[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Montefiore Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":637},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,75,0,25,[9,45,65,95,136,162,185,214,240,261,288,314,326,352,378,402,422,446,468,493,521,548,568,590,614],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053616","virtual-intelligence-for-transformative-lifestyle-solutions-in-pain-100053616",false,"NCT07124598","Virtual Intelligence for Transformative Lifestyle Solutions in Pain","VITALS-Pain","Inclusion Criteria:\n\n* Patients with opioid misuse or International Classification of Diseases 10th revision (ICD-10) diagnosis of opioid use disorder\n* Patients with Chronic pain of at least moderate intensity (\\>4 Pain Intensity Score) with no pain medication changes in 14 days\n* Ability to understand written\u002Fspoken instruction and provide informed consent in English\n* Ability and willingness to participate in all components of the study\n\nExclusion Criteria:\n\n* History of severe motion sickness, cybersickness, or conditions that could make participation in VR hazardous or cause adverse effects\n* Conditions that could prevent proper use of VR headset (such as vision problems that cannot be corrected by contact lenses or glasses that fit in VR, Significant hearing impairments that cannot be corrected by a hearing device)\n* History of seizures or seizure disorder\n* Acute exacerbation of psychiatric conditions such as self-injurious behaviors or suicidal risk that preclude the ability to participate in the study","ALL","18 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"NA","This pilot study aims to evaluate the feasibility and acceptability of a VR-based chronic pain management intervention with a virtual AI coach for patients with Opioid misuse and opioid use disorder (OM\u002FOUD). The intervention is a single-day 45-minute VR intervention which is subdivided into three smaller sessions:\n\nSession 1: A 15-minute AI check-in to ask questions about biopsychosocial health, Session 2: A 20-minute Pain Coping Skills Training (PCST) session offering psychoeducation on managing chronic pain Session 3: A 10-minute stress reduction exercise.\n\nThe VR sessions will be conducted using hardware (VR Headset Device - Meta Quest 3) and software developed by AugMend Health Company.\n\nThe study will be conducted in a clinical setting at the Montefiore Multidisciplinary Pain Medicine Program (MMPP), a Pain Medicine outpatient specialty practice within a major urban medical center. MMPP providers see thousands of patients every month, some of which have concurrent opioid misuse or OM\u002FOUD.",[27],"Chronic Pain",[29,30,31,32],"Virtual Reality (VR)-based Chronic Pain Management","Opioid Management","Opioid Use Disorder","Artificial Intelligence (AI)","RECRUITING","2026-07-10",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":34,"type":37},{"date":40,"type":21},"2026-12",{"name":42,"class":43},"Montefiore Medical Center","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":44},"100053460","phase-4-the-effect-of-multimodal-pain-regimen-on-use-of-narcotics-after-rotator-cuff-tear-repair-100053460","NCT07076069","The Effect of Multimodal Pain Regimen on Use of Narcotics After Rotator Cuff Tear Repair","Inclusion Criteria:\n\n* Adults with rotator cuff tears who have failed conservative therapy and are now undergoing arthroscopic rotator cuff repair.\n\nExclusion Criteria:\n\n* Patients without capacity to consent for the study\n* Patients not able to have local nerve block\n* Patients who underwent previous shoulder surgery on the same side, kindling revision rotator cuff repair\n* Patients who are unable to record and verbalize their pain level due to altered mental status\n* Patients who are unable to tolerate any of the medications included in the multimodal pain regimen or standard pain regimen due to severe allergies or inability to consume medication\n* Patients with history of previously diagnosed alcohol or drug abuse, renal impairment, peptic ulcer disease, and gastrointestinal bleeding\n* Patients who are pregnant",{"count":52,"type":21},130,[54],"PHASE4","The goal of this clinical trial is to understand which group of pain control medications work best in adults after rotator cuff surgery.",[57,58],"Rotator Cuff Repairs","Pain Management",{"date":36,"type":37},{"date":61,"type":37},"2025-07-21",{"date":63,"type":21},"2028-06",{"name":42,"class":43},{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":4},"100640381","enhancing-cancer-care-restoreme-app-for-personalized-nutrition-and-activity-in-cancer-patients-100640381","NCT07575685","Enhancing Cancer Care: RestoreMe App for Personalized Nutrition and Activity in Cancer Patients","Enhancing Cancer Care: RestoreMe Application for Personalized Nutrition and Activity in Cancer Patients","RestoreMe","Inclusion Criteria:\n\n* Age \\> 18\n* Planned to receive, or have received, cancer treatments including radiation therapy, chemotherapy, immunotherapy, or surgery\n* Must have a smartphone or other device with the ability to receive text messages, download and use mobile applications.\n* Ability to read and write English\n* Provide written informed consent to participate in the study.\n* Concurrent enrollment on other trials is permitted.\n\nExclusion Criteria:\n\n* Poorly controlled diabetes (defined as fasting glucose level \\> 200 mg\u002FdL despite attempts to improve glucose control by fasting duration and adjustment of medications).\n* Any medical condition requiring fluid restriction or nutrient restrictions.",{"count":74,"type":21},150,[24],"This is a single institution feasibility study of the updated RestoreMe app. The investigators plan to recruit 150 participants to this study with participants being recruited either prior to the initiation of their curative treatment or during and after completion of their cancer therapy. This design will allow the investigators to assess the feasibility of using the RestoreMe app in both the active treatment setting and follow up\u002Fsurvivorship setting. Information gathered from this feasibility study will inform future trial design for prospective intervention using the RestoreMe app.",[78,79,80,81],"Nutrition Aspect of Cancer","Cancer","Dietary Recommendations","Mobile Applications",[83,84,85],"Patient Reported Outcomes","Biomarker","Activity","NOT_YET_RECRUITING","2026-06-30",{"date":89,"type":37},"2026-07-02",{"date":91,"type":21},"2026-07",{"date":93,"type":21},"2035-07",{"name":42,"class":43},{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":111,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":133,"leadSponsor":135,"locationsCount":44},"100573018","phase-4-broadening-antiemetics-research-by-comparing-the-effectiveness-of-fosaprepitant-and-metoclopramide-100573018","NCT06740812","Broadening Antiemetics Research by Comparing the Effectiveness of Fosaprepitant and Metoclopramide","Broadening Antiemetics Research by Comparing the Effectiveness of Fosaprepitant and Metoclopramide: A Randomized Control Trial","BARF RCT","Inclusion Criteria:\n\n* Adults at least 18 years old\n* Present to ED for treatment of Nausea and\u002For vomiting as defined by the International Classification of Diseases (ICD-10) or identified by treating clinician\n\nExclusion Criteria:\n\n* Pregnancy, desiring pregnancy, or lactating\n* Antiemetic use or intravenous fluids prior to presenting to ED for evaluation and management\n* Bradycardia (\\\u003C 60 bpm heart rate)\n* Prolonged QTc (greater than 490ms)\n* Not conversant in English or Spanish\n* Altered mental status\n* Dementia\n* Lack of phone for follow-up communication",{"count":104,"type":21},212,[54],"The study team proposes a double-blind, comparative effectiveness, randomized controlled trial (RCT) to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic metoclopramide. Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin (NK-1) which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex. Currently, fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration (USFDA) approved indications for nausea and vomiting: chemotherapy-induced and postoperative. Neurokinin inhibitors are highly effective and generally well-tolerated. Therefore, this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in emergency departments (EDs). Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time.",[108,109,110],"Nausea and Vomiting","Nausea","Vomiting",[112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128],"Signs and Symptoms, Digestive","Antiemetics","Autonomic Agents","Peripheral Nervous System Agents","Physiological Effects of Drugs","Gastrointestinal Agents","Antipruritics","Dermatologic Agents","Neurotransmitter Agents","Molecular Mechanisms of Pharmacological Action","Neurokinin-1 Receptor Antagonists","Fosaprepitant","Aprepitant","Dopamine Receptor Antagonist","Randomized Control Trial","Metoclopramide","Adults","2026-06-25",{"date":131,"type":37},"2026-06-29",{"date":40,"type":21},{"date":134,"type":21},"2027-09",{"name":42,"class":43},{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":44},"100635106","spark-cgm-implementation-100635106","NCT07548372","SPARK-CGM Implementation","Supporting Primary Care Adoption, Resources, and Knowledge for Continuous Glucose Monitoring","Inclusion Criteria:\n\nClinic level:\n\n* All adult Montefiore primary care sites\n* Clinician and clinic staff will be eligible if they provide direct patient care or are involved in CGM prescribing, authorization, onboarding, or education at participating primary care clinics. Eligible clinicians include physicians, nurse practitioners, physician assistants, and clinicians in training. Eligible clinic staff may include nurses, medical assistants, and other relevant administrative staff\n\nPatient level:\n\n* Age 18 years or older\n* Receive primary care at participating sites\n* Diagnosis of any diabetes mellitus\n* Treated with insulin therapy\n\nExclusion Criteria:\n\nClinic level:\n\n\\- Sites participating in pilot phase of CGM initiative\n\nPatient level:\n\n\\- Existing CGM prescription within 24 months before the study start",{"count":144,"type":21},20000,[24],"Continuous glucose monitoring (CGM) is a technology that helps individuals with diabetes track their sugar levels in real-time, leading to more in-range blood sugars, fewer episodes of dangerously low blood sugar, and improved quality of life. Despite these benefits, CGM is not widely used in primary care settings, where most people receive their diabetes care. The investigators aim to make CGM more accessible and equitably prescribed in primary care practices. The study team will support primary care to increase CGM use with a program called SPARK-CGM (Supporting Primary Care Adoption, Resources, and Knowledge for CGM) across a large network of primary care clinics at Montefiore Medical Center. This program will provide primary care providers (PCPs) with education, tools, and support to incorporate CGM into their routine care for people with diabetes. Investigators plan to test SPARK-CGM to evaluate whether it increases CGM prescriptions who are eligible to receive this technology.",[148],"Diabetes Mellitus",[150,151,152,153],"Implementation","HbA1c","Multi-component Implementation","Continuous glucose monitoring","2026-06-22",{"date":156,"type":37},"2026-06-23",{"date":158,"type":37},"2026-05-01",{"date":160,"type":21},"2028-05",{"name":42,"class":43},{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":183,"leadSponsor":184,"locationsCount":44},"100610474","phase-4-giving-asthmatics-intramuscular-steroids-for-preventing-return-to-the-emergency-department-100610474","NCT07228052","Giving Asthmatics Intramuscular Steroids for Preventing Return to the Emergency Department","Giving Asthmatics Intramuscular Steroids for Preventing Return to the Emergency Department: A Randomized Control Trial","GASPING","Inclusion Criteria:\n\n* Adults ≥18 years old presenting to the ED with an asthma exacerbation\n* Diagnosed with asthma per International Classification of Diseases, 10th Revision (ICD-10) criteria or by the treating clinician\n* Discharged from the ED with a primary diagnosis of asthma exacerbation\n* Initiated systemic corticosteroids during the ED visit\n* Must be English or Spanish speaking\n\nExclusion Criteria:\n\n* Current use of systemic corticosteroids, including Emergency Medical Services (EMS) administration before ED arrival\n* History of severe adverse reactions to corticosteroids\n* Heart failure and uncontrolled diabetes (glucose \\>300mg\u002FdL in the ED)\n* Pregnancy or breastfeeding as prednisone is the preferred treatment for asthma in this population\n* Inability to provide informed consent",{"count":171,"type":21},182,[54],"This study aims to compare the efficacy of a one-time IM dose of dexamethasone versus a 5-day course of prednisone in adult ED patients presenting with asthma exacerbations. This is a randomized, controlled, double-blind, non-inferiority trial conducted at two urban EDs within the Montefiore Health System.",[175],"Asthma",[177,178,179],"dexamethasone","prednisone","randomized controlled trial",{"date":181,"type":37},"2026-06-24",{"date":91,"type":21},{"date":40,"type":21},{"name":42,"class":43},{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":193,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":197,"conditions":198,"keywords":201,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":212,"locationsCount":213},"100643571","buprenorphine-implementation-at-syringe-service-programs-to-reduce-overdoses-100643571","NCT07631598","Buprenorphine Implementation at Syringe Service Programs to Reduce Overdoses","Buprenorphine Implementation at Syringe Services Programs To Reduce Overdoses: A Type 1 Hybrid Effectiveness-Implementation Trial","BISTRO","Inclusion Criteria:\n\n1. ≥ 18 years old;\n2. Meet DSM-5 criteria for moderate or severe OUD;\n3. Interest in receiving buprenorphine treatment;\n4. Speaks English or Spanish;\n5. Currently an SSP client at the time of enrollment;\n6. Ability to provide informed consent.\n\nExclusion Criteria:\n\n1. Current use of prescribed opioid agonist treatment, as assessed by self-report, at the time of enrollment;\n2. Unstable mental health or medical condition that requires an immediate clinical evaluation or higher level of care;\n3. Allergy to buprenorphine;\n4. Currently detained in jail, prison, residential substance use treatment facility, or other overnight facility as required by court of law. or have pending legal action that could prevent participation on study activities.",true,{"count":195,"type":21},512,[24],"This study is testing whether offering buprenorphine treatment directly at syringe service programs (SSPs) helps more people start and stay in treatment for opioid use disorder (OUD) than referring them to community buprenorphine treatment providers. Buprenorphine is a medication that helps reduce opioid cravings and withdrawal symptoms.\n\nThe study compares two ways of connecting people to treatment:\n\nReferral to a community treatment provider (usual care before the new program begins).\n\nOnsite, low-threshold buprenorphine treatment at the SSP, which allows participants to start medication quickly and without having to establish care at another provider.\n\nParticipants will be adults who have opioid use disorder and are SSP clients. Each SSP will begin offering the new onsite buprenorphine program at different times during the study. Researchers will collect information before and after the new program begins to see how it affects treatment engagement and health outcomes.\n\nThe study will also examine how easy or difficult it is for SSPs to start and run the new program, how acceptable it is to staff and participants, and whether it is cost-effective.\n\nThe overall goal is to find better ways to expand access to life-saving opioid treatment in community-based settings.",[31,199,200],"Opioid Use Disorder, Severe","Opioid Use Disorder, Moderate",[202,203,204,205,206],"Buprenorphine","Overdose Prevention","Low-Threshold Treatment","Community-Based Treatment","Medication for Opioid Use Disorder","2026-06-19",{"date":156,"type":37},{"date":210,"type":21},"2026-08-10",{"date":63,"type":21},{"name":42,"class":43},8,{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":223,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":239,"locationsCount":44},"100609458","a-prospective-study-to-evaluate-the-efficacy-of-iovera-lumbar-medial-branch-cryoneurolysis-versus-radiofrequency-ablation-for-the-treatment-of-chronic-low-back-pain-100609458","NCT07214844","A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain","A Prospective, Randomized, Assessor Blind, Active-controlled, Single-center Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Facet-mediated Chronic Low Back Pain","Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria to be eligible for participation:\n\n* Subjects at least 18 years of age at Screening\n* Primary complaint of axial low-back pain suggestive of bilateral facet joint involvement (i.e., facet mediated CLBP) by evidence of provocative testing (e.g., axial loading, paraspinal tenderness)\n* Low back pain is chronic (i.e., ≥ 3 months' duration)\n* Low back