[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Brigham and Women's Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":602},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,194,0,25,[9,43,71,93,123,147,164,191,216,241,266,285,307,329,357,381,400,420,440,462,489,513,536,562,578],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100413738","phase-4-ultrasound-therapy-in-cardiac-amyloidosis-100413738",false,"NCT04667494","Ultrasound Therapy In Cardiac Amyloidosis","UTICA","Inclusion Criteria:\n\n* Age \\> 18 years for AL-CA, \\> 65 years for ATTR-CA, \\> 65 years for controls\n* Willing and able to provide consent\n* Diagnosis of systemic light chain amyloidosis by standard criteria (see below) and in hematological remission (normal serum free light chain levels)\n\n  * (immunofixation of serum and urine, IgG free light chain (FLC) assay, a biopsy of fat pad\u002F bone marrow, or organ biopsy, followed by typing of the light chain using immunohistochemistry or immunogold assay with confirmation by Mass spectroscopy as needed) AND\n  * proof of cardiac involvement by AL amyloidosis\n  * abnormal cardiac biomarkers (Abnormal high sensitivity TnT 5th generation levels (\\>9 ng\u002FL: female, \\>14 ng\u002FL: male) or abnormal age appropriate N terminal pro-brain natriuretic peptide, NT-proBNP (abnormal values: \\\u003C50 years: \\>450 pg\u002Fml; 50-75 years:\\>900 pg\u002Fml; \\>75 years: \\>1800 pg\u002Fml) or\n  * abnormal echocardiogram (wall thickness \\> 12 mm) or\n  * abnormal cardiac MRI (wall thickness \\> 12 mm or extracellular volume \\> 0.35) OR\n* Diagnosis of transthyretin cardiac amyloidosis by standard criteria\n\n  * endomyocardial biopsy followed by typing of the transthyretin amyloidosis using immunohistochemistry or immunogold assay with confirmation by Mass spectroscopy as needed\n  * extracardiac biopsy with typical cardiac imaging findings, or\n  * grade 2 or grade 3 myocardial uptake of technetium-99m pyrophosphate (PYP) if AL amyloidosis is excluded\n\nExclusion Criteria:\n\n* Hemodynamic instability\n* Severe claustrophobia despite use of sedatives\n* Decompensated heart failure (unable to lie flat for 1 hour)\n* Concomitant non-ischemic non-amyloid heart disease (valvular heart disease or dilated cardiomyopathy)\n* Severe valve stenosis or regurgitation in the aortic, mitral or tricuspid valves, including prior valve replacement\n* Severe pulmonary artery hypertension\n* Severe lung disease\n* Known obstructive epicardial coronary artery disease with stenosis \\> 50% in any single territory\n* Prior cardiac surgery\n* Regional wall motion abnormality on echocardiogram\n* Left ventricular ejection fraction \\\u003C 40%\n* Pregnant state\n* Documented allergy to N-13 ammonia or Definity\n* Contraindications to DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension:\n\n  o Patients with known or suspected Right-to-left, bi-directional, or transient right-to-left cardiac shunts, Hypersensitivity to perflutren\n* Contraindications or challenges to sonotherapy\n\n  * Severe electrolyte abnormalities\n  * QTc prolongation (values are greater than 450 milliseconds in males and greater than 470 milliseconds in females)\n  * BMI \\> 35 kg\u002Fm2\n  * Documented intracardiac thrombus\n  * Atrial fibrillation not on anticoagulation\n  * Prior history of stroke\n* Any other reason determined by the investigator that makes a subject a poor candidate for ultrasound therapy",true,"ALL","18 Years","90 Years",{"count":22,"type":23},70,"ESTIMATED","INTERVENTIONAL",[26],"PHASE4","This is a prospective pilot clinical study of subjects with cardiac amyloidosis and control subjects without amyloidosis where we plan to evaluate changes in myocardial blood flow, systolic and diastolic function before and after sonotherapy.",[29],"Amyloidosis Cardiac","RECRUITING","2026-08-20",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":34},"2023-08-31",{"date":38,"type":23},"2027-04-30",{"name":40,"class":41},"Brigham and Women's Hospital","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":24,"phases":52,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":42},"100623360","epifaith-resident-learning-curve-trial-100623360","NCT07395622","EpiFaith Resident Learning Curve Trial","Impact of the EpiFaith® Syringe on the Learning Curve of Anesthesia Residents for the Labor Epidural Technique: A Quasi-Experimental Study","Inclusion Criteria:\n\n* Anesthesiology residents with fewer than 5 prior epidural placement experiences\n\nExclusion Criteria:\n\n* anesthesiology residents with more than 5 prior epidural placement experiences",{"count":51,"type":23},34,[53],"NA","This study aims to evaluate the impact of the EpiFaith® syringe on the learning curve of anesthesia residents for the labor epidural technique. Anesthesia residents with prior experience placing \\< 5 labor epidurals will be enrolled. Their performance of 20 sequential labor epidural placements with either standard technique with a beveled glass syringe or the EpiFaith® syringe will be observed. Successful epidural placement over time with sequential epidural placement attempts will be measured between groups. The primary outcome will be rate of successful epidural placement. Success will be defined as a composite of 4 criteria: maximum 3 attempts for placement; no need to re-site at a different level; no required intervention by the supervising attending anesthesiologist; and adequate analgesia with a visual analog score (VAS) \\<3 at 30 minutes. We hypothesize that use of the EpiFaith® syringe will enable a faster learning curve for successful epidural placement. A cumulative sum chart (CUSUM) analysis will evaluate whether the EpiFaith® syringe causes deviation from the control learning curve. Secondary outcomes will include rate of inadvertent dural puncture and epidural replacement rate.",[56,57,58],"Epidural Analgesia","Epidural Analgesia for Labour and Delivery","Learning Curve",[60,61,62,63],"labor epidural","learning curve","epidural syringe","anesthesia residents","2026-08-19",{"date":33,"type":34},{"date":67,"type":34},"2023-09-01",{"date":69,"type":23},"2026-12-01",{"name":40,"class":41},{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":42},"100652446","burnout-and-safety-assessment-in-home-hospital-versus-brick-and-mortar-hospital-100652446","NCT07773168","Burnout and Safety Assessment in Home Hospital Versus Brick-and-Mortar Hospital","Burnout and Safety Assessment for Frontline Clinical Employees in Home Hospital and Brick-and-Mortar Hospital","BSAFE","Eligibility criteria:\n\n* Clinician (nurse, physician, advanced practice provider, paramedic, social worker, physical therapist, occupational therapist, and speech therapist)\n* Delivers care for at least 25% of their clinical effort in home hospital or brick-and-mortar inpatient ward.\n\nExclusion criteria:\n\n\\- None",{"count":80,"type":23},500,"OBSERVATIONAL","The goal of this observational study is to learn about burnout and workplace violence among frontline clinicians working in Home Hospital programs compared with traditional brick-and-mortar hospitals. The main questions it aims to answer are:\n\n1. Do Home Hospital clinicians experience different levels of burnout than clinicians working in traditional inpatient hospital settings?\n2. Do Home Hospital clinicians experience different rates of workplace violence and harassment than clinicians working in traditional inpatient hospital settings?\n\nResearchers will compare clinicians working primarily in Home Hospital settings with clinicians working primarily in brick-and-mortar hospitals to assess differences in burnout, workplace safety, and work experience.\n\nParticipants will:\n\n* Complete a one-time anonymous online survey through REDCap.\n* Answer questions about their demographic and professional background.\n* Complete validated questionnaires assessing burnout, workplace safety culture, and experiences with workplace violence or harassment.