[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Inova Health Care Services\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":526},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,46,69,88,114,137,159,181,200,222,244,266,289,312,339,360,383,403,425,447,472,494,507],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100053503","pragmatic-trial-of-messaging-to-providers-about-treatment-of-heart-failure-at-inova-100053503",false,"NCT05433220","PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure at Inova","PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure (PROMPT-HF) at Inova","PROMPTHF-Inova","Inclusion Criteria:\n\n* Age\\>18 Years\n* Seen by a Cardiologist in an Inova clinic or Inova hospital setting\n* Left Ventricular Ejection Fraction ≤40%\n\nExclusion Criteria:\n\n* Opted out of EHR-based research\n* Hospice care\n* Already receiving maximally titrated doses of each of the four classes of evidence- based HFrEF medical therapy\n* Prior heart transplant","ALL","18 Years",{"count":20,"type":21},5000,"ESTIMATED","INTERVENTIONAL",[24],"NA","A randomized, single-blind intervention trial to test the comparative effectiveness of an electronic health record best practice advisory system that informs clinicians of guideline-indicated and FDA-approved heart failure medications currently not prescribed to their patients with heart failure versus usual care (no alert and how things are done currently). The purpose of the alert is to stimulate appropriate medication prescription for patients with heart failure and a reduced ejection fraction. This will be done across outpatient Inova clinics and at the five Inova hospitals.",[27],"Heart Failure",[27,29,30,31,32],"GDMT","NYHA","HFrEF","Implementation","RECRUITING","2026-07-10",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":37},"2022-08-25",{"date":41,"type":21},"2027-08-25",{"name":43,"class":44},"Inova Health Care Services","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":45},"100630257","burn-pit-exposure-in-veterans-a-cancer-screening-pilot-study-at-the-inova-saville-cancer-screening--prevention-center-100630257","NCT07485322","Burn Pit Exposure in Veterans: A Cancer Screening Pilot Study at the Inova Saville Cancer Screening & Prevention Center","Inclusion Criteria:\n\n* ≥ 35 years\n* Veteran of the United States Armed Forces (retired\u002Fno longer enlisted) with a prior deployment resulting in exposure (based on self-report or official records, if available) to burn pits for \\>1 week (exposure defined as on the base or close enough to the base to see the smoke from the burn pit, an area of land used for the open-air combustion of trash and other solid waste products).\n* Ability to understand and willing to sign informed consent\n* Ability to understand and willing to sign HIPAA Authorization\n\nExclusion Criteria:\n\n* No history of malignancy within the past 5 years (non-melanoma skin cancer and in situ carcinoma would still be eligible) and not currently being worked up clinically for suspicion of cancer.\n* For women of childbearing potential, not pregnant.",true,"35 Years","85 Years",{"count":56,"type":21},100,[24],"The goal of this study is to determine the feasibility and participant satisfaction associated with a more intensive cancer screening regimen in veterans exposed to burn pits. The study results may describe the clinical and psychosocial impact such screening has on this potential population. The study hopes to share the premalignant and malignant findings identified and follow-up healthcare utilization associated with high-intensity cancer screening during the approximately 3-year study period (three annual screening assessments and an additional year of follow-up to determine participants' cancer status). The study will also explore the performance of new tools (nasal brush, multi-cancer detection blood test, and radiomic analysis) in detecting the development of cancer during the study period.",[60],"Cancer","2026-06-30",{"date":63,"type":37},"2026-07-02",{"date":65,"type":37},"2026-06-17",{"date":67,"type":21},"2029-07-31",{"name":43,"class":44},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":45},"100587682","occupational-cancer-screening-in-firefighters-a-pilot-study-within-the-inova-health-system-100587682","NCT06931561","Occupational Cancer Screening in Firefighters: A Pilot Study Within the Inova Health System","Inclusion Criteria:\n\n* Age ≥ 35 years old\n* at least 10 cumulative years working as a firefighter\n* Actively serving as a firefighter (active or volunteer) with completion of NFPA physical examination within the past 6 months\n* Ability to understand and willing to sign informed consent\n* Ability to understand and willing to sign the Health Insurance Portability and Accountability Act (HIPAA) Authorization\n* Additional eligibility criteria in protocol\n\nExclusion Criteria:\n\n* No prior history of any invasive cancer within the previous 5 years (non-melanoma skin cancer and in situ carcinoma would still be eligible) and no current diagnostic workup for suspicion of cancer\n* Received a whole-body MRI, whole-body ultrasound, or been tested with a MCD within the past 1-year\n* For women of childbearing potential, pregnancy and no plans for pregnancy for the duration of the study\n* Additional exclusion criteria in protocol",{"count":76,"type":21},800,[24],"The purpose of this study is to further understand the clinical impact and follow-up steps that may be required based on using whole-body Magnetic Resonance Imaging (MRI) or whole-body ultrasound and blood tests to detect multiple cancers in firefighters.\n\nThis study involves an investigational test (cancer blood test) that has not been approved by the U.S. Food and Drug Administration (FDA).\n\nWhole-body MRI and whole-body ultrasound are approved by the U.S. Food and Drug Administration (FDA) to be used in the diagnosis of some cancers and is approved for adults and children who present other signs of potential disease. In this study, however, the whole-body MRI and the whole-body ultrasound are considered investigational devices because they are not yet approved for use in healthy adults with no other cancer indications.",[60],"2026-06-10",{"date":82,"type":37},"2026-06-12",{"date":84,"type":37},"2025-02-11",{"date":86,"type":21},"2028-09-30",{"name":43,"class":44},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":52,"sex":96,"minAge":18,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},"100514376","hemoglobin-testing-in-pregnant-patients-100514376","NCT05977686","Hemoglobin Testing in Pregnant Patients","Point-Of-Care Anemia Testing in Pregnant Patients - A Prospective Observational Study","AnemiaPOC","Inclusion Criteria:\n\n* Pregnant women ages 18-50 years old\n\nExclusion Criteria:\n\n* Patients with hemoglobinopathies (qualitative defects, sickle-cell anemia) and hemoglobin synthesis disorders (quantitative defects such as thalassemia)\n* Patients with peripheral vascular diseases and skin conditions that affect blood vessels in the digit\n* Patients with hyperbilirubinemia","FEMALE","50 Years",{"count":99,"type":21},250,"OBSERVATIONAL","The project is a prospective observational study aimed to assess and to validate the use of point-of-care hemoglobin testing in pregnancy. Point-of-care hemoglobin testing has the potential to (1) increase access to hemoglobin monitoring in pregnancy in low resource settings, (2) increase availability of hemoglobin monitoring in anemic patients, and (3) provide immediate results for real-time patient counseling and intervention. However, to date, point-of-care hemoglobin testing devices have not yet been studied for use in an ambulatory obstetric population. The Masimo device is a Root Radical 7 Pulse CO-Oximeter, manufactured by Masimo, Inc. This device is non-invasive and placed externally on a patient's finger to generate an estimation of a patient's hemoglobin value. The HemoCue® device is a minimally-invasive device that relies on the finger prick method to get a capillary hemoglobin measurement, and The Rubby is a mobile application based platform that uses a photo of the participants nailbed to estimate hemoglobin values. Participants in this study will be approached at the Obstetrics and Gynecology clinics at George Washington Medical Faculty Associates. Point-of-care hemoglobin measurements will be assessed using the non-invasive Masimo device along with minimally-invasive hemoglobin HemoCue® Hb 801 device and compared to traditional venipuncture hemoglobin testing.",[103,104],"Post Partum Hemorrhage","Anemia of Pregnancy","2026-04-21",{"date":107,"type":37},"2026-04-23",{"date":109,"type":37},"2025-12-03",{"date":111,"type":21},"2026-12",{"name":43,"class":44},2,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":121,"enrollmentInfo":122,"targetDuration":123,"studyType":100,"phases":4,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},"100588311","optimal-adult-heart-transplant-immunosuppression-with-microrna-levels-100588311","NCT06939751","OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels","OPTIMAL","Inclusion Criteria:\n\n* Age ≥ 18 years at enrollment\n* Receipt of orthotopic heart transplant (OHT) within the prior 1 month ± 2 weeks\n* Planned follow-up at the transplant center for a minimum of one-year.\n* Patient able and willing to comply with the study visit schedule, study procedures, and study requirements.\n\nExclusion Criteria:\n\n* Recipient of a multi-organ transplant\n* History of prior solid organ transplant before the index heart transplant\n* Ongoing mechanical circulatory support or hemodynamic instability (e.g., inotrope or vasopressor therapy)\n* Ongoing need for renal replacement therapy and\u002For dialysis\n* Active infection requiring either a) hospitalization b) treatment with antimicrobial therapy or c) reduction in immunosuppression\n* Active rejection being treated with intravenous medications or plasmapheresis","99 Years",{"count":99,"type":21},"3 Years","This study aims to develop and refine a microRNA (miR) biomarker panel that can be used to phenotype net immune state after heart transplantation using circulating miRs (associated with drug doses and levels). These miRs will be used to characterize the overall immune state in adult heart transplant patients and predict patients that will go on to develop infection and rejection. MicroRNAs (miRs) are small, non-coding RNA molecules that regulate gene expression and serve as molecular biomarkers found in the circulation.",[126,127],"Cardiac Failure","Graft Rejection","2026-04-20",{"date":130,"type":37},"2026-04-22",{"date":132,"type":37},"2025-10-28",{"date":134,"type":21},"2032-01-01",{"name":43,"class":44},7,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":45},"100626569","phase-4-volume-reduction-for-open-fracture-irrigation-100626569","NCT07437339","Volume Reduction for Open Fracture Irrigation","Volume Reduction for Open Fracture Irrigation: A Randomized Prospective Feasibility Trial","Inclusion Criteria:\n\n* Age 18 or older\n* Patient diagnosed with a Type I, II, or III open fracture of the appendicular skeleton by a study surgeon\n* For the purposes of this study, an open fracture is a fracture associated with a soft tissue wound which may or may not be contiguous with the fracture.\n* Open fractures of the carpals, tarsals, metacarpals, metatarsal, and\u002For phalanges without the involvement of a long bone or the hindfoot will not be considered.\n\nExclusion Criteria:\n\n* Patient is unable to understand Informed Consent and\u002For HIPAA Authorization Form\n* Patient does not speak English\n* Patient is pregnant\n* Patient is unable or (in the judgment of research personnel) unlikely to attend follow-up visits.\n* Patient was previously enrolled in a study which has the same primary outcomes or may influence infection rate or bone healing\n* Patient declines to participate in study",{"count":145,"type":21},200,[147],"PHASE4","The purpose of this study is to help doctors who treat open fractures understand how much fluid is required when cleaning out the wound. Participants will spend about 12 months in this study and will be asked to answer study questions about your recovery at your typical follow up clinic visits with your surgeon. After the surgeon has determined a participant's bone has healed, any remaining study visits can be conducted over the phone, email, and\u002For mail. Participants will not be asked to attend additional clinic visits as part of this study. Researchers will compare two different fluid volume protocols to determine if one results in better fracture and\u002For wound healing.",[150],"Open Fracture","2026-04-08",{"date":153,"type":37},"2026-04-13",{"date":155,"type":37},"2026-03-02",{"date":157,"type":21},"2027-12-31",{"name":43,"class":44},{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":96,"minAge":18,"maxAge":97,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":45},"100605798","absorbable-staples-versus-conventional-skin-closure-in-women-undergoing-cesarean-delivery-100605798","NCT07167199","Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery","Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery: A Randomized Control Trial","Inclusion Criteria:\n\n* 18-50 years of age\n* Women ≥ 24 weeks viable gestation\n* Will be undergoing cesarean delivery\n\nExclusion Criteria:\n\n* Patient unwilling or unable to provide consent.\n* No or very limited prenatal care or a non-resident patient who is unlikely to follow-up after delivery.\n* Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 \\\u003C200, or other\n* Decision not to have skin closure (e.g. secondary wound closure, mesh closure)\n* Current skin infection\n* Coagulopathy\n* High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, tubal ligation, bowel or adnexal surgery)\n* Incarcerated individuals\n* Intraamniotic infection\n* Subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.",{"count":167,"type":21},237,[24],"Despite the high numbers of cesareans being performed, scientific evidence behind which surgical techniques are best remains uncertain. Our objective is to determine if subcuticular absorbable staples improve operative time and wound cosmetics",[171],"Pregnancy","NOT_YET_RECRUITING","2026-04-01",{"date":175,"type":37},"2026-04-02",{"date":177,"type":21},"2026-08-01",{"date":179,"type":21},"2027-09-01",{"name":43,"class":44},{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":188,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":136},"100557036","optimal-pediatric-heart-transplant-immunosuppression-with-micrornas-100557036","NCT06532890","Optimal Pediatric Heart Transplant Immunosuppression With MicroRNAs","OPTIMA","Inclusion Criteria:\n\n* Age ≤ 18 years at time of transplant listing\n* Subject is within 10-50 days post-orthotopic heart transplant at time of enrollment.\n* Planned follow-up at the transplant center for a minimum of one-year.