pain is moderate to severe (score of ≥ 5 to ≤ 9) on the 0 to 10 NRS at Screening\n* Low back pain causes functional impairment (≥ 30% on ODI) at Screening\n* Successful trial of two diagnostic medial branch blocks consisting of two positive blocks with local anesthetic only (i.e., no steroids) that results in at least 80% relief of primary (index) pain for the duration of the local anesthetic used\n* Failure of at least three months of conservative non-operative therapy (e.g., physical therapy, chiropractic care, sleep hygiene, weight loss, spinal injections, NSAIDs, physician-directed exercise program or other appropriate analgesics)\n* Able to provide informed consent, adhere to the study visit schedule, and complete all study assessment\n\nExclusion Criteria:\n\nSubjects who meet any of the following exclusion criteria will not be eligible for participation in this study:\n\n* Active workers' compensation, personal injury, Social Security disability insurance (SSDI), or other litigation\u002Fcompensation related to the spine\n* Serious spinal disorders (verified on magnetic resonance imaging (MRI)) that may impact outcomes, including any of the following:\n\n  1. Suspected cauda equina syndrome (e.g., bowel\u002Fbladder dysfunction)\n  2. Infection\n  3. Tumor\n  4. Traumatic fracture\n  5. Systemic inflammatory spondyloarthropathy\n  6. Lumbar radiculopathy\u002Fradiculitis (i.e., root irritation and deficit)\n  7. Neurogenic claudication Prior lumbar spinal fusion surgery at the intended treatment levels\n* Comorbidity that, in the judgment of the Investigator, may affect the subject's ability to participate in the study including lumbar radiculopathy and neuropathic pain disorder\n* Currently pregnant, nursing, or planning to become pregnant during the study\n* Known contraindication to study device, including any of the following:\n\n  1. Cryoglobulinemia\n  2. Paroxysmal cold hemoglobinuria\n  3. Cold urticaria\n  4. Raynaud's disease\n  5. Open and\u002For infected wounds at or near the treatment site\n  6. Coagulopathy\n* Severe chronic pain disorder that in the opinion of the investigator may impact study outcomes\n* Presence of any of the following:\n\n  1. Spinal neurostimulator\n  2. Intrathecal analgesic drug pump\n  3. Cardiac implantable device\n* Current manifestation of poorly controlled mental illness or catastrophizing that in the opinion of the investigator may meaningfully impact treatment outcomes, including any of the following:\n\n  1. Mood disorder (e.g., depression, bipolar)\n\n     Patient Health Questionnaire (PHQ-9) ≥ 12 at Screening\n  2. Psychotic disorder (e.g., schizophrenia)\n  3. Catastrophizing\n\nPatient Catastrophizing Scale (PCS) score \\> 30 at Screening\n\n* Subject received other spine intervention\u002Ftherapies in the 30 days prior to block administration (e.g., spinal injections, minimally invasive therapies, surgical therapies) at the intended lumbar treatment levels\n* Subject received radiofrequency ablation in the low back region ≤ 6 months before study enrollment at the intended lumbar treatment levels\n* Pain relief following diagnostic medial branch blocks lasted longer than the duration of the local anesthetic used (i.e., \\> 24 hours)\n\n  1. History, suspicion, or clinical manifestation of:\n  2. Alcohol abuse or dependence\n  3. Illicit drug use\n* Opioid abuse or dependence (≥40 mg medication PO\u002Fday in past 30 days)\n* Given the COVID-19 pandemic, the subject must be medically fit\u002Fcleared for surgery by the investigator. If there is a concern about a subject's recent or potential exposure to COVID-19, or if the subject is not medically fit\u002Fcleared for surgery due to suspected COVID-19 illness\u002Fsymptoms (or other serious illness), the subject must be excluded.",{"count":222,"type":21},110,[24],"A research study is being conducted to compare two treatments for long-term low back pain:\n\n* One uses the iovera° system, which applies cold to certain nerves in the lower back.\n* The other is the standard treatment called radiofrequency ablation, which uses heat.\n\nThe primary objective is to find out which treatment works better to reduce back pain. Participants in this study will be randomly placed in one of the two treatment groups. The clinical research team will check on participant pain levels and overall health before and after the procedure for about 12 months. The entire study will last about 14 months for each participant.",[226],"Low Back Pain, Chronic",[228,229,230,231,232],"Iovera","Radiofrequency ablation","cryoneurolysis","low back pain","lumbar medial branch","2026-06-16",{"date":235,"type":37},"2026-06-17",{"date":237,"type":37},"2026-04-16",{"date":160,"type":21},{"name":42,"class":43},{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":193,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":22,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":255,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":44},"100555300","digital-mind-body-intervention-among-black-and-hispanic-patients-living-with-inflammatory-bowel-disease-100555300","NCT06510296","Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease","DMBI","Inclusion Criteria:\n\n* age ≥ 18 years\n* self-identify as Black\u002FAfrican American and\u002For Hispanic\u002FLatino(a\u002Fx)\n* diagnosed with Crohn's disease or ulcerative colitis\n* ability to provide informed consent in English\n* elevated psychological distress: at least one T-score within 2.5 standard deviations above the mean -- NIH Toolbox Perceived Stress Scale or in the domains of either Anxiety or Depression on the NIH PROMIS-29.\n\nExclusion Criteria:\n\n* Anxiety, depression, or perceived stress T-scores above 2.5 standard deviations above the mean.\n* Current suicidality, past suicide attempt, or psychiatric hospitalization.",{"count":248,"type":21},40,[24],"The bidirectional effects between psychological distress and inflammatory bowel disease (IBD) activity mean that not only does increased IBD activity trigger psychological distress, but psychological distress triggers increased IBD activity (i.e., gut-brain interaction). Comorbid psychological distress is linked to increased health resource utilization and poor health-related quality of life (HRQoL). This has prompted calls for integrating psychological care into IBD practice with restoration of quality of life as a clinical target of IBD management alongside endoscopic healing. The IBD Social Cognitive Model (IBD SCM) posits that patient psycho-behavioral modifiers contribute to IBD outcomes and not disease modifiers alone. While a co-localized gastro-psychologist in an IBD medical home is an emerging mode of delivering psycho-behavioral care among people living with IBD, access and scalability of this form of support is not yet widespread, particularly in resource-limited settings. Though many people with IBD have significant psychological distress, mental health care is underutilized with cost cited as a barrier.\n\nThe emergence of digital interventions in clinical practice presents an opportunity to address access, scalability, and cost barriers. However, current testing of digital interventions to address gut-brain interactions (digital mind-body intervention, DMBI) among people with IBD involves mostly women with high educational attainment who have full time employment and do not receive social service benefits. Individuals with limited resources and those from racial and ethnic minority groups (e.g. Black, Hispanic) often have socioecological factors, such as healthcare access and mental health stigma, that impede their use of psycho-behavioral resources. DMBI development informed by participatory research approaches are, therefore, critical to facilitate equitable engagement and utilization. Beneficial effects of psycho-behavioral treatment among people with IBD are strongest for those who have psychological distress and for acceptance, mindfulness, and values-based approaches.