[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Boston Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":683},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,47,74,103,127,160,187,212,236,263,293,321,345,370,397,416,443,467,496,526,552,579,603,626,654],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100594689","a-universal-primary-care-based-intervention-to-reduce-youth-overdose-risk-100594689",false,"NCT07022717","A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk","A Universal Primary Care Based Pilot Intervention to Reduce Youth Overdose Risk","Inclusion Criteria for providers:\n\n* Physicians and advance practice providers within Pediatric Primary Care and Family Medicine at Boston Medical Center (BMC)\n* ≥ 2 clinic sessions per\u002Fweek\n\nExclusion Criteria for providers:\n\n* None\n\nInclusion criteria for youth:\n\n* Ages 13-26\n* Scheduled for a comprehensive physical exam with a provider who is participating in the trial\n* English speaking\n\nExclusion criteria for youth:\n\n* Caregivers of youth ages 13-17 unable to provide informed consent or are not English speaking\n* Cognitive limitation or intellectual disability that in the opinion of their provider would not\n* Any medical\u002Fpsychiatric condition that causes acute distress and requires emergency evaluation\n* Under legal custody of the Department of Children and Families (DCF)","ALL","13 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"NA","Adolescent (ages 10-19) overdose deaths are the third leading cause of pediatric death and continue to rise in the United States. Healthcare providers have regular and trusted relationships with youth and have experience in providing public health injury prevention counseling. Youth have different motivations for using drugs, and many who experience fatal overdose do not have a history of opioid use. Primary care pediatric providers regularly provide developmentally appropriate injury prevention counseling for leading causes of pediatric fatal and nonfatal injury such as drowning prevention and firearms safety. However, there are no recommended, evidence-based overdose prevention interventions for youth, including in health care settings, even though research supports pediatricians and youth-serving clinicians providing harm reduction strategies such as naloxone distribution and overdose education. Among adults, overdose prevention education reduces overdose, is cost-effective, and can be learned by laypersons. Content commonly includes awareness of fentanyl in the drug supply, risk reduction (e.g., not using alone, risks of polysubstance use), and how to recognize and respond to an overdose, including the use of naloxone.\n\nThis study is a pilot two-arm cluster randomized controlled trial (RCT) of a brief overdose prevention education intervention that will be developed in collaboration with the Community Advisory Board (CAB). The primary outcome of this study is to assess the feasibility and acceptability of the brief youth overdose prevention intervention as measured by provider feasibility and acceptability as well as youth acceptability.",[27],"Overdose",[29,30,31,32,33],"Brief overdose prevention","Naloxone","Youth patients","Health care providers","Primary care","RECRUITING","2026-06-29",{"date":37,"type":38},"2026-06-30","ACTUAL",{"date":40,"type":38},"2025-08-25",{"date":42,"type":21},"2026-09",{"name":44,"class":45},"Boston Medical Center","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":71,"leadSponsor":73,"locationsCount":46},"100600379","boston-medical-center-ultrasound-decongestion-study-in-heart-failure-100600379","NCT07096726","Boston Medical Center Ultrasound Decongestion Study in Heart Failure","Boston Medical Center Ultrasound Decongestion Study","BUDS-HF","Inclusion Criteria:\n\n* Patient with a primary diagnosis of acute on chronic decompensated heart failure who is admitted to inpatient or presents to the outpatient Boston Medical Center (BMC) Heart Failure Infusion clinic for decongestion treatment.\n* Willing and able to receive short abdominal and thoracic ultrasounds throughout hospitalization\n* Patients with right and\u002For left ventricular failure\n\nExclusion Criteria:\n\n* Hemodynamic instability defined as systolic blood pressure \\\u003C85 mmHg or mean arterial pressure \\\u003C60 mm Hg for greater than 24 hours duration\n* Abdominal surgery in the past 1 month\n* Significant acute or chronic liver disease\n* End stage renal disease on dialysis\n* Advanced chronic kidney disease (CKD) \\[Stage V CKD with glomerular filtration rate (GFR) \\\u003C15\\] to exclude renal vein doppler ultrasound\n* Severe acute kidney injury (AKI) or requiring renal replacement therapy\n* Known abdominal thrombus in the inferior vena cava (IVC) or portal vein\n* Acute myocarditis\n* Acute valvular disease\n* Acute type 1 myocardial infarction\n* Medical condition precluding abdominal ultrasound due to significant discomfort or pain\n* Adults not able to provide consent (a simple teach back method of key aspects discussed in consent form will be utilized to verify if patient is able to adequately provide informed consent)","18 Years",{"count":57,"type":21},200,[24],"The purpose of this study is to analyze the utility of a novel five-point ultrasound as a predictor of volume overload in diverse patients who are admitted with volume overload\u002Fcongestive heart failure (CHF) exacerbation at Boston Medical Center (BMC), the largest safety-net hospital in New England. Current standard of care (SOC) involves the utilization of laboratory markers and physical exam, which is often inconsistent and equivocal. The investigators will assess will assess if ultrasound-assisted diuresis reduces recurrent episodes of volume overload\u002Fdecompensated heart failure.",[61,62],"Congestive Heart Failure","Volume Overload",[64,65,66,67],"Venous Excess Ultrasound (VExUS)","Ultrasound-assisted diuresis","Heart Failure with Preserved Ejection Fraction (HFpEF)","Heart Failure with Reduced Ejection Fraction (HFrEF)","NOT_YET_RECRUITING",{"date":37,"type":38},{"date":42,"type":21},{"date":72,"type":21},"2027-12",{"name":44,"class":45},{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":46},"100577496","cervical-preparation-for-same-day-dilation--evacuation-100577496","NCT06799052","Cervical Preparation for Same-Day Dilation & Evacuation","Same-Day Cervical Preparation Prior to Second Trimester Dilation & Evacuation: A Noninferiority Randomized Control Trial Comparing Single-Balloon Catheter and Osmotic Dilators","Inclusion Criteria:\n\n* Between 16 weeks 0 days - 18 weeks 6 days gestational age who are pursuing termination, based on reliable gestational age (defined as ultrasonography performed by a clinical provider, or a certain last menstrual period)\n* Able to provide informed consent\n* English- or Spanish-speaking\n* Singleton intrauterine pregnancy\n\nExclusion Criteria:\n\n* Allergy to betadine, aquacryl hydrogel, latex-free silicone single-balloon catheter, synthetic or natural osmotic dilators\n* Fetal demise or known fetal anomaly\n* BMI \\>45\n* Incarceration or other inability to give informed consent\n* Decide to undergo cervical preparation overnight prior to next-day D\\&E",true,"FEMALE","16 Years",{"count":5,"type":21},[24],"This is a noninferiority randomized control trial of two cervical preparation methods prior to same-day Dilation \\& Evacuation (D\\&E). Cervical preparation is a process that softens and dilates the cervix prior to a procedure.\n\nThe primary objective is to evidence noninferiority of cervical preparation using a single-balloon catheter method when compared to a group receiving osmotic dilators, specifically in D\\&E operative time.