[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Wake Forest University Health Sciences\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":607},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,201,0,25,[9,43,71,97,120,139,165,190,217,241,264,285,308,329,354,377,399,424,450,471,494,517,540,562,583],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100053480","evaluation-of-the-pathobiology-of-calr-mutated-mpn-cells-100053480",false,"NCT06480591","Evaluation of the Pathobiology of CALR-mutated MPN Cells","Inclusion Criteria:\n\n* Written (or electronic) informed consent and HIPAA authorization for release of personal health information by participant or his\u002Fher legally authorized representative (LAR).\n* Age ≥ 18 years at the time of enrollment\n* Diagnosis of myeloproliferative neoplasm (MPN) according to 2022 World Health Organization classification of MDS\u002FMPNs\n* CALR-positive genetic mutation\n\nExclusion Criteria:\n\n\\- Diagnosis of MPN with JAK2 V617F mutation",true,"ALL","18 Years",{"count":20,"type":21},35,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to understand why there is a greater risk of thrombosis in patients who have the JAK2 mutation as compared to those with CALR mutations.",[25],"Myeloproliferative Neoplasm",[27,28,29],"Thrombosis","JAK2 mutation","CALR mutation","RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2025-01-21",{"date":38,"type":21},"2027-09",{"name":40,"class":41},"Wake Forest University Health Sciences","OTHER",2,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":16,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100053731","lung-bases-4-life-mobile-low-dose-computed-tomography-ldct-screening-ages-40-54-100053731","NCT04577599","Lung B.A.S.E.S. 4 Life Mobile Low-dose Computed Tomography (LDCT) Screening: Ages 40-54","Lung B.A.S.E.S 4 Life Mobile Low-dose Computed Tomography (LDCT) Screening: Assessing Incidence and Stage of Lung Cancer Diagnosis in Subjects Ages 40-54 With a 30 Pack Year History or More Within North and South Carolina","Inclusion Criteria:\n\n* Subject must meet all the following applicable inclusion criteria to participate in this study:\n\n  1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n  2. Age 40-54 years at the time of consent.\n  3. A positive smoking history of greater\u002Fequal to 30 pack years and they are either currently smoking or have quit within the last 15 years.\n  4. Ability to read and understand the English and\u002For Spanish language.\n  5. Ability to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n* Subjects meeting any of the criteria below may not participate in the study:\n\n  1. Known diagnosis of lung cancer in the past 5 years.\n  2. Any known contraindication to having a low-dose CT Scan.\n  3. Known pregnancy.","40 Years","54 Years",{"count":53,"type":21},1160,"INTERVENTIONAL",[56],"NA","Low-dose CT Screening has been shown in two large trials in the United States (NLST) and Europe (NELSON) to increase overall survival in subjects 55 years of age and older with a strong smoking history. Unfortunately, in both North Carolina (NC) and South Carolina (SC), subjects are found to have the above referenced smoking history prior to reaching the minimum age in these studies. This study is aimed at decreasing the minimum age of screening in a high-risk population.",[59,60],"Lung Neoplasms","Lung Cancer",[62,60,63],"Screening","Smoking",{"date":33,"type":34},{"date":66,"type":34},"2021-01-07",{"date":68,"type":21},"2028-10",{"name":40,"class":41},1,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":16,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":80,"conditions":81,"keywords":87,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":70},"100053511","chaamp-charlotte-advocate-mgus-project-internal-pilot-study-100053511","NCT06644625","CHAAMP (CHArlotte Advocate MGUS Project) Internal Pilot Study","SCREENING Inclusion Criteria:\n\n* Age 30 years or older at the time of consent\n* Either:\n\n  1. Self-identify as Black and\u002For African American OR\n  2. First-degree relatives (parents, siblings, or children) of patients of any race or ethnicity diagnosed with a plasma cell disorder, including MGUS, smoldering multiple myeloma (SMM), multiple myeloma (MM), solitary plasmacytoma, plasma cell leukemia, AL amyloidosis, POEMS syndrome, and Waldenström's Macroglobulinemia\n* Capable and willing to provide informed consent. NOTE: HIPAA (Health Insurance Portability and Accountability Act) authorization for the release of personal health information may be included in the informed consent or obtained separately\n* Reside in Charlotte, NC, or the surrounding area, based on self-report\n\nSCREENING Exclusion Criteria:\n\n* Self-reported history of MGUS, SMM, MM, AL amyloidosis, plasma cell leukemia, solitary plasmacytoma, Waldenstrom Macroglobulinemia, and POEMS.\n\nLONGITUDINAL Inclusion Criteria:\n\n* Test positive for monoclonal gammopathy during screening portion of the study\n* Consent to the longitudinal portion of the study\n\nLONGITUDINAL Exclusion Criteria:\n\n* The participant previously underwent diagnostic work up as part of CHAAMP Internal Pilot that did not result in a diagnosis of MGUS, Smoldering Multiple Myeloma or other non-plasma cell disorder.","30 Years",{"count":79,"type":21},1665,"The purpose of this study is to identify multiple myeloma in the precancerous MGUS stage in order to reduce the risk of delayed diagnosis of multiple myeloma, decrease morbidity related to multiple myeloma at progression, and improve long term outcomes.",[82,83,84,85,86],"Multiple Myeloma","Multiple Myeloma Progression","Monoclonal Gammopathy of Undetermined Significance (MGUS)","Smoldering Multiple Myeloma (SMM)","Plasma Cell Disorders",[88,89,90],"multiple myeloma","hematology","plasma cell disorders",{"date":33,"type":34},{"date":93,"type":34},"2025-03-01",{"date":95,"type":21},"2035-01",{"name":40,"class":41},{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":54,"phases":106,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100053842","postoperative-radiotherapy-for-intermediate--and-high-risk-patients-with-hnscc-greater-than-6-weeks-after-surgery-100053842","NCT06607406","Postoperative Radiotherapy for Intermediate- and High-risk Patients With HNSCC Greater Than 6 Weeks After Surgery","A Randomized Trial of Accelerated Postoperative Radiotherapy for Intermediate- and High-risk Patients With HNSCC (Head and Neck Squamous Cell Carcinoma) Initiating Radiotherapy Greater Than 6 Weeks After Surgery (PORTRush)","Inclusion Criteria:\n\n* Pathologically confirmed head and neck squamous cell carcinoma of the oral cavity, oropharynx, larynx, hypopharynx, sinus, or lymph nodes of the neck of unknown primary.\n* Planned for curative intent postoperative radiotherapy based on pathologic risk factors.\n\n  * Patients with non-HPV-mediated oropharyngeal squamous cell carcinoma or non-oropharyngeal squamous cell carcinoma must have at least one of the following: pathologic tumor classification pT3-4, multiple lymph nodes involved with cancer, perineural invasion, lymphovascular invasion, close margins (within 2 mm for oropharyngeal cancer status post transoral resection; within 5 mm for all others) or cleared margins (initially positive, subsequently cleared in an additional specimen), extranodal extension (any extent), or positive surgical margins.\n  * Patients with HPV-mediated oropharyngeal squamous cell carcinoma must have at least one of the following pathologic risk factors: extranodal extension (any extent), positive surgical margins, or more than 4 lymph nodes involved with cancer.\n* Complete macroscopic surgical resection with curative intent for HNSCC with an anticipated interval between the primary surgical resection and initiation of postoperative radiotherapy greater than 42 days but less than or equal to 112 days from surgery. Note: the start date of the time to initiation of PORT is the first (primary) surgical resection. This does not include diagnostic procedures (e.g., biopsy, diagnostic tonsillectomy) or any subsequent surgical interventions for any reason (e.g., wound complications).