"briefSummary":161,"conditions":162,"keywords":165,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":170,"locationsCount":44},"100054088","early-intervention-100054088","NCT05326165","Early Intervention","Preventing the Progression of Low Volume Swelling to Breast Cancer-related Lymphedema: a Pilot Study","Inclusion Criteria:\n\n* Eligible participants will be female, \\>\u002F= 18 years, who underwent BC surgery for invasive or in-situ carcinoma with unilateral axillary lymph node dissection (ALND) (with or without contralateral prophylactic SLNB). Because of the extremely low incidence of BC in children and males, only female participants over the age of 18 will be included.\n* Eligible participants will demonstrate low volume swelling (RVC 5-\\\u003C10%) \\>\u002F=12 weeks postoperatively\n* Eligible participants will read and comprehend English, with the ability to understand and the willingness to sign a written consent document.\n* Most patients treated for breast cancer will have undergone SLNB for axillary staging, and are therefore at lower risk for BCRL, compared to patients with ALND and\u002For regional lymph node radiation (RLNR). We have chosen to include only patients at high risk of BCRL, i.e., those who have undergone ALND, and we will not be including those who are at low BCRL risk, i.e., had only SLNB for axillary staging on the side of BC.\n\nExclusion Criteria:\n\n* Participants who have bilateral BC (ie. contralateral staging SLNB or ALND) will not be eligible due to the need of a contralateral control arm for the RVC equation.\n* Participants will not be eligible if they have been diagnosed and\u002For treated for BCRL.\n* Participants will not be eligible if they have metastases that may cause BCRL. Participants with metastatic disease will be excluded.\n* Participants with implanted cardiac devices and those who are pregnant will be excluded from the Sozo measurement component of the study.",{"count":159,"type":20},40,[23],"This research study is a Pilot Study examining the use of a compression sleeve with embedded sensor to prevent lymphedema.",[163,164],"Breast Cancer","Breast Cancer Treatment Related Lymphedema",[163,164],{"date":35,"type":36},{"date":168,"type":20},"2027-05",{"date":93,"type":20},{"name":42,"class":43},{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":128,"minAge":17,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":181,"conditions":182,"keywords":193,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":44},"100053937","screening-for-bcrl-in-targeted-therapy-for-breast-cancer-100053937","NCT05142800","Screening For BCRL In Targeted Therapy For Breast Cancer","Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer","Inclusion Criteria:\n\n* Subjects who are receiving treatment in the MGH Breast Cancer Center who are enrolled in a DF\u002FHCC-regulated targeted therapy trial for the treatment of early or metastatic breast cancer or patients being treated with a targeted therapy that may alter their risk of developing edema or BCRL will be eligible.\n* Subjects that will be eligible for the study include:\n* Females between 18 and 80 years of age\n* With a history of breast cancer\n* 4 weeks or more post-surgery\n* With or without edema\n* Undergoing treatment with targeted therapy for early or metastatic disease.\n\nExclusion Criteria:\n\n\\- Patients who cannot attain 90 degrees of shoulder abduction (position of measurement with Perometer).","80 Years",{"count":180,"type":20},261,"This a prospective, longitudinal study designed to track edema and Breast Cancer Related Lymphedema (BCRL) onset in breast cancer patients taking targeted therapy treatments for early and metastatic breast cancer.\n\nA Perometer and Sozo devise will be used to measure volume changes",[183,184,185,186,187,188,189,190,191,192,163],"Lymphedema","Lymphedema Arm","Lymphedema of Upper Arm","Lymphedema of Upper Limb","Lymphedema of the Hands","Edema","Edema Arm","Breast Cancer Lymphedema","Breast Cancer Metastatic","Breast Cancer Stage",[183,184,185,186,187,188,189,190,191,192,163],{"date":35,"type":36},{"date":196,"type":36},"2018-12-13",{"date":198,"type":20},"2026-09-30",{"name":42,"class":43},{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":21,"phases":210,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":222},"100053551","mobile-application-to-improve-health-related-outcomes-in-patients-with-advanced-lung-cancer-100053551","NCT06427954","Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer","Randomized Trial of Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer","THRIVE","Inclusion Criteria:\n\n* Adults (greater than or equal to 18 years)\n* Diagnosed with advanced non-small cell lung cancer (NSCLC) that is not being treated with curative intent or extensive stage small cell lung cancer (SCLC) within the past 12 weeks.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0-2 (i.e., fully active to at least ambulatory and up and about more than 50% of waking hours).\n* Sufficient English proficiency to utilize THRIVE in English (Note: patients can complete outcome measures in Spanish if preferred).\n\nExclusion Criteria:\n\n* Significant uncontrolled psychiatric disorder (e.g., psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the ability to participate in study procedures.",{"count":209,"type":20},250,[23],"Multi-site randomized trial of the THRIVE digital health application versus usual care to evaluate the effect of THRIVE on quality of life (QOL), physical and psychological symptoms, coping, and self-efficacy in 250 patients with newly diagnosed advanced lung cancer.",[213],"Lung Cancer",[215],"Quality of life",{"date":35,"type":36},{"date":218,"type":36},"2024-08-06",{"date":220,"type":20},"2027-12",{"name":42,"class":43},3,{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":16,"minAge":230,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":21,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":44},"100053631","thoracoabdominal-asynchrony-and-respiratory-distress-100053631","NCT04626154","Thoracoabdominal Asynchrony and Respiratory Distress","Validation of a Non-Invasive Device for Thoracoabdominal Asynchrony-Based Respiratory Effort Assessment in Pediatric Patients","Inclusion Criteria:\n\n1. patients 28-days to 17-years of age\n2. who have respiratory distress and those who do not have respiratory distress\n\nExclusion Criteria:\n\nHardware, clinical care, or dermal injury that would preclude the application of TAA device","28 Days","17 Years",{"count":233,"type":20},20,[23],"The investigators hypothesize that a simple 3-point tracking device that uses motion sensors attached to the abdomen and chest of a child will provide information regarding thoracoabdominal asynchrony (TAA), a major component of respiratory distress, and ultimately help guide a clinician to initiate, escalate, de-escalate, or stop respiratory support interventions.