\n* Caregiver able and willing to comply with the study visit schedule, study procedures, and study requirements.\n\nExclusion Criteria:\n\n* Recipient of a multi-organ transplant\n* History of prior solid organ transplant before the index heart transplant\n* Ongoing mechanical circulatory support or hemodynamic instability after transplant\n* Active infection requiring either a) hospitalization or b) treatment with antimicrobial drugs (does not include prophylaxis for infection or suppressive antibiotics given after transplant)\n* History of treated rejection prior to study enrollment\n* Inability to collect specified blood volume after enrollment and prior to 50 days post-transplant",{"count":189,"type":21},150,"This study aims to discover circulating microRNAs (associated with drug doses and levels) that can be used to characterize the overall immune state in pediatric heart transplant patients and predict patients that will go on to develop infection and rejection. MicroRNAs (miRs) are small, non-coding RNA molecules that regulate gene expression and serve as molecular biomarkers found in the circulation.",[126,127],"2026-03-24",{"date":194,"type":37},"2026-03-25",{"date":196,"type":37},"2025-02-06",{"date":198,"type":21},"2029-10-01",{"name":43,"class":44},{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":52,"sex":96,"minAge":18,"maxAge":97,"enrollmentInfo":208,"targetDuration":4,"studyType":22,"phases":210,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":113},"100467749","phase-2-prevention-of-postpartum-hemorrhage-with-tranexamic-acid-100467749","NCT05370820","Prevention of Postpartum Hemorrhage With Tranexamic Acid","Prevention of Postpartum Hemorrhage: Pharmacokinetics (PK) Abd Pharmacodynamics (PD) of Tranexamic Acid","Optimum OB-TXA","Inclusion Criteria:\n\n* Women who are scheduled to under medically indicated cesarean section at greater than 34+0 weeks gestation or women who are scheduled to undergo an elective cesarean section at 39+0 weeks gestation in accordance with recommendations from the American Congress of Obstetricians and Gynecologists\n* Women who are indicated to have a vaginal delivery at \\> 34+0 weeks gestation.\n* Pregnant women with normal serum creatinine (serum creatinine \\\u003C 0.9) within 2 weeks of estimated\u002Fscheduled delivery\n* Women between the ages of 18 and 50 years old\n* Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization.\n\nExclusion Criteria:\n\n* active thrombotic or thromboembolic disease\n* a history of arterial or venous thromboembolic event\n* inherited thrombophilia or preexisting conditions that predisposes them to thromboembolic events (i.e. lupus, antiphospholipid syndrome, thrombocytosis or thrombophilic thrombocytopathy)\n* a subarachnoid hemorrhage\n* acquired defective color vision\n* history of seizure disorder\n* known renal dysfunction (serum creatinine = or \\>0.9)\n* multiple gestations (twin or triplet pregnancies)\n* hypersensitivity to Tranexamic acid or anti-fibrinolytic therapy\n* history of liver dysfunction at the discretion of the investigator",{"count":209,"type":21},120,[211],"PHASE2","In part 1 of the study, the investigators conducted a prospective, open-label, dose finding pharmacokinetic (PK) study in 43 pregnant 3rd trimester women scheduled for non-emergent cesarean section.\n\nThe investigators administered three doses of the drug (5 mg\u002Fkg, 10 mg\u002Fkg and 15 mg\u002Fkg) in an escalating fashion by cohort with the lowest dose first. The drug was administered intravenously at the time of umbilical cord clamping for a non-emergent cesarean section. A maximum of 1 g was administered. TXA serum levels at several time points after delivery were assayed to see if they reach the target plasma concentration of 10 ug\u002FmL. A PK model was constructed for determining the optimal TXA dose administered at parturition.\n\nIn part 2 of the study, the investigators aim to compare PKPD endpoints using prophylactic TXA via IV and IM routes administered pre-cord clamp. The investigators will administer 1 g TXA within 10 minutes of skin incision via intravenous infusion (up to n=15), intravenous bolus \\\u003C 2 minutes (up to n=15) and intramuscular injection (up to n=15). The investigators will target women undergoing scheduled cesarean delivery \\> 34 weeks gestation, women undergoing vaginal delivery \\> 34 weeks of gestation and morbidly obese women (BMI\\>=40) undergoing either a vaginal or cesarean delivery. The investigators will use advanced modeling techniques to determine time to achieve PKPD targets and duration remaining at those targets. The goal will be to determine how the optimal dose may vary if route of administration is modified. The investigators plan to enroll 45 patients in addition to the 43 that were enrolled during part 1. Our goal is to 30 participants, but the investigators will enroll 45 to account for lost to follow-up. The investigators also aim to enroll 30 patients undergoing vaginal delivery and 30 morbidly obese women (BMI \\>= 40) undergoing either a vaginal or cesarean delivery but the investigators will enroll 45 patients for each of these groups to account for loss to follow up. In addition, the investigators will enroll 30 pregnant patients receiving no medication acting as the control group, but the investigators will enroll 45 to account for loss to follow up.",[103],"2026-03-23",{"date":216,"type":37},"2026-03-27",{"date":218,"type":37},"2022-12-28",{"date":220,"type":21},"2027-06-01",{"name":43,"class":44},{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":22,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":45},"100394700","hemodynamic-monitoring-to-prevent-adverse-events-following-cardiogenic-shock-trial-100394700","NCT04419480","Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial","HALO-Shock","Inclusion Criteria:\n\n1. Subject or legal representative has signed Informed Consent Form (ICF) and the patient has the capacity to participate in the study and complete the study questionnaires, in the estimation of the study investigator.\n2. Age ≥ 18 years\n3. NYHA Class III with dyspnea upon mild physical activity, regardless of left ventricular ejection fraction (LVEF).\n4. Survive to discharge during a current hospital admission with cardiogenic shock (CS) as defined by clinical criteria previously used in cardiogenic shock trials: systolic blood pressure \\\u003C 90 mmHg for \\> 30 minutes or requiring infusion of catecholamines to maintain the systolic blood pressure above 90 mmHg, with evidence of end-organ dysfunction such as pulmonary edema or impaired end-organ perfusion including altered mentation, oliguria with urine output \\\u003C 30 mL\u002Fh, or serum lactate \\> 2 mmol\u002FL (5). Hemodynamic criteria include cardiac index ≤ 1.8 L\u002Fmin\u002Fm2 without vasoactive pharmacologic agents, or cardiac index ≤ 2.2 L\u002Fmin\u002Fm2 and pulmonary artery occlusion pressure ≥ 15 mmHg with vasoactive agents.\n5. Patients must have internet and phone access (to allow communication of the implanted device with the researchers).\n\nExclusion Criteria:\n\n1. Technical obstacles which pose an inordinately high procedural risk, in the judgment of the investigator.\n2. Treatment with ongoing mechanical circulatory support (MCS) such as a durable left ventricular assist device (LVAD) or recipient of a heart transplantation for the treatment of cardiogenic shock during the index hospitalization for CS.\n3. If of childbearing potential with a positive pregnancy test.\n4. Transition to hospice care.