\n* Age ≥ 18 years at the time of enrollment.\n* ECOG performance status of 0-1.\n* Ability to understand and the willingness to sign an IRB-approved informed consent document directly, in English or Spanish, and to complete study-related forms and activities.\n\nExclusion Criteria:\n\n* Recurrent head and neck cancer that has recurred after prior courses of definitive RT or surgery followed by postoperative RT\u002FCRT. Note that individuals who have been treated with surgery alone and are now recurrent are eligible.\n* Second primary head and neck cancer after initial treatment of a prior head and neck cancer.\n* History of prior radiotherapy to the head and neck region, such that any portion of the anticipated target volume overlaps with any region that was previously targeted.\n* Active malignancy other than the head and neck cancer to be treated with PORT (excluding non-melanoma skin cancer, in situ carcinoma of any site).\n* Metastatic disease from the head and neck cancer to be treated with PORT defined as distant organ involvement outside of the head and neck and\u002For non-regional lymph node involvement outside of the head and neck.\n* Time from primary surgical resection to anticipated initiation of PORT greater than 112 days.\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Not a candidate for radiation therapy per treating clinician. For example, individuals who are pregnant or plan to become pregnant (due to the risks of the developing fetus) or any other contraindication to radiation therapy.",{"count":105,"type":21},75,[56],"The goal of this clinical trial is to determine whether accelerated radiotherapy (involving 6 treatments per week) is better than standard radiotherapy (involving 5 treatments per week) at treating cancer of the head and neck when initiated more than 6 weeks after surgery.",[109,110],"Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma HNSCC",[112,113],"Radiotherapy","Accelerated radiotherapy",{"date":33,"type":34},{"date":36,"type":34},{"date":117,"type":21},"2030-01",{"name":40,"class":41},3,{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":70},"100054000","factors-affecting-post-transplant-cyclophosphamide-ptcy-efficacy-100054000","NCT03555851","Factors Affecting Post-transplant Cyclophosphamide (PTCy) Efficacy","Elucidation of Factors Predicting Efficacy and Toxicity of Post Transplantation Cyclophosphamide (PTCy) as a Strategy for Graft Versus Host Disease Prevention in Haploidentical, Matched Related Donor and Matched Unrelated Donor Peripheral Blood Hematopoietic Cell Transplantation","Inclusion Criteria\n\nRecipients and donors must meet all of the following applicable inclusion criteria to participate in this study:\n\n1. Informed consent and HIPAA authorization for release of personal health information signed by the subject.\n2. Age ≥ 18 years at the time of consent.\n3. Subject is scheduled as a recipient or respective donor (Donor consent\u002Fparticipation is not required for subjects undergoing matched unrelated donor HCT) for the following hematopoietic stem cell transplants (HCT) procedures using a non-myeloablative regimen at Levine Cancer Institute (LCI), and has been deemed a qualified candidate by his\u002Fher physician, per LCI medical standards: haplo-identical donor HCT, match related donor (MRD) HCT, matched unrelated donor (MUD) HCT.\n4. Recipient only: Planned post-transplant cyclophosphamide\n5. As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study\n\nExclusion Criteria\n\nSubjects meeting any of the criteria below may not participate in the study:\n\n1. Recipient only (applies only to haplo-identical and MRD HCT recipients; not required for MUD HCT recipients): Does not have a respective donor who is willing to sign informed consent for participation in this study.\n2. Recipient only: Treatment with any investigational drug within 30 days prior to day -6 of treatment\n3. Donor only (applies only to haplo-identical and MRD HCTs; donor participation is not required for MUD HCTs): Does not have a respective recipient who is willing to sign informed consent for participation in this study.",{"count":128,"type":21},120,"This study will examine the influence of donor and recipient pharmacogenetics (PG), drug pharmacokinetics (PK), and T cell phenotypes and how it may permit a tailored dosing strategy to improve the therapeutic index of post-transplant cyclophosphamide (PTCy) and optimize the graft versus tumor effect, while minimizing acute and chronic graft versus host disease (GVHD).",[131,132],"Leukemia, Not Otherwise Specified","Leukemia, Other",{"date":33,"type":34},{"date":135,"type":34},"2018-07-13",{"date":137,"type":21},"2035-08",{"name":40,"class":41},{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":16,"sex":17,"minAge":50,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":148,"conditions":149,"keywords":155,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":70},"100053329","pre-malignant-states-to-hematologic-malignancies-in-firefighters-100053329","NCT06870760","Pre-malignant States to Hematologic Malignancies in Firefighters","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information.\n2. Age ≥ 40-49 years at the time of consent (self-reported)\n3. Ability of the participant to understand and comply with study procedures for the entire length of the study\n4. Currently employed by Charlotte Fire Department (CFD) with at least 5 years on-the -job experience (self-reported)\n\nExclusion Criteria:\n\nAnyone with a current diagnosis of a hematologic malignancy will be excluded.","49 Years",{"count":147,"type":21},300,"The purpose of the study is to evaluate if firefighter exposure to hazardous compounds will increase the incidence of premalignant hematological states which subsequently increases the risk of the development of hematologic malignancies, and potentially other pathophysiological consequences.",[150,151,152,153,82,154],"Clonal Hematopoiesis of Indeterminate Potential","Monoclonal Gammopathy","Non Hodgkin Lymphoma","Leukemia","Plasma Cell Disorder",[156,157,158],"Firefighters","CHIP","MGUS",{"date":33,"type":34},{"date":161,"type":34},"2026-06-23",{"date":163,"type":21},"2027-04",{"name":40,"class":41},{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":54,"phases":174,"briefSummary":176,"conditions":177,"keywords":181,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":70},"100053280","phase-3-reck-vs-exparel-in-robotic-nephrectomy-100053280","NCT07092566","R.E.C.K vs Exparel in Robotic Nephrectomy","Efficacy of Ropivacaine Epinephrine Clonidine Ketorolac (R.E.C.K) vs Exparel in Robotic Nephrectomy: a Randomized, Prospective Trial","Inclusion Criteria:\n\n1. Ability to understand and willingness to sign an IRB-approved informed consent\n2. Age ≥ 18 years at the time of consent.\n3. Planned robotic partial or radical nephrectomy\n\nExclusion Criteria:\n\n1. Determined not to be a candidate to receive R.E.C.K or Exparel per the enrolling investigator\n2. Known pregnancy\n3. Chronic opioid use within 30 days (as per patient report) prior to randomization (defined as ≥ 30 MME\u002Fday)\n4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements as determined by the investigator.