\n\nSecondary objectives will compare the two methods for adequate dilation, ability to complete the operation in the same day, participant pain, satisfaction and safety.",[88,89,90],"Abortion, Second Trimester","Procedural Pain","Procedural Complication",[92,93,94,95,96],"Cervical Dilation and Evacuation (D&E)","Transcervical single-balloon catheter","Osmotic dilators","Adequate dilation","Patient satisfaction",{"date":37,"type":38},{"date":99,"type":38},"2025-06-12",{"date":101,"type":21},"2026-12",{"name":44,"class":45},{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":17,"minAge":111,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":124,"leadSponsor":126,"locationsCount":46},"100553098","carbohydrate-fluids-and-post-operative-nausea-and-vomiting-100553098","NCT06481670","Carbohydrate Fluids and Post Operative Nausea and Vomiting","The Effects of Pre-operative Carbohydrate Fluids on PONV Incidence and Intensity in Orthognathic Surgery Patients","PONV","Inclusion Criteria:\n\n* Healthy, American Society of Anesthesiologists (ASA) I-II patients undergoing orthognathic surgery (single jaw, double jaw +\u002F- adjunctive procedures including segmental Le Forts\u002Fgenioplasty\u002Fseptoplasty\u002Fturbinectomy)\n* Operating room (OR) time scheduled prior to 12 pm\n\nExclusion Criteria:\n\n* Non-English speaking\u002Fpoor English comprehension\n* Patient refusal\n* Surgically Assisted Rapid Palatal Expansion (SARPE)\n* Orthognathic surgery patients in addition to adjunctive procedures such as temporomandibular joint (TMJ) replacement, fat grafting, liposuction, or septorhinoplasty\n* General Anesthesia using total IV anesthesia (TIVA)\n* History of gastroesophageal reflux disease (GERD) or patient's with conditions that impair gastrointestinal (GI) motility\n* History of motion sickness or postoperative nausea and vomiting (PONV)\n* Hx of Diabetes Mellitus, endocrine disorders, or allergy to medications of the study\n* Pre-operative scopolamine patch","19 Years",{"count":5,"type":21},[24],"This study is a prospective randomized clinical controlled trial testing the effects of pre-operative \\>50 g pre-operative carbohydrate fluids (apple juice) on a patient's post-operative nausea and vomiting (PONV) incidence and intensity. Optimizing fluid therapy in the peri-operative setting has been proven to improve patient outcomes and reduce complications and length of hospital stay. Based on practice guidelines under the American Society of Anesthesiologists, pre-operative hydration with complex carbohydrate drinks is safe and should be encouraged as it helps with improving metabolism to an anabolic state, decreases insulin resistance, reduces anxiety, and reduces PONV. While pre-operative carbohydrate (CHO) fluids have already been studied and adopted by other surgical specialities (Vascular, General Surgery, Orthopaedics, etc.), this has not yet been studied in oral and maxillofacial surgery, especially at Boston Medical Center (BMC).\n\nDuring surgery, each participant will undergo our current Enhanced Recovery After Surgery \"ERAS\" protocol, which includes general anesthesia using inhalational gas, judicious IV fluids, intra-operative steroid and ondansetron (anti-emetic), use of 0.5% bupivacaine local anesthesia per quadrant at surgery end time, use of a throat pack, and orogastric\u002Fnasogastric (OG\u002FNG) tube suctioning prior to extubation to minimize ingestion of blood. Pain and anxiety medications prior to and during surgery include 2 mg midazolam, fentanyl per anesthesia, toradol, and dexmedetomidine. Having this protocol will help minimize confounding variables that could affect the primary outcome-- incidence and severity of PONV.\n\nThe objectives for this research are:\n\n* To evaluate if pre-operative clear CHO help reduce incidence and intensity of PONV.\n* To assess if pre-operative clear carbohydrate fluids affect length of hospital stay\n* To determine if pre-operative CHO reduce patient's pre-\u002Fpost-operative anxiety\n* To compare the amount\u002Fnumber of opioids and anti-emetics needed post-operatively between the two groups\n* To compare ability for patients to return to PO hydration via the amount of fluid ingestion (mL) vs. if they need IV fluids due to decreased PO intake\u002Finability to tolerate PO fluids\n* To evaluate if patient Apfel score is also a strong indicator for incidence\u002Fseverity of PONV",[116,117],"Nausea, Postoperative","Vomiting, Postoperative",[119,120,121],"Orthognathic surgery","Carbohydrate rich drinks","Enhanced recovery after surgery (ERAS)",{"date":37,"type":38},{"date":42,"type":21},{"date":125,"type":21},"2027-03",{"name":44,"class":45},{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":17,"minAge":135,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":139,"conditions":140,"keywords":145,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},"100550030","simulation-trial-of-telemedical-support-for-paramedics-100550030","NCT06441760","Simulation Trial of Telemedical Support for Paramedics","Efficacy of Teleconsultation to Improve Prehospital Patient Safety for Critically Ill Infants and Children - A Multicenter, Simulation-based Randomized Control Trial","R01","Inclusion Criteria:\n\n* Certified Emergency Medical Technicians (EMTs), Advanced EMTs (AEMTs), and Paramedics (EMT-Ps) who provide direct scene response.\n* Board-certified Pediatric Emergency Medicine (PEM) and Emergency Medicine (EM) physicians whose practice includes online medical support for EMS are eligible.\n* The control arm will include physicians who provide radio\u002Ftelephone support in usual care at each site. In the intervention arm, experts will be PEM with\u002Fwithout EMS board-certification as they have relevant pediatric training and experience.\n\nExclusion Criteria:\n\n* EMS personnel providing interfacility transport and\u002For pediatric specialty transport\n* Resident physicians-in-training\n* Non-physician providers","21 Years",{"count":137,"type":21},420,[24],"In the United States, the current standard of prehospital (i.e. outside of hospitals) emergency care for children with life-threatening illnesses in the community includes remote physician support for paramedics providing life-saving therapy while transporting the child to the hospital. Most prehospital emergency medical services (EMS) agencies use radio-based (audio only) communication between paramedics and physicians to augment this care. However, this communication strategy is inherently limited as the remote physician cannot visualize the patient for accurate assessment and to direct treatment.\n\nThe purpose of this pilot randomized controlled trial (RCT) is to evaluate whether use of a 2-way audiovisual connection with a pediatric emergency medicine expert (intervention = \"telemedical support\") will improve the quality of care provided by paramedics to infant simulator mannequins with life threatening illness (respiratory failure). Paramedics receiving real-time telemedical support by a pediatric expert may provide better care due to decreased cognitive burden, critical action checking, protocol verification, and error correction. Because real pediatric life-threatening illnesses are rare, high stakes events and involve a vulnerable population (children), this RCT will test the effect of the intervention on paramedic performance in simulated cases of pediatric medical emergencies.\n\nThe two specific aims for this research are:\n\n* Aim 1: To test the intervention efficacy by determining if there is a measurable difference in the frequency of serious safety events between study groups\n* Aim 2: To compare two safety event detection methods, medical record review, and video review",[141,142,143,144],"Emergencies","Cardiopulmonary Arrest","Acute Respiratory Failure","Status Epilepticus",[146,147,148,149,150,151,152],"Prehospital emergency care","Emergency medical services (EMS)","Paramedics","Infant simulator mannequins","Telemedical support","Critically ill infants and children","Pediatric emergencies",{"date":37,"type":38},{"date":155,"type":38},"2025-07-10",{"date":157,"type":21},"2028-12",{"name":44,"class":45},9,{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":46},"100524243","integrative-mindfulness-based-predictive-approach-for-chronic-low-back-pain-treatment-100524243","NCT06106191","Integrative Mindfulness-Based Predictive Approach for Chronic Low Back Pain Treatment","IMPACT","Inclusion Criteria:\n\n* Chronic low back pain, which is pain that persists for at least 3-months and has resulted in pain on at least half the days in the past 6 months\n* Willing and able to provide online or telephone informed consent\n* Speak English as the intervention manual is currently written in English\n\nExclusion Criteria:\n\n* Red flags- recent (past month) worsening of pain, unexplained fever, unexplained weight loss\n* Pregnancy\n* Metastatic cancer\n* Not a patient at a participating clinic or persons not planning to continue as a patient at a participating clinic for 6 or more months",{"count":168,"type":21},350,[24],"This study will identify unique signatures that people have which can cause pain by evaluating biological, psychological, and social markers using artificial intelligence. These markers can be used to accurately predict the response of diverse individuals with chronic low back pain (cLBP) to Mindfulness-Based Stress Reduction. This will help enhance clinician decision-making and the targeted treatment of chronic pain.