\n\nAIMS To determine if the TAA-monitoring device can be used to detect differences in respiratory synchrony in a manner that is clinically applicable. The investigators hope that the device will detect 1) major asynchrony events in a timely manner so as to prompt clinician intervention during future use; and 2) asynchrony events that may be less visible to the naked eye that may be precursors to more severe events.",[237],"Respiratory Insufficiency",{"date":35,"type":36},{"date":240,"type":36},"2020-10-16",{"date":242,"type":20},"2029-06-01",{"name":42,"class":43},{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":251,"minAge":17,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":21,"phases":253,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":44},"100054212","effects-of-resistance-exercise-among-tgd-individuals-initiating-estrogen-based-gender-affirming-hormone-therapy-100054212","NCT07400419","Effects of Resistance Exercise Among TGD Individuals Initiating Estrogen-Based Gender-Affirming Hormone Therapy","STRENGTH","Inclusion Criteria:\n\n* ≥ 18 years\n* Initiating GAHT with estradiol (oral, sublingual, patch, injection) AND androgen suppression (leuprolide, spironolactone or bicalutamide)\n* Identifies as either a transgender female\u002Fwoman, gender-diverse, non-binary, gender non-confirming, gender-fluid, and\u002For gender-queer\n* Assigned male sex at birth\n\nExclusion Criteria:\n\n* Current condition(s) which may preclude the ability to participate in a resistance exercise program (including but not limited to conditions which may significantly impair mobility and balance)\n* Current condition(s) where resistance exercise program may be contraindicated (including but not limited to decompensated heart failure, unstable ischemic heart disease, pulmonary hypertension, aortic aneurysm, moderate to severe valvopathies, and\u002For moderate to severe chronic respiratory insufficiency)\n* Use of testosterone therapy for \\> 1 month in the last 6 months\n* Use of gender-affirming hormone therapy with androgen\u002Ftestosterone suppression and\u002For estradiol therapy within 1 year of enrollment\n* Use of gender-affirming hormone therapy with androgen\u002Ftestosterone suppression and\u002For estradiol therapy for \\> 1 year at any time period prior to enrollment\n* History of an orchiectomy\n* Current resistance exercise (including but not limited to use of resistance bands, suspension equipment, body weight exercise, free weight exercise) of 60 minutes or greater per week\n* Enrollment in another study that the study investigators deem as potentially interfering with study participants or study endpoints","MALE",{"count":19,"type":20},[23],"Estrogen-dominant gender-affirming hormone therapy (GAHT) is standard of care for transgender women and gender-diverse individuals and typically consists of estrogen together with anti-androgen\u002F testosterone therapy. Estrogen and testosterone balance influences fat and muscle mass, muscular strength and the development of sarcopenia. Sarcopenia, a condition characterized by the loss of muscular mass, strength, and function, in turn, is associated with increased mortality and adverse health outcomes. Estrogen-dominant GAHT may have deleterious effects on body composition and muscular performance that place TGD individuals at-risk for sarcopenia. As part of NCT04128488, our investigative team found that appendicular lean mass (ALM)\u002F height2 decreases after estrogen-based GAHT, thereby portending a higher risk for sarcopenia after GAHT. Early recognition of the changes in body composition and muscular performance leading to sarcopenia are critical, providing potential avenues to intervene and abrogate untoward downstream health effects. A promising intervention is resistance exercise, which has been shown in select populations to improve muscular mass and strength and reduce fat mass, and, thus, mitigate progression to sarcopenia in at-risk populations. For this prospective, pilot clinical trial, investigators will enroll participants who are about to be initiated on estrogen-dominant gender-affirming hormone therapy. Investigators will be randomizing participants 1:1 to either an at-home resistance exercise intervention or no exercise intervention (nutritional and exercise counseling only) for 12 weeks and assess muscle mass, strength, and function both before and after this 12-week period. The exercise intervention group will be provided with the necessary materials to complete the exercise program along with weekly virtual visits with our study team in order to learn their assigned exercises for the week. Further, survey tools will be administered to ascertain whether the resistance exercise intervention may affect gender congruence.",[256],"Muscle Mass and Strength",[258,259,260,261],"Transgender women","Gender-Diverse","Estrogen-dominant gender-affirming hormone therapy","Sarcopenia",{"date":35,"type":36},{"date":264,"type":36},"2026-04-16",{"date":266,"type":20},"2028-04-01",{"name":42,"class":43},{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":276,"enrollmentInfo":277,"targetDuration":4,"studyType":21,"phases":279,"briefSummary":281,"conditions":282,"keywords":288,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":300,"locationsCount":44},"100053678","phase-4-varenicline-and-accelerated-transcranial-magnetic-stimulation-tms-for-quitting-nicotine-use-pilot-study-100053678","NCT07145866","Varenicline and Accelerated Transcranial Magnetic Stimulation (TMS) for Quitting Nicotine Use (Pilot Study)","Evaluation of Varenicline and Accelerated TMS for Reduction of Nicotine Use","V-TMS","Inclusion Criteria:\n\n* Age ≥ 18 and ≤65;\n* The ability to give written, informed consent;\n* Fluency in English;\n* Reported interest in quitting nicotine vaping or smoking within the next month;\n* Nicotine dependence, as defined by a score of ≥4 on the 10-question E-cigarette Dependence Inventory (ECDI) or Fagerström Test for Nicotine Dependence (FTND);\n* Smoke or vape nicotine daily for at least the past 90 days, as confirmed by self-report and timeline follow-back methods;\n* Saliva cotinine \\>30ng\u002FmL;\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding;\n* Use of smoking cessation pharmacotherapy in the past month;\n* Unwilling to abstain during the study from using smoking cessation aids other than those provided by the study;\n* Prior adverse drug reaction to varenicline;\n* Contraindication to D-Cycloserine (including allergy to D-Cycloserine, significant renal impairment or known kidney disease, pregnancy)\n* Receiving or planning to receive other TMS treatments or investigational drugs during course of participation\n* Contraindications to TMS (including seizures, metallic implants, severe existing tinnitus, etc.);\n* Contraindications to MRI (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia);\n* Inpatient psychiatric hospitalization or suicide attempts in the past six months, or recent active suicidal ideation or suicidal behavior identified at enrollment or baseline visits;\n* History of seizures and\u002For history of TBI subtypes associated with elevated seizure risk (e.g. penetrating injury and intraparenchymal hemorrhage)\n* History of unstable neurological illness or major medical illness, such as epilepsy or renal impairment, in the past six months, unless clearly resolved;\n* In the opinion of the investigators, evidence of active problem substance use severe enough to compromise ability to safely participate;\n* In the opinion of the investigators, unable to safely participate in this study and\u002For provide reliable data (e.g., claustrophobia, unable to tolerate TMS or MRI procedures, etc.).","65 Years",{"count":278,"type":20},30,[280],"PHASE4","The goal of this clinical trial is to learn if a combination of varenicline and enhanced accelerated Transcranial Magnetic Stimulation (aTMS) works to help adults quit using nicotine products. Researchers will compare varenicline + active aTMS with a single dose of D-Clycloserine to varenicline + sham (inactive) aTMS with a placebo pill to see the effect of enhanced aTMS on reaching abstinence. The main question it aims to answer is: Does receiving active enhanced aTMS + varenicline lead to higher abstinence rates and lower nicotine craving?