[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Medstar Health Research Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":656},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,54,79,105,134,161,183,204,226,255,279,298,319,348,376,400,422,443,472,499,535,562,586,609,634],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100643017","early-phase-1-coupled-gentamicin-lactobacillus-rhamnosus-in-nlutd-100643017",false,"NCT07643974","Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD","Effect of Dose Timing of Coupled Intravesical Gentamicin and Lactobacillus Rhamnosus LGG on Success and Length of Colonization in Men and Women With SCI\u002FD and NLUTD","Inclusion Criteria:\n\n* Neurologic diagnosis\n* ≥18 years old\n* Neurogenic bladder for at least 6 months\n* No USQNB-IC A, B1, or B2 symptoms\n* No currently diagnosed UTI (within 24 hours of initiating instillations)\n* Community dwelling (not in acute hospital setting)\n\nExclusion Criteria:\n\n* Known genitourinary pathology beyond NLUTD (i.e. kidney stones, bladder stones, vesicoureteral reflux, etc.)\n* Use of prophylactic antibiotics or any antibiotics within 2 weeks of beginning instillations\n* Instillation of intravesical agents other than saline bladder wash\n* Immunodeficiency\n* Psychologic or psychiatric conditions influencing the ability to follow instructions\n* Allergy to ampicillin, daptomycin, gentamicin\u002Fgentamycin, or probiotics\n* Participation in another study which could confound results","ALL","18 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","The main objective of the proposed research study is to determine in men and women with spinal cord injury\u002Fdisease and neurogenic bladder whether the dose of coupled gentamicin \\& Lactobacillus rhamnosus GG affects the recolonization of the bladder, and whether the rate of success differs by sex. Secondary objectives include determining whether that recolonization lasts 7, 14, or 28 days; and safety of the coupled gentamicin \\& Lactobacillus instillations.",[27,28,29,30,31,32],"Spinal Cord Injury","Neurogenic Bladder (NB)","Neurogenic Lower Urinary Tract Dysfunction","Multiple Sclerosis","Spina Bifida","Urinary Tract Infection(UTI)",[34,35,36,37,38,39,40],"gentamicin","gentamycin","lactobacillus","spinal cord injury","spinal cord disease","urinary tract infection","neurogenic bladder","NOT_YET_RECRUITING","2026-06-08",{"date":44,"type":45},"2026-06-12","ACTUAL",{"date":47,"type":21},"2026-06",{"date":49,"type":21},"2027-09",{"name":51,"class":52},"Medstar Health Research Institute","OTHER",2,{"id":55,"slug":56,"hasResults":12,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100617432","intervention-for-chronic-insufficient-sleep-in-young-adult-cancer-patients-and-survivors-100617432","NCT07318545","Intervention for Chronic Insufficient Sleep in Young Adult Cancer Patients and Survivors","Intervention for Chronic Insufficient Sleep in Young Adult Cancer Patients and Survivors: Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18-42 at time of enrollment\n* history of cancer diagnosis (any type) diagnosed at\u002Fafter age 15, received all treatment before age 40\n* at least 6 months from date of cancer diagnosis\n* history of chronic sleep disorder with Insomnia Severity Index \\>\u002F= 8\n\nExclusion Criteria:\n\n* Refusal to try the study intervention\n* diagnosed untreated obstructive sleep apnea syndrome, or restless leg syndrome\n* narcolepsy, schizophrenia, bi-polar disorder, and\u002For poorly controlled psychiatric diagnoses\n* disease-related prognosis of less than 6 months or currently enrolled in hospice care\n* planned travel out of the continental United States during the study period.","42 Years",{"count":63,"type":21},74,[65],"NA","Young adult cancer survivors (YACS) commonly experience chronic insomnia due to many factors such as cancer related symptoms, effects of anti-cancer therapies, co-morbid mood disorders, and\u002For other psychosocial and economic stressors. Cognitive behavioral therapy for insomnia (CBT-I) is the gold standard for insomnia management but remains challenging to deliver to patients due to limited numbers of trained therapists, inconvenient scheduling availability, or prohibitive therapy costs. To address this critical gap in young adult cancer survivorship, the investigators propose to develop and test efficacy of the More Sleep Hours Electronic Education Program (More SHEEP), a novel system of smart speaker, smart lighting, and specialized Wi-Fi router that delivers AI-driven CBT-I to patients at home.",[68],"Cancer",[70,71],"Young adult","Cancer survivor",{"date":73,"type":45},"2026-06-09",{"date":75,"type":21},"2026-09-01",{"date":77,"type":21},"2028-05-31",{"name":51,"class":52},{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":87,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100564844","pomegranate-trial-comparing-reia-pessary-versus-standard-of-care-pessary-for-pelvic-organ-prolapse-treatment-100564844","NCT06634459","POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment","The POMEGRANATE Trial: A Randomized Controlled Trial Comparing Pessary Home Management of Reia Pessary Versus Standard of Care Pessary for Treatment of Pelvic Organ Prolapse","POMEGRANATE","Inclusion Criteria:\n\n* English-speaking natal females ≥ 18 years of age\n* Willing to self-maintain (insert\u002Fremove) pessary\n* Pessary naïve with Stage II-IV POP desiring conservative management with a pessary\n* Primary indication for use of pessary is treatment of pelvic organ prolapse\n\nExclusion Criteria:\n\n* Primary indication for pessary use is for management of stress urinary incontinence\n* Prior mesh-augmented prolapse repair (i.e. transvaginal mesh, sacrocolpopexy)\n* Short vaginal length (TVL \\\u003C 8cm) or subjective vaginal narrowing\n* Vaginal fistula (e.g. rectovaginal, vesicovaginal or any type of fistula involving the vagina)\n* Vaginal, rectal or bladder malignancy\n* Genitourinary infection requiring treatment (See below 1)\n* Ongoing treatment for vaginal infections (e.g., chronic bacterial vaginosis) (See below 2)\n* Inflammatory bowel disease (Crohn's or ulcerative colitis)\n* Pelvic or anorectal chronic pain\n* Pelvic floor surgery within the past 6 months or planning to undergo pelvic floor surgery\n* Congenital malformation of the bladder, rectum or vagina\n* Pregnant or planning pregnancy in the next 6 months\n* Prior failure of pessary for POP\n* History of hydroureter, hydronephrosis, or impaired renal function secondary to prolapse\n\n  1. Patients with acute vaginal infections will be eligible for enrollment 2 weeks after completing treatment with resolution of symptoms\n  2. OK to be on prophylactic\u002Fsuppressive therapy for HSV","FEMALE",{"count":89,"type":21},218,[65],"This multi-centered, randomized controlled trial will evaluate the safety and efficacy of home use of the novel Reia System (RS), which includes the Reia pessary and applicator, compared to standard pessary care (Gellhorn or ring with\u002Fwithout support without knob) among women with stage II-IV pelvic organ prolapse (POP). A total of 200 participants will be recruited among pessary naïve patients who are symptomatic and choose a vaginal pessary for management of their POP from study sites specializing in Urogynecology and Reconstructive Pelvic Surgery (URPS). Participants will be assigned via 1:1 randomization using computer generated numbers in permutated groups of variable block sizes to either the intervention (the Reia System, RS) or standard pessary care (SPC) stratified by site. Participation in this trial will involve a total of four visits over six months. The primary outcome measure will be satisfaction measured at the six-month time point. Secondary outcomes will include validated surveys to assess quality of life, number of self-management events, ease\u002Fdifficulty of pessary insertion\u002Fremoval, importance of ability to self-manage pessary, and adverse events.