[{"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:":628},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,82,0,25,[9,42,67,91,115,139,177,206,225,244,272,305,323,346,369,390,408,431,454,491,511,535,559,584,611],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100633794","phase-1-safety-and-tolerability-study-of-vvz-2471-in-healthy-volunteers-100633794",false,"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.",true,"ALL","18 Years","65 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The goal of this study is to do follow-up testing on the safety and tolerability of 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. This research is supported by and included in the NIH HEAL Initiative (https:\u002F\u002Fheal.nih.gov\u002F).",[28],"Healthy Controls","NOT_YET_RECRUITING","2026-08-19",{"date":32,"type":33},"2026-08-20","ACTUAL",{"date":35,"type":22},"2026-08-15",{"date":37,"type":22},"2031-12-30",{"name":39,"class":40},"Virginia Commonwealth University","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":41},"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":50,"type":22},40,[52],"NA","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.",[55],"Alveolar Bone Loss",[57,58,59],"Dental Implant","Alveolar Ridge Preservation (ARP)","Maxilla","RECRUITING",{"date":32,"type":33},{"date":63,"type":33},"2026-06-18",{"date":65,"type":22},"2028-04",{"name":39,"class":40},{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":12,"sex":17,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":41},"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).","13 Years","17 Years",{"count":76,"type":22},45,[52],"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.",[80],"Prevention",[82,83,84],"Firearm injury prevention","community based programs","youth advisory board",{"date":32,"type":33},{"date":87,"type":22},"2026-09",{"date":89,"type":22},"2027-01",{"name":39,"class":40},{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":99,"studyType":100,"phases":4,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":41},"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":21,"type":22},"24 Months","OBSERVATIONAL","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.",[103,104],"BK Virus Infection","Kidney Transplant; Complications",[106,107],"Immune Registry","BK in Kidney Transplant Recipients","2026-08-18",{"date":32,"type":33},{"date":111,"type":33},"2024-05-29",{"date":113,"type":22},"2027-07",{"name":39,"class":40},{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":124,"briefSummary":126,"conditions":127,"keywords":130,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100572039","phase-2-addition-of-antibiotics-to-upfront-treatment-regimen-for-colorectal-cancer-100572039","NCT06728072","Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer","Pilot Study Evaluating Microbiome Modulation Therapy (MBMT) With Ciprofloxacin, Metronidazole, and Aspirin in Addition to Standard of Care Chemotherapy in Patients Undergoing First-Line Therapy for Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Diagnosis of stage IV colorectal cancer\n* Measurable disease by Response evaluation criteria in solid tumors (RECIST) 1.1 criteria\n* Planned first-line treatment with a 5FU-based doublet chemotherapy regimen for colon cancer, specifics of the regimen at the discretion of the treating physician Note: Patients who have received adjuvant therapy \\>6 months prior are eligible\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2\n* Absolute neutrophil count (ANC) ≥1,500 cells\u002FμL\n* Platelet count ≥100,000 cells\u002FμL\n* Hemoglobin ≥8 g\u002FdL Note: The use of transfusion or other intervention to achieve hemoglobin ≥8 g\u002FdL is acceptable.\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) Note: Patients with documented liver metastases: AST and ALT ≤5 × ULN\n* Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥40 mL\u002Fmin using the Cockcroft-Gault equation: (140 - age) × body weight\u002Fplasma creatinine × 72 (× 0.85 if female)\n* Radiographically measurable disease by RECIST 1.1\n* Nonpregnant and not actively breastfeeding\n* Sexually active patients of childbearing potential and their partners must agree to use medically acceptable form of contraception, per treating investigator, throughout the study Patients should continue to use medically acceptable methods of contraception after study treatment ends, following the guidance for their specific chemotherapy regimen.\n\nChildbearing potential excludes:\n\nAge \\> 50 years and naturally amenorrhoeic for \\> 1 year OR previous hysterectomy or bilateral salpingo-oophorectomy\n\n* Patients on a pre-existing daily aspirin regimen may participate in the study without interrupting this regimen.\n* Patients with a contraindication to aspirin may participate in the study. These patients will not be required to take aspirin as part of the study treatment.\n\nExclusion Criteria:\n\n* Total colectomy\n* Diagnosed with Cockayne Syndrome\n* Using disulfiram, tizanidine, or theophylline and unable to stop taking these medications for the length of the microbiome modulation therapy\n* On methotrexate doses of 15 mg\u002Fweek or more\n* History of allergic reaction to ciprofloxacin, metronidazole, or aspirin\n* Fuss course of antibiotics in the 30 days before chemotherapy start Note: Full course is defined as ≥5 doses with an intent to treat a defined infection. Use of antibiotics intended for prophylaxis at the time of surgery is allowed\n* Corrected QT interval (QTc) \\>480 on baseline ECG\n* Diagnosed with a malabsorptive syndrome\n* Inability to swallow tablets",{"count":123,"type":22},97,[125],"PHASE2","This is a 2-arm, noncomparative phase 2 trial designed to evaluate treatment outcomes with or without the addition of ciprofloxacin, metronidazole, and aspirin to first-line chemotherapy for patients with stage IV colorectal cancer (CRC).",[128,129],"Colorectal Cancer","CRC",[128,129],"2026-08-14",{"date":108,"type":33},{"date":134,"type":33},"2025-03-07",{"date":136,"type":22},"2035-07-01",{"name":39,"class":40},2,{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":17,"minAge":147,"maxAge":74,"enrollmentInfo":148,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":150,"conditions":151,"keywords":159,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":41},"100652345","bedside-cranial-ultrasound-for-risk-stratified-imaging-in-pediatric-acute-brain-injury-100652345","NCT07772323","Bedside Cranial Ultrasound for Risk-Stratified Imaging in Pediatric Acute Brain Injury","Bedside Cranial Point-of-Care Ultrasound (cPOCUS) for Risk-Stratified Imaging in Pediatric Acute Brain Injury: A Prospective Diagnostic-Accuracy and Longitudinal Biomarker Cohort Study (CUPID-Peds)","CUPID-Peds","Inclusion Criteria:\n\n* Children 2 to 17 years of age\n* Undergoing a clinically indicated (standard-of-care) head CT for suspected acute brain injury (including trauma, headache with neurologic findings, altered mental status, focal deficit, seizure, post-cardiac-arrest, oncologic neurologic emergency, or intracranial infection)\n* Seen in the pediatric Emergency Department or Pediatric Intensive Care Unit at the Children's Hospital of Richmond at VCU (CHoR-VCU)\n* Consent obtainable from a legally authorized representative (LAR)\n* Cranial ultrasound feasible within