\n\nThe overall objective is to use a unique machine learning (ML) approach to determine the biomarker signature of persons undergoing mindfulness based stress reduction (MBSR) treatment for their chronic low back pain (cLBP). This signature will facilitate clinical prediction and monitoring of patient response to MBSR treatment.\n\nThe design of the study is a single-arm clinical trial of the evidence-based MBSR program for patients with cLBP.",[172],"Chronic Low-back Pain",[174,175,176,177,178,179,180],"Mindfulness based stress reduction (MBSR)","Machine learning (ML)","Biopsychosocial data","PEG (Pain, Enjoyment, General activity)","Pain interference","Pain intensity","Depression",{"date":37,"type":38},{"date":183,"type":38},"2024-07-25",{"date":185,"type":21},"2029-12",{"name":44,"class":45},{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":200,"conditions":201,"keywords":205,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":211,"locationsCount":46},"100326360","early-phase-1-nutrition-in-patient-with-critical-limb-ischemia-100326360","NCT03529019","Nutrition in Patient With Critical Limb Ischemia","Perioperative Nutritional Optimization in Patients With Critical Limb Ischemia","NutriVasc","Inclusion Criteria:\n\n* Critical Limb Ischemia\n\nExclusion Criteria:\n\n* Female patients who are pregnant or lactating\n* Chronic Kidney Disease Stages 4 and 5\n* Patients who are on dialysis","99 Years",{"count":197,"type":21},30,[199],"EARLY_PHASE1","A prospective pilot study examining nutritional supplements among vascular surgery patients with Critical Limb Ischemia (CLI). CLI patients have a high rate of malnutrition and has the potential to benefit greatly from nutritional intervention. The investigators plan to evaluate nutrition and functional status of patients by assessing objective lab values and the use of the hand grip strength test. Providing perioperative nutritional supplements to patients has potentially improved their nutritional status, which in turn may improve the patient's clinical status after surgery.",[202,203,204],"Critical Limb Ischemia","Malnutrition","Nutritional Supplements",[206],"Enhanced Recovery After Surgery Protocol",{"date":37,"type":38},{"date":209,"type":38},"2018-10-02",{"date":42,"type":21},{"name":44,"class":45},{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":222,"conditions":223,"keywords":227,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":235,"locationsCount":46},"100644783","substance-use-prevention-for-recently-displaced-adults---supra-r33-rct-100644783","NCT07672457","Substance Use Prevention for Recently Displaced Adults - SUPRA (R33) RCT","SUPRA RCT R33","Inclusion Criteria:\n\n1. Age 18 or over\n2. Have been displaced at least once due to Anti-Terrorist Operation (ATO) or full-scale invasion since 2014\n3. Self-reported use of at least one substance other than alcohol and tobacco within the past 3 months\n4. Ability to provide informed consent and speak Ukrainian or Russian\n\nExclusion Criteria:\n\n1. Self-reported diagnosis of a substance use disorder\n2. Inability to provide informed consent",{"count":220,"type":21},144,[24],"This study is a randomized controlled trial among 144 internally displaced people to determine the feasibility, acceptability, and preliminary effectiveness of a single-session Acceptance of Commitment Therapy (ACT) group therapy on preventing or reducing substance use behaviors.",[224,225,226],"Prevention","Substance Use","Refugee Health",[228,229,225],"Displacement","Ukraine","2026-06-23",{"date":35,"type":38},{"date":233,"type":21},"2027-04",{"date":157,"type":21},{"name":44,"class":45},{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":245,"conditions":246,"keywords":251,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":262,"locationsCount":46},"100578511","therapy-dog-visits-for-patients-hospitalized-with-traumatic-injuries-100578511","NCT06812247","Therapy Dog Visits for Patients Hospitalized With Traumatic Injuries","Inclusion Criteria:\n\n* Patients admitted to the Trauma and Acute Care Surgery (TACS) service following a trauma\n* English or Spanish speaking\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Fear of dogs, allergy to dogs\n* Immunocompromised\n* Contact precautions\n* Delirious, intubated, or otherwise unable to consent",{"count":243,"type":21},80,[24],"Animal assisted therapy (AAT) with dogs has been shown to be beneficial for a wide range of patients with both acute and chronic illnesses, including spinal cord injuries, heart failure, myocardial infarctions, strokes, cancer, post-traumatic stress disorder, and depression. Studies have also demonstrated that even in healthy adults, the presence of dogs is associated with physiologic changes such as increased pain threshold, decreased blood pressure, and decreased heart rate. However, few studies have investigated the role of AAT in the post-operative course in adults. This study will investigate the impact of therapy dog visits on pain and anxiety scores for trauma patients at Boston Medical Center (BMC).",[247,180,248,249,250],"Trauma Injury","Anxiety","Anger","Pain",[252,253,254,255],"Therapy dogs","Healing pups","Animal assisted therapy (AAT)","Traumatic injuries recovery","2026-06-13",{"date":258,"type":38},"2026-06-16",{"date":260,"type":38},"2025-06-04",{"date":101,"type":21},{"name":44,"class":45},{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":274,"conditions":275,"keywords":277,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":46},"100642889","health-related-social-needs-food-boxes-delivery-program-100642889","NCT07643909","Health-Related Social Needs Food Boxes Delivery Program","Nourishing At Home: Health-Related Social Needs Food Boxes Delivery Program","HRSN","Inclusion Criteria:\n\n* Participant has a child younger than 18 years seen by the Boston Medical Center Pediatrics Department and the child has a qualifying Health condition \\[listed below\\]\n* Screens positive for food insecurity risk (Hunger Vital Sign + 1-Item VLFS) and\u002For has received food support (billing code on the electronic health record for food need using a positive response to the THRIVE question \"Do you need support with food? \\[apply for Supplemental Nutrition Assistance Program (SNAP), Women, Infants and Children (WIC), referral to food pantry\\]\" (ICD-10 Z-59.48)), and\u002For has received a food insecurity resource guide and\u002For has received food emergency (referral to the BMC food pantry within seven days of encounter).\n* Child of participant has a health-related condition such as: a behavioral health need (anxiety, Attention-Deficit\u002FHyperactivity Disorder (ADHD), depression, serious emotional disturbance, serious mental illness, substance use disorder, trauma\u002Fstress disorder), complex physical health condition (autoimmune conditions, developmental disabilities, GI conditions, hematological conditions, metabolic conditions, and neurologic conditions), needs assistance with self-care tasks or more complex tasks, has repeated Emergency Department (ED) use (2 or more times in past 6 months or 4 or more times in the past 12 months).\n* Participant speaks English and\u002For Spanish\n\nExclusion Criteria:\n\n* High-risk adolescent pregnancy\n* Postpartum \\\u003C2 months",{"count":272,"type":21},50,[24],"Nourishing At Home: Health-Related Social Needs Food Boxes Delivery Program is a pilot intervention study evaluating whether home delivery of medically tailored food boxes can reduce food insecurity and improve health outcomes among pediatric families including caregiver physical and mental health, child physical health, and overall family well-being.",[276],"Food Insecurity",[278,279,280,281,282,283,284],"Health-related social needs (HRSNs)","Very low food security","Healthcare utilization","Food home delivery","Food access","Caregiver anxiety","Caregiver depression","2026-06-10",{"date":287,"type":38},"2026-06-12",{"date":289,"type":21},"2026-08",{"date":291,"type":21},"2028-09",{"name":44,"class":45},{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":22,"phases":302,"briefSummary":303,"conditions":304,"keywords":306,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":46},"100564923","improving-mental-health-in-forcibly-displaced-populations-100564923","NCT06635486","Improving Mental Health in Forcibly Displaced Populations","Adaptation of an Open Source Cognitive Behavioral Treatment Protocol Designed to Improve Mental Health in Forcibly Displaced Populations","Inclusion Criteria:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* have Venezuelan nationality\n* have arrived in Lima in years 2014 to the present\n* be 18 years of age or older\n\nIn addition, in order to be eligible to participate in this study, an individual must meet one of the following criteria:\n\n* score 10 points or more at the Patient Health Questionnaire (PHQ-9) or\n* score 10 points or more at the General Anxiety Disorder (GAD-7) or\n* have a history of trauma exposure as listed in the Life Events Checklist (LEC-5) and score 31 points or more in the PTSD Checklist (PCL-5)\n\nExclusion Criteria:\n\nAn individual is excluded from the study if they respond positively to one or more of the following questions during screening:\n\n* Suicidal ideation: \"When someone feels as upset as you do, they may have thoughts that life isn't worth living. What thoughts have you had like this?