[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Virginia Commonwealth University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":613},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,85,0,25,[9,57,91,114,136,156,182,206,229,252,274,293,318,347,367,390,417,438,459,484,503,519,537,561,582],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100053754","establishing-biomarkers-and-clinical-endpoints-in-myotonic-dystrophy-type-1-end-dm1-extension-100053754",false,"NCT07700225","Establishing Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1) Extension","END-EXT","Inclusion Criteria:\n\n* Age 18 to 70 years (inclusive)\n* Written, voluntary informed consent must be obtained prior to any study procedures. In cases where a Legally Authorized Representative (LAR) provides consent, verbal assent will be obtained from the subject, as determined by the investigator and documented directly on the consent form. Capacity to consent will be determined by the neurologist at the Baseline visit and will be signed off on the Inclusion\u002FExclusion checklist.\n* Clinical diagnosis of DM1 based on research criteria or positive genetic test. The research criteria for clinical diagnosis of DM1 require myotonia, muscle weakness in a characteristic distribution, and history of similar findings in a first degree relative. Genetic testing confirmed the diagnosis of DM1 in \\> 99% of individuals who satisfied these criteria. OR A diagnosis of CDM, which is defined as children having symptoms of myotonic dystrophy in the newborn period (\\\u003C30 days), such as hypotonia, feeding or respiratory difficulty, requiring hospitalization to a ward or to the neonatal intensive care unit for 3 days or more; and a genetic test suspicious of an expanded trinucleotide (CTG) repeat in the DMPK gene in the child or first degree relative. An expanded CTG repeat size in the child is considered greater than 200 repeats or E1-E4 classification (E1= 200-500, E2=500-1,000, E3=1,000-1,500, E4\\>1,500)\n\nExclusion Criteria:\n\n* Symptomatic renal or liver disease, uncontrolled diabetes or thyroid disorder, or active malignancy other than in situ skin cancer.\n* Current alcohol or substance use disorder.\n* Concurrent pregnancy or planned pregnancy during the course of the study.\n* Concurrent medical condition that would, in the opinion of the investigator or clinical evaluator. compromise performance on study measures.\n* Use of mexiletine or other anti-myotonia agents within 72 hours of any study visit.","ALL","18 Years","70 Years",{"count":21,"type":22},1000,"ESTIMATED","4 Years","OBSERVATIONAL","Myotonic Dystrophy type 1 (DM1) is an autosomal dominant multisystemic disorder that causes progressive disability and shortened life expectancy. It is characterized by progressive weakness and myotonia, which preferentially affects the craniofacial, hand, and distal leg muscles. Many patients also experience difficulties with cognition, cardiac arrhythmias, respiratory failure, or cataracts. Currently there is no treatment to slow progression or reverse the symptoms.",[27,28,29,30,31,32,33],"DM1","Myotonic Dystrophy","Myotonic Dystrophy 1","Myotonic Dystrophy Type 1","Myotonic Dystrophy Type-1","Myotonic Dystrophy, Type 1 (DM1)","Myotonic Muscular Dystrophy",[27,15,35,30,36,37,38,39,40,41,42,43],"END-DM1 Extension","Steinert's Disease","Muscular Dystrophy","Neuromuscular Disease","DMPK","Natural History","Myotonia","DMCRN","Myotonic Dystrophy Clinical Research Network","RECRUITING","2026-07-08",{"date":47,"type":48},"2026-07-13","ACTUAL",{"date":50,"type":22},"2026-07",{"date":52,"type":22},"2032-12",{"name":54,"class":55},"Virginia Commonwealth University","OTHER",1,{"id":58,"slug":59,"hasResults":12,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":12,"sex":64,"minAge":18,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100625767","cardiovascular-health-education-via-virtual-reality-for-breast-cancer-survivors-receiving-anthracyclines-or-trastuzumab-100625767","NCT07426913","Cardiovascular Health Education Via Virtual Reality for Breast Cancer Survivors Receiving Anthracyclines or Trastuzumab","Cardiovascular Health Education Via Virtual Reality for Breast Cancer Survivors Receiving Anthracyclines or Trastuzumab - Phase 2","Inclusion Criteria:\n\n* 18 years of age or older\n* Able to speak and read in English\n* Actively receiving Trastuzumab or an anthracycline-based treatment\n* Currently receiving immunotherapy. This includes pembrolizumab and atezolizumab.\n* Diagnosed with stages 0-III Breast Cancer\n\nExclusion Criteria:\n\n\\- History of prior Breast Cancer diagnosis (i.e., not their first breast cancer diagnosis)","FEMALE",{"count":66,"type":22},30,"INTERVENTIONAL",[69],"NA","The main goal of this study is to test a virtual reality (VR) program, Survivors' Virtual Reality Survivorship Experience (SurviVRSE), designed to help Breast Cancer survivors (n=30) learn about heart health. The aims are to test the usability, feasibility, and acceptability o the intervention. Additionally, follow-up assessments will examine changes in women's cancer therapy related cardiac dysfunction knowledge and heart healthy behaviors (e.g., physical activity).",[72,73,74,75],"Breast Cancer","Anthracycline Related Cardiotoxicity in Breast Cancer","Virtual Reality","Trastuzumab",[77,78,79,80,81,54],"virtual reality","breast cancer","antracyclines","trastuzumab","VCU","2026-07-01",{"date":84,"type":48},"2026-07-02",{"date":86,"type":48},"2026-05-20",{"date":88,"type":22},"2027-02-28",{"name":54,"class":55},3,{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":17,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":67,"phases":101,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":56},"100629482","a-hospital-based-intervention-for-youth-injured-through-violence-100629482","NCT07475247","A Hospital-based Intervention for Youth Injured Through Violence","Youth participant inclusion criteria:\n\n* Aged 13-17 years old\n* English speaking\n\nYouth participant exclusion criteria:\n\n* Youth aged \\\u003C13 years and \\>17 years old\n* Non-English speaking\n* Youth of caregivers younger than 18 years old\n\nAdult\u002Fcaregiver participant inclusion criteria:\n\n\\- Aged 18 years or older\n\nAdult\u002Fcaregiver participant exclusion criteria:\n\n\\- Aged younger than 18 years","13 Years","17 Years",{"count":100,"type":22},360,[69],"The firearm violence epidemic is a major public health problem, especially for youth. Every day in the US, approximately 100 people fall casualty to firearms through forms of violence, such as homicide, suicide, and unintentional or accidental injuries. Among youth, firearm violence remains the leading cause of death, and each year the rate of firearm-related mortality is increasing. Beyond the significant and devastating cost of human life, firearm violence is an enormous economic burden to the US, which totals an estimated $229 billion annually. In urban communities with high rates of firearm-related violence, firearm-related emergency department visits are extremely draining on the hospital system. At the national level, firearm-related injuries account for $2.8 billion annually in emergency department care each.",[104],"Violence",[74,106],"Fire-arm violence among youth","2026-06-30",{"date":84,"type":48},{"date":110,"type":48},"2026-04-01",{"date":112,"type":22},"2028-10",{"name":54,"class":55},{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":67,"phases":122,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":56},"100583274","phase-1-safety-and-efficacy-of-low-dose-colchicine-in-patients-with-statin-intolerance-the-lodoco-stint-pilot-study-100583274","NCT06874192","Safety and Efficacy of LOw DOse COlchicine in Patients With STatin INTolerance: the LODOCO STINT Pilot Study","Inclusion Criteria:\n\n* History of statin intolerance (As defined by the NLA 2023 guidelines) Patients who have experienced one or more adverse effects associated with statin therapy, which resolves or improves with dose continuation or reduction\n* Stable dose of lipid-lowering regimen (statin or non-statin) for at least one month\n* Patients able to provide informed consent.\n* Aged 18 to 80 will be enrolled in the study.\n\nExclusion Criteria:\n\n* Known hypersensitivity to colchicine, current use of colchicine or other anti-inflammatory medications.