[{"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:":665},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,75,0,25,[9,51,76,105,132,160,182,214,231,257,283,308,335,359,384,404,424,450,475,504,545,571,597,615,640],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100643571","buprenorphine-implementation-at-syringe-service-programs-to-reduce-overdoses-100643571",false,"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,"ALL","18 Years",{"count":22,"type":23},512,"ESTIMATED","INTERVENTIONAL",[26],"NA","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.",[29,30,31],"Opioid Use Disorder","Opioid Use Disorder, Severe","Opioid Use Disorder, Moderate",[33,34,35,36,37],"Buprenorphine","Overdose Prevention","Low-Threshold Treatment","Community-Based Treatment","Medication for Opioid Use Disorder","RECRUITING","2026-08-20",{"date":41,"type":42},"2026-08-21","ACTUAL",{"date":44,"type":42},"2026-08-17",{"date":46,"type":23},"2028-06",{"name":48,"class":49},"Montefiore Medical Center","OTHER",8,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":58,"minAge":20,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":24,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"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":60,"type":23},338,[26],"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.",[64],"Cesarean Scar Defect",[66],"Isthmocele","2026-08-07",{"date":69,"type":42},"2026-08-11",{"date":71,"type":23},"2026-08",{"date":73,"type":23},"2032-06-01",{"name":48,"class":49},2,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":24,"phases":86,"briefSummary":87,"conditions":88,"keywords":94,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100585191","hepquant-study-to-assess-the-role-of-blood-based-biomarkers-and-quantitative-mr-imaging-for-patients-receiving-radiation-therapy-for-liver-cancer-100585191","NCT06899152","HepQuant: Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer","HepQuant: Pilot Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer","HepQuant","The following criteria must be met for subjects to be considered for the trial. Additional exclusion criteria must be met for subjects interested in the HepQuant subset of the trial. The first 20 qualifying subjects will be enrolled for the additional HepQuant test.\n\nInclusion Criteria:\n\n* Age \\> 18\n* Patient has the psychological ability and general health needed to provide informed consent, completion of study requirements, and required follow-up\n* Patient provides study-specific informed consent prior to study entry\n* All primary histologies (Hepatocellular carcinoma or Cholangiocarcinoma) as well as hepatic metastases are eligible\n* Prior history of radiation therapy (external beam or radioembolization) is allowed, with no limit to the number of prior courses of radiation therapy\n* Any number of lesions (with no size limit) of pathologically documented (histologically or cytologically) or radiographically proven tumor\u002Fmetastasis that are being targeted\n* Prior history of liver resection, transarterial chemoembolization (TACE), or ablation are allowed with no restriction on number of prior therapies, or time from current study registration\n* Prior history of chemotherapy, immunotherapy, or targeted biological therapy is allowed\n* Concurrent enrollment on other prospective registry or treatment intention trials is allowed\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding females\n* Subjects with history of claustrophobia impacting ability to perform MRI during the study\n* Subjects who fulfill any of the contraindications for MRI; examples include any ferromagnetic material, any metallic shrapnel or fragments or implanted electronic devices contained within the body or metal-containing tattoos\n* Unable to participate in MR assessments due to physical limitations of equipment tolerances (MRI bore size and\u002For weight limit)\n* Any person unable to lie still within the environment of the MRI scanner or maintain a breath hold for the required period to acquire images\n\nExclusion criteria for HepQuant SHUNT DuO testing ONLY:\n\n* Known history or suspected hypersensitivity to human serum albumin, or its preparations\n* Subjects with extensive resection of large segments of small intestine (short gut) or severe gastroparesis (e.g., diabetic or medication-induced gastroparesis)\n* Subjects on either a non-selective beta blocker (propranolol, nadolol), or an angiotensin converting enzyme (ACE) inhibitor, or angiotensin receptor blocker (ARB) who are unwilling or unable to delay taking their normal dose the morning of their testing\n* Subjects who are allergic to any ingredient in the formulations or components in the HepQuant SHUNT DuO kit including the human serum albumin (HSA) or cholate compounds (theoretical - none yet reported)\n* Subjects unwilling or unable to fast for at least 5 hours. Fasting means no intake of food or food supplements, including fiber preparations or biosimilars; or any preparations or resins (cholestyramine, colestipol, colesevelam) that might act within the gut lumen to bind the orally administered d4-cholate in the HepQuant test.",{"count":85,"type":23},40,[26],"This is a pilot and feasibility study assessing the role of quantitative multiparametric MRI and blood-based biomarkers for the measurement of liver function in patients receiving radiation therapy for liver cancer, including hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver metastases regardless of primary histology, that are undergoing photon radiation either in the de-novo or re-irradiation setting. The goal of this study is to prospectively evaluate the feasibility of using quantitative multiparametric MRI to monitor liver function at baseline and following liver radiation therapy.",[89,90,91,92,93],"Liver Cancer","Hepatocellular Carcinoma","Hepatocellular Cancer","Cholangiocarcinoma","Liver Metastases",[95,96,97],"Blood-based biomarkers","Quantitative MR imaging","Radiotherapy",{"date":69,"type":42},{"date":100,"type":42},"2025-07-16",{"date":102,"type":23},"2031-07",{"name":48,"class":49},1,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":24,"phases":113,"briefSummary":114,"conditions":115,"keywords":119,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":104},"100467144","efficacy-and-tolerability-of-a-hybrid-fractional-laser-for-the-treatment-of-acne-scars-in-patients-with-skin-of-color-100467144","NCT05362929","Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color","Inclusion Criteria:\n\n* Healthy males and females, ≥ 18 years of age at time of informed consent, seeking treatment for acne scarring\n* Subject must voluntarily sign and date an IRB approved informed consent form\n* Subjects with diagnosis of acne scarring recorded over the past 6 months\n* Able to read, understand and voluntarily provide written informed consent.