\n* Provide optional free-text feedback about their work experience.",[84,85],"Burnout, Healthcare Workers","Workplace Violence","2026-08-18",{"date":31,"type":34},{"date":89,"type":34},"2026-07-04",{"date":91,"type":23},"2027-07",{"name":40,"class":41},{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":18,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":24,"phases":104,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":4},"100596306","imaging--vs-scalp-targeted-accelerated-tms-for-depression-the-number-needed-to-scan-trial-100596306","NCT07043738","Imaging- vs. Scalp-Targeted Accelerated TMS for Depression: The Number Needed to Scan Trial","NNS","Inclusion Criteria:\n\n* Age 22-80\n* English proficiency sufficient for informed consent, questionnaires\u002Ftasks, and treatment\n* Primary diagnosis of major depressive disorder per DSM-V criteria (Quick Structured Clinical Interview for DSM-5)\n\n  * \\>20 on Beck Depression Inventory (BDI)\n  * \\>20 on the Montgomery-Åsberg Depression Rating Scale (MADRS)\n  * Moderate to severe level of treatment resistance (Maudsley Staging Method)\n* Stable antidepressant medication regimen, or remain medication free, for 4 weeks prior to treatment and to remain on this regimen throughout the study until the 1-month post-treatment visit.\n* Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial\n* Agreement to lifestyle considerations\n\n  * Abstain from becoming pregnant from screening to one-month after treatment (the MRI visit)\n  * Continue usual intake patterns of caffeine- or xanthine-containing products (e.g. coffee, tea, soft drinks, chocolate) throughout treatment\n  * Abstain from alcohol, tobacco, and recreational drugs for at least 24 hours before the start of each MRI and TMS session","22 Years","80 Years",{"count":103,"type":23},160,[53],"Transcranial magnetic stimulation(TMS) is a non-invasive form of brain stimulation that is cleared by the United States Food and Drug Administration (FDA) for depression. Conventional TMS involves daily weekday treatments for 6-8 weeks. These treatments are targeted using each person's scalp measurements. With conventional TMS, approximately 50-55% of people show a 50% or more improvement in depressive symptoms (in other words, they \"respond\" to treatment).\n\nStudies are trying to make TMS work better and faster. A new form of TMS called accelerated TMS (aTMS) involves mutliple treatments a day. One specific aTMS protocol involves 10 treatments per day for 5 days. These treatments are targeted using each person's brain scan (magentic resonance imaging, MRI). With this specific aTMS protocol, approximately 70-90% of people show a 50% or more imporvement in depressive symptoms. While these results are exciting, scientists are not sure why this specific aTMS protocol works better than conventional TMS. It could be the dose and schedule of treatment, or it could be the MRI-based targeting. Answering this question is important because MRI-based targeting is expensive and difficult to do in many settings.\n\nThis study aims to determine if MRI-based targeting is better than scalp-based targeting for aTMS for depression. In this study, everyone who enrolls and meets criteria will be randomly assigned to MRI- versus scalp-based aTMS targeting.",[107],"Major Depressive Disorder (MDD)",[109,110,111,112,113,114,115],"Accelerated Transcranial Magnetic Stimulation","Depression","Major Depressive Disorder","Treatment resistant depression","TMS","Transcranial Magnetic Stimulation","Neuromodulation","NOT_YET_RECRUITING",{"date":64,"type":34},{"date":119,"type":23},"2026-10-01",{"date":121,"type":23},"2032-10-01",{"name":40,"class":41},{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":24,"phases":132,"briefSummary":133,"conditions":134,"keywords":138,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":42},"100587886","experiment-3-mixed-vs-blocked-dashboard-paradigm-100587886","NCT06934213","Experiment 3: Mixed vs Blocked; Dashboard Paradigm","Prevalence Effects in Visual Search: Theoretical and Practical Implications (J)","Inclusion Criteria:\n\n• Pass Ishihara color vision test\n\nExclusion Criteria:\n\n• vision less than 20\u002F25 with correction\n\n\\- history of neuromuscular or visual disorders",{"count":131,"type":23},50,[53],"The goal is to look for qualitative differences in visual search behavior when one search is performed many times in a row compared to when multiple search tasks are intermixed. Four search tasks are tested. The target is the same in every task but the types of distractors change from task to task. In this version, observers get some degree of choice in what they are searching.",[135,136,137],"Vision","Healthy","Attention",[139,140],"visual search","visual attention",{"date":64,"type":34},{"date":143,"type":34},"2024-06-01",{"date":145,"type":23},"2029-06-30",{"name":40,"class":41},{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":24,"phases":156,"briefSummary":157,"conditions":158,"keywords":159,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":160,"startDateStruct":161,"completionDateStruct":162,"leadSponsor":163,"locationsCount":42},"100587846","mixed-vs-blocked-search-four-unique-tasks-100587846","NCT06933693","Mixed Vs Blocked Search: Four Unique Tasks","Prevalence Effects in Visual Search: Theoretical and Practical Implications","Inclusion Criteria:\n\n* Pass Ishihara color vision test\n\nExclusion Criteria:\n\n* vision less than 20\u002F25 with correction\n* history of neuromuscular or visual disorders",{"count":155,"type":23},40,[53],"The goal is to look for qualitative differences in visual search behavior when one search is performed many times in a row compared to when multiple search tasks are intermixed. Four search tasks are tested. In the Mixed condition, the four tasks are randomly changed from trial to trial. In the Blocked condition, each task is run as a block of 100 trials.",[135,136,137],[139,140],{"date":64,"type":34},{"date":143,"type":34},{"date":145,"type":23},{"name":40,"class":41},{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":24,"phases":174,"briefSummary":175,"conditions":176,"keywords":180,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":42},"100628626","stable-pilates-for-hypermobility-100628626","NCT07464093","STABLE Pilates for Hypermobility","Pilates for Hypermobility: A Pilot Feasibility Study","STABLE","Inclusion Criteria:\n\n* ≥ 18 years old;\n* Self-reported hypermobility with confirmed or suspected diagnosis of hEDS\u002FHSD;\n* Self-reported persistent pain ≥ 3 months;\n* A minimum of 3\u002F10 self-reported pain intensity in the past week\n* Able to get on and off the floor without assistance;\n* Able to communicate fluently in English; and\n* Able to provide written, informed consent\n\nExclusion Criteria:\n\n* Regular ongoing mind-body practice (e.g. Tai chi, yoga, pilates) defined as a regular weekly practice of at least 20min\u002Fweek over the past 6 months;\n* Recent surgery or acute bone, joint or nerve injury (\\\u003C6 months);\n* Have a history of a severe or progressive neurological or movement disorder;\n* Pregnant, planning to become pregnant during the study, or currently breast feeding;\n* Unable to get on and off the floor without assistance;\n* Unable to complete study procedures due to cognitive impairment;\n* Unable to provide written, informed consent; or\n* Currently participating in or planning to participate in another physical activity, mind-body or pain-related intervention research study in the next 4 months.",{"count":173,"type":23},100,[53],"This study is looking at whether Pilates-based exercise can help with hypermobility-related symptoms, like pain.",[177,178,179],"Ehlers-Danlos Syndrome (EDS)","Hypermobile EDS (hEDS)","Hypermobile Spectrum Disorder",[181,182,183],"hypermobility","pilates","pain","2026-08-17",{"date":64,"type":34},{"date":187,"type":34},"2026-07-09",{"date":189,"type":23},"2027-12",{"name":40,"class":41},{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":24,"phases":200,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":215},"100614353","phase-1-nad-augmentation-to-prevent-or-reverse-alzheimers-disease-in-people-with-down-syndrome-100614353","NCT07278492","NAD Augmentation to Prevent or Reverse Alzheimer's Disease in People With Down Syndrome","Nicotinamide Adenine Dinucleotide Augmentation to Prevent or Reverse the Progression of Alzheimer's Disease in People With Down Syndrome","Inclusion Criteria:\n\n1. A diagnosis of full trisomy for chromosome 21 or complete unbalanced translocation of chromosome 21, confirmed by karyotype analysis or clinical documentation.\n2. 18 years or older\n3. Participant has a caregiver\u002F informant who has direct contact with the participant \\>10 hours\u002F week and who can provide information about participant's health\n4. Participant or Legal Authorized Representative is able to understand and willing to provide written informed consent and capable of completing study assessments.