\n* Renal impairment (eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m2)\n* Transaminitis (ALT or AST \\>3 times upper limit of normal)\n* Cirrhosis\n* Severe Heart Failure\n* Active cancer or currently on chemotherapy\n* Irritable Bowel Syndrome, Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis) or other diarrheal related GI pathologies\n* Active infection\n* Autoimmune or inflammatory condition\n* Pregnancy or breastfeeding.","80 Years",{"count":66,"type":22},[123],"PHASE1","Statins are a class of cholesterol lowering medications that contribute to reducing a person's risk of experiencing a cardiovascular event like heart attack. Along with the ability to lower cholesterol, statins also possess anti-inflammatory properties which contribute to their cardioprotective effects. Some people experience side effects while taking statins and are unable to continue treatment with them,which can then increase a person's risk of having cardiovascular issues due to untreated high cholesterol levels. Prior studies have shown that inflammation in the body may lead to an increased risk of a future cardiovascular events. Low dose colchicine (LODOCO), an anti-inflammatory agent, has been shown to reduce cardiovascular events by inhibiting inflammation, a major cause of cardiovascular disease. The United States Food and Drug Administration (FDA) has approved LODOCO to reduce the risk of a future cardiac events for those who have existing heart disease or possess multiple risk factors for heart disease.",[126],"Statin Adverse Reaction",[128],"statin intolerance","2026-06-29",{"date":82,"type":48},{"date":132,"type":48},"2025-03-12",{"date":134,"type":22},"2026-08-30",{"name":54,"class":55},{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":67,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":56},"100501166","comprehensive-tobacco-cessation-for-cancer-patients-and-survivors-100501166","NCT05805722","Comprehensive Tobacco Cessation for Cancer Patients and Survivors","Building a Comprehensive Tobacco Cessation Program for Cancer Patients and Survivors: \"A Breath of Fresh Air\"","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with study procedures and availability for the duration of the study\n* Have a documented history of cancer of any type, whether active or in remission\n* Identify as a current or recently-quit tobacco user\n\nExclusion Criteria:\n\n* Not a VCUHealth patient\n* Non English-speaking",{"count":144,"type":22},75,[69],"The purpose of this research study is to learn how best to incorporate tobacco cessation treatment into clinical care for cancer patients, survivors, and caregivers.",[148,149],"Tobacco Use Cessation","Cancer",{"date":107,"type":48},{"date":152,"type":48},"2023-04-12",{"date":154,"type":22},"2029-09-30",{"name":54,"class":55},{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":162,"sex":17,"minAge":18,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":67,"phases":166,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":56},"100432839","examining-the-impact-of-exercise-training-on-vascular-dysfunction-in-individuals-with-mental-health-disorders---study-1-100432839","NCT04916327","Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1","Inclusion Criteria:\n\n* apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease\n* for PTSD group, a score of ≥ 33 on PCL-5 checklist\n* for GAD group, a score of ≥ 10 on the GAD-7 self-report scale and \\\u003C 33 on the PCL-5 checklist\n* for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and \\\u003C 33 on the PCL-5 checklist\n\nExclusion Criteria:\n\n* taking medications that could influence cardiovascular function\n* current smokers who have recently quit smoking\n* illicit drug use or excessive alcohol consumption\n* pregnant women\n* significant calorie restriction or vitamin\u002Fmineral deficiencies\n* limited English proficiency",true,"35 Years",{"count":165,"type":22},720,[69],"The purpose of this research study is to examine the role oxidants, substances produced in the blood that can damage blood vessel function, may play in blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and\u002For generalized anxiety disorder (GAD)).",[169],"Peripheral Vascular Diseases",[171,172,173,174,175],"cardiovascular disease","vascular function","PTSD","GAD","Oxidant",{"date":82,"type":48},{"date":178,"type":48},"2021-08-23",{"date":180,"type":22},"2026-08",{"name":54,"class":55},{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":67,"phases":191,"briefSummary":193,"conditions":194,"keywords":196,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},"100411885","phase-2-total-neoadjuvant-therapy-with-mfolfox-and-short-course-radiation-in-resectable-rectal-cancer-100411885","NCT04643366","Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer","Phase 2 Study of Total Neoadjuvant mFOLFOX and Short-Course Radiotherapy in Resectable Rectal Cancer","Inclusion Criteria:\n\n* Pathologic diagnosis of adenocarcinoma of the rectum (diagnosis by tissue biopsy) within 90 days prior to registration. At least a portion of the tumor must be located below the peritoneal reflection or begin within 12 cm of the anal verge on flexible endoscopy\n* Clinically staged (AJCC 8th ed.) T3-4 N0 M0 or T any N1-2 M0 based upon the following minimum diagnostic workup:\n* Colonoscopy, unless patient presents with an obstructing lesion\n* Within 30 days before initiating MFOLFOX6 treatment:\n* History\u002Fphysical examination\n* Imaging to exclude distant metastases: either contrast-enhanced CT of the chest, abdomen, and pelvis; or whole-body PET-CT; or MRI\n* Pelvic MRI (preferred) or transrectal ultrasound (TRUS) for T staging Note: Patients may have initiated standard mFOLFOX6 treatment before study registration provided that they met the above criteria before initiating treatment and can feasibly continue to CRT according to the timeline described in Section\n* ECOG Performance Status ≤2\n* Age ≥ 18 years\n* Adequate bone marrow function defined as follows:\n* Absolute neutrophil count (ANC) ≥ 1,200 cells\u002Fmm3\n* Platelets ≥ 100,000 cells\u002Fmm3\n* Hemoglobin ≥ 8.0 g\u002FdL (Note: The use of transfusion or other intervention to achieve Hgb ≥8.0 g\u002FdL is acceptable.)\n* Adequate liver and renal function defined as follows:\n* AST and alkaline phosphatase \\\u003C 2.5 x upper limit of normal (ULN)\n* Bilirubin ≤ 2.5 ULN\n* Calculated creatinine clearance (CrCl) \\> 30 mL\u002Fmin using Cockcroft-Gault formula as calculated by the standard Cockcroft-Gault equation using age, actual weight, creatinine, and gender\n* Must be deemed a candidate for curative resection by the surgical oncologist who will be performing the operation\n* Women of childbearing potential (WCBP) must have a negative serum pregnancy test performed within 7 days prior to the start of chemotherapy.\n* WCBP and men must agree to use a medically accepted form of birth control during the treatment and for 3 months following completion of chemotherapy.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior RT that would result in unsafe overlap of RT fields with the planned study treatment, per the treating radiation oncologist\n* Clinically significant cardiac disease, including major cardiac dysfunction, that in the opinion of the treating medical oncologist would preclude them from receiving systemic therapy with 5-fluorouracil, leucovorin or oxaliplatin.\n* Serious (ie, ≥ grade 3) uncontrolled infection\n* Pulmonary or respiratory condition that, in the opinion of the treating medical oncologist would preclude them from receiving systemic therapy with 5-fluorouracil, leucovorin or oxaliplatin.\n* Major surgery within 28 days of study enrollment (other than diverting colostomy)\n* History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis) requiring significant intervention (eg, hospitalization, surgery, immunosuppressive medications) that would, in the opinion of the investigator, preclude study therapy\n* Prior known allergic reaction to 5-fluorouracil, leucovorin, or oxaliplatin\n* Known dipyrimidine dehydrogenase deficiency (DPD)\n* Any evidence of distant metastases (M1)\n* Pregnant or breast feeding\n* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements",{"count":190,"type":22},64,[192],"PHASE2","This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.",[195],"Rectal Cancer",[197,198],"Resectable","Rectal",{"date":82,"type":48},{"date":201,"type":48},"2021-01-28",{"date":203,"type":22},"2032-01-31",{"name":54,"class":55},4,{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":67,"phases":215,"briefSummary":216,"conditions":217,"keywords":220,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":56},"100645254","tens-of-auricular-vagal-nerve-for-radiation-necrosis-100645254","NCT07680127","TENS of Auricular Vagal Nerve for Radiation Necrosis","Transcutaneous Auricular Vagal Nerve Stimulation for Treatment of Radiation Necrosis","Inclusion Criteria:\n\n* History of glioma or metastatic brain lesion previously treated with whole brain radiation, stereotactic radiation surgery, or fractionated radiation therapy\n* Magnetic resonance imaging (MRI) findings consistent with possible radiation necrosis within 6 weeks prior to enrollment.\n* Candidate for tissue biopsy and Laser Interstitial Thermal Therapy (LITT) ablation of the lesion\n* At least 18 years of age\n* If on corticosteroids, able to discontinue at least 5 days prior to start of transcutaneous auricular vagus nerve stimulation (taVNS) (Arm 1) or sham treatment (Arm 2). A stable physiologic dose of corticosteroids, if used as hormone replacement therapy, may be allowed upon discussion with the investigator. 