\n\nAlthough high quality evidence demonstrates psychological improvement with DMBI in IBD, feasibility and acceptability of applying DMBI to IBD patients from racial and ethnic minority groups is lacking.",[252,253,254],"Crohn's Disease","Ulcerative Colitis","Inflammatory Bowel Diseases",{"date":235,"type":37},{"date":257,"type":21},"2027-07",{"date":259,"type":21},"2028-09",{"name":42,"class":43},{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":269,"enrollmentInfo":270,"targetDuration":4,"studyType":22,"phases":272,"briefSummary":273,"conditions":274,"keywords":277,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":44},"100510705","open-trial-of-trauma-focused-psychodynamic-psychotherapy-for-people-living-with-hiv-and-ptsd-100510705","NCT05929911","Open Trial of Trauma-focused Psychodynamic Psychotherapy for People Living With HIV and PTSD","Pilot Feasibility Proposal to Adapt Trauma-focused Psychodynamic Psychotherapy (TFPP) for PLWH and PTSD","TFPP-PLWH","Inclusion Criteria:\n\n* Diagnosis of DSM-5 defined PTSD, per the Clinician Administered PTSD Scale \\& CAPS-5 total severity score greater than or equal to 25\n* HIV diagnosis (by medical records or HIV testing)\n* Stable psychiatric\u002Fpsychotropic medication for \\>=2 months and ongoing during treatment\n\nExclusion Criteria:\n\n* Psychosis\n* Bipolar I\n* Acute suicidality\n* Current substance use disorder\n* Organic mental syndrome or intellectual disability\n* Unstable non-HIV medical conditions","65 Years",{"count":271,"type":21},20,[24],"People living with HIV (PLWH) have a higher rate of post-traumatic stress disorder (PTSD) diagnosis than the general population. Comorbid PTSD is also associated with negative HIV-related health outcomes. Unfortunately, little outcome research has examined the usefulness of PTSD treatments for PTSD. This pilot study adapts for PLWH a non-exposure based psychotherapy for PTSD focused on reflecting on one's emotions and relationships and understanding and working through how trauma may have disrupted them. The study team is interested in better understanding the needs of PLWH with PTSD, learning whether PLWH with PTSD find this treatment acceptable and helpful, and beginning to understand the relationship between HIV-related health factors (e.g., inflammation and stress biology) and PTSD, and how these health factors may improve during treatment.",[275,276],"Post Traumatic Stress Disorder (PTSD)","HIV",[276,278,279],"psychotherapy","trauma","2026-06-10",{"date":282,"type":37},"2026-06-12",{"date":284,"type":37},"2024-04-26",{"date":286,"type":21},"2027-06",{"name":42,"class":43},{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":193,"sex":17,"minAge":18,"maxAge":295,"enrollmentInfo":296,"targetDuration":4,"studyType":22,"phases":298,"briefSummary":299,"conditions":300,"keywords":303,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":44},"100474646","1470nm-laser-for-the-treatment-of-androgenetic-alopecia-and-scarring-alopecia-100474646","NCT05460611","1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia","A Pilot Study Evaluating the Safety and Efficacy of a 1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia","Inclusion Criteria:\n\n* Healthy males and females, ≥ 18 years of age at time of informed consent, seeking treatment for hair loss\n* Subject must voluntarily sign and date an IRB approved informed consent form\n* Subjects with diagnosis of biopsy proven androgenetic alopecia or scarring alopecia with hair loss recorded over the past 6 months\n* Subjects must have a stable hair loss treatment regimen with a plateau in results for at least 3 months\n* Able to read, understand and voluntarily provide written informed consent\n* Subject is determined to be healthy, non-smoker who agrees not to make any changes to their daily hair treatment regimen during the study\n* Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements\n* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period\n\nExclusion Criteria:\n\n* Subject does not have the capacity to consent to the study\n* Subject has other types of alopecia of the scalp like alopecia areata\n* History of intralesional steroid injections to the scalp in the last 12 months\n* Pregnant women\n* Any medical condition that in the consideration of the investigator, would present an increased risk of a photosensitivity reaction to the subject\n* Any previous surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months\n* Allergy or history of prior reaction to lidocaine\n* History of immunosuppression\u002Fimmune deficiency disorders (including AIDS and HIV infection), and\u002For any history of systemic chemotherapy for prior 12 months\n* History or current use of the following prescription medications:\n\n  i. Immunosuppressive medications\u002Fbiologics, 6 months prior to and during the study ii. Accutane or other systemic retinoids within the past twelve months\n* Smoking or vaping in the past 12 months\n* History of uncontrolled hyperlipidemia, diabetes mellitus, hepatitis, or bleeding disorders\n* History of major depressive disorders or endocrine disorders including but not limited to; hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism","99 Years",{"count":297,"type":21},10,[24],"Single-center, open-label, baseline-controlled, pilot study evaluating the use of a Nonablative 1470 nm laser for the treatment of androgenetic alopecia and scarring alopecia.",[301,302],"Scarring Alopecia","Androgenetic Alopecia",[304,305],"alopecia","laser","2026-06-09",{"date":308,"type":37},"2026-06-11",{"date":310,"type":37},"2023-12-07",{"date":312,"type":21},"2028-07",{"name":42,"class":43},{"id":315,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":22,"phases":317,"briefSummary":25,"conditions":318,"keywords":319,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":325,"locationsCount":44},"100602521",{"count":20,"type":21},[24],[27],[29,30,31,32],"2026-06-08",{"date":280,"type":37},{"date":323,"type":21},"2026-06",{"date":40,"type":21},{"name":42,"class":43},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":22,"phases":336,"briefSummary":338,"conditions":339,"keywords":341,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":44},"100604185","phase-2-the-selective-personalized-radio-immunotherapy-for-locally-advanced-non-small-cell-lung-cancer-trial-2-100604185","NCT07146230","The Selective Personalized Radio-Immunotherapy for Locally Advanced Non-Small Cell Lung Cancer Trial 2","The Selective Personalized Radio-Immunotherapy for Locally Advanced NSCLC Trial 2 (SPRINT 2)","SPRINT 2","Inclusion Criteria:\n\n1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act) obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations.\n2. Patient is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations, including follow-up.\n3. Age \\> 18 years at time of study entry\n4. Body weight ≥35 kg\n5. Life expectancy of at least 12 weeks\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n7. Previously untreated, pathologically proven NSCLC and one of the following stages:\n\n   1. American Joint Committee on Cancer (AJCC) version 8 Stage II disease, medically or technically unresectable\n   2. AJCC version 8 Stage III disease\n   3. Recurrent disease after curative-intent treatment for early-stage NSCLC, with current disease burden that would qualify as AJCC version 8 stage II-III\n8. PD-L1 testing performed using an FDA-approved immunohistochemical assay and demonstrating tumor proportion score (TPS) of at least 50%.\n9. Whole body PET\u002FCT within 42 days prior to study entry demonstrating at least one hypermetabolic pulmonary lesion or thoracic lymph node.\n10. MRI of the brain or head CT with contrast within 42 days prior to study entry.\n11. PFTs within 42 days of study entry are recommended but not required.\n12. Adequate normal organ and marrow function as defined below:\n\nHemoglobin ≥9.0 g\u002FdL Absolute neutrophil count (ANC) ≥ 1.5 × 109 \u002FL Platelet count ≥75 × 109\u002FL Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with Gilbert's syndrome.\n\nSerum albumin ≥ 3.0 g\u002FdL AST (SGOT)\u002FALT (SGPT) ≤2.5 x institutional upper limit of normal Measured creatinine clearance \\>40 mL\u002Fmin or Calculated creatinine clearance \\>40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.\n\n* Males: (Weight in kg) x (140 - Age) ÷ (72 x serum creatinine in mg\u002FdL)\n* Females: (Weight in kg) x (140 - Age) x 0.85 ÷ (72 x serum creatinine in mg\u002FdL)\n\nExclusion Criteria:\n\n1. Participation in another clinical study with an investigational product during the last 3 months\n2. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study\n3. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy, with these exceptions:\n\n   1. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n   2. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment on this study may be included after consultation with the Study Physician.\n4. Any concurrent chemotherapy, Intraperitoneal (IP) chemotherapy, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n5. History of another primary malignancy except for\n\n   1. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence\n   2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n   3. Adequately treated carcinoma in situ without evidence of disease\n6. History of leptomeningeal carcinomatosis\n7. Prior radiotherapy that would preclude safe delivery of radiotherapy as specified in this study.\n8. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first planned dose of IP.\n9. History of allogenic organ transplantation.\n10. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion:\n\n    1. Patients with vitiligo or alopecia\n    2. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n    3. Any chronic skin condition that does not require systemic therapy\n    4. Patients without active disease in the last 5 years may be included but only after consultation with the study physician\n    5. Patients with celiac disease controlled by diet alone\n11. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent\n12. History of grade 3 or greater edema (e.g., peripheral, pulmonary)\n13. History of venous thrombosis within the past 3 months prior to the planned first dose of study treatment. Note: Subjects with thrombosis due to mechanical obstruction by the tumor that is found incidentally and is asymptomatic and does not require therapy may be enrolled at the investigator's discretion and should be closely monitored.\n14. Cardiac or peripheral vascular disease meeting any of the following criteria:\n\n    1. History of myocardial infarction in the prior 12 months\n    2. History of stroke or transient ischemic attack requiring medical therapy\n15. Congestive heart failure ≥ Class 3 based on New York Heart Association Functional Classification\n16. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart)\n17. History of active primary immunodeficiency\n18. Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening.\n\n    1. Participants with a past or resolved HBV infection (defined as the presence of anti HBc and absence of HBsAg) are eligible.\n    2. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n19. Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n20. Current or prior use of immunosuppressive medication within 14 days before the first dose of IP. The following are exceptions to this criterion:\n\n    1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n    2. Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n    3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n21. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 90 days after the last dose of IP.\n22. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.\n23. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n24. Patients who have received prior anti-PD-1 or anti PD-L1 therapy:\n\n    1. Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy\n    2. All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.\n    3. Must not have experienced a ≥Grade 3 immune related AE or an immune-related neurologic or ocular AE of any grade while receiving prior immunotherapy. Note: Patients with endocrine AE of ≤Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n    4. Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \\> 10 mg prednisone or equivalent per day.",{"count":335,"type":21},52,[337],"PHASE2","This is a randomized trial evaluating the efficacy and safety of sequential dual-agent immunotherapy and risk-adapted radiotherapy for patients with locally advanced non-small cell lung cancer (NSCLC) with a PD-L1 tumor proportion score of at least 50%. Participants will be randomized between two dual-agent immunotherapy regimens: durvalumab + monalizumab versus durvalumab + oleclumab.",[340],"Non-small Cell Lung Cancer",[342,343,344,345],"Immunotherapy","Radiotherapy","Patient reported outcomes","Biomarkers",{"date":306,"type":37},{"date":348,"type":21},"2026-09",{"date":350,"type":21},"2029-02",{"name":42,"class":43},{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":363,"conditions":364,"keywords":367,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":44},"100642854","phase-4-intravenous-metoclopramide-versus-intravenous-acetaminophen-for-acute-concussion-treatment-100642854","NCT07634393","Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment","A Randomized Study of Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment","IMPACT","Inclusion Criteria:\n\n* Adults presenting to one of the study emergency departments (EDs)\n* Acute minor traumatic brain injury\u002Fconcussion as defined by the Zurich Consensus Statement, including symptoms in somatic, cognitive, emotional, behavioral, physical, cognitive impairment, or sleep domains\n* ED visit occurring within 7 days of the head injury\n* Overall pain intensity greater than \\>=6 on a 0-10 scale\n* Rivermead Post-Concussion Questionnaire (RPQ) score of at least 10\n* Reported post-concussion symptoms were not present prior to the injury\n* Treating attending physician plans to administer a parenteral medication\n\nExclusion Criteria:\n\n* Already treated with an anti-dopaminergic medication for post-concussion symptoms\n* Contraindications to study medications, including:\n* Pheochromocytoma\n* Seizure disorder\n* Parkinson's disease\n* Use of monoamine oxidase (MAO) inhibitors\n* Use of anti-rejection transplant medications\n* Pregnant patients will not be excluded because both acetaminophen and metoclopramide are commonly used during pregnancy.",{"count":361,"type":21},200,[54],"The IMPACT study is a randomized, double-blind clinical trial evaluating two commonly used intravenous medications - metoclopramide and acetaminophen - for treating acute post-concussion symptoms in emergency department patients after mild head injury. The study aims to determine which treatment more effectively improves symptoms such as headache, dizziness, nausea, concentration difficulties, and emotional changes within the first week after injury.\n\nParticipants will be enrolled across two Montefiore emergency departments and followed using a validated post-concussion symptom questionnaire. Findings from this study may help improve evidence-based treatment strategies for patients experiencing concussion-related symptoms after head trauma.",[365,366],"Concussion Post Syndrome","Head Trauma Injury",[368,369,370,127],"Concussion","Head Trauma","Acetaminophen","2026-06-06",{"date":280,"type":37},{"date":374,"type":21},"2026-08-01",{"date":376,"type":21},"2028-08-04",{"name":42,"class":43},{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":382,"acronym":383,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":386,"briefSummary":388,"conditions":389,"keywords":390,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":401,"locationsCount":44},"100604337","phase-3-dronabinol-and-epidiolex-to-manage-uncontrolled-residual-symptoms-of-buprenorphine-initiation-trial-100604337","NCT07148206","Dronabinol and Epidiolex to Manage Uncontrolled Residual Symptoms of Buprenorphine Initiation Trial","DEMURE","Inclusion Criteria:\n\n* Fluency in English and Spanish\n* The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of OUD\n* Newly initiated on buprenorphine within 21 days\n* Positive urine toxicology for opioids other than buprenorphine in the past week OR opioid withdrawal symptoms in the past week based on the Clinical Opioid Withdrawal Scale (COWS) \\>=5\n* Any cannabis use in the past at or after the age of 18 years based on self-report\n\nExclusion Criteria:\n\n* Urine toxicology positive for cannabinoids\n* Inability to provide informed consent\n* Liver tests (AST or ALT) \\>3 times the upper limit of normal, or a history of liver disease\n* Pregnancy or breast\u002Fchest feeding\n* Unstable cardiac disease, history of hypotension or syncope\n* Psychotic disorder, or history of suicidal behavior and\u002For ideation\n* Progressive neurological conditions, frequent falls, or history of epileptic seizures\n* Severe alcohol use disorder, benzodiazepine use disorder or stimulant use disorder\n* Other serious medical conditions that would be a contraindication to THC or CBD use",{"count":248,"type":21},[387],"PHASE3","The goal of this pilot study is to test novel, adjunctive pharmacotherapy for patients with opioid use disorder (POUD) who may be at risk for overdose and other poor opioid use disorder (OUD) outcomes even after initiating buprenorphine. The investigator team proposes to test the effectiveness of combined dronabinol (synthetic delta-9-tetrahydrocannabinol \\[THC\\]) and Epidiolex (cannabidiol \\[CBD\\]) - two FDA-approved cannabinoids - to improve retention in buprenorphine treatment and reduce opioid use among POUD who are early in treatment. POUD who are early in treatment are at a critical juncture-a moment of opportunity and motivation, but also of high risk of return to opioid use and loss to