\n5. Known allergy to R.E.C.K. and\u002For Exparel",{"count":173,"type":21},170,[175],"PHASE3","The purpose of the study is to evaluate the efficacy of R.E.C.K (ropivacaine epinephrine clonidine ketorolac) vs Exparel during robotic partial and radical nephrectomy in a single institution, prospective, randomized trial. The study will evaluate post operative Numerical Rating Score (NRS) pain scores, post operative pain medication intake (opioids and over-the-counter pain medicines) and length of stay across the two patient cohorts. The findings will help to inform whether the increased cost of Exparel when compared to R.E.C.K is justified.",[178,179,180],"Renal Carcinoma","Nephrectomy \u002F Methods","Pain Management",[182,183],"Analgesics","Nephrectomy",{"date":33,"type":34},{"date":186,"type":34},"2025-11-14",{"date":188,"type":21},"2027-10",{"name":40,"class":41},{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":17,"minAge":197,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":54,"phases":200,"briefSummary":201,"conditions":202,"keywords":206,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":42},"100606424","resilience-enhancement-using-electronic-frailty-index-directed-care-pathway-100606424","NCT07175376","Resilience Enhancement Using Electronic Frailty Index-Directed Care Pathway","Resilience Enhancement Utilizing an Electronic Frailty Index-Directed Care Pathway for Older Adults Receiving Chemotherapy (RESILIENCE-e): A Prospective Single-Arm Interventional Study","Inclusion Criteria:\n\nPatients with cancer:\n\n* Ability to understand and willingness to sign an IRB-approved informed consent\n* Age ≥ 65 years at the time of enrollment.\n* Planned to initiate an outpatient chemotherapy regimen (including myelosuppressive biologic\u002Fimmune therapies) for cancer treatment (any type or stage), either as an initial therapy or as a new line of therapy, with curative or palliative intent.\n* eFI pre-frail or frail status (available in EHR; defined as eFI \\> 0.10) within 30 days before enrollment.\n* Ability to read and understand the English language\n\nProviders:\n\n* Treating medical oncologist of at least one patient participant who enrolled on to the study and completed baseline assessment.\n\nExclusion Criteria:\n\nPatients:\n\n* Documented physical or psychological comorbidity that would limit participant's ability to understand or comply with study procedures for the entire length of the study per the enrolling investigator.\n* Chemotherapy planned at a facility outside the Atrium Health system.\n* Currently receiving chemotherapy (defined as planned to continue an on-going treatment rather than starting a new regimen).","65 Years",{"count":199,"type":21},32,[56],"The study purpose is to gain a better understanding of the needs of adults aged 65 and older while they are receiving chemotherapy by measuring their resilience and tailor care plans based on their individual needs.",[203,204,205],"Cancer","Frail","Chemotherapy",[203,207,208],"Frailty Index","eFI score","2026-07-01",{"date":211,"type":34},"2026-07-02",{"date":213,"type":34},"2026-03-16",{"date":215,"type":21},"2027-05",{"name":40,"class":41},{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":54,"phases":226,"briefSummary":227,"conditions":228,"keywords":230,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":70},"100601226","physician-engagement-in-ems-transport-refusal-rates-100601226","NCT07107737","Physician Engagement in EMS Transport Refusal Rates","The Role of Direct Physician Engagement in EMS Transport Refusal Rates: A Prospective Study","Inclusion Criteria:\n\n• Adult patients ≥18 years old in care of Mecklenburg EMS (MEDIC) on an emergency basis (911 call) who wish to refuse transportation to the hospital in whom MEDIC has, via existing processes and decision-making, engaged online medical control EMS Physicians for further guidance\n\nExclusion Criteria:\n\n* Patients \\\u003C18 years old.\n* Patient refuses to speak with online medical control EMS Physicians. MEDIC or patient requests to have primary care physician.\n* Lack of clinical capacity.\n* Incarcerated population.",{"count":225,"type":21},250,[56],"The primary goal of this study is to find out if patients who speak with an EMS physician over the phone are less likely to refuse care compare to patients who do not speak with an EMS physician.",[229],"Refusal of Transport",[231,232,233],"EMS transport","emergency treatment","EMS protocol","2026-06-30",{"date":209,"type":34},{"date":237,"type":34},"2026-04-12",{"date":239,"type":21},"2026-11",{"name":40,"class":41},{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":247,"enrollmentInfo":248,"targetDuration":4,"studyType":54,"phases":250,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":257,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":70},"100573317","pharmacogenomic-testing-in-pediatric-hematologyoncology-patients-100573317","NCT06744712","Pharmacogenomic Testing in Pediatric Hematology\u002FOncology Patients","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information, and assent when applicable, from the participant, parent or legal guardian.\n2. Age ≤ 26 years at the time of consent.\n3. Newly diagnosed with a malignancy and planning to undergo anti-cancer therapy; or bone marrow transplant candidate with a non-malignant diagnosis who has not yet undergone myeloablative conditioning regimen.\n\nExclusion Criteria:\n\n1. Anti-cancer therapy has already been initiated. Note: Enrollment after initiation of intrathecal chemotherapy will be allowed.\n2. Previously received bone marrow transplant or planning to receive as part of initial upfront therapy for a malignant condition.\n3. Prior history of tissue or organ transplant.","26 Years",{"count":249,"type":21},130,[56],"Pharmacogenomic (PGx) testing involves analyzing variants of genes associated with drug metabolism, transport and medication targets. PGx testing uses an individual's genetic factors, such as single nucleotide polymorphisms (SNPs), to personalize therapy or dose a selection of medications. PGx testing has traditionally been used to test single genes, but there are now platforms allowing a panel of genes to be tested at once. To date there has not been a comprehensive screening of pediatric oncology patients to determine the prevalence of genetic variants that may affect anticancer therapy and supportive care medications. This study would allow us to summarize the frequency of clinically relevant gene-drug interactions and actionable genetic polymorphisms in pediatric oncology patients.",[253],"Pediatric Cancer",[255,256],"Pharmacogenomic","Anti-Cancer Therapy","NOT_YET_RECRUITING",{"date":211,"type":34},{"date":260,"type":21},"2026-08",{"date":262,"type":21},"2028-07",{"name":40,"class":41},{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":54,"phases":273,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":119},"100241546","phase-2-prospective-evaluation-of-high-dose-systemic-methotrexate-in-patients-with-breast-cancer-and-leptomeningeal-metastasis-100241546","NCT02422641","Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis","Traditional Incision and Drainage of Cutaneous Abscess Vs. Minimally Invasive Incision and Drainage With Vessel Loop: A Randomized Controlled Trail","Inclusion Criteria\n\n* Adults (male and female) age \\>18\n* Eastern Cooperative Group (ECOG) Performance Scale 0-1 (see Appendix I)\n* Histologically or cytologically confirmed invasive breast cancer of the following subtype:\n* TRIPLE NEGATIVE (ER-negative, PR-negative, and HER2-negative disease). Triple-negative patients will be defined per ASCO-CAP Guidelines.\n* HER2-POSITIVE: HER2-positive patients will be defined per ASCO-CAP Guidelines.\n* HORMONE REFRACTORY: Patients with ER\u002FPR-positive disease according to ASCO-CAP guidelines above may be considered if they have disease progression after two lines of hormonal therapy (administered in the adjuvant or metastatic setting), or are deemed clinically hormone-resistant taking into consideration the rate of progression of disease or a short interval of time on first line hormonal therapy before progression. Clinically hormone-resistant patients MUST also be discussed with the Study Chair, Study co-chair or designee in advance for approval.\n\nNOTE: ASCO-CAP guidelines state that ER and PR assays be considered positive if there are at least 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal (normal epithelial elements) and external controls. HER2-positive is defined as HER2 IHC 3+, ISH ≥ 2.0, or average HER2 copy number ≥ 6.0 signals.