\n\nParticipants will be asked to:\n\n* Complete 2 brain MRI scans\n* Take varenicline every day for 12 weeks\n* Quit using nicotine products at the end of the second week of varenicline\n* Complete one day of up to 20 TMS treatments\n* Take a single dose of D-Cycloserine medication on the day of TMS treatment\n* Complete 12 brief, weekly follow-up visits\n* Complete a brief daily survey each day that they take the study drug",[283,284,285,286,287],"Nicotine Dependence","Transcranial Magnetic Stimulation","Vaping","Smoking Cessation","Smoking (Tobacco) Addiction",[285,289,290,291,292,293,284,294,295],"Smoking","Nicotine","Adults","Cessation","Varenicline","TMS","D-Cycloserine",{"date":35,"type":36},{"date":298,"type":20},"2026-08",{"date":220,"type":20},{"name":42,"class":43},{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":276,"enrollmentInfo":308,"targetDuration":4,"studyType":21,"phases":309,"briefSummary":310,"conditions":311,"keywords":314,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":44},"100054247","phase-4-the-effects-of-lumateperone-on-obesity-and-physiologic-aging-and-their-association-with-antidepressant-response-in-bipolar-depression-100054247","NCT07699445","The Effects of Lumateperone on Obesity and Physiologic Aging and Their Association With Antidepressant Response in Bipolar Depression","The Effects of Lumateperone on Obesity and Physiologic Aging and Their Correlation With Antidepressant Response in Bipolar Depression","Inclusion Criteria:\n\n1. Aged 18 to 65 years.\n2. Meets DSM-V criteria for Bipolar I Disorder -Depressed without psychosis as confirmed by a semi-structured clinical interview that includes the Mini International Neuropsychiatric Interview.\n3. Current episode at least 4 weeks in duration but not longer than 12 months.\n4. Depression score \\> 20 on the Montgomery Asberg Depression Rating Scale (MADRS).\n5. BMI \\> 30\n6. Capable of providing informed consent.\n\nExclusion Criteria:\n\n1. Meets DSM-V criteria for Schizophrenia, Schizoaffective disorder, or has significant mood-incongruent psychotic symptoms.\n2. Young Mania Rating Scale score \\>12.\n3. Meets DSM-V criteria for rapid cycling.\n4. Co-Morbid psychiatric illness, other than generalized anxiety and specific phobias, that in the opinion of the investigator is severe enough that it would likely interfere with the interpretation of changes in the subject's mood state.\n5. Meets DSM-V criteria for an active substance use disorder within the past month.\n6. Active medical condition that in the opinion of the investigator would contribute to the subject's depressed mood (e.g. hypothyroidism).\n7. Significant risk of suicide or self -harm as assessed by clinical interview and the Columbia Suicide Severity Rating Scale (C-SSRS).\n8. Significant risk of harm to others as assessed by clinical interview.\n9. Pregnancy, or, in women of child-bearing potential, an unwillingness to use an accepted method of birth control for the duration of the study.\n10. Current or prior treatment with lumateperone.\n11. Moderate or severe hepatic impairment.\n12. Current treatment with strong or moderate CYP3A4 inhibitors or CYP3A4 inducers.\n13. History of seizure disorder.\n14. Significant cardiovascular or cerebrovascular disease that, in the opinion of the investigator, would increase study risk.\n15. Dementia-related psychosis.\n16. Known hypersensitivity or allergy to lumateperone or any of its components.",{"count":7,"type":20},[280],"This research study examines how a medication called lumateperone may affect mood symptoms, and inflammation in adults with bipolar disorder over approximately 6 weeks. An MRI scan to calculate biological age of the brain will also be obtained at the start of the study.",[312,313],"Bipolar Depression Depressed Phase","Obesity & Overweight",[315,60,316],"Bipolar disorder","obesity","2026-07-07",{"date":35,"type":36},{"date":320,"type":20},"2026-07-31",{"date":322,"type":20},"2028-07-31",{"name":42,"class":43},{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":332,"conditions":333,"keywords":336,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":345},"100487619","ctdna-and-organ-preservationpathologic-cr-in-rectal-cancer-100487619","NCT05629442","ctDNA and Organ Preservation\u002FPathologic CR in Rectal Cancer","A Study of the Role of Circulating Tumor DNA in Predicting the Likelihood of Organ Preservation or Pathologic Complete Response After Neoadjuvant Therapy for Rectal Cancer","Inclusion Criteria:\n\n* Participants with T3, T4, or node-positive non-metastatic rectal cancer.\n* Participants must have original tumor tissue (formalin-fixed, paraffin embedded specimens) available for analysis or be willing to undergo a baseline research biopsy.\n* Participants must be 18 years of age or older.\n* ECOG 0-2.\n* Participants must be eligible for at least 3 months of FOLFOX, FOLFIRINOX\u002FFOLFOXIRI, or CAPOX\n* Participants must be eligible for long course chemoradiation to 40-54 Gy.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants must not have any other organ cancer evident at the time of enrollment.\n* Participants may not have any other concurrent serious illness that makes participation on this study impractical or clinically inappropriate.\n* Participants must not be actively or planning to be pregnant or breastfeeding",{"count":19,"type":20},"This prospective observational, non-therapeutic study for patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy.\n\nThis research study involves the collection of data and biospecimens (blood and tissue) to see if the presence of circulating tumor DNA (genetic material) ctDNA will help monitor rectal cancer more closely and potentially detect a recurrence before routine scans, performed per standard of care\n\nC2i Genomics, a biotechnology company, and the Spier Foundation are supporting this research study by providing funding for the study.",[334,335],"Rectal Cancer","Non Metastatic Rectal Cancer",[334,335],"2026-06-29",{"date":339,"type":36},"2026-07-01",{"date":341,"type":20},"2026-10-01",{"date":343,"type":20},"2030-06",{"name":42,"class":43},2,{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":16,"minAge":353,"maxAge":17,"enrollmentInfo":354,"targetDuration":4,"studyType":21,"phases":356,"briefSummary":357,"conditions":358,"keywords":360,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":44},"100574900","behavioral-intervention-for-youth-to-promote-vaping-cessation-100574900","NCT06765291","Behavioral Intervention for Youth to Promote Vaping Cessation","VIA","Inclusion Criteria:\n\n* Age 14-18 inclusive\n* Self-report of at least weekly nicotine vaping (or use of other non combusted nicotine products, \"vaping\") for the prior ≥3 months\n* Self-report of no regular combusted tobacco use (i.e., 5 or more days of smoke smoked tobacco use per week) prior to enrollment and exhaled CO \\\u003C10 ppm for those with an in person baseline visit\n* Report willingness to try to quit or reduce vaping in the next 30 days\n* Able to understand study procedures and read and write in English or Spanish\n* Have a parent or legal guardian who is able to participate in the opt out process\n* Competent and willing to provide written informed consent (if age 18) or assent (if under 18)\n\nExclusion Criteria:\n\n* Use of a smoking cessation medication in the prior month (nicotine patch, gum, nasal spray, or inhaler, varenicline, bupropion)\n* Unwilling to abstain during the study from using smoking cessation aids other than those provided by the study\n* Unwilling to provide saliva or urine samples\n* Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol","14 Years",{"count":355,"type":20},400,[23],"This study will test the hypothesis that the