6. Ability to understand and willingness to sign an institutional review board (IRB) approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* New onset neurologic deficits secondary to radiation necrosis requiring initiation of dexamethasone therapy or other intervention prior to enrollment\n* Currently receiving bevacizumab for treatment of radiation necrosis or has received bevacizumab \\\u003C 6 weeks prior to study enrollment.\n* Currently receiving any investigational agents for treatment of radiation necrosis or has participated in a study of an investigational agent for radiation necrosis within 3 weeks prior to study enrollment.\n* History of cardiac conduction disorders or presence of implanted electronic devices\n* Active Crohn's disease or other inflammatory bowel disease.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.",{"count":214,"type":22},40,[69],"This is a multi-center, randomized, blinded trial evaluating the effect of transcutaneous auricular vagal nerve stimulator (taVNS) on radiation necrosis-related cerebral edema. In this study, consenting and eligible patients will be assigned to one of two arms: treatment (Arm 1) or sham (Arm 2). Patients in both arms will have imaging performed and tissue and blood collected for assessment of changes in area of contrast enhancement and cerebral edema, inflammatory markers, and markers of blood-brain barrier permeability.",[218,219],"Radiation Necrosis","Cerebral Edema",[218],"NOT_YET_RECRUITING","2026-06-25",{"date":84,"type":48},{"date":225,"type":22},"2026-07-31",{"date":227,"type":22},"2029-08-31",{"name":54,"class":55},{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":67,"phases":237,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":56},"100626260","alveolar-ridge-preservation-arp-in-the-posterior-maxilla-after-the-extraction-of-maxillary-molars-100626260","NCT07433322","Alveolar Ridge Preservation (ARP) in the Posterior Maxilla After the Extraction of Maxillary Molars","Alveolar Ridge Preservation (ARP) in the Posterior Maxilla: A Clinical and Economic Evaluation of ARP After the Extraction of Maxillary Molars","Inclusion Criteria:\n\n* Intact or \\\u003C5mm dehiscence buccally and palatally\n* Initial residual bone height (RBH) of at least 6 mm. 3-A minimum distance of 1 mm between root apices and sinus membrane.\n\nExclusion Criteria\n\n* Medically compromised\n* heavy smokers\n* young (\\\u003C18 yrs.) or those refusing treatment are excluded.",{"count":214,"type":22},[69],"Dental implants are a fixed replacement solution with reported long-term survival rates between 94-98% over 20-40 years. In order to ensure successful implant therapy, adequate bone and soft tissue as well as correct 3D positioning of the implant are required. Upon extraction of a tooth, socket width can decrease by up to 60% within six months post-extraction, with a 11-22% vertical reduction. Additionally, sinus pneumatization occurs post-extraction as the maxillary sinus expands into the empty socket due to disuse atrophy and intra-sinus air pressure, as explained by Wolff's law. This further reduces residual bone height (RBH), often resulting in posterior maxillary sites requiring supplemental procedures to prevent bone loss or to augment the bone height at the time of implant placement. However, if the bone height and width dimensions are sufficient before and after extraction - in that, even with the aforementioned loss in width and height percentages in the latter, a standard implant may still be placed in the surrounding bone, one can argue that grafting may not be necessarily done at the time of extraction. Rather, it can be tailored to the patients' needs; thus potentially reducing overall post-operative discomfort and pain.",[240],"Alveolar Bone Loss",[242,243,244],"Dental Implant","Alveolar Ridge Preservation (ARP)","Maxilla",{"date":246,"type":48},"2026-06-26",{"date":248,"type":22},"2026-06",{"date":250,"type":22},"2028-04",{"name":54,"class":55},{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":259,"targetDuration":261,"studyType":24,"phases":4,"briefSummary":262,"conditions":263,"keywords":266,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":273,"locationsCount":56},"100557503","immune-registry-for-bk-in-kidney-transplant-recipients-100557503","NCT06538961","Immune Registry for BK in Kidney Transplant Recipients","Immune Registry for BK (Polyomavirus Hominis 1) in Kidney Transplant Recipients","Inclusion Criteria:\n\n* Adult (\\>18 years old) male and female, deceased donor KT recipients\n* Will include single organ transplants.\n* Each participant must also have recently been diagnosed with BK viremia.\n* In addition to the aforementioned inclusion criteria, each participant in the sub-study must also have recently been diagnosed with BK viremia or have difficult-to-treat BKV \\> 3 logs (BKV log does not decrease by more than 1 log copy\u002Fml drop on second per protocol lab).\n\nExclusion Criteria:\n\n* Prisoners will not be included in the study\n* Multi-organ transplants and pregnant women",{"count":260,"type":22},60,"24 Months","Kidney transplantation (KT) is the best treatment modality available to date for patients with advanced kidney disease and the success of KT is dependent on maintaining a selective intricate balance between the risk of rejection and infections in KT recipients. BK virus is an important clinical infection affecting the post-transplant outcomes in KT recipients. BK nephropathy can affect 8-15% of patients after KT causing acute kidney injury, increased risk of rejection and fibrosis leading to additional hospital stays, increasing overall health care cost burden, and in some cases graft loss. The exact pathogenesis and treatment options for BK nephropathy are not clearly understood. It is debatable whether BK nephropathy is a full fledge donor-derived infection or reactivation of the recipient's latent infection. Irrespective of etiology, the common consensus is that treatment of BK virus infection depends on the selective restoration of host immune responses and balancing the risk of rejection vs worsening of infection.",[264,265],"BK Virus Infection","Kidney Transplant; Complications",[267,268],"Immune Registry","BK in Kidney Transplant Recipients",{"date":246,"type":48},{"date":271,"type":48},"2024-05-29",{"date":50,"type":22},{"name":54,"class":55},{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":162,"sex":17,"minAge":18,"maxAge":280,"enrollmentInfo":281,"targetDuration":4,"studyType":67,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":56},"100633794","phase-1-safety-and-tolerability-study-of-vvz-2471-in-healthy-volunteers-100633794","NCT07531316","Safety and Tolerability Study of VVZ-2471 in Healthy Volunteers","Inclusion Criteria\n\nParticipants must meet all of the following criteria to be eligible for the study:\n\n1. Demographics: Male or female, between 18 and 65 years of age.\n2. High Impulsivity: Must demonstrate high impulsivity during the screening period, defined as an Immediate Memory Task (IMT) Commission Error by Correct Deletions (CE\u002FCD) ratio \\> 0.25.\n3. Informed Consent: Able to understand study procedures, follow instructions, and provide written informed consent in the English language.\n4. Health Status: Be in generally good health based on medical history, physical exam, clinical laboratory values, vital signs, and ECG done during the screening period, as deemed by the Principal Investigator (PI) or designee.\n5. Vital Signs (Resting): Resting pulse between 55 and 95 bpm; Systolic Blood Pressure between 90-120 mmHg; Diastolic Blood Pressure between 50-80 mmHg.\n6. Vital Signs (Orthostatic): A set of orthostatic vital signs completed during screening and on each study visit demonstrating a decrease in Systolic Blood Pressure\\\u003C 20 mmHg and Diastolic Blood Pressure \\\u003C10 mmHg upon standing.\n7. BMI: Body Mass Index between 18.5 and 35 kg\u002Fm².\n8. Toxicology: Urine drug test negative for non-prescribed substances and a breath (or oral fluid) alcohol screen negative during screening.\n9. Cardiac Safety: QTcF interval \\\u003C 450 ms and ECG findings considered normal or not clinically significant at screening by the PI\u002Fdesignee.\n10. Laboratory Values: Clinical labs completed during screening must meet the following safety thresholds:\n\n    * Serum creatinine, AST, ALT, BUN: \\\u003C 1.5 x Upper Limit of Normal (ULN)\n    * Platelet count: \\>140 x 10⁹\u002FL\n    * INR: \\\u003C 1.2\n    * PT\u002FaPTT: \\\u003C 1.2 x ULN\n    * Fibrinogen: \\> 175 mg\u002FdL\n11. Female Participants: Must not be of childbearing potential. They must be either post-menopausal or surgically sterile. They must not be pregnant or breastfeeding.\n12. Male Participants: Male subjects of reproductive potential must use a highly effective contraceptive method from first dose through 90 days after the last dose and to refrain from sperm donation during the same period.\n\nExclusion Criteria\n\nParticipants meeting any of the following criteria will be excluded:\n\nPsychiatric \\& Substance Use\n\n1. Psychosis and bipolar disorder: Any lifetime history of psychosis or bipolar disorder.