\n\nNOTE: A patient who has a change in receptor status (e.g. PR negative to positive) may be stratified as triple negative or hormone positive, contrary to the most recent receptor testing, for the purposes of the study, based upon the clinical course at the discretion of the Study Chair, Study co-chair, or designee in advance for approval.\n\n* Cytologic or unequivocal radiographic confirmation of leptomeningeal metastasis by dural puncture and\u002For neuroimaging with or without known brain metastasis\n* Adequate organ function as follows:\n\nEstimated creatinine clearance \\>70 cc\u002Fmin (calculated by Cockcroft-Gault formula) White blood cell counts \\>3000 cells\u002FmcL Absolute neutrophil count \\>1500 cells\u002FmcL Platelet count \\>100,000 cells\u002FmcL Hematocrit \\>30% Serum bilirubin \\\u003C1.5 x the ULN or \\\u003C5x the ULN if secondary to liver metastasis Alanine aminotransferase or aspartate aminotransferase \\\u003C2.5x the ULN or \\\u003C5x the ULN if secondary to liver metastasis Alkaline phosphatase \\\u003C2.5x the ULN or \\\u003C5x the ULN if secondary to liver metastasis\n\n\\- Able to provide confirmed consent\n\nExclusion Criteria\n\n* Prior allergy or adverse reaction to methotrexate\n* New York Heart Association Heart Failure Class \\>3\n* Active diabetes insipidus\n* Active mucositis\n* Chemotherapy or stereotactic radiotherapy within the last 2 weeks\n* Partial brain radiotherapy (i.e. \\\u003C40% of total brain volume) within the last 2 weeks\n* Whole brain radiotherapy within the last 6 months or partial brain radiotherapy exceeding \\>40% of total brain volume within the last 6 months\n* Prior treatment with any methotrexate containing systemic regimen within 1 year (excluding intrathecal methotrexate)\n* Concurrent or planned systemic chemotherapy, radiotherapy, new hormonal or anti- HER2 directed therapy directed at management of breast cancer (existing anti-HER2 therapy can be continued as recently recommended in the National Consensus Guidelines (26)\n* Uncontrolled or progressive systemic disease or other concurrent condition which in the Investigator's opinion makes HD-MTX an undesirable treatment option for the patient or would jeopardize compliance\n* Contraindication to MRI\n* Use of salicylates, non-steroidal anti-inflammatory drugs, or sulfonamide medications within one week of start of methotrexate\n* Pregnant women or women who are breastfeeding.\n* Patients with significant visceral fluid collections including ascites, pericardial effusions, pleural effusions or others may experience delayed clearance of methotrexate because of third space accumulation which could result in methotrexate toxicity and inability to tolerate the proposed study treatment. While these are not absolute exclusions the Study Chair or co-Chairs should be contacted to discuss possible enrollment. Patients with significant ascites defined as European Association for the Study of the Liver \\> grade 2 (Appendix IV), or with asymptomatic pleural effusions with an estimated size \\>200 mL, or with symptomatic pleural effusion of any size will be excluded.\n\nNOTE: Systemic staging of the chest\u002Fabdomen\u002Fpelvis is required for study entry. See Sections 8.1.9. Body fluid will be assessed based on this study.",{"count":272,"type":21},16,[274],"PHASE2","This study is a prospective evaluation of systemic, intravenous high-dose methotrexate (HD-MTX, 8 g\u002Fm2) in patients with triple negative, HER2-positive, and hormone refractory breast cancer with leptomeningeal metastasis (LMD) with or without brain parenchymal involvement.",[277,278],"Metastatic Breast Cancer","Leptomeningeal Disease",{"date":211,"type":34},{"date":281,"type":4},"2015-05",{"date":283,"type":21},"2027-07",{"name":40,"class":41},{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":54,"phases":293,"briefSummary":294,"conditions":295,"keywords":297,"overallStatus":257,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":70},"100602707","mindfulness-in-nonflaccid-facial-paralysis-100602707","NCT07127016","Mindfulness in Nonflaccid Facial Paralysis","Inclusion Criteria:\n\n\\- Diagnosed with non-flaccid facial paralysis (NFFP) due to Bell's Palsy, Ramsay Hunt syndrome, Lyme disease, or post-acoustic neuroma resection, at least 8 months from the initial diagnosis\n\nExclusion Criteria:\n\n* Received treatments such as botox or physical therapy for facial paralysis\n* History of malignancy or facial surgery",{"count":292,"type":21},24,[56],"The purpose of this study is to learn more about how mindfulness techniques can help reduce anxiety, depression and body image disturbance as well as improve synkinesis in individuals with non-flaccid facial paralysis.",[296],"Facial Paralysis",[298,299,300],"non-flaccid facial paralysis","synkinesis","mindfulness","2026-06-29",{"date":234,"type":34},{"date":304,"type":21},"2026-07",{"date":306,"type":21},"2027-01",{"name":40,"class":41},{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":16,"sex":17,"minAge":315,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":70},"100585036","optimizing-health-related-quality-of-life-measurement-in-adolescent-and-young-adult-oncology-100585036","NCT06897137","Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology","Optimizing Health Related Quality of Life Measurement in Adolescent and Young Adult Oncology: A Promising Solution (PROMIS AYA) - Aim 2","AYAs with a cancer history (AYA-C)\n\nInclusion Criteria:\n\n* Young adults between the ages of 15 to 39 years;\n* First diagnosed with cancer during 15 to 39 years of age;\n* Able to read and understand English;\n* Live in the United States;\n* Have a new cancer diagnosis and are receiving curative treatment OR are currently 0 to 10 years post-treatment.\n\nExclusion Criteria:\n\n* Diagnosed with basal cell skin cancer; or\n* Are currently receiving hospice care.\n\nAYAs General Population (AYA-GP)\n\nInclusion Criteria:\n\n* Young adults between the ages of 15 to 39 years;\n* Able to read and understand English; and\n* Live in the United States.\n\nCaregivers of AYAs with cancer (AYA-Cg)\n\nInclusion Criteria:\n\n* 18 years of age or older;\n* Able to read and understand English;\n* Live in the United States;\n* Have a child\u002Fward\u002Fpartner for whom they have provided care, AND\n* Their child\u002Fward\u002Fpartner is 15 to 25 years of age and meets the other eligibility criteria as an AYA participant with a cancer history (described above).","15 Years",{"count":317,"type":21},3000,"This study evaluates how adolescent and young adults with cancer in the U.S. and their loved ones respond to questions that will later be used with people who may have cancer and other chronic health conditions",[320,321,322],"Malignant Solid Neoplasm","Hematopoietic Neoplasms","Lymphatic System Neoplasm",{"date":234,"type":34},{"date":325,"type":34},"2026-04-26",{"date":327,"type":21},"2028-01",{"name":40,"class":41},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":16,"sex":17,"minAge":336,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":54,"phases":339,"briefSummary":340,"conditions":341,"keywords":343,"overallStatus":257,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":70},"100603444","narrative-medicine-effects-on-burnout-and-stress-100603444","NCT07136597","Narrative Medicine Effects on Burnout and Stress","Investigating the Utility and Efficacy of Narrative Medicine Based Flash-writing on Healthcare Occupational Burnout and Stress Mitigation Among Atrium Health Wake Forest Baptist Faculty","Inclusion Criteria:\n\n* Study participants must be current faculty at Atrium Health Wake Forest Baptist (AHWFB) within three departments: internal medicine, surgery and pediatrics\n\nExclusion Criteria:\n\n* Faculty who are not currently working at AHWFB may be excluded","21 Years",{"count":338,"type":21},60,[56],"A rising area of interest over the past several years has been on the issue of physician burnout. Burnout can be