\n* Subject is determined to be healthy, non-smoker\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* Subjects does not have the capacity to consent to the study\n* Subject underwent any acne scar treatments in the past 6 months prior to enrollment in the study\n* Subject has active papulopustular or cystic acne within the past 6 months\n* Any history of keloidal scarring\n* Any previous surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months\n* History of immunosuppression\u002Fimmune deficiency disorders (including AIDS and HIV infection), and\u002For any history of systemic chemotherapy for prior 12 months\n* Subject has no health contraindications to receiving local lidocaine and epinephrine injections, including but not limited to any form of heart disease or arrhythmia, untreated or uncontrolled severe hypertension, uncontrolled hyperthyroidism, uncontrolled diabetes, pheochromocytoma, cocaine use\n* History or current use of the following prescription medications:\n\nImmunosuppressive medications\u002Fbiologics, 6 months prior to and during the study.\n\nAccutane or other systemic retinoids within the past twelve months TCA, MAO, or beta-blockers\n\n* Smoking or vaping in the past 12 months\n* History of photosensitivity and\u002For connective tissue disease\n* History of 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\n* History of ongoing pregnancy, active breastfeeding, cancer, and epilepsy",{"count":112,"type":23},50,[26],"The investigators aim to investigate the efficacy and tolerability of a hybrid non-ablative\u002Fablative laser for acne scarring in skin of color.",[116,117,118],"Acne Scars - Mixed Atrophic and Hypertrophic","Hyperpigmentation","Laser-Induced Hyperpigmentation",[120,121,122,123,124,125],"skin of color","fitzpatrick skin type III","fitzpatrick skin type IV","fitzpatrick skin type V","acne scarring","sciton",{"date":69,"type":42},{"date":128,"type":42},"2023-10-11",{"date":130,"type":23},"2029-07",{"name":48,"class":49},{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":24,"phases":141,"briefSummary":143,"conditions":144,"keywords":149,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":104},"100439396","prophylactic-antibiotics-useful-with-antibiotic-impregnated-external-ventricular-drains-evds-100439396","NCT05001750","Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?","Are Long Term Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?","Inclusion Criteria:\n\n* patients over the age of 18 years\n* patients diagnosed with a subarachnoid hemorrhage, intracerebral hemorrhage, or acute ischemic stroke who require an EVD for management of their underlying condition. In certain cases (a small minority), an EVD must be replaced due to failure (i.e., blood clot interrupting flow). In such cases, patients will be re-dosed with antibiotics prior to catheter exchange in typical fashion and continue in their previously randomized treatment group\n\nExclusion Criteria:\n\n* patients who were on antibiotics within the week prior to admission\n* patients with leukopenia (\\\u003C5000) at baseline\n* patients with signs of meningitis, ventriculitis or any other infection at presentation\n* patients who are pregnant or prisoners\n* patients aged \\\u003C 18 years old",{"count":140,"type":23},84,[142],"PHASE1","The principal objective of this study is to compare the incidence of ventriculostomy related infections (VRIs) in patients who receive twenty-four hours of antibiotics, beginning no more than sixty minutes prior to EVD placement, to the incidence of VRIs in patients who also receive a pre-procedural dose of antibiotics with continued dosing of antibiotics for the duration of the external ventricular drain (EVD). At this time, the duration of prophylactic antibiotic use with antibiotic impregnated EVDs is unknown.",[145,146,147,148],"Subarachnoid Hemorrhage","Intracerebral Hemorrhage","Ventriculitis, Cerebral","Hydrocephalus",[150,146,151,148],"Subarachnoid hemorrhage","Ventriculitis","2026-08-06",{"date":154,"type":42},"2026-08-10",{"date":156,"type":42},"2021-06-14",{"date":158,"type":23},"2028-08",{"name":48,"class":49},{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":18,"sex":19,"minAge":166,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":24,"phases":169,"briefSummary":170,"conditions":171,"keywords":174,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":179,"leadSponsor":181,"locationsCount":104},"100648328","surgical-recovery-support-pillow-for-spine-surgeries-100648328","NCT07720856","Surgical Recovery Support Pillow for Spine Surgeries","Inclusion Criteria:\n\n* Adult patients who have lumbar fusion surgery, who consent to participate\n\nExclusion Criteria:\n\n* Pediatric patients 18 years old and under","19 Years",{"count":168,"type":23},10,[26],"The present study investigates the feasibility of a support pillow for use after spinal surgical procedures, and more particularly, to protect the midline region of the back following spinal surgery.\n\nExisting cushioning pillows do not accommodate the anatomy of the human back nor the requirements of isolating a vertical spinal incision. For example, donut-style or ring-shaped pillows are designed for entirely different purposes, such as hemorrhoidal relief, and cannot provide the desired spinal relief. As a result, there is no suitable, dedicated support structure that allows a patient to rest on their back while eliminating pressure on the surgical site. Accordingly, there is a need for a device that permits postoperative spinal surgery patients to sit or lie in a supine or reclined position without the surgical incision contacting or being compressed by any supporting surface.",[172,173],"Spine Surgery Complications","Infection",[175],"Post-surgical pillow","2026-08-05",{"date":67,"type":42},{"date":154,"type":23},{"date":180,"type":23},"2026-09-30",{"name":48,"class":49},{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":191,"phases":4,"briefSummary":192,"conditions":193,"keywords":204,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":104},"100562965","cardiovascular-multimodality-imaging-study-100562965","NCT06610019","Cardiovascular Multimodality Imaging Study","Risk Stratification of Ischemic and Non-ischemic Cardiomyopathies in Racial and Ethnic Minority Groups in the Bronx - Cardiovascular Multimodality Imaging Study","Inclusion Criteria:\n\n* Any adult patient (18 years or older) referred for a cardiovascular magnetic resonance (CMR) imaging study in the Montefiore Health System\n\nExclusion Criteria:\n\n* Any patient who does not meet above criteria",{"count":190,"type":23},10000,"OBSERVATIONAL","Determining the etiology of cardiomyopathy is of high clinical importance for optimal treatment strategy and prediction of prognosis. There is increased risk for cardiovascular disease and higher propensity for cardiovascular related mortality among Black and non-Hispanic White patients. Recently, advanced cardiac imaging has become a vital tool in diagnosis and risk stratification of cardiovascular disease. Very limited data is available on the prevalence and characteristics of different cardiovascular diseases in Hispanic and African American minority groups, therefore, studying different racial and ethnic minority groups in the Bronx population is an exceptionally valuable source to determine the prevalence of cardiomyopathies among minority groups along with study survival in this population. This study aims to determine the etiology of cardiovascular disease in a diverse patient population by utilizing various cardiovascular imaging modalities, with a focus on cardiac magnetic resonance (CMR) imaging and to develop risk stratification models by