\n2. Current Psychiatric Disorder: Current or recent (within the last year) DSM-5 diagnosis of any other psychiatric disorder that would make study participation unsafe, including but not limited to depressive disorders, trauma- or stress related disorders, and anxiety disorders that in the opinion of the investigator would make study participation unsafe.\n3. Substance Use Disorder: Current DSM-5 diagnosis (any severity) of an alcohol or drug use disorder, or use of illicit\u002Fnon-prescribed substances within the last 12 months.\n\n   o Note: Tobacco use disorder is not considered exclusionary.\n4. Suicidality: Current or recent suicidal or homicidal ideation (C-SSRS \"yes\" answers on any questions) or a history of suicide attempt within the past 12 months.\n\n   Medical \\& Neurological\n5. Neurological Disorders: History of neurological disorders including epilepsy or a family history of epilepsy, intractable\u002Fcomplicated migraine syndromes, cluster headache syndrome, extrapyramidal\u002Fpyramidal disorders, cerebrovascular, or degenerative disorders.\n6. Seizure History: Any lifetime history of seizure.\n7. Traumatic Brain Injury (TBI): Lifetime history of brain injury with loss of consciousness \\> 30 minutes, Past-year brain injury with loss of consciousness \\\u003C 30 minutes.\n8. Cardiovascular Conditions: History of heart failure, cardiomyopathy, sick sinus syndrome, second or third-degree AV block, myocardial infarction, pulmonary congestion, symptomatic\u002Fsignificant cardiac arrhythmia, or clinically significant abnormal conduction on baseline ECG.\n9. Bleeding \\& Coagulation: Recent history (within 6 months) of clinically significant bleeding; or history of intracranial hemorrhage, subdural\u002Fepidural hematoma, hemorrhagic stroke, AVM, or bleeding diatheses.\n10. Systemic Disease: History of malignancy (cancer), or significant respiratory, gastrointestinal, renal, urological, reproductive, endocrine, dermatological, or metabolic disorders.11. Liver\u002FPancreas: Pancreatic or liver disease that currently requires medical treatment.\n\n12\\. Positive HIV, HCV or HBC test results indicative of HIV infection or active hepatitis B or hepatitis C infection.\n\nMedications \\& Interactions 13. CYP3A4 Interactions: Currently taking prescription\u002FOTC drugs or supplements known to significantly inhibit CYP3A4 (e.g., clarithromycin, ketoconazole, ritonavir, grapefruit juice) or induce CYP3A4 (e.g., phenobarbital, rifampicin, St. John's Wort).\n\n14\\. CNS Active Medications: Currently taking a 5-HT2AR or mGluR5 antagonist or other CNS active medications that may increase risk as deemed by the PI or designee (e.g., antidepressants, antipsychotics, mood stabilizers, anticonvulsants, opioids, CGRP antagonists, triptans, ergotamines, or anxiolytics).\n\n15\\. Study Drug History: Any previous medically adverse reaction to a 5-HT2AR or mGluR5 antagonist.\n\n16\\. Concurrent Trials: Participation in another clinical trial with study medication administration within 30 days prior to first dosing.\n\nOther 17. General Safety: Any current, uncontrolled clinically significant medical condition that would make study participation unsafe, as deemed by the PI or designee.","65 Years",{"count":260,"type":22},[123],"The goal of this study is to do follow-up safety testing and how well people are able tolerate an experimental (not FDA approved) medication . This study is seeking non-illicit drug using adults to test the medication. Results of this study will help us to develop future studies to test the medication with people who use substances.",[285],"Healthy Controls","2026-06-23",{"date":222,"type":48},{"date":289,"type":22},"2026-07-15",{"date":291,"type":22},"2031-12-30",{"name":54,"class":55},{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":64,"minAge":301,"maxAge":302,"enrollmentInfo":303,"targetDuration":4,"studyType":67,"phases":305,"briefSummary":306,"conditions":307,"keywords":308,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":56},"100641245","phase-2-single-fraction-interstitial-breast-brachytherapy-100641245","NCT07654257","Single FrAction Interstitial BreaSt BracHytherApy","Single FrAction Interstitial BreaSt BracHytherApy (SASHA)","SASHA","Inclusion Criteria:\n\n* Female\n* New diagnosis of Ductal Carcinoma in Situ (DCIS) and\u002For invasive breast carcinoma per histologic evaluation\n* Age 40-85 at diagnosis\n* Previous lumpectomy with surgical margins histologically free of invasive tumor and DCIS as determined by the pathologist\n* T stage of Tis, T1, or T2\n* T2 tumors must be ≤3 cm in maximum diameter\n* If the tumor is human epidermal growth factor receptor (HER2)-positive, the patient is planning to receive or has already received HER2-directed therapy\n* For patients with invasive breast cancer, an axillary staging procedure must be performed (either sentinel node biopsy alone or axillary dissection \\[with a minimum of 6 axillary nodes removed\\]) and the axillary node(s) must be pathologically negative Note: N0(i+) is not an exclusion criterion\n\nNote: Patients meeting all of the following criteria are not required to undergo the axillary staging procedure:\n\n* ≥70 years of age\n* Estrogen receptor (ER)+, progesterone receptor (PR)+\u002F-, HER2-\n* Grade 1-2 breast cancer\n* Tumor ≤2 cm in size\n\nNote: If patients meet all the following criteria, the decision to avoid sentinel lymph node biopsy can be at the discretion of the breast surgeon:\n\n* 50-69 years of age\n* Grade 1-2 breast cancer\n* Clinically negative axilla by ultrasound and\u002For magnetic resonance imaging (MRI)\n* ER+, PR+, HER2-\n* Tumor ≤2 cm in size\n* Agrees to comply with aromatase inhibitor recommendation\n* Ability to begin brachytherapy within 12 weeks following lumpectomy, re- excision of margins, or completion of chemotherapy\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Active collagen-vascular disease\n* Paget's disease of the breast\n* Any prior history of DCIS or invasive breast cancer prior to the current diagnosis\n* Any prior history of breast radiation therapy (RT) or thoracic RT for any condition\n* Multicentric carcinoma (DCIS or invasive)\n* Synchronous bilateral invasive or non-invasive breast cancer\n* Surgical margins that cannot be microscopically assessed or that are positive\n* Treatment with neoadjuvant chemotherapy\n* Excision cavity that cannot be clearly delineated or is not amenable to implant per the treating investigator\n* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements","40 Years","85 Years",{"count":304,"type":22},134,[192],"This phase 2, single arm prospective study has been designed to determine the safety of delivering accelerated partial breast irradiation (APBI) with a multicatheter interstitial implant in a single fraction over 1 day. This is a method of delivering radiation therapy directly into or close to a tumor.",[72],[72,309],"Radiation","2026-06-16",{"date":312,"type":48},"2026-06-18",{"date":314,"type":22},"2026-09-01",{"date":316,"type":22},"2036-09-30",{"name":54,"class":55},{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":17,"minAge":325,"maxAge":326,"enrollmentInfo":327,"targetDuration":4,"studyType":67,"phases":329,"briefSummary":330,"conditions":331,"keywords":334,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":344,"leadSponsor":346,"locationsCount":56},"100641619","using-apollo-neuro-in-autistic-children-with-self-injurious-behavior-100641619","NCT07648420","Using Apollo Neuro in Autistic Children With Self-Injurious Behavior","Feasibility and Usability of the Apollo Neuro, a Wearable Sensory Device, in Autistic Children With Self-Injurious Behavior","Inclusion Criteria for child:\n\n* Diagnosis of autism spectrum disorder (ASD), as reported by caregiver\n* Presence of self-injurious behavior, as reported by caregiver\n* Demonstrates sensory over and\u002For under- responsivity\n* Aged 6 years to 14 years, 11 months (179 months) at the time of enrollment\n* Has a caregiver willing and able to provide consent and participate in study procedures\n\nExclusion Criteria for child:\n\n* Has medical condition that may increase risk with use of a wearable nibrotactile device, including:\n\n  * implanted medical or neurological devices (e.g., pacemaker)\n  * significant cardiac conditions or arrhythmias\n  * history of syncope (fainting)\n* Known seizure disorder without physician clearance\n* Regular use of nibrotactile or autonomic- modulating wearable devices within the past 90 days\n* Any condition that, in the judgment of the investigator, would interfere with safe participation or interpretation of study procedures\n\nInclusion Criteria for Caregiver:\n\n* Parent or legal guardian of the enrolled child participant\n* Able to provide informed consent in English\n* Able and willing to support device use according to study protocol and complete study-related data collection\n* Has access to a smartphone or compatible device capable of operating the Apollo Neuro application for the duration of study period\n\nExclusion Criteria for Caregiver:\n\n• Unable to provide informed consent in English","6 Years","179 Months",{"count":328,"type":22},18,[69],"This study will evaluate the feasibility and acceptability of the Apollo Neuro, a wearable vibrotactile sensory device, in autistic children who engage in self-injurious behavior (SIB).