defined as a chronic occupational stress response characterized by multi-dimensional exhaustion and diminished sense of fulfillment in one's personal and professional life. Regarding the effects of emotional, occupational and physical stress on job satisfaction, standard of care and staff retention, it is important to determine meaningful methods to alleviate and prevent burnout among healthcare professionals.",[342],"Healthcare Professionals",[344,345,346],"stress mitigation","exhaustion","mental health challenges","2026-06-26",{"date":301,"type":34},{"date":350,"type":21},"2026-09",{"date":352,"type":21},"2026-12",{"name":40,"class":41},{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":361,"enrollmentInfo":362,"targetDuration":4,"studyType":54,"phases":364,"briefSummary":365,"conditions":366,"keywords":368,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":70},"100604001","enhancing-slow-wave-sleep-in-depression-100604001","NCT07143838","Enhancing Slow Wave Sleep in Depression","Investigating Slow Wave Sleep Enhancement to Improve Cognitive Function in Adults With Depression","Inclusion Criteria:\n\n* Ability to complete overnight sleep study including placement of EEG leads\n* Ability to read and understand English.\n* Moderate depression\n* Self-reported cognitive complaints\n\nExclusion Criteria:\n\n* Previous adverse reaction to transcranial electrical stimulation\n* Presence of implanted devices (e.g. intracranial device, cochlear implant)\n* Presence of metal in head (e.g. surgical clip)\n* Sensitivity or allergy to silver\n* Presence of significant neurologic disease (e.g. Parkinson's disease, epilepsy\u002Fseizure disorder, severe migraine disorder)\n* History of significant head trauma\n* History of stroke or other ischemic event\n* Diagnosed with schizophrenia, bipolar disorder, substance use disorder, or presence of current suicidal ideation\n* Currently taking medications that could alter EEG or cognitive function\n* Presence of severe insomnia\n* Presence of severe, untreated sleep apnea\n* Currently pregnant\n* Planned travel outside time zone during the study","80 Years",{"count":363,"type":21},12,[56],"The goal of this pilot study is to determine if non-invasive brain stimulation during sleep can increase deep sleep in adults with depression. It will also determine if increased deep sleep improves cognitive performance and mood ratings. Participants will be asked to wear a non-invasive device that records their brain activity and delivers transcranial electrical stimulation during sleep. Participants will also wear an actigraphy watch that measures activity levels throughout the study. In addition, participants will complete several cognitive assessments and mood and sleep questionnaires throughout the study.",[367],"Depression - Major Depressive Disorder",[369,370],"Sleep","Depression",{"date":301,"type":34},{"date":373,"type":34},"2026-06-04",{"date":375,"type":21},"2027-03",{"name":40,"class":41},{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":361,"enrollmentInfo":384,"targetDuration":4,"studyType":54,"phases":386,"briefSummary":387,"conditions":388,"keywords":391,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":398,"locationsCount":70},"100471170","randomized-control-trial-cryoablation-as-an-adjunct-to-surgical-stabilization-of-rib-fractures-100471170","NCT05415384","Randomized Control Trial, Cryoablation as an Adjunct to Surgical Stabilization of Rib Fractures","Single Center, Randomized Control Trial of Cryoablation During Surgical Stabilization of Rib Fractures","Inclusion Criteria:\n\n* The patient is admitted to the trauma service.\n* The patient has multiple displaced rib fractures (≥2 ribs), offered fixation, and consents to SSRF\n* The patient is not being treated for chronic pain\n* The patient is \\>18 years of age.\n* Surgery anticipated \\\u003C120 hours from injury\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years or ≥ 80 years\n* Flail chest: either radiographic or clinical. Radiographic flail chest is defined on CT chest as ≥ 2 ribs each fractured in ≥ 2 places. Clinical flail is defined as visualization of a segment of chest wall with paradoxical motion on physical exam.\n* Moderate or severe traumatic brain injury (Intra-cranial hemorrhage visualized on CT head with GCS at the time of consideration for enrollment \\\u003C 12)\n* Prior or expected emergency exploratory laparotomy during this admission\n* Prior or expected emergency thoracotomy during this admission\n* Prior or expected emergency craniotomy during this admission\n* Spinal cord injury\n* Pelvic fracture that has required, or is expected to require, operative intervention during this admission\n* The patient was unable to accomplish activities of daily living independently prior to injury (e.g., dressing, bathing, preparing meals)\n* The patient is incarcerated\n* The patient is known to be pregnant\n* Unable to perform Video Assisted Thoracoscopy (VATS) at time of SSRF due to lung isolation or previous pathology",{"count":385,"type":21},80,[56],"To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of Surgical Stabilization of Rib Fractures (SSRF) without cryoablation",[389,390],"Pain, Postoperative","Rib Fracture Multiple",[392,393],"Locoregional pain","thoracotomy",{"date":301,"type":34},{"date":396,"type":34},"2022-08-01",{"date":239,"type":21},{"name":40,"class":41},{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":16,"sex":17,"minAge":406,"maxAge":407,"enrollmentInfo":408,"targetDuration":4,"studyType":54,"phases":409,"briefSummary":411,"conditions":412,"keywords":415,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":423,"locationsCount":70},"100364556","early-phase-1-uric-acid-klotho-and-salt-sensitivity-in-young-adults-born-preterm-100364556","NCT04026776","Uric Acid, Klotho and Salt Sensitivity in Young Adults Born Preterm","PEPC3","Inclusion Criteria:\n\n* Singleton birth\n* Born at less than 34 weeks gestational age (preterm cohort)\n* Born at greater than 36 weeks gestational age (term cohort)\n\nExclusion Criteria:\n\n* Twin birth\n* Congenital anomalies or genetic syndromes\n* Currently pregnant or breast feeding\n* Subject-reported history of hypertension\n* Current use of antihypertensive medications\n* Active cancer\n* Chronic kidney disease\n* Heart failure\n* Liver failure","22 Years","33 Years",{"count":128,"type":21},[410],"EARLY_PHASE1","The purpose of this research is to learn about how salt in the diet influences blood pressure in young adults who were born prematurely.",[413,414],"Salt; Excess","Blood Pressure Disorders",[416,417,418],"Uric Acid sensitivity","Salt sensitivity","Blood Pressure Influences",{"date":301,"type":34},{"date":421,"type":34},"2020-09-02",{"date":352,"type":21},{"name":40,"class":41},{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":17,"minAge":432,"maxAge":433,"enrollmentInfo":434,"targetDuration":4,"studyType":54,"phases":436,"briefSummary":438,"conditions":439,"keywords":441,"overallStatus":257,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":448,"leadSponsor":449,"locationsCount":70},"100644410","phase-1-breast-milk-enema-administration-to-stimulate-passage-of-meconium-100644410","NCT07661992","Breast-milk Enema Administration to Stimulate Passage of Meconium","Breast-Milk Enema Administration to Stimulate Meconium Passage in Preterm Infants","BEAM","Inclusion Criteria:\n\n* Preterm infants born at \\>23 and \\\u003C28 weeks' gestational age born at Atrium Health Wake Forest Baptist Hospital or transferred in the first 24 hours of life.\n* postnatal age \\>48 hours, absence of spontaneous passage of meconium by \\>48 hours of life\n* availability of mother's own milk\n* written informed consent obtained from a parent or legal guardian.\n\nExclusion Criteria:\n\n* Infants with Necrotizing Enterocolitis (NEC) ≥ stage II\n* spontaneous intestinal perforation (SIP)\n* gastrointestinal or anorectal malformations\n* infants that have developed severe hemodynamic instability or sepsis with need for vasoactive drugs\n* significant hematologic abnormalities such as neutropenia or thrombocytopenia.