follow up.",[31],[202,391,392,393,394,395,396],"delta-9-Tetrahydrocannabinol (THC)","Cannabidiol (CBD)","Cannabinoids","Opioid Use","Opioid Withdrawal","Retention to Treatment",{"date":306,"type":37},{"date":399,"type":21},"2026-10",{"date":160,"type":21},{"name":42,"class":43},{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":409,"minAge":18,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":22,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":418,"leadSponsor":420,"locationsCount":421},"100643758","impact-of-a-bladder-flap-on-cesarean-scar-niche-development-100643758","NCT07634679","Impact of a Bladder Flap on Cesarean Scar Niche Development","B-FIND","Inclusion Criteria:\n\n* Age 18 years or older\n* Primary low transverse cesarean section performed at Montefiore Weiler or Wakefield Hospitals\n* Able to provide informed consent in English or Spanish\n* Plan for postpartum care at Montefiore Medical Center\n\nExclusion Criteria:\n\n* History of a prior uterine surgery\n* Known congenital uterine anomalies\n* Inability to safely access lower uterine segment at time of delivery\n* Hysterotomy is extended past\u002Foutside the lower uterine segment at time of surgery\n* Hysterectomy is indicated prior to postpartum follow-up","FEMALE",{"count":52,"type":21},[24],"The goal of this trial is to examine if the completion or omission of a bladder flap impacts the location and formation of cesarean scar niche in women undergoing primary cesarean section. The main question it aims to answer is if omission of a bladder flap changes the prevalence of cesarean scar niche on a 6-8 week postpartum ultrasound. Researchers will compare participants that have a bladder flap made to those that have a bladder flap omitted at time of their primary cesarean delivery. Participants will have routine postpartum care and be asked to return for a 6-8 week postpartum transvaginal ultrasound.",[414],"Cesarean Scar Defect (Isthmocele)","2026-06-04",{"date":306,"type":37},{"date":323,"type":21},{"date":419,"type":21},"2032-05-01",{"name":42,"class":43},2,{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":429,"maxAge":18,"enrollmentInfo":430,"targetDuration":4,"studyType":22,"phases":432,"briefSummary":433,"conditions":434,"keywords":437,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":443,"completionDateStruct":444,"leadSponsor":445,"locationsCount":44},"100643818","coblator-wand-comparative-analysis-100643818","NCT07635719","Coblator Wand Comparative Analysis","Comparative Analysis of Efficiency, Technical Performance, and Environmental Cost Between Reprocessed and New Coblator Wands in Intracapsular Tonsillectomies and Adenoidectomies","Inclusion Criteria:\n\n* Pediatric patients scheduled for tonsillectomy and\u002For adenoidectomy\n* Parental consent and child assent (when applicable)\n\nExclusion Criteria:\n\n* Pregnancy","1 Year",{"count":431,"type":21},30,[24],"This study will address the gap in coblator wands by comparing the performance of reprocessed coblator wands with new wands in terms of efficiency and technical issues. As part of the evaluation, the investigator team will conduct the technical performance of the life cycle assessment of reprocessed versus new coblation wands based on the methodology described in the literature (see References) in studies of laryngoscopes.",[435,436],"Tonsillectomy","Adenoidectomy",[438,439,440],"Coblator wand","Product performance","Usability","2026-06-03",{"date":306,"type":37},{"date":323,"type":21},{"date":40,"type":21},{"name":42,"class":43},{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":22,"phases":454,"briefSummary":455,"conditions":456,"keywords":459,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":44},"100637702","feasibility-of-internet-based-hiv-prevention-research-100637702","NCT07625917","Feasibility of Internet-based HIV Prevention Research","Inclusion Criteria:\n\n* 18 years or older\n* US residency\n* English or Spanish fluency\n* injection drug use (self-report, past 30 days)\n* basic reading comprehension\n\nExclusion Criteria:\n\n* HIV status known to be positive",{"count":453,"type":21},500,[24],"The study will use social media to recruit a diverse sample of people who self-report injecting drugs, assessing the feasibility of online assessments and participants' ability to perform at-home self-administered HIV testing. Participants will complete online questionnaires at baseline and will be mailed HIV testing kits that they will self-administer and mail to a central laboratory. Investigators will track completion of questionnaires and whether at-home self-administered HIV tests were completed and sent to the laboratory.",[457,458],"HIV Prevention","Injection Drug Use",[460],"HIV testing","2026-05-29",{"date":415,"type":37},{"date":464,"type":37},"2025-08-01",{"date":466,"type":21},"2028-05-29",{"name":42,"class":43},{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":22,"phases":478,"briefSummary":479,"conditions":480,"keywords":483,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":490,"leadSponsor":492,"locationsCount":44},"100601386","phase-2-desloratadine-to-prevent-taxane-induced-peripheral-neuropathy-in-patients-with-breast-cancer-100601386","NCT07109817","Desloratadine to Prevent Taxane-induced Peripheral Neuropathy in Patients With Breast Cancer","Desloratadine to Prevent Taxane-induced Peripheral Neuropathy in Patients With Breast Cancer (DETOXp)","DETOXp","Inclusion Criteria:\n\n* Patients must have histologically confirmed breast cancer, stage I-III as per the American Joint Committee on Cancer (AJCC) 8th edition (Anatomic Staging)\n* Patients must be planned to receive taxane-based regimen for breast cancer (Adjuvant or neoadjuvant) of at least 12 weeks duration. Patients planned to receive taxanes in combination with other chemotherapy drugs (including platinums) are eligible. Patients planned to receive taxanes plus single or dual antiher2 therapy are also eligible. Patients planned to receive taxane-based regimen with immune checkpoint inhibitors are also allowed\n* Age ≥18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%)\n* Patients must have an adequate organ and marrow function as defined below:\n* absolute neutrophil count ≥1,000\u002Fmicroliter (mcL)\n* platelets ≥100,000\u002FmcL\n* total bilirubin ≤ institutional upper limit of normal (ULN)\n* AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN\n* Creatinine ≤ institutional ULN\n* Patients 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* Patients with prior diagnosis of diabetes mellitus are allowed if the patient has no peripheral neuropathy\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n* Patients must not have received prior taxane or platinum therapy\n* Women of childbearing potential must have a negative pregnancy test: serum or urine beta human chorionic gonadotropin (hCG) within 14 days prior to first dose of study treatment\n* Potential fertile subjects must agree to use adequate contraception (double barrier methods of birth control or abstinence) prior to start of treatment, for the duration of treatment, and 28 days after last study medication dose. If male, must also agree to refrain from donating sperm during this period\n\nExclusion Criteria:\n\n* Patients with prior diagnosis of peripheral neuropathy\n* Patients who received chemotherapy for the current breast cancer diagnosis before the planned taxane-based regimen\n* Patients who are receiving any other investigation agents\n* Patients with concurrent use of antihistamines during or for 2 days prior to the study period\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to desloratadine\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant or breastfeeding women are not allowed in the study\n* Patients who are taking probiotics\n* Patients who are using chronic laxatives or enema\n* Patients who used antibiotics within 4 weeks of registration",{"count":477,"type":21},116,[337],"This is a double-blinded randomized controlled clinical trial that aims to study if desloratadine can reduce rates of peripheral neuropathy development in patients with breast cancer receiving taxane chemotherapy. Researchers will compare desloratadine to a placebo (look-alike substance with no drug) and use validated neurotoxicity and quality of life questionnaires to determine if desloratadine can be used to prevent or make taxane induced peripheral neuropathy (TPIN) symptoms better.",[481,482],"Breast Cancer","Peripheral