\n\nParticipants will wear the device for at least 3 hours per day over a 30-35 day period with caregiver support. Outcomes will include adherence to device use, caregiver-reported feasibility and acceptability, and descriptive characterization of caregiver-reported self- injurious and repetitive behaviors during the study period. This preliminary, single-group study is not designed to evaluate efficacy and will inform the design of future controlled trials.",[332,333],"Self-Injurious Behavior","Autism Spectrum Disorder",[335,336,337,338,339],"Apollo Neuro Device","Sensory Responsivity","Autonomic Regulation","Wearable Device","Vibrotactile Stimulation","2026-06-15",{"date":342,"type":48},"2026-06-17",{"date":50,"type":22},{"date":345,"type":22},"2026-11",{"name":54,"class":55},{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":162,"sex":17,"minAge":18,"maxAge":353,"enrollmentInfo":354,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":356,"conditions":357,"keywords":359,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":56},"100582237","the-impact-of-chronic-e-cigarette-usage-on-microvascular-health-100582237","NCT06860698","The Impact of Chronic E-Cigarette Usage on Microvascular Health","e-Cig users arm\n\nInclusion Criteria:\n\n* Between 18 and 29 years of age\n* Used e-cigarettes with nicotine (≥3 times\u002Fweek for ≥6 months)\n\nExclusion Criteria:\n\n* 17 years old and younger or 30 years old or older.\n* Former combustible tobacco user\u002F former smoker\n* Use of cigarettes for 15 days or more in the past 60 days\n* Use of other tobacco products (cigars, hookah, smokeless), marijuana and\u002For illicit or prescription drugs weekly or more frequently in the past 60 days\n* Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, cerebral diseases or sleep disorders\n* Disorder or use of medication that affects cardiopulmonary health\n* Evidence of pregnancy or current nursing\n\nNon e-Cig using arm\n\nInclusion\n\n\\- Between 18 and 29 years of age\n\nExclusion\n\n* 17 years old and younger or 30 years old and older\n* Use of cigarettes or other tobacco products more than 50 times in their lifetime.\n* Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, cerebral diseases or sleep disorders\n* Disorder or use of medication that affects cardiopulmonary health\n* Evidence of pregnancy or current nursing","29 Years",{"count":355,"type":22},44,"The study is focused on investigating the mechanisms involved in microvascular health in subjects that use e-cigarettes frequently. To explore microvascular health, different techniques and compounds. For one of the tests, iontophoresis, the drug's use will be stored and handled as described by the approved IND and non-IDS plan.",[358],"E-Cig Use",[360],"Microvascular Health",{"date":342,"type":48},{"date":363,"type":48},"2023-07-14",{"date":365,"type":22},"2026-07-28",{"name":54,"class":55},{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":67,"phases":377,"briefSummary":378,"conditions":379,"keywords":382,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":385,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":389,"locationsCount":56},"100562296","functional-outcomes-in-conduction-system-pacing-and-right-ventricular-synchrony-focus-right-100562296","NCT06601322","Functional Outcomes in CondUction System Pacing and Right Ventricular Synchrony (FOCUS-Right)","Functional Outcomes in CondUction System Pacing and Right Ventricular Synchrony The FOCUS-Right Pilot Study (FOCUS-Right)","FOCUS-Right","Inclusion Criteria:\n\n* presence of dual chamber LBBAP implantation\n* presence of anodal capture with bipolar pacing configuration as determined at pacing implant.\n\nExclusion Criteria:\n\n* Known history of chronotropic incompetence\n* high degree or complete heart block\n* inability to tolerate NVP during initial device interrogation\n* pregnancy\n* inability to undergo MRI or exercise utilizing supine bicycle at target work-load\n* presence of MRI unsafe pacemaker components.",{"count":376,"type":22},20,[69],"The goal of this prospective single center clinical trial is to evaluate the safety and feasibility of performing simultaneous exercise stress cardiac magnetic resonance (CPET-CMR) and cardiopulmonary exercise testing in patients with pre-existing left bundle branch area pacemakers (LBBAP) programmed to an atrial sensing mode. Measurements of right ventricular, left ventricular function, and exercise capacity will be obtained at various LBBAP programming parameters at rest and during low intensity exercise. The main aims of the study are:\n\n* Demonstrate the safety and feasibility of performing CPET-CMR in patients with pre-existing LBBAP programmed to P-synchronous ventricular pacing mode.\n* Generate preliminary data evaluating differences in RV function, LV function, and exercise capacity during various pacemaker programming settings.",[380,381],"Left Branch Bundle Block","RV - Right Ventricular Abnormality",[383,384],"Pacemaker","CPET-CMR",{"date":342,"type":48},{"date":387,"type":48},"2024-08-23",{"date":50,"type":22},{"name":54,"class":55},{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":399,"conditions":400,"keywords":402,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":56},"100624918","evaluating-urinary-cxcl10-for-enhanced-detection-of-acute-rejection-in-kidney-transplant-patients-with-low-dd-cfdna-100624918","NCT07415876","Evaluating Urinary CXCL10 for Enhanced Detection of Acute Rejection in Kidney Transplant Patients With Low DD-CFDNA","Evaluating Urinary CXCL10 for Enhanced Detection of Acute Rejection in Kidney Transplant Patients With Low DD-CFDNA: Diagnostic Performance and Transport Stability Across Shipping Conditions (CLEAR-CXCL10)","Prospective Inclusion Criteria:\n\n* Age ≥18 years\n* Undergoing a clinically indicated biopsy\n* Able to provide informed consent\n* Willing to provide a urine sample and allow access to relevant clinical\n\nRetrospective Inclusion Criteria:\n\n* Age ≥18 years\n* Biopsy-confirmed rejection (positive histology)\n* Donor-derived cell-free DNA\\\u003C1% result at time of biopsy\n* Availability of stored urine sample collected at time of biopsy\n\nExclusion Criteria (applies to both arms):\n\n* Individuals under 18 years of age\n* Individuals unable to provide informed consent (for prospective enrollment)\n* Pregnant women\n* Prisoners\n* Adults unable to consent",{"count":398,"type":22},50,"Kidney transplant rejection remains a significant challenge to long-term graft survival. While histological biopsy continues to be the gold standard for diagnosing rejection, noninvasive biomarkers such as donor-derived cell-free DNA (dd-cfDNA) have gained traction for their ability to detect allograft injury. However, dd-cfDNA may lack sensitivity in certain clinical scenarios particularly in cases of localized immune activation leading to false negatives despite biopsy-confirmed rejection.",[401],"Kidney Transplant Rejection",[403,404,405,406,407,408],"CXCL10","CXCR3+T cells","ccfDNA","dd-cfDNA","ABMR","TCMR","2026-06-09",{"date":411,"type":48},"2026-06-10",{"date":413,"type":48},"2026-06-04",{"date":415,"type":22},"2027-01",{"name":54,"class":55},{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":97,"maxAge":98,"enrollmentInfo":423,"targetDuration":4,"studyType":67,"phases":425,"briefSummary":426,"conditions":427,"keywords":429,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":436,"leadSponsor":437,"locationsCount":56},"100616427","enhancing-an-existing-prevention-strategy-to-reduce-intentional-firearm-injuries-among-high-risk-youth-phase-1-100616427","NCT07305467","Enhancing an Existing Prevention Strategy to Reduce Intentional Firearm Injuries Among High-risk Youth (Phase 1)","Inclusion Criteria:\n\n* Youth aged approximately 13-17 years.\n* Identified as at elevated risk for firearm-related injury (e.g., history of violent injury, referred by violence prevention programs).\n* Able to provide assent (and parental\u002Fguardian consent if under 18).\n* Sufficient proficiency in English to complete study procedures.\n\nExclusion Criteria:\n\n* Significant cognitive impairment or developmental disability that would preclude comprehension of the intervention content or study procedures.