\n5. In addition, female participants must Not be pregnant and not planning to become pregnant over the next 6 months.\n\nExclusion Criteria\n\n1. Fasting morning UACR \\> 5,000 mg\u002F g creatinine\n2. Other laboratory abnormalities:\n\n   1. Has AST or ALT \\> 3 times the upper limit of normal\n   2. eGFR \\\u003C 30 mL\u002F min \u002F 1.73 m2\n   3. Hematocrit \\\u003C 0.34 or \\> 0.50 L\u002FL\n3. A major adverse cardiovascular event in preceding 3 months\n4. Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter\n5. Current alcohol or substance use disorder or dependence (DSM 5 criteria).\n6. Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures.\n7. An acute illness, including COVID-19, requiring hospitalization within the past 3 months or any acute illness, including COVID-19, within the past month.\n8. Has a history of anaphylaxis from vitamin B3 derivatives\n9. BMI \\> 42.5 kg\u002F m2\n10. Non-ambulatory",{"count":199,"type":23},24,[201],"PHASE1","The aim of the study is to determine the safety and tolerability of different increasing doses of MIB-626 (a microcrystalline form of β nicotinamide mononucleotide; NMN) given daily for 28 consecutive days to adults with Down syndrome (DS). The study will also explore how the drug moves through the body over time (pharmacokinetics or PK) and how the drug affects the body in different ways (pharmacodynamics or PD). The study participants will be monitored for adverse events and measurements to detect safety events will take place including laboratory tests of blood counts, chemistries and coagulation profile, and electrocardiogram (ECG). The trial will enroll a total of 24 adults with DS who are 18 years or older and are medically stable. People enrolled in the study will be randomly assigned to receive either the active intervention (MIB-626) tablets, or placebo tablets for 28 days. Study participants will be followed for an additional 28 days (total 56 days of follow-up). This study will also explore the effect of MIB-626 on different measures associated with aging and risk of Alzheimer's Disease (AD).",[204],"Down Syndrome (DS)",[206,207,208],"Down Syndrome","NMN","safety",{"date":64,"type":34},{"date":211,"type":23},"2026-08-31",{"date":213,"type":23},"2028-05-31",{"name":40,"class":41},2,{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":24,"phases":225,"briefSummary":226,"conditions":227,"keywords":229,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":237,"leadSponsor":239,"locationsCount":240},"100652522","a-structured-peer-support-intervention-for-patients-undergoing-hematopoietic-stem-cell-transplantation-100652522","NCT07774104","A Structured Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation","STEPP-3","Inclusion Criteria:\n\n* Adult patients (aged 18 years and older) with hematologic malignancies, scheduled to undergo autologous or allogeneic HSCT\n* Ability to speak, read, and respond to questions in English or Spanish to complete study procedures\n\nExclusion Criteria:\n\n* Patients undergoing HSCT for benign hematologic conditions\n* Patients with acute or unstable psychiatric or cognitive conditions (e.g., dementia) which the treating clinicians believe prohibits informed consent or compliance with study procedures\n* Patients undergoing HSCT for the second time",{"count":224,"type":23},350,[53],"This randomized clinical trial is evaluating the impact of a structured peer support intervention (STEPP) on psychological distress and quality of life among patients undergoing hematopoietic stem cell transplantation.",[228],"Hematopoietic Stem Cell Transplantation",[230,231,232,233],"Peer Support","Stem Cell Transplantation","Psychological Distress","Social Support","2026-08-14",{"date":64,"type":34},{"date":69,"type":23},{"date":238,"type":23},"2030-07-31",{"name":40,"class":41},3,{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":249,"targetDuration":251,"studyType":81,"phases":4,"briefSummary":252,"conditions":253,"keywords":256,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":42},"100648308","artificial-intelligence-based-health-assessment-from-face-photographs---healthy-volunteer-study-100648308","NCT07719049","Artificial Intelligence-Based Health Assessment From Face Photographs - Healthy Volunteer Study","Artificial Intelligence-Based Phenotyping of Health From Photographs - Healthy Volunteer Study","FaceAge","Inclusion Criteria:\n\n* The protocol enrolls healthy volunteers from the adult (age 18 and above) general population. All races and genders will be included.\n\nExclusion Criteria:\n\n* Any skin condition or recent facial injury that could affect facial appearance.\n* Inability to follow study instructions or provide informed consent.\n* Taking new or strong medication on the day of image capture could potentially affect appearance or alertness.",{"count":250,"type":23},10000,"3 Years","The investigators aim to examine how FaceAge estimates (a measure of biological age based on facial features) change across different time points and identify factors that may influence these changes. This will help the investigators understand the consistency and reliability of the FaceAge algorithm and allow them to make improvements.",[254,255],"Aging","Facial Aging",[257,254,258],"Artificial Intelligence","Biomarkers of Aging","2026-08-13",{"date":184,"type":34},{"date":262,"type":34},"2025-10-23",{"date":264,"type":23},"2027-10",{"name":40,"class":41},{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":273,"minAge":19,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":24,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":4},"100648188","ai-chatbot-for-prostate-radiation-therapy-patient-education-100648188","NCT07719062","AI Chatbot for Prostate Radiation Therapy Patient Education","Clinical Evaluation of Large Language Model (LLM) Methods to Support Prostate Cancer Radiation Therapy Patient Education","Inclusion Criteria:\n\n* Age 18 years or older\n* Current diagnosis of prostate cancer\n* Planning to receive definitive prostate cancer radiation therapy at Brigham and Women's Hospital Department of Radiation Oncology\n* English-speaking\n* Ability to understand and willingness to provide informed consent\n\nExclusion Criteria:\n\n* Adults unable to consent independently\n* Individuals who are not yet adults\n* Prisoners","MALE",{"count":131,"type":23},[53],"This study will evaluate whether an artificial intelligence chatbot can help patients better understand radiation therapy for localized prostate cancer. Participants will be adults with prostate cancer who are planning definitive radiation therapy at Brigham and Women's Hospital.\n\nAll participants will receive standard radiation therapy education and clinician-led discussions as part of routine care. In addition, participants will interact with an educational chatbot about prostate cancer radiation therapy. The chatbot is designed to provide plain-language information about treatment logistics, preparation, possible side effects, follow-up, and when to contact the care team. The chatbot will not provide diagnosis, treatment recommendations, individualized medical advice, or replace conversations with clinicians.\n\nParticipants will complete questionnaires before and after using the chatbot. The study will measure changes in patient understanding, confidence in managing symptoms, usability of the chatbot, and safety-related concerns identified during clinician review of chatbot responses.",[278],"Prostate Cancer Patients",{"date":184,"type":34},{"date":281,"type":23},"2026-08",{"date":283,"type":23},"2027-08",{"name":40,"class":41},{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":24,"phases":294,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":42},"100638035","transcutaneous-auricular-vagus-nerve-stimulation-treatment-for-rosacea-100638035","NCT07600424","Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea","Transcutaneous Auricular Vagus Nerve Stimulation Treatment for Rosacea: A Pilot Trial","Inclusion Criteria:\n\n* Adults aged 18 years of age and older\n* Dermatologist confirmed diagnosis of rosacea\n* Clinician's Erythema Assessment of at least 3 (moderate to severe disease)\n* Willingness to adhere to current rosacea regimen without additions or laser treatments (e.g. PDL) during the study period.\n\nExclusion Criteria:\n\n* Changes to rosacea regimen (prescription topical or oral medications) within 4 weeks of randomization.