\n* Infants will also be excluded in the absence of written informed consent from a parent or legal guardian.","23 Weeks","28 Weeks",{"count":435,"type":21},20,[437],"PHASE1","Lack of passage of meconium in preterm infants delays feeding advancement and may represent a risk factor for necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP). Usual management of meconium impaction has included glycerin suppositories and normal saline enemas. Various methods are used in routine neonatal care to promote meconium evacuation; however, there is no consensus on the agents used and the frequency of applications",[440],"Breast-milk",[442,443,444],"Meconium","rectal enemas","low birth weight infants","2026-06-25",{"date":234,"type":34},{"date":304,"type":21},{"date":306,"type":21},{"name":40,"class":41},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":54,"phases":458,"briefSummary":459,"conditions":460,"keywords":462,"overallStatus":257,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":466,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":470,"locationsCount":70},"100645146","phase-1-amnion-membrane-powder-mohs-study-100645146","NCT07680023","Amnion Membrane Powder Mohs Study","A Phase I Study of Human Amnion Membrane Powder for Enhanced Wound Healing of Mohs Surgery Wound Sites","Inclusion Criteria:\n\n* The subject requires Mohs surgery on the scalp, with the resulting wound extending to the subgalea (all subcutaneous fat removed) and a surface area of at least 4cm2.\n* The subject is willing to complete all follow-up evaluations required by the study protocol.\n* The subject is to abstain from any other covering or treatment of the wound(s) for the duration of the study unless otherwise directed by the study surgeon or their surrogate\n* The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.\n* The subject and\u002For guardian is\u002Fare able to read and understand instructions and give informed, voluntary, written consent.\n* The subject is able and willing to follow the protocol requirements.\n\nExclusion Criteria:\n\n* The subject's wound site is smaller than 4cm2.\n* The subject's wound site does not extend to the subgalea.\n* The subject has invasive melanoma or high-risk squamous cell carcinoma (defined by poor differentiation, presence of perineural invasion) in which the standard of care is to be referred for adjuvant radiation oncology\n* The subject has a microbiologically proven pre-existing local or systemic bacterial infection.\n* The subject has been receiving a systemic antibiotic for more than 48 hours prior to grafting.\n* Unstable cardiac disorders within the past 6 months including angina, abnormal ECG, history of cardiac arrest, surgery and\u002For other interventional procedure that would preclude the indicated procedure.\n* Hepatic disease or altered liver function as defined by ALT or AST value \\> 3 times the upper limit of normal and\u002For T. Bilirubin \\>1.5 mg\u002FdL at screening.\n* Renal disease or altered renal function as defined by serum creatinine \\> 2 mg\u002FdL at screening, or ESRD.\n* Hemoglobin \\\u003C10.0 or \\>19.0 g\u002FdL\n* Untreated coagulopathy or platelet disorder, or INR \\> 1.6, PTT \\> 38 sec; PLT \\\u003C 50,000 at screening.\n* The subject is known to have a pre-existing, chronic condition that, in the opinion of the Investigator, may interfere with complete re-epithelialization including but not limited to untreated malignancy, uncontrolled diabetes (HbA1c \\>10), autoimmune disease or other immunocompromised diseases, hematological diseases, peripheral artery diseases, and \u002For malnourishment with an albumin \\\u003C 2.5.\n* The subject currently uses illicit substances or has drug or alcohol dependency.\n* The subject is unable to follow the protocol.\n* The subject is taking medication known to have an effect on wound healing or skin pigmentation within 30 days prior to surgery (e.g. corticosteroids, retinoids etc.)\n* The subject has a known hypersensitivity to Compound Sodium Lactate for Irrigation (Hartmann's) solution.\n* The subject is pregnant or lactating or intends to become pregnant during the study.\n* The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.",{"count":435,"type":21},[437],"The purpose of this research study is to test the safety of the amnion membrane powder to see if it improves wound healing in patients undergoing Mohs surgery on the scalp.",[461],"Wound Heal",[463,464,465],"MOHS surgery","amnion membrane powder","scalp wound healing",{"date":209,"type":34},{"date":468,"type":21},"2026-10",{"date":188,"type":21},{"name":40,"class":41},{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":478,"enrollmentInfo":479,"targetDuration":4,"studyType":54,"phases":481,"briefSummary":482,"conditions":483,"keywords":485,"overallStatus":257,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":489,"startDateStruct":490,"completionDateStruct":491,"leadSponsor":493,"locationsCount":70},"100443468","phase-2-augmentation-cystoplasty-using-an-autologous-neo-bladder-construct-100443468","NCT05054790","Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct","A Phase 2 Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct In Subjects With Fibrotic Contracted Bladder","Inclusion Criteria:\n\n* Subjects with small contracted and\u002For fibrotic non-neurogenic bladder.\n* Small bladder \\\u003C150cc capacity\n* Willing and able to give signed informed consent in English.\n* Ability of subject to be successfully trained in clean intermittent catheterization and bladder cycling\n* Failure to respond to maximum approve dose of medical therapy (e.g. anticholinergics) or failure to tolerate \u002Fcontraindication to such agents\n* Medical need for bladder augmentation, as defined by the presence of:\n\n  1. Decreased and inadequate bladder compliance with a bladder pressure ≥40 cmH20. OR\n  2. New-onset of upper urinary tract changes (hydronephrosis, vesicoureteral reflux) in the last 12 months\n\nExclusion:\n\n* Neurogenic bladder\n* Recent (\\\u003C 12 months) urological or intraperitoneal surgery or device implantation; recent (\\\u003C6 month neurologic surgery-brain or spine)\n* Any prior bladder augmentation procedure\n* Known or suspected limitation to obtaining omentum for implantation procedure (e.g., extensive intraperitoneal adhesions)\n* Any contraindication to general anesthesia\n* Any contraindication or known anaphylactic or severe systemic reaction to either human blood products or materials of bovine origin\n* Human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV), active hepatitis A (HAV) or other known active infection\n* Subjects with active tuberculosis (TB) requiring treatment in the past 3 years. Subjects with a current positive (≥5 mm induration for high-risk subjects; otherwise ≥10 mm of induration) purified protein derivative (PPD) test are excluded unless they have completed a full course of treatment for latent TB and have a negative chest x-ray film at enrollment.\n* Subjects known to be colonized with either methicillin-resistant staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE), or gentamicin-resistant organisms.\n* Receipt of blood or blood products for transfusion during the 3 months prior to biopsy\n* Immunocompromised subjects or subjects receiving immunosuppressive agents (inhaled corticosteroids and chronic low-dose corticosteroids \\[≤0.25 mg\u002Fkg prednisone or equivalent per day\\] are permitted).\n* Brief pulsed corticosteroids for intermittent symptoms (e.g., asthma) are permitted.\n* Known history of hypersensitivity to aminoglycosides or fluoroquinolones.