the protocol time window (within 6 hours of head CT)\n\nExclusion Criteria:\n\n* Open skull fracture\n* Prior hemicraniectomy\n* Cranial surgical defect at the insonation site\n* Anticipated transition to comfort-only care\n* Any clinical condition in which cranial ultrasound would delay a time-critical intervention","2 Years",{"count":149,"type":22},220,"Acute brain injury (ABI) is a leading cause of death and long-term disability in children. Diagnosis depends on fast neuroimaging, and head computed tomography (CT) is the bedside reference standard despite exposing the developing brain to ionizing radiation. A safe, portable, radiation-free bedside tool is needed to help decide which children need a head CT, to speed CT when injury is present, and to safely monitor injured children between scans. This study evaluates B-mode cranial point-of-care ultrasound (cPOCUS) performed through the temporal (and frontal) bone windows in children undergoing a clinically indicated head CT in the pediatric emergency department (ED) and pediatric intensive care unit (PICU). Children's thin skulls provide adequate acoustic windows in more than 95% of cases. cPOCUS is acquired by trained research scanners within 6 hours of head CT and interpreted offline by two blinded expert readers; the radiology CT report is the diagnostic gold standard. This is a prospective observational study; cPOCUS results are not returned to the clinical team in real time and do not change clinical care.",[152,153,154,155,156,157,158],"Acute Brain Injury","Traumatic Brain Injury","Intracranial Hemorrhage","Hydrocephalus","Stroke","Brain Neoplasm","Hypoxia-Ischemia, Brain",[160,161,162,163,164,165,166,167,168,169],"cranial ultrasound","point-of-care ultrasound","cPOCUS","transcranial B-mode ultrasound","pediatric neuroimaging","head CT","midline shift","diagnostic accuracy","radiation reduction","neurocritical care","2026-08-13",{"date":30,"type":33},{"date":173,"type":22},"2026-11-30",{"date":175,"type":22},"2028-11-30",{"name":39,"class":40},{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":17,"minAge":184,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":189,"conditions":190,"keywords":193,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":41},"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":187,"type":22},18,[52],"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.",[191,192],"Self-Injurious Behavior","Autism Spectrum Disorder",[194,195,196,197,198],"Apollo Neuro Device","Sensory Responsivity","Autonomic Regulation","Wearable Device","Vibrotactile Stimulation",{"date":200,"type":33},"2026-08-17",{"date":202,"type":22},"2026-12",{"date":204,"type":22},"2027-11",{"name":39,"class":40},{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":212,"targetDuration":214,"studyType":100,"phases":4,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":222,"leadSponsor":224,"locationsCount":41},"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":213,"type":22},1000,"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.",[217],"Amyloidosis, Hereditary","2026-08-10",{"date":220,"type":33},"2026-08-12",{"date":87,"type":22},{"date":223,"type":22},"2030-12-01",{"name":39,"class":40},{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":23,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":41},"100500716","neuroscience-informed-treatment-to-remotely-target-reward-mechanisms-in-post-acute-anorexia-nervosa-100500716","NCT05799872","Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa","Inclusion Criteria:\n\n1. Age \\> or = 18 years old\n2. Ability to read and speak in English\n3. DSM-5 diagnosis of AN or atypical AN at admission to higher-level care\n4. In higher-level care discharging to outpatient care or discharged to outpatient care within the past 3 months\n5. Current BMI \\> or = 18.5 kg\u002Fm2 (or will be by time of discharge)\n6. BMI increase of \\> or = 0.5 kg\u002Fm2 while in higher-level care\n7. Ability to designate and sign a release of information for a primary physical or mental health provider for study duration\n8. Willingness to participate in weekly assessments (e.g., weight monitoring) and audio or video recording of study therapy sessions for study duration\n9. Access to a smartphone and\u002For computer permitting engagement in remote therapy and assessment.\n\nExclusion Criteria:\n\n1. Medical instability for outpatient care;\n2. Pregnancy\n3. Lifetime DSM-5 primary psychotic or bipolar-I disorder\n4. Current DSM-5 substance use disorder\n5. Enrollment in outpatient therapy with highly overlapping content to PAT-AN",{"count":232,"type":22},90,[52],"The investigators will recruit individuals with broadly-defined AN (n = 80) who are currently in or have recently participated in higher-level eating disorder treatment (e.g., residential, partial hospitalization\u002Fday treatment, intensive outpatient treatment). Interested participants will sign consent, complete eligibility assessments, and will be randomized to receive Positive Affect Treatment for Anorexia Nervosa (PAT-AN) or Psychoeducation and Behavioral Therapy (PBT) through teletherapy shortly following discharge from higher level of care. Participants can participate in most other forms of outpatient treatment while receiving the research intervention. Participants will engage in 24 weeks of PAT-AN or PBT starting in the first 3 months post-discharge. At each session, the investigators will complete brief measures assessing treatment acceptability, affect, and eating disorder symptoms. Participants will also complete an assessment battery of self-report, EMA, and neurocognitive measures evaluating primary outcomes (BMI; eating disorder symptoms), secondary outcomes (depression, anxiety, and suicidality), and presumed treatment mechanisms at baseline, end of treatment (EOT), and 3-month follow-up (FU). All assessments will be remotely delivered via HIPAA-compliant platforms.",[236],"Anorexia Nervosa",{"date":238,"type":33},"2026-08-11",{"date":240,"type":33},"2023-12-06",{"date":242,"type":22},"2026-08-31",{"name":39,"class":40},{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":17,"minAge":214,"maxAge":74,"enrollmentInfo":251,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":253,"conditions":254,"keywords":258,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":271},"100573561","trial-readiness-and-endpoint-assessment-in-pediatric-myotonic-dystrophy-extension-100573561","NCT06747884","Trial Readiness and Endpoint Assessment in Pediatric Myotonic Dystrophy Extension","TREAT-EXT","Inclusion Criteria (Congenital Myotonic Dystrophy Group):\n\n* Age 5-17 years, 11 months at enrollment. Lower age limit not applicable for participants who have completed ASPIRE-DM1 protocol. Upper age limit not applicable for participants who previously participated in TREAT-01-001 (TREAT-CDM) study\n* A diagnosis of CDM, 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* Written, voluntary informed consent must be obtained before any study related procedures are conducted.\n\nInclusion Criteria (Childhood Myotonic Dystrophy Group):\n\n* Age 3-17 years, 11 months at enrollment. Upper age limit not applicable for participants who previously participated in TREAT-01-001 (TREAT-CDM) study.