QuitVaping (QV) intervention and additional texting support will improve nicotine abstinence rates in adolescents as compared to Enhanced Usual Care (EUC: education about nicotine, vaping and addiction, advice to quit vaping, referral to TIQ texting support). Approximately 400 adolescents will be randomly assigned to one of two arms (1) QuitVaping intervention plus texting support to quit vaping and (2) EUC only.",[285,359,283],"Vaping Teens",[285,361,362],"Nicotine Depedence","Vaping Cessation","2026-06-26",{"date":337,"type":36},{"date":366,"type":36},"2025-06-18",{"date":368,"type":20},"2029-02-21",{"name":42,"class":43},{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":21,"phases":379,"briefSummary":380,"conditions":381,"keywords":384,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":4},"100480998","phase-4-pragmatic-amiodarone-trial-to-reduce-postoperative-atrial-fibrillation-in-patients-undergoing-cardiac-surgery-100480998","NCT05543278","Pragmatic Amiodarone Trial to Reduce Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery","PATRONUS","Inclusion Criteria:\n\n* \\>= 18 years of age\n* All genders\n* All non-coronary artery bypass cardiac surgery patients\n* Preoperative normal sinus rhythm\n\nExclusion Criteria:\n\n* Pre-existing atrial fibrillation or atrial arrhythmias\n* Pre-existing heart block\n* Cardiogenic shock\n* Sick sinus syndrome\n* Marked sinus bradycardia\n* Preoperative amiodarone use\n* Contraindication to amiodarone use\n\n  * PR interval \\> 240 ms\n  * QTc \\> 550 ms\n  * 2nd or 3rd degree heart block\n  * Liver impairment (INR \\> 1.7, AST\u002FALT \\> 2x normal)\n  * Uncontrolled hyperthyroidism or hypothyroidism\n  * Interstitial lung disease\n  * Pregnancy and\u002For breastfeeding\n  * Known hypersensitivity to any components of amiodarone, including iodine\n* Emergent operation\n* Planned MAZE or Pulmonary Vein Isolation procedure",{"count":378,"type":20},242,[280],"Postoperative atrial fibrillation is quite common after cardiac surgery with up to 1 in 3 patients experiencing this abnormal heart rhythm. Amiodarone, a medication commonly used to treat atrial fibrillation, has been previously shown to be an effective prophylactic agent at decreasing the occurrence of postoperative atrial fibrillation in patients who underwent coronary artery bypass surgery. However, despite many studies which have demonstrated its effectiveness, it has not been widely used due to the concern of side effects that can occur such as slow heart rate, low blood pressure, and lung toxicity. We have designed a study to test the effectiveness and safety of a short course of postoperative prophylactic amiodarone for patients undergoing non-coronary artery bypass cardiac surgery. We hypothesize that patients who receive the prophylactic amiodarone will have decreased rates of postoperative atrial fibrillation without significantly increased side effects compared to patients who receive the standard postoperative care after non-coronary artery bypass cardiac surgery.",[382,383],"Surgery, Cardiac","Atrial Fibrillation",[385,386],"Postoperative atrial fibrillation","POAF",{"date":388,"type":36},"2026-06-30",{"date":390,"type":20},"2027-01",{"date":392,"type":20},"2028-12",{"name":42,"class":43},{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":21,"phases":403,"briefSummary":404,"conditions":405,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":4},"100590264","peer-recovery-coaching-for-tobacco-abstinence-in-people-with-opioid-use-disorder-100590264","NCT06965153","Peer Recovery Coaching for Tobacco Abstinence in People With Opioid Use Disorder","Peer Recovery Coaching for Promoting Tobacco Abstinence in People With Opioid Use Disorder","PeerTTS","Inclusion Criteria:\n\n* Adults (≥ 18 years of age)\n* reporting current daily cigarette smoking (≥ 5 cigarettes per day in past 7 days),\n* who are interested in quitting or cutting down on smoking in the next 3 months (yes\u002Fno),\n* stable on their medication treatment for OUD (MOUD) at MGH (confirmed with patient's buprenorphine prescriber).\n\nExclusion Criteria:\n\n* life expectancies \\\u003C 1 year (per chart review by physician Co-I) or with any serious psychiatric or cognitive problem that would preclude ability to provide informed consent (i.e., unstable or untreated bipolar disorder, schizophrenia spectrum disorder, psychotic disorder, or actively suicidal)\n* participants who have recent unstable cardiovascular or cerebrovascular disease (e.g., recovery phase of acute myocardial infarction, severe cardiac arrhythmias, and cerebrovascular accident; See Human Subjects) per discussion with their MOUD prescriber.",{"count":19,"type":20},[23],"Tobacco use is a leading cause of premature death among individuals with opioid use disorder (OUD). Nearly 75% of individuals receiving medication treatment for OUD report concurrent tobacco use disorder (MOUD-TUD), yet evidence-based TUD treatment (i.e., Food and Drug Administration-approved medications and counseling) is less effective in those with MOUD-TUD compared to the general smoking population. Innovative interventions for promoting TUD cessation in individuals with MOUD-TUD are urgently needed. Major factors maintaining TUD in those with OUD that have not been addressed in existing treatment interventions in this population are the small social networks comprised of other smokers, pro-smoking social norms in social networks, and limited social support for quitting smoking. Peer recovery coaches (PRCs) are people with lived OUD experience who provide peer coaching to individuals with OUD and have been shown to promote increased OUD treatment retention and illicit opioid abstinence. PRCs who are in OUD-TUD recovery and trained in TUD treatment, are well positioned to provide a social model for nonsmoking and to alter the pro-smoking social norms that maintain TUD in those receiving MOUD; but this has never been tested. The investigators hypothesize that a tobacco cessation intervention, delivered by PRCs in OUD and TUD recovery with TUD training, combined with a safe and effective FDA-approved cessation medication (dual nicotine replacement therapy \\[NRT\\]), will be feasible, acceptable and have a greater effect on tobacco abstinence rates than current standard care TUD treatment (non-peer delivered TUD coaching plus dual NRT). To test this hypothesis, in this 3-year pilot R34, the investigators propose to adapt a behavioral TUD intervention, PeerTTS, to people with OUD and TUD and to train PRCs in OUD and TUD recovery to deliver the intervention. The investigative team will then conduct a pilot randomized controlled trial (RCT) in 60 participants with MOUD-TUD interested in reducing or quitting tobacco at MGH. Participants will be randomized to receive 12 weeks of 1) PeerTTS, defined as PRC-delivered tobacco cessation coaching plus dual NRT or 2) standard care (SOC), defined as non-peer delivered TUD coaching plus dual NRT. The proposed work will adapt and test whether a peer recovery coach-delivered tobacco cessation intervention is feasible, acceptable, and potentially more effective than standard care, when combined with first line pharmacotherapy in those with MOUD-TUD. The pilot RCT will provide quantitative and qualitative data to inform a fully powered R01 or equivalent testing a refined version of the PeerTTS intervention for individuals with MOUD-TUD who face a disproportionate burden of tobacco use and related mortality. This proposal aligns with NIDA's high priority research areas to test novel treatments that sustain recovery in individuals with poly-substance use (OUD and TUD) and to advance the science of