\n* History of true allergy to iodine or iodinated x-ray contrast agents\n* Use of any investigational product within 3 months\n* Prior participation in the study\n* Any history of alcohol and\u002For any drug abuse\n* Current incarceration for any reason\n* Unwillingness, inability, or unlikely compliance with study related procedures\n* Any circumstance in which the investigator deems participation in the study is not in the subject's best interest\n* Subjects with an Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) value \\>3 times the upper limit of normal\n* Subjects with an albumin value \\\u003C3.0 g\u002FdL\n* Subjects with a history of an anaphylactic or a severe systemic reaction to the biodegradable polymers glycolic acid (PGA) and lactic-co-glycolic acid (PLGA)\n* Subjects with acute or chronic abdominal skin infections and\u002For acute or chronic inflammatory bowel disease\n* Subjects with uncontrolled diabetes, unstable cardiac and\u002For pulmonary disorders, or bleeding disorders\n* Subjects who have received Botulinum Toxin A injections into the bladder within the previous 12 months.\n* Female subjects who are pregnant, planning to get pregnant or lactating\u002Fbreast-feeding.\n* Female subjects of child-bearing potential unwilling to practice an effective method of birth control as determined by the investigator (e.g., oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy) for duration of the study.\n\n  * If a patient has had a hysterectomy, a bilateral oophorectomy, documented ovarian failure or is older than age 51.5 years and has not had a menstrual period in more than 12 months, they will be considered to be non-childbearing. This will be ascertained from patient interview\u002Fself-report, medical records (if necessary) and the investigator's judgment. \"Spontaneous menopause,\" occurs in the United States at a mean age of 51.5 years.","60 Years",{"count":480,"type":21},10,[274],"The purpose of this research study is to find out if autologous \"neo-bladder\" construct for the treatment of fibrotic and\u002For contracted bladder can improve bladder compliance and be safe long term. The neo-bladder is like a reservoir or pouch that will be surgically attached to the bladder to assist with urine collection.",[484],"Contracted Bladder",[486,487,488],"Neo-bladder","fibrotic bladder","bladder compliance",{"date":234,"type":34},{"date":352,"type":21},{"date":492,"type":21},"2027-12",{"name":40,"class":41},{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":500,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":54,"phases":504,"briefSummary":505,"conditions":506,"keywords":508,"overallStatus":257,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":514,"completionDateStruct":515,"leadSponsor":516,"locationsCount":70},"100643707","rise-stroke-mobility-study-100643707","NCT07638462","RIsE Stroke Mobility Study","RIsEStroke (Recovery Insights Into Early Mobility Post Stroke)","RIsE","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Hospitalized patients with acute ischemic stroke\n* Initial National Institutes of Health Stroke Scale (NIHSS) score of 10 or greater\n* Baseline modified Rankin Scale (mRS) score of 0-2\n* Current modified Rankin Scale (mRS) score of 3-5\n\nExclusion Criteria:\n\n* Current or expected End-of-life discussions\n* Current plans for surgical intervention\n* Patients with pre-mRS of 3-5\n* Patients with orthopedic, musculoskeletal, integumentary injury that would prevent safe weight bearing, mobility or equipment use\n* Uncontrolled cardiorespiratory dysfunction or disease\n* Active\u002Funcontrolled seizures\n* Isolation status that would prevent mobility outside of the room\n* Weight that exceeds the safe limits of mobility equipment",{"count":503,"type":21},50,[56],"This study is designed to better understand how patients with severe stroke move during their hospital stay. It will track their activity using a small wearable device (activPAL) along with standard mobility information already collected in clinical care. The goal is to learn what typical movement patterns look like early after a stroke and how well patients meet mobility goals while in the hospital. What is learned from this study may allow determination of how treatment for stroke patients may be improved to improve patient long-term mobility.",[507],"Acute Ischemic Stroke",[509,510,511],"stroke","mobility","advanced therapy","2026-06-24",{"date":445,"type":34},{"date":304,"type":21},{"date":163,"type":21},{"name":40,"class":41},{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":523,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":525,"targetDuration":4,"studyType":54,"phases":527,"briefSummary":528,"conditions":529,"keywords":531,"overallStatus":257,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":535,"startDateStruct":536,"completionDateStruct":537,"leadSponsor":539,"locationsCount":70},"100643816","phase-3-magnesium-with-metoprolol-for-rate-control-in-atrial-fibrillation-100643816","NCT07632157","MAGNEsium With meToprolol for Rate Control In Atrial Fibrillation","MAGNEsium With meToprolol for Rate Control In Atrial Fibrillation (MAGNETIC-AF)","MAGNETIC-AF","Inclusion Criteria:\n\n* Age \\> 18 years or older\n* Able to provide informed consent\n* Primary diagnosis atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR) greater than or equal to 120 beats per minute\n* Metoprolol as rate control agent\n* English speaking\n\nExclusion Criteria:\n\n* Hemodynamically unstable patients (SBP \\\u003C90, MAP \\\u003C65)\n* Impaired consciousness\n* Acute heart failure exacerbation based on clinical diagnosis, physician exam, bedside echo, and\u002For additional imaging\n* Patient in AFF RVR that is highly suspected to be a compensatory mechanism for an alternative clinical diagnosis\n* Rhythms other than atrial fibrillation, such as sick sinus syndrome or wide-complex ventricular response\n* Acute myocardial infarction\n* Contraindications to magnesium sulfate (including myasthenia gravis)\n* Allergy or sensitivity to any study drugs\n* Previously enrolled in this trial during a different patient encounter\n* Withdrew from study",{"count":526,"type":21},196,[175],"The purpose of this research study is to find out if the use of magnesium in addition to Metoprolol, a rate controlling medication that you would be offered in the Emergency Department today unrelated to this study, will help reduce your high heart rate (rapid ventricular response).",[530],"Atrial Flutter With Rapid Ventricular Response",[532,533,534],"AFF RVR","intravenous magnesium","atrial flutter",{"date":301,"type":34},{"date":468,"type":21},{"date":538,"type":21},"2028-12",{"name":40,"class":41},{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":547,"minAge":18,"maxAge":4,"enrollmentInfo":548,"targetDuration":4,"studyType":54,"phases":549,"briefSummary":551,"conditions":552,"keywords":554,"overallStatus":257,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":560,"leadSponsor":561,"locationsCount":42},"100639514","phase-4-azithromycin-for-cerclage-prophylaxis-100639514","NCT07608562","Azithromycin for Cerclage Prophylaxis","Evaluating Azithromycin Prophylaxis and Mycoplasma Prevalence in High-Risk Pregnancies Requiring Cerclage: A Prospective Cohort Study","Inclusion Criteria:\n\n* Singleton gestation at 16+0 to 23+6 weeks of gestational age at the time of enrollment\n* Indication for transvaginal cerclage placement\n* Intact amniotic membranes\n\nExclusion Criteria:\n\n* Evidence of active infection or chorioamnionitis at presentation\n* Preterm prelabor rupture of membranes (PPROM)\n* Multiple gestation\n* HIV positive status\n* Known severe allergy or contraindication to macrolide antibiotics (azithromycin or erythromycin)\n* Use of systemic antibiotics within the past 7 days (to avoid altered baseline vaginal microbiome)\n* Major fetal anomaly or known chromosomal abnormalities that significantly affect viability\n* Any maternal condition that would ethically preclude expectant management of pregnancy irrespective of cerclage","FEMALE",{"count":385,"type":21},[550],"PHASE4","The primary goal is to assess the effectiveness in pregnancy prolongation utilizing azithromycin at the time of