\n* A diagnosis of ChDM, defined as: children having cognitive deficits, muscle weakness, myotonia that developed after age 1 and prior to age 10 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* Written, voluntary informed consent must be obtained before any study related procedures are conducted.\n\nExclusion Criteria:\n\n* Any other non-DM1 illness that would interfere with the ability to undergo safe testing or would affect the interpretation of the results, in the opinion of the site investigator\n* Significant trauma within the past month\n* Internal metal or devices (exclusion for DEXA component)\n* Use of anticoagulants, such as warfarin or a direct oral anticoagulant (e.g., dabigatran) due to the increased risk of bleeding with biopsy\n* Platelet count \\\u003C50,000\n* History of a bleeding disorder\n* Participation in a clinical trial involving an investigational product\n* History of adverse reaction to lidocaine (if participating in muscle biopsy)",{"count":252,"type":22},200,"This is a natural history study to improve the types of assessments and biological samples that will be used in clinical drug trials in both congenital myotonic dystrophy and childhood myotonic dystrophy.",[255,256,257],"Congenital Myotonic Dystrophy","Childhood Myotonic Dystrophy","Myotonic Dystrophy",[259,256,255,257,260,261,262,249,263],"DM1","Myotonia","Dystrophy Myotonic","DMCRN","TREAT CDM","2026-08-07",{"date":238,"type":33},{"date":267,"type":33},"2025-06-06",{"date":269,"type":22},"2030-06",{"name":39,"class":40},4,{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":279,"enrollmentInfo":280,"targetDuration":281,"studyType":100,"phases":4,"briefSummary":282,"conditions":283,"keywords":289,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":41},"100645776","establishing-biomarkers-and-clinical-endpoints-in-myotonic-dystrophy-type-1-end-dm1-extension-100645776","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.","70 Years",{"count":213,"type":22},"4 Years","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.",[259,257,284,285,286,287,288],"Myotonic Dystrophy 1","Myotonic Dystrophy Type 1","Myotonic Dystrophy Type-1","Myotonic Dystrophy, Type 1 (DM1)","Myotonic Muscular Dystrophy",[259,277,290,285,291,292,293,294,295,260,262,296],"END-DM1 Extension","Steinert's Disease","Muscular Dystrophy","Neuromuscular Disease","DMPK","Natural History","Myotonic Dystrophy Clinical Research Network","2026-08-05",{"date":299,"type":33},"2026-08-06",{"date":301,"type":22},"2026-08",{"date":303,"type":22},"2032-12",{"name":39,"class":40},{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":17,"minAge":312,"maxAge":279,"enrollmentInfo":313,"targetDuration":4,"studyType":23,"phases":314,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":318,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":322,"locationsCount":41},"100507376","transdermal-rotigotine-as-adjunct-to-behavioral-therapy-for-cocaine-use-disorder-100507376","NCT05886582","Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder","Phase 2a Double-Blind Placebo-Controlled Trial of Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder","Inclusion Criteria:\n\n* Male or female subjects between 25 and 70 years of age.\n* Meet current DSM-5 criteria for Cocaine Use Disorder (CocUD), moderate or severe\n* Able to understand and comply with study procedures\n* Have positive urine result for cocaine metabolite benzoylecgonine (BE) during at least one screening visit (out of up to three visits, depending on participants' preference) AND\u002FOR self-report of recent cocaine use (approximately past 30 days).\n* Have hematology and chemistry laboratory tests that are within normal limits, except that liver function tests must be no more than 2x of the upper limit of normal (if any elevation is above the limit - must be judged by the study physician to be clinically insignificant).\n* No clinically significant abnormalities on baseline ECG.\n* Be able to demonstrate an understanding of study procedures and follow instructions including behavioral laboratory and fMRI testing.\n* Women must either be unable to conceive (i.e., surgically sterilized, sterile, or postmenopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device with spermicide, or condoms). Men will be advised to use condoms. All females must provide negative pregnancy urine tests before study entry, at each visit during the study, and the end of study participation.\n* Body Mass Index (BMI) between 18-45kg\u002FM2 and weight of at least 50kg at screening\n\nExclusion Criteria:\n\n* Have concurrent secondary DSM-5 diagnosis of any psychoactive substance use disorder other than cocaine, alcohol, methamphetamine, nicotine, opioid, or marijuana use disorder.\n* Have a DSM-5 axis I psychiatric disorder other than substance use disorder, including but not limited to Bipolar I Disorder, Schizophrenia, or other psychotic disorder that require treatment with antipsychotics, or a neurological disorder requiring ongoing treatment and\u002For making study participation unsafe. Comorbid PTSD, Generalized Anxiety Disorder and Major Depressive Disorder will be allowed.\n* Consistent and regular (as opposed to intermittent, infrequent, or as needed) use of medications contraindicated for concurrent use along with RTG, or would confound the mechanism of RTG action and data interpretation. These include DA antagonists such as antipsychotic medications (especially neuroleptics) or metoclopramide.\n* Subjects with evidence or history of any clinically significant medical disorder including biliary obstruction, clinically significant hepatic disease, severe cardiovascular or pulmonary disease, bronchial asthma, renal, or endocrine disease. However, controlled hypertension, controlled hypothyroidism, and cancer in remission over 5 years will not be excluded.\n* Have a history of seizures (excluding childhood febrile seizures) or loss of consciousness (e.g. from traumatic brain injury) for more than 30 minutes.\n* Have significant current suicidal or homicidal ideation or a suicide attempt within the past 6 months, based on the Columbia Suicide Severity Rating Scale (C-SSRS).\n* Be HIV positive by self-report or history.\n* Be pregnant or nursing or not using a reliable form of contraception if able to conceive. All females must provide negative pregnancy urine tests before study entry, at each visit during the study, and the end of study participation\n* Have any other illness, or condition, which in the opinion of the clinical co-investigator (Arias) would preclude safe and\u002For successful completion of the study.\n* Be allergic to rotigotine.\n* Have taken any investigational drug within 45 days prior to baseline\n* Demonstrate intolerance to, poor adherence to, or extreme skin irritation by daily application of known placebo \"practice\" skin patches during the screening phase\n* Current\u002Fpending criminal charges that may result in incarceration within the next 60 days\n* Self-report of allergic or other reactions to sulfites (e.g. in foods)","25 Years",{"count":50,"type":22},[125],"This is a randomized, double-blind, placebo-controlled phase 2b pilot clinical trial to determine whether non-ergoline D3\u002FD2\u002FD1 dopamine (DA) receptor agonist rotigotine (RTG), in combination with treatment as usual, including individual or group behavioral therapy can a) reduce cocaine use and also b) increase brain activity in frontocortical areas of the brain, and, as a reflection of that - improve top-down cognitive control in persons with cocaine use disorder (CocUD).