\n* Current psychiatric or medical instability requiring immediate treatment or hospitalization. - Non-English speaking (due to limited resources for translation of study measures and intervention materials in this pilot).",{"count":424,"type":22},45,[69],"Over the past three decades, substantial resources have been devoted to developing youth violence prevention (YVP) programs. These programs have demonstrated positive effects on reducing aggression and related behaviors, firearm-specific risk factors were largely overlooked due to historical barriers to firearm research. This omission is concerning, as firearms are now the leading cause of injury and death among U.S. youth. Existing YVP strategies such as Emerging Leaders address general violence risk but do not directly target firearm-related risks or suicide prevention. There remains a critical gap in prevention strategies that integrate firearm-specific content while leveraging established program infrastructure.",[428],"Prevention",[430,431,432],"Firearm injury prevention","community based programs","youth advisory board","2026-06-08",{"date":409,"type":48},{"date":50,"type":22},{"date":415,"type":22},{"name":54,"class":55},{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":280,"enrollmentInfo":445,"targetDuration":4,"studyType":67,"phases":446,"briefSummary":447,"conditions":448,"keywords":450,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":456,"leadSponsor":458,"locationsCount":56},"100606638","enhancing-addiction-treatment-through-psychoeducation-100606638","NCT07178158","Enhancing Addiction Treatment Through Psychoeducation","Enhancing Addiction Treatment Through Psychoeducation: Evaluating the Feasibility and Acceptability of a Neuroscience-Informed Mobile App","Inclusion Criteria:\n\n* current DSM-5 opioid and\u002For stimulant use disorder\n* currently on medication treatment for SUD\n* owning a smartphone with sufficient functionality to download and utilize the NIPA app.\n\nExclusion Criteria:\n\n* current psychosis, mania, or suicidal\u002Fhomicidal ideation\n* non-English speaking",{"count":214,"type":22},[69],"Addiction is a brain disorder characterized by a broad range of both apparent and subtle cognitive impairments in attention, memory, executive functions, and decision-making. These cognitive problems are clinically significant and may contribute to poor treatment outcomes in people with Substance Use Disorders (SUDs), such as a high risk of dropout, low treatment compliance, and shorter periods of abstinence. Studies on cognitive function in SUDs reveal that chronic use of drugs and alcohol can also negatively affect another crucial component of cognition: awareness, or metacognition. Metacognition is defined as an individual's ability to perceive and understand their cognitive functions and use this understanding to regulate them. One of the key consequences of metacognitive impairments is the lack of insight in people with SUDs, which adversely affects treatment outcomes. Substance users with poor metacognition are more reluctant to initiate or continue treatment and are more likely to deny their cognitive problems. Therefore, improving metacognition may remove or reduce motivational barriers to invest time and effort in the recovery process in general, and in the brain recovery process specifically. Despite the importance of neurocognition and metacognition in the recovery process for substance users, there is a dearth of interventions designed to target these functions.",[449],"Substance Use Disorders",[451,452,453],"tES\u002FTMA: Transcranial electrical stimulation","CT: Cognitive Training","DASES: Drug Abstinence Self-Efficacy Scale",{"date":409,"type":48},{"date":82,"type":22},{"date":457,"type":22},"2027-04-30",{"name":54,"class":55},{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":162,"sex":17,"minAge":23,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":67,"phases":467,"briefSummary":468,"conditions":469,"keywords":472,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":56},"100571029","advancing-water-security-a-community-participatory-school-based-hydration-intervention-100571029","NCT06714929","Advancing Water Security: A Community Participatory School-Based Hydration Intervention","Inclusion Criteria:\n\n* Lunchroom observations: All students (K-5th \\[Pre-Kindergarten if applicable\\]) who eat lunch in the cafeteria on assessment days are eligible\n* BMI and dental caries assessments: 1) student enrolls in study while in 3rd grade (followed through 5th g)\n* Student surveys: Students in 4th-5th grade are eligible to complete surveys assessing beverage intake and perceptions of hydration practices within their school district.\n* Staff surveys: All staff in the target schools will be eligible to complete the Personnel Survey.\n\nExclusion Criteria:\n\n* Lunchroom observations: None.\n* BMI and dental caries assessments: Students are ineligible if they are unable to complete assessments due to developmental or physical reasons, 2) planning to move in the study duration\n* Student surveys: None.\n* Staff surveys: None.",{"count":466,"type":22},7200,[69],"The goal of this study is to determine the effectiveness and sustainability of a community-participatory hydration intervention over 3 years within a district that has newly installed hydration stations and is operating under a policy designed to enhance heathy hydration practices and promote equitable access to drinking water.",[470,471],"Dental Caries","Obesity Prevention",[473,474,475,476,477],"hydration","water","sugar-sweetened beverages","dental caries","overweight and obesity",{"date":411,"type":48},{"date":480,"type":48},"2024-08-14",{"date":482,"type":22},"2028-05-31",{"name":54,"class":55},{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":67,"phases":492,"briefSummary":493,"conditions":494,"keywords":495,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":56},"100534473","a-virtual-reality-brief-violence-intervention-preventing-gun-violence-among-violently-injured-adults-100534473","NCT06239285","A Virtual Reality Brief Violence Intervention: Preventing Gun Violence Among Violently Injured Adults","Inclusion Criteria:\n\n* violently injured patients from VCU's Level 1 Trauma Center\n* 18 years or older\n* English-speaking\n\nExclusion Criteria:\n\n* Under 18 years old\n* Not a victim of Violent crime",{"count":491,"type":22},220,[69],"The overall aim of the proposed project is to develop and evaluate the effectiveness of Brief Violence Intervention-Virtual Reality (BVI-VR) for reducing firearm-related violence, re-injury, and mortality among victims of violence. Outcome measures of firearm-related violence will come from multiple sources, including criminal background checks, hospital data, state-level data, semi-structured clinical assessments, and self-report assessments. In addition, the study aims to understand the impact of BVI-VR on psychosocial mediators resulting in a reduction of firearm-related violence. This will include self-report surveys, neurocognitive assessments, and clinical assessments. The economic efficiency of BVI-VR as a firearm-related violence intervention will also evaluated. To achieve these aims, a randomized control trial (RCT) in a large sample of violently injured adults (18+ years) from VCU Health will be conducted.",[104],[496],"Firearm Violence Victim",{"date":411,"type":48},{"date":499,"type":48},"2024-02-26",{"date":501,"type":22},"2026-10",{"name":54,"class":55},{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":509,"targetDuration":510,"studyType":24,"phases":4,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":516,"leadSponsor":518,"locationsCount":56},"100514142","southeastern-attr-amyloidosis-consortium-seattrac-family-registry-100514142","NCT05974644","Southeastern ATTR Amyloidosis Consortium: SEATTRAC Family Registry","Inclusion Criteria:\n\n* Over the age of 18 years\n* Carrier of a pathogenic hATTR mutation confirmed on whole blood gene testing or mass spectrometry\n* Willing to return for required follow-up visits\n\nExclusion Criteria:\n\n* Patient having undergone heart transplantation or implantation of mechanical circulatory support\n* Patients unable to provide informed consent\n* Patients having undergone liver transplantation\n* Patients have evidence of light chain amyloidosis",{"count":21,"type":22},"3 Years","The study design is a prospective registry including asymptomatic and symptomatic patients who carry a pathogenic TTR mutation. The study will enroll patients who meet the inclusion criteria and none of the exclusion criteria until 1000 patients are enrolled, at which point in time the study investigators will evaluate whether further patient accrual is meaningful.",[513],"Amyloidosis, Hereditary",{"date":409,"type":48},{"date":50,"type":22},{"date":517,"type":22},"2030-12-01",{"name":54,"class":55},{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":525,"enrollmentInfo":526,"targetDuration":4,"studyType":67,"phases":528,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":532,"startDateStruct":533,"completionDateStruct":534,"leadSponsor":536,"locationsCount":56},"100486745","the-impact-of-improved-vagal-function-on-periaqueductal-gray-connectivity-100486745","NCT05618067","The Impact of Improved Vagal Function on Periaqueductal Gray Connectivity","Inclusion Criteria:\n\n* Age 18-50 years\n* Diagnosis of POTS, orthostatic intolerance (with or without syncope), syncope, or near-syncope\n* Can speak and read in English\n* Upcoming new patient VCU Comprehensive Autonomics Center clinic visit scheduled at least 1 week in the future\n\nExclusion Criteria:\n\n* Inflammatory arthritis, connective tissue or auto-immune disorder\n* Any chronic neurological disorder besides POTS, orthostatic intolerance (with or without syncope), syncope, or near-syncope\n* Patients who have already had a new patient clinic visit where they were exposed to breathing exercise education\n* Evidence of unstable medical disorder, such as kidney (rising creatinine, or end-stage renal failure) or liver impairment (rising AST or ALT, or end-stage with coagulopathy), poorly controlled significant cardiovascular (CHF), respiratory, endocrine (diabetes - A1c \\> 9 - or untreated thyroid dysfunction) or uncontrolled psychiatric illness (such as untreated depression, psychosis, etc.)