\"\n* Homicidal ideation: \"When someone feels as upset as you do, they may have thoughts about hurting the person who has upset or hurt them. What thoughts have you had like this?\"\n* Psychosis: \"Do you have a diagnosis of psychosis or schizophrenia?\"",{"count":301,"type":21},90,[24],"This project aims to improve mental health support for Venezuelan migrants living in Lima, Peru, who often face challenges like anxiety, depression, and post-traumatic stress disorder (PTSD). Since 2015, millions of Venezuelans have fled their country due to a severe humanitarian crisis, including extreme inflation, food shortages, and political unrest. Many of these individuals now live in Peru, where they struggle to access mental health services.\n\nA new type of intervention that is both evidence-based and culturally adapted to meet the specific needs of Venezuelan migrants is the focus of this research. The intervention is designed to be delivered by trained lay providers-people from the community who have received special training but are not professional mental health workers. The intervention consists of 6 to 12 weekly online sessions, each lasting about an hour. These sessions will cover various therapeutic techniques, including cognitive restructuring (changing negative thought patterns), behavioral activation (encouraging positive activities), and emotional regulation (managing feelings). The sessions will be conducted remotely, allowing participants to join from the comfort of their homes.This approach is intended to make mental health care more accessible and relatable for migrants, who may feel more comfortable receiving help from someone who understands their cultural background and experiences.",[248,305,180],"Post Traumatic Stress Disorder",[307,308,309,310,311,312],"Venezuelan migrants","Cognitive behavioral intervention (CBT)","Culturally adapted","Lay providers","Feasibility","Acceptability","2026-05-27",{"date":315,"type":38},"2026-05-28",{"date":317,"type":38},"2025-04-15",{"date":319,"type":21},"2027-06",{"name":44,"class":45},{"id":322,"slug":4,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":81,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":328,"phases":4,"briefSummary":329,"conditions":330,"keywords":333,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":46},"100565223","NCT06639386","Vaccine Confidence Study Among Historically Marginalized Racial and Ethnic Groups","Examining Underlying Factors and Root Cause of Successful Evidence Based Interventions (EBIs) Among Historically Marginalized Racial and Ethnic Groups Using the Consolidated Framework for Implementation Research (CFIR)","Inclusion Criteria:\n\nParent and child-\n\n* The birthing parent of any age of a child (aged 12-24 months) who receives primary care at Boston Medical Center\n* A birthing parent who is registered as a patient at Boston Medical Center\n* The birthing parent must have been pregnant between the months of October and February (RSV season)\n* The birthing parent must be comfortable completing an interview in English, Spanish, or Haitian Creole.\n\nClinician\n\n* Clinical provider (including Community Health Workers, Physicians, Physician Assistants and Nurse Practitioners) aged 18+ years at Boston Medical Center within Pediatrics, Family Medicine, or OB\u002FGYN. These clinicians will have been involved in past or current successful vaccine-specific Evidence Based Interventions (EBI) beyond BMC and its affiliated Community Health Center (CHC).\n\nEBI Expert\n\n* Content experts (aged 18+ years) in the areas of Implementation Science, Vaccine-specific EBIs, and Prenatal genetic counseling\n\nExclusion Criteria:\n\n* Clinical provider (including Community Health Workers, Physicians, Physician Assistants and Nurse Practitioners) at NON-BMC clinic\u002FCommunity Health Center\n* Content experts - NON-Vaccine evidence based interventions (EBIs)",{"count":243,"type":21},"OBSERVATIONAL","Achieving optimal vaccination rates is vital for protecting the health and well-being of all individuals. This specific study focuses on the MMR and RSV vaccines in pregnancy and early childhood, which have been shown to reduce RSV and MMR-related illnesses, hospitalizations, and deaths. Efforts to improve vaccination rates have not been equally effective across the entire population; this has resulted in poorer outcomes from interventions for certain populations who are vaccine-hesitant.\n\nThis study seeks to understand how to best increase vaccine confidence in marginalized populations. To do this, the investigators will interview parents of children who receive care at Boston Medical Center (BMC), Community Health Workers and other Clinical providers at BMC, leading experts in the fields of vaccine confidence and implementation science, and key public health stakeholders\u002Fofficials.",[331,332],"Vaccine Hesitancy","Vaccine Refusal",[334,335,336,337],"Vaccine confidence","Marginalized populations","MMR vaccine","RSV vaccine","2026-05-25",{"date":313,"type":38},{"date":341,"type":38},"2025-01-31",{"date":343,"type":21},"2026-07",{"name":44,"class":45},{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":17,"minAge":352,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":22,"phases":355,"briefSummary":356,"conditions":357,"keywords":359,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":368,"leadSponsor":369,"locationsCount":46},"100570864","behavior-analytic-support-of-needle-related-hospital-visits-for-autistic-patients-100570864","NCT06712784","Behavior Analytic Support of Needle-related Hospital Visits for Autistic Patients","Supporting Patients With Autism Spectrum Disorder (ASD) During Needle-related Hospital Visits Through the Use of Behavior Analytic Strategies","Inclusion Criteria:\n\n* Caregivers of autistic patients who have been historically engaged in challenging behaviors during needle-related procedures at a Boston Medical Center (BMC)\n* Established BMC autistic patients (ages 3+) who have a history of engaging in challenging behaviors in the presence of needle-related medical stimuli.\n* BMC Medical Providers (i.e., phlebotomists, medical doctors, registered nurses, certified nursing assistants, registered dieticians, and medical assistants) who either: 1) order needle-related medical procedures for participants to be conducted during procedure visits and\u002For 2) are present to conduct the ordered procedure\n* English speaking participants\n\nExclusion Criteria:\n\n* Patients who are unable to visit BMC a minimum of 2 times per month\n* No history of challenging behaviors in medical appointments involving the presentation of needle(s)\n* Patients and caregivers who do not speak English or are unable to utilize interpreter services to complete assessments and surveys","3 Years",{"count":354,"type":21},10,[24],"The purpose of this study is to evaluate the effectiveness of the behavior analytic intervention in reducing the number of challenging behaviors exhibited by patients with Autism Spectrum Disorder (ASD) while increasing compliance with needle-related simulations and procedures. A second purpose is to assess the social validity of this study as evidenced by patient and\u002For caregiver acceptability. The study wil take place at Boston Medical Center (BMC).