applying advanced cardiovascular imaging markers.",[194,195,196,197,198,199,200,201,202,203],"Non-ischemic Cardiomyopathy","Cardiomyopathies","Hypertrophic Cardiomyopathy","Right Ventricular Arrhythmogenic Cardiomyopathy","Cardiac Amyloidosis","Anderson Fabry Disease","Sarcoidosis","Cancer Therapy-related Cardiac Dysfunction","Ventricular Arrythmia","Heart Failure",[205,206,207],"Cardiovascular Mortalities","Cardiomagnetic Resonance (CMR) Imaging","Prospective",{"date":154,"type":42},{"date":210,"type":42},"2023-05-01",{"date":212,"type":23},"2031-12",{"name":48,"class":49},{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":191,"phases":4,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":230,"locationsCount":75},"100536579","social-determinants-of-health-medication-use-and-quality-of-life-in-inflammatory-bowel-disease-100536579","NCT06266663","Social Determinants of Health, Medication Use, and Quality of Life in Inflammatory Bowel Disease","Inclusion Criteria:\n\n* clinical diagnosis of Crohn's disease, ulcerative colitis, or indeterminate colitis ≥ 3 months investigator confirmed on the basis of supportive clinical data such as colonoscopy, pathology and\u002For radiology\n* age 18 years or older\n* ability to provide informed consent in English or Spanish\n* basic computer proficiency (i.e. to complete online survey)\n\nExclusion Criteria:\n\n* race and ethnicity self-identified as other than Hispanic, Non-Hispanic Black, or Non-Hispanic White",{"count":221,"type":23},400,"Optimizing health related-quality of life (HRQoL) for patients with inflammatory bowel disease (IBD), who often experience a relapsing disease course, is an essential component of care. Improving IBD disease control is linked to increased health-related quality of life. Even as many effective pharmacotherapies to promote disease control are available, evidence suggests that Hispanic and Non-Hispanic Black IBD patients may not receive full benefit from these therapies compared to their Non-Hispanic White counterparts. Underlying mechanisms that contribute to observed disparities in the use of IBD medical therapies are likely multifactorial. Adequate access to treatment has been implicated. Hispanic and Non-Hispanic Black IBD patients are more likely to be Medicaid-insured, and Medicaid insurance has been associated with increased emergency room visits, a proxy for sub-optimal IBD control. Medication adherence has also been proposed as a potential mediating factor. IBD therapies can be time-consuming and costly, which can pose a challenge in achieving medication adherence. While previous studies suggest Black IBD patients have lower medication adherence than Non-Hispanic White patients, it is unclear the extent to which social factors contribute to this observation. The purpose of this study is to evaluate the association between social determinants of health, medication adherence, and HRQoL among Hispanic and Non-Hispanic Black IBD patients. Understanding potentially modifiable psychosocial factors that contribute to medication adherence and HRQoL will provide targets for later intervention towards the goal of health equity.",[224],"Inflammatory Bowel Diseases","2026-08-04",{"date":176,"type":42},{"date":228,"type":42},"2024-04-26",{"date":180,"type":23},{"name":48,"class":49},{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":19,"minAge":238,"maxAge":20,"enrollmentInfo":239,"targetDuration":4,"studyType":24,"phases":241,"briefSummary":242,"conditions":243,"keywords":246,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":254,"leadSponsor":256,"locationsCount":104},"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":240,"type":23},30,[26],"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.",[244,245],"Tonsillectomy","Adenoidectomy",[247,248,249],"Coblator wand","Product performance","Usability","2026-07-30",{"date":252,"type":42},"2026-07-31",{"date":71,"type":23},{"date":255,"type":23},"2027-02",{"name":48,"class":49},{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":24,"phases":267,"briefSummary":269,"conditions":270,"keywords":272,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":280,"leadSponsor":282,"locationsCount":104},"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":266,"type":23},182,[268],"PHASE4","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.",[271],"Asthma",[273,274,275],"dexamethasone","prednisone","randomized controlled trial","2026-07-23",{"date":278,"type":42},"2026-07-24",{"date":276,"type":42},{"date":281,"type":23},"2026-12",{"name":48,"class":49},{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":18,"sex":58,"minAge":20,"maxAge":290,"enrollmentInfo":291,"targetDuration":4,"studyType":24,"phases":293,"briefSummary":294,"conditions":295,"keywords":297,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":302,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":104},"100554674","phase-1-mifepristone-vs-misoprostol-100554674","NCT06502158","Mifepristone vs Misoprostol","Mifepristone Versus Misoprostol for Cervical Preparation Prior to Procedural Abortion at 12 to 16 Weeks' Gestation in an Academic Medical Center: a Randomized Controlled Pilot Trial","Inclusion Criteria:\n\n* English or Spanish-speaking\n* Capacity to consent\n* Seeking induced abortion of a singleton pregnancy between 12 weeks, 0 days and 16 weeks, 6 days (based on age at day of surgery)\n\nExclusion Criteria:\n\n* History of more than two prior Cesarean deliveries\n* Sonographic evidence of placenta previa\n* Sonographic concern for morbidly adherent placenta\n* Prior obstetric hemorrhage requiring transfusion\n* Obstructive cervical or lower uterine segment fibroid\n* Current therapeutic anticoagulation use\n* Cerclage in situ\n* History of more than one prior cervical excisional procedure\n* BMI greater than 50 kg\u002Fm\\^2","45 Years",{"count":292,"type":23},94,[142],"The Investigator team hypothesizes that in a randomized trial comparing mifepristone-alone or misoprostol-alone for cervical preparation for procedural abortions at 12 to 16 weeks in hospital-based care, the proportion of patients who achieve successful cervical dilation will be different between the study groups.",[296],"Cervical Preparation",[298,299,300,301],"Procedural Abortion","Surgical Abortion","Abortion, First Trimester","Cervical Dilators",{"date":278,"type":42},{"date":304,"type":42},"2024-10-31",{"date":306,"type":23},"2027-06",{"name":48,"class":49},{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":18,"sex":316,"minAge":20,"maxAge":317,"enrollmentInfo":318,"targetDuration":4,"studyType":24,"phases":320,"briefSummary":321,"conditions":322,"keywords":324,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":334,"locationsCount":104},"100389298","the-impact-of-dietary-pattern-on-erectile-function-100389298","NCT04349059","The Impact of Dietary Pattern on Erectile Function","The Impact of a Plant-Based Diet Versus an Animal-Based Diet on Erectile Function in Healthy Men With Normal Erectile Function: The ERECTION Study","ERECTION","Inclusion Criteria:\n\n* Subject provides written informed consent and HIPAA authorization in English before any study procedures are conducted.