\n\nRotigotine is a marketed non-ergoline D3\u002FD2\u002FD1 DA agonist (RTG, Neupro®) in the form of a transdermal patch that is FDA-approved for the treatment of Parkinson's Disease and Restless Legs Syndrome. The premise of this project was based on apparent beneficial effects of RTG in a different human population characterized by executive function (EF) impairment. In light of the deficits in EF common in persons with CocUD, RTG may hold the potential for cognitive improvement in persons with CocUD who are in treatment as usual to both attend to and retain psychoeducation concepts better. In addition, rotigotine may help these individuals in recovery maintain goals better, where goal maintenance is a crucial integrative product of successful EF.",[317],"Substance-Related Disorders",{"date":218,"type":33},{"date":320,"type":33},"2023-09-11",{"date":173,"type":22},{"name":39,"class":40},{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":330,"targetDuration":4,"studyType":23,"phases":331,"briefSummary":332,"conditions":333,"keywords":335,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":41},"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":50,"type":22},[52],"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.",[334],"Substance Use Disorders",[336,337,338],"tES\u002FTMA: Transcranial electrical stimulation","CT: Cognitive Training","DASES: Drug Abstinence Self-Efficacy Scale","2026-08-04",{"date":264,"type":33},{"date":342,"type":33},"2026-07-23",{"date":344,"type":22},"2027-04-30",{"name":39,"class":40},{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":23,"phases":355,"briefSummary":356,"conditions":357,"keywords":360,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":367,"leadSponsor":368,"locationsCount":41},"100584680","patient-reported-outcomes-of-donor-site-healing-using-different-palatal-protection-techniques-100584680","NCT06892496","Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques","Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques: a Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* At least 18 years of age\n* Healthy or Mild controlled systemic diseases with no functional limitations (ASA I or ASA II)\n* Sites with 1 to 3 teeth or implants requiring soft-tissue grafting\n* Minimum palatal thickness of 2 mm\n* Willing to participate and sign an informed consent\n\nExclusion Criteria:\n\n* Patients with systemic conditions that could impair wound healing (i.e. diabetes, immunosuppressive, chemotherapy, etc.)\n* Pregnant patients\n* Patients with bleeding disorders or taking anticoagulants\n* Smokers\n* Patients with a history of palatal graft harvesting",{"count":354,"type":22},56,[52],"This study has been initiated to evaluate the question, \"What is the best way to protect the palate after a gum graft is removed?\" The overall objective is to determine if there is a difference in PROMs of donor site healing using different palatal post-operative protection techniques.",[358,359],"Mucosal Erosion","Gingival Recession",[361,362,363,364],"soft tissue graft","pain","wound healing","CPS: Chairside polymer stent",{"date":297,"type":33},{"date":134,"type":33},{"date":89,"type":22},{"name":39,"class":40},{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":375,"enrollmentInfo":376,"targetDuration":4,"studyType":23,"phases":378,"briefSummary":379,"conditions":380,"keywords":382,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":384,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":41},"100582307","a-single-session-intervention-adaptation-of-the-habit-framework-for-the-prevention-of-eating-disorders-100582307","NCT06861608","A Single-session Intervention Adaptation of the Habit Framework for the Prevention of Eating Disorders","Inclusion Criteria:\n\n* EAT-26 score ≥ 20 ( EAT-26, participants will meet the \"referral criteria\" which includes a score of 20 or more or meeting frequency criteria on bingeing, purging, laxative\u002Fdiuretic use, and\u002For exercise.)\n* English-language fluency, self-reported3\n* Access to a phone, tablet, or computer\n\nExclusion Criteria:\n\n* Failure to correctly complete one of the attention checks in the survey prior to the intervention\n* Failure to correctly complete both anagram tasks in the survey prior to the intervention\n* Completion of the screening survey or pre-intervention surveys in an improbably fast time","22 Years",{"count":377,"type":22},160,[52],"The purpose of this proposal is to launch the first trial of a single-session intervention (SSI) specifically for the prevention of eating disorders (EDs).",[381],"Eating Disorder Not Otherwise Specified",[383],"prevention of eating disorders",{"date":297,"type":33},{"date":386,"type":33},"2025-01-15",{"date":388,"type":22},"2026-12-31",{"name":39,"class":40},{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":396,"enrollmentInfo":397,"targetDuration":4,"studyType":23,"phases":399,"briefSummary":400,"conditions":401,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":403,"startDateStruct":404,"completionDateStruct":405,"leadSponsor":407,"locationsCount":41},"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":398,"type":22},12,[52],"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.",[402],"Postural Tachycardia Syndrome",{"date":297,"type":33},{"date":301,"type":22},{"date":406,"type":22},"2028-12",{"name":39,"class":40},{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":414,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":417,"briefSummary":418,"conditions":419,"keywords":421,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":41},"100622755","assessing-ambulatory-and-non-ambulatory-community-mobility-in-people-with-lower-limb-amputation-100622755","NCT07387744","Assessing Ambulatory and Non-ambulatory Community Mobility in People With Lower Limb Amputation","Inclusion Criteria:\n\n* Unilateral or bilateral major lower limb amputation (e.g., proximal to or through the ankle joint)\n* \\>6 months since LLA Fitted with a prosthetic limb\n* Fitted with a prosthetic limb\n* Use a wheelchair or scooter for mobility for part of a day at least once per week\n\nExclusion Criteria:\n\n* Unstable heart condition (including unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, hypertension, and acute pericarditis)\n* Acute systemic infection Prisoner or institutionalized such that self-determined mobility is restricted\n* Prisoner or institutionalized such that self-determined mobility is restricted\n* Decisionally challenged individuals (Modified Telephone Interview for Cognitive Status score ≤24)\n* Undergoing active cancer treatment\n* Participating in prosthetic rehabilitation\n* Clinical discretion of the principal investigator to exclude patients who are determined to be unsafe and\u002For inappropriate to participate in the protocol\n* Inability to communicate verbally in English","85 Years",{"count":416,"type":22},50,[52],"Mobility is a fundamental aspect of daily life, enabling individuals to participate in social, occupational, and recreational activities. Community mobility, defined as movement in environments outside the home, is particularly important for quality-of-life. Following lower limb amputation (LLA), mobility limitations are common and persistent. With rehabilitation and prosthetic training, many regain the ability to ambulate but results vary as only 25 - 58% of patients regain ambulatory ability and less than half of those who become ambulatory achieve sufficient ability to walk in community settings. As a result, \\~40% of people with LLA are ambulatory but also use wheeled mobility (e.g., wheelchair, scooter) for some or all of their community mobility tasks. To date, the complementary role of wheeled and ambulatory mobility in maximizing community mobility has been overlooked, with clinical research overwhelmingly focused on assessing and improving ambulatory ability despite its impracticality for many community settings.",[420],"Amputation",[422,423],"Lower Limb Amputation (LLA)","Global Positioning System (GPS)",{"date":425,"type":33},"2026-07-27",{"date":427,"type":33},"2026-04-21",{"date":429,"type":22},"2027-08",{"name":39,"class":40},{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":23,"phases":439,"briefSummary":440,"conditions":441,"keywords":445,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":41},"100647625","phase-2-metronomic-decitabine-cedazuridine-and-venetoclax-in-rr-aml-hr-mds-hrap-mpn-100647625","NCT07710534","Metronomic Decitabine-Cedazuridine and Venetoclax in R\u002FR AML, HR-MDS, HR\u002FAP MPN","Metronomic Decitabine-Cedazuridine and Venetoclax in Relapsed\u002FRefractory Acute Myeloid Leukemia R\u002FR AML), High Risk Myelodysplastic Syndrome (HR-MDS), and High-Risk Myeloproliferative Neoplasms (HR\u002FAP MPN)","Inclusion Criteria:\n\n* Age ≥18 years at time of enrollment\n* Diagnosis of one of the following by World Health Organization (WHO) International Consensus Classification (ICC) criteria as determined by local assessment:\n\n  * Relapsed\u002F refractory acute myeloid leukemia (R\u002FR AML) as defined by ≥5% marrow blasts or unequivocal, measurable extramedullary disease\n  * High Risk Myelodysplastic Syndrome (HR-MDS) (high\u002Fvery high risk MDS by Revised International Prognostic Scoring System (IPSS-R) or Molecular International Prognostic Scoring System (IPSS-M)\n  * high-risk accelerated-phase myeloproliferative neoplasm (HR\u002FAP-MPN) defined by ≥10% blasts in blood or bone marrow\n* Eastern Cooperative Oncology Group (ECOG) Performance status 0-3\n* White blood cell (WBC) count ≤25 × 109\u002FLiter (L) (cytoreduction with hydroxyurea or steroids is allowed to achieve this)\n* Aspartate Aminotransferase (AST)\u002F Alanine Aminotransferase (ALT) ≤3 × upper limit of normal (ULN) (≤5 × ULN if due to leukemic involvement)\n* Total bilirubin ≤2 × ULN (unless the elevation is due to Gilbert's or hemolysis)\n* Creatinine clearance ≥ 30 milliliters \u002F minute (mL\u002Fmin)\n* Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of non-childbearing potential are those who have had a hysterectomy or bilateral oophorectomy, or who have completed menopause (no menses for at least one year and age ≥65 or follicle-stimulating hormone levels in the menopausal range).\n* Subjects and their partners with reproductive potential must agree to use effective contraceptive measures during the study and for 3 months after the last dose of study treatment. Effective contraception includes methods such as oral contraceptives or double-barrier method.\n\nExclusion Criteria:\n\n* Prior use of hypomethylating agent and venetoclax in combination (Note, use of hypomethylating agent and\u002For venetoclax separately in alternative combinations with other drugs is allowed)\n* Inability to tolerate oral therapies, or medical co-morbidities that significantly impact parenteral absorption\n* Acute promyelocytic leukemia myeloproliferative neoplasm (MPN) with the Philadelphia chromosome translocation (BCR:ABL) translocation\n* Clinically significant cardiovascular disease as defined by unstable angina\n* New York Heart Association class III\u002FIV congestive heart failure\n* Treatment with any investigational drug or therapy within 2 weeks of study treatment or 5 half-lives before the first dose of study treatment, whichever is shorter\n* Known hypersensitivity to azacitidine, venetoclax, decitabine or cedazuridine\n* Cytotoxic chemotherapy or prior azacitidine or decitabine within 2 weeks of first dose of study treatment\n* Concurrent use of AML\u002FMDS\u002FMPN therapies including lenalidomide, erythropoietin, luspatercept, cytotoxic chemotherapies, targeted agents, etc Note: hydroxyurea is allowed in Cycle 1 if necessary for cytoreduction and\u002For cytarabine not exceeding a maximum dose of 1 gram per meter squared (g\u002Fm2) in Cycle 1 is also allowed for cytoreduction\n* Uncontrolled intercurrent illness or infection (those with controlled HIV, hepatitis, or other chronic infections are eligible)\n* Untreated central nervous system disease\n* Pregnancy or breastfeeding\n* Other active malignancy requiring systemic therapy during duration of trial or otherwise would confound endpoints (eg, second malignancy present where survival is expected to be less than 6 months)",{"count":50,"type":22},[125],"This is a single-center randomized phase 2 open-label clinical trial.",[442,443,444],"Relapsed \u002F Refractory AML","High Risk Myelodysplastic Syndrome","High Risk Myeloproliferative Neoplasms",[442,443,444],"2026-07-13",{"date":448,"type":33},"2026-07-17",{"date":450,"type":22},"2026-09-30",{"date":452,"type":22},"2033-12-31",{"name":39,"class":40},{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":463,"conditions":464,"keywords":470,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":488,"leadSponsor":490,"locationsCount":41},"100593973","transcranial-doppler-evaluation-after-endovascular-thrombectomy-for-acute-ischemic-stroke-precise-tcd-100593973","NCT07013396","Transcranial Doppler Evaluation After Endovascular Thrombectomy for Acute Ischemic Stroke (PRECISE-TCD)","A Prospective Evaluation of Clinical Outcomes in Acute Ischemic Stroke After Endovascular Treatment Using Transcranial Doppler (PRECISE-TCD)","Inclusion Criteria:\n\n* Anterior circulation large vessel occlusion, including ACA, MCA, or ICA stroke, treated with endovascular thrombectomy, including tandem occlusions\n* Age ≥ 18 years\n* Ability to detect an adequate acoustic window via TCD.\n\nExclusion Criteria:\n\n* Inadequate acoustic windows defined as lack of bilateral MCA signal at standard depths.