\n\nSpecific Aims\n\nAim 1: To compare satisfaction with pessary use and management between subjects randomized to the Reia System and those randomized to standard of care pessary.\n\nAim 2: To assess successful fitting, number of refitting visits, number of self-management events and continued pessary use over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.\n\nAim 3: To compare ease\u002Fdifficulty of pessary use and importance of ability to self-manage, as well as quality of life over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.\n\nAim 4: To measure rates of adverse events and risk factors for adverse events over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.",[93,94],"Pelvic Organ Prolapse","Prolapse","RECRUITING","2026-04-08",{"date":98,"type":45},"2026-04-13",{"date":100,"type":45},"2024-11-01",{"date":102,"type":21},"2026-10-30",{"name":51,"class":52},9,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":122,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":53},"100627230","palliative-care-intervention-to-improve-health-related-quality-of-life-for-patients-on-long-term-lvad-support-100627230","NCT07445932","Palliative Care Intervention to Improve Health Related Quality of Life for Patients on Long-Term LVAD Support","The PALL-VAD Study: Palliative Care Intervention to Improve Health Related Quality of Life for Patients With Heart Failure on Long-Term LVAD Support: A Pilot, Prospective, Randomized Trial","PALL-VAD","Inclusion Criteria:\n\n* LVAD patients \\>= 18 years of age\n* \\>= 1 year post-LVAD implantation\n\nExclusion Criteria:\n\n* Listed for heart transplantation. Undergoing evaluation for heart transplantation, however, is not an exclusion.\n* Non-English speaking\n* Receiving outpatient palliative care in the last 6 months\n* Renal replacement therapy\n* Non-cardiac terminal illness\n* Women who are pregnant or planning to become pregnant\n* Inability to comply with study protocol and follow up\n* Inabilty to provide consent.\n* Cognitive impairment or intellectual disability that prohibits successful completion of the HRQoL scales or compliance with the study protocol and follow up.",{"count":114,"type":21},90,[65],"Background: While left ventricular assist device (LVAD) therapy improves survival in patients with advanced heart failure (AHF), unique LVAD-related burdens may impact health-related quality of life (HRQoL). Palliative care specialists are key members of the multidisciplinary care team for patients with long-term-LVAD (LT-LVAD), offering specialized, comprehensive, holistic care.\n\nProblem: A seminal study of palliative care in patients with heart failure (PAL-HF trial) demonstrated that outpatient palliative care improved HRQoL, depression, anxiety, and spiritual well-being compared to usual care. The impact of longitudinal palliative care on HRQoL in LT-LVAD patients is unknown.\n\nObjective: The investigators aim to conduct the first study examining a palliative care intervention to improve HRQoL among LT- LVAD recipients (patients who have lived with LT-LVAD for at least six months and are not heart transplant candidates) at two centers (MedStar Health and Inova) in the Mid-Atlantic Region. Given the demographics of the study institutions, the investigators anticipate a socioeconomically and racially diverse cohort of patients with subgroups who may disproportionately experience LVAD-related burdens relative to benefits.\n\nAims: The first aim is to assess baseline measures of HRQoL in LT-LVAD patients to understand differences in HRQoL across subgroups and multiple, understudied domains. The second aim is to test the feasibility and acceptability of a randomized, unblinded pilot study of a palliative care interdisciplinary intervention in this population.\n\nSignificance: Results of this study will inform the development of a large randomized controlled trial to test the effectiveness of palliative care intervention in improving HRQoL in LT-LVAD patients. If results are positive, this will revolutionize the post-LVAD treatment paradigm, by making palliative care integration the standard of care for longitudinal LT-LVAD patient management.",[118,119,120,121],"Advanced Heart Failure","Mechanical Circulatory Support","Left Ventricular Assist Device","Palliative Care",[123,124,125],"advanced heart failure","left ventricular assist device","palliative care","2026-02-25",{"date":128,"type":45},"2026-03-03",{"date":130,"type":21},"2026-03-01",{"date":132,"type":21},"2027-03-01",{"name":51,"class":52},{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":87,"minAge":18,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":149,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":4},"100625310","pilot-study-of-intrapartum-insulin-pump-100625310","NCT07420972","Pilot Study of Intrapartum Insulin Pump","Pilot Study of Intrapartum Insulin Pump Use: Feasibility, Efficacy and Safety","Inclusion Criteria:\n\n* Singleton gestation\n* Established Type 1 or 2 diabetes mellitus\n* Use of continuous subcutaneous insulin infusion for ≥2 months prior to delivery, -Demonstrated cognitive ability to self-manage insulin, familiarity with pump technology, availability of necessary supplies, stable clinical status\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Planned cesarean delivery without labor\n* Significant comorbidities affecting insulin requirements (e.g., steroid therapy)\n* Stillbirth prior to presenting for delivery\n* Known severe fetal anomalies.",{"count":142,"type":21},30,[65],"People with type 1 or type 2 diabetes often use insulin pumps to manage their blood sugar during pregnancy. These pumps can help keep blood sugar in a healthy range. However, when people come to the hospital to give birth, they are often asked to stop using their insulin pump and switch to insulin given through an IV. This change can be stressful and may make blood sugar harder to control during labor. There is not enough research to know if it is safe and practical for people to keep using their insulin pump while in labor.\n\nThe goal of this study is to learn whether it is safe, practical, and acceptable for pregnant people with diabetes to continue using their insulin pump during labor. The study will also look at how this approach compares to standard care, which uses IV insulin.\n\nThis is a small pilot study. About 30 pregnant people with type 1 or type 2 diabetes will take part. All participants already use an insulin pump and receive care through the MedStar Diabetes in Pregnancy Program. Participants will be allowed to continue using their own insulin pump during labor, following a hospital safety plan. Their outcomes will be compared to similar patients from the past who used IV insulin during labor.\n\nThe main focus of the study is to see how often people can safely stay on their insulin pump during labor and how well this approach fits into hospital care. The study will also collect information about blood sugar levels during labor and health outcomes for newborns, such as low blood sugar, breathing problems, or need for care in the neonatal intensive care unit. These outcomes are being studied to help plan future research.