\n5. Intolerance to or inability to adhere to antiplatelet therapy for 1 year after device implantation.\n6. Presence of an active, uncontrolled infection.\n7. Any condition other than heart failure that could limit survival to less than 6 months\n8. Discharge to facility other than acute rehabilitation or to the ambulatory setting.\n9. No access to internet or phone.",{"count":230,"type":21},40,[24],"Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock",[234,27,235],"Cardiogenic Shock","Ambulatory Hemodynamic Monitoring","2026-03-12",{"date":238,"type":37},"2026-03-16",{"date":240,"type":37},"2020-12-31",{"date":242,"type":21},"2028-12-31",{"name":43,"class":44},{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":252,"targetDuration":254,"studyType":100,"phases":4,"briefSummary":255,"conditions":256,"keywords":257,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":45},"100314839","inova-cardiogenic-shock-registry-inova-shock-100314839","NCT03378739","Inova Cardiogenic Shock Registry (INOVA SHOCK)","Implementation of a Cardiogenic Shock Team and Clinical Outcomes (INOVA-SHOCK Registry)","INOVASHOCK","Inclusion Criteria:\n\n-Patients at the IHVI with documented Cardiogenic Shock team intervention for acute decompensated heart failure cardiogenic shock, or acute myocardial infarction cardiogenic shock.\n\nExclusion Criteria:\n\n-Patients under the age of 18 will be excluded.",{"count":253,"type":21},3000,"1 Year","To collect retrospective clinical outcomes related to acute decompensated heart failure cardiogenic shock, acute myocardial infarction cardiogenic shock and compare current versus historical survival rates.\n\nTo collect Inova Heart and Vascular Institute (IHVI) site specific outcomes before and after initiation of the Cardiogenic Shock team on January 1, 2017.\n\nTo collect outcomes related to implementation of mechanical circulatory support versus no circulatory intervention and type of intervention (extracorporeal membrane oxygenation (ECMO) versus intracorporeal axial-flow (Impella).\n\n• Assess survival at three time points.",[234],[258,259],"cardiogenic","shock",{"date":238,"type":37},{"date":262,"type":37},"2018-01-01",{"date":264,"type":21},"2099-12-31",{"name":43,"class":44},{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":96,"minAge":272,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":275,"conditions":276,"keywords":279,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":45},"100537119","comparison-of-two-salpingectomy-techniques-for-sterilization-at-the-time-of-cesarean-delivery-100537119","NCT06273683","Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery","Inclusion Criteria:\n\n* request for permanent sterilization at the time of cesarean delivery\n* 24 weeks' gestation or beyond\n* 21 years old or older\n* Medicaid sterilization consent per Virginia Department of Medical Assistance Services regulations (if Medicaid recipient).\n\nExclusion Criteria:\n\n* vaginal delivery\n* history of prior adnexal surgery (such as prior bilateral tubal ligation or unilateral salpingectomy oophorectomy)\n* placenta accreta spectrum\n* placenta previa\n* history of bleeding diathesis.","21 Years",{"count":274,"type":21},900,"One in three women of reproductive age utilize tubal sterilization for contraception, and sterilization is often requested at time of cesarean delivery. Complete salpingectomy for the purpose of permanent sterilization at the time of cesarean birth is increasingly being performed worldwide.\n\nA preferred complete salpingectomy technique for the purpose of sterilization at the time of cesarean delivery has not emerged in current practice. The objective is to compare short-term clinical outcomes and cost of salpingectomy using a hand-held bipolar energy instrument with those of traditional suture ligation. This retrospective cohort study will be conducted from 2017-2023 at a single tertiary care hospital. The investigators hypothesize that bipolar energy instrument use will not significantly improve clinical outcomes.",[277,278],"Permanent Sterilization","Pregnancy Related",[280],"Sterilization, salpingectomy, cesarean delivery","2026-03-03",{"date":283,"type":37},"2026-03-05",{"date":285,"type":37},"2024-03-11",{"date":287,"type":21},"2027-12",{"name":43,"class":44},{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":96,"minAge":18,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":311},"100573449","activity-coaching-during-pelvic-radiation-therapy-100573449","NCT06746428","Activity Coaching During Pelvic Radiation Therapy","ACTIVATE: A Pilot Randomized Activity Coaching Trial to Increase Vitality and Energy During Post-operative Pelvic Radiation Therapy for Endometrial Cancer","ACTIVATE","Inclusion Criteria:\n\n* At least 18 years of age\n* Pathologic diagnosis of endometrial cancer (any histology, Stage I-IVA)\n* Has undergone modified radical or radical hysterectomy\n* Plan to receive adjuvant treatment with pelvic external beam radiation therapy at ISCI\n* ECOG performance status of 0-1\n* Patient has a computer, smart phone, or tablet virtual access to the web-based platform and email\n* Able to read, understand and provide written informed consent\n* Deemed appropriate for unmonitored exercise by treating physician based on the following evidence-based criteria (1)\n\n  * Walk without any assistance or assistance device\n  * Absence of significant cognitive impairment\n  * Absence of high risk for falls\n* Participant does not need to refrain from any activity\n\nExclusion Criteria:\n\n* Unable to schedule and attend coaching visits\n* Participation in a regular exercise program of ≥150 minutes of moderate intensity exercise a week at baseline\n* Unable to perform the five-times stand test\n* Medical comorbidities including:\n\n  * Unstable angina\n  * Uncontrolled dysrhythmias\n  * Acute pulmonary embolus\n  * Active pulmonary infection",{"count":298,"type":21},16,[24],"Research has shown that for women who are undergoing pelvic radiation therapy, fatigue is a common side effect. Fatigue that occurs during radiation therapy can make it harder to perform daily living activities. While there are studies that recommend exercise as a treatment for fatigue in cancer patients and survivors, there are currently no studies that focus on the role of exercise for women undergoing pelvic radiation therapy. The purpose of this study is to see if incorporating an activity coaching program is helpful in improving treatment-related fatigue for women undergoing pelvic radiation therapy for endometrial cancer.",[302,303,304],"Radiation Therapy","Gynecologic Cancer","Exercise Therapy",{"date":281,"type":37},{"date":307,"type":37},"2025-01-27",{"date":309,"type":21},"2026-07-01",{"name":43,"class":44},4,{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":320,"minAge":18,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":22,"phases":323,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":45},"100618715","men-with-prostate-cancer-optimizing-wellness-by-enhanced-relief-from-hot-flashes-with-acupuncture-100618715","NCT07335224","Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture","MPOWER: A Pilot Trial Among Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture","MPOWER","Inclusion Criteria:\n\n* Male\n* At least 18 years of age\n* Histologically or cytologically confirmed adenocarcinoma of prostate of any stage I-IV\n* Undergoing androgen deprivation therapy (ADT) and\u002For androgen receptor pathway