\n\nA Single Subject Design (SSD) wil be utilized as it allows for detailed, individualized assessment of how interventions affect behavior over time in this type of behavior analytic research. By focusing on each participant as an individual and having each participant act as their own control, it demonstrates clear cause-and-effect relationships, showing how behavior changes with the introduction or withdrawal of an intervention. This method is flexible, enabling ongoing adjustments to treatments based on real-time data, making it particularly useful in personalized interventions and ensuring effectiveness for patients with unique needs such as those who would be eligible to enroll and participate in this study.",[358],"Autism Spectrum Disorder",[360,361,362,363],"Behavior analytic research","Needle-related healthcare visits","Simulation visits","Differential reinforcement of alternative behavior (DRA)","2026-05-02",{"date":366,"type":38},"2026-05-05",{"date":343,"type":21},{"date":125,"type":21},{"name":44,"class":45},{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":22,"phases":379,"briefSummary":380,"conditions":381,"keywords":383,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":394,"leadSponsor":396,"locationsCount":46},"100606301","cardiac-anodal-biphasic-pacing-100606301","NCT07173777","Cardiac Anodal Biphasic Pacing","ABP","Inclusion Criteria:\n\nCohort A\n\n• Planned interventional cardiac procedure\n\nCohort B\n\n* Planned generator exchange of dual chamber cardiac implantable electronic device (CIED)\n* Functioning atrial lead\n\nCohort C\n\n* Planned de novo implant or generator exchange of CIED with cardiac resynchronization therapy\n* Functioning atrial lead\n\nExclusion Criteria:\n\n* Permanent atrial fibrillation\n* Third degree AV block without stable escape rhythm\n* Ischemic heart disease or coronary disease \\> 40%\n* Unable to receive heparin\n* Are not fluent in English\n* Unable to read in English\n* Not able to provide informed consent\n* Women who are pregnant",{"count":378,"type":21},108,[24],"The goal of this study is to test a new pacing method called anodal biphasic pacing (ABP) to determine if this pacing works as well-or better-than current pacing methods. This new method may improve how the heart works and reduce some of the problems caused by regular pacing.\n\nCurrent implantable pacemakers use a monophasic cathodal waveform to stimulate the heart. Monophasic cathodal pacing (MCP) waveforms slow conduction, impair contractility, cause inflammation, increase risk of atrial fibrillation, heart failure, and mortality. Anodal biphasic pacing (ABP) is an alternative waveform that can stimulate the heart. ABP preconditions the heart and then initiates cardiac contraction. ABP may address the limitations of MCP.",[382],"Cardiac Pacing",[384,385,386,387,388,389],"Anodal biphasic pacing (ABP)","Monophasic cathodal pacing (MCP)","Ejection fraction","Cardiac implantable electronic device","Cardiac contractility modulation","Implantable cardiac defibrillator","2026-04-27",{"date":392,"type":38},"2026-04-28",{"date":343,"type":21},{"date":395,"type":21},"2027-07",{"name":44,"class":45},{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":404,"briefSummary":405,"conditions":406,"keywords":409,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":414,"leadSponsor":415,"locationsCount":46},"100578056","glaucoma-drop-aids-part-2-100578056","NCT06806332","Glaucoma Drop Aids Part 2","Inclusion Criteria:\n\n* Currently on the same topical ophthalmic medications for treatment of glaucoma for a minimum of two months\n* Patient of Boston University Eye Associates\n\nExclusion Criteria:\n\n* Changed glaucoma medications within the past 2 months",{"count":243,"type":21},[24],"Glaucoma medications are vital to disease management and prevention of further loss of vision as over time glaucoma will lead to irreversible blindness. The average size of a glaucoma medication bottle is around 10cc and these medications when used 2-3 times daily are expected to last patients an entire month. The investigators found that at Boston Medical Center (BMC) a majority of Yawkey Eye Clinic patients are unable to deliver the drops into their eyes due to poor vision or difficulty squeezing drop bottles. These patients also often deliver more than a necessary amount leading to premature completion of the bottle. However, because the cost benefit ratio of these drop aids is unclear, they are not routinely offered to the patients. Although the efficacy of these drop aids has not been well studied, if effective, the cost of these drop aids would more than pay themselves by improving medication compliance and visual function of the patients. This study aims to determine the efficacy of the Nanodropper in the BMC Yawkey Eye Clinic patient population.",[407,408],"Glaucoma","Intraocular Pressure",[410,411],"Eye drop aid","Nanodropper",{"date":392,"type":38},{"date":343,"type":21},{"date":319,"type":21},{"name":44,"class":45},{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":81,"sex":17,"minAge":55,"maxAge":423,"enrollmentInfo":424,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":427,"conditions":428,"keywords":430,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":442,"locationsCount":46},"100585562","phase-4-botox-into-the-sternocleidomastoid-muscles-scm-100585562","NCT06903975","BoTox Into the Sternocleidomastoid Muscles (SCM)","The Effect of Injection of prabotulinumtoxinA-xvfs (Jeuveau) Into the Bilateral Sternocleidomastoid Muscles on Neck Circumference and Aesthetics","Inclusion Criteria:\n\n* Age eligible individual seeking a more feminine neck appearance\n\nExclusion Criteria:\n\n* Prior neuromodulator injections in the sternocleidomastoid muscles (SCM) within the past year\n* Current anticoagulant use\n* Body mass index (BMI) \\>30\n* Anticipation of significant weight gain or loss during the study period (e.g. patients taking or planning to take within the study period a semaglutide medication.)\n* Prior allergy to botulinum toxin A\n* Currently pregnant or breastfeeding","65 Years",{"count":197,"type":21},[426],"PHASE4","Botulinum toxin injections have been used both in the face and neck for many years. However, injection into the sternocleidomastoid muscle (SCM) has only been done to treat neck spasms. In this study botulinum toxin will be injected into the SCM to determine if this will result in a temporary slimming effect on the neck and produce a more feminine, youthful neck contour.",[429],"Neck Muscle Issue",[431,432,433,434,435],"Neck circumference","Neck aesthetics","Sternocleidomastoid muscles (SCM)","Botulinum injection","PrabotulinumtoxinA-xvfs injection","2026-04-14",{"date":438,"type":38},"2026-04-17",{"date":440,"type":38},"2025-05-14",{"date":289,"type":21},{"name":44,"class":45},{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":17,"minAge":450,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":22,"phases":452,"briefSummary":453,"conditions":454,"keywords":456,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":466,"locationsCount":46},"100603548","delirium-in-neurodegenerative-disease-patients-a-music-therapy-intervention-for-hospital-care-100603548","NCT07137949","Delirium in Neurodegenerative Disease Patients: A Music Therapy Intervention for Hospital Care","DyNamic","Inclusion Criteria:\n\n* Admitted as inpatient to Boston Medical Center.\n* Cognitive impairment or neurodegenerative diseases as defined by either:\n\n  * Diagnosis of Parkinson's Disease, Dementia with Lewy Bodies (ICD-10 G20 and G31.83 respectively), Alzheimer's Disease-related dementias (ICD-10 6D80), vascular dementia (F01), or other cognitive impairment (R41) on active problem list or past medical history\n  * \"Cognitive impairment\" on active problem list or past medical history\n  * Documentation elsewhere in the electronic medical record (e.g. notes) of any of these conditions\n* Participants with cognitive impairment will be included. If unable to consent, legally authorized representative (LAR) based on HRP-013-SOP-LARs, Children, and Guardians will be contacted to consent.\n* Spanish speaking participants will be included. Screening and informed consent procedures will be conducted using a certified medical interpreter. All intervention sessions and study team interactions will be conducted using these interpreter services.\n* Patients admitted to an intensive care unit will be included as long as they are not receiving continuous intravenous sedative medications. Potential participants in the intensive care unit setting will be discussed with a PI\u002Fco-I to ensure participation is appropriate on a case-by-case basis. The PI\u002FCo-I will confirm with the treating physician that there are no reasons as to why the potential participant should not be enrolled in the study.