\n\nAfter delivery, participants will be asked to share their experience. This includes how satisfied they were with their diabetes care during labor, how much control they felt over their care, and how difficult or easy the treatment was to manage. Nurses and doctors will also provide feedback about caring for patients who use insulin pumps during labor.\n\nParticipants will continue to check their blood sugar using continuous glucose monitoring, with fingerstick checks when needed. If any safety concerns arise, such as blood sugar levels that are too high or too low, participants will switch to standard IV insulin.\n\nThis study is not meant to prove that one method is better than another. Instead, it will help researchers decide whether a larger study should be done in the future. The long-term goal is to improve diabetes care during labor and support safe, patient-centered options for people with diabetes and their babies.",[146,147,148],"Diabetes","Diabetes (Insulin-requiring, Type 1 or Type 2)","Pregnancy",[150,146,151,152,148],"Insulin pump","Type 1 diabetes","Labor","2026-02-11",{"date":155,"type":45},"2026-02-19",{"date":157,"type":21},"2026-04",{"date":159,"type":21},"2028-04",{"name":51,"class":52},{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":170,"phases":4,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":181,"locationsCount":182},"100622974","patient-and-caregiver-perspectives-on-intravesical-instillations-for-urinary-symptoms-100622974","NCT07390591","Patient and Caregiver Perspectives on Intravesical Instillations for Urinary Symptoms","Intravesical Gentamicin Coupled With Lactobacillus Rhamnosus for Urinary Health- Early Career","Inclusion Criteria:\n\nCriteria for patients:\n\n* Age 18+\n* Diagnosis of NLUTD\n* Chronic catheter usage (minimum 6 months), either intermittent catheterization or indwelling catheter\n* Community-dwelling\n* Experience using intravesical Lactobacillus, gentamicin, or combination of the two\n\nCriteria for caregivers:\n\n* Age 18+\n* Care for patient with diagnosis of NLUTD\n* Care for patient who has used catheters chronically (minimum 6 months)\n* Experience facilitating patients' use of intravesical Lactobacillus, gentamicin, or combination of the two\n\nExclusion Criteria:\n\n* Psychiatric or psychologic conditions impacting ability to consent",{"count":169,"type":21},60,"OBSERVATIONAL","The goal of this observational qualitative study is to learn about the experiences and perspectives of patients with neurogenic lower urinary tract dysfunction (NLUTD) and their caregivers regarding different types of intravesical instillations used for urinary health. The study aims to understand the perceived benefits, challenges, and opportunities related to Lactobacillus-only, gentamicin-only, and combined gentamicin-Lactobacillus instillations. The main question this study seeks to answer is:\n\n1\\. Determine patient and caregivers' preferences, and overall experiences regarding intravesical therapeutics for urinary symptoms and UTI\n\nResearchers will compare responses from four groups: participants who have used Lactobacillus-only instillations, gentamicin-only instillations, combined gentamicin-Lactobacillus instillations, and caregivers who have experience supporting instillations.\n\nParticipants will take part in a one-hour semi-structured interview and may be contacted for brief follow-up discussions to clarify findings. Interviews will be audio-recorded, transcribed, and analyzed using qualitative data software to identify themes related to treatment preferences and acceptability.",[173,29,174],"Spinal Cord Injuries","Neurogenic Bladder","2026-01-28",{"date":177,"type":45},"2026-02-05",{"date":179,"type":45},"2025-06-19",{"date":49,"type":21},{"name":51,"class":52},1,{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":170,"phases":4,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":182},"100610123","diagnostic-journey-patient-experience-and-disparities-in-the-treatment-of-spinal-muscular-atrophy-sma-in-the-medstar-health-system-100610123","NCT07223489","Diagnostic Journey, Patient Experience, and Disparities in the Treatment of Spinal Muscular Atrophy (SMA) in the MedStar Health System","Understanding the Diagnostic Pathway and Treatment Experience of Patients With Spinal Muscular Atrophy (SMA)","SMA","Inclusion Criteria:\n\n* SMA diagnosis, age greater than or equal to 18 years\n\nExclusion Criteria:\n\n* Deceased",{"count":192,"type":21},200,"Evaluate the diagnostic journey, patient experience, and disparities in the treatment of Spinal Muscular Atrophy (SMA) in the MedStar Health System.",[195],"Spinal Muscular Atrophy (SMA)","2026-01-14",{"date":198,"type":45},"2026-01-16",{"date":200,"type":45},"2025-10-10",{"date":202,"type":21},"2026-12-30",{"name":51,"class":52},{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":182},"100618901","comparing-collared-and-collarless-femoral-stems-in-primary-total-hip-arthroplasty-100618901","NCT07337642","Comparing Collared and Collarless Femoral Stems in Primary Total Hip Arthroplasty","Comparing Collared and Collarless Femoral Stems in Total Hip Arthroplasty","Inclusion Criteria:\n\n* Adults (≥ 18 years old) scheduled for primary, uncemented THA using a cementless femoral stem\n* Diagnosis of primary osteoarthritis or other non-inflammatory degenerative joint disease.\n* Ability and willingness to comply with study procedures and follow-up schedule.\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Patients not indicated for a cementless THA\n* Prior surgery on the ipsilateral hip (e.g., prior THA, internal fixation, osteotomy)\n* Use of cemented or hybrid femoral components.\n* Revision THA or conversion THA\n* Active or prior infection of the hip joint.\n* Severe osteoporosis (T-score ≤ -2.5) or known metabolic bone disease.\n* Inability to complete follow-up or anticipated relocation out of the area.","99 Years",{"count":213,"type":21},100,[65],"This is a prospective randomized control trial comparing two collared and collarless femoral implants used in primary total hip arthroplasty. The specific aims of this trial are to:\n\nSA1: Prospectively assess clinical outcomes in patients undergoing primary total hip arthroplasty with a collared versus collarless femoral stem of the same design.\n\nSA2: Evaluate serial radiographs to quantify differences in subsidence between collared and collarless implant groups.\n\nSA3: Report and compare incidence rates of intraoperative and postoperative periprosthetic fractures and aseptic loosening following primary total hip arthroplasty with use of either a collared or collarless stem.