inhibitors\n* Experiencing moderate to severe daily interference from hot flashes, as indicated by the Hot Flash Related Daily Interference Scale (score≥4)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Able to read, understand, and provide written informed consent\n\nExclusion Criteria:\n\n* Severe or uncontrolled concurrent disease, infection or co-morbidity that, in the opinion of the Investigator, would make the patient inappropriate for enrollment\n* Known hypersensitivity to the acupuncture needles\n* Any condition that in the opinion of the Investigator would impair the patients' ability to comply with the study procedures\n* Unable to comply with study requirements\n* Use of acupuncture for hot flashes within 6 months prior to enrollment","MALE",{"count":322,"type":21},24,[24],"Prostate cancer is the most common cancer among men in the United States. Many men with prostate cancer are treated with hormone therapy, also called androgen deprivation therapy (ADT). While this treatment is effective, it often causes bothersome side effects such as hot flashes, poor sleep, fatigue, and other physical and emotional symptoms. There is currently no standard treatment to help manage these side effects in men. Acupuncture is a non-drug treatment that has been shown to help reduce hot flashes and related symptoms in women receiving hormone therapy for breast cancer. However, much less is known about whether acupuncture is helpful for men receiving hormone therapy for prostate cancer. This study will test whether an acupuncture program, combined with usual lifestyle education, is feasible and acceptable for men undergoing ADT. The study will also explore whether acupuncture may help reduce hot flashes and improve related symptoms. A total of 24 men with prostate cancer receiving ADT will be randomly assigned to one of two groups: one group will begin acupuncture right away, and the other group will begin acupuncture after a delay, with regular check-ins during the waiting period. All participants will receive standard lifestyle education. Participants will be followed for about five months and will be asked to complete daily hot flash diaries, questionnaires about their symptoms and quality of life, and wear a Fitbit to track sleep. The results of this pilot study will help determine whether a larger study should be conducted to better understand the role of acupuncture in managing hormone therapy side effects in men with prostate cancer.",[326,327,328,329,330],"Hot Flashes","Acupuncture Therapy","Vasomotor Symptoms","Androgen Deprivation Therapy","Prostatic Neoplasms","2026-02-02",{"date":333,"type":37},"2026-02-04",{"date":335,"type":37},"2026-01-08",{"date":337,"type":21},"2027-06-30",{"name":43,"class":44},{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":22,"phases":348,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":4},"100559444","phase-2-fostamatinib-for-treating-acute-respiratory-distress-syndrome-ards-in-hospitalized-adults-100559444","NCT06564207","Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults","Randomized, Double-Blinded, Placebo-Controlled Phase 2 Study for the Long Term Evaluation of Fostamatinib for the Treatment of Adult Patients With Acute Respiratory Distress Syndrome (ARDS)","FOSTA-ARDS","Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Subject (or legal representative) provides informed consent to study participation.\n* Subject (or legal representative) understands and agrees to comply with planned study procedures.\n* Hospitalized with acute respiratory failure from ARDS with ratio of partial pressure of arterial oxygen to fraction of inspired oxygen PaO2\u002FFiO2 of 200 mm of Hg or less with positive end expiratory pressure (PEEP) equal to or higher than 5 cm of H2O and requiring invasive mechanical ventilation or extracorporeal support.\n* Functional respiratory imaging (FRI) compatible CT scan of the chest within the prior 7 days.\n* Duration of invasive mechanical ventilation \\\u003C 10 days.\n* Females of childbearing potential must agree to be abstinent or seek a highly effective form of contraception from the time of enrollment through 30 days after the last day of study drug.\n\nExclusion Criteria:\n\n* Severe hepatic impairment (Child-Pugh Class C).\n* Abnormal liver function tests (AST or ALT \\> 3x ULN or AST or ALT \\> 3x ULN)\n* Pregnant or nursing.\n* Participation in any other clinical trial, or receipt of an investigational medicinal product within 30 days prior.\n* Known concomitant life-threatening disease with a life expectancy \\\u003C 6 months.\n* Known hypersensitivity to fostamatinib.\n* Uncontrolled hypertension (Systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg).\n* Neutrophil count \\\u003C 1000\u002FuL\n* Death expected within 72 hours\n* Received a live vaccine in the last 30 days\n* Those who were cognitively impaired or mentally disabled prior to acute illness\n* Patients with acute coronary syndrome, ejection fraction \\\u003C30%, or active unstable arrhythmias",{"count":230,"type":21},[211],"This study is designed to evaluate the safety and efficacy of fostamatinib in hospitalized adult participants with acute respiratory distress syndrome (ARDS).",[351,352],"Acute Respiratory Distress Syndrome","ARDS","2026-01-30",{"date":331,"type":37},{"date":356,"type":21},"2026-08-30",{"date":358,"type":21},"2027-10-31",{"name":43,"class":44},{"id":361,"slug":362,"hasResults":11,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":367,"targetDuration":368,"studyType":100,"phases":4,"briefSummary":369,"conditions":370,"keywords":373,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":45},"100524256","a-pilot-prospective-clinical-trial-using-remote-monitoring-for-cancer-patients-undergoing-outpatient-chemotherapy-100524256","NCT06106360","A Pilot Prospective Clinical Trial Using Remote Monitoring for Cancer Patients Undergoing Outpatient Chemotherapy","A Pilot Prospective Clinical Trial Using Remote Patient Monitoring for Cancer Patients Undergoing Outpatient Chemotherapy","Inclusion Criteria:\n\n* Planned to be treated with a new cytotoxic chemotherapy or chemoimmunotherapy regimen for a solid tumor or malignant hematology condition for at least 4 months\n* ECOG performance status of 0-2\n* Age of 18 or older patient with any solid tumor or hematologic malignancy\n* English or Spanish speaker\n* Own an Apple iPhone\n* Capacity and willingness to provide informed consent\n\nExclusion Criteria:\n\n* Patients undergoing concurrent radiation since they will be seen on a daily basis by clinic care teams and are not likely to benefit from active remote patient monitoring\n* Patients unwilling or unable to comply with the protocol, including wearing the Apple Watch (including recharging daily) and answering queries on the Locus Health iPhone application per the protocol and study group cadence\n* Any condition for which in the Investigator's opinion would limit compliance with study requirements",{"count":56,"type":21},"120 Days","A pilot study using remote monitoring technology developed by Locus Health in cancer patients undergoing chemotherapy treatment.",[371,372],"Solid Tumor","Hematological Malignancy",[374],"Wearable Electronic Devices","2025-12-04",{"date":377,"type":37},"2025-12-08",{"date":379,"type":37},"2023-10-26",{"date":381,"type":21},"2026-06-26",{"name":43,"class":44},{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":121,"enrollmentInfo":389,"targetDuration":391,"studyType":100,"phases":4,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":45},"100567995","in-search-of-best-practices-for-patients-with-heart-failure-and-secondary-mitral-regurgitation-an-evaluation-of-the-inova-heart-failure-treatment-algorithm-100567995","NCT06675448","In Search of Best Practices for Patients With Heart Failure and Secondary Mitral Regurgitation: An Evaluation of the Inova Heart Failure Treatment Algorithm","Inclusion Criteria:\n\n* Symptomatic MR (≥2+) due to cardiomyopathy of either ischemic or nonischemic etiology\n* Subject has been adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, MR, and HF.