\n* Subject is taking no medical therapy other than: prn MDIs, medication(s) for anxiety, depression, and\u002For ADHD (these medications include, but are not limited to, SSRIs, SNRIs, Stimulants), no change in supplements if applicable.\n\nThe anxiety, depression, and\u002For ADHD will have been controlled (per report of subject) for the last 6 months.\n\n* IIEF score greater or equal to 22\n* Subject will have had penile-sexual intercourse (either vaginal or anal penetration) within 12 weeks of enrollment.\n* Male aged 18-35 years old\n* Lives within commuting distance of Montefiore Health System\n* Subject's significant other (if applicable) agrees to support the subject during the study\n* Subject agrees to photograph and share all items consumed\u002Fdrunk during the dietary intervention\n* Subject agrees to avoid all illicit drugs, NSAIDS, and alcohol for at least two days prior to Rigiscan™ recording and on the days and nights of Rigiscan™ recording\n* Subject agrees to refrain from sexual activity for at least 24 hours prior to Rigiscan™ placement and to have no sexual activity on the days and nights of Rigiscan™ recording.\n* Subject agrees to not view, read, or otherwise consume erotic or pornographic material for 24 hours prior to both the days and nights of Rigiscan™ recording and on the days and nights of Rigiscan™ recording.\n* Subject agrees to not have an orgasm for 24 hours prior to both the days and nights of RigiscanTM recording and on the days and nights of Rigiscan™ recording.\n* Subject agrees to come to Montefiore to undergo Rigiscan™ training\n* Subject agrees to only consume\u002Fdrink permitted food\u002Fbeverages.\n* Subject agrees to attend all in person visits at Montefiore, to begin fasting at 11pm the night before each visit, and to undergo all blood draws\u002Fsalivary\u002Fother testing.\n* Subject agrees to not use mouthwash or mouth rinses or intentionally spit for the entire duration of the study. Subjects will be asked to refrain from using mouthwash for at least 2 days prior to enrollment. Subject agrees to not brush his teeth in the morning of the day of each study visit. Tooth brushing is otherwise permissible.\n* BMI \\\u003C30, BMI \\>=18.5, weight \\>110 lbs.\n* Subject agrees to comply with the study procedures and visits.\n* Subject exercises for at least 15 minutes at least two times per week\n* If exercise is done, subjects will exercise for the same amount of time and at a similar intensity each day of Rigiscan™ testing. Otherwise, no exercise will be performed on Rigiscan™ days.\n* If enrolled, subjects agree to not modify their dietary habits throughout the duration of the study other than during the two evenings and two full days when food is provided.\n\nExclusion Criteria:\n\n* Relevant dietary allergy\n* Vegetarian or Vegan dietary pattern\n* History of an eating disorder and\u002For food addiction\n* Hypertension and or history of hypertension with or without medical treatment. Systolic blood pressure \\> 150mmHg and\u002For diastolic blood pressure \\>100mmHg on Visit one. Heart rate \\>99 on Visit one. Systolic blood pressure \\\u003C 85mmHg and\u002For diastolic blood pressure \\\u003C 50mmHg on Visit one. Heart rate \\\u003C 35 on Visit one.\n* BMI \\>=30, BMI \\\u003C18.5, or weight \\\u003C= 110lbs\n* Known chronic medical disease other than non-inflammatory musculoskeletal disease, asthma, anxiety, depression, and\u002For ADHD.\n\nSubjects who have had changes in the dosage or type of their medication(s) for anxiety, depression, and\u002For ADHD within 3 months of enrollment.\n\nSubjects who have scheduled or planned medication and\u002For medication dose changes during the study period. These medication changes include the initiation of a new medication, discontinuation of a medication, modification of medication dose, and\u002For the route of administration of a medication.\n\nSubjects who are taking benzodiazepines and\u002For beta blockers\n\n* History of kidney disease or hyperkalemia\n* Subject has received an investigational drug within 30 days prior to signing consent\n* Erectile dysfunction\n* Has any condition (e.g., psychiatric illness) or situation that, in the investigator's opinion, may confound the study results, or may interfere significantly with the patient's ability to adhere with study procedures\n* Currently undergoing treatment for Peyronie's Disease\n* Abnormal Testosterone or Thyroid Stimulating Hormone level\n* Treated hypogonadism or hypothyroidism\n* Planned travel during the study\n* The subject is trans-gender\n* History of substance abuse in the last 12 months\n* Illicit drug use, smoking, or vaping within 4 weeks\n* Upper respiratory illness within two weeks on screening\n* If profession requires being on call, no overnight or on call duties during the study\n* Subject reports any communicable skin or venereal disease\n* Subject reports rash or lesion on the penis or surrounding area.\n* STOP-Bang score \\> 2\n* Having the diagnosis of Restless Leg Syndrome.\n* Having insomnia as defined by: Subject with insomnia would have difficulty initiating or maintaining sleep (30 minutes or more at sleep initiation or 30 minutes or more to fall back asleep if wakes during the night). The above occurs at least 3 times per week for at least 1 month. Furthermore, there must be adequate opportunity for sleep and there must be associated morbidity (feels tired during the day). Definition based on: The International Classification of Sleep Disorders - Third Edition (ICSD-3), 2014.","MALE","35 Years",{"count":319,"type":23},46,[26],"The goal of this study is to determine whether erectile function is impacted by dietary patterns in healthy men with normal erectile function.",[323],"Erectile Dysfunction",[325,326,327,328],"Diet","Erectile function","Plant-based","Animal-based","2026-07-22",{"date":278,"type":42},{"date":332,"type":42},"2023-10-30",{"date":281,"type":23},{"name":48,"class":49},{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":24,"phases":343,"briefSummary":344,"conditions":345,"keywords":348,"overallStatus":351,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":4},"100648339","phase-1-talquetamab-and-belantamab-mafodotin-in-relapsedrefractory-multiple-myeloma-tablemm-100648339","NCT07720843","TAlquetamab and BeLantamab Mafodotin in Relapsed\u002FRefractory Multiple Myeloma (TaBleMM)","TaBleMM","Inclusion Criteria:\n\n1. Male or Female subjects \\> 18 years of age\n2. Be willing and able to provide written informed consent prior to any protocol-related procedures including screening evaluations.\n\n   * Must meet 2014 International Myeloma Working Group (IMWG) guideline for diagnosis of Multiple Myeloma (and not smouldering myeloma) Dose Escalation: Participants in dose escalation must have measurable disease as defined by IMWG criteria, or have active bone findings on PET\u002FCT or \\>1 measurable plasmacytoma that can be monitored on other imaging modalities.\n\n     1. Dose Expansion: Participants must have measurable disease by IMWG criteria.\n3. Have been previously treated with at least 1 prior line of MM therapy and have previously been exposed to an Immunomodulatory Drug (IMiD), PI, and CD38 either in combination or as single agents and are relapsed\u002Frefractory or intolerant of prior therapies.