\n\nHypothesis: The addition of a collar to the same designed triple-taper primary hip stem will lead to a reduction in subsidence and incidence of perioperative and periprosthetic femur fractures.",[217],"Primary Total Hip Arthroplasty","2026-01-12",{"date":220,"type":45},"2026-01-13",{"date":222,"type":45},"2025-12-03",{"date":224,"type":21},"2027-12-31",{"name":51,"class":52},{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":237,"conditions":238,"keywords":241,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":53},"100617430","cognitive-behavioral-theory-assisted-virtual-reality-for-chronic-cancer-pain-vr-can-100617430","NCT07318519","Cognitive Behavioral Theory-assisted Virtual Reality for Chronic CANcer Pain (VR-CAN)","Cognitive Behavioral Theory-assisted Virtual Reality for Chronic Cancer Pain (VR-CAN): Device Prototype Development and Feasibility Testing","VR-CAN","Inclusion Criteria:\n\n* age at least 18 years old\n* cancer diagnosis, undergoing treatment\n* chronic cancer pain (i.e., cancer pain at least 3 months duration) with baseline pain severity at least 4\u002F10 (where 0=no pain, 10=worst pain)\n\nExclusion Criteria:\n\n* intractable nausea\u002Fvomiting, motion sickness, seizures\u002Fepilepsy, and\u002For cranial structures\u002Fabnormalities preventing VR headset use\n* moderate-severe pain of non-cancer etiology\n* enrolled in another pain study\n* unable to complete survey measures or interviews in English or Spanish",{"count":235,"type":21},40,[65],"While chronic cancer pain affecting as many as 75% of patients is typically addressed using pharmacologic interventions, experts and patients alike support maximizing any relevant non-pharmacologic interventions as well, such as cognitive behavioral therapy. Virtual reality, a novel technology that can temporarily immerse users in a calm, pleasant environment, has been increasingly shown to facilitate improvement in different acute and chronic pain syndromes by providing distraction from pain and lowering pain sensation. To address the significant needs of patients living with chronic cancer pain, we aim to develop and pilot test a prototype device that will leverage cognitive behavioral therapy principles to deliver a novel virtual reality pain therapy. The investigators will do this through the following steps:\n\nStep 1. Develop and refine a CBT-assisted VR prototype for patients with chronic cancer pain (VR-CAN).\n\nStep 2. Conduct a randomized controlled trial to examine the feasibility, acceptability, usability, safety, and initial clinical impact of the developed VR-CAN prototype compared to a tablet-based two-dimensional video control group.\n\nStep 3. Collect and evaluate qualitative post-intervention data on VR-CAN participants' preferences, thoughts, and feelings about the VR-CAN technology and protocol to optimize for a future, larger, fully powered randomized controlled trial.",[68,239,240],"Cancer Pain","Chronic Cancer Pain",[242,243,244,245,246],"cancer","pain","chronic pain","cognitive behavioral therapy","virtual reality","2026-01-02",{"date":249,"type":45},"2026-01-06",{"date":251,"type":45},"2025-07-01",{"date":253,"type":21},"2027-05-31",{"name":51,"class":52},{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":267,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":182},"100610499","digital-intervention-for-symptom-management-in-cancer-and-opioid-sparing-using-virtual-reality-discovr-study-100610499","NCT07228377","Digital Intervention for Symptom Management in Cancer and Opioid Sparing Using Virtual Reality (DISCOVR) Study","Digital Intervention for Symptom Management in Cancer and Opioid Sparing Using Virtual Reality (DISCOVR) - Feasibility, Acceptability, Usability Testing of a Novel Intervention","DISCOVR","Inclusion Criteria:\n\n* age ≥18 years old\n* living with active cancer diagnosis (any solid tumor type)\n* report chronic cancer pain (≥3 months) with baseline severity moderate-severe (i.e., self-report pain score (SRPS) ≥4\u002F10, where 0=no pain, 10=worst pain)\n* prescribed chronic opioid therapies (may be long-acting formulations, short-acting formulations, or both)\n\nExclusion Criteria:\n\n* history of intractable nausea\u002Fvomiting, motion sickness, seizures\u002Fepilepsy, and\u002For cranial structure abnormalities preventing VR headset use\n* moderate-severe pain of non-cancer etiology (e.g., chronic lumbago)\n* enrolled in another pain study\n* unable to complete surveys in English or Spanish.",{"count":7,"type":21},[65],"Patients living with cancer commonly have chronic pain due to the disease or to cancer treatments. Virtual reality, a new technology that immerses the user in pleasant, diverting, and exciting virtual environments, may lower chronic cancer pain to improve quality of life and complement need for pain medications like opioids. The investigators aim to learn from patients about the experience of cancer pain, develop a virtual reality prototype specific to cancer pain management, and test the feasibility and acceptability of this technology to improve the cancer pain experience.",[68],[268,244,269,246,270],"cancer pain","opioid","technology","2025-12-22",{"date":273,"type":45},"2025-12-24",{"date":275,"type":45},"2025-12-01",{"date":277,"type":21},"2026-08-31",{"name":51,"class":52},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":182},"100616684","early-phase-1-intravesical-lactobacillus-crispatus-clinical-safety-and-microbiome-evaluation-100616684","NCT07308808","Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome Evaluation","Inclusion Criteria:\n\n* Age ≥ 18 years\n* SCI with at least 6-month duration\n* NLUTD\n* Utilizing intermittent catheterization for bladder management\n* Community dwelling\n\nExclusion Criteria:\n\n* Use of prophylactic antibiotics\n* Instillation of intravesical antimicrobials to prevent UTI\n* Psychological or psychiatric conditions influencing the ability to follow instructions\n* Use of oral or IV antibiotics in the past 2 weeks\n* Pregnancy\n* Known genitourinary pathology beyond NLUTD\n* Participation in another study that could confound results of the proposed study",{"count":235,"type":21},[24],"The goal of this clinical trial is to determine whether Lactobacillus crispatus strains isolated from the lower urinary tracts of adult women can be used as an antibiotic-sparing treatment for urinary symptoms and urinary tract infection (UTI) among adults with neurogenic lower urinary tract dysfunction (NLUTD). The main question\\[s\\] it aims to answer are:\n\n1. To identify soluble bactericidal compounds produced by urinary isolates of L. crispatus that kill uropathogenic E. coli (UPEC).\n2. To determine if intravesical instillation of L. crispatus is safe and well tolerated in adults with NLUTD due to SCI who use intermittent catheterization (IC).\n\nIf there is a comparison group: Researchers will compare L. Crispatus to standard care saline to see if there is a difference in urinary symptoms and urinary microbiome.\n\nParticipants will be asked to complete daily symptom surveys, complete 2 bladder instillations, and collect, freeze, and return 14 urine samples.",[289,174,290],"Spinal Cord Injuries (SCI)","Urinary Tract Infection (Diagnosis)",{"date":292,"type":45},"2025-12-30",{"date":294,"type":45},"2025-09-09",{"date":296,"type":21},"2027-03-30",{"name":51,"class":52},{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":306,"briefSummary":308,"conditions":309,"keywords":312,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":314,"startDateStruct":315,"completionDateStruct":316,"leadSponsor":318,"locationsCount":182},"100616084","phase-4-rimegepant-as-preemptive-treatment-for-predictable-trigger-induced-migraine-in-adult-patients-in-the-us-100616084","NCT07301008","Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US","RIM","Inclusion Criteria:\n\n* Patients with at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders-3 (ICHD-3)\n* Men and women ≥ 18 years old .