\n* NYHA functional class II, III, or ambulatory IV\n* Local heart team has determined that MV surgery will not be offered as a treatment option even if the subject is randomized to the Control group.\n* LVEF ≤50%.\n* LVESD ≤70 mm\n* The primary regurgitant jet , in the opinion of the MitraClip implanting investigator, can be successfully treated by the MitraClip (if a secondary jet exists, it must be considered clinically insignificant).\n* Transseptal catheterization and femoral vein access is feasible per the MitraClip implanting investigator.\n* Age 18 y or older\n* Subject or guardian agrees to all provisions of the protocol\n* NT-proBNP≥ 1500ng\u002Fml or BNP≥ 300ng\u002Fml\n\nExclusion Criteria:\n\n* Untreated clinically significant coronary artery disease requiring revascularization\n* CABG, PCI, or TAVR within the prior 30 d\n* Aortic or tricuspid valve disease requiring surgery or transcatheter intervention\n* COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use\n* Cerebrovascular accident within prior 30 d\n* Severe symptomatic carotid stenosis (N70% by ultrasound)\n* Carotid surgery or stenting within prior 30 d\n* ACC\u002FAHA stage D HF\n* Presence of any of the following:\n* Estimated PASP N70 mm Hg assessed by site based on echocardiography or right heart catheterization, unless active vasodilator therapy in the catheterization laboratory is able to reduce the PVR to b3 Wood units or between 3 and 4.5 Wood units with v wave less than twice the mean of the PCWP\n* Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing HF other than dilated cardiomyopathy of either ischemic or nonischemic etiology\n* Infiltrative cardiomyopathies (eg, amyloidosis, hemochromatosis, sarcoidosis)\n* Hemodynamic instability requiring inotropic support or mechanical heart assistance\n* Physical evidence of right-sided congestive HF with echocardiographic evidence of moderate or severe right ventricular dysfunction\n* Implant of CRT or CRT-D within the last 30 d\n* Mitral valve orifice area \\\u003C4.0 cm2 by site-assessed TTE\n* Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets, or sufficient reduction in MR by the MitraClip\n* Hemodynamic instability defined as persistent systolic pressure \\\u003C90 mm Hg with or without afterload reduction, cardiogenic shock, or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device\n* Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 m\n* Life expectancy \\\u003C12 m due to noncardiac conditions\n* Investigators opinion a condition that could limit the subject's participation\n* Status 1 heart transplant or prior orthotopic heart transplantation\n* Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure\n* Echocardiographic evidence of intracardiac mass, thrombus, or vegetation\n* Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (ie, noncompliant, perforated)\n* Active infections requiring current antibiotic therapy\n* TEE is contraindicated or high risk\n* Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically\n* Pregnant or planning pregnancy within next 12m\n* Currently participating in an investigational drug or another device study that has not reached its primary end point\n* Subject belongs to a vulnerable population or has any disorder that compromises his\u002Fher ability to give written informed consent and\u002For to comply with study procedures.",{"count":390,"type":21},50,"12 Months","The overarching goal of this research proposal is to study the feasibility and clinical impact of implementing an Inova system-wide heart failure treatment algorithm for patients with symptomatic heart failure due to reduced left ventricular ejection fraction (HFreF) and secondary MR\n\nAim is to check the effectiveness of the IHFTA in identifying patients who are most likely to benefit from percutaneous transcatheter Mitraclip repair in real world",[394,395,27],"Mitral Regurgitation","Valvular Heart Disease","2025-12-01",{"date":109,"type":37},{"date":399,"type":37},"2021-01-28",{"date":401,"type":21},"2030-09-10",{"name":43,"class":44},{"id":404,"slug":405,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":11,"sex":96,"minAge":18,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":22,"phases":412,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":45},"100607197","impact-of-the-neurocuple-device-on-pain-management-after-cesarean-delivery-100607197","NCT07185425","Impact of the NeuroCuple Device on Pain Management After Cesarean Delivery","Management of Postoperative Pain After Cesarean Delivery Using Non-pharmacological Analgesic Device, NeuroCuple™","Inclusion Criteria:\n\n* Female 18 years or older able to provide informed consent in English or Spanish\n* Scheduled for a planned or unplanned non-emergent cesarean delivery under neuraxial anesthesia\n* Intact skin surfaces around the operative skin incision area at the site of patch application\n* Pfannestiel skin incision\n\nExclusion Criteria:\n\n* Active drug abuse\n* Chronic opioid user\n* Severe chronic pain\n* Psoriasis vulgaris or other skin conditions precluding safe device application\n* Subject is concurrently participating in another research study with an investigational drug or medical device that in the Investigator's opinion could impact subject safety or study results\n* Subject with reasons to maintain an epidural beyond operative room\n* Subject with complex surgery or subject who may need more than a cesarean surgery with possible tubal sterilization procedure\n* Subject is deemed not suitable for the study at the discretion of the principal Investigator",{"count":411,"type":21},180,[24],"This will be a single-center, sham-controlled, 3 arms, randomized (1:1:1) prospective study in females undergoing cesarean delivery to investigate the impact of NeuroCuple™ non-pharmacological analgesic device for management of postoperative pain. The investigators hypothesize that women treated with the Neurocuple device will experience less pain and consequently require less opioid pain medication after cesarean delivery compared to women who receive standard post-surgical medication.",[415,416,171],"Pain","Analgesia","2025-10-14",{"date":419,"type":37},"2025-10-16",{"date":421,"type":37},"2025-10-13",{"date":423,"type":21},"2027-09",{"name":43,"class":44},{"id":426,"slug":427,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":22,"phases":433,"briefSummary":434,"conditions":435,"keywords":437,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":446,"locationsCount":113},"100594762","phase-2-early-screening-and-treatment-of-heart-complication-in-sickle-cell-disease-100594762","NCT07023666","Early Screening and Treatment of Heart Complication in Sickle Cell Disease","Early Detection and Management of Cardiac Iron Overload in Sickle Cell Disease Using Multimodal Imaging for Improved Clinical Outcomes","Inclusion Criteria:\n\n* At least 18 years of age\n* Diagnosis of sickle cell disease (any genotype)\n* Serum ferritin levels ≥ 400 ng\u002FmL (up to 80 patients), or less than 400 ng\u002FmL in those who have cardiac symptoms including shortness of breath and lower extremity edema (up to 20 patients)\n* Willingness to undergo regular imaging (echocardiograms, ECG, cardiac MRI)\n* ECOG performance status of 0-1\n* Able to read, understand and provide written informed consent\n* Deemed appropriate for participation by the treating physician\n\nExclusion Criteria:\n\n* Unable to schedule and required follow-up visits\n* Medical comorbidities including:\n* Known heart failure\n* Unstable angina\n* Uncontrolled dysrhythmias\n* Acute pulmonary embolism\n* Active infection or severe comorbid conditions that in the view of the investigator would limit participation\n* History of hypersensitivity or contraindication to chelation therapy\n* Severe renal or hepatic impairment\n* Pregnancy of breastfeeding",{"count":56,"type":21},[211],"This study tests whether early heart screening and treatment for iron overload in subjects with sickle cell disease can prevent heart problems and reduce hospitalizations.",[436],"Sickle Cell Disease",[438,439,440],"Iron Overload","Cardiomyopathies","Arrhythmias","2025-10-09",{"date":417,"type":37},{"date":444,"type":37},"2025-10-07",{"date":337,"type":21},{"name":43,"class":44},{"id":448,"slug":449,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":453,"eligibilityCriteria":454,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":22,"phases":457,"briefSummary":458,"conditions":459,"keywords":461,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":113},"100576781","phase-2-the-study-of-atezolizumab-bevacizumab-and-memantine-in-patients-with-hepatocellular-carcinoma-hcc-100576781","NCT06789757","The Study of Atezolizumab, Bevacizumab and Memantine in Patients With Hepatocellular Carcinoma (HCC)","An Open Label Phase II Study of Atezolizumab, Bevacizumab and Memantine in Patients With Hepatocellular Carcinoma","(HCC)","Inclusion Criteria:\n\n1. Age 18 or older.\n2. Patients have newly diagnosed and previously untreated, histologically or radiologically confirmed hepatocellular carcinoma with at least one lesion that is measurable by RECIST 1.1 criteria. A prior HCC lesion that was treated surgically or by radiation is allowed as long as it was at least 2 years or more from the current HCC diagnosis.\n3. Patient's cancer must be deemed locally advanced and unresectable\n4. Patients must have a Childs-Pugh cirrhosis score of A5 or A6.\n5. Eastern Cooperative Oncology Group Performance Status of 0-1.\n6. Patients must have bone marrow and organ function as defined below:\n\n   * Absolute Neutrophil Count ≥ 1,500\u002FμL\n   * Platelets ≥ 100,000\u002FμL\n   * Hemoglobin ≥ 90 g\u002FL (9g\u002FdL)\n   * Total Bilirubin ≤ 3 x ULN\n   * AST(SGOT)\u002FALT(SGPT)\u002FAlkaline Phosphatase ≤ 3 x ULN Or ≤5x ULN if due to liver involvement by tumor\n   * Creatinine ≤ 2.0 mg\u002FdL\n   * eGFR (using Cockcroft Gault equation) \\> 40ml\u002Fmin\n7. Chemotherapy is harmful to the human fetus. For this reason, sexually active males and females with partners of childbearing potential must agree to use an accepted and effective method of contraception prior to study entry and for the duration of the study.\n8. Patients must demonstrate the ability to understand and the willingness to sign a written informed consent document.\n9. Men and women, regardless of race, ethnic group, or sexual orientation are eligible for this study.\n10. Patient must be able to swallow oral medication.\n\nExclusion Criteria:\n\n1. Patients with Childs-Pugh B or C cirrhosis.\n2. Female patients who are pregnant or breast-feeding.\n3. Concomitant illness that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants.\n4. Any history or evidence of severe illness or any other condition that would make the patient, in the opinion of the investigator unsuitable for the study. This would include any uncontrolled or untreated viral infection such as HIV, HBV, HCV etc.\n5. Subject is enrolled in a separate interventional clinical trial.\n6. Active tuberculosis.\n7. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n8. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.\n9. Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or bevacizumab formulation.\n10. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n11. Uncontrolled tumor-related pain. Patients requiring pain medication must be on a stable regimen at study entry.\n12. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment.\n13. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.\n\n18\\. Active, untreated grade 2 or 3 varices. Patients with treated varices to the point that they are grade 1 or less will be allowed.\n\n19\\. Patients already on memantine for any reason prior to enrollment will be excluded.",{"count":456,"type":21},19,[211],"The purpose of this research is to see the effect of triplet therapy with atezolizumab, bevacizumab, and memantine in treatment of your hepatocellular carcinoma.",[460],"Hepatocellular Carcinoma",[462,463,464],"Atezolizumab","Bevacizumab","Memantine","2025-10-02",{"date":444,"type":37},{"date":468,"type":37},"2025-02-25",{"date":470,"type":21},"2028-01-27",{"name":43,"class":44},{"id":473,"slug":474,"hasResults":11,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":22,"phases":481,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":113},"100516693","phase-2-a-prospective-study-of-memantine-in-patients-with-cirrhosis-and-liver-cancer-100516693","NCT06007846","A Prospective Study of Memantine in Patients With Cirrhosis and Liver Cancer","A Prospective Cohort Study of Single Agent Memantine in Patients With Child-Pugh Score ≥ B7 Cirrhosis and Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Age 18 or older.\n2. Patients have newly diagnosed and previously untreated, histologically or radiologically confirmed hepatocellular carcinoma with at least one lesion that is measurable by RECIST 1.1 criteria. A prior HCC lesion that was treated surgically or by radiation is allowed as long as it was at least 2 years or more from the current HCC diagnosis.\n3. Patient's cancer must be deemed locally advanced and unresectable as per the consensus of the Inova Multidisciplinary Cancer Care Conference.\n4. Patients must have a Child-Pugh cirrhosis score of B7 or greater and deemed not a candidate for aggressive systemic treatment.\n5. Eastern Cooperative Oncology Group Performance Status of 0-2.\n6. Patients must have adequate blood counts and organ function.\n7. Memantine is harmful to the human fetus. For this reason, sexually active males with partners of childbearing potential must agree to use an accepted and effective method of contraception prior to study entry and for the duration of the study. Women of child bearing potential must have a negative serum pregnancy test result within 24 hours prior to initiation of study treatment. They must also agree to use agree to use an accepted and effective method of contraception prior to study entry and for the duration of the study.\n8. Patients must demonstrate ability to understand and the willingness to sign a written informed consent document.\n9. Men and women, regardless of race, ethnic group or sexual orientation are eligible for this study.\n\nExclusion Criteria:\n\n1. Patients with Child-Pugh A cirrhosis.\n2. Female patients who are pregnant or breast-feeding.\n3. Concomitant illness or history that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants.\n4. Life-threatening intercurrent illness.\n5. Anticipated poor compliance.\n6. Subject is enrolled in a separate interventional clinical trial.\n7. Active tuberculosis.\n8. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n9. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n10. Uncontrolled tumor-related pain. Patients requiring pain medication must be on a stable regimen at study entry for at least 10 days prior to study entry.\n11. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment.\n12. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.\n13. Patients undergoing other anti-cancer treatment. Palliative radiation for symptom control will be allowed while on protocol.",{"count":480,"type":21},12,[211,482],"PHASE3","This is a single-site prospective study to describe efficacy endpoints of single agent memantine in patients with unresectable, locally advanced, or metastatic HCC otherwise not deemed candidates for intensive systemic therapy. In addition to the primary endpoint and multiple secondary efficacy endpoints, we will describe changes in quality of life on treatment over time.",[460,485],"Cirrhosis","2025-09-26",{"date":488,"type":37},"2025-09-30",{"date":490,"type":37},"2023-07-31",{"date":492,"type":21},"2026-08-31",{"name":43,"class":44},{"id":495,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":22,"phases":497,"briefSummary":25,"conditions":498,"keywords":499,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":504,"leadSponsor":506,"locationsCount":45},"100472541",{"count":20,"type":21},[24],[27],[27,29,30,31,32],"2025-08-19",{"date":502,"type":37},"2025-08-24",{"date":39,"type":37},{"date":505,"type":21},"2026-08",{"name":43,"class":44},{"id":508,"slug":509,"hasResults":11,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":22,"phases":515,"briefSummary":516,"conditions":517,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":525,"locationsCount":45},"100471731","phase-2-the-purpose-of-this-research-study-is-to-see-if-combining-gemcitabine-cisplatin-and-durvalumab-chemotherapy-treatments-with-a-direct-tumor-therapy-yittrium-90-y-90-will-work-better-together-to-shrink-tumors-and-control-cancer-100471731","NCT05422690","The Purpose of This Research Study is to See if Combining Gemcitabine, Cisplatin and Durvalumab Chemotherapy Treatments With a Direct Tumor Therapy Yittrium-90 (Y-90) Will Work Better Together to Shrink Tumors and Control Cancer","A Phase II Single-center, Open-label, Single Arm Study of Induction Gemcitabine, Cisplatin and Durvalumab Followed by Gemcitabine, Cisplatin and Yttrium-90 (Y-90) Radioembolization for the Treatment of Locally Advanced Unresectable Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n* Adult males and females at least 18 years of age\n* Histologically and\u002For cytologically confirmed iCCA that is previously untreated or, if systemic therapy has been rendered for prior disease, has been administered at least 6 months before the development of recurrent or de novo new sites of disease.\n* Unresectable disease, as deemed by the Inova multidisciplinary tumor board (i.e. disease that cannot be safely resected with negative margins, leaving 2 adjacent segments of liver with intact portal venous and hepatic arterial inflow and intact biliary and hepatic venous outflow with the future liver remnant of sufficient volume to avoid postoperative liver insufficiency)\n* Measurable disease per RECIST 1.1 at least 2 cm in size\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Noncirrhotic liver - patients should not have a preexisting diagnosis of cirrhosis either diagnosed via biopsy or with features consistent with cirrhosis on imaging (e.g. shrunken liver with nodularity consistent with cirrhosis). Child-Pugh score must be less than 5.\n* No evidence of extrahepatic disease, except for regional adenopathy that would be resected as part of a standard oncologic surgical procedure\n* Adequate organ function as indicated by the following laboratory values (Table 1)\n* Ability to complete testing in the protocol\n* Able and willing to consent to protocol\n\nExclusion Criteria:\n\n* Female patients who are pregnant or breast-feeding\n* History of allogeneic organ transplantation.\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n  * Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  * Patients with controlled type 1 diabetes on an insulin regimen are eligible for the study.\n  * Patients with vitiligo or alopecia.\n  * Any chronic skin condition that does not require systemic therapy.\n  * Patients without an active autoimmune disease in the last 5 years may be included but only after consultation with the study physician.\n  * Patients with diet controlled celiac disease.\n* Current or recent use of immunosuppressive medication within 14 days before durvalumab initiation except if:\n\n  * Intranasal, inhaled, topical or local steroid injections\n  * Systemic corticosteroids at physiologic doses that do not exceed 10 mg\u002Fday of prednisone or its equivalent.\n  * Steroids as premedication for hypersensitivity reactions, (i.e. CT scan premedication).\n* Child-Pugh B7 or greater cirrhosis\n* Extrahepatic or perihilar cholangiocarcinoma\n* Gallbladder cancer\n* Pancreatic or ampullary cancer\n* Portal vein thrombosis involving the main portal vein or first order right or left portal vein branches\n* Extrahepatic disease, other than regional lymph nodes that would be removed at time of surgery as part of a routine oncologic procedure for iCCA\n* Previous treatment with chemotherapy, intra-arterial or radiotherapy for iCCA is exclusionary, with the exception of adjuvant therapy with capecitabine which is allowed.\n* Contraindication to durvalumab, gemcitabine, or cisplatin\n* Active hepatitis B or C for which patients refuse treatment. Patients who are newly diagnosed with active disease as part of protocol screening and are agreeable to initiate on antiviral treatment are allowed to enroll.\n* Contraindication found during work-up angiography, including significant lung shunting (lung dose \\>30 Gy for a single treatment or \\>50 Gy cumulative), or non-manageable extrahepatic deposition of technetium Tc 99m macroaggregated albumin on scintigraphy performed after planning angiography\n* \\> 75% hepatic tumor burden\n* Inability to protect non-target arteries to intestines or solid organs from radioembolization\n* Serum albumin \\\u003C 3 g\u002FdL\n* Serum bilirubin \\> 2 mg\u002FdL, serum aspartate aminotransferase or alanine aminotransferase \\> 5 times upper limit of normal\n* Concomitant illness that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants.\n* Life-threatening intercurrent illness\n* Anticipated poor compliance\n* Prisoners or subjects who are involuntarily incarcerated\n* Persons with decisional incapacity\u002Fcognitive impairment\n* Any history or evidence of severe illness or any other condition that would make the patient, in the opinion of the investigator unsuitable for the study\n* Subject is enrolled in a separate interventional clinical trial",{"count":298,"type":21},[211],"The purpose of this research is to see if combining gemcitabine, cisplatin and Durvalumab chemotherapy treatments with a direct tumor therapy called Yittrium-90, will work better together to shrink the tumor and control cancer.",[518],"Intrahepatic Cholangiocarcinoma","2025-07-07",{"date":521,"type":37},"2025-07-10",{"date":523,"type":37},"2024-06-12",{"date":86,"type":21},{"name":43,"class":44},""]