\n4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less\n5. Must have adequate organ and hematologic function as defined:\n\n   1. Absolute Neutrophil Count (ANC) \\> 1000 in the absence of growth factor support (granulocyte colony stimulating factor \\[GSCF\\] within 7 days or pegylated granulocyte colony stimulating factor \\[peg-G-CSF\\] within 14 days)\n   2. Hemoglobin \\> 8 g\u002FdL.\n   3. Platelet Count \\> 75 x10\\^9\u002FL in the absence of transfusion support within 7 days.\n   4. Aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT) ≤2.5 × upper limit of normal (ULN); bilirubin ≤1.5 × ULN. Subjects with Gilbert's syndrome may have a bilirubin level \\\u003C3.0 × ULN\n6. Estimated glomerular filtration rate (eGFR) \\> 30 as calculated by the Modified Diet in Renal Disease (MDRD) formula. All prior treatment-related toxicities (as defined by National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI-CTCAE\\] v6.0) must be \\\u003C Grade 1 at the time of enrollment, except for alopecia. Spot urine (albumin\u002Fcreatinine ratios) \\\u003C 500 mg\u002Fg (56mg\u002Fmmol) OR urine dipstick Negative\u002Ftrace (if \\> + only eligible if confirmed \\\u003C500 mg\u002Fkg \\[56mg\u002Fmmol\\] by albumin\u002Fcreatinine ratio \\[spot urine from first void\\])\n7. Sex and contraceptive\u002Fbarrier requirements:\n\n   * Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n   * Female participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n   * A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies:\n\n     * Is not a woman of childbearing potential (WOCBP) OR\n     * Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), preferably with low user dependency during the intervention period and for at least 4 months after the last dose of study intervention, and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.\n     * A WOCBP must have a negative highly sensitive serum pregnancy test within 72 hours before dosing on Cycle 1 Day 1 and agree to use a highly effective method of contraception during the study and for 4 months after the last dose of belantamab mafodotin.\n   * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n   * Nonchildbearing potential is defined as follows (by other than medical reasons):\n\n     * ≥45 years of age and has not had menses for \\>1 year\n     * Participants who have been amenorrheic for \\\u003C2 years without history of a hysterectomy and oophorectomy must have a follicle-stimulating hormone value in the postmenopausal range upon screening evaluation.\n     * Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.\n   * Male participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n   * Male participants are eligible to participate if they agree to the following during the intervention period and for 6 months after the last dose of study treatment to allow for clearance of any altered sperm:\n\n     * Refrain from donating sperm\n     * PLUS either:\n     * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR\n     * Must agree to use contraception\u002Fbarrier as detailed below:\n     * Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \\\u003C1% per year, as when having sexual intercourse with a WOCBP (including pregnant females).\n   * Contraceptive highly recommended during belantamab mafodotin studies\\*\n   * Highly Effective Methods† That Have Low User Dependency\n\n     * Implantable progestogen-only hormone contraception associated with inhibition of ovulation†\n     * Intrauterine device (IUD)\n     * Intrauterine hormone-releasing system (IUS)†\n     * Bilateral tubal occlusion\n     * Vasectomized partner\n   * Note: Vasectomized partner is a highly effective contraceptive method provided that the partner is the sole sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used. Spermatogenesis cycle is approximately 90 days.\n   * Highly Effective Methods† That Are User Dependent\n\n     * Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation‡\n\n       * oral\n       * intravaginal\n       * transdermal\n       * injectable\n     * Progestogen-only hormone contraception associated with inhibition of ovulation\n\n       * oral\n       * injectable\n   * Sexual abstinence\n   * Note: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.\n   * \\*Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for those participating in clinical studies.\n   * †Failure rate of \\\u003C1% per year when used consistently and correctly. Typical use failure rates differ from those when used consistently and correctly.\n   * ‡Male condoms must be used in addition to hormonal contraception. If locally required, in accordance with Clinical Trial Facilitation Group (CTFG) guidelines, acceptable contraceptive methods are limited to those that inhibit ovulation as the primary mode of action.\n   * Note: Periodic abstinence (calendar, sympto-thermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method (LAM) are not acceptable methods of contraception for this study. Male condom and female condom should not be used together (due to risk of failure with friction).\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this trial:\n\nA subject who meets any of the following criteria must not be enrolled on the study:\n\n1. Diagnosis of any of the following:\n\n   1. Amyloidosis\n   2. Plasma Cell Leukemia\n   3. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)\n   4. Myelodysplastic Syndrome, Myeloproliferative Neoplasia, or any other primary hematologic malignancy concurrent with Multiple Myeloma\n   5. Any other history of malignancy other than Multiple Myeloma deemed at high risk of recurrence during study. Indolent cancers (e.g. prostate cancer without radiographic evidence of disease or history of resected local breast cancer on long term hormonal therapy) are acceptable.\n2. Treatment with any of the following:\n\n   1. Systemic anticancer therapy \\\u003C 14 days prior to first dose of study related therapy (Step-Up Dose 1), or \\\u003C30 days for monoclonal antibodies (e.g. anti-CD38 antibodies). mAb for serious conditions unrelated to MM, such as COVID, may be permitted but need to be discussed with the medical monitor.\n   2. Limited field radiotherapy \\\u003C 7 days or extended field radiotherapy \\\u003C 8 weeks prior to C1D1\n   3. Major surgery \\\u003C 4 weeks of the first dose of study drug on C1D1\n   4. Any live or attenuated vaccines within 30 days of C1D1\n3. History of refractoriness to Talquetamab or Belantamab mafodotin\n\n   • Participants who received \\\u003C 3 cycles of Talquetamab time limited therapy such as for bridging to other therapies without evidence of disease progression on treatment will be considered eligible after discussion with medical monitor.\n4. Active central nervous system involvement of disease, unless they are clinically stable for \\> 4 weeks after completing treatment prior to screening (a brain and\u002For other anatomic regions with CNS involvement MRI within 1 month of enrollment is required).\n\n   • Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin or any other components of the study treatment.