\n\nExclusion Criteria:\n\n* Admitted to observation status (as these patients would not be expected to remain inpatient long enough to undergo the MT intervention)\n* Patients who will be discharged within 24 hours of eligibility based on discussion with primary admitting team\n* Self-reported history of musicogenic seizures\n* Hearing loss: unable to hear a recorded sound \\\u003C70 decibels (dB)\n* Dislike of music: Barcelona Music Reward Questionnaire score of \\\u003C40\n* Patients who are currently prisoners\n* Patients in the intensive care unit receiving continuous intravenous sedative medication\n* Pregnant women","60 Years",{"count":197,"type":21},[24],"In this pilot study a new kind of music therapy will be created and tested to help prevent confusion, called delirium, that can happen in the hospital. This can affect people with brain diseases like Alzheimer's disease and Parkinson's disease.\n\nEach of the anticipated 30 participants will have up to five music therapy sessions. The sessions will be made just for them and may include live music, playing instruments, or listening to recorded music. Surveys will be used to learn how easy the therapy is to do in the hospital and what people think about how helpful the sessions may be for future patients.",[455],"Delirium",[457,458,459],"Music therapy","Hospital acquired delirium","Neurodegenerative disease patients","2026-03-31",{"date":462,"type":38},"2026-04-01",{"date":464,"type":38},"2026-03-11",{"date":101,"type":21},{"name":44,"class":45},{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":471,"acronym":472,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":22,"phases":476,"briefSummary":477,"conditions":478,"keywords":480,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":495},"100498358","prep-and-moud-rapid-access-for-persons-who-inject-drugs-the-chorus-study-100498358","NCT05769218","PrEP and MOUD Rapid Access for Persons Who Inject Drugs: The CHORUS+ Study","CHORUS+","Inclusion Criteria:\n\n* Injected opioids within the past 6 months (by self-report)\n* Willingness to provide contact information for two family members or friends\n* Willingness to sign medical records release forms\n* Ability to speak English\n* Plans to reside in Boston area for the next 6 months\n* Are medically cleared to take PrEP and MOUD (normal renal and PrEP-related labs)\n\nExclusion Criteria:\n\n* Persons with previous HIV diagnosis (by self-report; confirmed via HIV test result)\n* Express desire to harm themselves or others\n* Individuals who are pregnant at baseline\n* Individuals who are already enrolled in an interventional study",{"count":475,"type":21},284,[24],"The US opioid overdose epidemic has been accompanied by an increase in human immunodeficiency (HIV) among persons who inject drugs. HIV pre-exposure prophylaxis (PrEP) is an FDA approved medication taken daily orally by individuals who are HIV negative, but who are at increased risk for HIV. In order to obtain PrEP, a prescription is needed. Before being prescribed HIV PrEP, it is recommended by the Centers for Disease Control and Prevention (CDC) to obtain an HIV test first. Although home HIV self-test kits are recommended by the CDC and are locally available, uptake remains low.\n\nCHORUS+ (Comprehensive HIV, Hepatitis C, and Opioid Use Disorder Response to the Unaddressed Syndemic +) is a theory-based, peer-delivered, mobile phone-supported intervention focused on enhancing uptake and adherence to HIV PrEP (primary outcome), and continuation of MOUD (secondary outcome) among persons who inject opioids. At recruitment, the intervention will include HIV self-testing, rapid initiation of PrEP and MOUD, and 6-month peer recovery coaching (PRC) to support adherence to these medications. This research study seeks to determine the efficacy of a novel intervention to increase the uptake of evidence-based measures to prevent HIV and treat opioid use disorder.\n\nThe efficacy of this multi-site, two-arm randomized control trial of CHORUS+ and usual care \\[passive referral\\]. This study is not testing the efficacy of PrEP or HIV home testing which is already known. In addition the investigators will determine the influence of HIV self-testing on PrEP uptake and adherence. In the CHORUS+\u002F intervention arm, there will be a baseline in-person session with the participant to encourage uptake of PrEP and MOUD using motivational interviewing (MI).",[479],"Opioid Use Disorder",[481,482,483,484,485,486,487],"Medication for opioid use disorder","Human immunodeficiency (HIV)","Pre-exposure prophylaxis (PrEP)","Peer recovery coaching (PRC)","Motivational interviewing (MI)","HIV self testing","People who inject opioids (PWIO)",{"date":489,"type":38},"2026-04-06",{"date":491,"type":38},"2024-12-19",{"date":493,"type":21},"2028-06-30",{"name":44,"class":45},2,{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":502,"enrollmentInfo":503,"targetDuration":4,"studyType":22,"phases":505,"briefSummary":506,"conditions":507,"keywords":510,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":525,"locationsCount":495},"100534267","hybrid-closed-loop-effectiveness-trial-in-adults-with-type-1-diabetes-100534267","NCT06236607","Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes","Inclusion Criteria:\n\n* Clinical diagnosis of T1D for at least 12 months, on MDI for at least 6 months;\n* A1c ≥7.0% with no upper limit at screening (The investigator will consider the participant A1c level, compliance with current diabetes management, and prior acute diabetic complications. For this reason, there is no upper limit on A1c specified for eligibility);\n* Able to understand, speak and read English (Given the language limitations in currently available pump interfaces, subjects who are not able to understand written English will not be eligible);\n* Willingness to use either lispro or aspart insulin and no other insulin or new non-insulin diabetes pharmacotherapy during the study;\n* Total daily dose of insulin of at least 10 units\u002Fday;\n* Investigator believes that the participant will be able to successfully adhere to the study protocol.\n\nExclusion Criteria:\n\n* Current use of insulin pump or closed loop insulin pump system;\n* Unable to provide informed consent;\n* Currently taking hydroxyurea or have medical condition that may necessitate use of hydroxyurea;\n* Current use of SGLT-2 inhibitors or sulfonylureas (If using GLP-1RA, pramlintide or metformin, must be on a stable dose for 3 months prior to enrollment);\n* Tape allergy or skin condition precluding use of pump or CGM;\n* Females who are pregnant or intending to become pregnant (since automated algorithm adaption for some of the HCL systems used in the trial cannot be configured to adjust to changing insulin demands of pregnancy);\n* Current renal dialysis or plan to begin renal dialysis during study. Most recent eGFR \\\u003C30 ml\u002Fmin is exclusionary (within last 2 years is acceptable);\n* Active cancer treatment;\n* Extreme visual or hearing impairment that would impair ability to use CGM and pump;\n* Cognitive concerns;\n* Significant psychiatric diagnosis or substance abuse disorder that in the investigator's opinion impairs ability of the individual to participate.","75 Years",{"count":504,"type":21},140,[24],"Minoritized individuals with type 1 diabetes (T1D) have approximately 2% higher average A1c levels and twice the rate of hospitalizations, complications, and mortality as their white counterparts. However, the efficacy trials establishing the benefits of hybrid closed loop (HCL) pump therapy in T1D have been in more socially advantaged and predominantly non-Hispanic white patients. Use of this technology by individuals with T1D from underserved communities remains very low.\n\nThe investigators plan to conduct a randomized effectiveness trial - with broader eligibility criteria (including markedly elevated A1c) and longer follow up than the previous HCL efficacy trials - to evaluate the benefits, safety risks and treatment complications of HCL use in underserved adults with T1D. A comprehensive mixed-methods approach will be implemented to capture information about the user experience.