\n* Facial hair, tattoos, or other characteristics that would interfere with erythema assessments\n* History of symptomatic cardiac arrythmias (e.g. heart block, sick sinus syndrome, bradyarrhythmia)\n* Presence of a pacemaker, implanted defibrillator, or neurostimulator\n* Seizure disorder or epilepsy\n* Trigeminal Neuralgia within the past year\n* Severe coronary disease or recent myocardial infarction within the past 5 years\n* Severe autonomic dysfunction (e.g., frequent syncope, hospitalization)\n* History of recurrent syncope or unexplained fainting\n* Use of brimonidine or oxymetazoline within the past 4 weeks\n* Use of beta-blockers, anticholinergics, or vagal-modulating drugs within the past 4 weeks\n* Severe phymatous rosacea\n* Ear deformity, piercings, or other condition that prevents the use of the taVNS device\n* Known hypersensitivity to electrode materials\n* Patients who are pregnant.",{"count":293,"type":23},10,[53],"A single arm, pilot study among individuals with rosacea and at least moderate flushing or rednesss will be enrolled in a 4-week trial of taVNS. The particicpants will be followed for an additional 4-weeks following the intervention period to evaluate the durability of the results",[297,298,299],"Rosacea","Rosacea, Erythematotelangiectatic","Flushing","2026-08-12",{"date":234,"type":34},{"date":303,"type":34},"2026-05-23",{"date":305,"type":23},"2028-02-28",{"name":40,"class":41},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":314,"enrollmentInfo":315,"targetDuration":4,"studyType":24,"phases":316,"briefSummary":317,"conditions":318,"keywords":320,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":42},"100611827","targeted-accelerated-tms-for-post-traumatic-stress-disorder-100611827","NCT07245641","Targeted Accelerated TMS for Post-Traumatic Stress Disorder","TAP","Inclusion Criteria\n\n* Age 18-65\n* DSM-5 diagnosis of PTSD per PTSD Checklist for DSM-5 (CAPS-5)\n* At least moderate symptoms of PTSD per PCL-5 (≥21)\n* English proficiency sufficient to understand risks\u002Fbenefits\n* No new medications or medication increases before, during, or after aTMS\n* Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial\n* Agreement to lifestyle considerations:\n* Abstain from becoming pregnant from screening to one-month after treatment (the MRI visit)\n* Continue usual intake patterns of caffeine- or xanthine-containing products (e.g. coffee, tea, soft drinks, chocolate) throughout treatment\n* No changes to routine intake of alcohol, tobacco, and recreational drugs if patients are using them at baseline for at least 24 hours before the start of each MRI and TMS session","65 Years",{"count":155,"type":23},[53],"Post-traumatic stress disorder (PTSD) is a highly prevalent and debilitating condition among veterans and active-duty military personnel, with rates as high as 30% in certain combat-exposed populations. Conventional treatments such as prolonged exposure therapy and pharmacotherapy have limited efficacy and high dropout rates, highlighting the need for novel, rapidly effective interventions.\n\nTranscranial magnetic stimulation (TMS) has been well established for treatment-resistant depression (TRD). Traditional TMS, which involves 6 to 7 weeks of daily, weekday scalp-targeted treatment, shows open-label response and remission rates of 58.1% and 30%, respectively. However, such protocols may be impractical for military personnel with limited medical leave. A new form of accelerated TMS (aTMS) that involves 10 imaging-guided treatments per day for 5 consecutive days has demonstrated substantial antidepressant benefits within days and response rates of 69% at 1-month follow-up. This protocol has not been tested for PTSD, in part because there was no causally informed brain circuit target. In this study, the investigators will test aTMS for PTSD using a novel PTSD circuit that the investigators have derived.",[319],"Post Traumatic Stress Disorder (PTSD)",[109,321,322,113,115],"Post traumatic stress disorder","PTSD",{"date":259,"type":34},{"date":325,"type":34},"2025-12-15",{"date":327,"type":23},"2028-01",{"name":40,"class":41},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":101,"enrollmentInfo":337,"targetDuration":4,"studyType":24,"phases":339,"briefSummary":341,"conditions":342,"keywords":346,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":354,"leadSponsor":356,"locationsCount":42},"100628463","phase-2-cortishock-p-trial-of-corticosteroids-in-inflammation-enriched-heart-failure-cardiogenic-shock-100628463","NCT07461961","CORTISHOCK-P: Trial of Corticosteroids in Inflammation-Enriched Heart Failure Cardiogenic Shock","CORTISHOCK-P: A Randomized Pilot Trial of Corticosteroids as a Pharmacologic Adjunct to Temporary Mechanical Circulatory Support in Inflammation-Enriched Heart Failure Cardiogenic Shock","CORTISHOCK-P","Inclusion Criteria:\n\nAge ≥ 18 and ≤ 80 years.\n\nHospitalized in the Intensive Care Unit (ICU).\n\nCardiogenic shock defined by clinical and hemodynamic criteria.\n\nHypotension defined by SBP \\\u003C90 mmHg for \\>30 min, MAP \\\u003C60 mmHg for \\>30 min, or requirement of vasopressors to maintain SBP ≥90 mmHg or MAP ≥60 mm Hg.\n\nHypoperfusion defined by altered mental state, cold extremities, livedo reticularis, urine output \\\u003C30 mL\u002Fh, or lactate ≥2 mmol\u002FL.\n\nIf invasive hemodynamic monitoring is available, CI \\\u003C2.2 L\u002Fmin\u002Fm2.\n\nSCAI stage B or stage C at the time of screening.\n\nFor SCAI Stage B (Beginning Shock), clinical evidence of hemodynamic instability (including relative hypotension, a decline in SBP of ≥20-30 mmHg, or MAP \\\u003C20% from baseline, or tachycardia) without hypoperfusion (normal lactate).\n\nFor SCAI Stage B, hypotension SBP \\\u003C90 mmHg or MAP \\\u003C60 mmHg or \\> 30 mmHg drop from baseline, or tachycardia heart rate ≥100 bpm.\n\nFor SCAI Stage C, requiring only one vasoactive\u002Finotrope and\u002For IABP from admission with CS until randomization, AND Vasoactive-inotropic score (VIS) \\\u003C40.\n\nFor SCAI Stage C, NONE of the following criteria of deterioration from admission until randomization: failure to respond to initial single vasopressor\u002Finotrope drug and addition of a second drug, or failure to respond to IABP and need for new MCS device.\n\nFor SCAI Stage C, use of vasoactive agents at the time of randomization must not show: low starting dose with escalation, intermediate starting dose without escalation or de-escalation, or high starting dose with de-escalation.\n\nFor SCAI Stage C, worst lactate 2 - 5 mmol\u002FL and increase ≥ 100% from baseline lactate ≥ 2mmol\u002FL or worst lactate ≥5mmol\u002FL.\n\nDocumented history of chronic heart failure with reduced ejection fraction (LVEF \\\u003C40%).\n\nEtiology of cardiogenic shock must be congestive heart failure decompensation (HF-CS).\n\nhsCRP ≥20 mg\u002FL, reflecting a pro-inflammatory state.\n\nLess than 48 hours since admission\n\nExclusion Criteria:\n\nCardiogenic shock caused by acute myocardial infarction (AMI-CS).\n\nOther special conditions causing cardiogenic shock, including post-cardiotomy CS, peripartum, adrenergic, valvular, restrictive, post-embolic, conduction or rhythm disorders, or related to cardiotropic drug intoxication.\n\nCirculatory shock of another cause, such as septic, hemorrhagic, or anaphylactic shock.\n\nShock post-cardiac arrest.\n\nOnset of cardiogenic shock \\>48 hours.\n\nSCAI stage A, D, or E at the time of enrollment.\n\nSevere hyperglycemia at baseline, defined as blood glucose ≥300 mg\u002FdL despite insulin therapy.\n\nOngoing uncontrollable infection, suspected concomitant sepsis, or mixed septic-cardiogenic shock.\n\nIschemic hepatitis or ALT \\>500 IU\u002FL due to causes other than suspected hypoperfusion.\n\nSevere refractory acute kidney injury (AKI) at baseline, defined as new persistent anuria (urine output \\\u003C50 mL\u002Fday) or refractory AKI requiring new emergent renal replacement therapy.\n\nKnown allergy to methylprednisolone or other steroid analogues.\n\nCardiac transplant patient or on the transplant list.\n\nPatient planned for implantation of a durable LVAD.\n\nMoribund patients (SAPS2 \\>90) or predicated mortality \\>90% within 30 days.\n\nSigns of extremis, including lactate \\>5 mmol\u002FL, pH \\\u003C7.2, or refractory shock requiring escalation to \\>3 vasopressors at screening.\n\nPregnant woman, parturient, or breastfeeding mother.