peer recovery support. It also aligns with calls to enhance PRC training to include additional evidence-based competencies that improve health.",[406],"Peer Recovery Coaching for TUD","2026-06-25",{"date":337,"type":36},{"date":410,"type":20},"2026-07-15",{"date":412,"type":20},"2028-01-01",{"name":42,"class":43},{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":75,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":21,"phases":421,"briefSummary":422,"conditions":423,"keywords":425,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":431,"completionDateStruct":432,"leadSponsor":434,"locationsCount":44},"100618720","prep4u-assessing-the-effectiveness-of-integrated-same-day-lenacapavir-initiation-and-follow-up-choice-on-prep-persistence-100618720","NCT07335289","PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence","Inclusion Criteria:\n\n* HIV negative\n* Eligible for HIV PrEP per CDC guidelines\n* Able and willing to provide informed consent\n* Willing to receive injectable lenacapavir and adhere to study procedures\n* Residing inMassachusetts with expected availability for 6-month follow-up\n\nExclusion Criteria:\n\n* Known HIV infection at baseline\n* Contraindication to lenacapavir injection (e.g., hypersensitivity, significant drug interactions)\n* Pregnancy at baseline (participants who become pregnant during the trial may remain enrolled if they choose)\n* Participation in another interventional HIV prevention study\n* Any condition judged by the investigator to compromise safety or study integrity",{"count":355,"type":20},[23],"PrEP4U is designed as a pragmatic, randomized implementation trial to test strategies that could directly inform real-world roll-out of lenacapavir. By integrating:\n\n* Same-day initiation based on rapid HIV testing, and\n* Choice of follow-up delivery location (home, community, or clinic) the study addresses two of the most pressing implementation questions for long-acting injectable PrEP.\n\nThe primary hypothesis is that giving participants choice in follow-up location will improve PrEP persistence compared to a clinic-only model. Secondary analyses will evaluate safety of rapid testing, acceptability, and participant costs. Exploratory analyses will assess HIV incidence and resistance.\n\nFindings from PrEP4U will provide essential evidence to guide scalable, equitable, person-centered delivery models for lenacapavir PrEP in the U.S. and globally.",[424],"HIV Pre-exposure Prophylaxis Use",[426,427,428],"HIV PrEP","Injectable PrEP","Lenacapavir","2026-06-24",{"date":407,"type":36},{"date":388,"type":20},{"date":433,"type":20},"2027-02-01",{"name":42,"class":43},{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":21,"phases":444,"briefSummary":445,"conditions":446,"keywords":451,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":44},"100613359","two-post-operative-pain-protocols-at-discharge-for-orthopaedic-patients-100613359","NCT07265557","Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients","A Pilot Randomized Controlled Trial Comparing Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients: A Pilot Study","Inclusion Criteria:\n\n1. Patients 18 years of age or older\n2. Underwent a major operative orthopaedic procedure\n\nExclusion Criteria:\n\n1. Contraindication for NSAIDs.\n2. Preoperative chronic opioid use (preoperative use of \\>14 days and average of \\>30 Morphine Milligram Equivalents per day).\n3. Active treatment for opioid use disorder.\n4. Previous or current illicit drug use.\n5. Major surgery for pathologic (cancer-related) condition.\n6. Hand surgery.\n7. Concurrent operative treatment by another specialty team.\n8. Discharged to an extended medical care facility.\n9. Incarceration.\n10. Women who are pregnant or planning to become pregnant in the next 6 weeks.\n11. Expected injury survival of less than 6 weeks.\n12. Terminal illness with expected survival of less than 6 weeks.\n13. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.\n14. Currently enrolled in a trial that does not permit co-enrollment.\n15. Prior enrollment in the trial.\n16. Unable to obtain informed consent.\n17. Non-English speaking\n18. Eligible patient was not approached prior to hospital discharge (missed participant).\n19. Did not provide informed consent (declined participation).\n20. Other reason to exclude the patient, as approved by the Principal Investigator",{"count":443,"type":20},100,[23],"This is a single-center, pilot randomized controlled trial designed to evaluate the feasibility of a definitive trial comparing opioid-free discharge prescriptions to usual care (which includes opioids) in patients undergoing major orthopaedic surgery. The main objective is to inform the design and feasibility of the definitive RCT.",[447,448,449,450],"Orthopaedic Related Pain (Musculoskeletal Pain)","Opioid","Pain","Pilot Study",[448,452,453],"Pilot study","Musculoskeletal Pain","2026-06-23",{"date":407,"type":36},{"date":457,"type":36},"2025-10-06",{"date":459,"type":20},"2026-12-31",{"name":42,"class":43},{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":21,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":222},"100593735","phase-4-rituximab-versus-ravulizumab-inebilizumab-satralizumab-and-eculizumab-in-nmosd-100593735","NCT07010302","Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD","A Comparative Clinical Effectiveness Trial of Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab and Eculizumab To Prevent Relapses in Neuromyelitis Optica Spectrum Disorder","BEST-NMOSD","Inclusion Criteria:\n\n* Diagnosis of NMOSD according to the 2015 International Panel for NMO Diagnosis (IPND) consensus criteria.\n* Seropositivity for AQP4 immunoglobulin G (AQP4-IgG) confirmed by a cell-based assay (either live or fixed) that meets the threshold for positivity set by the local testing laboratory.\n* Age ≥18 years at the time of consent.\n* Ability and willingness to provide informed consent and comply with all study procedures, including scheduled visits, laboratory tests, and assessments.\n* Eligible to receive any of the study drugs based on clinical judgment\n\nExclusion Criteria:\n\n* Known active hepatitis B virus (HBV) infection, defined as a positive hepatitis B surface antigen or detectable HBV DNA by PCR.\n* Known active hepatitis C virus (HCV) infection, defined as detectable HCV RNA by PCR.\n* Known active or latent tuberculosis, evidenced by a positive interferon-gamma release assay (IGRA) unless fully treated per local guidelines before enrollment.\n* Known or suspected immunodeficiency disorders, including but not limited to HIV infection with CD4 count \\\u003C200 cells\u002Fmm³ or any condition requiring chronic immunosuppressive therapy outside the scope of the study drugs.\n* Pregnancy or breastfeeding, or intention to conceive during the study period. Pregnancy is excluded due to insufficient safety data for the investigational treatments in this population. Women of childbearing potential must agree to use effective contraception throughout the study and for a defined period following the last dose of study drug, per product labeling or institutional guidance.\n* Any medical, psychiatric, or neurological condition that, in the investigator's opinion, may interfere with study participation, pose additional risk to the participant, or confound interpretation of study results.\n* Inability or unwillingness to comply with the requirements of the protocol, including scheduled visits, evaluations, or procedures, based on investigator assessment.