\n* Pregnancy\n* Incarceration",{"count":462,"type":22},100,"Endovascular thrombectomy (EVT) improves outcomes in acute ischemic stroke caused by large vessel occlusion. Despite successful recanalization, early neurological deterioration (END) remains frequent and is associated with poor outcomes. Transcranial Doppler (TCD) provides noninvasive, real-time assessment of cerebral blood flow velocities and may identify hemodynamic patterns associated with deterioration after EVT. PRECISE-TCD is a prospective, single-center observational study enrolling 180-300 patients undergoing EVT for anterior circulation large vessel occlusion at a tertiary academic medical center. Serial TCD examinations are performed immediately after EVT, daily for 72 hours, and as close as possible to early neurological deterioration events or clinically indicated head CT within 72 hours. The primary outcome is the association between TCD-derived hemodynamic parameters and END within 72 hours. Secondary outcomes include NIHSS at 24 hours and discharge, discharge disposition, and modified Rankin Scale at 90 days.",[465,466,467,468,469],"Anterior Cerebral Artery Syndrome","Anterior Cerebral Artery Stroke","Acute Ischemic Stroke","Cardioembolic Stroke","Vasogenic Cerebral Edema",[471,472,473,474,475,476,477,478,479,480,481,482,483,484],"systolic blood pressure","Transcranial Doppler","Large Vessel Occlusion","mean flow velocity","early neurological deterioration","cerebral hemodynamics","endovascular thrombectomy","cerebral autoregulation","blood pressure management","collateral circulation","pulsatility index","peak systolic velocity","end-diastolic velocity","Modified Rankin Scale",{"date":486,"type":33},"2026-07-16",{"date":301,"type":22},{"date":489,"type":22},"2029-08",{"name":39,"class":40},{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":23,"phases":500,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":41},"100590359","phase-1-study-to-evaluate-the-feasibility-of-twice-daily-use-of-topical-azelaic-acid-in-breast-cancer-patients-undergoing-radiation-100590359","NCT06966388","Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation","Pilot Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation","Inclusion Criteria:\n\nAge ≥ 18 years\n\n* Self-reports as Black, Asian, Hispanic\u002FLatin, ethnically originating from the Mediterranean rim or Pacific rim, or she\u002Fhe tans easily in the sun\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (Appendix 1, Section 18)\n* Attestation by the patient that she\u002Fhe is not pregnant, lactating, or planning to become pregnant, or planning to father a baby during the study period\n* Histologic confirmation of breast malignancy (with TNM staging) If the patient did not receive adjuvant chemotherapy, adjuvant radiation must start within 180 days of lumpectomy or mastectomy. If the patient received adjuvant chemotherapy, adjuvant radiation should start within 60 days of the last dose of chemotherapy\n* Treatment plan includes one of the following:\n\n  * Conventionally fractionated whole breast radiation (45-50 Gray in 25 fractions)\n  * Moderately hypofractionated whole breast radiation (42.56 Gray in 16 fractions or 40 Gray in 15 fractions)\n  * Conventionally fractionated chest wall radiation (45-50 Gray in 25 fractions)\n  * Partial breast radiation (42.56 Gray in 16 fractions, 40 Gray in 15 fractions, or 30 Gray in 5 fractions) if using 3D conformal radiation or if the tumor is located close to the skin surface\n* Treatment of the regional lymph nodes, a tumor bed boost (4-8 fractions), and use of tissue-equivalent bolus on the chest wall may be included at the discretion of the treating physician.\n* Radiation will be photon-based. Note: If the patient receives a boost, photons and\u002For electrons may be used at the discretion of the treating physician.\n\nExclusion Criteria:\n\n* Prior radiotherapy to any portion of the planned treatment site\n* Current inflammatory breast cancer or gross dermal involvement at initiation of radiotherapy\n* Concomitant immunotherapy or cytotoxic chemotherapy. Concomitant HER2 directed therapy or concomitant endocrine therapy is allowed\n* Active rash or dermatitis within the treatment field, or a history of any rash or dermatologic condition within the treatment field\n* Active collagen vascular diseases (ie lupus erythematosus, scleroderma, dermatomyositis)\n* History of organ transplant or bone marrow transplant\n* History of hypersensitivity or allergic reaction to any ingredients in the topical azelaic acid formulation\n* Has used within 28 days prior to baseline:\n\n  * topical retinoids to the breast\n  * oral retinoids\n  * systemic (oral or injectable) antibiotics known to have an impact on the severity of skin rash or sun-sensitivity (eg, containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim)\n  * systemic corticosteroids or immunosuppressive drugs, except as part of standard chemotherapy treatment or used for an IV contrast allergy\n* Has used on treated breast within 2 weeks prior to baseline:\n\n  * topical corticosteroids\n  * topical antibiotics\n  * topical medications for skin rash (eg, metronidazole, azelaic acid)\n* Radiation therapy will be proton therapy or carbon therapy\n* External beam partial breast irradiation, brachytherapy partial breast irradiation, or intraoperative radiation are included in the treatment plan 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":499,"type":22},33,[25],"This pilot study will evaluate the feasibility of at least twice daily use of azelaic acid in breast cancer patients undergoing radiation treatment.",[503],"Breast Cancer",{"date":505,"type":33},"2026-07-14",{"date":507,"type":33},"2025-08-13",{"date":509,"type":22},"2027-11-30",{"name":39,"class":40},{"id":512,"slug":513,"hasResults":12,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":517,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":23,"phases":521,"briefSummary":522,"conditions":523,"keywords":527,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":534,"locationsCount":138},"100481396","phase-1-intestinal-microbiota-transplant-in-alcohol-associated-liver-disease-100481396","NCT05548452","Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease","Intestinal Microbiota Transplant in Alcohol-Associated Chronic Liver Disease and Cirrhosis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial","IMPACT","Inclusion Criteria:\n\n-\\>18 years of age\n\n* Advanced liver disease\n* Able to give written, informed consent\n* Alcohol as a cause of advanced liver disease\n* Continued sustained drinking\n* Having previously declined a referral to traditional AUD therapy services or having failed such treatments\n\nExclusion Criteria:\n\n* Lack of sustained drinking\n* Recent or current alcoholic hepatitis\n* Alcohol withdrawal symptoms\n* Clinically significant use of illicit drugs\n* Uncontrolled mood disorders or primary psychotic conditions\n* MELD score\\>17\n* Unclear diagnosis of chronic liver disease\n* Current hepatic encephalopathy on lactulose and\u002For rifaximin\n* WBC count\\\u003C1000\n* Non-elective hospitalization within last month\n* on dialysis\n* known untreated, in-situ luminal GI cancers\n* chronic intrinsic GI diseases (ulcerative colitis, Crohn's disease or microscopic colitis, eosinophilic gastroenteritis and celiac disease)\n* Dysphagia within 2 weeks\n* History of aspiration, gastroparesis, intestinal obstruction\n* Ongoing absorbable antibiotic use\n* Severe anaphylactic food allergy\n* allergy to ingredients Generally Recognized As Safe in the G3 capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil)\n* Adverse event attributable to prior IMT\n* ASA Class IV or V\n* Pregnant or nursing patients\n* acute illness or fever on the day of planned FMT\n* Immunosuppression\n* Other conditions which make patients are poor candidate for this study per investigator judgement",{"count":520,"type":22},80,[25,125],"The purpose of this research study is to test the safety, tolerability, and effectiveness of the capsules that contain bacteria from healthy individuals when used to treat alcohol craving and drinking.",[524,525,526],"Liver Disease; Alcohol-Related","Cirrhosis","Alcohol Use Disorder",[528,526,525,529],"Intestinal