transvaginal cervical cerclage placement.",[553],"Cervical Insufficiency",[555,556,557],"short cervix","pregnancy prolongation","cerclage",{"date":445,"type":34},{"date":260,"type":21},{"date":538,"type":21},{"name":40,"class":41},{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":17,"minAge":569,"maxAge":570,"enrollmentInfo":571,"targetDuration":4,"studyType":54,"phases":572,"briefSummary":573,"conditions":574,"keywords":576,"overallStatus":257,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":580,"leadSponsor":582,"locationsCount":70},"100635490","auditory-stimulation-for-insomnia-and-depression-100635490","NCT07553364","Auditory Stimulation for Insomnia and Depression","Feasibility of Using Alpha Phase-Locked Auditory Stimulation for Insomnia Symptoms in People With Depression","Inclusion Criteria:\n\n* Ability to complete overnight EEG study including placement of EEG leads\n* Ability to read and understand English\n* Presence of Insomnia\n* Moderate Depression\n* Home internet and smartphone (Android or Apple) device access\n\nExclusion Criteria:\n\n* Presence of severe, untreated sleep apnea\n* Presence of restless leg syndrome\n* Significant neurological disease (e.g. Parkinson's disease, epilepsy)\n* Diagnosed with schizophrenia, bipolar disorder, substance use disorder, or presence of current suicidal ideation\n* Has active implanted device ( e.g. intracranial device, cochlear implant)\n* Currently deaf or experiencing hearing loss or using hearing aids\n* Currently taking medications that could alter EEG\n* Currently pregnant","20 Years","50 Years",{"count":7,"type":21},[56],"The goal of this clinical trial is to determine if alpha phase-locked auditory stimulation can improve sleep in people with insomnia and depression. The main goals of the pilot study are the following:\n\nDetermine whether alpha phase-locked auditory stimulation (active stimulation) improves objective and subjective sleep in individuals with insomnia and depression.\n\nThe study team hypothesizes that active auditory stimulation will reduce objective and subjective sleep onset latency (SL) and wake after sleep onset (WASO) compared to a sham stimulation.\n\nParticipants will:\n\n* Wear Elemind Neuromod headband nightly for 4 weeks (1 week baseline, 1 week active\u002Fsham stimulation, 1 week washout, and 1 week opposite condition - active\u002Fsham stimulation)\n* Wear actigraphy watch for duration of the study\n* Complete questionnaires regarding their sleep, mood, and satisfaction with the device",[367,575],"Insomnia",[577,370,575],"sleep",{"date":347,"type":34},{"date":304,"type":21},{"date":581,"type":21},"2027-12-01",{"name":40,"class":41},{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":17,"minAge":589,"maxAge":406,"enrollmentInfo":590,"targetDuration":4,"studyType":54,"phases":592,"briefSummary":593,"conditions":594,"keywords":597,"overallStatus":257,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":602,"startDateStruct":603,"completionDateStruct":604,"leadSponsor":605,"locationsCount":606},"100636064","phase-2-the-catsindo-trial---clinical-and-translational-study-in-newly-diagnosed-osteosarcoma-100636064","NCT07560826","The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma","Pre-Enrollment Criteria:\n\n1. Suspected diagnosis of high-grade osteosarcoma based on clinical and radiographic findings.\n2. Informed consent (and assent, if applicable) obtained, per institutional guidelines.\n3. Participants must be ≤ 22 years of age at the time of consent.\n\nInclusion Criteria:\n\n1. Participants with localized or metastatic high-grade osteosarcoma.\n2. Participants must be ≤ 22 years of age at the time of consent.\n3. Participants must have a body surface area of greater than or equal to 0.8 m2.\n4. Participants receiving or planning to receive induction\u002Fneoadjuvant MAP chemotherapy with HD-MTX given at the standard dose of 12 gm\u002Fm2 (maximum 20 gm).\n\n   NOTE: Participants may be participating on other clinical studies such as the COG trial AOST2032 or any other clinical trial as long as their treatment includes MAP chemotherapy with the standard HD-MTX dose of 12 gm\u002Fm2 (maximum 20 gm).\n5. Participants may receive other chemotherapy agents in their treatment provided that drug(s) are not known to interfere with HD-MTX clearance when given concurrently. Medications known to interfere with HD-MTX clearance are listed in Appendix A.\n6. Participants must meet minimum organ function requirements to receive HD-MTX:\n\n   * Adequate liver function defined as: total bilirubin ≤ 1.5x upper limit of normal (ULN) for age at the time of consent and alanine aminotransferase (ALT\u002FSGPT) ≤ 135 U\u002FL for age at the time of consent.\n   * Adequate renal function defined as: a serum creatinine based on age\u002Fgender OR - a 24-hour urine Creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m2, OR - an estimated glomerular filtration rate (GFR) of greater than or equal to 70 mL\u002Fmin\u002F1.73 m2 for age at the time of consent.\n   * Adequate bone marrow function defined as: peripheral absolute neutrophil count (ANC) ≥ 1000\u002FµL, platelet count ≥ 100,000\u002FµL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment), and hemoglobin ≥ 8.0 g\u002FdL (transfusion independent, defined as not receiving red blood cell transfusions within a 7-day period prior to enrollment)\n7. Adequate cardiac function, defined as a left ventricular ejection fraction (LVEF) ≥ 50%, assessed per institutional standard of care using non-invasive imaging modalities such as a Multi-Gated Acquisition (MUGA) scan or echocardiogram (echo).\n\n   NOTE: Cardiac function assessment will be performed as part of routine clinical care. No additional imaging or procedures will be mandated by the research protocol.\n8. Informed consent, and assent when appropriate, must be obtained, per institutional guidelines.\n9. Participants can enroll after initiation of induction MAP chemotherapy so long as they are enrolled prior to the second cycle of chemotherapy (prior to week 6 cisplatin and doxorubicin).\n10. Participants must be willing and able to comply with all study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n1. Female participants who are pregnant and\u002For lactating and breast feeding their infant(s).\n\n   NOTE: Pregnancy testing will follow institutional standard of care practice and is not mandated by the protocol.\n2. Sexually active participants of reproductive potential who have not agreed to use an effective contraceptive method for the duration of protocol therapy, at the discretion of the investigator.","7 Years",{"count":591,"type":21},46,[274],"The goal of this study is to learn whether children, adolescents, and young adults with newly diagnosed high-grade osteosarcoma can be safely discharged from the hospital at slightly higher methotrexate blood levels after receiving standard high-dose methotrexate chemotherapy. Participants are 22 years old or younger and are receiving standard MAP (high-dose methotrexate with doxorubicin and cisplatin) chemotherapy as part of their routine cancer treatment.\n\nThe main questions this study aims to answer are:\n\n* Is hospital discharge at higher methotrexate levels safe, based on side effects or hospital re-admission within 7 days?\n* Can patient-derived osteosarcoma tumor organoids be successfully generated across multiple centers?\n\nResearchers will compare safety outcomes and hospital length of stay to historical patient data discharged at lower methotrexate levels.\n\nParticipants will receive standard chemotherapy, meet study-defined discharge criteria, be monitored for side effects, and have the option to provide tumor and blood samples for future research.",[595,596],"Osteosarcoma in Children","Osteosarcoma in Adolescents and Young Adults",[598,599,600,601],"Osteosarcoma","CATSINDO","Organoids","Interventional",{"date":445,"type":34},{"date":260,"type":21},{"date":538,"type":21},{"name":40,"class":41},8,""]