\n* Average of 2-8 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the screening visit\n* Headache\u002Fmigraine onset before age 50 years\n* Migraine attacks, on average, lasting 4-72 hours if untreated\n* At least 48 hours between migraine attacks\n* Ability to distinguish migraine attacks from tension or cluster headaches\n* Particpants on SOC treatment should be on stable regimen for at least 3 months prior to enrollment and should not change their regimen during the course of the study\n* Participant may have been on treatment with Botox or mAbs for the last 6 months\n* Participants experience migraine ≥75% of the time following exposure to a trigger during the run-in period. Acceptable triggers include exercise, alcohol ( less than one drink per day for woman and less than two drinks per day for men), air travel that lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours, stress or weekend\u002F let-down\n\nExclusion Criteria:\n\n* Using gepants as preventive treatment (atogepant once daily (QD) or rimegepant every other day (EOD)), or using zavegepant or ubrogepant as an acute treatment\n* History of use of narcotic or barbiturate containing medications, including opioids (e.g., morphine, codeine, oxycodone, and hydrocodone) on ≥5 days per month on a regular basis for ≥3 months prior to screening\n* Current evidence of uncontrolled, unstable, or recently diagnosed cardiovascular disease, uncontrolled hypertension, or uncontrolled diabetes.\n* Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder.\n* Women must not be pregnant, lactating or breastfeeding",{"count":169,"type":21},[307],"PHASE4","Single-center, open label, prospective study conducted at Medstar Georgetown Headache Center. Men and woman ≥ 18 years old that are diagnosed with migraine with or without aura for at least 1 year, who report a reliable migraine trigger. Acceptable triggers for the study will include exercise, alcohol (less than one drink per day for woman and less than two drinks per day for men), air travel that lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours, stress or stress let-down headache.",[310,311],"Migraine","Trigger Induced Migraine",[313],"Trigger- induced migraine",{"date":273,"type":45},{"date":294,"type":45},{"date":317,"type":21},"2027-01",{"name":51,"class":52},{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":87,"minAge":327,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":22,"phases":330,"briefSummary":331,"conditions":332,"keywords":338,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":347},"100577357","approve-trial-evaluating-a-prescription-digital-therapeutic-for-treatment-of-oab-in-women-100577357","NCT06797245","APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women","The APPROVE Trial: A Randomized Controlled Trial Evaluating the Efficacy and Safety of a Prescription Digital Therapeutic for Treatment of Overactive Bladder in Women","APPROVE","Inclusion Criteria:\n\n* Women ≥ 22 years old\n* Bothersome OAB symptoms (defined as bother rating ≥ 5 on ICIQ-FLUTS question #3b or #9b)\n* English-speaking\n* Willing to forego other treatment outside of medications for the 8-week trial period\n* Use of at least one mobile App\n\nExclusion Criteria:\n\n* Stress-predominant mixed urinary incontinence (defined as QUID stress score \\> QUID urge score)\n* Voiding dysfunction defined as response ≥ 2 on ICIQ-FLUTS question #7a\n* Bladder pain defined as response ≥ 2 on ICIQ-FLUTS question #4a\n* Use of an OAB medication (anticholinergic or beta-agonist) within the past two weeks\n* Currently using intermittent or indwelling catheter\n* History of bladder\u002Furethral, colon\u002Fanal, or cervical cancer\n* Current or prior use of sacral neuromodulation, tibial stimulation or onabotulinum toxin type A intradetrusor injection\n* Currently taking antibiotics\u002Fdrugs for urinary tract infection\\^\n* Currently undergoing or unwilling to forego pelvic floor physical therapy with a physical therapist or prescription device for the 8-week intervention period\n* Planning surgery for pelvic organ prolapse within 12 months of randomization\n* Pelvic surgery within the past 6 months\n* Planning to undergo pessary fitting °\n\n  * Those on antibiotics for urinary tract infection will be eligible for enrollment 2 weeks after completing antibiotic therapy with subjective resolution of UTI symptoms °Will be eligible after completing pessary fitting\n\nhttps:\u002F\u002Fresearchdata.medstar.net\u002Fredcap\u002Fsurveys\u002F?s=MM7WN7EXACX4PNXJ","22 Years",{"count":329,"type":21},596,[65],"The APPROVE trial is a multi-centered, randomized controlled trial designed to assess differences in symptom improvement, quality of life, bladder symptoms, satisfaction with treatment and continued treatment efficacy in women with overactive bladder (OAB) randomized to a prescription digital therapeutic (PDTx) app called RiSolve compared to standard behavioral education (handouts).",[333,334,335,336,337],"Overactive Bladder (OAB)","Urinary Urgency","Urinary Urge Incontinence (UUI)","Nocturia","Urinary Frequency",[333],"2025-10-24",{"date":341,"type":45},"2025-10-27",{"date":343,"type":45},"2025-03-17",{"date":345,"type":21},"2028-07",{"name":51,"class":52},10,{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":87,"minAge":18,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":22,"phases":357,"briefSummary":358,"conditions":359,"keywords":365,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":182},"100571838","npwt-reduction-mammaplasty-100571838","NCT06725459","NPWT Reduction Mammaplasty","Assessing the Application of Closed Incision Negative Pressure Wound Therapy to Reduction Mammaplasty","Inclusion Criteria:\n\n* Female patients\n* Age 18 years or older\n* Scheduled to undergo bilateral reduction mammaplasty with a Wise pattern (anchor) incision and a superomedial, inferior, or central mound pedicle at MedStar Georgetown University Hospital or MedStar Good Samaritan Hospital\n* Able to comply with study procedures and follow-up visits\n\nExclusion Criteria:\n\n* Younger than 18 years of age\n* Biologically male patients\n* Scheduled to undergo unilateral breast mammaplasty\n* Currently pregnant or lactating\n* Use of steroids or other immune modulators known to affect wound healing\n* Current smokers who have not paused for a minimum of 4 weeks prior to surgery\n* History of breast cancer\n* History of oncologic or reconstructive breast surgery\n* History of radiation to the breast\n* History of chemotherapy or hormone therapy\n* Tattoos in the area of skin incision\n* Skin conditions known to affect wound healing or scarring of the breast (e.g., cutis laxa)\n* Significant history of scar problems (e.g., hypertrophic scarring or keloids) post-surgical incisions with active bleeding\n* Exposure of blood vessels, organs, bone, or tendon at the base of the reference wound\n* Known allergies to product components (e.g., medical or NPWT tape)\n* Unable to comply with NPWT requirements, including those unable to present for postoperative follow-up\n* Lactating at the time of surgery\n* Require deviation from standard operative or closure techniques (e.g., staples, free nipple grafts)\n* Considered part of a vulnerable population (adults unable to consent, infants, children, teenagers, pregnant women, prisoners)\n* Experience intraoperative complications due to surgical complications not related to the NPWT instrumentation (e.g., expanding hematoma)",{"count":356,"type":21},92,[65],"In this prospective, randomized, split-body control trial, we aim to compare complications, patient-reported outcomes, and cost differentials following reduction mammaplasty with prophylactic closed incision negative pressure wound therapy versus standard adhesive dressing.",[360,361,362,363,364],"Healthy","Macromastia","Negative Pressure Therapy","Mammaplasty","Wound Healing",[366,367,368,369],"mammaplasty","macromastia","breast reduction","negative pressure