\n5. Any of the following cardiovascular events within 6 months prior to C1D1:\n\n   1. Known heart failure with reduced left ventricular ejection fraction \\\u003C 45%\n   2. Congestive heart failure New York Heart Association Class III or IV\n   3. Unstable angina pectoris\n   4. Unstable symptomatic ischemic heart disease\n   5. Myocardial infarction\n   6. Uncontrolled hypertension despite appropriate medical therapy\n   7. Ongoing symptomatic cardiac arrhythmias \\> grade 2\n   8. Pulmonary embolism or cerebrovascular events\n   9. Any other serious cardiac condition (e.g. pericardial effusion or restrictive cardiomyopathy)\n   10. Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram abnormalities such as second degree (Mobitz Type II) or third degree atrioventricular (AV) block.\n6. History of autoimmune disease requiring systemic immunosuppressive therapy with daily dose of prednisone \\> 10mg or equivalent doses, or any other form of immunosuppressive therapy.\n7. Any concurrent or uncontrolled medical, comorbid, or psychiatric condition that would, in the opinion of the investigator, limit compliance with study protocols.\n\n   * Female subjects who are actively breastfeeding or pregnant on study start.\n   * Presence of active renal condition (infection, requirement for dialysis, or any other condition that could affect participant's safety).\n   * Active infection requiring treatment.\n   * Evidence of active mucosal or internal bleeding.\n   * Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice. NOTE: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) is acceptable if participant otherwise meets entry criteria.\n   * Current corneal epithelial disease except mild punctuate keratopathy.\n   * Contact lenses are not allowed for participants while they are receiving belantamab mafodotin treatment. Contact lens use may be restarted after discontinuation of belantamab mafodotin treatment, provided the eye-care specialist confirms there are no other contraindications.\n   * HIV considerations:\n   * Participants with known HIV infection are excluded, unless the following criteria are met:\n\n     * Established antiretroviral therapy (ART) for at least 4 weeks and HIV viral load \\\u003C400 copies\u002FmL\n     * CD4+ T-cell (CD4+) counts ≥350 cells\u002FµL\n     * No history of AIDS-defining opportunistic infections within the last 12 months\n   * Note: consideration must be given to ART and prophylactic antimicrobials that may have a drug: drug interaction and\u002For overlapping toxicities with belantamab mafodotin or other combination products as relevant.\n   * Hepatitis B considerations:\n   * Has documented presence of HBsAg and\u002For HBcAb at screening or within 3 months prior to the first dose of study intervention. Participants with hepatitis B will be excluded unless the following criteria can be met:\n\nSerology: HBcAb+ HBsAg- Screening: HBV DNA undetectable During study treatment: Monitoring as per protocol • Antiviral prophylaxis must be given; choice of therapy as per local guidance\n\nSerology: HBsAg+ at screening or within 3 months prior to first dose Screening: HBV DNA undetectable • Highly effective antiviral treatment started at least 4 weeks prior to first dose of study treatment • Baseline imaging per protocol • Participants with cirrhosis are excluded During study treatment: • Antiviral treatment maintained throughout study treatment • Monitoring and management as per protocol\n\n* Hepatitis C considerations:\n* Participants with a positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months before first dose of study treatment are excluded unless the following conditions are met:\n* Participants with a positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative hepatitis C RNA test is obtained.\n* Positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months before first dose of study treatment unless the participant can meet the following criteria:\n* RNA test negative\n* Successful antiviral treatment (usually 8 weeks duration) is required, followed by a negative HCV RNA test after a washout period of at least 4 weeks.\n* Note: Hepatitis RNA testing is optional and participants with a negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing.",{"count":112,"type":23},[142],"This is a Phase 1, open-label dose escalation study evaluating the safety and clinical efficacy of Talquetamab in combination with Belantamab mafodotin for a time-limited interval followed by Belantamab mafodotin and Pomalidomide maintenance.\n\nThe study will enroll subjects with Multiple Myeloma that have previously been treated with at least one prior line of therapy and have been treated with IMiDs, proteasome inhibitors, and anti-CD38 therapies either in combination or as single agent and are relapsed or are refractory to, or intolerant of, established therapies with clinical benefit in Multiple Myeloma.\n\nTalquetamab will be administered with step up dosing on day 1, 3, 5 with or without day 7 pending target dose (TD1) of Talquetamab (Tal) in dose level. Two weeks after TD1, patients will enroll on C1D1 of Tal (TD2) with Belantamab (Bela). Tal will subsequently be dosed every two weeks. Bela will be administered every 8 weeks on D1 of odd numbered cycles or until resolution of any ocular toxicities to grade 1 or better. After 6 cycles of induction, patients may transition to Bela\u002FPom maintenance.",[346,347],"Relapse Multiple Myeloma","Refractory Multiple Myeloma",[349,350],"Minimal Residual Disease","Very Good Partial Response","NOT_YET_RECRUITING","2026-07-17",{"date":329,"type":42},{"date":355,"type":23},"2026-09-01",{"date":357,"type":23},"2032-03",{"name":48,"class":49},{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":24,"phases":368,"briefSummary":369,"conditions":370,"keywords":371,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":104},"100473886","phase-4-low-dose-buprenorphine-initiation-for-opioid-use-disorder-100473886","NCT05450718","Low-dose Buprenorphine Initiation for Opioid Use Disorder","A Pilot Randomized Controlled Trial of Low-dose Buprenorphine Initiation for Opioid Use Disorder","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Any gender, aged 18 years or greater\n4. Opioid Use Disorder (based on Diagnostic and Statistical Manual- Version 5 criteria)\n5. Ability to take sublingual medication\n6. Willingness to adhere to the assigned buprenorphine initiation regimen\n7. Fluency in English or Spanish\n8. For participants of reproductive potential: agreement to use highly effective contraception during study participation\n\nExclusion Criteria:\n\n1. Use of FDA-approved medications for opioid use disorder treatment (within 7 days prior to screening), including methadone, buprenorphine, or naltrexone\n2. Diagnosis of Alcohol Use Disorder, severe or Benzodiazepine Use Disorder, severe (based on Diagnostic and Statistical Manual- Version 5 criteria)\n3. Severe untreated mental illness, meaning psychosis or suicidality\n4. Presence of an acute or chronic medical condition that would make participation medically hazardous\n5. Pregnancy or lactation\n6. Known allergic reactions to buprenorphine or naloxone\n7. Inability to consent due to cognitive impairment",{"count":367,"type":23},70,[268],"The purpose of this study is to test whether low-dose buprenorphine initiation for treatment of opioid use disorder is safe and effective.",[29],[372,373,374,375,376],"micro-induction","microdosing","low-dose