\n\nAdult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice).",{"count":338,"type":23},30,[340],"PHASE2","This pilot study investigates whether giving a short course of intravenous corticosteroids (methylprednisolone) alongside standard medical care can help patients recovering from heart failure-related cardiogenic shock. Heart failure-related cardiogenic shock happens when chronic heart dysfunction causes poor blood circulation and congestion throughout the body. Often, this condition triggers severe inflammation, making it harder for the heart and other organs to recover, even when temporary mechanical heart pumps are used to support blood flow.\n\nThe study aims to see if reducing this inflammation with corticosteroids is safe and can help patients get better faster. Researchers will enroll 30 adult patients hospitalized with early-stage (SCAI Stage B or C) cardiogenic shock related to heart failure. To participate, patients must also show high levels of inflammation in their blood, specifically a high-sensitivity C-reactive protein (hsCRP) level of 20 mg\u002FL or higher\n\nParticipants will be randomly assigned by chance to one of two groups. One group will receive the standard of care alone. The other group will receive the standard of care plus a 7-day course of intravenous methylprednisolone.\n\nThe main goal of the study is to measure the change in inflammation levels (hsCRP) over 7 days. Researchers will also monitor how well the patients' organs recover, track their need for blood pressure medications or mechanical heart pumps, and monitor for any side effects to ensure the treatment is safe",[343,344,345],"Cardiogenic Shock","Heart Failure","Inflammation",[347,348,349,350],"cardiogenic shock","heart failure cardiogenic shock","inflammation","corticosteroids","2026-08-11",{"date":259,"type":34},{"date":119,"type":23},{"date":355,"type":23},"2029-02-01",{"name":40,"class":41},{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":314,"enrollmentInfo":364,"targetDuration":4,"studyType":24,"phases":366,"briefSummary":367,"conditions":368,"keywords":370,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":42},"100615706","phase-2-psilocybin-assisted-psychotherapy-for-the-treatment-of-severe-alcohol-use-disorder-100615706","NCT07296094","Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder","Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder: A Double-Blind, Dose-Comparison Concurrent Control Randomized Trial","To be eligible, individuals must be:\n\n* English speaking adults between ages 18 and 65\n* Diagnosis of DSM5 AUD, severe\n* Completion of inpatient withdrawal management (i.e. \"detox\") for AUD within 90 days of enrollment\n* Amenable to attending all psychotherapy and study visits at BWH CCI\n* Able to identify an individual who can act as points of contact during the trial\n* Have a friend or family member who can bring the participant home after the psilocybin sessions and stay overnight\n\nIndividuals with any of the following will be excluded:\n\n* • Any personal history of a psychotic disorder (schizophrenia, schizoaffective disorder, brief psychotic disorder, delusional disorder, schizophreniform disorder, substance-induced psychotic disorder or major depression with psychotic features) or any bipolar-spectrum disorder\n* Participants with a family history of first-degree relatives with psychotic disorder or bipolar-spectrum disorder\n* Participants who have a significant suicide risk as defined by current suicidal ideation (Columbia-Suicide Severity Rating Scale (C-SSRS) score 2 to 5) and\u002For recent (within the past 6 months) active suicidal ideation (C-SSRS score 4 or 5)\n* Participants who have a history of significant or serious adverse reaction to classic psychedelics\n* Homicidality within the last six months\n* History of DSM5 hallucinogen use disorder\n* Positive breath alcohol level at screening\n* Need for inpatient withdrawal management for alcohol at the time of screening\n* Current DSM5 opioid, cocaine, stimulant or sedative\u002Fhypnotic use disorder\n* Systolic blood pressure persistently above 165mmHg during screening\n* History of hypersensitivity to psilocybin\n* Use of psilocybin or other psychedelics with 5-HT2B activity in the prior 12 months\n* Significant EKG abnormalities including QTc prolongation defined as \\>450 ms for men and women, or a diagnosis or family history of Long QT syndrome.\n* History of any cardiac valvulopathy that raises the risk for participation as determined by the cardiology consultant\n* History of intracranial mass or bleed, seizure disorder other than alcohol withdrawal seizures, liver cirrhosis, renal failure, obstructive lung disease requiring supplemental oxygen, hyperthyroidism, narrow-angle glaucoma, uncontrolled cardiac arrythmias, heart failure\n* History of head trauma, stroke, or myocardial infarction in one year prior to enrollment.\n* Expected to require surgical treatment at any point during the trial\n* Liver dysfunction with LFTs \\> 3x upper normal limit at screening and Total bilirubin \\> 2.5x the upper normal limit\n* MRI contraindications (other ferromagnetic implants, body weight greater than 550 lbs., etc.)\n* Pregnant or breastfeeding\n* High risk for adverse emotional or behavioral reaction based on the opinion of the study investigators such as evidence of a personality disorder\n* Currently taking medications with serotonergic activity (other than SSRIs\u002FSNRIs); inhibitors of UGT1A9, UGT1A10, MAO, and aldehyde or alcohol dehydrogenase; antipsychotics (e.g., first and second generation); mood stabilizers (e.g., lithium, valproic acid); or significant inhibitors of UGT enzymes that metabolize psilocin\n* Selective serotonergic reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors are allowed if participants have been on stable doses of the medication(s) for at least 90 days prior to enrollment.\n* Currently receiving insulin for blood sugar management.",{"count":365,"type":23},36,[340],"This study aims to determine the safety and preliminary efficacy of psilocybin-assisted psychotherapy in improving alcohol-related outcomes among adults with severe alcohol use disorder in a a double-blind, dose-comparison concurrent control, randomized trial. Participants will undergo structured psychotherapy and will be randomized to two psilocybin sessions to receive either a full dose (30mg or 40mg) or low dose (10mg or 15mg).",[369],"Alcohol Use Disorder",[371,372,373,374],"alcohol use disorder","psilocybin","inpatient withdrawal management","psychedelic",{"date":259,"type":34},{"date":377,"type":23},"2026-08-15",{"date":379,"type":23},"2030-02",{"name":40,"class":41},{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":17,"sex":387,"minAge":19,"maxAge":314,"enrollmentInfo":388,"targetDuration":4,"studyType":24,"phases":390,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":42},"100553251","phase-2-intravenous-oxytocin-for-post-operative-pain-after-minimally-invasive-hysterectomy-100553251","NCT06483659","Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy","Inclusion Criteria:\n\n* Ages 18-65 years old\n* ASA category 1-3\n* Scheduled to undergo minimally invasive hysterectomy\n* No documented allergy to oxytocin\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) group 4 or greater\n* Age \\>65 years old\n* Additional surgical procedures including but not limited to minor laparotomy, omentectomy, cystectomy, vaginectomy, and\u002For ablation of endometriosis.\n* Active opioid prescription of the equivalent of oxycodone \\>10 mg \u002Fday\n* Opioid use disorder, including patients in treatment receiving naltrexone or Suboxone (Buprenorphine-naloxone)\n* Allergies to any study medication: acetaminophen, celecoxib, ketorolac, fentanyl, hydromorphone, or oxycodone.\n* Epidural\u002FRegional anesthesia for intra-operative or post-operative pain.\n* Inability to understand the questionnaires\n* Intra-operative and post-operative exclusion: Procedure converted to open or extension of primary surgery, Intra-operative EBL \\>500 ml., Placement of epidural catheter or regional anesthesia at PACU for pain management, Hospitalization of the patient due to surgical or anesthetic complications","FEMALE",{"count":389,"type":23},152,[340],"This is a randomized, double-blinded, placebo-controlled trial to compare the effectiveness of IV oxytocin infusion to placebo on peri-operative opioid consumption and reducing post-operative pain following a minimally invasive hysterectomy under general anesthesia.",[393],"Postoperative Pain",{"date":259,"type":34},{"date":396,"type":34},"2025-06-01",{"date":398,"type":23},"2028-06-30",{"name":40,"class":41},{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":24,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":42},"100623061","post-surgery-wound-healing-tracking-with-myhealthpal-app-100623061","NCT07391735","Post-Surgery Wound Healing Tracking With MyHealthPal App","Postoperative Pain Procedure Patient Remote Monitoring With MyHealthPal Clinical Study","Inclusion Criteria:\n\n* Adults (18 years old and older).