therapy",{"date":341,"type":45},{"date":372,"type":45},"2024-12-17",{"date":374,"type":21},"2026-11-01",{"name":51,"class":52},{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":384,"briefSummary":386,"conditions":387,"keywords":388,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":182},"100387361","phase-2-intravesical-lactobacillus-for-urinary-symptoms-among-people-with-nlutd-who-use-indwelling-catheters-100387361","NCT04323735","Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters","Inclusion Criteria:\n\n* Neurogenic bladder for at least 6 months;\n* Utilizing indwelling catheterization for bladder management;\n* Women must be premenopausal and not currently menstruating;\n* Community dwelling\n* physical disability\n\nExclusion Criteria:\n\n* Use of prophylactic antibiotics;\n* Instillation of intravesical antimicrobials to prevent UTI;\n* Psychologic or psychiatric conditions influencing the ability to follow instructions;\n* Use of oral or IV antibiotics within the past 2 weeks;\n* Sexual activity within the previous 72 hours;\n* Participation in another study with which results could be confounded.",{"count":383,"type":21},182,[385],"PHASE2","The objectives of the proposed research among this population are: 1) to define clinically meaningful change (i.e. differentiating states of health and illness) with respect to urinary symptoms, urine inflammation, cultivable bacteria, and the urine ecosystem; and 2) to determine the optimal intravesical Lactobacillus RhamnosusGG (LGG®) dose to be used to reduce urinary symptoms in a future clinical trial.",[174],[389,390,391],"Indwelling catheter","Foley catheter","Suprapubic Catheter","2025-10-20",{"date":394,"type":45},"2025-10-22",{"date":396,"type":45},"2020-01-10",{"date":398,"type":21},"2026-09",{"name":51,"class":52},{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":22,"phases":409,"briefSummary":410,"conditions":411,"keywords":412,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":182},"100456970","phase-2-intravesical-lgg-vs-saline-bladder-wash-rct-100456970","NCT05230511","Intravesical LGG VS Saline Bladder Wash RCT","Intravesical Lactobacillus rhamnosusGG Versus Saline Bladder Wash: A Randomized, Controlled, Comparative Effectiveness Clinical Trial","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. SCI at least 6 months duration;\n3. NLUTD (as determined by their SCI physician or urologist);\n4. Utilizing intermittent catheterization for bladder management; and\n5. Community dwelling (discharged from the acute care setting).\n\nExclusion Criteria:\n\n1. Known genitourinary pathology beyond neuropathic bladder (i.e., vesicoureteral reflux, bladder or kidney stones, etc.);\n2. Use of prophylactic antibiotics;\n3. Instillation of intravesical agents (e.g., gentamycin, saline; or Lactobacillus);\n4. Immunodeficiency;\n5. Any oral antibiotics within the past 2 weeks;\n6. Psychologic or psychiatric conditions influencing the ability to follow instructions;\n7. Participation in another study in which results would be confounded;\n8. 6 months since prior exposure to intravesical LGG®; and\n9. Active cancer (or within 5 years) or active autoimmune disorder",{"count":408,"type":21},120,[385],"This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI).",[173,174],[413],"Intermittent Catheter","2025-08-25",{"date":416,"type":45},"2025-08-29",{"date":418,"type":45},"2022-06-13",{"date":420,"type":21},"2026-12-31",{"name":51,"class":52},{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":430,"targetDuration":432,"studyType":170,"phases":4,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":442},"100419049","mitral-valve-screening-survey-100419049","NCT04736667","Mitral Valve Screening Survey","Mitral Valve Screening Survey (MVSS)","MVSS","Inclusion Criteria:\n\n* Subject failed screening for TMVI\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Subject unable or unwilling to give informed consent\n* Subject proceeded with TMVI.",{"count":431,"type":21},1000,"5 Years","This study aims to examine the clinical profile\u002Fanatomical characteristics and natural history of patients who subsequently fail screening for transcatheter mitral valve intervention (TMVI).",[435],"Mitral Valve Disease",{"date":416,"type":45},{"date":438,"type":45},"2021-08-06",{"date":440,"type":21},"2027-02",{"name":51,"class":52},16,{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":87,"minAge":18,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":22,"phases":452,"briefSummary":453,"conditions":454,"keywords":459,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":182},"100592080","assessment-of-tubal-occlusion-during-minimally-invasive-myomectomy-100592080","NCT06988774","Assessment of Tubal Occlusion During Minimally Invasive Myomectomy","ATOM","Inclusion Criteria:\n\n* Patients undergoing minimally invasive laparoscopic or robotic-assisted uterine-preserving gynecologic surgery for removal of uterine fibroids (myomectomy) by a minimally invasive gynecologic surgeon at MedStar.\n\nExclusion Criteria:\n\n* Patients with both fallopian tubes absent\n* Patients in whom it is not possible to place a uterine manipulator or catheter\n* Patient with known tubal disease or occlusion, or patients who have undergone prior tubal surgery\n* Patients with allergy to methylene blue dye or G6PD deficiency\n* Patients with positive pregnancy test on day of surgery",{"count":451,"type":21},50,[65],"This study uses a procedure called chromopertubation to look at how fibroids and fibroid surgery affect the fallopian tubes. Specifically, this study will test if the fallopian tubes are occluded or patent (open) before and after surgically removing fibroids.\n\nChromopertubation is a commonly performed and well-established procedure that is done during laparoscopic surgery to determine if the fallopian tubes are open or blocked. It includes inserting a dilute solution of saline with a small amount of medical-grade blue dye (called methylene blue) into the uterine cavity to see if it spills out of the fallopian tubes. Chromopertubation is considered a safe procedure - the main risk is an allergic reaction to the dye, which is very rare. The minimum amount of methylene blue dye will be used to further reduce risks of a reaction.\n\nOpen fallopian tubes are necessary to become pregnant without the use of IVF. While it is known that some conditions can affect the functioning of the fallopian tubes, there is a lack of research about how fibroids affect the tubes. It is also not known how much about how the process of removing fibroids may affect the fallopian tubes. The investigators hypothesize that tubal occlusion will be observed in patients with fibroids and that the frequency of tubal occlusion will change after myomectomy compared to pre-myomectomy.