Neuropathy",[344,345,484,485,486],"Taxane","Neuroinflammatory","Cytokine","2026-05-28",{"date":461,"type":37},{"date":323,"type":21},{"date":491,"type":21},"2030-09",{"name":42,"class":43},{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":501,"enrollmentInfo":502,"targetDuration":4,"studyType":22,"phases":504,"briefSummary":505,"conditions":506,"keywords":508,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":44},"100639711","phase-4-non-antibiotic-management-in-acute-uncomplicated-diverticulitis-100639711","NCT07625267","Non-antibiotic Management in Acute Uncomplicated Diverticulitis","Non-antibiotic Management in Acute Uncomplicated Diverticulitis: Randomized Open Label-controlled Trial","NAMAD","Inclusion Criteria:\n\n* Left-sided diverticulitis, primary or recurrent\n* Signs of diverticulitis on CT-confirmed Hinchey (0 or 1a based on CT final report)\n* White Blood Cell (WBC) count \\\u003C15,000mm\\^3\n* Controlled symptoms in the ED (i.e., Pain score \\\u003C5 on VAS scale, tolerating PO intake, no fever)\n\nExclusion Criteria:\n\n* Signs of complicated diverticulitis on CT with abscess, fistula, free air, Micro perforation, or signs of other diagnosis on CT Abdomen and pelvis\n* Inflammatory bowel disease\n* American Society for Anesthesiologists (ASA) physical status classification of \\>=3\n* Immunocompromised patient; (i.e., haematological malignancies, AIDS patients with low CD4+ counts, transplantation, chemotherapy, splenectomy, long-term corticosteroid use and genetic disorders such as severe combined immunodeficiency\n* Pregnancy\n* Ongoing antibiotic therapy or in the previous 2 weeks\n* High fever, affected general condition, peritonitis or sepsis\n* Subjects who do not have the capacity to consent","80 Years",{"count":503,"type":21},556,[54],"Diverticulitis is a common condition that causes swelling and pain in part of the colon (the large intestine). Doctors classify it as \"mild\" when there are no serious complications.\n\nFor many years, doctors in the United States have treated mild diverticulitis with antibiotics. New studies from Europe suggest that many people with mild diverticulitis may not need antibiotics and can get better with just pain medicines. But this approach has not been tested in the United States, where antibiotics are still the standard treatment.\n\nThe goal of this clinical trial is to find out if people with mild diverticulitis can be safely treated at home without antibiotics. The main questions it aims to answer are:\n\n* Are people treated without antibiotics admitted to the hospital more often than people treated with antibiotics?\n* Do people treated without antibiotics have more emergency room visits, worsening of their disease, or need for surgery?\n\nResearchers will compare two groups of people who come to the emergency department with mild diverticulitis to see if treatment without antibiotics is as safe as treatment with antibiotics.\n\nParticipants will:\n\n* Be sent home with pain medicines (ibuprofen and acetaminophen) only, or with pain medicines plus an antibiotic taken by mouth for 7 days\n* Follow a liquid diet and slowly return to normal food as they feel better\n* Come back to clinic for a check-up at 1 to 2 weeks\n* Answer phone calls about their health at 4 weeks, 3 months, and 6 months",[507],"Acute Uncomplicated Diverticulitis",[509,510,511,512,513],"Diverticulitis, Colonic","Anti-Bacterial Agents","Outpatients","Watchful Waiting","Acute Disease","2026-05-26",{"date":415,"type":37},{"date":517,"type":21},"2026-07-01",{"date":519,"type":21},"2028-06-30",{"name":42,"class":43},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":409,"minAge":529,"maxAge":530,"enrollmentInfo":531,"targetDuration":4,"studyType":22,"phases":533,"briefSummary":534,"conditions":535,"keywords":537,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":44},"100637160","phase-4-comparing-pain-improvement-for-intravenous-versus-oral-acetaminophen-in-acute-pelvic-pain-100637160","NCT07595302","Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain","Comparing Pain Improvement for Intravenous Versus Oral Acetaminophen in Acute Pelvic Pain: A Randomized, Double-Blind, Double-Dummy Controlled Trial (PIVOTAL Trial)","PIVOTAL","Inclusion Criteria:\n\n* Female sex at birth\n* Presentation to the Emergency Department (ED) with pelvic pain\n* Baseline numeric pain score (NRS) ≥4\n* Ability to provide informed consent in English or Spanish\n\nExclusion Criteria:\n\n* Receipt of any analgesic medication within 2 hours or acetaminophen within 6 hours\n* Known allergy or intolerance to acetaminophen","16 Years","50 Years",{"count":532,"type":21},140,[54],"The investigator team proposes a randomized, double-blind, double-dummy comparative effectiveness trial conducted in two urban emergency departments (EDs) in the Bronx, New York. This study is designed to determine the relative efficacy of IV acetaminophen compared to PO acetaminophen in treating pelvic pain. This design focuses on the early onset of action and short-term efficacy, which may better capture potential differences between IV and PO acetaminophen in the acute ED setting.",[536],"Pelvic Pain",[538,539,179],"pregnancy","acetaminophen","2026-05-18",{"date":542,"type":37},"2026-05-20",{"date":544,"type":21},"2026-07-30",{"date":546,"type":21},"2027-06-30",{"name":42,"class":43},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":552,"acronym":553,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":22,"phases":556,"briefSummary":557,"conditions":558,"keywords":559,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":44},"100545446","phase-2-antiemetic-fosaprepitant-to-remedy-nausea-and-vomiting-100545446","NCT06382012","Antiemetic Fosaprepitant To Remedy Nausea and Vomiting","AFTR NV RCT","Inclusion Criteria:\n\n* Adults at least 18 years old\n* Present to an emergency department (ED) for nausea and\u002For vomiting as defined by the International Classification of Diseases (ICD-10), or identified by treating clinician\n* Following the approval of a protocol amendment, study patients who have received an antiemetic and remain persistently nauseated after 2 hours will be eligible to participate in the study\n\nExclusion Criteria:\n\n* Pregnancy, desiring pregnancy, or lactating\n* Antiemetic medication use less than 2 hours prior to screening\n* Bradycardia (heart rate less than 60 bpm heart rate)\n* Prolonged QTc (\\>480ms)\n* Not conversant in English or Spanish\n* Altered mental status\n* Dementia\n* Lack of phone for follow-up communication",{"count":361,"type":21},[337,387],"The study team proposes a randomized, double-blind, RCT to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic ondansetron. Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin (NK-1) which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex. Currently, fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration (USFDA) approved indications for nausea and vomiting: chemotherapy-induced and postoperative. Neurokinin inhibitors are highly effective and generally well-tolerated. Therefore, this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in EDs. Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time. The outcome for the efficacy analysis will be no need for additional medication to treat nausea and vomiting within 2 hours of investigational medication administration. The primary outcome for the tolerability analysis will be the development of any new symptom within 2 hours of medication administration.",[108,109,110],[123,110,126,560,128],"Ondansetron","2026-05-14",{"date":540,"type":37},{"date":564,"type":37},"2024-11-13",{"date":566,"type":21},"2027-03",{"name":42,"class":43},{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":572,"acronym":573,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":575,"enrollmentInfo":576,"targetDuration":4,"studyType":22,"phases":577,"briefSummary":579,"conditions":580,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":44},"100584694","phase-1-dfmo-maintenance-for-patients-with-relapsedrefractory-ewing-sarcoma-or-osteosarcoma-100584694","NCT06892678","DFMO Maintenance for Patients With Relapsed\u002FRefractory Ewing Sarcoma or Osteosarcoma","DFMO","Inclusion Criteria:\n\n* Patients \\\u003C 40 years of age at the time of enrollment\n* Diagnosis of relapsed osteosarcoma or relapsed Ewing sarcoma who have completed all planned therapy for their relapse, as described in the protocol, and have no evidence of disease\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2\n* Myelosuppressive chemotherapy: At least 14 days must have elapsed since completion of myelosuppressive therapy\n* Monoclonal antibodies: At least 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to Grade \\\u003C 2\n* Biologic therapy (defined