\n* Neuropathy, central nervous system disorder (e.g., Cerebral palsy, developmental delay, seizure disorder, MS, stroke, etc.)\n* Treatment with a drug or medical device within the previous 30 days that has not received regulatory approval\n* Use of hormones (except insulin, thyroid replacement or oral contraceptives, which will be carefully documented)\n* Current substance or alcohol abuse\n* Any major surgical intervention with general anesthesia in the last 60 days and minor procedure, such as tooth extraction, endoscopy, etc., with local or conscious sedation within 7 days\n* Any on-going or pending medical, health or disability related litigation, or current pursuit of disability\n* Any condition that in the judgment of the investigator would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which would clearly confound the interpretation of the study results (specific reason will be documented)\n* Chronic use of narcotics for pain\n* Claustrophobia or any metal hardware that may interfere with MRI\n* Investigators and study staff","50 Years",{"count":527,"type":22},12,[69],"This study is being to see if participating in breathing exercise training and practicing this training will help with Postural tachycardia syndrome (POTS). The information may help doctors to learn more about how the different parts of people's brains communicate.",[531],"Postural Tachycardia Syndrome",{"date":409,"type":48},{"date":50,"type":22},{"date":535,"type":22},"2028-12",{"name":54,"class":55},{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":543,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":545,"enrollmentInfo":546,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":547,"conditions":548,"keywords":551,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":554,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":560},"100456529","dmcrn-02-001-assessing-pediatric-endpoints-in-dm1-100456529","NCT05224778","DMCRN-02-001: Assessing Pediatric Endpoints in DM1","Assessing Pediatric Endpoints in DM1 (ASPIRE-DM1)","ASPIRE-DM1","Inclusion Criteria:\n\n* Age neonate to 3 years 11 months at enrollment.\n* A diagnosis of CDM, which is defined as children having symptoms of myotonic dystrophy in the newborn period (\\\u003C30 days), such as hypotonia, feeding or respiratory difficulty, requiring hospitalization to a ward or to the neonatal intensive care unit for more than 72 hours; and a genetic test confirming an expanded trinucleotide (CTG) repeat in the DMPK gene in the child or mother. An expanded CTG repeat size in the child is considered greater than 200 repeats or E1-E4 classification (E1= 200-500, E2=500-1,000, E3=1,000-1,500, E4\\>1,500).\n* Guardian is willing and able to sign consent and follow study procedures\n\nExclusion Criteria:\n\n* Any other non-DM1 illness that would interfere with the ability or results of the study in the opinion of the site investigator\n* Significant trauma within one month\n* Internal metal or devices (exclusion for DEXA component)\n* History of bleeding disorder or platelet count \\\u003C50,000\n* History of reaction to local anesthetic","59 Months",{"count":398,"type":22},"The overall goal of the study is to establish valid clinical endpoint assessments for children with congenital myotonic dystrophy type 1 and develop biomarkers for the condition.",[549,550],"Congenital Myotonic Dystrophy","CDM",[552,553,549,550],"Clinical Research","Myotonic dystrophy",{"date":411,"type":48},{"date":556,"type":48},"2022-08-24",{"date":558,"type":22},"2026-12",{"name":54,"class":55},5,{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":568,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":570,"conditions":571,"keywords":572,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":575,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":581},"100361086","estab-biomarkers-and-clinical-endpoints-in-myotonic-dystrophy-type-1-end-dm1-100361086","NCT03981575","Estab Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1)","Establishing Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1)","Inclusion criteria:\n\n* Age 18 to 70 (inclusive)\n* Competent to provide informed consent\n* Clinical diagnosis of DM1 based on research criteria1 or positive genetic test\n* Comment: The clinical research criteria require myotonia, muscle weakness in a characteristic distribution, and history of similar findings in a first degree relative. Genetic testing confirmed the diagnosis of DM1 in \\> 99% of individuals who satisfied these criteria.2\n\nExclusion criteria:\n\n* Symptomatic renal or liver disease, uncontrolled diabetes or thyroid disorder, or active malignancy other than skin cancer.\n* Current alcohol or substance abuse\n* Concurrent enrollment in clinical trial for DM1, or participation in trial within 6 months of entry.\n* Concurrent pregnancy or planned pregnancy during the course of the study.\n* Concurrent medical condition that would, in the opinion of the investigator or clinical evaluator, compromise performance on study measures.\n* Note: non-ambulatory participants are not excluded, but are limited to \\\u003C15% of enrollment.\n\nInclusion criteria for participants in the muscle biopsy sub-study:\n\n• Of the 95 patients undergoing the tibialis anterior muscle biopsy, at least half will have at least moderate weakness of ankle dorsiflexion, defined as MRC score ≤ 4+. This is in order to obtain a muscle tissue sample in a person more severely affected with myotonic dystrophy. Approximately 10 patients at each site will undergo the muscle biopsy.\n\nExclusion criteria for 95 participants in the muscle biopsy sub-study:\n\n* Known CTG repeat expansion size less than 100 repeats, unless there are clear cut signs of limb weakness and muscle wasting. This is in order to obtain a muscle tissue sample in a person more severely affected with myotonic dystrophy.\n* Use of anticoagulant such as warfarin or a direct oral anticoagulant (e.g. dabigatran) due to the increased risk of bleeding.\n* Use of aspirin or non-steroidal anti-inflammatory agents should be discontinued 3 days prior to the biopsy procedure, if possible.\n* Platelet count \\\u003C50,000 (if known) due to the increased risk of bleeding.\n* History of a bleeding disorder due to the increased risk of bleeding.\n* Advanced wasting of tibialis anterior (TA) muscle that precludes needle muscle biopsy in order to ensure that a sample taken would be of muscle and not just fat and fascia.\n* Previous muscle biopsy of either TA in order to provide muscle tissue samples of non-biopsied muscles.",{"count":569,"type":22},700,"Building on previous work of the Myotonic Dystrophy Clinical Research Network (DMCRN), the present study seeks to overcome insufficient data on natural history; lack of reliable biomarkers; and incomplete characterization and limited biological understanding of the phenotypic heterogeneity of Myotonic Dystrophy 1 by examining strategies to improve the reliability by making further refinements in our sample collection and analysis procedures by developing strategies for managing patient heterogeneity going forward.\n\nFunding Source- FDA OOPD",[29,27],[28,573,574,42],"END DM-1","Muscular Dystophy",{"date":411,"type":48},{"date":577,"type":48},"2019-01-01",{"date":579,"type":22},"2026-12-01",{"name":54,"class":55},17,{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":590,"minAge":18,"maxAge":4,"enrollmentInfo":591,"targetDuration":4,"studyType":67,"phases":592,"briefSummary":593,"conditions":594,"keywords":597,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":56},"100643338","phase-2-sacituzumab-tirumotecan-in-pts-w-nepc-after-progression-on-prior-chemotherapy-100643338","NCT07639086","Sacituzumab Tirumotecan in Pts w\u002F NEPC After Progression on Prior Chemotherapy","Sacituzumab Tirumotecan in Patients With Neuroendocrine Prostate Cancer After Progression on Prior Chemotherapy","STOP-NEPC","Inclusion Criteria\n\n1. Patients with histologically or cytologically confirmed diagnosis of de novo (d-NEPC) or treatment related NEPC (t-NEPC), defined by one or more of the following: histologically small cell prostate cancer or neuroendocrine differentiation by IHC, defined by positive staining by chromogranin or synaptophysin and\u002For additional neuroendocrine markers. Patients with t-NEPC must have history of treatment with ADT and\u002For an androgen receptor pathway inhibitor (ARPI) agent.