\n\nThis study will be conducted entirely during planned surgery for laparoscopic myomectomy. Chromopertubation will be performed at the beginning and again at the end of the surgery. This is expected to take less than 10 minutes in total. The results of the chromopertubation as well as background medical information will be recorded and the characteristics of the fibroids (size, number, and location) will be compared to the presence or abscence of tubal occlusion as determined by chromopertubation.",[455,456,457,458],"Fallopian Tube Patency Tests","Fibroid\u002FMyoma (Uterus\u002FCervix)","Myomectomy","Fallopian Tube Disease",[460,461,462,463],"chromopertubation","myomectomy","uterine fibroids","fallopian tube disease","2025-06-25",{"date":466,"type":45},"2025-06-29",{"date":468,"type":45},"2025-06-02",{"date":470,"type":21},"2026-04-30",{"name":51,"class":52},{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":22,"phases":480,"briefSummary":481,"conditions":482,"keywords":486,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":498,"locationsCount":182},"100576560","paraffin-wax-and-exercise-prospective-100576560","NCT06786884","Paraffin Wax and Exercise Prospective","A Pilot, Randomized Controlled Trial Evaluating the Effectiveness of Paraffin Wax On Burn Patient Function, Range of Motion and Scar","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients with burn scar that crosses an upper or lower extremity joint (shoulder, elbow, wrist, hand, hip, knee, ankle)\n* Patients that have been prescribed a rehabilitation program where paraffin wax could be used as an adjunct to rehab exercise therapy\n\nExclusion Criteria:\n\n* Adults unable to provide informed consent\n* Injury etiology other than burn (ex: cutaneous trauma, cold injury, etc.)\n* Pregnant women\n* Prisoners",{"count":142,"type":21},[65],"This study is being done to test if paraffin wax can be used to improve the range of motion and function for scars across joints when used in combination with scar rehabilitation therapy sessions. For those randomized to receive it, the paraffin wax will be used alongside the participants' exercise therapy treatments. Currently, treatments that are used in addition to rehabilitation therapy for increasing range of motion across joints in the burn population are limited. By getting more information about how paraffin wax may or may not work, patients in the future that have scars may be able to be helped.",[483,484,485],"Burn","Scar","Exercise Therapy",[487,488,489,490,491],"paraffin wax","burn scar","scar","burn","range of motion","2025-06-10",{"date":494,"type":45},"2025-06-13",{"date":496,"type":45},"2025-01-06",{"date":440,"type":21},{"name":51,"class":52},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":87,"minAge":18,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":22,"phases":508,"briefSummary":509,"conditions":510,"keywords":517,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":182},"100580670","vibrating-vs-traditional-therapy-for-treatment-of-entry-dyspareunia-100580670","NCT06840314","VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia","VIBRENT- VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia","VIBRENT","Inclusion Criteria:\n\n* Assigned female at birth\n* Age ≥ 18 years old\n* Genito-pelvic pain\u002Fpenetration disorder (per ICD-10 diagnosis codes: F52.5 Vaginismus not due to a substance or known physiological condition, F52.6 Dyspareunia not due to a substance or known physiological condition, N94.1 Dyspareunia, N94.2 Vaginismus, N94.81 Vulvodynia)\n\nExclusion Criteria:\n\n* Current or prior use of a therapeutic vaginal device used to treat GPPPD\n* Unmanaged genitourinary syndrome of menopause\n* History of pelvic radiation\n* History of genital tract malignancy\n* History of female genital mutilation\n* History of prior surgery for prolapse or incontinence, including vaginal mesh or midurethral sling mesh\n* Silicone allergy",{"count":169,"type":21},[65],"The goal of this randomized controlled trial is to determine whether the use of a novel vibrating pelvic floor therapeutic device (\"Kiwi\") improves sexual function in sexually active women aged 18 and older with genito-pelvic pain and penetration disorder (GPPPD) more effectively than traditional vaginal dilators.\n\nThe main questions it aims to answer are:\n\n1. Does the use of the Kiwi device lead to higher sexual function scores compared to traditional vaginal dilators\n2. Does the Kiwi device improve sexual distress, pain, and overall symptom severity more effectively than traditional vaginal dilators?\n\nResearchers will compare the Kiwi vibrating device to traditional cylindrical vaginal dilators to assess whether the Kiwi device results in greater improvements in sexual function and symptom relief.\n\nParticipants will:\n\n* Be randomly assigned to use either the Kiwi device or traditional vaginal dilators.\n* Use the assigned device three times per week for 15 minutes per session over four weeks.\n* Complete surveys before and after the study, including assessments of sexual function, pain, and overall improvement.",[511,512,513,514,515,516],"Genito-Pelvic Pain\u002FPenetration Disorder","Dyspareunia","Vaginismus","Pelvic Pain","Vestibulodynia","Vulvodynia (Chronic Vulvar Pain)",[518,519,520,521,522,523,524,525,526],"genito-pelvic pain\u002Fpenetration disorder","dyspareunia","entry dyspareunia","vaginismus","pelvic pain","female sexual function","pain with sex","vulvodynia","vestibulodynia","2025-05-16",{"date":529,"type":45},"2025-05-21",{"date":531,"type":45},"2025-03-01",{"date":533,"type":21},"2026-03",{"name":51,"class":52},{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":539,"acronym":540,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":542,"targetDuration":4,"studyType":22,"phases":544,"briefSummary":545,"conditions":546,"keywords":551,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":561,"locationsCount":53},"100530741","remote-symptom-collection-to-improve-postoperative-care-100530741","NCT06190730","REmote Symptom COllection to improVE postopeRative Care","RECOVER","Inclusion criteria\n\n1. At least 18 years old. Ages of subjects \\>89 will simply be reported as \\>90.\n2. Scheduled for a GI surgery for management of a tumor in a participating hospital.\n3. Fluent in oral and written English.\n4. Has consistent and continued full access to an operational Wi-Fi for the duration of the study.\n\nExclusion criteria\n\n1. Unable to provide informed consent.\n2. Not willing to commit to regular participation in the study to include daily use (40 days) of the study application.\n3. Life expectancy of less than 60 days.\n4. In the opinion of the investigator, participation in this study is contraindicated.",{"count":543,"type":21},281,[65],"There are vulnerabilities in post-discharge care transition for patients after undergoing resection of malignant gastrointestinal tumors. This study aims to investigate the possibility of utilizing Voice-Assisted Remote Symptom Monitoring System (VARSMS) to alleviate some of these challenges.",[547,548,549,550],"Gastrointestinal Cancer","Gastrointestinal Tumor","Gastrointestinal Tumor Surgery","Gastrointestinal Surgery",[552,553,554],"speech system","large language model","ai","2025-03-31",{"date":557,"type":45},"2025-04-03",{"date":559,"type":45},"2024-07-23",{"date":224,"type":21},{"name":51,"class":52},{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":568,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":570,"enrollmentInfo":571,"targetDuration":4,"studyType":22,"phases":573,"briefSummary":574,"conditions":575,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":582,"completionDateStruct":583,"leadSponsor":585,"locationsCount":4},"100546851","randomized-evaluation-for-failed-tavr-100546851","NCT06400342","Randomized Evaluation for Failed TAVR","Randomized Evaluation of Valve-In-Valve Versus Explantation for Failed TAVR (REVIVE-TAVR)","REVIVE-TAVR","Inclusion Criteria:\n\n* Heart Team has confirmed eligibility for both TAVR-explant and redo-TAVR for failed THV\n* Subject is symptomatic from their failed THV, as demonstrated by NYHA Functional Class ≥II\n* Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits\n* Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.