\n* Known hypersensitivity or severe allergic reaction to any component of the study drugs or pre-medications required for infusion.",{"count":470,"type":20},540,[280],"Neuromyelitis Optica Spectrum Disorder (NMOSD) is a rare autoimmune condition that mainly affects the eyes and spinal cord, causing serious symptoms such as vision loss, paralysis, and severe pain. This trial compares the effectiveness and safety of five medications commonly used to prevent NMOSD relapses: rituximab, ravulizumab, inebilizumab, satralizumab, and eculizumab.\n\nIn this study, 160 adults with NMOSD who test positive for a specific antibody (AQP4-IgG) will participate. They will be randomly assigned to receive either rituximab or one of the four other FDA-approved medications. The main goal is to find out which treatment best prevents relapses and has fewer serious side effects. The trial will also measure disability, patient satisfaction, quality of life, and biomarkers that help track disease activity.\n\nParticipants will have regular assessments, including medical exams, surveys, and tests for vision, walking ability, and brain function. They will report any side effects or health issues experienced during the study. The trial will last from one to four years for each participant.\n\nThis research aims to help patients and doctors make better-informed treatment decisions by providing clear evidence about the best available therapies for NMOSD.",[474],"NMOSD",{"date":429,"type":36},{"date":477,"type":20},"2026-08-01",{"date":479,"type":20},"2030-05",{"name":42,"class":43},{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":16,"minAge":488,"maxAge":17,"enrollmentInfo":489,"targetDuration":4,"studyType":21,"phases":491,"briefSummary":493,"conditions":494,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":44},"100404831","phase-2-oxytocin-for-weight-loss-in-adolescents-100404831","NCT04551482","Oxytocin for Weight Loss in Adolescents","Oxytocin as a Neuroendocrine Therapy for Obesity in Youth","Inclusion Criteria:\n\n* Males and Females, 10-18 years\n* Obesity (BMI ≥95th percentile for age and gender)\n* Willingness to maintain current diet and lifestyle for the duration of study participation\n\nExclusion Criteria:\n\n* Current substance abuse\n* Use of prescription or over-the-counter drugs or dietary\u002Fherbal supplements that may affect weight if dose increased in the three months preceding the baseline visit and\u002For if they plan to increase the dose during the 18 weeks of study participation.\n* Greater than 5kg weight loss over 3 months;\n* Follows a nonstandard diet (e.g., Paleo, Atkins, raw diet, macrobiotic diet)\n* Cardiovascular disease\n* Prolonged QT interval\n* Chronic inflammatory bowel disease and other inflammatory conditions\n* Epilepsy\n* TSH \\> 2.5 times upper limit of normal\n* Alanine transaminase (ALT) or aspartate transaminase (AST) \\>2.5 times upper limit of normal\n* Creatinine \\>1.5 mg\u002Fdl\n* Hyponatremia\n* Pregnancy\u002Fbreastfeeding or refusal to use contraception not containing estrogen throughout the study if female and sexually active\n* MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clips\n* Weight \\>450 lbs due to limits for MRI and DXA scanners\n* Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus if HbA1c \\>8%\n* Active eating disorder","10 Years",{"count":490,"type":20},55,[492],"PHASE2","This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin in youths with obesity, ages 10-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (1 spray per nostril, 4 times per day) for 12 weeks. Study visits include screening to determine eligibility, 2-part main study visits at baseline, week 8, and week 12, and safety check-in visits at weeks 1, and 4; phone calls at weeks 2, 6, and 10, with a safety follow-up visit 6 weeks after the last dose of study drug. Study procedures include appetite, behavioral, metabolic, and endocrine assessments.",[495,496],"Obesity, Adolescent","Oxytocin",{"date":363,"type":36},{"date":499,"type":36},"2021-07-28",{"date":501,"type":20},"2027-02-28",{"name":42,"class":43},{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":21,"phases":513,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":520,"leadSponsor":522,"locationsCount":4},"100644638","addressing-cancer-care-equity-with-social-determinants-of-health-screening-and-early-intervention-100644638","NCT07671209","Addressing Cancer Care Equity With Social Determinants of Health Screening and Early Intervention","ACCESS-Leukemia: Addressing Cancer Care Equity With Social Determinants of Health Screening and Early Intervention","ACCESS","Inclusion Criteria:\n\n1\\. Adult patients ≥18 years who are newly referred to the outpatient Adult Leukemia Treatment Program with the following diagnoses:\n\n1. Acute myeloid leukemia (AML)\n2. Acute lymphoblastic leukemia (ALL)\n3. Intermediate or high-risk myelodysplastic syndrome (MDS), as defined by the revised International Prognostic Scoring System (IPSS-R) and\u002For IPSS-molecular (IPSS-M)\n4. Intermediate or high-risk chronic myelomonocytic leukemia (CMML) by the CMML-specific prognostic scoring system (CPSS-Mol)\n5. Patients with lower risk MDS or CMML may also be included if baseline peripheral blood labs indicate anticipated transfusion dependence, defined as needing ≥2 units of red blood cells every 28 days\n6. Patients with lower risk MDS or CMML may also be included if anticipated visits with the leukemia clinic exceed once per month by primary oncologist\n\n2\\. Ability to complete surveys in English, Spanish, or with assistance of an interpreter.\n\nExclusion Criteria:\n\n1. Adults unable to consent due to lack of capacity based on their leukemia clinician assessment.\n2. Individuals who are not yet adults (infants, children, teenagers).",{"count":512,"type":20},80,[23],"The purpose of this study is to explore if screening health-related social needs and early social work consultation is feasible and acceptable for adults with leukemias. The study examines whether the intervention (ACCESS-Leukemia) improves outcomes. Researchers will compare social determinants of health screening and early involvement of social work to usual care.",[516],"Leukemia, Acute","2026-06-22",{"date":363,"type":36},{"date":410,"type":20},{"date":521,"type":20},"2027-07-15",{"name":42,"class":43},{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":529,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":21,"phases":533,"briefSummary":535,"conditions":536,"keywords":538,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":542,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":44},"100643971","phase-1-ventricular-mtor-inhibition-to-prevent-hydrocephalus-after-brain-hemorrhage-100643971","NCT07662174","Ventricular mTOR Inhibition to Prevent Hydrocephalus After Brain Hemorrhage","VENTURE-PHH: Ventricular mTOR Inhibition to Prevent Hydrocephalus After Brain Hemorrhage","VENTURE-PHH","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of aneurysmal subarachnoid hemorrhage (aSAH)\n* Hunt Hess grade IV to V\n* Radiographic evidence of intraventricular hemorrhage (IVH)\n* Clinically indicated EVD placement as part of standard neurocritical care\n* Ability to enroll during the acute post-hemorrhagic inflammatory period, ideally within 24 hours of EVD placement\n\nExclusion Criteria:\n\n* Pre-existing ventriculoperitoneal shunt dependence\n* Severe baseline immunosuppression\n* Uncontrolled systemic infection unrelated to hemorrhage\n* Pregnancy\n* Anticipated withdrawal of life-sustaining therapy within 24 hours\n* Inability to safely receive investigational ventricular therapy",{"count":532,"type":20},15,[534,492],"PHASE1","Hydrocephalus is a serious condition in which fluid builds up inside the brain, often requiring lifelong surgical placement of a shunt to drain excess cerebrospinal fluid (CSF). One of the most common causes of hydrocephalus is bleeding into the brain's fluid spaces after aneurysm rupture, prematurity, or infection. Currently, no medication exists to prevent hydrocephalus from developing after these injuries. The investigators' recent research suggests that hydrocephalus may result not only from blocked fluid pathways but also from harmful inflammation within the brain's ventricular system. The investigators discovered that inflammation activates the choroid plexus, the tissue that produces CSF, causing excessive CSF production and inflammatory injury to the ventricular lining and surrounding brain tissue. The investigators also identified inflammatory biomarkers and extracellular vesicles in human CSF that may enable real-time monitoring of these disease processes.