\n* Ability to understand consent process and questionnaires. Patients with ready access to a smartphone, compatible smart device (operating system 5.0 version, also known as Lollipop, for Android and 13 or later version for iOS), smartphone aptitude, smartphone with sufficient memory space for the relevant app, and willingness to participate in the study as assessed by a questionnaire.\n* Patients undergoing one of the following surgeries within the Brigham and Women's Pain Management Practice:\n\n  1. Spinal cord stimulator implantation\n  2. Spinal cord stimulator explant\n  3. Spinal cord stimulator revision\n  4. Intrathecal pump implantation\n  5. Intrathecal pump explant\n  6. Intrathecal pump revision\n* Ability to attend all standard surgery follow-up appointments at Brigham and Women's Hospital.\n* Ability to understand and sign written informed consent documents.\n\nExclusion Criteria:\n\n* Cognitive or physical impairment that would prevent patient from entering data in MHP.\n* Any acute or chronic condition that would limit the ability of the patient to participate in the study.\n* Any patient who is experiencing an ongoing infection prior to undergoing a surgical revision\u002Fexplant",{"count":408,"type":23},150,[53],"The investigators want to explore the use of a smartphone app that allows patients to take photos of their wounds in early stages of healing, so that clinicians can monitor wound-healing remotely with the assistance of an AI program.\n\nParticipants will choose whether they want to be in the control group or the app group. Participants in the app group will be asked to download an app on their personal smartphone before their surgery. After the procedure, participants will upload a photo of their surgery site as well as answer some questions about its characteristics either on a daily or weekly basis. A healthcare provider and the app's AI algorithm will observe this information to determine the risk of infection. Participants in the control group will not be asked to use the app. Their medical record will be monitored by study staff intermittently to see if they develop infection. This study will take approximately 16 weeks.",[412],"Wound Infection and Wound Healing","2026-08-10",{"date":300,"type":34},{"date":416,"type":34},"2026-03-27",{"date":418,"type":23},"2027-12-31",{"name":40,"class":41},{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":24,"phases":429,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":435,"startDateStruct":436,"completionDateStruct":437,"leadSponsor":439,"locationsCount":42},"100579096","acute-hospital-care-at-home-for-people-living-with-dementia-100579096","NCT06819852","Acute Hospital Care at Home for People Living With Dementia","Skipping the Hospital: Acute Hospital Care at Home for People Living With Dementia","Inclusion Criteria:\n\n* Diagnosis of moderate or severe dementia (as ascertained by the Quick Dementia Rating System; QDRS)\n* Resides in a private or assisted living residence with or nearby (\\\u003C15min travel time) to a family caregiver\n* Resides within the Mass General Brigham (MGB) home hospital catchment area\n* Has had at least 1 hospitalization in the last 12 months.\n\nExclusion Criteria:\n\n* Hospitalized in the last 30 days\n* No functioning utilities, such as no working heat (October-April), no running water, or no electricity.\n* Resides in skilled nursing facility\n* Resides in group home\n* Domestic violence screen positive\n* In police custody\n* Family caregiver unable to initiate or maintain communication with care team\n* End-stage renal disease on hemodialysis\n* On methadone requiring daily pickup of medication\n* Active substance use disorder, without functioning treatment plan\n* Psychiatric diagnosis that would prohibit successful home hospital care\n* Acute delirium without explanation or without the ability to manage at home\n* Patients with cancer requiring consistent hospital-based treatments\n* Cannot ambulate to bedside commode with assistance present in the home (if different from baseline), unless home-based aides are available",{"count":428,"type":23},200,[53],"The investigators will perform a parallel-group multicenter randomized controlled trial of a 1-year pre-enrolled acute hospital care at home intervention vs usual care for people living with dementia. Patients will be randomized only after eligibility determination and after the family caregiver agrees to enroll; people living with dementia will assent when able. Patients will be allocated in a concealed fashion to the control and intervention groups in randomly selected block sizes of 4 or 6 in 4 strata reflecting their functional status (activities of daily living: 0, 1, 2-3, 4-6). Although family and clinicians cannot be blinded, the investigators will blind the data collectors and assessors.",[432,433,434],"Emergency Department Visit","Home Care Services","Dementia",{"date":300,"type":34},{"date":184,"type":23},{"date":438,"type":23},"2029-04-01",{"name":40,"class":41},{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":314,"enrollmentInfo":447,"targetDuration":4,"studyType":24,"phases":448,"briefSummary":449,"conditions":450,"keywords":452,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":4},"100650319","alpha-down-eeg-neurofeedback-for-alcohol-use-disorder-feasibility-trial-100650319","NCT07746154","Alpha Down EEG Neurofeedback for Alcohol Use Disorder: Feasibility Trial","Neurofeedback","Inclusion Criteria:\n\nAdults ages 18-65 Meets DSM-5 criteria for current Alcohol Use Disorder Willing and able to provide informed consent Participants must report alcohol consumption within the past 30 days. Not requiring inpatient withdrawal management at the time of enrollment\n\nExclusion Criteria:\n\nHistory of epilepsy or seizure disorder (excluding uncomplicated alcohol withdrawal seizures) Current psychosis, mania, or acute suicidality, or any psychiatric condition that would impair the ability to provide informed consent or safely participate Acute alcohol intoxication at the time of study visits (as determined by breathalyzer) Pregnancy or breastfeeding Implanted electronic medical devices or metal in the head (excluding dental work), if incompatible with EEG procedures Severe cognitive impairment interfering with informed consent or participation Any medical or psychiatric condition that, in the opinion of the investigators, would make participation unsafe or interfere with study procedures",{"count":293,"type":23},[53],"This pilot study is testing a short brain training program called neurofeedback in adults with alcohol use disorder. Participants will complete three sessions over about one week. The goal is to learn if this approach is easy to complete, well tolerated, and acceptable to participants. We will also explore whether it is associated with changes in alcohol cravings and drinking.",[451],"Alcohol Use Disorder (AUD)",[369,453],"EEG neurofeedback","2026-07-30",{"date":456,"type":34},"2026-08-04",{"date":458,"type":23},"2026-08-01",{"date":460,"type":23},"2028-02-01",{"name":40,"class":41},{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":24,"phases":470,"briefSummary":471,"conditions":472,"keywords":477,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":42},"100610222","phase-1-sparsentan-for-the-treatment-of-vegf-signaling-pathway-inhibitor-associated-proteinuria-100610222","NCT07224776","Sparsentan for the Treatment of VEGF Signaling Pathway Inhibitor-Associated Proteinuria","Inclusion Criteria:\n\n1. Adults (≥ 18 years old) with active malignancy who are currently treated with VSPIs\n2. New high-grade proteinuria, defined as ≥ 2+ proteinuria on dipstick or a calculated urinary protein-to-creatinine ratio ≥ 1.0 g\u002Fg\n3. Able to provide written inform consent\n\nExclusion Criteria:\n\n1. Estimated glomerular filtration rate (eGFR) \\\u003C 45 ml\u002Fmin\u002F1.73m2\n2. Baseline high grade proteinuria ≥ 2+ proteinuria on dipstick or a calculated urinary protein-to creatinine ratio or microalbumin-to-creatinine ≥ 1.0 g\u002Fg prior to VSPI initiation\n3. Acute kidney injury defined as serum creatinine at least 1.5 times above the most proximal serum creatinine prior to VSPIs initiation\n4. History of allergic reactions or angioedema to any angiotensin receptor blocker (ARB) or ERA, including sparsentan or irbesartan, or has a hypersensitivity to any of the excipients in the study medications.