as anti-cancer agents not known to be myelosuppressive): At least 7 days after the last dose of agent\n* Radiation therapy: At least 14 days must have elapsed after local External Beam Radiation Therapy (XRT), at least 90 days after Total Body Irradiation (TBI), craniospinal XRT or if radiation to greater than 50% of the pelvis, and at least 42 days if other substantial bone marrow radiation\n* Adequate bone marrow function defined as:\n* Peripheral absolute neutrophil count (ANC) greater or equal to 750\u002Fmicroliter\n* Platelet count greater or equal to 75,000\u002Fmicroliter (transfusion independent)\n* Adequate renal function defined by serum creatinine based on age and gender (see protocol)\n* Adequate liver function defined as:\n* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) for age AND\n* SGPT (ALT) ≤ 5.0 x ULN for age. For this study the ULN is 45 U\u002FL\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding females. Men and women of childbearing potential and their partners must agree to use adequate contraception while enrolled on this study. Based on the teratogenic potential of the agent, pregnant women will be excluded from this study. Because of potential risks to breastfed infants due to drug metabolites that could be excreted in breast milk, female patients who are lactating must agree to stop breastfeeding or will otherwise be excluded from this study. Females of childbearing potential must have a negative pregnancy test to be eligible for this study\n* Patients must not have an uncontrolled infection\n* Patients with a significant intercurrent illness (any ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the detailed exclusion criteria and that is expected to interfere with the action of study agents or to significantly increase the severity of the toxicities experienced from study treatment are not eligible","39 Years",{"count":20,"type":21},[578,337],"PHASE1","The purpose of this study is to determine the feasibility of administering DL-alpha-difluoromethylornithine (DFMO) to patients with relapsed Ewing sarcoma and osteosarcoma who have completed all planned therapy and have no evidence of disease.",[581,582],"Osteosarcoma Recurrent","Ewing's Tumor Recurrent","2026-05-12",{"date":561,"type":37},{"date":586,"type":37},"2025-04-07",{"date":588,"type":21},"2030-04",{"name":42,"class":43},{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":596,"eligibilityCriteria":597,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":598,"targetDuration":4,"studyType":22,"phases":600,"briefSummary":601,"conditions":602,"keywords":604,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":44},"100632183","opioid-tapering-after-hospital-discharge-testing-an-intervention-to-improve-post-operative-opioid-prescribing-100632183","NCT07510373","Opioid Tapering After Hospital Discharge: Testing an Intervention to Improve Post-operative Opioid Prescribing","Opioid Tapering After Hospital Discharge: Testing an Intervention to Improve Post-operative","DOTS","Inclusion Criteria (Aim 1):\n\n* Age ≥ 18 years\n* Any orthopedic surgery during hospitalization\n* No pre-operative opioid use (no opioids in EHR in past 1 month)\n\nExclusion Criteria (Aim 1):\n\n* Opioid Use Disorder \\[by International Classification of Diseases, 10th revision (ICD-10), in past 6 months}\n* Cancer (by ICD-10, in past 6 months)\n* Receiving hospice care (by ICD-10, in past 6 months)\n\nInclusion Criteria (Aim 2):\n\n* Meets criteria for inclusion in Aim 1\n\nExclusion Criteria (Aim 2):\n\n* Not fluent in English\n* Do not manage their own medications\n* Unable to provide consent over the phone\n* Orthopedic surgery due to cancer-related bone disease\n* No pre-operative opioid use (no opioids per New York state prescription drug monitoring program in past 1 month)",{"count":599,"type":21},42,[24],"The investigator team proposes a randomized clinical trial (RCT) to test a discharge opioid taper support (\"DOTS\") intervention that is embedded in the providers' workflow in the EHR to prompt them to prescribe an opioid taper for patients after orthopedic surgery that is tailored to patients' expected analgesic needs. DOTS includes: 1) a recommendation for a patient-specific opioid taper schedule based on opioid use prior to discharge, 2) an automated discharge opioid prescription based on the recommended taper schedule that providers can override, 3) a patient facing handout and 4) post-discharge telephonic support for patients.\n\nProviders will be randomly assigned 1:1 to 2 groups and who will each be assigned to DOTS (\"DOTS providers\") or TS (\"TS providers\") in a step-wedge design. EHR data will be extracted and telephone surveys of 100 patients over 12 weeks will be conducted after hospital discharge.\n\nThe two specific aims are:\n\n1. To determine the effectiveness of DOTS for reducing excessive opioid prescribing after orthopedic surgery.\n\n   Hypothesis 1: Patients discharged by DOTS providers will be prescribed a lower initial mean morphine equivalent daily dose (MMED), fewer opioid pills, and over 12 weeks, will have fewer subsequent opioid prescriptions and incident long-term opioid therapy, compared to patients discharged by non-DOTS providers.\n\n   Hypothesis 2. Age and frailty will be moderators; DOTS will be more effective at reducing excessive prescribing to older (65 years and older) and frailer patients.\n2. To determine the positive and negative impact of DOTS on patient outcomes.\n\nHypothesis 3: Compared to patients of non-DOTS providers, patients of DOTS providers will have improved pain and function, fewer adverse events, and less emergency post-operative care.\n\nHypothesis 4: Age and frailty will be moderators; DOTS will be more effective at improving positive and reducing negative outcomes in older and frailer patients.",[603],"Opioid Tapering",[605],"Post-operative opioid prescribing","2026-05-07",{"date":608,"type":37},"2026-05-11",{"date":610,"type":37},"2026-04-12",{"date":612,"type":21},"2028-04",{"name":42,"class":43},{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":620,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":17,"minAge":622,"maxAge":623,"enrollmentInfo":624,"targetDuration":4,"studyType":22,"phases":625,"briefSummary":626,"conditions":627,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":44},"100493858","evaluation-of-tenex-for-greater-trochanteric-pain-syndrome-gtps-100493858","NCT05710627","Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS)","Evaluation of Percutaneous Tenotomy of the Gluteus Medius and Iliotibial Band for Greater Trochanteric Pain Syndrome (GTPS): A Randomized Clinical Trial","RCT GTPS","Inclusion Criteria:\n\n* Aged 18-90\n* People with GTPS of all different levels and etiologies confirmed with MRI or CT scan\n* Ability to give informed consent forms independently\n* Failed conservative medical treatment for at least 6 months\n\nExclusion Criteria:\n\n* Significant mobility restrictions; people using wheelchairs\n* Pregnancy\n* Previous surgery to the GMed or ITB","30 Years","90 Years",{"count":74,"type":21},[24],"The objective of this study is to evaluate how an ultrasound-guided percutaneous procedure, TENEX, can help people with chronic hip pain resulting from a condition called Greater Trochanteric Pain Syndrome (GTPS) and to characterize the efficacy of percutaneous tenotomy (PUT) using TENEX®, a device used for the treatment of various tendinopathies. In this study an ultrasound (US) is performed to guide the partial release of gluteus medius and minimus and Iliotibial band tendons in patients diagnosed with refractory Greater Trochanteric Pain Syndrome (GTPS) vs control. The investigator team hypothesizes that the new TENEX can improve the pain level for individuals with GTPS to help those individuals perform their activities of daily living (ADLs), e.g., walking, standing, and side-lying, as well as demonstrate less medication utilization. The study predicts that this percutaneous outpatient procedure can decrease pain, increase mobility, and decrease medication utilization.\n\nThe study team hypothesizes that PUT can improve the pain level and function for individuals suffering with GTPS. The study will assess walking, standing, and side-lying tolerance, as well as medication utilization. The investigator team predicts that this percutaneous outpatient procedure can decrease pain and medication utilization while increasing mobility.",[628],"Greater Trochanteric Pain Syndrome","2026-05-05",{"date":631,"type":37},"2026-05-08",{"date":633,"type":37},"2025-03-11",{"date":635,"type":21},"2028-12",{"name":42,"class":43},""]