\n\nIn this project, the investigators will perform a first-in-human pilot study testing whether targeted \"intraventricular mTOR inhibition\" can reduce ventricular inflammation and prevent hydrocephalus after severe brain hemorrhage. The medication will be delivered via temporary ventricular drains already in place as part of routine clinical care. The investigators will study safety, inflammation, CSF production, brain imaging changes, and whether patients ultimately require permanent shunts. Although this initial study focuses on adults with hemorrhage-related hydrocephalus, our long-term goal is to develop non-surgical therapies that could help children with hydrocephalus caused by prematurity or infection, especially in regions where access to neurosurgical care and shunt surgery is limited.",[537],"Post-hemorrhagic Hydrocephalus (PHH)",[539,540,541],"hydrocephalus","brain hemorrhage","mTOR Inhibition",{"date":407,"type":36},{"date":544,"type":20},"2027-01-01",{"date":546,"type":20},"2027-12-31",{"name":42,"class":43},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":554,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":21,"phases":558,"briefSummary":559,"conditions":560,"keywords":565,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":572,"leadSponsor":574,"locationsCount":222},"100611939","phase-2-eldorado-elranatamab-versus-daratumumab-in-combination-with-rvd-lite-for-newly-diagnosed-transplant-ineligibledeferred-multiple-myeloma-100611939","NCT07247097","ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible\u002FDeferred Multiple Myeloma","ELDORADO: a Randomized Phase II Trial of Elranatamab or Daratumumab in Combination With Lenalidomide, Bortezomib, and Dexamethasone (RVd Lite) in Newly Diagnosed, Transplant Ineligible\u002FDeferred Multiple Myeloma","ELDORADO","Inclusion Criteria:\n\n* Participants must be at least 18 years of age\n* Newly diagnosed multiple myeloma, with monoclonal plasma cells in the bone marrow ≥10% or a biopsy proven plasmacytoma and either CRAB criteria or biomarker of malignancy\n\n  a. CRAB criteria, one or more of the following: i. Hypercalcemia: serum calcium (\\>1 mg\u002FdL) higher than the upper limit of normal or \\>11 mg\u002FdL ii. Renal insufficiency: creatinine clearance \\\u003C40 mL\u002Fmin (calculated per local practice) or serum creatinine \\>2 mg\u002FdL iii. Anemia: hemoglobin value \\>2 g\u002FdL below the lower limit of normal or hemoglobin \\\u003C10 g\u002FdL iv. Bone lesions: one or more lytic lesions on skeletal radiography, CT, or PET CT b. Biomarker of malignancy (one or more of the following): i. Clonal bone marrow plasma cells ≥60% ii. Involved:uninvolved serum free light chain ratio ≥100 iii. \\>1 focal lesion on magnetic resonance imaging (MRI)\n* Measurable disease as defined by one of the following:\n\n  1. Serum monoclonal protein ≥0.5 g\u002FdL. For IgA monoclonal protein, total IgA \\>500 mg\u002FdL is allowable.\n  2. Urine monoclonal protein ≥200 mg\u002F24 hours\n  3. Involved serum free light chain ≥100 mg\u002FL with abnormal free light chain ratio\n* Not considered eligible for high dose melphalan and autologous stem cell transplant per treating investigator or plan for deferred high dose melphalan and autologous stem transplant\n* ECOG performance status of 0-2\n* ANC ≥1000\u002FμL. G-CSF is not permitted within 14 days of screening.\n* Platelet count ≥75,000\u002FµL. Platelet count ≥50,000\u002FµL is permitted if bone marrow is \\>50% involved. Platelet transfusion and thrombopoietin receptor agonists are not permitted within 7 days of screening.\n* Hemoglobin ≥ 8 g\u002FdL. Red blood cell transfusions are permitted to meet eligibility criteria.\n* Calculated creatinine clearance of ≥ 30 mL\u002Fmin, not requiring dialysis, with calculation per local practice.\n* Serum bilirubin values \\\u003C 1.5 x ULN. Isolated bilirubin x 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \\\u003C35%. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin \\\u003C3 mg\u002FdL and normal direct bilirubin); and\n* Serum aspartate transaminase (ALT) and aspartate transaminase (AST) values \\\u003C 2.5 × the upper limit of normal (ULN) of the institutional laboratory reference range.\n* Must be able to comply with thromboembolism prophylaxis with e.g. acetylsalicylic acid (ASA), apixaban, rivaroxaban, lower molecular weight heparin, or equivalent.\n* Females of childbearing potential (FCBP) must:\n\n  1. Have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy within 10-14 days, with the second test within 24 hours of starting lenalidomide. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.\n  2. Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use and be able to comply with two reliable forms of contraception as defined by lenalidomide Risk Evaluation and Mitigation Strategy (REMS) program.\n* Male subjects must follow the lenalidomide REMS.\n* Ability and the willingness to undergo repeat bone marrow biopsy assessments.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior or current systemic therapy for any plasma cell disorder. An exception is emergency use of corticosteroids (equivalent to dexamethasone 40 mg daily for four days). After discussion with the principal investigator. one cycle of standard of care myeloma therapy (without anti-CD38 monoclonal antibody) is permissible to allow for stabilization of disease, during screening\u002Fprior to enrollment.\n* Pregnancy, currently breastfeeding, or planned breastfeeding.\n* Participant plans to father a child while enrolled in the study or within 100 days after last dose of study treatment.\n* Prior history of malignancies, other than MM, unless the patient has completed definitive treatment and has been free of the disease for ≥3 years. Patients who are free of disease \\\u003C3 years may enroll after approval of the PI (e.g. localized breast cancer considered to have very low risk of recurrence). Exceptions include the following (i.e. the following are eligible to participate):\n\n  1. Basal or squamous cell carcinoma of the skin\n  2. Carcinoma in situ of the cervix\n  3. Ductal carcinoma in situ of the breast\n  4. Incidental histologic finding of prostate cancer (T1a or T1b) managed with surveillance\n  5. Other malignancies of clinically localized disease may be permitted to enroll after discussion with the Sponsor-Investigator\n* Patients with plasma cell leukemia at time of screening, POEMS syndrome, or primary AL amyloidosis are excluded from this trial.\n* Seropositive for HIV infection.\n* Hepatitis B viral load positive.\n* Hepatitis C viral load positive.\n* Peripheral neuropathy ≥grade 2.