\n5. Any potassium value \\>5 mEq\u002FL in the 14 days preceding high-grade proteinuria\n6. History of organ transplantation, with the exception of corneal transplants.\n7. History of congestive heart failure (New York Heart Association Class II-IV)\n8. History of clinically significant cerebrovascular disease (transient ischemic attack or stroke) and\u002For coronary artery disease (hospitalization for myocardial infarction or unstable angina, new onset of angina with positive functional tests, coronary angiogram revealing stenosis, or a coronary revascularization procedure) within 6 months prior to screening.\n9. Jaundice, hepatitis, or known hepatobiliary disease (excluding asymptomatic cholelithiasis), or alanine aminotransferase and\u002For aspartate aminotransferase \\>2 times the upper limit of the normal at screening.\n10. Body weight \\\u003C50 kg at screening\n11. Unable to hold renin-angiotensin-aldosterone system (RAAS) inhibitors such as angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), spironolactone, eplerenone, aliskiren, aldosterone blockers during run-in period\n12. Concomitant use of the following medications:\n\n    1. Inhibitors of endothelin system such as ambrisentan, bosentan, macitentan\n    2. Potassium-sparing diuretics such as amiloride, triamterene\n    3. Antiarrhythmic medications such as amiodarone, digoxin\n    4. Weight loss medications such as orlistat or amphetamine derivative agents\n    5. St. John's wort or other hypericum-derived products\n    6. Strong CYP3A inhibitors such as ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin, ritonavir- or cobicistat-boosted regimens, boceprevir, telaprevir, conivaptan, mibefradil\n13. Pregnant or breastfeeding\n14. Concurrent participation in a study with an alternative experimental therapy that may interact with sparsentan\n15. Any condition that, in the view of the principal investigator, might place the patient at increased risk or compromise the integrity of the study\n16. Conflict with other study",{"count":469,"type":23},20,[201],"Single-center, open-label, two-stage pilot study examining the efficacy and safety of sparsentan for reducing high-grade proteinuria among patients with cancer who receive vascular endothelial growth factor inhibitors",[473,474,475,476],"Proteinuric Renal Disease","Proteinuric Kidney Disease","Proteinuria","Proteinuria in Nephrotic Range",[478,479,480,481],"vascular endothelial growth factor inhibitors","cancer","proteinuria","endothelin-1 antagonist","2026-07-29",{"date":454,"type":34},{"date":485,"type":34},"2026-07-10",{"date":487,"type":23},"2028-12-01",{"name":40,"class":41},{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":18,"minAge":495,"maxAge":496,"enrollmentInfo":497,"targetDuration":4,"studyType":24,"phases":498,"briefSummary":499,"conditions":500,"keywords":503,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":42},"100537746","phase-1-dolutegravir-pharmacokinetics-during-weekly-rifapentineisoniazid-for-tb-prevention-100537746","NCT06281834","Dolutegravir Pharmacokinetics During Weekly Rifapentine\u002FIsoniazid for TB Prevention","Inclusion Criteria:\n\n* (1) ART-naïve or ART-experienced HIV-infected children 4 weeks to \\\u003C12 years of age;\n* (2) no evidence of active TB based on an appropriate clinical evaluation;\n* (3) negative TB diagnostic test if performed (other than tuberculin skin testing);\n* (4) weight of at least 4 kilograms; and\n* (5) consent of the parent or legal guardian and assent of the child (if ≥7 years of age).\n\nExclusion Criteria:\n\n* (1) Baseline labs with evidence of ≥grade 3 abnormalities: alanine aminotransferase (ALT), total bilirubin, absolute neutrophil count (ANC), platelets, creatinine;\n* (2) presenting with acute respiratory distress or decompensation, or any clinical syndrome which could suggest undiagnosed TB or other opportunistic infection; or\n* (3) receipt of a medication that has drug-drug interactions with DTG or RPT.","4 Weeks","11 Years",{"count":7,"type":23},[201],"Tuberculosis (TB) is the leading cause of death among children living with HIV, yet insufficient data are available on the pharmacokinetics of newer TB prevention strategies in children. Short-course TB prevention\u002Flatent TB infection (LTBI) treatment regimens increase completion rates but have not been adequately studied among children living with HIV. Our prospective, open-label PK study will examine and extend use of weekly rifapentine and isoniazid (3HP) among children receiving dolutegravir. This will address gaps in knowledge by examining two-way PK of short-course LTBI treatment in a vulnerable pediatric population.",[501,502],"Pediatric HIV Infection","Latent Tuberculosis",[504,505,506],"Pediatric HIV","rifapentine","TB prevention",{"date":454,"type":34},{"date":509,"type":34},"2024-11-15",{"date":511,"type":23},"2027-06-01",{"name":40,"class":41},{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":18,"minAge":495,"maxAge":520,"enrollmentInfo":521,"targetDuration":4,"studyType":24,"phases":522,"briefSummary":523,"conditions":524,"keywords":526,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":42},"100444611","phase-1-dolutegravir-pharmacokinetics-among-hivtb-coinfected-children-receiving-standard-and-high-dose-rifampicin-100444611","NCT05069688","Dolutegravir Pharmacokinetics Among HIV\u002FTB Coinfected Children Receiving Standard and High-dose Rifampicin","Mind the Gaps: Pharmacokinetic Research to Advance Pediatric HIV\u002FTB Cotreatment and TB Prevention","Inclusion Criteria:\n\n* ART-naïve or ART-experienced HIV-infected children between 4 weeks and \\\u003C6 years of age\n* Active TB diagnosis\n* Weight of at least 3 kilograms\n* Consent of the parent or legal guardian\n\nExclusion Criteria:\n\n* Baseline labs with evidence of ≥grade 3 abnormalities: ALT, total bilirubin, absolute neutrophil count (ANC), platelets, or creatinine\n* Suspected TB meningitis or presenting with acute respiratory distress or decompensation\n* Receipt of a medication that has drug-drug interactions with dolutegravir or rifampicin","5 Years",{"count":469,"type":23},[201],"Tuberculosis (TB) is the leading cause of death among children with HIV, yet insufficient data are available on the pharmacokinetics of newer HIV\u002FTB cotreatment strategies in children. Current WHO-recommended rifampicin dosages result in low concentrations in most children, and high-dose rifampicin may improve outcomes and shorten treatment duration. Yet the impact of high-dose rifampicin on dolutegravir exposures has not been examined in children. This study aims to evaluate the safety and pharmacokinetics of dolutegravir twice daily among HIV\u002FTB coinfected children receiving standard-dose and high-dose rifampicin.",[501,525],"Tuberculosis Infection",[527,528,529],"pharmacokinetic","dolutegravir","rifampicin",{"date":454,"type":34},{"date":532,"type":34},"2023-07-07",{"date":534,"type":23},"2026-12-31",{"name":40,"class":41},{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":24,"phases":545,"briefSummary":546,"conditions":547,"keywords":549,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":42},"100612150","phase-1-ropeginterferon-for-high-risk-jak2-clonal-hematopoiesis-100612150","NCT07249840","Ropeginterferon for High Risk JAK2 Clonal Hematopoiesis","Pilot Study of Ropeginterferon for Patients With JAK2 V617F Clonal Hematopoiesis and High-Risk Features","Inclusion Criteria:\n\n* Adults age 18 years or older\n* Evidence of JAK2 V617F clonal hematopoiesis of indeterminate potential, as defined by a JAK2 V617F mutation detected on quantitative PCR. By definition, these patients do NOT have a diagnosis of an MPN, and must have at least one additional high-risk feature.\n* Have high-risk clinical\u002Flaboratory features, as defined as at least ONE of the following criteria:\n\n  * Patients with a venous or arterial thrombotic event within 1 year prior to or any time after diagnosis of JAK2 clonal hematopoiesis\n  * Patients with elevated laboratory parameters above normal limits at screening, but not meeting criteria for an MPN by WHO 2016 criteria. This would include patients with elevated laboratory parameters but an otherwise normal bone marrow biopsy.