Microbiota Transplant","Chronic Liver Disease",{"date":505,"type":33},{"date":532,"type":33},"2022-11-21",{"date":204,"type":22},{"name":39,"class":40},{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":542,"targetDuration":4,"studyType":23,"phases":544,"briefSummary":545,"conditions":546,"keywords":548,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":41},"100647247","impact-of-food-assistance-on-treatment-adherence-and-clinical-outcomes-in-food-insecure-cancer-pts-100647247","NCT07706192","Impact of Food Assistance on Treatment Adherence and Clinical Outcomes in Food-Insecure Cancer Pts","Impact of Food Assistance on Treatment Adherence and Clinical Outcomes in Food-Insecure Cancer Patients Undergoing Active Treatment","Inclusion Criteria:\n\n* Adult patients (≥18 years old) with a current diagnosis of cancer\n* Patients attending outpatient services at the VCU Massey Comprehensive Cancer Center\n* Patients who are willing to participate and provide informed consent\n* Responding \"sometimes true\" or \"often true\" to at least one of the two validate Hunger Vital Sign Screening questions\n\nExclusion Criteria:\n\n* Patients who are unable to provide informed consent due to cognitive impairment or language barriers\n* Patients who are enrolled in other clinical trials that prohibit participation in additional research\n* Patients who do not consent to being included in the food insecurity registry\n* Patients with medical conditions other than cancer",{"count":543,"type":22},350,[52],"Prospective cohort and descriptive study aimed at identifying cancer patients experiencing food insecurity at Virginia Commonwealth University (VCU) Massey Comprehensive Cancer Center. The study will involve evaluating the impact of a food assistance intervention on treatment adherence and clinical outcomes among food-insecure patients on active treatment.",[547],"Treatment Adherence",[547,549,550],"Food Insecurity","Cancer Patients on Active Treatment","2026-07-09",{"date":553,"type":33},"2026-07-15",{"date":555,"type":33},"2026-07-06",{"date":557,"type":22},"2035-08-31",{"name":39,"class":40},{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":23,"phases":567,"briefSummary":568,"conditions":569,"keywords":574,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":41},"100591497","phase-2-effects-of-lemborexant-on-insomnia-and-its-relationship-to-mood-and-behavior-on-opioid-use-disorder-subjects-100591497","NCT06981195","Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects","Neurofunctional Phenotyping to Investigate the Role of the Orexin System at the Intersection of Opioid Use Disorder and Insomnia Among Women and Men Receiving Buprenorphine","Inclusion Criteria:\n\n1. Be 18 + years-of-age\n2. Meet current DSM-5 criteria for opioid use disorder (OUD) with at least moderate severity\n3. Receiving outpatient treatment for OUD with sublingual buprenorphine film\u002Ftablets ranging 8mg to 24mg or with extended-release injectable buprenorphine\n4. Stabilized on current buprenorphine dosage for at least 4 weeks without intention for dose change within next 3 months.\n5. Screening urine toxicology positive for buprenorphine and an appropriate norbuprenorphine level as determined by a study clinician\n6. A screening urine toxicology negative for non-prescribed substances (except cannabinoids) with a negative breath (or oral fluid) alcohol screen\n7. Screen positive for chronic insomnia on the Insomnia Symptom Questionnaire (ISQ)\n8. Have an Insomnia Severity Index score at screening and baseline of 13 or higher\n9. Have no clinically significant medical or psychiatric disorder or condition, based on physical exam and medical history performed by study clinician, that in the judgement of the investigator would prevent participation or heighten safety risks\n10. Understand the study procedures and provide written informed consent in English language\n11. Access to necessary resources for completing virtual surveys and monitoring (i.e., computer or smartphone, internet or cell service)\n\nExclusion Criteria:\n\n1. Current diagnosis of sleep-related breathing disorder, narcolepsy, somnambulism, or sleep paralysis\n2. A positive screen for sleep apnea by the following: Sleep Disorders Screening Battery (STOP-BAG \\>5) OR home sleep apnea test using WatchPAT with Apnea Hypopnea Index (AHI) with 3% drop in oxygen saturation \\> 10 OR \\>50% of respiratory events being central if AHI is between 5-10 OR Oxygen Desaturation \\\u003C 88% for \\> 10 minutes, OR oxygen desaturation index (ODI) using 3% drop in oxygen saturation \\> 10\n3. Currently receiving treatment for insomnia (behavioral or pharmacologic)\n4. Currently taking a medication to treat a sleep-related condition (e.g., zolpidem) or unable to discontinue over-the-counter drug or supplement used to treat sleep-related condition\n5. Currently taking benzodiazepines or other CNS active medications that may increase risk to the participant, per PI discretion (e.g., opioids other than buprenorphine, antipsychotics)\n6. Current DSM-5 diagnosis (any severity) of alcohol or drug use disorder (e.g., benzodiazepine, stimulant) with non-prescribed substance use within last 3 months; nicotine use disorder is not considered exclusionary\n7. Cannabis use \\> 3 days\u002Fweek\n8. Uncontrolled serious psychiatric disorder that would make study participation unsafe (such as Bipolar I Disorder, ADHD, Schizophrenia, schizoaffective disorders, major depressive disorder with psychotic features, or a neurological disorder).\n9. Uncontrolled neurological, cardiovascular, or pulmonary medical condition such as seizure disorder, recent myocardial infarction, stroke, hospitalization for chronic obstructive pulmonary disease\n10. Baseline ECG with clinically significant abnormal conduction or with QTc of greater than 450ms\n11. Significant current suicidal or homicidal ideation (C-SSRS \"yes\" answers on questions 4 or 5) or a history of suicide attempt within the past 6 months\n12. Any of the following lab abnormalities: ALT\u002FAST 2 or more times the upper limit of normal, Total bilirubin 2 or more times the upper limit of normal, Creatinine 1.5 or more times the upper limit of normal\n13. Pregnant or breastfeeding; Females who are having sex that includes penile penetration must be non-pregnant, non-lactating, and either be of non-childbearing potential (e.g., sterilized via hysterectomy, bilateral tubal ligation, or bilateral oophorectomy, or at least 1 year post-menopausal) or of childbearing potential, and agree to use an acceptable form of contraception (e.g., IUD, hormonal implant, hormonal patch\u002Fring\u002Fpill, condoms (male or female), etc.)\n14. Currently taking prescription or over-the counter drugs or dietary supplements known to significantly inhibit CYP3A4 (such as clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir); or CYP3A4 inducers (such as phenobarbital, phenytoin, rifampicin, St. John's Wort, and glucocorticoids)\n15. Currently taking lemborexant or any previous medically adverse reaction to lemborexant or other dual orexin receptor antagonists\n16. Currently incarcerated or pending incarceration",{"count":462,"type":22},[125],"The goal of this clinical trial is to learn about how certain medications used to treat insomnia (e.g., Lemborexant) impact sleep, mood, and behavior in men and women with Opioid Use Disorder who are taking prescribed buprenorphine. The main questions it aims to answer are:\n\n1. What is the effect of the study drug (lemborexant) on sleep outcomes?