initiation","buprenorphine","micro-initiation",{"date":378,"type":42},"2026-07-21",{"date":380,"type":42},"2024-11-11",{"date":382,"type":23},"2027-06-30",{"name":48,"class":49},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":24,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":403,"locationsCount":104},"100455697","scalp-cooling-for-chemotherapy-induced-alopecia-in-patients-of-color-100455697","NCT05213936","Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color","Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color: A Clinical and Mechanistic Study","Inclusion Criteria:\n\n1. Age \\>= 18 years\n2. Female\n3. Hair type 3 (curly) or type 4 (kinky)\n4. Diagnosis of breast cancer or non-small cell lung cancer (NSCLC) or gynecologic cancer stage I-IV\n5. Patient will be starting \\>= 4 cycles of taxane-based chemotherapy treatment for curative intent after enrollment\n\n   a. Concurrent HER, cisplatin, cyclophosphamide therapies and doxorubicin therapies allowed\n6. Eastern Cooperative Oncology Group (ECOG) 0-2: fully active, restrictive in physically strenuous activity, ambulatory and capable of self-care\n\nExclusion Criteria:\n\n1. Hair type other than 3 or 4\n2. Male\n3. Use of hair weave or extensions without plans to remove\n4. Concurrent malignancy including hematologic malignancies (i.e. leukemia or lymphoma)\n5. Alopecia Common Terminology Criteria for Adverse Events \\> grade 1 at baseline\n6. Past chemotherapy administration if past treatment was \\\u003C= 10 years ago\n7. History of migraines or cluster headaches, anorexia, severe anemia, uncontrolled diabetes, hepatitis, thyroid dysfunction, cold urticaria, cold agglutinin disease, scalp metastases\n8. Planned bone marrow ablation chemotherapy or skull irradiation\n9. Pregnant patient",{"count":392,"type":23},41,[26],"The purpose of this study is to evaluate hairstyling techniques aimed at increasing efficacy of scalp cooling in the prevention of chemotherapy-induced alopecia, determine scalp cooling effect on persistent chemotherapy-induced alopecia, and elucidate molecular mechanisms and predictive biomarkers associated with scalp cooling success in patients with skin of color receiving chemotherapy for breast or non-small cell lung cancer.\n\nThis study is being conducted because prior studies have found scalp cooling to be highly effective in preventing hair loss resulting from chemotherapy. However, minority representation was largely limited in completed trials. A recent study found that scalp cooling devices are less efficacious in patients with skin of color, likely because patients with skin of color have hair is predominantly types 3 (curly) and 4 (kinky), which tend to become bulkier when wet and can interfere with scalp cooling cap fitting. The investigators plan to test two techniques aimed at improving scalp cooling efficacy in patients with skin of color through hairstyling methods that minimize hair volume in order to increase cooling cap to scalp contact: 1) cornrows\u002Fbraids\u002Ftwists or 2) water\u002Fconditioner emulsion on hair. Preliminary data show that breast cancer patients with type 3 or 4 hair receiving taxane chemotherapy and scalp cooling using these techniques to prepare the hair for scalp cooling cap fitting all experienced hair preservation. Additionally, the investigators will also assess persistent chemotherapy-induced alopecia outcomes and incidence by following patients up to 6 months after completing treatment. Finally, specific gene expression changes in taxane-induced chemotherapy-induced alopecia in vitro have been described previously. The investigators will test the hypothesis that scalp cooling reverses such changes in chemotherapy-induced alopecia, assess for biomarkers predictive for scalp cooling success, and investigate persistent chemotherapy-induced alopecia molecular mechanisms using non-invasive transcriptome sequencing on plucked hair follicles.",[396],"Alopecia","2026-07-14",{"date":399,"type":42},"2026-07-16",{"date":401,"type":42},"2022-10-24",{"date":255,"type":23},{"name":48,"class":49},{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":24,"phases":412,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":423,"locationsCount":104},"100598790","phase-4-the-effect-of-multimodal-pain-regimen-on-use-of-narcotics-after-rotator-cuff-tear-repair-100598790","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":411,"type":23},130,[268],"The goal of this clinical trial is to understand which group of pain control medications work best in adults after rotator cuff surgery.",[415,416],"Rotator Cuff Repairs","Pain Management","2026-07-10",{"date":419,"type":42},"2026-07-13",{"date":421,"type":42},"2025-07-21",{"date":46,"type":23},{"name":48,"class":49},{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":58,"minAge":20,"maxAge":431,"enrollmentInfo":432,"targetDuration":4,"studyType":24,"phases":434,"briefSummary":435,"conditions":436,"keywords":438,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":104},"100596691","phase-4-paracervical-block-for-pain-reduction-in-saline-infusion-sonograms-100596691","NCT07048769","Paracervical Block for Pain Reduction in Saline Infusion Sonograms","Paracervical Block for Saline Infusion Sonogram in Fertility Evaluation: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Undergoing uterine cavity and tubal patency evaluation via saline infusion sonogram with balloon catheter at Montefiore Institute for Reproductive Medicine and Health\n* Pre-medicated with 600-800 mg ibuprofen taken 30 minutes to 4 hours prior to procedure\n* Able to provide informed consent in English or Spanish\n* Capacity to consent\n\nExclusion Criteria:\n\n* Undergoing uterine cavity evaluation only (without tubal patency assessment)\n* No ibuprofen pre-medication prior to procedure\n* Received misoprostol within 24 hours prior to procedure\n* Known allergy to lidocaine","50 Years",{"count":433,"type":23},246,[268],"Inadequate pain management during gynecologic procedures is a growing women's health concern, especially as it reduces access to care for patients who may subsequently avoid further treatment. Although recent evidence has shown that local anesthesia reduces pain during certain gynecologic procedures, such as intrauterine (IUD) placements, there is still limited evidence on the effectiveness of local anesthesia during saline infusion sonograms (SIS). The SIS is a routine procedure performed during the fertility workup to evaluate the uterus and fallopian tubes. In this study, the investigators are determining if local anesthesia improves the pain experience for women undergoing SIS by randomly assigning 246 women to receive local anesthesia (lidocaine) versus placebo (capped needle pressing against areas where the paracervical block is performed). The investigators will compare their self-reported pain scores at various points in the procedure. If local anesthesia is shown to be effective at reducing pain, this could ultimately improve the patient experience in fertility evaluations moving forward and make this procedure more accessible to all women.",[437],"Pain During Saline Infusion Sonogram",[439,440,441],"paracervical block","saline infusion sonogram","Fertility