\n\nParticipants will be randomized (3:1 ratio) to one of three FDA-approved HCL systems or continuous glucose monitoring and multiple daily injection therapy. Subjects will be followed for 9 months to collect data on effectiveness (glucose % time-in-range 70-180 mg\u002FdL and % time \\\u003C 70 mg\u002FdL), safety (diabetic ketoacidosis and severe hypoglycemia events) and patient experience using the systems (including benefits and burdens, the impact of life stressors on HCL use, and how the match between HCL system functionality and the individual's needs and expectations impacts on user experience).",[508,509],"Diabetes Mellitus, Type 1","Diabetes Complications",[511,512,513,514,515,516,517,518,519],"Hybrid closed loop (HCL)","HCL pump therapy","Multiple daily injections (MDI)","Continuous glucose monitoring (CGM)","Glucose time-in-range (TIR)","Glucose management indicator (GMI)","Diabetic ketoacidosis","Patient reported outcomes (PRO)","Ecological momentary assessment (EMA)","2026-03-30",{"date":462,"type":38},{"date":523,"type":38},"2025-02-27",{"date":291,"type":21},{"name":44,"class":45},{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":532,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":22,"phases":536,"briefSummary":537,"conditions":538,"keywords":539,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":549,"leadSponsor":551,"locationsCount":46},"100588909","stepped-care-for-posttraumatic-stress-disorder-study-100588909","NCT06947538","Stepped Care for Posttraumatic Stress Disorder Study","Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Access, Engagement, and Effectiveness in Routine Care","STEPPS","Inclusion criteria:\n\nAssessed at pre-screening\n\n* Boston Medical Center primary care patient\n* At least 18 years of age\n* Access to computer or mobile device\n* Able to receive treatments in English or Spanish\n* Able to read at 4th grade level\n\nAssessed at baseline\n\n* Endorsement of Criterion A trauma using the Life Events Checklist for the DSM-5 (LEC-5), assessed at baseline\n* PTSD diagnosis, confirmed by the Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) assessed at baseline\n* Clinically appropriate for outpatient level of care\n* Stable on psychotropic medication for \\>4 weeks\n\nExclusion criteria:\n\nAssessed at pre-screening\n\n• Patient is currently engaged in clinician-administered therapy\n\nAssessed at baseline (clinician interview)\n\n* Patient is not clinically appropriate for outpatient level of care.\n* Acute risk for suicidal thoughts or behaviors, assessed by the Columbia Suicide Severity Rating Scale, administered by research clinician at baseline.",{"count":535,"type":21},428,[24],"Less than 20% of people with PTSD receive any treatment. This study extends a program of research by the investigator focused on developing adaptive (stepped) interventions for PTSD. The adaptive intervention sequences a digital mental health intervention (DMHI) and brief trauma- and skills-focused treatments for PTSD. The selected treatments are brief and scalable and less burdensome to systems of care. These treatments are: web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), Brief STAIR, and Written Exposure Therapy (WET).",[305],[540,541,542,543,544],"Stepped Care","Skills training in affective & interpersonal regulation (STAIR)","Digital Mental Health Intervention","Written Exposure Therapy (WET)","Adaptive Interventions","2026-03-12",{"date":547,"type":38},"2026-03-13",{"date":545,"type":38},{"date":550,"type":21},"2029-06",{"name":44,"class":45},{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":328,"phases":4,"briefSummary":561,"conditions":562,"keywords":565,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":578,"locationsCount":46},"100565227","sensory-outcomes-in-active-substance-users-100565227","NCT06639438","Sensory Outcomes in Active Substance Users","Molecular and Behavioral Characterization of Post-Operative Sensory Outcomes in Individuals With Chronic Pain or Persistent Opioid Use","Inclusion Criteria:\n\nOpioid user cohorts:\n\n* Individuals with current OUD as defined by The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)\n* Individuals requiring ≥20 mg of MME\u002Fday medication to manage a chronic pain problem.\n* Patients scheduled to undergo elective surgery\n* Able to provide informed consent\n\nControl Group Cohorts:\n\n* Individuals who are not taking high dose opioids (≤20 MME\u002Fday) nor illicit substances and have no history of opioid use disorder\n* Individuals with reported chronic pain not yet taking medication for their pain\n* Patients scheduled to undergo elective surgery\n* Able to provide informed consent\n\nExclusion Criteria:\n\nSubstance User Cohort:\n\n* Patients with contraindications for elective surgery\n* Individuals with no history of opioid use\n\nControl Group Cohort:\n\n* Individuals with a history of opioid use \\>20 MME\u002Fday or illicit substance use\n* Patients with contraindications for elective surgery.",{"count":560,"type":21},40,"The incidence and severity of postoperative pain after spine surgery are notably high, often requiring intensive management and potentially affecting the patient's recovery, satisfaction, and long-term outcomes. Post-operative pain is particularly difficult to manage in patients with substance use disorder likely due to a combination of withdrawal symptoms and molecular changes in the pain matrix. Opiates are the leading cause of overdose related fatalities, and carry a significant burden of substance related morbidity and mortality. As over 80% of patients undergoing low-risk surgery receive opioid prescriptions, the investigators aim to identify unique molecular characteristics of pain within current and previous opioid users, which have been understudied in this context. This study also seeks to understand the molecular mechanisms underlying worsened postoperative pain in patients with opioid use disorder (OUD).\n\nFlow cytometry analysis of human serum will be done, which will assess circulating immune cells that can contribute to exacerbated surgery site inflammation. Spatial profiling of gene expression will be done in the dermis using Visium slide sequencing, focusing on the interplay between nerve endings, resident immune cells, and supporting dermal cells, all of which collectively contribute to the sensation pain. Both the visual pain rating scale and McGill Pain Questionnaire will be used to comprehensively quantify pain outcomes during the participant's postoperative recovery stay after surgery in an effort to better understand postoperative pain management with biomarkers of worsened postoperative pain.",[563,564],"Post Operative Pain","Opioid Use, Unspecified",[566,567,568,569,570,571],"Opioid use disorder (OUD)","Gene expression","Visium slide sequencing","Inflammatory profile","Sensation pain","Flow cytometry","2026-02-06",{"date":574,"type":38},"2026-02-10",{"date":576,"type":38},"2025-02-02",{"date":101,"type":21},{"name":44,"class":45},{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":585,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":22,"phases":589,"briefSummary":590,"conditions":591,"keywords":593,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":601,"leadSponsor":602,"locationsCount":46},"100595466","adapted-hospital-discharge-intervention-the-connect-pilot-100595466","NCT07032818","Adapted Hospital Discharge Intervention: the CONNECT Pilot","Communication Outreach for Navigation and Needs-based Care Transitions (CONNECT): A Pilot Randomized Controlled Trial","CONNECT","Inclusion Criteria:\n\n* Registered language in Epic (written or spoken) is Spanish, Haitian Creole, Portuguese, Cape Verdean, or Vietnamese\n* Admitted to medicine team at Boston Medical Center (BMC)\n* Being discharged home (to the community)\n\nExclusion Criteria:\n\n* On airborne infections precautions at time of recruitment\n* On C diff precautions at time of recruitment\n* On suicide precautions at time of recruitment\n* Nurse report of participant displaying cognitive impairment, ongoing delirium, or aggression\n* Discharge observed during a prior admission",{"count":588,"type":21},60,[24],"Hospital discharge is a dangerous time for patients: one in five will suffer an adverse event, such as a medication error, and nearly 25% will be readmitted within 30 days. This time is even more dangerous for patients with who face communication barriers, including those with non-English language preference (NELP), low health literacy, and the elderly.