\n2. What is the effect of the study drug (lemborexant) on impulsive behavior (as measured by computer test performance)?\n3. What is the effect of the study drug (lemborexant) on mood and other behavior?\n\nResearchers will compare lemborexant to placebo (e.g., sugar pill) to see if participants assigned to 8 weeks of treatment with lemborexant have greater improvements on the measures listed above.\n\nParticipants will take the study medication (or placebo) each night for 8 weeks and be asked to come for a total of 23 study visits. Most of these visits will be very short (15-30 minutes). The longer visits will include the screening visit (about 2-3 hrs), baseline visit (about 2.5 hrs), and the post-medication visit (about 2 hrs). Study visits will include things like taking surveys about sleep, drug use, and mood, completing urine drug testing, checking vital signs (e.g., blood pressure), and completing interviews with the study staff. Participants will also be asked to provide two blood samples (one during screening and one after taking the medication). For three two-week periods, participants will be asked to wear a watch to track sleep at home, and to keep a log of sleep and wake times.",[570,571,572,573],"Opioid Use Disorder","Opioid Use","Insomnia","Orexin Antagonist",[575,576],"buprenorphine","lemborexant","2026-07-08",{"date":551,"type":33},{"date":580,"type":33},"2025-05-27",{"date":582,"type":22},"2029-07-30",{"name":39,"class":40},{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":588,"acronym":589,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":17,"minAge":591,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":23,"phases":594,"briefSummary":595,"conditions":596,"keywords":598,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":610,"locationsCount":41},"100520930","phase-1-the-effects-of-il-1-blockade-on-inotrope-sensitivity-in-patients-with-heart-failure-aid-heart-100520930","NCT06062966","The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART)","AID-HEART","Inclusion Criteria:\n\n* Primary diagnosis for the clinic visit is stage D heart failure being on chronic stable dose of inotrope therapy (dobutamine or milrinone for the previous 28 days)\n* Prior documentation of impaired left ventricular systolic function (ejection fraction \\\u003C50%) at most recent assessment by any imaging modality (within 12 months)\n* Stable dose of inotrope treatment without a recent hospitalization within the previous month\n* Age ≥21 years and willing\u002Fable to provide written informed consent\n* The patient is willing and able to comply with the protocol (i.e. self administration of the treatment, and exercise protocol).\n* Screening plasma C-reactive protein levels \\>2 mg\u002FL\n\nExclusion Criteria:\n\n* Concomitant clinically significant comorbidities including (but not limited to) acute coronary syndromes, uncontrolled hypertension or orthostatic hypotension, tachy- or brady-arrhythmias, acute or chronic pulmonary disease or neuromuscular disorders affecting respiration that would interfere with the execution, interpretation, or completion of the study\n* Recent (previous 3 months) or planned resynchronization therapy (CRT), or valve surgeries\n* Previous or planned implantation of left ventricular assist devices or heart transplant within the next 3 months\n* Recent (\\\u003C14 days) use of immunosuppressive or anti-inflammatory drugs (including oral corticosteroids at a dose of prednisone equivalent of 0.5 mg\u002Fkg\u002Fday but not including inhaled or low dose oral corticosteroids or non-steroidal anti-inflammatory drugs)\n* Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)\n* Active infection (of any type), including chronic\u002Frecurrent infectious disease (including HBV, HCV, and HIV\u002FAIDS) - but excluding HCV+ with undetectable plasma RNA\n* Prior (within the past 5 years) or current malignancy on targeted treatment - excluding carcinoma in situ \\[any location\\] or localized non-melanoma skin cancer\n* Stage V kidney disease or on renal-replacement therapy\n* Neutropenia (\\\u003C1,500\u002Fmm3 or \\\u003C1,000\u002Fmm3 in African-American patients)\n* Pregnancy or breastfeeding\n* Angina, hypertension, arrhythmias, electrocardiograph (ECG) changes, or other non-cardiac limitations that limit 6MWD obtained during the baseline testing\n* Hypersensitivity to anakinra or to E. coli derived products","21 Years",{"count":593,"type":22},20,[25],"End-stage heart failure (HF) is a progressive illness with a mortality rate similar to most advanced cancers.Roughly 5% of patients with HF have end-stage disease that is refractory to medical therapy (stage D heart failure). When patients reach this point in their disease, the only treatments known to prolong life are cardiac transplantation or left ventricular assist devices. In patients who do not qualify for these options, or elect a palliative approach, inotropes are frequently used to improve hemodynamics through an increase in cardiac output and reduction in filling pressures. While inotropes provide profound symptomatic relief, these benefits are accompanied by significant risks of progressive adverse cardiac remodeling, arrhythmias, and sudden death. There is, therefore, an urgent need to develop strategies to reduce the dose or duration of inotrope use in the management of patients with stage D of HF.",[597],"Heart Failure",[599,600,601,602,603,604],"Inotrope sensitivity","IL-1 Blockade","Subcutaneous (SC)","Hepatitis B Virus (HBV)","Hepatitis C Virus (HCV","6 Minute Walk Test (6MWT)",{"date":606,"type":33},"2026-07-10",{"date":608,"type":33},"2024-02-05",{"date":301,"type":22},{"name":39,"class":40},{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":615,"acronym":4,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":17,"minAge":617,"maxAge":591,"enrollmentInfo":618,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":620,"conditions":621,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":623,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":627,"locationsCount":41},"100510508","research-participation-with-transgender-and-gender-diverse-youth-100510508","NCT05927350","Research Participation With Transgender and Gender-Diverse Youth","Inclusion Criteria:\n\n* Gender identity different then sex assigned at birth\n* Between the ages 15-21 years\n\nExclusion Criteria:\n\n* Gender identity the same as their sex assigned at birth\n* Younger than 15 years of age, and older than 21 years of age","15 Years",{"count":619,"type":22},250,"Research has historically excluded the participation of transgender and gender-diverse people. The purpose of this research study is to find out about what goes into a transgender and gender-diverse youth's decision to participate in research. The results of this study will be used to improve access to research for transgender and gender-diverse youth and therefore, improve the representation of transgender and gender-diverse youth as research participants in research.",[622],"Transgender Persons",{"date":551,"type":33},{"date":625,"type":33},"2025-01-29",{"date":301,"type":22},{"name":39,"class":40},""]