\n* Patient has a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory, or inflammatory illness that could preclude study participation, pose an undue medical hazard, or interfere with the interpretation of the study results, including, but not limited to:\n\n  1. Congestive heart failure (New York Heart Association \\[NYHA\\] Class 3 or 4)\n  2. Unstable angina\n  3. Clinically significant, uncontrolled cardiac arrhythmia such a 2nd degree or 3rd degree atrioventricular block\n  4. Recent (within the preceding 6 months) myocardial infarction or stroke\n  5. Severe non-ischemic cardiomyopathy.\n  6. Uncontrolled hypertension\n  7. Diabetes mellitus with \\>2 episodes of ketoacidosis in the preceding 12 months\n  8. Chronic obstructive pulmonary disease (COPD) requiring \\>2 hospitalizations in the preceding 12 months.\n  9. Acute diffuse infiltrative pulmonary disease.\n  10. Active bacterial, viral, or fungal infection\n  11. Stroke, transient ischemic attack, or seizure within six months of starting treatment.\n* Patient has any other medical, psychiatric, or social condition that would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results.\n* Major surgery within 4 weeks prior to C1D1. Kyphoplasty or vertebroplasty are not considered major surgery.\n* Received an investigational drug (or vaccine) or used an invasive investigational medical device within four weeks before screening or is currently enrolled in an interventional investigational study.\n* Live or live-attenuated vaccine within 30 days prior to C1D1.",{"count":557,"type":20},160,[492],"This research study is being done to compare the efficacy and safety of the combination of elranatamab, lenalidomide, bortezomib, dexamethasone versus the combination of daratumumab, lenalidomide, bortezomib, dexamethasone for patients with newly diagnosed, transplant ineligible\u002Fdeferred multiple myeloma.",[561,562,563,564],"Multiple Myeloma","Newly Diagnosed Multiple Myeloma","Transplant Ineligible","Newly Diagnosed Multiple Myeloma (NDMM)",[566,567,554,568,569],"NDMM","multiple myeloma","RVd lite","transplant ineligible\u002Fdeferred",{"date":454,"type":36},{"date":477,"type":20},{"date":573,"type":20},"2035-12-01",{"name":42,"class":43},{"id":576,"slug":4,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":21,"phases":578,"briefSummary":55,"conditions":579,"keywords":580,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":586,"locationsCount":4},"100638186",{"count":53,"type":20},[23],[57,58],[60,61,62],"2026-06-20",{"date":407,"type":36},{"date":584,"type":20},"2026-06-01",{"date":67,"type":20},{"name":42,"class":43},{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":16,"minAge":594,"maxAge":595,"enrollmentInfo":596,"targetDuration":4,"studyType":21,"phases":598,"briefSummary":599,"conditions":600,"keywords":603,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":612,"completionDateStruct":613,"leadSponsor":614,"locationsCount":222},"100644110","digital-coach-to-support-exposure-therapy-homework-for-anxious-youth-100644110","NCT07666672","Digital Coach to Support Exposure Therapy Homework for Anxious Youth","Randomized Controlled Trial of the BraveBot Intervention as an Adjunctive Treatment for Young People With Anxiety and Related Disorders Receiving Outpatient, Exposure-Based Cognitive Behavioral Therapy","INCLUSION CRITERIA (youth participants):\n\n1. Has a clinical or subclinical anxiety or related disorder (e.g., panic disorder, social anxiety disorder, obsessive-compulsive disorder) for which exposure-based CBT is indicated.\n2. Between the ages of 12 and 22 years at the time of enrollment.\n3. Is either (a) currently receiving exposure-based CBT (or CBT in which exposure-based content is expected to be a core component) at a participating MGB outpatient program, or (b) on the waitlist for a participating program and expected to initiate exposure-based CBT in the near future.\n4. Sufficient ability to communicate in English (study materials, measures, and the BraveBot interface are currently English-only). For minors, at least one parent\u002Fguardian must be sufficiently proficient in English to understand the consent information.\n5. The youth and\u002For caregiver has access to a device that can receive SMS text reminders and open secure web links to complete exposure homework and brief post-exposure surveys.\n\nEXCLUSION CRITERIA (present at enrollment):\n\n1. Symptoms of suicidal or homicidal ideation, psychosis, or a non-anxiety-related primary mental health concern (i.e., where treatment for a disorder other than anxiety is indicated prior to exposure treatment, or independent exposure homework is not clinically appropriate as determined by the treating clinician). Examples include: current substance use or dependence requiring specialized or higher-level care that must be addressed before or instead of anxiety-focused exposure-based CBT; and current eating disorder severe enough to require intensive\u002Fspecialized treatment such that exposure-based CBT for anxiety\u002FOCD is not the appropriate primary focus.\n2. Youth is unable to complete homework independently.\n3. Any other condition or circumstance for which treatment for another primary psychiatric condition is clearly indicated prior to anxiety-focused exposure-based CBT, or for which out-of-session exposure homework is considered unsafe or inappropriate.\n\nThe investigators will also recruit up to 10 clinicians at participating programs who may use the BraveBot system with their patients (who have enrolled in the study independently) and complete brief baseline and end-of-study surveys.","12 Years","22 Years",{"count":597,"type":20},50,[23],"This study is testing a digital tool called BraveBot for young people who are receiving cognitive behavioral therapy (CBT) for anxiety, OCD, or related problems. BraveBot is a computer program, not a person. It talks with youth through their phone or computer while they do \"face-your-fears\"-style exposure therapy homework that their therapist has assigned. Sometimes an exposure is done with BraveBot's real-time coaching, and sometimes on their own; after each exposure, youth answer a few short questions about how it went.\n\nRather than dividing participants into separate groups, the study randomizes each individual exposure homework assignment. Every time a young person opens an eligible exposure, the system makes a 1:1 random assignment deciding whether that exposure is completed with BraveBot's support or independently (self-guided).\n\nThe main goal is to learn whether using BraveBot helps youth understand their exposure assignments better, put in more effort, stick with exposures when they are hard, feel more capable, and find exposures more helpful in \"fighting back\" against anxiety. The study also examines whether BraveBot increases the likelihood that assigned exposures are completed, and explores effects on anxiety symptoms and how safe, easy to use, and useful BraveBot feels for youth, their therapists, and parents.\n\nBraveBot does not replace the therapist, diagnose, or design exposures; it only supports the homework the clinician has assigned, and is used under clinician oversight. A built-in safety system can detect possible risk-related language, pause the session, show crisis resources (such as 988), and notify the treating clinician. The study is conducted within routine outpatient psychology clinics at Mass General Brigham. Up to 40 youth ages 12-22 will take part.",[601,602],"Anxiety Disorders","OCD",[604,605,606,607,608,609],"anxiety","exposure therapy","pediatric","large language model","conversational AI","randomized controlled trial","2026-06-18",{"date":429,"type":36},{"date":410,"type":20},{"date":521,"type":20},{"name":42,"class":43},""]