\n\nThe investigators will pilot a post-discharge educational intervention to reinforce written discharge instructions (known as the After Visit Summary or AVS) using a randomized controlled trial design (2:1 intervention: control). The control group will receive current standard of care discharge education which includes a nurse reviewing their AVS and an automated call in English that allows patients to numerically select types of problems\u002Fquestions that are then escalated to a nurse who should return their call within a few days. The intervention group will receive the standard of care discharge education with the AVS and an additional post-discharge educational call delivered by a registered nurse or other qualified health professional with the option to have written instructions professionally translated and sent via MyChart message--if available in their preferred language.",[592],"Communication Research",[594,595,596],"Discharge instructions","Non-English language preference","Adapting hospital discharge","2026-01-16",{"date":599,"type":38},"2026-01-20",{"date":597,"type":38},{"date":125,"type":21},{"name":44,"class":45},{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":609,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":22,"phases":613,"briefSummary":614,"conditions":615,"keywords":617,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":623,"completionDateStruct":624,"leadSponsor":625,"locationsCount":46},"100596282","improving-diabetes-care-with-strategies-for-addressing-health-related-social-needs-and-community-partnerships-100596282","NCT07043426","Improving Diabetes Care With Strategies For Addressing Health-Related Social Needs and Community Partnerships","THRIVE-DM: Improving Diabetes Care With Strategies For Addressing Health-Related Social Needs and Community Partnerships","THRIVE-DM","Inclusion Criteria:\n\n* Diagnosis: Must have a diagnosis of Type 2 Diabetes Mellitus (T2DM), confirmed by a current diagnosis in the medical record or at least two billing codes in the last two years, or an HbA1c level ≥6.5% in the last two years.\n* Uncontrolled T2DM: Must have an HbA1c ≥9% at the time of screening.\n* Health-Related Social Needs: Must have been screened for health related social needs (HRSNs) during a General Internal Medicine (GIM) visit in the last 3 months and screened positive for at least one HRSN.\n\nExclusion Criteria:\n\n* Patients enrolled in Complex Care Management (CCM).\n* Patients receiving hospice care.\n* Patients who are deceased\n* Patients with Type 1 Diabetes Mellitus (T1DM).",{"count":612,"type":21},900,[24],"The goal of this study is to develop, implement, and evaluate a patient-centered triage and referral model designed to improve health outcomes for individuals with uncontrolled type 2 diabetes mellitus (T2DM) and unmet health-related social needs. The intervention builds on the existing THRIVE infrastructure at Boston Medical Center (BMC), which includes screening for social needs and a resource referral guide. It integrates medical and social care by embedding a data-driven triage tool within the EPIC electronic health record system, engaging community health workers trained in population health, and initiating closed-loop EPIC integrated referrals to community-based organizations.\n\nThis study will use a hybrid type 3 effectiveness-implementation trial design to evaluate the implementation of the THRIVE-DM intervention at the clinic level. Preliminary effectiveness will be assessed by comparing THRIVE-DM to usual care in its ability to increase patient connections to community-based organizations and improve clinical outcomes. Using a stratified randomization approach, the investigators will compare referral closure rates, receipt of social services, hemoglobin A1C levels, and patterns of health service utilization between patients enrolled in THRIVE-DM and those receiving standard care",[616],"Diabetes Mellitus, Type 2",[609,618,619],"Community-based organizations","Triage","2025-12-26",{"date":622,"type":38},"2025-12-30",{"date":620,"type":38},{"date":233,"type":21},{"name":44,"class":45},{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":632,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":634,"enrollmentInfo":635,"targetDuration":637,"studyType":328,"phases":4,"briefSummary":638,"conditions":639,"keywords":641,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":653},"100305812","neuroprognostication-bias-a-collaboration-to-reduce-the-impact-of-self-fulfilling-prophecy-in-cardiac-arrest-100305812","NCT03261089","Neuroprognostication Bias: A Collaboration to Reduce the Impact of Self-fulfilling Prophecy in Cardiac ARrEst","Addressing an Inherent Bias in Neuroprognostication: A Collaboration to Reduce the Impact of Self-fulfilling Prophecy in Cardiac ARrEst","SPARE","Inclusion Criteria:\n\n* Initially unconscious following cardiac arrest from any non-perfusing rhythm (i.e., ventricular tachycardia, ventricular fibrillation, pulseless electrical activity, asystole)\n* Sustained return of spontaneous circulation (ROSC) as defined by maintained spontaneous circulation for at least 20 minutes after cardiopulmonary resuscitation.\n\nExclusion Criteria:\n\n\\- Isolated respiratory arrest without concomitant or ensuing cardiac arrest","89 Years",{"count":636,"type":21},600,"5 Years","Cardiovascular disease remains the leading cause of death in the United States. Mortality rates of cardiac arrest range from 60-85%, and approximately 80% of survivors are initially comatose. Of those who survive, 50% are left with a permanent neurological disability, and only 10% are able to resume their former lifestyle. Early prognosis of comatose patients after cardiac arrest is critical for management of these patients, yet predicting outcome for these patients remains quite challenging.\n\nThe primary study objective of SPARE is to assess the value of using a systematic, multi-modal approach for neuroprognostication in the unconscious post-cardiac arrest population. We hypothesize that prognostication using this approach will be significantly improved compared to historical controls. This approach will be novel because:\n\nAll patients who are unconscious at least 24 hours post-cardiac arrest, whereas previous studies on neurologic outcome tended to have restrictive inclusion criteria, such as no pre-existing neurologic impairment (e.g. dementia or prior cerebrovascular injury), or included an unduly restrictive population, such as patients with a strictly comatose state.\n\nThe prognostic modalities used to assess patients will be applied at specific time points that will maximize their utility.\n\nPatients' families and clinicians will be encouraged to provide adequate time to allow for a delayed recovery, especially in cases of uncertain outcome, thus minimizing the self-fulfilling prophesy bias of early withdrawal of life-sustaining therapies (WLST). This will be particularly pertinent in the comparison of US and Brazil\u002FItaly patients, as the Brazilian and Italian populations are not commonly exposed to premature WLST (as can be the case in the US), one of the major sources of biases in prognostication studies of cardiac arrest due to the self-fulfilling prophecy.",[640],"Cardiac Arrest",[642,643,644],"cardiac arrest","neuroprognostication","coma","2025-12-22",{"date":647,"type":38},"2025-12-24",{"date":649,"type":38},"2017-08-02",{"date":651,"type":21},"2027-08",{"name":44,"class":45},8,{"id":655,"slug":656,"hasResults":12,"nctId":657,"briefTitle":658,"officialTitle":659,"acronym":660,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":662,"enrollmentInfo":663,"targetDuration":4,"studyType":22,"phases":664,"briefSummary":665,"conditions":666,"keywords":668,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":682,"locationsCount":46},"100393201","intravascular-ultrasound-in-patients-with-end-stage-renal-disease-on-dialysis-100393201","NCT04399941","Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis","Role of Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis","IVUS in ESRD","Inclusion Criteria:\n\n* ESRD (end stage renal disease) patients at BMC (Boston Medical Center)\n* Receiving hemodialysis\n* Has a dialysis access malfunction\n* Undergoing a diagnostic fistulogram for the dialysis access malfunction\n\nExclusion Criteria:\n\n* None","85 Years",{"count":272,"type":21},[24],"Hemodialysis represents a life line of patients with end stage renal disease, who are commonly maintained on hemodialysis through catheters. Prolonged exposure to these catheters eventually damages the walls of veins, which results in stenosis at the local site. This condition is called central venous stenosis (CVS) and affects number of patients on hemodialysis in the United States and can compromise the dialysis efficacy. The current diagnostic modality for CVS is venography, which has several limitations. This study proposes to examine intravenous ultrasound (IVUS) as a potentially superior modality, which will provide additional information.",[667],"End Stage Renal Disease",[669,670,671,672,673,674,675],"intravenous ultrasound (IVUS)","central venous stenosis (CVS)","hemodialysis","dialysis access malfunction","fistulogram","stenosis","virtual histology (VH-IVUS) software","2025-11-26",{"date":678,"type":38},"2025-12-01",{"date":680,"type":38},"2021-08-03",{"date":42,"type":21},{"name":44,"class":45},""]