\n\n   Note: Pure small cell\u002FNEPC or NEPC mixed with adenocarcinoma or other histologic subtype are eligible\n2. Patients must have progressed following at least one course (minimum of 4 cycles) of platinum-based chemotherapy (alone or in combination with etoposide or taxane). Patients who received prior taxane alone for treatment of mHSPC or mCRPC, and patients who received a checkpoint inhibitor immunotherapy alone or in combination with prior chemotherapy are eligible. Patients who received a non-ADC drug through a prior clinical trial or Tarlatamab are also eligible provided they had also received at least one course of platinum-based chemotherapy.\n3. Patients who have measurable metastatic disease per PCWG modified RECIST 1.1 criteria as assessed by the local site investigator\u002Fradiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions. Patients with radiologically positive pelvic nodal, bone or soft tissue metastatic disease, are acceptable. Progressive disease is defined per PCWG modified RECIST 1.1 criteria.\n\n   Note: Patients who have prior prostatectomy, definitive or salvage radiation, are eligible.\n4. Male participant at least 18 years of age at the time of providing the informed consent.\n5. If capable of producing sperm, the participant agrees to the following during the intervention period and for at least 120 days after:\n\n   * Refrains from donating sperm\n   * Uses a penile\u002Fexternal condom when having penile-vaginal intercourse with a nonparticipant of childbearing potential who is not currently pregnant PLUS partner use of an additional contraceptive method (refer to Section 10.4.2), as a condom may break or leak Note: If the participant is azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview), no contraception is required.\n6. If capable of producing ejaculate whose partner is pregnant or breastfeeding must agree to use a penile\u002Fexternal condom during each episode of sexual activity in which the partner is at risk of drug exposure via ejaculate.\n7. The participant (or legally acceptable representative if applicable) provides written informed consent for the study.\n8. Has provided an archival tumor tissue sample collected within 12 months prior to the enrollment or most recently obtained core, incisional, or excisional biopsy of a tumor lesion from prostate or a metastatic site, from which NEPC was diagnosed. Irradiated tissue is not acceptable. Sites should follow local guidelines regarding fresh tissue collection.\n9. Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except for alopecia and vitiligo). Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible.\n10. Adequate organ function as defined below. Specimens must be collected within 10 days before the start of study intervention. Any value of serum prostate specific antigen (PSA) is considered eligible.\n11. Absolute neutrophil count ≥1500\u002FµL\n12. Platelets ≥100,000\u002FµL\n13. Hemoglobin ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL\n14. Creatinine clearance ≥30 mL\u002Fmin\n15. Total bilirubin ≤1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN\n16. ALT\u002FAST ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)\n17. Albumin ≥3.0 g\u002FdLb\n18. INR or PT\u002FaPTT ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants a Criteria must be met without colony-stimulating factors, erythropoietin dependency, and without pRBC transfusion within the preceding 2 weeks.\n\n    b Criteria must be met without albumin supplementation within the last 72 hours.\n19. Has ECOG performance status of 0 or1\n20. Be willing and able to comply with study procedures, laboratory tests, and other requirements of the study.\n21. HIV-infected participants must have well-controlled HIV on ART, defined as:\n\n    * Having a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening\n    * Having achieved and maintained virologic suppression, defined as confirmed HIV RNA level below 50 or the LLOQ using the locally available assay, at the time of screening and for at least 12 weeks before screening\n    * Absence of any AIDS-defining opportunistic infections within the past 12 months\n    * Being on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before enrollment and agreeing to continue ART throughout the study Note: The ART regimen must not contain any antiretroviral medications that are strong CYP3A4 inducers\u002Finhibitors\u002Fsubstrates. Refer to https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally approved label for all concomitant therapy to ensure it is not a strong inducer\u002Finhibitor\u002Fsubstrate of CYP3A4.\n\n    Note: HIV testing at screening is not required unless there is a known history of HIV infection or it is mandated by local guidelines\n22. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load before enrollment.\n\n    Note: Participants should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.\n\n    Hepatitis B testing at screening is not required unless there is a known history of HBV infection or it is mandated by local guidelines\n23. Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\nNote: Participants must have completed curative antiviral therapy at least 4 weeks before enrollment. Hepatitis C testing at screening is not required unless there is a known history of HCV infection or it is mandated by local guidelines\n\nExclusion Criteria\n\n1. Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing.\n2. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \\>480 ms, and\u002For other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention.\n3. Received prior treatment with a TROP2-targeted ADC.\n4. Received prior treatment with a topoisomerase 1 inhibitor-containing ADC.\n5. Received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention. ADT and\u002For antiandrogens\u002FARPI is allowed.\n6. Received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and\u002For has had radiation pneumonitis.\n\n   Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.\n7. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n\n   Refer to Section 6.2 for information on COVID-19 vaccines.\n8. Is currently receiving a strong inducer\u002Finhibitor of CYP3A4 that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting study intervention is 2 weeks.\n\n   Note: A list of strong inducers\u002Finhibitors of CYP3A4 can be found at the following website: https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally approved label for all concomitant therapy to ensure it is not a strong inducer\u002Finhibitor of CYP3A4.\n9. Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anticancer therapy is prohibited.\n10. Has received an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.\n11. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n    Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) who have undergone potentially curative resection are not excluded.\n\n    Note: Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.\n12. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously-treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable, and have not required steroid treatment for at least 14 days before the first dose of study intervention.\n13. Has an active infection requiring systemic therapy (except those permitted per Section 5.1)\n14. Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the individual's ability to cooperate with the requirements of the study, or interfere with the individual's participation for the full duration of the study, such that it is not in the best interest of the individual to participate, in the opinion of the treating investigator.\n15. Severe hypersensitivity (Grades ≥3) to study intervention, any of their excipients, and\u002For to another biologic therapy.\n16. Has had major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention. Anticipation of the need for major surgery during the course of treatment with study intervention is also exclusionary.\n\n    Note: Participants who underwent major surgery must have adequately recovered from toxicity and\u002For complications from the surgery before starting study intervention.\n17. Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n18. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc), any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen.\n19. Has a \"superscan\" bone scan. This is defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated.","MALE",{"count":376,"type":22},[192],"This is a phase 2, open-label, single-arm study of sacituzumab tirumotecan in neuroendocrine prostate cancer (NEPC) with progression after platinum-based chemotherapy.",[595,596],"Prostate Cancer","Neuroendocrine Prostate Cancer (NEPC)",[598,599,600,601,602,603,604,605],"Neuroendocrine Prostate Cancer","Progression","NEPC","Small Cell Prostate Cancer","Treatment-Emergent NEC Prostate Cancer","Sacituzumab Tirumotecan","TROP2","Platinum-Refractory Prostate Cancer","2026-06-05",{"date":411,"type":48},{"date":609,"type":22},"2026-08-31",{"date":611,"type":22},"2032-03-31",{"name":54,"class":55},""]