\n\nExclusion Criteria:\n\n* Ongoing sepsis, including active endocarditis;\n* Severe dementia (resulting in either inability to provide informed consent for the trial\u002Fprocedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);\n* Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams;\n* Pregnancy or intent to become pregnant for the next 12 months;\n\nCoronary obstruction risk:\n\n\\- Patients at risk of coronary obstruction may be enrolled into the randomized cohort if the operators determine that redo-TAVR can be safely accomplished with leaflet modification or other coronary protection strategies.","100 Years",{"count":572,"type":21},264,[65],"REVIVE TAVR is an acronym for the Randomized Evaluation of Valve-In-Valve versus Explantation for failed TAVR. This is a prospective, multicenter, global randomized trial investigating the safety and efficacy of reintervention for transcatheter heart valve (THV) failure by comparing redo-TAVR (TAV-in-TAV) with TAVR surgical explantation (TAVR-explant) in subjects who are suitable for both options in a real-world clinical setting",[576,577,578],"Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure","Prosthetic Valve Malfunction","Prosthesis Failure","2025-01-21",{"date":581,"type":45},"2025-01-24",{"date":531,"type":21},{"date":584,"type":21},"2036-05-01",{"name":51,"class":52},{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":592,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":17,"minAge":594,"maxAge":4,"enrollmentInfo":595,"targetDuration":4,"studyType":22,"phases":597,"briefSummary":598,"conditions":599,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":182},"100576558","hand-exoskeleton-training-study-100576558","NCT06786858","Hand Exoskeleton Training Study","Home Training for Upper Limb Stroke Rehabilitation Using a Hand Exoskeleton","HandMATE","Inclusion Criteria:\n\n* Age of 21 or older\n* diagnosis of stroke more than 6 months prior confirmed from MRI or CT\n* voluntary hand activity (score of 1 or more, finger extension item, Fugl-Meyer Test)\n* adequate cognitive status\n* Impaired ability to open affected hand\n\nExclusion Criteria:\n\n* hemispatial neglect\n* severe sensory loss (2 or more on the sensory item, NIH Stroke Scale\u002FScore)\n* receiving or planning to receive antispasticity medications during enrollment into the study\n* less than full passive range of motion in finger joints\n* receiving physical or occupational therapy outside of study protocols\n* have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols","21 Years",{"count":596,"type":21},15,[65],"The goal of this study is to evaluate the HandMATE device's effectiveness in the rehabilitation of stroke patients and asses if the HandMATE application is received well by stroke survivors.\n\nParticipants will use the HandMate device in clinic and in the home. They will also complete clinical upper extremity assessments.",[600],"Stroke","2025-01-15",{"date":603,"type":45},"2025-01-22",{"date":605,"type":45},"2022-01-04",{"date":607,"type":21},"2025-01-31",{"name":51,"class":52},{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":4,"eligibilityCriteria":615,"healthyVolunteers":616,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":617,"targetDuration":4,"studyType":170,"phases":4,"briefSummary":619,"conditions":620,"keywords":622,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":53},"100439891","regenerative-peripheral-nerve-interfaces-to-treat-painful-digit-and-hand-neuromas-after-amputation-100439891","NCT05008185","Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation","Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation: A Prospective Observational Trial\"","Inclusion Criteria:\n\n* 18 years or older\n* History of unilateral digit, multiple digit, or partial hand amputation\n* Discrete neuroma pain on clinical exam\n* Following standard of care (SOC), confirmation through a local block and\u002For ultrasound imaging will be performed if indicated\n* Must be seen by a hand therapist for at least 6-week trial of desensitization therapy\n\nExclusion Criteria:\n\n* Patients with previous surgical treatment for symptomatic neuromas of the digits or hand\n* Patients with other major injuries more proximal in the ipsilateral extremity that cause chronic pain or functional loss\n* women pregnant at time of enrollment\n* prisoners\n* adults who are unable to consent",true,{"count":618,"type":21},80,"This study is being done to demonstrate the effectiveness of Regenerative Peripheral Nerve Interfaces (RPNI) surgery in treating symptomatic neuromas of the hand and digits following amputation compared to standard of care using a Prospective, Observational Trial",[621],"Neuroma",[621,623,624,625],"Neuroma Pain","Finger Amputation","Hand Amputation","2024-11-26",{"date":628,"type":45},"2024-11-29",{"date":630,"type":45},"2021-10-05",{"date":632,"type":21},"2025-08",{"name":51,"class":52},{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":640,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":642,"enrollmentInfo":643,"targetDuration":4,"studyType":22,"phases":644,"briefSummary":645,"conditions":646,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":651,"completionDateStruct":653,"leadSponsor":654,"locationsCount":655},"100550312","optimal-pacing-rate-for-cardiac-resynchronization-therapy-100550312","NCT06445439","Optimal Pacing Rate for Cardiac Resynchronization Therapy","Optimal Pacing Rate for Cardiac Resynchronization Therapy After Atrioventricular Node Ablation in Persistent Atrial Fibrillation and Heart Failure","OPT-RATE AF","Inclusion Criteria:\n\n1. Age 18 years or older\n2. History of persistent or permanent atrial fibrillation\n3. Implantation of CRT or conduction system pacing in prior 3 months to 5 years of study start\n4. History of intrinsic AVN block or have undergone AVN ablation in prior 3 months to 5 years of study start\n5. LVEF ≥ 50%\n6. N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\>400 pg\u002FmL in the last 24 months\n7. Clinical HF diagnosis or NYHA class II or higher\n8. Able to provide informed consent\n\nExclusion Criteria:\n\n1. LVEF \\\u003C50%\n2. Wide QRS (greater than 150ms)\n3. Isolated RV pacing\n4. Severe valvular disease\n5. Severe coronary artery disease as defined by one of the following:\n\n   1. ACS or PCI within 1 year\n   2. Any angina (CCS class 1+)\n   3. Unrevascularizable severe CAD (\\>70% stenosis in 1+ major vessels and\u002For based on functional assessment)\n6. ESRD\n7. Significant primary pulmonary disease on home oxygen\n8. Major orthopedic issues, such as being wheelchair bound and\u002For unable to perform a six-minute walk test\n9. Ventricular ectopy \\>15% premature ventricular contractions (PVC)\n10. End stage cancer diagnosis\n11. Life expectancy less than one year\n12. Palliative or hospice care\n13. Hypertrophic cardiomyopathy (HCM)\n14. Uncorrected ventricular septal defect\n15. Infiltrative cardiomyopathy (CM)\n16. Uncontrolled hypertension as defined by blood pressure \\>160\u002F100 mm Hg on two measurements ≥15 minutes apart\n17. Hemoglobin \\\u003C7 g\u002FdL\n18. Age \\>90 years old\n19. Pregnant or intends to become pregnant","90 Years",{"count":169,"type":21},[65],"This is a prospective, randomized crossover study. The objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves exercise tolerance during the 6-minute walk test. The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa.",[647],"Atrial Fibrillation, Persistent","2024-10-09",{"date":650,"type":45},"2024-10-15",{"date":652,"type":45},"2023-12-19",{"date":632,"type":21},{"name":51,"class":52},5,""]