evaluation","2026-07-08",{"date":444,"type":42},"2026-07-09",{"date":446,"type":42},"2025-07-02",{"date":448,"type":23},"2027-07",{"name":48,"class":49},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":191,"phases":4,"briefSummary":460,"conditions":461,"keywords":463,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":473,"locationsCount":474},"100529511","international-registry-of-intra-arterial-and-endosaccular-flow-diverters-irf-100529511","NCT06174727","International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)","Outcomes of Intra-arterial and Endosaccular Flow Diverters for Treatment of Intracranial Aneurysms - International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)","IRF","Inclusion Criteria:\n\n* Consecutive adult patients (18 years of age or older)\n* Underwent endovascular treatment with one of the following devices:\n\n  a. Endoluminal Flow Diverter Stents: i. Pipeline Flex (Covidien, California, USA) ii. Pipeline Flex with Shield Technology (Covidien) iii. Surpass Streamline (Stryker Neurovascular, California, USA) iv. Surpass Evolve (Stryker) v. Silk flow diverter (Balt Extrusion, Montmorency, France) vi. Flow-Redirection Intraluminal Device (FRED; MicroVention) vii. Flow-Redirection Intraluminal Device X (FRED X; MicroVention) viii. p64 Flow Modulation Device (phenox GmbH) ix. Endovascular clip system (eCLIPs) (eCLIPsTM, eVasc Neurovascular, Vancouver, BC, Canada)\n\n  b. Intrasaccular Flow Disruptors: i. Woven EndoBridge (WEB; MicroVention) ii. Luna\u002FArtisse System (Medtronic) iii. Medina Embolic Device (Medtronic) iv. Contour Neurovascular System (Cerus Endovascular) v. Neqstent Coil Assisted Flow Diverter (Cerus Endovascular) vi. pCONus and pCANvas (phenox GmbH) vii. Nexus Aneurysm Embolization System (EndoStream Medical) viii. CITADEL™ Embolization Device (Balt, USA)\n* Complete medical records and follow-up data available\n\nExclusion Criteria:\n\n* Incomplete procedural or follow-up records\n* Non-flow-diverter or non-flow-disruptor treatments (e.g., coiling-only cases)\n* Aneurysms treated with investigational devices not listed within Inclusion Criteria",{"count":459,"type":23},5000,"This multicenter retrospective cohort study aims to evaluate and compare the technical performance, safety, and clinical outcomes of intracranial aneurysms treated with flow diverter stents and endosaccular flow disruptors.",[462],"Intracranial Aneurysm",[464,465,466,467,468],"Endovascular","Registry","Flow Diverter Stents","Endosaccular Flow Disruptors","Flow Diversion",{"date":417,"type":42},{"date":471,"type":42},"2023-10-01",{"date":448,"type":23},{"name":48,"class":49},13,{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":24,"phases":485,"briefSummary":486,"conditions":487,"keywords":492,"overallStatus":351,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"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":484,"type":23},150,[26],"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.",[488,489,490,491],"Nutrition Aspect of Cancer","Cancer","Dietary Recommendations","Mobile Applications",[493,494,495],"Patient Reported Outcomes","Biomarker","Activity","2026-06-30",{"date":498,"type":42},"2026-07-02",{"date":500,"type":23},"2026-07",{"date":502,"type":23},"2035-07",{"name":48,"class":49},{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":24,"phases":514,"briefSummary":515,"conditions":516,"keywords":520,"overallStatus":351,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":542,"leadSponsor":544,"locationsCount":104},"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":513,"type":23},212,[268],"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.",[517,518,519],"Nausea and Vomiting","Nausea","Vomiting",[521,522,523,524,525,526,527,528,529,530,531,532,533,534,535,536,537],"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":540,"type":42},"2026-06-29",{"date":281,"type":23},{"date":543,"type":23},"2027-09",{"name":48,"class":49},{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":24,"phases":554,"briefSummary":555,"conditions":556,"keywords":558,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":104},"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":553,"type":23},20000,[26],"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.",[557],"Diabetes Mellitus",[559,560,561,562],"Implementation","HbA1c","Multi-component Implementation","Continuous glucose monitoring","2026-06-22",{"date":565,"type":42},"2026-06-23",{"date":567,"type":42},"2026-05-01",{"date":569,"type":23},"2028-05",{"name":48,"class":49},{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":24,"phases":580,"briefSummary":581,"conditions":582,"keywords":584,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":596,"locationsCount":104},"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":579,"type":23},110,[26],"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.",[583],"Low Back Pain, Chronic",[585,586,587,588,589],"Iovera","Radiofrequency ablation","cryoneurolysis","low back pain","lumbar medial branch","2026-06-16",{"date":592,"type":42},"2026-06-17",{"date":594,"type":42},"2026-04-16",{"date":569,"type":23},{"name":48,"class":49},{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":601,"acronym":602,"eligibilityCriteria":603,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":604,"targetDuration":4,"studyType":24,"phases":605,"briefSummary":606,"conditions":607,"keywords":4,"overallStatus":351,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":610,"startDateStruct":611,"completionDateStruct":612,"leadSponsor":614,"locationsCount":104},"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":85,"type":23},[26],"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.",[608,609,224],"Crohn's Disease","Ulcerative Colitis",{"date":592,"type":42},{"date":448,"type":23},{"date":613,"type":23},"2028-09",{"name":48,"class":49},{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":621,"eligibilityCriteria":622,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":623,"enrollmentInfo":624,"targetDuration":4,"studyType":24,"phases":626,"briefSummary":627,"conditions":628,"keywords":631,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":638,"leadSponsor":639,"locationsCount":104},"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":625,"type":23},20,[26],"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.",[629,630],"Post Traumatic Stress Disorder (PTSD)","HIV",[630,632,633],"psychotherapy","trauma","2026-06-10",{"date":636,"type":42},"2026-06-12",{"date":228,"type":42},{"date":306,"type":23},{"name":48,"class":49},{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":4,"eligibilityCriteria":646,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":647,"enrollmentInfo":648,"targetDuration":4,"studyType":24,"phases":649,"briefSummary":650,"conditions":651,"keywords":654,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":657,"lastUpdatePostDateStruct":658,"startDateStruct":660,"completionDateStruct":662,"leadSponsor":664,"locationsCount":104},"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":168,"type":23},[26],"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.",[652,653],"Scarring Alopecia","Androgenetic Alopecia",[655,656],"alopecia","laser","2026-06-09",{"date":659,"type":42},"2026-06-11",{"date":661,"type":42},"2023-12-07",{"date":663,"type":23},"2028-07",{"name":48,"class":49},""]