\n\n    * White blood cell count \\> 10 K\u002FuL OR\n    * Hemoglobin \\> 16 g\u002FdL in women and \\> 16.5 g\u002FdL in men; OR hematocrit \\>48% for women and \\>49% for men OR\n    * Platelets \\>400 K\u002FuL\n  * Patients with JAK2 VAF \\>20%\n* Willing to have a bone marrow biopsy at study entry to exclude an MPN diagnosis. Screening bone marrow biopsy must not be diagnostic of any overt hematologic malignancy by morphologic assessment and must be consistent with a diagnosis of clonal hematopoiesis as determined by multi-institutional hematopathology review. A historical bone marrow biopsy is allowed if within 3 months of C1D1 and records and pathology can be obtained. In cases where the bone marrow biopsy results are uncertain, study eligibility should be discussed with the PI. All patients will have an erythropoietin level drawn to rule out a PV diagnosis by WHO 2016 criteria.\n* Must have adequate organ function as demonstrated by the following:\n\n  * ALT (SGPT) and AST (SGOT) ≤ 2.5x upper limit of normal (ULN),\n  * Direct bilirubin ≤ 1.5 x ULN\n  * eGFR \\>60 mL\u002Fmin\n  * leukocytes ≥3,000\u002FmcL\n  * absolute neutrophil count ≥1,500\u002FmcL\n  * Platelets ≥100,000\u002FmcL\n* ECOG performance status (PS) ≤ 3\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months of C1D1 are eligible for this trial.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* The effects of ropeginterferon on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men and women of childbearing potential treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of ropeginterferon administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Meeting WHO 2016 criteria for a MPN.\n* Pregnant or lactating.\n* Any active malignancy in the past 2 years prior to C1D1, with the exception of non-melanoma skin cancer, or cervical carcinoma in situ or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis. Any malignancy treated with curative intent and no evidence for active disease in the last 2 years are eligible.\n* Evidence of severe retinopathy or clinically relevant ophthalmologic disorder.\n* Participation in an investigational drug or device trial within 2 weeks prior to C1D1\n* Documented autoimmune disease at screening or in the medical history which is active and serious\n* History of significant and clinically relevant psychiatric illnesses, including prior suicide attempts or risk of suicide on screening\n* History of thyroid dysfunction not adequately controlled\n* History of major organ transplantation\n* History of uncontrolled severe seizure disorder\n* Participants who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ropeginterferon.",{"count":544,"type":23},12,[201],"The goal of this clinical trial is to learn if the drug ropeginterferon alfa-2b can be used safely to treat patients with a JAK2 mutation and high risk features, but do not yet have a myeloproliferative neoplasm. The main questions it aims to answer are:\n\n* Can we enroll 12 patients with JAK2 mutations and high risk features without a myeloproliferative neoplasm on a clinical trial evaluating the drug ropeginterferon?\n* Is ropeginterferon safe to use in these patients?\n\nParticipants will:\n\n* Receive ropeginterferon as an injection under the skin once every 4 weeks\n* Visit the clinic every 1-3 months for checkups and tests",[548],"JAK2 Mutation",[550,551,552,553],"Clonal hematopoiesis","CHIP","JAK2","Myeloproliferative neoplasm","2026-07-27",{"date":556,"type":34},"2026-07-28",{"date":558,"type":34},"2026-07-24",{"date":560,"type":23},"2030-08",{"name":40,"class":41},{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":24,"phases":569,"briefSummary":570,"conditions":571,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":573,"startDateStruct":574,"completionDateStruct":575,"leadSponsor":577,"locationsCount":42},"100526480","a-device-to-prevent-sudden-unexpected-death-in-epilepsy-detecting-peri-ictal-body-position-100526480","NCT06135285","A Device to Prevent Sudden Unexpected Death in Epilepsy: Detecting Peri-Ictal Body Position","Inclusion criteria:\n\n1\\. Adults 18 years of age or older admitted to the BWH EMU with drug-resistant epilepsy, defined by the failure of at least two anti-seizure medications and a documented history of electroclinical seizures\n\nExclusion criteria:\n\n1. Suspicion of functional dissociative seizures (psychogenic nonepileptic seizures)\n2. Patients admitted for medication adjustment only",{"count":131,"type":23},[53],"The goal of this study is to assess the performance of a commercial sheet sensor in determining body position after generalized tonic-clonic (GTC) seizures. If a sheet sensor could accurately detect GTC seizures, this could be a step towards autonomously repositioning patients with the aid of a smart mattress.\n\nPrimary Objective\n\nMilestones:\n\nFeasibility objective: Monitor 50 patients with the objective of capturing at least 20 GTCS events. Primary analytic objective: Achieve detection of anatomical landmarks with body position change within 5 seconds with an accuracy of 75% both interictally and post-GTCS.\n\nSecondary Objective Detect the postictal prone position with an accuracy of 100%.",[572],"Epilepsy",{"date":554,"type":34},{"date":377,"type":23},{"date":576,"type":23},"2027-06",{"name":40,"class":41},{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":585,"targetDuration":4,"studyType":24,"phases":587,"briefSummary":588,"conditions":589,"keywords":592,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":598,"completionDateStruct":599,"leadSponsor":601,"locationsCount":42},"100648678","combination-tonsillectomy-and-hypoglossal-nerve-stimulation-for-osa-patients-with-lateral-pharyngeal-collapse-100648678","NCT07724938","Combination Tonsillectomy and Hypoglossal Nerve Stimulation for OSA Patients With Lateral Pharyngeal Collapse","HGNS+T","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of obstructive sleep apnea with apnea-hypopnea index (AHI) ≥ 15 events\u002Fhour\n* Complete oropharyngeal lateral wall (OPLW) collapse identified on DISE\n* Candidate for HGNS implantation based on standard clinical criteria\n* Presence of small (1-2+) tonsils and eligibility for tonsillectomy\n* Untreated OSA at the time of enrollment\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Absence of tonsils\n* Presence of large tonsils (3-4+; not eligible for HGNS)\n* Predominant central or mixed sleep apnea (\\>25% central or mixed events)\n* Any unstable or serious medical condition that, in the opinion of the investigator, would increase risk or interfere with study participation\n* Ineligibility for HGNS implantation based on standard clinical or surgical criteria\n* Inability to comply with study procedures or follow-up assessments",{"count":586,"type":23},72,[53],"The goal of this clinical trial is to learn whether removing the tonsils at the time of hypoglossal nerve stimulation improves treatment of obstructive sleep apnea in adults whose airway collapses from the side of the upper airway during sleep. The main questions it aims to answer are:\n\n1. Does hypoglossal nerve stimulation combined with tonsillectomy reduce the severity of obstructive sleep apnea more than hypoglossal nerve stimulation alone?\n2. Does tonsillectomy improve how effectively hypoglossal nerve stimulation opens and stabilizes the upper airway?\n\nResearchers will compare participants who receive hypoglossal nerve stimulation with tonsillectomy to participants who receive hypoglossal nerve stimulation alone.\n\nParticipants will:\n\n* Complete sleep studies, questionnaires, and other assessments before and after treatment\n* Be randomly assigned to receive hypoglossal nerve stimulation either with or without tonsillectomy\n* Return for follow-up visits and sleep testing to evaluate treatment effectiveness\n* In a subset of participants, complete additional overnight testing to measure how treatment changes upper-airway collapsibility",[590,591],"Obstructive Sleep Apnea","Sleep Disordered Breathing",[593,594,595],"Obstructive sleep apnea","Hypoglossal nerve stimulation","Tonsillectomy","2026-07-23",{"date":558,"type":34},{"date":281,"type":23},{"date":600,"type":23},"2031-02",{"name":40,"class":41},""]